EVOFEM BIOSCIENCES, INC., 10-Q filed on 11/13/2025
Quarterly Report
v3.25.3
Cover - $ / shares
 9 Months Ended
Sep. 30, 2025
Nov. 12, 2025
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Sep. 30, 2025  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2025  
Current Fiscal Year End Date --12-31  
Entity File Number 001-36754  
Entity Registrant Name EVOFEM BIOSCIENCES, INC.  
Entity Central Index Key 0001618835  
Entity Tax Identification Number 20-8527075  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 7770 Regents Road  
Entity Address, Address Line Two Suite 113-618  
Entity Address, City or Town San Diego  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 92122  
City Area Code (858)  
Local Phone Number 550-1900  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   126,685,925
Entity Listing, Par Value Per Share $ 0.0001  
v3.25.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Current assets:    
Cash and cash equivalents
Restricted cash 840 741
Trade accounts receivable, net 4,435 9,832
Inventories 1,684 1,577
Prepaid and other current assets 959 1,459
Total current assets 7,918 13,609
Property and equipment, net 420 458
Operating lease right-of-use assets 195 89
Intangible asset, net (Note 7) 5,238 9,597
Other noncurrent assets 36 36
Total assets 13,807 23,789
Current liabilities:    
Accounts payable 11,624 16,172
Short term debt 291 135
Accrued expenses 1,363 5,509
Accrued compensation 3,609 3,494
Operating lease liabilities – current 124 82
Derivative liabilities 1,140 1,359
Contingent liabilities - current (Note 7) 215 592
Other current liabilities 8,161 7,362
Total current liabilities 78,186 80,448
Operating lease liabilities - noncurrent 72 7
Contingent liabilities - noncurrent (Note 7) 5,718 9,809
Total liabilities 83,976 90,264
Commitments and contingencies (Note 7)  
Convertible and redeemable preferred stock 4,897 4,782
Stockholders’ deficit:    
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding at both September 30, 2025 and December 31, 2024
Common Stock, $0.0001 par value; 3,000,000,000 shares authorized; 123,956,354 and 113,356,354 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 12 11
Additional paid-in capital 831,816 829,026
Accumulated other comprehensive loss (6,718) (2,630)
Accumulated deficit (900,176) (897,664)
Total stockholders’ deficit (75,066) (71,257)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit 13,807 23,789
Baker Bros. Notes [Member]    
Current liabilities:    
Convertible notes 18,509 14,974
Related Party [Member]    
Current liabilities:    
Convertible notes 983
Adjuvant Notes [Member]    
Current liabilities:    
Convertible notes $ 32,167 $ 30,769
v3.25.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2025
Dec. 31, 2024
Convertible preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 5,000,000 5,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 3,000,000,000 3,000,000,000
Common stock, shares issued 123,956,354 113,356,354
Common stock, shares outstanding 123,956,354 113,356,354
Series E-1 Convertible and Redeemable Preferred Stock [Member]    
Convertible preferred stock, shares authorized 10,000 10,000
Convertible preferred stock, shares issued 2,582 2,068
Convertible preferred stock, shares outstanding 2,582 2,068
Series F-1 Convertible and Redeemable Preferred Stock [Member]    
Convertible preferred stock, shares authorized 95,000 95,000
Convertible preferred stock, shares issued 26,280 26,280
Convertible preferred stock, shares outstanding 26,280 26,280
Series G-1 Convertible and Redeemable Preferred Stock [Member]    
Convertible preferred stock, shares authorized 5,000 5,000
Convertible preferred stock, shares issued 1,587 0
Convertible preferred stock, shares outstanding 1,587 0
v3.25.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Income Statement [Abstract]        
Product sales, net $ 4,952 $ 4,496 $ 10,622 $ 12,259
Operating Expenses:        
Cost of goods sold 905 869 2,025 2,322
Gain on change in accounting estimates on contingent royalty liability (Note 7) (1,933) (1,933)
Amortization of intangible asset 80 301 410 301
Research and development, net 470 332 (3,819) 1,196
Selling and marketing 2,391 2,382 7,616 6,970
General and administrative 2,088 3,052 6,296 8,143
Total operating expenses 4,001 6,936 10,595 18,932
Income (loss) from operations 951 (2,440) 27 (6,673)
Other income (expense):        
Interest income 3 3 13 13
Other expense, net (682) (562) (1,944) (1,736)
Loss on issuance of financial instruments (3,300)
Gain (loss) on debt extinguishment, net (143) 977
Change in fair value of financial instruments (1,845) 769 (490) 4,896
Total other income (expense), net (2,524) 67 (2,421) 850
Loss before income tax benefit (expense) (1,573) (2,373) (2,394) (5,823)
Income tax benefit (expense) 4 8 (3)
Net loss (1,569) (2,365) (2,397) (5,823)
Convertible and redeemable preferred stock deemed dividends (111) (5) (115) (99)
Net loss attributable to common stockholders $ (1,680) $ (2,370) $ (2,512) $ (5,922)
Net loss per share attributable to common stockholders- basic $ (0.01) $ (0.02) $ (0.02) $ (0.09)
Net loss per share attributable to common stockholders- diluted $ (0.01) $ (0.02) $ (0.02) $ (0.09)
Weighted-average shares used to compute net loss per share attributable to common shareholders - basic 119,578,093 96,459,121 116,229,614 64,924,454
Weighted-average shares used to compute net loss per share attributable to common shareholders - diluted 119,578,093 96,459,121 116,229,614 64,924,454
v3.25.3
Condensed Consolidated Statements of Comprehensive Operations (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Income Statement [Abstract]        
Net loss $ (1,569) $ (2,365) $ (2,397) $ (5,823)
Other comprehensive income (loss):        
Change in fair value of financial instruments attributed to credit risk change (Note 4) (4,162) (1,069) (4,088) (1,001)
Reclassification adjustment related to debt extinguishment 143 143
Comprehensive loss $ (5,731) $ (3,291) $ (6,485) $ (6,681)
v3.25.3
Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders' Deficit (Unaudited) - USD ($)
$ in Thousands
Temporary Equity [Member]
Series E-1 Convertible and Redeemable Preferred Stock [Member]
Temporary Equity [Member]
Series F-1 Convertible and Redeemable Preferred Stock [Member]
Temporary Equity [Member]
Series G-1 Convertible and Redeemable Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
AOCI Attributable to Parent [Member]
Retained Earnings [Member]
Total
Balance at Dec. 31, 2023 $ 1,874 $ 2,719   $ 2 $ 823,036 $ (849) $ (888,699) $ (66,510)
Balance, shares at Dec. 31, 2023 1,874 22,280   20,007,799        
Stock-based compensation   237 237
Change in fair value of financial instruments attributed to credit risk change (Note 4)   324 324
Series E-1 Shares dividends $ 47   (47) (47)
Series E-1 Shares dividends, shares 47              
Net income (loss)   (4,809) (4,809)
Issuance of Common Stock upon noncash exercise of purchase rights   $ 2 87 89
Issuance of common stock upon noncash exercise of purchase rights, shares       17,725,000        
Issuance of Common Stock upon exercise of warrants   15 15
Issuance of common stock upon non-cash exercise of warrants, shares       246,153        
Issuance of Common Stock upon conversion of notes   $ 1 34 35
Issuance of common stock upon conversion of notes, shares       10,731,443        
Balance at Mar. 31, 2024 $ 1,921 $ 2,719   $ 5 823,409 (525) (893,555) (70,666)
Balance, shares at Mar. 31, 2024 1,921 22,280   48,710,395        
Balance at Dec. 31, 2023 $ 1,874 $ 2,719   $ 2 823,036 (849) (888,699) (66,510)
Balance, shares at Dec. 31, 2023 1,874 22,280   20,007,799        
Change in fair value of financial instruments attributed to credit risk change (Note 4)               (1,001)
Net income (loss)               (5,823)
Balance at Sep. 30, 2024 $ 1,973 $ 2,786   $ 10 825,430 (1,707) (894,621) (70,888)
Balance, shares at Sep. 30, 2024 2,017 23,540   100,328,686        
Balance at Mar. 31, 2024 $ 1,921 $ 2,719   $ 5 823,409 (525) (893,555) (70,666)
Balance, shares at Mar. 31, 2024 1,921 22,280   48,710,395        
Stock-based compensation   219 219
Change in fair value of financial instruments attributed to credit risk change (Note 4)   (256) (256)
Series E-1 Shares dividends $ 47   (47) (47)
Series E-1 Shares dividends, shares 47              
Net income (loss)   1,351 1,351
Issuance of Common Stock upon noncash exercise of purchase rights   $ 2 66 68
Issuance of common stock upon noncash exercise of purchase rights, shares       24,350,000        
Issuance of Common Stock upon conversion of notes   $ 1 15 16
Issuance of common stock upon conversion of notes, shares       9,768,291        
Balance at Jun. 30, 2024 $ 1,968 $ 2,719   $ 8 823,709 (781) (892,251) (69,315)
Balance, shares at Jun. 30, 2024 1,968 22,280   82,828,686        
Stock-based compensation   203 203
Change in fair value of financial instruments attributed to credit risk change (Note 4)   (1,069) (1,069)
Series E-1 Shares dividends $ 5   (5) (5)
Series E-1 Shares dividends, shares 49              
Net income (loss)   (2,365) (2,365)
Issuance of Common Stock upon noncash exercise of purchase rights   $ 2 9 11
Issuance of common stock upon noncash exercise of purchase rights, shares       17,500,000        
Extinguishment of Baker Notes (Note 4)   143 143
Issuance of Series F-1 Shares to Aditxt (Related Party) $ 67   1,193 1,193
Issuance of Series F-1 Shares to Aditxt (Related Party), shares   1,260            
Allocation of reinstatement proceeds (Related Party)   316 316
Balance at Sep. 30, 2024 $ 1,973 $ 2,786   $ 10 825,430 (1,707) (894,621) (70,888)
Balance, shares at Sep. 30, 2024 2,017 23,540   100,328,686        
Balance at Dec. 31, 2024 $ 1,979 $ 2,803 $ 11 829,026 (2,630) (897,664) (71,257)
Balance, shares at Dec. 31, 2024 2,068 26,280 113,356,354        
Stock-based compensation 70 70
Change in fair value of financial instruments attributed to credit risk change (Note 4) 647 647
Series E-1 Shares dividends $ 3 (3) (3)
Series E-1 Shares dividends, shares 53              
Net income (loss) 956 956
Balance at Mar. 31, 2025 $ 1,982 $ 2,803 $ 11 829,096 (1,983) (896,711) (69,587)
Balance, shares at Mar. 31, 2025 2,121 26,280 113,356,354        
Balance at Dec. 31, 2024 $ 1,979 $ 2,803 $ 11 829,026 (2,630) (897,664) (71,257)
Balance, shares at Dec. 31, 2024 2,068 26,280 113,356,354        
Change in fair value of financial instruments attributed to credit risk change (Note 4)               (4,088)
Net income (loss)               (2,397)
Balance at Sep. 30, 2025 $ 2,089 $ 2,803 $ 5 $ 12 831,816 (6,718) (900,176) (75,066)
Balance, shares at Sep. 30, 2025 2,582 26,280 1,587 123,956,354        
Balance at Mar. 31, 2025 $ 1,982 $ 2,803 $ 11 829,096 (1,983) (896,711) (69,587)
Balance, shares at Mar. 31, 2025 2,121 26,280 113,356,354        
Stock-based compensation 31 31
Change in fair value of financial instruments attributed to credit risk change (Note 4) (573) (573)
Series E-1 Shares dividends $ 1 (1) (1)
Series E-1 Shares dividends, shares 179              
Net income (loss) (1,784) (1,784)
Issuance of Common Stock upon noncash exercise of purchase rights $ 1 1 2
Issuance of common stock upon noncash exercise of purchase rights, shares       5,300,000        
Issuance of Aditxt Notes – Related Party (Note 4) 2,296 2,296
Balance at Jun. 30, 2025 $ 1,983 $ 2,803 $ 12 831,424 (2,556) (898,496) (69,616)
Balance, shares at Jun. 30, 2025 2,300 26,280 118,656,354        
Stock-based compensation 23 23
Change in fair value of financial instruments attributed to credit risk change (Note 4) (4,162) (4,162)
Net income (loss) 1,569 (1,569)
Issuance of Common Stock upon noncash exercise of purchase rights
Issuance of common stock upon noncash exercise of purchase rights, shares       5,300,000        
Issuance of Series G-1 convertible and redeemable preferred stock upon conversion of convertible notes (Note 8) 369 369
Issuance of series G-1 convertible and redeemable preferred stock upon exchange of notes, shares     1,573          
Series E-1 and G-1 Shares dividends $ 106 $ 5 (111) (111)
Series E-1 and G-1 Shares dividends, shares 282   14          
Balance at Sep. 30, 2025 $ 2,089 $ 2,803 $ 5 $ 12 $ 831,816 $ (6,718) $ (900,176) $ (75,066)
Balance, shares at Sep. 30, 2025 2,582 26,280 1,587 123,956,354        
v3.25.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Cash flows from operating activities:    
Net loss $ (2,397) $ (5,823)
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities:    
Loss on issuance of financial instruments 3,300
Gain on debt extinguishment (977)
Gain on change in accounting estimates on contingent royalty liability (1,933)
Change in fair value of financial instruments 490 (4,896)
Inventory write-down for excess & obsolescence 178
Loss on contingent liability 25 840
Stock-based compensation 124 659
Depreciation 14 25
Amortization of intangible asset 410 301
Noncash interest expense 1,760 1,673
Noncash right-of-use amortization 95 69
Net loss on disposal or impairment of property and equipment 20 11
Gain on accounts payable and accrued expenses settlements (5,618)
Changes in operating assets and liabilities:    
Trade accounts receivable 5,397 345
Inventories (285) 234
Prepaid and other assets 500 195
Accounts payable (1,365) (211)
Accrued expenses and other liabilities 1,016 2,234
Accrued compensation 115 613
Contingent liabilities (475)
Operating lease liabilities (94) (69)
Net cash, cash equivalents and restricted cash used in operating activities (2,023) (1,477)
Cash flows from investing activities:    
Payments related to asset acquisition (57) (509)
Purchases of property and equipment (2) (14)
Net cash, cash equivalents and restricted cash used in investing activities (59) (523)
Cash flows from financing activities:    
Proceeds from issuance of Aditxt Notes – Related Party 2,425
Borrowings under short-term debt and Notes – carried at fair value 383 397
Proceeds from reinstatement of Merger Agreement – Related Party 1,000
Proceeds from issuance of preferred stock – Related Party 1,260
Payments under short term debt and Notes – carried at fair value (627) (515)
Net cash, cash equivalents and restricted cash provided by financing activities 2,181 2,142
Net change in cash, cash equivalents and restricted cash 99 142
Cash, cash equivalents and restricted cash, beginning of period 741 580
Cash, cash equivalents and restricted cash, end of period 840 722
Supplemental disclosure of noncash investing and financing activities:    
Net increase/(decrease) in contingent liabilities (3,950) 13,743
Exchange of convertible notes to Series G-1 convertible and redeemable preferred stock 369
Addition to ROU asset and lease liability due to new leases 201 90
Purchases of property and equipment included in accounts payable and accrued expenses 78 78
Series E-1 and G-1 Shares deemed dividends 115 99
Issuance of Common Stock upon exercise of purchase rights 2 168
Issuance of Common Stock upon conversion of notes 51
Issuance of Common Stock upon exercise of warrants 15
Allocation of reinstatement proceeds – Related Party 316
Acquisition related amounts included in accounts payable and accrued expenses $ 70
v3.25.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Jun. 30, 2025
Mar. 31, 2025
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2025
Sep. 30, 2024
Pay vs Performance Disclosure [Table]                
Net Income (Loss) $ (1,569) $ (1,784) $ 956 $ (2,365) $ 1,351 $ (4,809) $ (2,397) $ (5,823)
v3.25.3
Insider Trading Arrangements
 3 Months Ended
Sep. 30, 2025
Insider Trading Arrangements [Line Items]  
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
Rule 10b5-1 Arrangement Modified false
Non-Rule 10b5-1 Arrangement Modified false
v3.25.3
Description of Business and Basis of Presentation
 9 Months Ended
Sep. 30, 2025
Accounting Policies [Abstract]  
Description of Business and Basis of Presentation

1. Description of Business and Basis of Presentation

 

Description of Business

 

Evofem is a San Diego-based commercial-stage biopharmaceutical company committed to commercializing innovative products to address unmet needs in women’s sexual and reproductive health.

 

The Company’s first commercial product, PHEXX®, was approved by the FDA on May 22, 2020, for the prevention of pregnancy and launched in the U.S. in September 2020. PHEXX is the first and only non-hormonal prescription contraceptive vaginal gel. Women use it when they have sex, applying PHEXX 0-60 minutes prior to intercourse. Because PHEXX is hormone-free and non-systemic, it is not associated with side effects of hormonal contraceptive methods, which include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions including clotting disorders, hormone-sensitive cancers, diabetes, or a BMI over 30, as well as women who are breast feeding, and / or who smoke. Per National Center for Health Statistics (NCHS)-published data, more than 23.3 million women in the U.S. do not want to get pregnant and will not use a hormonal contraceptive.

 

The Company acquired global rights to SOLOSEC® on July 14, 2024 and relaunched the brand in November 2024. SOLOSEC is an FDA-approved single-dose oral antimicrobial agent that provides a complete course of therapy for the treatment of two common sexual health infections – bacterial vaginosis (BV) and trichomoniasis. This acquisition aligns with and advances the Company’s mission to commercialize innovative and differentiated products for women’s sexual and reproductive health.

 

Outside the U.S., the Company’s strategy is to commercialize its products in global markets through commercial partnerships and/or license agreements.

 

●The Company licensed commercial rights to PHEXX and SOLOSEC in the Middle East and North Africa (MENA) to Pharma 1 Drug Store, LLC, an emerging Emirati health care company (Pharma 1), in July 2024 and May 2025, respectively. Pharma 1 filed for regulatory approval of PHEXX in the United Arab Emirates (UAE) in June 2025 and of SOLOSEC in the UAE in September 2025.
●PHEXX was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control.
●PHEXX has also been submitted for approval in Mexico, Ethiopia and Ghana.

 

Basis of Presentation and Principles of Consolidation

 

The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q.

 

The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 2024 included in its Annual Report on Form 10-K as filed with the SEC on March 24, 2025 as amended on March 28, 2025 (the 2024 Audited Financial Statements).

 

The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible and redeemable preferred stock and stockholders’ deficit for the periods presented. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2024 was derived from the 2024 Audited Financial Statements.

 

 

Risks, Uncertainties and Going Concern

 

Any disruptions in the commercialization of PHEXX or SOLOSEC and/or the products’ supply chains could have a material adverse effect on the Company’s business, results of operations and financial condition.

 

The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

 

The Company’s principal operations are related to the commercialization of PHEXX and, since July 2024, SOLOSEC. Additional activities have included raising capital, identifying alternative manufacturing to lower PHEXX cost of goods sold (COGS), seeking ex-U.S. licensing partners to add non-dilutive capital to the balance sheet and geographically diversify the revenue stream, seeking product in-licensing/acquisition opportunities to expand and diversify the U.S. revenue stream, and establishing and maintaining a corporate infrastructure to support commercial products. The Company has incurred operating losses and negative cash flows from operating activities since inception. As of September 30, 2025, the Company had a working capital deficit of $70.3 million and an accumulated deficit of $900.2 million.

 

On January 6, 2025, the Company received a written notice from the OTC Markets notifying the Company that, because the closing bid price for the Company’s Common Stock was below $0.01 per share for 30 consecutive calendar days, the Company was not compliant with the minimum bid price requirement for continued listing on the OTCQB, as set forth in the OTCQB listing standards, section 2.3 (the Minimum Bid Price Requirement). In accordance with OTCQB Listing Standards, Section 4.1, to regain compliance with the Minimum Bid Price Requirement the Company’s closing bid price was required to be equal to or greater than $0.01 for ten consecutive trading days during the 90-day compliance period which ended April 6, 2025.

 

On April 22, 2025, the Company received a written notice from the OTC Markets that it did not regain compliance with the Minimum Bid Price Requirement during the specified period, and as such, its Common Stock was removed from OTCQB and began trading on the OTC Pink Current (OTCPK) at market open on April 23, 2025. OTC Markets concurrently notified the Company that if the closing bid price for the Company’s Common Stock is $0.01 or higher for 30 consecutive calendar days, and the Company meets all of the eligibility requirements listed under Section 1 of the OTCQB Rules, Evofem may request to be moved back to OTCQB.

 

The Company’s Common Stock was moved to and began trading on the Over-the-Counter Integrated Disclosure (OTCID), the new basic reporting market tier launched by the OTC Markets Group, at market open on July 1, 2025.

 

Management’s plans to meet its cash flow needs in the next 12 months include generating recurring product revenue from PHEXX and SOLOSEC, earning milestone payments by achieving certain regulatory milestone under the License and Supply Agreement with Pharma 1 for SOLOSEC, restructuring its current payables, and obtaining additional funding through non-dilutive or dilutive financings, collaborations or partnerships with other companies, including license agreements for PHEXX and/or SOLOSEC in the U.S. or foreign markets, or through other potential business combinations.

 

The Company anticipates it will continue to incur net losses for the foreseeable future. According to management estimates, liquidity resources as of September 30, 2025, were not sufficient to maintain the Company’s cash flow needs for the twelve months from the date of issuance of these unaudited interim condensed consolidated financial statements.

 

If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for PHEXX and/or SOLOSEC, or other means, or is unable to obtain funding on terms favorable to the Company, or if there is another event of default affecting the notes payable, there will be a material adverse effect on commercialization operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.

 

 
v3.25.3
Summary of Significant Accounting Policies
 9 Months Ended
Sep. 30, 2025
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the interim condensed consolidated financial statements and the notes thereto.

 

Significant estimates affecting amounts reported or disclosed in the interim condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items; the allowance for expected credit losses estimate; the assumptions used in estimating the fair value of convertible notes, preferred stock, warrants and purchase rights issued; the assumptions used in the valuation of inventory, intangible asset, and contingent liabilities; the useful lives and recoverability of long-lived assets; the assumptions used to estimate the amount due under the contingent Rush Royalty liability; and the valuation of deferred tax assets. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

 

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (CODM), the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. The Company’s CODM assesses performance and decides how to allocate resources for the Company’s one operating segment based on consolidated net loss that is reported on the interim condensed consolidated statements of operations. The Company has also evaluated the significant segment expenses incurred by the single segment that are regularly provided to the CODM. The significant segment expenses regularly provided to the CODM are consistent with those reported on the interim condensed consolidated statements of operations and include cost of goods sold, research and development, selling and marketing, and general and administrative. The CODM uses these expense categories, along with data on product sales, net, to make key operating decisions, such as the strategic direction of the Company, pursuing and/or approving product acquisitions, decisions about key personnel, and approving annual operating budgets. The Company manages assets on a consolidated basis as reported on the interim condensed consolidated balance sheets.

 

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the condensed consolidated balance sheets.

 

The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances on amounts in excess of federally insured limits due to the financial position of the depository institutions in which these deposits are held.

 

The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the U.S. and, expected to begin in the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies, mail-order specialty pharmacies and, in the UAE, its licensee Pharma 1. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. As of September 30, 2025 and December 31, 2024, based on the evaluation of these factors, the Company did not record an allowance for expected credit losses.

 

In the U.S., products are distributed primarily through three major distributors and mail-order pharmacies, which receive service fees calculated as a percentage of the gross sales and a fee-per-unit shipped, respectively. These entities are not obligated to purchase any set number of units; they distribute products on demand as orders are received.

 

For the three and nine months ended September 30, 2025, the Company’s three largest customers combined made up approximately 75% and 74% of its gross product sales, respectively. For the three and nine months ended September 30, 2024, the Company’s three largest customers combined made up approximately 80% and 79% of its gross product sales, respectively. As of September 30, 2025 and December 31, 2024, the Company’s three largest customers combined made up 83% and 89%, respectively, of its trade accounts receivable balance.

 

 

Significant Accounting Policies

 

There have been no changes to the significant accounting policies that were described in Note 2 – Summary of Significant Accounting Policies of the 2024 Audited Financial Statements in the Company’s Annual Report.

 

Cash, Cash Equivalents and Restricted Cash

 

Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit as described in Note 7- Commitments and Contingencies.

 

Net Loss Per Share

 

Basic net loss per share attributable to Common Stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. The net loss available to Common Stockholders is adjusted for amounts in accumulated deficit related to the deemed dividends triggered for certain financial instruments. Such adjustment was $0.1 million in each of the three and nine months ended September 30, 2025. Such adjustment was immaterial and $0.1 million in the three and nine months ended September 30, 2024, respectively. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and, therefore, basic and diluted net loss per share were the same for each of the three and nine months ended September 30, 2025 and 2024. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Common shares were calculated for the convertible preferred stock and the convertible debt using the if-converted method.

 

          
   September 30, 
   2025   2024 
Options to purchase Common Stock   3,372    3,747 
Warrants to purchase Common Stock   263,062,099    20,807,539 
Purchase rights to purchase Common Stock   1,508,548,899    1,529,448,899 
Convertible debt   2,923,775,388    2,577,050,313 
Series E-1 Shares   167,654,737    131,023,274 
Series F-1 Shares   1,706,493,507    1,528,571,429 
Series G-1 Shares   103,029,458    - 
Total(1)   6,672,567,460    5,786,905,201 

 

(1) The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted net loss per share as per GAAP, whereas the total Common Stock reserved for future issuance in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 

Recently Adopted Accounting Pronouncements

 

No significant new standards were adopted during the nine months ended September 30, 2025.

 

 

Recently Issued Accounting Pronouncements — Not Yet Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standards setting bodies that are adopted as of the specified effective date.

 

In October 2023, the FASB issued Accounting Standards Update (ASU) 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, designed to clarify or improve disclosure and presentation requirements on a variety of topics and align the requirements in the FASB Accounting Standards Codification (ASC) with the SEC regulations. This guidance is effective for the Company no later than June 30, 2027. The Company is still evaluating the impact of ASU 2023-06.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes: Improvements to Income Tax Disclosures, addressing income tax disclosures, requiring entities to annually disclose specific categories in the rate reconciliation and provide additional information for certain reconciling items and categories. ASU 2023-09 will be effective for the Company beginning with the annual filing for the period ending December 31, 2025 and early adoption is allowed. The Company is still evaluating the impact of ASU 2023-09.

 

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which primarily requires disaggregation of specific expense categories in disclosures within the footnotes on an annual and interim basis. ASU 2024-03 is effective for the Company’s annual period ending December 31, 2027 and interim periods thereafter. Early adoption is permitted. In January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03. The Company is still evaluating the impacts of ASU 2024-03 and ASU 2025-01.

 

In November 2024, the FASB issued ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, designed to clarify the requirements for accounting for the settlement of a debt as an induced conversion versus as an extinguishment. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2024-04.

 

In July 2025, the FASB issued ASU 2025-05, Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, to provide a practical expedient related to the estimation of expected credit losses for current accounts receivable and current contract assets that arise from transactions accounted for under ASC 606. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2025-05.

 

The Company does not believe the impact of any other recently issued standards and any issued but not yet effective standards will have a material impact on its condensed consolidated financial statements upon adoption.

 
v3.25.3
Revenue
 9 Months Ended
Sep. 30, 2025
Revenue from Contract with Customer [Abstract]  
Revenue

3. Revenue

 

The Company recognizes revenue from the sale of PHEXX and SOLOSEC in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product to a customer. Any payments received before the Company satisfies its performance obligations are considered deferred revenue until the obligations are satisfied. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are primarily located in the U.S., and expected to begin in the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies, and mail-order specialty pharmacies. Payment terms typically range from 31 to 66 days, include prompt pay discounts, and vary by customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the condensed consolidated balance sheets, net of various allowances as described in the Trade Accounts Receivable policy in Note 2 – Summary of Significant Accounting Policies to the 2024 Audited Financial Statements.

 

The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when the performance obligation is satisfied. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

 

 

Our products are sold to domestic customers at the Wholesale Acquisition Cost (WAC), or in some cases at a discount to WAC. However, the Company records product revenue net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following:

 

  ● Distribution services fees
  ● Prompt pay and other discounts
  ● Product returns
  ● Chargebacks
  ● Rebates
  ● Patient support programs, including our co-pay programs

 

An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method and the estimated amounts are recorded as a reduction to accounts receivable or as a current liability based on the nature of the allowance and the terms of the related arrangements. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed and adjustments are made if necessary. Any adjustments made to these provisions would also affect net product revenue and earnings.

 

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relies on historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports.

 

The specific considerations that the Company uses in estimating these amounts related to variable consideration are as follows:

 

Distribution services fees – The Company pays distribution service fees to its wholesale distributors and mail-order specialty pharmacies. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product and, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheets.

 

Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the Company offers a prompt pay discount to each wholesale distributor and retail pharmacy customers. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.

 

The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized.

 

Product returns – Domestic customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. PHEXX has a shelf life of 48 months. SOLOSEC has a shelf life of 60 months. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

Chargebacks – Certain government entities and covered entities (e.g., Veterans Administration, 340B covered entities, group purchasing organizations) are able to purchase products at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in each channel and related chargeback that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.

 

Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are invoiced in arrears. The Company also has a commercial rebate program whereby certain customers receive a rebate as contractually arranged. The Company estimates the amount of rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

 

Patient support programs – The Company voluntarily offers a co-pay program to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs based on the expected number of claims and related cost associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Patient support program estimates are recorded as other current liabilities on the condensed consolidated balance sheets.

 

The variable consideration discussed above was recorded in the condensed consolidated balance sheets and consisted of $0.1 million and $0.3 million in contra trade accounts receivable as of September 30, 2025 and December 31, 2024, respectively, and $8.0 million and $7.2 million in other current liabilities as of September 30, 2025 and December 31, 2024, respectively.

 
v3.25.3
Debt
 9 Months Ended
Sep. 30, 2025
Debt Disclosure [Abstract]  
Debt

4. Debt

 

Baker Notes (temporarily owned by Aditxt from December 11, 2023 through February 26, 2024 and owned by Future Pak, LLC since July 23, 2024)

 

On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the Baker Bros. SPA) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $25.0 million and (ii) warrants to purchase shares of Common Stock (the Baker Warrants) in a private placement, which closed in two closings (April 24, 2020, the Baker Initial Closing, and June 9, 2020, the Baker Second Closing). As a result of the two closings, the Company issued and sold Baker Notes with an aggregate principal amount of $25.0 million and Baker Warrants exercisable for 2,731 shares of Common Stock. Upon the completion of the underwritten public offering in June 2020, the exercise price of the Baker Warrants was $4,575 per share. The Baker Warrants had a five-year term with a cashless exercise provision and were immediately exercisable at any time from their respective issuance date. The April 2020 Baker Warrants expired on April 24, 2025. The June 2020 Baker Warrants expired on June 9, 2025.

 

The Baker Notes have a five-year term, with no pre-payment ability during the first three years. Interest on the unpaid principal balance of the Baker Notes (the Baker Outstanding Balance) accrues at 10.0% per annum, with interest accrued during the first year from the two respective closing dates recognized as payment-in-kind. The effective interest rate for the periods was 10.0%. Accrued interest beyond the first year of the respective closing dates is to be paid in arrears on a quarterly basis in cash or recognized as payment-in-kind, at the direction of the Baker Purchasers. As discussed below, with the amendment to the Baker Bros. Purchase Agreement, interest payments were paid in-kind. Interest pertaining to the Baker Notes for the three and nine months ended September 30, 2025 was approximately $2.9 million and $8.5 million, respectively, which was added to the outstanding principal balance. Interest pertaining to the Baker Notes for the three and nine months ended September 30, 2024 was approximately $2.7 million and $7.8 million, respectively, which was added to the outstanding principal balance. The Company accounts for the Baker Notes under the fair value method as described below and, therefore, the interest associated with the Baker Notes is included in the fair value determination.

 

The Baker Notes were callable by the Company on 10 days’ written notice beginning on the third anniversary of the initial closing date of April 24, 2020 at a call price equal to 100% of the Baker Outstanding Balance plus accrued and unpaid interest if the Company’s Common Stock as measured using a 30-day volume weighted average price (VWAP) was greater than the benchmark price of $9,356.25 as stated in the Baker Bros. Purchase Agreement, or 110% of the Baker Outstanding Balance plus accrued and unpaid interest if the VWAP was less than such benchmark price. The Baker Purchasers also had the option to require the Company to repurchase all or any portion of the Baker Notes in cash upon the occurrence of certain events. In a repurchase event, as defined in the Baker Bros. Purchase Agreement, the repurchase price will equal 110% of the Baker Outstanding Balance plus accrued and unpaid interest. In the event of default or the Company’s change of control, the repurchase price would equal to the sum of (x) three times of the Baker Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. The Baker Notes were convertible at any time at the option of the Baker Purchasers at the conversion price of $4,575 per share prior to the First and Second Baker Amendments (as defined below).

 

On November 20, 2021, the Company entered into the first amendment to the Baker Bros. Purchase Agreement (the First Baker Amendment), in which each Baker Purchaser had the right to convert all or any portion of the Baker Notes into Common Stock at a conversion price equal to the lesser of (a) $4,575 and (b) 115% of the lowest price per share of Common Stock (or, as applicable with respect to any equity securities convertible into Common Stock, 115% of the applicable conversion price) sold in one or more equity financings until the Company has met a qualified financing threshold defined as one or more equity financings resulting in aggregate gross proceeds to the Company of at least $50 million (the Financing Threshold).

 

 

The First Baker Amendment extended, effective upon the Company’s achievement of the Financing Threshold, the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXX by June 30, 2022 to June 30, 2023. Additionally per the First Baker Amendment, if the Company were to issue warrants to purchase capital stock of the Company (or other similar consideration) in any equity financing that closed on or prior to the date on which the Company met the Financing Threshold, the Company was required to issue to the Baker Purchasers an equivalent coverage of warrants (or other similar consideration) on the same terms as if the Baker Purchasers had participated in the financing in an amount equal to the then outstanding principal of Baker Notes held by the Baker Purchasers. In satisfaction of this requirement and in connection with the closing of the May 2022 Public Offering, the Company issued warrants to purchase 582,886 shares of the Company’s Common Stock at an exercise price of $93.75 per share to the Baker Purchasers (the June 2022 Baker Warrants). As required by the terms of the First Baker Amendment, the June 2022 Baker Warrants have substantially the same terms as the warrants issued in the May 2022 Public Offering. Refer to Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit for further information. The exercise price of the initial Baker Warrants and the June 2022 Baker Warrants was reset multiple times as a result of various Notes issuances in accordance with the agreement. The exercise price was $0.0154 per share as of September 30, 2025.

 

On March 21, 2022, the Company entered into the second amendment to the Baker Bros. Purchase Agreement (the Second Baker Amendment), which granted each Baker Purchaser the right to convert all or any portion of the Baker Notes into Common Stock at a conversion price equal to the lesser of (a) $725.81 or (b) 100% of the lowest price per share of Common Stock (or as applicable with respect to any equity securities convertible into Common Stock, 100% of the applicable conversion price) sold in any equity financing until the Company (i) met the qualified financing threshold by June 30, 2022, defined as a single underwritten financing resulting in aggregate gross proceeds to the Company of at least $20 million (Qualified Financing Threshold) and (ii) disclosed top-line results from the EVOGUARD clinical trial (the Clinical Trial Milestone) on or before October 31, 2022. The Second Baker Amendment also provided that the exercise price of the Baker Warrants will equal the conversion price of the Baker Notes. The Company met the Qualified Financing Threshold upon the closing of the May 2022 Public Offering, and as of September 30, 2022, the conversion price and exercise price of the Baker Warrants was reset to $93.75. The Company achieved the Clinical Trial Milestone in October 2022. Also, with the achievement of the Qualified Financing Threshold and the Clinical Trial Milestone, the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXX was extended to June 30, 2023, which was subsequently waived via the Baker Fourth Amendment as discussed below.

 

On September 15, 2022, the Company entered into the third amendment to the Baker Bros. Purchase Agreement (the Third Baker Amendment), pursuant to which the conversion price was amended to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period; an interest make-whole payment due in certain circumstances was removed; and certain change of control and liquidation payment amounts were reduced from three times the outstanding amounts of the Baker Notes to two times the outstanding amounts. In addition, the Third Baker Amendment provided that the Company may make future interest payments to the Baker Purchasers in kind or in cash, at the Company’s option. On the same day, the Company also entered into a Secured Creditor Forbearance Agreement with the Baker Purchasers (Forbearance Agreement), according to which the Baker Purchasers agreed to forebear the defaults that existed at that time.

 

On December 19, 2022, the Company entered into the First Amendment to the Forbearance Agreement (the Amendment) effective as of December 15, 2022 to amend certain provisions of the Forbearance Agreement dated September 15, 2022. The Amendment revised the Forbearance Agreement to (i) amend the Fifth Recital Clause to clarify that the Purchasers consent to any additional indebtedness pari passu, but not senior to that of the Purchasers, in an amount not to exceed $5.0 million, and (ii) strike and entirely replace Section 4 to clarify the terms of the Purchasers’ consent to Interim Financing (as defined therein). No other revisions were made to the Forbearance Agreement.

 

 

On March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Baker Bros. Purchase Agreement. The Notice of Default claimed that the Company failed to maintain the “Required Reserve Amount” as required by the Third Baker Amendment. The Designated Agent, at the direction of the Baker Purchasers, accelerated repayment of the outstanding balance payable. As a result, approximately $92.7 million, representing two times the sum of the outstanding balance and all accrued and unpaid interest thereon and all other amounts due under the Baker Bros. Purchase Agreement and other documents, was due and payable within three business days of receipt of the Notice of Default. In addition, the Company did not meet the $100.0 million cumulative net sales threshold by June 30, 2023 and as such was in default as of that date. As discussed below, all existing defaults were cured upon the signing of the Fourth Baker Amendment.

 

On September 8, 2023, the Company entered into the Fourth Amendment to the Baker Bros. Purchase Agreement (the Fourth Baker Amendment) with the Baker Purchasers. The Fourth Amendment amends certain provisions within the Baker Bros. Purchase Agreement including:

 

  (i) the rescission of the Notice of Default delivered to the Company on March 7, 2023 and waiver of the Events of Default named therein;
     
  (ii) the waiver of any and all other Events of Default existing as of the Fourth Amendment date;
     
  (iii)

the removal of the conversion feature into shares of Company Common Stock, including the removal of any requirement to reserve shares of Common Stock for conversion of the Baker Notes as well as any registration rights related thereto;

     
  (iv) the clarification that for the sole purpose of enabling ex-U.S. license agreements for such assets, any Patents, Trademarks or Copyrights acquired after the Effective Date shall be excluded from the definition of Collateral; and,
     
  (v) the removal of the requirement for the Company to achieve $100 million in cumulative net PHEXX sales in the specified timeframe.

 

The outstanding balance of the Baker Notes will continue to accrue interest at 10% per annum and, in the event of a default in the agreement or a failure to pay the Repurchase Price (as defined below) on or before September 8, 2028 (the Maturity Date), the Baker Purchasers may collect on the full principal amount then outstanding.

 

The Company paid the required $1.0 million upfront payment in September 2023 and is required to make quarterly cash payments based upon a percentage of the Company’s global net product revenue. The cash payments will be determined based upon the quarterly global net revenue of PHEXX according to the table below.

 

Quarterly global net revenue   Quarterly cash payment
≤ $5.0 million   3% of such global net revenues
>$5.0 million and ≤ $7.0 million   3% on net revenue ≤ $5.0 million;
4% on the net revenue over $5.0 million
Greater than $7.0 million   3% on the net revenue ≤ $5.0 million;
4% on the net revenue over $5.0 million and up to $7.0 million;
5% on net revenue over $7.0 million

 

The quarterly cash payments became payable beginning in the fourth quarter of 2023 and have been timely paid since.

 

Regardless of the percentage paid, the quarterly cash payment amounts, along with the $1.0 million upfront payment, will be deducted from the Repurchase Price as Applicable Reductions. Quarterly cash payments that will be treated as Applicable Reductions paid to date as of September 30, 2025, amount to $1.1 million.

 

The Fourth Amendment also granted the Company the ability to repurchase the principal amount and accrued and unpaid interest of the Baker Notes for up to a five-year period for the one-time Repurchase Price designated below:

 

Date of Notes’ Repurchase   Repurchase Price
On or prior to September 8, 2024   $14,000,000 (less Applicable Reductions)
September 9, 2024-September 8, 2025   $16,750,000 (less Applicable Reductions)
September 9, 2025-September 8, 2026   $19,500,000 (less Applicable Reductions)
September 9, 2026-September 8, 2027   $22,250,000 (less Applicable Reductions)
September 9, 2027-September 8, 2028   $25,000,000 (less Applicable Reductions)

 

 

The Company evaluated whether any of the Embedded Features required bifurcation as a separate component. The Company elected the fair value option (FVO) under ASC 825, Financial Instruments (ASC 825), as the Baker Notes are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the debt instrument at fair value, inclusive of the Embedded Features, with changes in fair value related to changes in the Company’s credit risk being recognized as a component of accumulated other comprehensive loss in the condensed consolidated balance sheets. All other changes in fair value were recognized in the condensed consolidated statements of operations.

 

As part of the consideration for the Merger, on December 11, 2023, the Baker Purchasers signed an agreement to assign the Baker Notes to Aditxt (the December Assignment Agreement). Upon execution of the December Assignment Agreement, Aditxt assumed all terms under the Baker Notes, with Aditxt becoming the new senior secured debtholder of the Company, governed by the requirements under the Fourth Baker Amendment. The Baker Notes were re-assigned back to the Baker Purchasers on February 26, 2024 (the February Assignment Agreement).

 

Due to the execution of the February Assignment Agreement, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated, were extinguished on February 26, 2024, resulting in removing the fair value of the old Baker Notes of $13.5 million. The newly re-assigned Baker Notes were subsequently recorded at fair value using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.

 

On July 23, 2024, the Company consented to the transfer of ownership of the Baker Notes from Baker Brothers Life Sciences, 667, L.P., and Baker Bros. Advisors, LP, each a Delaware limited partnership (collectively, Baker) to Future Pak, LLC (the Assignee) (the July 2024 Assignment). The terms of the Baker Notes were not changed in connection with the assignment from Baker to the Assignee. Due to the July 2024 Assignment, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated, were extinguished on July 23, 2024, resulting in removing the fair value of the old Baker Notes of $12.3 million and the related accumulated other comprehensive income of $0.1 million as of the date of the extinguishment. The newly re-assigned Baker Notes were subsequently recorded at fair value using the valuation methods discussed in Note 6 – Fair Value of Financial Instruments.

 

The Company did not repurchase the Baker Notes prior to September 8, 2025. As of September 30, 2025, the Baker Notes are recorded at fair value in the condensed consolidated balance sheet as short-term Notes – carried at fair value with a total fair value of $15.2 million, and the total outstanding balance including principal and accrued interest is $117.6 million. As of December 31, 2024, the Baker Notes were recorded at fair value in the condensed consolidated balance sheet as short-term Notes – carried at fair value with a total balance of $13.8 million, and the total outstanding balance including principal and accrued interest was $109.5 million.

 

On September 27, 2024, the Assignee, as agent for the Purchasers (in such capacity, the Designated Agent), provided a Notice of Event of Default and Reservation of Rights (the September 2024 Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The September 2024 Notice of Default claims that by entering into arrangements to pay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. SPA.

 

According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to the total outstanding balance, including principal and accrued interest. Pursuant to Section 5.7(b) of the Baker Bros. SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).

 

On October 27, 2024, the Designated Agent sent an amended and supplemental notice to the Initial Notice of Default (the Amended Notice of Default) which added new claims of default based on the Company’s payment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services; allegedly triggering an Event of Default under Section 9.1(e) of the Baker Bros. Purchase Agreement, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the Baker Bros. SPA thereby provided notice to the Company that the Forbearance Agreement was terminated as of October 27, 2024.

 

On November 8, 2024, the Designated Agent sent an amended and supplemental notice to the Notices (the Third Amended Notice of Default) which added new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.

 

The Events of Defaults have not been waived or cured. The Company strongly disagrees with the Designated Agent’s claim that an Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the Baker Bros. SPA.

 

 

Adjuvant Notes

 

On October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers or Adjuvant), pursuant to which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $25.0 million.

 

The Adjuvant Notes have a five-year term, and in connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable on the date of the consummation of a change of control transaction at the option of the Adjuvant Purchasers. The Adjuvant Notes have interest accruing at 7.5% per annum on a quarterly basis in arrears to the outstanding balance of the Adjuvant Notes and are recognized as payment-in-kind. The effective interest rate for the nine months ended September 30, 2025 was 7.5%.

 

Interest expense for the Adjuvant Notes consists of the following, and is included in convertible notes, net – Adjuvant on the condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024 and in other expense, net on the condensed consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

 

                 
   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2025   2024   2025    2024 
Coupon interest  $599   $556   $1,763   $1,637 
Amortization of issuance costs   -    -    -    28 
Total  $599   $556   $1,763   $1,665 

 

The Adjuvant Notes are convertible, subject to customary 19.99% beneficial ownership limitations, into shares of the Company’s Common Stock, par value $0.0001 per share, at any time at the option of the Adjuvant Purchasers at a conversion price of $6,843.75 per share. In connection with certain Company change of control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable at the option of the Adjuvant Purchasers. To the extent not previously prepaid or converted, the Adjuvant Notes were originally automatically convertible into shares of the Company’s Common Stock at a conversion price of $6,843.75 per share immediately following the earliest of the time at which the (i) 30-day volume-weighted average price of the Company’s Common Stock was $18,750 per share, or (ii) the Company achieved cumulative net sales of $100.0 million, provided such net sales were achieved prior to July 1, 2022.

 

On April 4, 2022, the Company entered into the first amendment to the Adjuvant Purchase Agreement (the Adjuvant Amendment). The Adjuvant Amendment extended the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXX by June 30, 2022 to June 30, 2023. The Adjuvant Amendment also provided for an adjustment to the conversion price of the Adjuvant Notes such that the conversion price (the Conversion Price) for these Notes, effective as of the May 2023 reverse stock split, will now be the lesser of (i) $678.49 and (ii) 100% of the lowest price per share of Common Stock (or with respect to securities convertible into Common Stock, 100% of the applicable conversion price) sold in any equity financing until the Company met the Qualified Financing Threshold. Effective as of the Company’s achievement of the Qualified Financing Threshold, the automatic conversion provisions in the Agreement were further amended to provide that the Adjuvant Notes will automatically convert into shares of the Company’s Common Stock at the Conversion Price immediately following the earliest of the time at which the (i) 30-day volume-weighted average price of the Company’s Common Stock is $18,750 per share, or (ii) the Company achieves cumulative net sales of PHEXX of $100.0 million, provided such net sales were achieved prior to July 1, 2023.

 

The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. On September 12, 2022, the Company was in default of the Adjuvant Notes due to the default with the Baker Notes under the cross-default provision. On September 15, 2022, the Company entered into a Forbearance Agreement (the Adjuvant Forbearance Agreement) with the Adjuvant Purchasers, pursuant to which the Adjuvant Purchasers agreed to forbear from exercising any of their rights and remedies during the Forbearance Period as defined in therein, but solely with respect to the specified events of default provided under the Adjuvant Forbearance Agreement.

 

Also on September 15, 2022, the Company entered into the second amendment to the Adjuvant Purchase Agreement (the Second Adjuvant Amendment), pursuant to which the conversion price per share was reduced to $26.25, subject to adjustment for certain dilutive Company equity issuance adjustments for a two-year period. In addition, the Company entered into an exchange agreement, pursuant to which the Adjuvant Purchasers agreed to exchange 10% of the outstanding amount of the Adjuvant Notes as of September 15, 2022 (e.g. $2.9 million of the Adjuvant Notes) for rights to receive 109,842 shares of Common Stock (the Adjuvant Purchase Rights). The number of shares for each Adjuvant Purchase Right was initially fixed, but is subject to certain customary adjustments and, until the second anniversary of issuance (i.e., October 14, 2022), adjustments for certain dilutive Company equity issuances. Refer to Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit for discussion regarding additional issuances of purchase rights under this provision. The Adjuvant Purchase Rights expire on June 28, 2027 and do not have an exercise price per share and, therefore, will not result in cash proceeds to the Company. As of September 30, 2025, all Adjuvant Purchase Rights remain outstanding and the conversion price of the Adjuvant Notes was $0.0154. Assuming this conversion price per share, the Adjuvant Notes could be converted into 2,088,759,258 shares of Common Stock.

 

 

The Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments and are classified as current liabilities in the condensed consolidated balance sheets. The aggregate proceeds of $25.0 million were initially classified as restricted cash for financial reporting purposes due to contractual stipulations that specify the types of expenses the money can be spent on and how it must be allocated. The conversion feature was evaluated and is classified as part of stockholders’ deficit in accordance with ASC 815, Derivatives and Hedging (ASC 815) as of September 30, 2025. See Note 6 - Fair Value of Financial Instruments for a description of the accounting treatment for the Adjuvant Purchase Rights.

 

The Company was in default of the Adjuvant Notes as of September 30, 2023, due to the failure to meet the cumulative net sales requirement. However, Adjuvant forbore such default in October 2023 and therefore the Company is no longer in default.

 

As of September 30, 2025, the Adjuvant Notes are recorded in the condensed consolidated balance sheet as convertible notes, net – Adjuvant with a total balance of $32.2 million. The balance is comprised of $22.5 million in principal and $9.7 million in accrued interest. As of December 31, 2024, the Adjuvant Notes were recorded in the condensed consolidated balance sheet as convertible notes, net – Adjuvant with a total balance of $30.8 million. The balance was comprised of $22.5 million in principal and $8.3 million in accrued interest.

 

On April 10, 2025, Aditxt, the Company and Adjuvant entered into a Call Option Agreement wherein Adjuvant granted to Aditxt, a call option to purchase, at the sole discretion of Aditxt, all of the convertible Adjuvant Notes and Rights to receive Common Stock (the Securities) held by Adjuvant for an aggregate purchase price of $13.0 million. The call option expired on June 30, 2025.

 

As described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, on August 22, 2025, the Company entered into an Exchange Agreement with Adjuvant providing for the exchange of a portion of the Adjuvant Notes due in the aggregate original principal and accrued interest amount of approximately $0.4 million into an aggregate 365 shares of Series G-1 Preferred Stock, par value $0.0001 per share (the Series G-1 Shares). The exchange was accounted for as a partial debt extinguishment via delivery of other financial assets and the difference between the carrying value of the extinguished debt and the fair value of the Series G-1 Shares at issuance of approximately $0.4 million was recorded as an increase to capital contribution during the three months ended September 30, 2025.

 

On October 13, 2025 the Company and the Adjuvant Purchasers entered into a third amendment to the Adjuvant Purchase Agreement (the Adjuvant Third Amendment).

 

The Adjuvant Third Amendment amends certain provisions including updating the date that the Adjuvant Notes will be payable in full to the earlier of (a) six months after the October 13, 2025, (b) at the election of Adjuvant, the date of a consummation of a Change of Control (as defined in the Adjuvant Purchase Agreement), and (c) the date of any acceleration of the Adjuvant Notes in accordance with Section 8 (the Maturity Date, as per the Adjuvant Purchase Agreement). The Adjuvant Notes may not be prepaid prior to the date that is six months after October 13, 2025 without prior written consent of Adjuvant.

 

Term Notes

 

Original SSNs and Exchanged SSNs

 

The Company entered into eight Securities Purchase Agreements (SPAs) between December 2022 and September 2023 with certain investors; each of the agreements was materially similar. Pursuant to each SPA, the Company agreed to sell in a registered direct offering (i) unsecured 8.0% senior subordinated notes with the maturity dates and aggregate issue prices (ii) warrants to purchase the listed number of shares of the Company’s Common Stock, $0.0001 par value per share (including prefunded Common Stock Warrants as a part of the September 2023 SPA) and (iii) Series D Preferred Stock (the Preferred Shares; December 2022 SPA only) (collectively, the Original Senior Subordinated Notes, or Original SSNs). Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) below the stated conversion rate and strike price at issuance.

 

On December 1, 2023, the Company entered into restructuring agreements with the holders of the Original SSNs, pursuant to which the Company and each holder agreed to, among other things, to (i) change the governing law and jurisdiction of the Notes from New York to Delaware and (ii) reissue the Notes (the Exchanged SSNs) under Section 3(a)(9) exemption of the Securities Act of 1993, as amended (the Restructuring Agreements). The maturity date of the Exchanged SSNs is December 1, 2026. No new consideration was paid and, other than the maturity date, no other terms of the Original SSNs were changed in conjunction with the Restructuring Agreements.

 

Assuming the applicable conversion price per share, the Exchanged SSNs could be converted into 584,994,694 shares of Common Stock as of September 30, 2025.

 

The Exchanged SSNs’ interest rates are subject to increase to 12% upon an event of default and the Exchanged SSNs have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the Exchanged SSNs at a redemption premium of 32.5%. The purchasers of the Exchanged SSNs can also require the Company to redeem their respective Exchanged SSNs a) at the respective premium rate tied to the occurrence of certain subsequent transactions, and b) in the event of subsequent placements (as defined). Also, pursuant to the terms of the Restructuring Agreement, Purchasers have certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions. The conversion price for the Exchanged SSNs was $0.0154 as of September 30, 2025.

 

The Company evaluated the Original SSNs in accordance with ASC 480 and determined that the Original SSNs were all liability instruments at issuance. The applicable Original SSNs were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable Original SSNs.

 

Pursuant to the Restructuring Agreement, the Company evaluated the Exchanged SSNs under ASC 470 – Debt (ASC 470), and concluded that the exchange represented a non-substantial modification of the Original SSNs. Accordingly, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs.

 

 

The Company also evaluated the warrants in accordance with ASC 480 and ASC 815 and as of both September 30, 2025 and December 31, 2024, the warrants are recorded in equity.

 

On December 21, 2023, warrants to purchase up to 9,972,074 shares of the Company’s Common Stock were exchanged for 613 shares of the Company’s series F-1 convertible and redeemable preferred stock (Series F-1 Shares, as defined below). The Series F-1 Shares, some of which were also issued based on the partial value of certain purchase rights, as described above, were immediately exchanged for Aditxt series A-1 preferred stock; 26,280 Series F-1 Shares were outstanding as of both September 30, 2025 and December 31, 2024; these shares are held by Aditxt.

 

As described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, on August 22, 2025, the Company entered into Exchange Agreements with certain SSN holders providing for the exchange of a portion of the SSNs due in the aggregate original principal and accrued interest amount of approximately $1.2 million into an aggregate 1,208 shares of Series G-1 Shares. The exchange was accounted for as a partial debt extinguishment via delivery of other financial assets and the difference between the fair value of the extinguished debt and the fair value of the Series G-1 Shares at issuance of an immaterial amount was recorded as a deemed dividend during the three months ended September 30, 2025.

 

Aditxt Notes and Warrants

 

On April 8, 2025, the Company entered into a securities purchase agreement (the Aditxt April SPA) with Aditxt providing for the sale and issuance of senior subordinated convertible notes due in the aggregate original principal amount of $2.3 million (the Aditxt April Note) and warrants to purchase an aggregate of 149,850,150 shares (the Aditxt April Warrants) of Common Stock of the Company, par value $0.0001 (collectively, the Aditxt April Offering). The Company waived Aditxt’s default under the terms of the A&R Merger Agreement due to the full Fifth Parent Investment, as defined in the Fifth Amendment to the A&R Merger Agreement, entered into on March 22, 2025 (the Fifth Amendment) not being made by the deadline set forth in the Fifth Amendment.

 

On June 26, 2025, the Company entered into a securities purchase agreement (the Aditxt June SPA) with Aditxt providing for the sale and issuance of senior subordinated convertible notes due in the aggregate original principal amount of $1.4 million (the Aditxt June Note, or together with the Aditxt April Note, the Aditxt Notes) and warrants to purchase an aggregate of 92,407,592 shares (the Aditxt June Warrants) of Common Stock of the Company, par value $0.0001 (collectively, the Aditxt June Offering).

 

In both the Aditxt April Offering and the Aditxt June Offering, Aditxt paid approximately $650 for each $1,000 of the principal amount of the Notes and Warrants and the Company issued a total of 242,257,742 warrants to purchase shares of Common Stock with an exercise price of $0.0154. In each of the Aditxt April Notes and the Aditxt June Notes, the notes are unsecured senior subordinated notes, have an interest rate of 8%, and mature three years from the respective issuance dates. The net proceeds after the offering costs to the Company from the Aditxt April Offering and Aditxt June Offering were approximately $2.4 million. Assuming the applicable conversion price per share, the Aditxt Notes could be converted into 250,021,436 shares of Common Stock as of September 30, 2025.

 

The Aditxt April Notes’ and the Aditxt June Notes’ interest rates are subject to increase to 12% upon an event of default and they have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the respective notes at a redemption premium of 32.5%. Aditxt can also require the Company to redeem the notes a) at the respective premium rate tied to the occurrence of certain subsequent transactions, and b) in the event of subsequent placements (as defined). Also, pursuant to the terms of the respective SPAs, Aditxt has certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions, and the shares of Company Common Stock underlying the Aditxt April Offering and the Aditxt June Offering are unregistered. Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) below the stated conversion rate and strike price at issuance.

 

The Company evaluated the Aditxt April Notes and Aditxt June Notes in accordance with ASC 480 and determined that the notes were all liability instruments at issuance. The notes were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable Aditxt Notes.

 

The Company also evaluated the Aditxt April Warrants and the Aditxt June Warrants in accordance with ASC 480 and ASC 815 and as of September 30, 2025 the warrants are recorded in equity.

 

Summary of SSNs and Warrants at Issuance (December 2022 to September 2023 and April to June 2025):

 

   Principal At Issuance   Net Proceeds Before Issuance                
Notes  (in
Thousands)		   costs (in
Thousands)		   Common
Warrants		   Preferred
Shares		  

Original

Maturity Date

 

Current

Maturity Date

  
December 2022 Notes(4)  $2,308   $1,500    369,230    70 - Series D    12/21/2025(4)  12/1/2026  
February 2023 Notes(1)(4)   1,385    900    653,538    -   2/17/2026(4)  12/1/2026  
March 2023 Notes(4)   600    390    240,000    -   3/17/2026(4)  12/1/2026  
March 2023 Notes(2)(4)   538    350    258,584    -   3/20/2026(4)  12/1/2026  
April 2023 Notes(4)   769    500    615,384    -   3/6/2026(4)  12/1/2026  
July 2023 Notes(4)   1,500    975    1,200,000    -   3/6/2026(4)  12/1/2026  
August 2023 Notes(4)   1,000    650    799,999    -   8/4/2026(4)  12/1/2026  
September 2023 Notes(3)(4)   2,885    1,875    26,997,041    -   9/26/2026(4)  12/1/2026  
Aditxt April Note   2,308    1,500    149,850,150    -   4/8/2028   4/8/2028  
Aditxt June Note   1,423    925    92,407,592    -   6/26/2028   6/26/2028  
Total Offerings  $14,716   $9,565    273,391,518               

 

(1) Warrants include 99,692 issued to the placement agent.
(2) Warrants include 43,200 issued to the placement agent.
(3) Warrants include 22,189,349 common warrants at $0.13 per share at issuance and 4,807,692 pre-funded warrants exercisable at $0.001 per share.
(4) As described above, for accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs. The maturity date under the Exchanged SSNs is December 1, 2026.

 

Short-term Debt

 

Insurance Premium Finance Agreement

 

In June 2024, the Company entered into an insurance premium finance agreement with First Insurance Funding (FIF) to finance a portion of the year’s D&O and general insurance policies. The total amount financed was $0.4 million at an annual interest rate of 8.57%. The Company made nine equal payments, commencing in July 2024. The Company recorded the total financed amount as a short-term debt on the condensed consolidated balance sheet as of December 31, 2024. The interest expense, included in other income (expense), net, in the condensed consolidated statement of operations, was immaterial for the three and nine months ended September 30, 2024.

 

In June 2025, the Company entered into an insurance premium finance agreement with First Insurance Funding (FIF) to finance a portion of its current policy year’s Directors and Officers (D&O) and general insurance policies. The total amount financed was $0.4 million at an annual interest rate of 7.82%. The Company will make eight equal payments, commencing in August 2025. The Company recorded the total financed amount as a short-term debt on the condensed consolidated balance sheets. The interest expense, included in other expense, net, in the condensed consolidated statement of operations, was immaterial for the three and nine months ended September 30, 2025.

 

 
v3.25.3
Balance Sheet Details
 9 Months Ended
Sep. 30, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Details

5. Balance Sheet Details

 

Inventories

 

Inventories consist of the following (in thousands):

    

   September 30, 2025   December 31, 2024 
Raw materials  $

134

   $350 
Work in process   

792

    982 
Finished goods   

758

    245 
Total  $

1,684

   $1,577 

 

Prepaid and Other Current Assets

 

Prepaid and other current assets consist of the following (in thousands):

  

   September 30, 2025   December 31, 2024 
Insurance  $

650

   $391 
Prescription Drug User Fee Act (PDUFA) fees   

-

    606 
Outside service retainers   

70

    160 
Short-term deposits   

127

    127 
Other   

112

    175 
Total  $959   $1,459 

 

Property and Equipment, Net

 

Property and equipment, net, consists of the following (in thousands):

    

   Useful Life   September 30, 2025   December 31, 2024 
Research equipment   5 years   $

96

   $585 
Computer equipment and software   3 years    34    145 
Construction in-process   -    402    429 
 Property and equipment, gross        532    1,159 
Less: accumulated depreciation        (112)   (701)
Total, net       $420   $458 

 

Depreciation expense for property and equipment was immaterial in each of the three and nine months ended September 30, 2025 and 2024, respectively.

 

 

Intangible Asset, Net

 

Intangible asset, net, acquired in July 2024, consists of the following (in thousands):

    

   Useful Life  September 30, 2025   December 31, 2024 
Intellectual property  16 years  $

6,267

   $10,216 
Less: accumulated amortization      (1,029)   (619)
Total, net     $5,238   $9,597 

 

The intangible asset relates entirely to the asset acquired with the SOLOSEC asset acquisition and, as described further in Note 7 – Commitments and Contingencies, the useful life is based on the SOLOSEC IP patent expiration. Amortization expense was $0.1 million and $0.4 million in the three and nine months ended September 30, 2025, respectively. Amortization expense is expected to be approximately $0.1 million for the remainder of 2025 and $0.4 million in each subsequent year until the intangible asset is fully amortized, which will be in approximately 14.9 years. As described in Note 2 – Summary of Significant Accounting Policies, the intangible asset value is adjusted at each reporting date in conjunction with the mark-to-market adjustment of the contingent liabilities, which could impact the expected amortization. The initial intangible asset fair value was $16.1 million at acquisition; this was reduced by $5.9 million for the year ended December 31, 2024. The net adjustment for the nine months ended September 30, 2025 was a reduction to the intangible balance of $3.9 million.

 

Accrued Expenses

 

Accrued expenses consist of the following (in thousands):

    

   September 30, 2025   December 31, 2024 
Clinical trial related costs  $

-

   $2,498 
Accrued royalty   39    1,976 
Accrued compensation for non-employee directors   697    505 
Other   627    530 
Total  $1,363   $5,509 

 
v3.25.3
Fair Value of Financial Instruments
 9 Months Ended
Sep. 30, 2025
Fair Value Disclosures [Abstract]  
Fair Value of Financial Instruments

6. Fair Value of Financial Instruments

 

Fair Value of Financial Liabilities

 

The following tables summarize the Company’s debt instruments as of September 30, 2025 and December 31, 2024, respectively (in thousands):

    

    Principal     Accrued     Net Carrying     Fair Value  
As of September 30, 2025   Amount     Interest     Amount     Amount     Leveling  
Baker Notes(1)(2)   $ 117,634     $ -     $ 117,634     $ 15,174       Level 3  
Adjuvant Notes(3)     22,500       9,667       32,167        N/A       N/A  
December 2022 Notes(1) (4)     629        -       629        233        Level 3  
February 2023 Notes (1) (4)     946        -       946        350        Level 3  
March 2023 Notes (1) (4)     1,100        -       1,100        407        Level 3  
April 2023 Notes (1) (4)     707        -       707        262        Level 3  
July 2023 Notes (1) (4)     1,380        -       1,380        511        Level 3  
August 2023 Notes (1) (4)     963        -       963        357        Level 3  
September 2023 Notes (1) (4)     3,283        -       3,283        1,215        Level 3  
Aditxt Notes(1)     3,850        -       3,850        983        Level 3  
Totals   $ 152,992     $ 9,667     $ 162,659     $ 19,492       N/A  

 

   Principal   Accrued   Net Carrying   Fair Value 
As of December 31, 2024  Amount   Interest   Amount   Amount   Leveling 
Baker Notes(1)(2)  $109,488   $-   $109,488   $13,801    Level 3 
Adjuvant Notes(3)   22,500    8,269    30,769    N/A     N/A 
December 2022 Notes(1) (4)   973    -    973    118    Level 3 
February 2023 Notes (1) (4)   980    -    980    120    Level 3 
March 2023 Notes (1) (4)   1,209    -    1,209    147    Level 3 
April 2023 Notes (1) (4)   883    -    883    108    Level 3 
July 2023 Notes (1) (4)   1,322    -    1,322    161    Level 3 
August 2023 Notes (1) (4)   1,119    -    1,119    136    Level 3 
September 2023 Notes (1) (4)   3,147    -    3,147    383    Level 3 
Totals  $141,621   $8,269   $149,890   $14,974    N/A 

 

(1) These liabilities are/were carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest was included in the determination of fair value. The related debt issuance costs were expensed.

 

(2) The Baker Notes principal amount includes $33.4 million and $24.9 million of interest paid in-kind as of September 30, 2025 and December 31, 2024, respectively.

 

(3) The Adjuvant Notes are recorded in the condensed consolidated balance sheets at their net carrying amount which includes principal and accrued interest.
   
(4) For accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs.

 

 

The following tables summarize the Company’s derivative liabilities as of September 30, 2025 and December 31, 2024 as discussed in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (in thousands):

   

   Fair Value     
   September 30, 2025   December 31, 2024   Leveling 
Purchase rights  $

1,140

   $1,359    Level 3 
Total derivative liabilities  $1,140   $1,359      

 

Change in Fair Value of Level 3 Financial Liabilities

 

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes, SSNs, and Aditxt Notes measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):

    

  

Baker Notes

(Assigned to

Future Pak;

Note 4)

  

Total SSNs

and Aditxt Notes
(Note 4)

   Total 
Balance at June 30, 2025  $14,609   $172   $14,781 
Extinguishment/conversion   -    (16)   (16)
Payments   (143)   -    (143)
Change in fair value presented in the condensed consolidated statements of operations   708    -    708 
Change in fair value presented in the condensed consolidated statements of comprehensive operations   -    4,162    4,162 
Balance at September 30, 2025  $15,174   $4,318   $19,492 

 

  

Baker Notes

(Assigned to

Future Pak;

Note 4)

  

Total SSNs

and Aditxt Notes
(Note 4)

   Total 
Balance at December 31, 2024  $13,801   $1,173   $14,974 
Balance at issuance   -    129    129 
Extinguishment/conversion   -    (16)   (16)
Payments   (391)   -    (391)
Change in fair value presented in the condensed consolidated statements of operations   708    -    708 
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,056    3,032    4,088 
Balance at September 30, 2025  $15,174   $4,318   $19,492 

 

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):

 

   Baker Notes
(Assigned to
Future Pak;
Note 4)		   Total SSNs
(Note 4)		   Total 
Balance at June 30, 2024  $12,280   $959   $13,239 
Balance at issuance   12,280    -    12,280 
Extinguishment/conversion   (12,280)   -    (12,280)
Payments   (125)   -    (125)
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,721    (652)   1,069 
Balance at September 30, 2024  $13,876   $307   $14,183 

 

  

Baker Notes

(Assigned to
Future Pak;

Note 4)

   Total SSNs
(Note 4)		   Total 
Balance at December 31, 2023  $13,510   $1,221   $14,731 
Balance at issuance   24,670    -    24,670 
Extinguishment/conversion   (25,790)   (51)   (25,841)
Payments   (378)   -    (378)
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,864    (863)   1,001 
Balance at September 30, 2024  $13,876   $307   $14,183 

 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):

 

   Purchase Rights  

Derivative

Liabilities Total

 
Balance at June 30, 2025  $3   $3 
Exercises   

-

   - 
Change in fair value presented in the condensed consolidated statements of operations   1,137    1,137
Balance at September 30, 2025  $1,140   $1,140 

 

   Purchase Rights  

Derivative

Liabilities Total

 
Balance at December 31, 2024  $1,359   $1,359 
Exercises   (1)   (1)
Change in fair value presented in the condensed consolidated statements of operations   (218)   (218)
Balance at September 30, 2025  $1,140   $1,140 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):

 

   Purchase Rights   Derivative
Liabilities
Total		 
Balance at June 30, 2024  $942   $942 
Exercises   (11)   (11)
Change in fair value presented in the condensed consolidated statements of operations   (769)   (769)
Balance at September 30, 2024  $162   $162 

 

   Purchase Rights   Derivative
Liabilities
Total		 
Balance at December 31, 2023  $1,926   $1,926 
Balance at issuance   3,300    3,300 
Exercises   (168)   (168)
Change in fair value presented in the condensed consolidated statements of operations   (4,896)   (4,896)
Balance at September 30, 2024  $162   $162 

 

 

Valuation Methodology

 

Baker Notes

 

The fair value of the Baker Notes is determined using a Monte Carlo simulation-based model and is subject to uncertainty due to the assumptions used in the model. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation. The Monte Carlo simulation takes into account several embedded features and factors and management inputs, including the exercise of the repurchase rights, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution. For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions related to forecasts of future revenue, and the selection of the royalty (5.0%) and discount (15.0%) rates.

 

Exchanged SSNs and Aditxt Notes

 

The fair value of the Exchanged SSNs and Aditxt Notes issued, as described in Note 4 – Debt, were determined by estimating the fair value of the Market Value of Invested Capital (MVIC) of the Company on a going-concern basis. This was estimated using a form of the market approach where comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An option-pricing model (OPM) was then applied to value the Exchanged SSNs by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating, the result is the incremental value allocated to each class under that series.

 

Purchase Rights

 

The Adjuvant Purchase Rights and the May Note Purchase Rights (collectively Purchase Rights) are recorded as derivative liabilities in the condensed consolidated balance sheets. The Purchase Rights are valued using an OPM, like a Black-Scholes model, with changes in the fair value being recorded in the condensed consolidated statements of operations. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price and the expected term the Purchase Rights will be held prior to exercise and a risk-free interest rate.

 

 

Warrants

 

Warrants are classified as equity and the Company re-evaluates the classification of its warrants at the close of each reporting period to determine their proper balance sheet classification. The warrants are valued using an OPM based on the applicable assumptions, which include the exercise price of the warrants, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price, the expected term the warrants will be held prior to exercise, a risk-free interest rate, and probability of change of control event. Additionally, because the warrants are re-priced under certain provisions in the agreements, at each re-pricing event the Company must value the warrants using a Black-Scholes model immediately prior to and immediately following the re-pricing event. The incremental fair value is recorded as an increase to accumulated deficit and additional paid-in capital, in accordance with ASC 470.

 

SOLOSEC Asset Acquisition Intangible Asset and Contingent Liabilities

 

The total consideration for the SOLOSEC asset acquisition included an up-front payment (paid at closing), sales-based payments to be paid over the next 15 years (the Earnout Term) in each year in which SOLOSEC adjusted net revenue is over a specified threshold, a $10.0 million one-time payment once the cumulative SOLOSEC adjusted net revenues reach $100 million, and assumption of quarterly royalty payments based on SOLOSEC net revenue. As discussed in Note 7 – Commitments and Contingencies, the fair value of the consideration is attributed to the SOLOSEC product line and was therefore recorded as an intangible asset.

 

The fair value of the total consideration, including cash paid and future sales-based payments, is determined using a Monte Carlo simulation model, which assumes the Company’s revenue follows a geometric Brownian motion. Using specific revenue factors, including expected growth, risk adjustments, and revenue volatility, future revenues were simulated through the Earnout Term to assess whether sales-based payments would be triggered in each relevant period, as stipulated by the SOLOSEC Asset Purchase Agreement. The average output of the Monte Carlo simulations for each period provides the expected payment value, which is then discounted to its present value to derive the fair value of future sales-based payments and recorded as contingent liabilities. The discount rate is a market index rate based on the Company’s credit risk.

 

The fair value of the SOLOSEC contingent liabilities is subject to uncertainty due to the assumptions made by management that are used in the Monte Carlo simulation-based model. These factors include the estimated future SOLOSEC net revenue, the risk-neutral revenue calculation and simulation assumptions, payment timing, and the discount rate.

 

The fair value of the SOLOSEC contingent liabilities will be updated at each reporting period using the methodology described above. Any changes to the fair value will be recorded as an adjustment to the carrying value of both the contingent liabilities and the SOLOSEC IP intangible asset as per ASC 323, Investments – Equity Method and Joint Ventures (ASC 323). Periodic intangible amortization will also be prospectively updated based on the new fair value of the SOLOSEC IP.

 
v3.25.3
Commitments and Contingencies
 9 Months Ended
Sep. 30, 2025
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7. Commitments and Contingencies

 

SOLOSEC

 

The Company reviewed the SOLOSEC acquisition in accordance with ASC 805, Business Combinations (ASC 805), including applying the screen test. In accordance with ASC 805, the Company engaged a third-party valuation specialist to estimate the fair value for the SOLOSEC IP as well as for the total consideration. Per the valuation, the fair value of the SOLOSEC IP exceeded 90% of the total consideration, which indicates that the screen test failed. Further, the Company did not acquire any substantive processes, which indicates that the acquisition is an asset acquisition rather than a business combination. The Company recorded the fair value of the future sales-based payments as contingent liabilities in accordance with ASC 450, Contingencies (ASC 450) and the fair value of the total consideration plus the transaction costs as an intangible asset in accordance with ASC 350, Intangibles (ASC 350).

 

Per the Transition Services Agreement (TSA) entered into in conjunction with the SOLOSEC asset acquisition, the Company is committed to purchasing finished goods inventory from the seller through a transition period ending in November 2026 at a pre-defined unit price. The total expected commitment is approximately $3.5 million; however, the quantities to be purchased can be negotiated if both parties agree. The Company concluded that the inventory purchase commitment does not meet the definition of a derivative under ASC 815. During the three and nine months ended September 30, 2025, there were approximately $0.4 million and $0.8 million in purchases under this commitment, respectively. The Company expects to purchase approximately $0.6 million in the remainder of the year ending December 31, 2025, and $1.9 million in the year ended December 31, 2026 under this commitment. The TSA also required the seller to provide transitional support services until the Company fully established SOLOSEC operations; the Company was obligated to pay an immaterial amount quarterly for these services.

 

The Company is also obligated to pay a quarterly royalty, in amounts equal to a certain percentage of the SOLOSEC net revenue, beginning July 14, 2024. There are no minimum quarterly or annual royalty payment amounts. Such royalty costs were immaterial and $0.1 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, $0.2 million and $5.4 million related to the future payments related to the SOLOSEC acquisition, including sales-based payments, one-time payment, and quarterly royalty payments, was included in contingent liabilities – current and contingent liabilities – noncurrent, respectively, in the condensed consolidated balance sheet. Such amounts were $0.7 million and $9.7 million, respectively, as of December 31, 2024.

 

 

Fleet Lease

 

In December 2019, the Company and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement whereby the Company leases vehicles to be delivered by the Lessor from time to time with various monthly costs depending on whether the vehicles are delivered for a term of 24 or 36 months, commencing on each corresponding delivery date. The leased vehicles are for use by eligible employees of the Company’s commercial operations team. As of September 30, 2025, there were a total of 18 leased vehicles.

 

The Company determined that the leased vehicles are accounted for as operating leases under ASC 842, Leases (ASC 842). In May and June 2024, the Company extended the lease term by an additional 12 months for vehicles with initial terms of 24 months. The Company determined that such extensions were accounted for as modifications; the Company reassessed the lease classification and the incremental borrowing rate on the modification date and accounted for these modifications accordingly.

 

In the second and third quarter of 2025, the Company replaced the leased vehicles; the vehicles have a lease term of 24 months. In conjunction with the new leases, the Company assessed the incremental borrowing rate and also determined that the leased vehicles should be accounted for as operating leases under ASC 842.

 

Supplemental Financial Statement Information

 

     

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
Lease Cost (in thousands)  Classification  2025   2024   2025   2024 
Operating lease expense  Research and development  $

1

   $-   $

3

   $2 
Operating lease expense  Selling and marketing   11    40    86    135 
Operating lease expense  General and administrative   2    3    8    8 
Total     $14   $43   $97   $145 

 

Lease Term and Discount Rate  September 30, 2025   December 31, 2024 
Weighted Average Remaining Lease Term (in years)   1.65    0.77 
Weighted Average Discount Rate   12%   12%

 

Maturity of Operating Lease Liabilities (in thousands)  September 30, 2025 
Remainder of 2025 (3 months)  $34 
Year ending December 31, 2026   127 
Year ending December 31, 2027   52 
Total lease payments   213 
Less imputed interest   (17)
Total  $196 

 

         
   Nine Months Ended September 30, 
Other information (in thousands)  2025   2024 
Operating cash outflows in operating leases  $94   $218 
Non-cash addition to ROU assets and lease liabilities due to new leases  $201   $90 

 

Other Contractual Commitments

 

In November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture PHEXX, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were $0.3 million and $1.1 million in purchases under the supply and manufacturing agreement for the three and nine months ended September 30, 2025, respectively, and $0.8 million and $1.0 million in purchases during each of the three and nine month periods ended September 30, 2024.

 

Related Party Transactions

 

Windtree

 

On March 20, 2025, Windtree Therapeutics, Inc. (Windtree) and the Company entered into a License and Supply Agreement, as amended on March 28, 2025 (collectively, the Windtree License and Supply Agreement), wherein Windtree agreed to become a manufacturer and supplier of PHEXX. The Company expects to significantly reduce its COGS once the Company begins selling PHEXX manufactured under the Windtree License and Supply Agreement. The Company will not have any financial obligations until submitting a binding forecast six months prior to the scheduled manufacturing date. Because Saundra Pelletier, the Company’s CEO, is also on the board of Windtree, the Company evaluated the relationship between the entities and determined that Windtree is a related party of the Company. Due to the related party nature of the entities, the Company will add additional disclosures around any transactions that occur between the companies under the Windtree License and Supply Agreement once they begin; as of the date of this Quarterly Report, no transactions have been started.

 

Aditxt

 

Aditxt was considered a related party of the Company during the three and nine months ended September 30, 2025 because Saundra Pelletier, the Company’s Chief Executive Officer, served as a member of Aditxt’s Board of Directors from June 9, 2025 until September 23, 2025. Ms. Pelletier’s term expired on that date.

 

Merger

 

On July 14, 2024, the Company entered into an Amended and Restated Agreement and Plan of Merger (the “A&R Merger Agreement”) with Aditxt, Inc. (“Aditxt”), pursuant to which Aditxt was expected to acquire the Company in an all-stock transaction. The A&R Merger Agreement was amended several times, including the Sixth Amendment to the A&R Merger Agreement, entered into on August 26, 2025 (the Sixth Amendment). The Sixth Amendment was entered into to (i) amend section 1.5 and 3.1(b)(ii) to update the definition of “Unconverted Company Preferred Stock” to include Series G-1 Shares; (ii) amend section 1.6 to update the definition of “Company Shareholder Approval” to include the outstanding shares of Company Common Stock (including all of the Company’s Preferred Stock, on the basis and to the extent it is permitted to so vote) entitled to vote thereon and each series of the Unconverted Company Preferred Stock; (iii) amend section 6.23 to clarify that the Company will assist in obtaining Exchange Agreements (as defined in the A&R Merger Agreement, as amended) to exchange Company convertible notes and purchase rights for an aggregate of not more than 89,021 shares of Parent Preferred Stock from the applicable Company shareholders; (iv) amend section 7.2(j) to change the number of dissenting shares to no more than 5,932,818 shares of Common Stock or 202 shares of Preferred Stock; (v) add a new section 7.2(k) to require waivers from each holder of the Company’s E-1 Convertible Preferred Stock, with respect to the last sentence of Section 2, the entirety of Section 6, any price adjustment provisions that may be triggered under Section 8(a)(ii), Section 12(c), and Section 12(d) of the Series E-1 Certificate of Designations; and (vi) to replace, in its entirety, the Certificate of Designations for Exchanged Parent Preferred Stock included as Exhibit C to the A&R Merger Agreement.

 

On October 20, 2025, the Company terminated the A&R Merger Agreement after the proposed merger was not approved by the Company’s stockholders. No termination fee or other cash consideration was paid by either party, and no further obligations remain under the agreement.

 

Notes

 

As discussed in Note 4 – Debt, on April 8, 2025 and June 26, 2025, the Company entered into two securities purchase agreements with Aditxt (the Aditxt April Note and the Aditxt June Note). Under these agreements the Company issued senior subordinated convertible notes in the aggregate original principal amount of $3.7 million and warrants to purchase up to 242,257,742 shares of the Company’s Common Stock. The notes bear interest at 8%, mature three years from issuance, and were issued at a discount of $650 per $1,000 of principal. Net cash proceeds to the Company were approximately $2.4 million. The warrants have an exercise price of $0.0154 per share.

 

Adjuvant

 

Because Adjuvant has significant voting power due to its increased beneficial ownership limitation, the Company evaluated the relationship between the entities and determined that Adjuvant is a related party of the Company. Except for the exchange from the Adjuvant Notes to Series G-1 Shares during the third quarter of 2025 as described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, and the Adjuvant Third Amendment as described and defined in Note 10 – Subsequent Events, there was no other transaction occurred between two entities in 2025.

 

 

Contingencies

 

From time to time the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. As of September 30, 2025, there were no other claims or actions pending against the Company which management believes have a probable, or a reasonably possible, probability of an unfavorable outcome other than the TherapeuticsMD, Inc. (TherapeuticsMD) dispute as described below.

 

During the nine months ended September 30, 2025, the Company settled a portion of its trade payables with numerous vendors, which resulted in a $3.1 million reduction in trade payables and a $2.5 million reduction in accrued expenses. However, the Company may receive trade payable demand letters from other vendors that could lead to potential litigation. As of September 30, 2025, approximately 75% of the Company’s trade payables were greater than 90 days past due.

 

On December 14, 2020, a trademark dispute captioned TherapeuticsMD, Inc. v Evofem Biosciences, Inc., was filed in the U.S. District Court for the Southern District of Florida against the Company, alleging trademark infringement of certain trademarks owned by TherapeuticsMD under federal and state law (Case No. 9:20-cv-82296). On July 18, 2022, the Company settled the lawsuit with TherapeuticsMD, with certain requirements which were required to be performed by July 2024 (the Settlement Timeline), including changing the name of PHEXX. The Company failed to meet the terms of the settlement agreement by the Settlement Timeline. As a result, the Company is currently working with TherapeuticsMD on resolution of this issue. In September 2024, the Company filed an application for a new name, which was approved by the FDA in April 2025. The Company is advancing its re-branding plans and timeline. In accordance with ASC 450, the Company has accrued the present value of the probable settlement amounts remaining payable over the next several years, which was $0.4 million and $0.8 million as of September 30, 2025 and December 31, 2024, respectively, as a component of contingent liabilities in the condensed consolidated balance sheets.

 

As of September 30, 2025, the Company has received multiple letters from purported Company stockholders demanding that the Company’s board of directors take action on behalf of the Company to remedy allegations regarding the Company’s disclosures to shareholders with respect to various alleged omissions of material information in both its preliminary proxy statement filed September 23, 2024 and definitive proxy statement filed September 8, 2025 relating to the A&R Merger Agreement, as amended, and demands made under Section 220 of the DGCL for books and records related to the transaction and disclosures in the proxy statement. The Company believes all such demands are without merit. Furthermore, on October 20, 2025, the Company terminated the A&R Merger Agreement after the Merger was not approved by the required number of shareholders at the Special Meeting as further discussed in Note 10 – Subsequent Events. The Company continues to work with each of the firms representing the stockholders to resolve.

 

On September 27, 2024, Future Pak, LLC, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Baker Bros. SPA, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The Notice of Default claims that by entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. SPA. According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to $106.8 million. Pursuant to Section 5.7(b) of the Baker Bros. SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).

 

On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Notice of Default which adds additional claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Securities Purchase and Security Agreement dated April 23, 2020, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (the Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the Baker Bros. SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024. The Company strongly disagrees with the Designated Agent’s claim that any Event of Default has occurred.

 

 

On November 8, 2024, the Designated Agent sent an amended and supplemented notice to the Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the Baker Bros. SPA.

 

Intellectual Property Rights

 

In 2014, the Company entered into an amended and restated license agreement (the Rush License Agreement) with Rush University Medical Center (Rush University), pursuant to which Rush University granted the Company an exclusive, worldwide license of a patent and certain know-how related to its vaginal pH modulator technology (US6706276, the Rush Patent). Pursuant to the Rush License Agreement, until the expiration of the Rush Patent, the Company was obligated to pay Rush University an earned royalty during the patent term, calculated as a mid-single digit percentage of PHEXX net sales (the Rush Royalty). In September 2020, the Company entered into the first amendment to the Rush License Agreement, pursuant to which the Company agreed to pay a minimum annual royalty amount of $0.1 million to the extent the earned royalties did not equal or exceed $0.1 million commencing January 1, 2021 until the expiration of the patent, including any granted Patent Term Extensions (PTEs).

 

The Rush Patent would expire on March 6, 2021 (the Original Expiration Date) if no PTE was obtained. Rush University filed an application for PTE in July 2020, which would extend the expiration date of the Rush Patent to March 6, 2026 if granted. Multiple Orders Granting Interim Extension (OGIEs) were received from the U.S. Patent and Trademark Office (USPTO) while the PTE was under evaluation. The last OGIE expired on March 6, 2025.

 

Because the USPTO had granted multiple OGIEs to Rush University, between the date of the original PTE application (July 2020) and the final OGIE expiration (March 2025), the Company determined it was probable that the PTE extending the expiration to March 6, 2026 would be granted. Therefore, the Company accrued a total of $2.8 million related to the Rush Royalty as a contingent liability after the Original Expiration Date in accordance with ASC 450, of which $0.9 million was paid in good faith and $1.9 million was unpaid and included in accrued expenses in the condensed consolidated balance sheet as of December 31, 2024.

 

During the first quarter of 2025, the Company’s legal counsel ascertained that no further OGIEs were granted after March 6, 2025 and the PTE had also still not been granted. As a result, the Company discontinued accruing the Rush Royalty since, based on the new information, the Company deemed it remote that the PTE would ultimately be granted. Amounts previously accrued under the rush License Agreement were still being assessed at that time and as such, no adjustments were made. No royalty costs were recorded for the three and nine months ended September 30, 2025. For the three and nine months ended September 30, 2024, $0.2 million and $0.6 million, respectively, of Rush Royalty costs were recorded in cost of goods sold.

 

Furthermore, in August 2025 the FDA confirmed that the relevant active ingredient covered by the Rush Patent had previously been used in other FDA-approved products and, as such, no PTE should be granted, the Company and its legal counsel determined that the Rush Patent expired on the Original Expiration Date and as such it is no longer probable that the Company will be required to pay any expenses related to the Rush Royalty accrued after that date. The Company reversed the outstanding accrued Rush Royalty contingent liability of $1.9 million during the three months ended September 30, 2025. Because the gain was material to cost of goods sold, the amount was presented separately on the condensed consolidated statement of operations as a gain on change in accounting estimates on contingent royalty liability.

 

If the Company determines to pursue a refund of the estimated royalties paid but not earned per its current analysis, it could potentially receive a refund of $0.9 million from Rush University (the amount paid for royalties accrued after the Original Expiration Date). Conversely, if Rush University pursues payment of the amounts accrued but not paid for the time covered by the OGIEs, the maximum liability that the Company could incur is approximately $2.3 million. Based on the current analysis, the Company could have an additional gain of up to $0.9 million or a loss of up to $2.3 million.

 

Our vaginal pH modulator (PHEXX) remains protected in the U.S. by four Orange Book patents which are solely-owned by Evofem.

 
v3.25.3
Convertible and Redeemable Preferred Stock and Stockholders’ Deficit
 9 Months Ended
Sep. 30, 2025
Equity [Abstract]  
Convertible and Redeemable Preferred Stock and Stockholders’ Deficit

8. Convertible and Redeemable Preferred Stock and Stockholders’ Deficit

 

Warrants

 

In April and June 2020, pursuant to the Baker Bros. Purchase Agreement, as discussed in Note 4 – Debt, the Company issued warrants to purchase up to 2,731 shares of Common Stock in a private placement at an exercise price of $4,575 per share. The Second Baker Amendment provides that the exercise price of the Baker Warrants will equal the conversion price of the Baker Notes. The exercise price of the Baker warrants was $0.0154 per share as of September 30, 2025.

 

 

In May 2022, the Company completed an underwritten public offering (the May 2022 Public Offering) which included the issuance of common warrants to purchase 362,640 shares of Common Stock at a price to the public of $93.75 and the issuance of common warrants to purchase 205,360 shares of Common Stock at a price to the public of $93.63 (the May 2022 Common Stock Warrants). The May 2022 Common Stock Warrants were exercisable beginning on May 24, 2022 and have a five-year term. Due to features in the May 2022 Common Stock Warrants, including dilution adjustments requiring strike price resets, additional warrants have been periodically issued as required in the warrant agreements. As of September 30, 2025, there were 894,194 May 2022 Common Stock Warrants outstanding with an exercise price of $0.0154.

 

In June 2022, as required by the Second Baker Amendment, the Company issued the June 2022 Baker Warrants to purchase up to 582,886 shares of the Company’s Common Stock, $0.0001 par value per share. The June 2022 Baker Warrants have an exercise price of $93.75 per share and a five-year term and were exercisable beginning June 28, 2022. The June 2022 Baker Warrants also contain customary 4.99% and 19.99% limitations on exercise provisions. The exercise price and number of shares issuable upon exercise of the June 2022 Baker Warrants is subject to adjustment for certain dilutive issuances, stock splits and similar recapitalization transactions. The exercise price of these warrants was $0.0154 per share as of September 30, 2025.

 

In February, March, April, July, August, and September 2023, pursuant to the SSNs as discussed in Note 4 – Debt, the Company issued warrants to purchase up to 1,152,122 shares of the Company’s Common Stock at an exercise price of $2.50 per share, up to 2,615,383 shares of the Company’s Common Stock at an exercise price of $1.25 per share, and up to 22,189,349 shares of the Company’s Common Stock at an exercise price of $0.13 per share. The exercise price of these warrants was $0.0154 per share as of September 30, 2025. During the second quarter of 2025, pursuant to the Aditxt Notes, as discussed in Note 4 – Debt, the Company issued warrants to purchase up to 242,257,742 shares of the Company’s Common Stock at an exercise price of $0.0154 per share.

 

On December 21, 2023, warrants to purchase up to 9,972,074 shares of the Company’s Common Stock were exchanged for 613 shares of the Company’s Series F-1 Shares.

 

As of September 30, 2025, warrants to purchase up to 263,062,099 shares of the Company’s Common Stock remain outstanding at a weighted average exercise price of $0.18 per share. In accordance with ASC 815, the warrants are classified as equity instruments as of both September 30, 2025 and December 31, 2024. During the first quarter of 2024, the Company obtained waivers from a majority of the convertible instrument holders, removing the requirement for shares to be reserved for conversion of their instruments, which will prevent the instruments from needing to be liability classified due to an insufficient number of authorized shares going forward. The Company will continue to re-evaluate the classification of its warrants at the close of each reporting period to determine the proper balance sheet classification for them. These warrants are summarized below:

 

Type of Warrants  Underlying Common Stock
to be Purchased		   Exercise Price   Issue Date  Exercise Period 
Common Warrants   888   $11,962.50   April 11, 2019   October 11, 2019 to April 11, 2026 
Common Warrants   1,480   $11,962.50   June 10, 2019   December 10, 2019 to June 10, 2026 
Common Warrants   8,003   $735.00   January 13, 2022   March 1, 2022 to March 1, 2027 
Common Warrants   8,303   $897.56   March 1, 2022   March 1, 2022 to March 1, 2027 
Common Warrants   6,666   $309.56   May 4, 2022   May 4, 2022 to May 4, 2027 
Common Warrants   894,194   $0.0154   May 24, 2022   May 24, 2022 to May 24, 2027 
Common Warrants   582,886   $0.0154   June 28, 2022   May 24, 2022 to June 28, 2027 
Common Warrants   49,227   $0.0154   December 21, 2022   December 21, 2022 to December 21, 2027 
Common Warrants   130,461   $0.0154   February 17, 2023   February 17, 2023 to February 17, 2028 
Common Warrants   258,584   $0.0154   March 20, 2023   March 20, 2023 to March 20, 2028 
Common Warrants   369,231   $0.0154   April 5, 2023   April 5, 2023 to April 5, 2028 
Common Warrants   349,463   $0.0154   July 3, 2023   July 3, 2023 to July 3, 2028 
Common Warrants   615,384   $0.0154   August 4, 2023   August 4, 2023 to August 4, 2028 
Common Warrants   12,721,893   $0.0154   September 27, 2023   September 27, 2023 to September 27, 2028 
Common Warrants   149,850,150   $0.0154   April 8, 2025   April 8, 2025 to April 8, 2030 
Common Warrants   92,407,592   $0.0154   June 26, 2025   June 26, 2025 to June 26, 2030 
Prefunded Common Warrants   4,807,694   $0.0010   September 27, 2023   September 27, 2023 to September 27, 2028 
Total   263,062,099              

 

Preferred Stock

 

Effective December 15, 2021, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized to issue up to 5,000,000 shares of total preferred stock. The certificate of incorporation was further amended several times, most recently on August 22, 2025 in order to authorize various series of convertible and redeemable preferred stock; authorized series currently include convertible and redeemable preferred stock designated for Series B-1 and B-2, Series C, Series E-1, Series F-1, Series G-1, and nonconvertible and redeemable preferred stock (Series D), par value $0.0001 per share.

 

 

Convertible and Redeemable Preferred Stock

 

On August 7, 2023, the Company filed a Certificate of Designation of Series E-1 Convertible Preferred Stock (E-1 Certificate of Designation), par value $0.0001 per share (the Series E-1 Shares). On June 30, 2025, the holders of a majority of issued and outstanding shares of the Series E-1 Shares approved by written consent in lieu of a meeting the Amended and Restated Certificate of Designations of Series E-1 Convertible Preferred Stock (the A&R E-1 Certificate of Designations). The Company’s Board of Directors also approved the A&R E-1 Certificate of Designations on June 30, 2025. The A&R E-1 Certificate of Designations increases the number of total authorized shares from 2,300 to 10,000 in order to authorize a sufficient number of shares for the payment of dividends in kind in the form of additional shares of Series E-1 Shares and update certain definitions. The A&R E-1 Certificate of Designations became effective on September 30, 2025. The Series E-1 Shares are convertible into shares of Common Stock at a conversion price of $0.40 per share, as adjusted, and are both counted toward quorum on the basis of and have voting rights equal to the number of shares of Common Stock into which the Series E-1 Shares are then convertible. The Series E-1 Shares are senior to all Common Stock with respect to preferences as to dividends, distributions, and payments upon a dissolution event. In the event of a liquidation event, the Series E-1 Shares are entitled to receive an amount per share equal to the Black Scholes Value as of the liquidation event plus the greater of 125% of the conversion amount (as defined in the Certificate of Designation) and the amount the holder of the Series E-1 Shares would receive if the shares were converted into Common Stock immediately prior to the liquidation event. If the funds available for liquidation are insufficient to pay the full amount due to the holders of the Series E-1 Shares, each holder will receive a percentage payout. The Series E-1 Shares were entitled to dividends at a rate of 10% per annum (which increased as per the provision below as of April 1, 2025) or 12% upon a triggering event. On the 18-month anniversary of the initial issuance date for the Series E-1 convertible preferred stock, the dividend rate increased by 30% and will remain at that rate until no E-1 Shares remain outstanding. Dividends are payable in shares of Common Stock and may, at the Company’s election, be capitalized and added to the principal balance of Series E-1 Shares monthly. The Series E-1 Shares also have a provision that allows them to be converted to Common Stock at a conversion rate equal to the Alternate Conversion Price (as defined in the Certificate of Designation) times the number of shares subject to conversion times the 25% redemption premium in the event of a Triggering Event (as defined in the Certificate of Designation) such as in a liquidation event. The Series E-1 Shares are mandatorily redeemable in the event of bankruptcy. Series E-1 Shares rank higher than all shares of the Company’s Common Stock and Series F-1 Shares (defined below) with respect to the preferences as to dividends and any distributions and payments upon the liquidation, dissolution, and winding up of the Company.

 

On August 7, 2023, certain investors party to the December 2022 Notes and the February 2023 Notes exchanged $1.8 million total in principal and accrued interest under the outstanding convertible promissory notes for 1,800 shares of Series E-1 Shares (the August 2023 Preferred Stock Transaction). Per the Series E-1 Convertible Preferred Stock Certificate of Designation, the conversion rate can also be adjusted in several future circumstances, such as on certain dates after the exchange date and upon the issuance of additional convertible securities with a lower conversion rate or in the instance of a Triggering Event. As such, the conversion price has been adjusted several times and was $0.0154 as of September 30, 2025. The Series E-1 Shares are classified as mezzanine equity within the condensed consolidated balance sheets in accordance with ASC 480 because of a fixed 25% redemption premium upon a Triggering Event and no mandatory redemption feature. During the three and nine months ended September 30, 2025, $0.1 million in deemed dividends were recorded as an increase to the Series E-1 Shares outstanding for each period. During the three and nine months ended September 30, 2024, an immaterial amount and $0.1 million, respectively, in deemed dividends were recorded as an increase to the number of Series E-1 Shares outstanding.

 

On December 11, 2023, the Company filed a Certificate of Designation of Series F-1 Convertible Preferred Stock (F-1 Certificate of Designation), par value $0.0001 per share (the Series F-1 Shares). An aggregate of 95,000 shares was authorized. The Series F-1 Shares are convertible into shares of Common Stock at a conversion price of $0.0635 per share and do not have the right to vote on any matters presented to the holders of the Company’s Common Stock. The Series F-1 Shares are senior to all Common Stock and subordinate to the Series E-1 Shares with respect to preferences as to distributions and payments upon a dissolution event. In the event of a liquidation event, the Series F-1 Shares are entitled to receive an amount per share equal to the Black Scholes Value as of the liquidation event plus the greater of 125% of the conversion amount (as defined in the F-1 Certificate of Designation) and the amount the holder of the Series F-1 Shares would receive if the shares were converted into Common Stock immediately prior to the liquidation event. If the funds available for liquidation are insufficient to pay the full amount due to the holders of the Series F-1 Shares, each holder will receive a percentage payout. The Series F-1 Shares are not entitled to dividends. The Series F-1 Shares also have a provision that allows them to be converted to Common Stock at a conversion rate equal to the Alternate Conversion Price (as defined in the F-1 Certificate of Designation) times the number of shares subject to conversion times the 25% redemption premium in the event of a Triggering Event (as defined in the F-1 Certificate of Designation) such as in a liquidation event. The Series F-1 Shares are mandatorily redeemable in the event of bankruptcy. In June 2024, the Required Holders, as defined in the F-1 Certificate of Designation, approved an amended and restated certificate of designation (the Amended F-1 Certificate of Designation) to the Company’s certificate of designation designating the rights, preferences, and limitations of the Company’s Series F-1 Shares. Series F-1 Shares rank higher than all shares of the Company’s Common Stock with respect to the preferences as to dividends and any distributions and payments upon the liquidation, dissolution, and winding up of the Company. The Amended F-1 Certificate of Designation provides for the removal of the conversion price adjustment provisions previously included and changed the conversion price to $0.0154.

 

On December 21, 2023, the Company issued a total of 22,280 Series F-1 Shares to certain investors pursuant to an exchange transaction, 613 of the Series F-1 Shares were issued in exchange for warrants to purchase up to 9,972,074 shares of the Company’s Common Stock and 21,667 Series F-1 Shares to exchange a partial value of the outstanding purchase rights. Immediately subsequent to the exchange transaction, the holders of the Series F-1 Shares exchanged their Series F-1 Shares for Aditxt’s Series A-1 preferred stock, and as a result, Aditxt currently holds the Company’s Series F-1 Shares.

 

During the second half of 2024, as part of the funding requirement by Aditxt pursuant to the A&R Merger Agreement, the Company issued a total of 4,000 Series F-1 Shares to Aditxt for an aggregate purchase price of $4.0 million. Additionally, Aditxt also paid the Company $1.0 million in May 2024 in conjunction with signing the Reinstatement and Fourth Amendment to the Merger Agreement. The 4,000 Series F-1 Shares were recorded at fair value with the variance between the immaterial fair value and the total $5.0 million cash received being recorded as additional paid-in-capital in the condensed consolidated balance sheet. As discussed in Note 7 – Related Party Transactions, Aditxt currently holds all outstanding Series F-1 Shares. Accordingly, transactions related to the Series F-1 Preferred Stock are considered related-party transactions under ASC 850.

 

 

On August 22, 2025, the Company filed a Certificate of Designations creating the Series G-1 Preferred Stock (G-1 Certificate of Designations), par value $0.0001 per share (the Series G-1 Shares). The Company’s Board of Directors approved the G-1 Certificates of Designations on August 22, 2025 and the G-1 Certificate of Designations became effective upon filing with the State of Delaware on the same day. Subsequently on August 22, 2025, the Company entered into Exchange Agreements with certain investors (the G-1 Investors) providing for the exchange of certain SSNs and a portion of the Adjuvant Notes due in the aggregate original principal and accrued interest amount of approximately $1.6 million into an aggregate 1,573 shares of Series G-1 Shares (collectively, the G-1 Offering). The Series G-1 Preferred Shares entitles the holder thereof to vote together with the common shareholders as a single class and to cast that number of votes per share as is equal to the number of shares of Common Stock into which it is then convertible. Each of the Series G-1 Shares has a stated value of $1,000 per share and is convertible into shares of Common Stock at a rate determined by dividing (i) the stated value of such Series G-1 Shares plus any declared and unpaid dividends on such shares by (ii) the conversion price of $0.0154 per share, subject to adjustment as provided in the Certificate of Designations. The Certificate of Designations also provides that in the event of certain Triggering Events (as defined below), any holder may, at any time, convert any or all of such holder’s Series G-1 Shares at a conversion rate equal to the product of (i) the Alternate Conversion Price (as defined below) and (ii) the quotient of (x) the 25% redemption premium multiplied by (y) the amount of Series G-1 Preferred Stock subject to such conversion. Triggering Events include, among others, (i) a failure to timely deliver shares of Common Stock, upon a conversion, (ii) a suspension of trading or the failure to be traded or listed on an eligible market for five consecutive days or more, (iii) the failure to pay any dividend to the holders of Series G-1 Preferred Stock when required, (iv) the failure to remove restrictive legends when required, (v) proceedings for a bankruptcy, insolvency, reorganization or liquidation, which are not dismissed with 30 days, (vi) commencement of a voluntary bankruptcy proceeding, and (vii) final judgments against the Company for the payment of money in excess of $0.1 million. Alternate Conversion Price means the lowest of (i) the applicable conversion price the in effect, (ii) 80% of the volume weighted average price (VWAP) of the Common Stock on the trading day immediately preceding the delivery of the applicable conversion notice, (iii) 80% of the VWAP of the Common Stock on the trading day of the delivery of the applicable conversion notice and (iv) 80% of the price computed as the quotient of (I) the sum of the VWAP of the Common Stock for each of the three (3) trading days with the lowest VWAP of the Common Stock during the fifteen (15) consecutive trading day period ending and including the trading day immediately preceding the delivery of the applicable conversion notice, divided by (II) three (3). Each holder of Series G-1 Shares is entitled to receive dividends at a rate of 8% per annum, paid in the form of Common Stock or paid-in-kind as additional shares of Series G-1 Shares, at the Company’s discretion (the Series G-1 Dividends) payable to the holders of the Series G-1 Shares on a monthly basis.

 

The fair value of the G-1 Shares issued was determined by estimating the fair value of the MVIC of the Company on a going-concern basis. This was estimated using a form of the market approach where comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An OPM was then applied to value the G-1 Shares by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating, the result is the incremental value allocated to each class under that series.

 

Common Stock

 

Effective September 14, 2023, the Company further amended its amended and restated certificate of incorporation to increase the number of authorized shares of Common Stock to 3,000,000,000 shares.

 

Purchase Rights

 

On September 15, 2022, the Company entered into certain exchange agreements with the Adjuvant Purchasers and the May 2022 Notes Purchasers to exchange, upon request, the Purchase Rights for an aggregate of 942,080 shares of the Company’s Common Stock. The number of right shares for each Purchase Right is initially fixed at issuance, but subject to certain customary adjustments for certain dilutive Company equity issuances until the second anniversary of issuance. These Purchase Rights expire on June 28, 2027. Refer to Note 6 – Fair Value of Financial Instruments for the accounting treatment of the Purchase Rights. In 2023, the Company subsequently signed an additional agreement with the holders of the Purchase Rights upon which the total aggregate value of the Purchase Rights is fixed at $24.7 million, to be paid in a variable number of shares based on the current exercise price. On December 21, 2023, the Company issued 21,667 shares of the Series F-1 Shares in exchange for a partial value of certain purchase rights, as described above.

 

In connection with the SSNs issuances, during the three and nine months ended September 30, 2024, the Company increased the number of outstanding Purchase Rights by zero and 1,161,636,815, respectively, due to the reset of their exercise price. This was recorded as a loss on issuance of financial instruments as an immaterial amount in the condensed consolidated statements of operations for each period. No such exercise price reset occurred during the three and nine months ended September 30, 2025. The exercise price will be further adjusted if any other convertible instruments have price resets. In addition, the Company issued 5,300,000 and 10,600,000 shares of Common Stock upon the exercise of certain Purchase Rights during the three and nine months ended September 30, 2025, respectively. The Company issued 17,500,000 and 59,575,000 such shares upon the exercise of certain Purchase Rights during the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, Purchase Rights to receive 1,508,548,899 shares of the Company’s Common Stock remained outstanding.

 

 

Common Stock Reserved for Future Issuance

 

Common Stock reserved for future issuance is as follows in common equivalent shares as of September 30, 2025:

  

Common Stock issuable upon the exercise of stock options outstanding   3,372 
Common Stock issuable upon the exercise of Common Stock warrants   10,595,019 
Common Stock available for future issuance under the 2019 ESPP   509 
Common Stock available for future issuance under the Amended Inducement Plan   609 
Common Stock reserved for the exercise of purchase rights   741,490,642 
Common Stock reserved for the conversion of convertible notes   421,784,555 
Common Stock reserved for the conversion of series E-1 preferred stock   46,570,761 
Total Common Stock reserved for future issuance(1)   1,220,445,467 

 

(1) The potentially dilutive securities in Note 2 – Summary of Significant Accounting Policies includes all potentially dilutive securities that are not included in the diluted EPS as per U.S. GAAP, whereas the total Common Stock reserved for future issuance in the table above includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 
v3.25.3
Stock-based Compensation
 9 Months Ended
Sep. 30, 2025
Share-Based Payment Arrangement [Abstract]  
Stock-based Compensation

9. Stock-based Compensation

 

Equity Incentive Plans

 

No equity awards were issued in either period presented. The following table summarizes stock-based compensation expense related to stock options granted to employees, non-employee directors and consultants included in the condensed consolidated statements of operations as follows (in thousands):

 

                 
   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2025   2024   2025   2024 
Research and development  $-   $5   $1   $31 
Selling and marketing   2    18    7    77 
General and administrative   21    180    116    551 
Total  $23   $203   $124   $659 

 

Stock Options

 

As of September 30, 2025, unrecognized stock-based compensation expense for employee stock options was approximately $0.1 million, which the Company expects to recognize over a weighted-average remaining period of 0.2 years, assuming all unvested options become fully vested.

 
v3.25.3
Subsequent Events
 9 Months Ended
Sep. 30, 2025
Subsequent Events [Abstract]  
Subsequent Events

10. Subsequent Events

 

Termination of Aditxt Merger

 

On October 20, 2025, the Company held a Special Meeting of Stockholders. After the Company’s stockholders did not approve the transactions contemplated by the A&R Merger Agreement, the Company delivered a notice of termination to Aditxt notifying it that the Company was exercising its right to terminate the A&R Merger Agreement effective October 20, 2025. The termination was in accordance with (i) Section 8.1(b)(ii), which allows either party to terminate the A&R Merger Agreement if the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time, on September 30, 2025, and (ii) as per Section 8.1(b)(iv), which allows either party to terminate the A&R Merger Agreement if the Company Shareholder Approval shall not have been obtained at a duly held Company Shareholders Meeting at which a vote was taken on the approval of the Agreement and the Transactions, including the Merger.

 

As a result of the termination of the A&R Merger Agreement, all other ancillary agreements related to the A&R Merger Agreement, with the exception of the obligations under the Non-Disclosure Agreement, entered into by and between the Company and Aditxt, as of October 23, 2023, terminated concurrently with the termination of the A&R Merger Agreement. No consideration was paid in connection with the termination.

 

Adjuvant Third Amendment

 

On October 13, 2025 the Company and the Adjuvant Purchasers entered into the Adjuvant Third Amendment, which amends certain provisions within the Adjuvant Purchase Agreement including updating the date that the Notes will be payable in full to the earlier of (a) six months after the October 13, 2025, (b) at the election of Adjuvant, the date of a consummation of a Change of Control (as defined in the Adjuvant Purchase Agreement), and (c) the date of any acceleration of the Adjuvant Notes in accordance with Section 8 (the Maturity Date, as per the Adjuvant Purchase Agreement). The Adjuvant Notes may not be prepaid prior to the date that is six months after October 13, 2025 without prior written consent of Adjuvant.

 

2025 Equity Incentive Plan

 

On October 3, 2025, our board of directors approved, and recommended our stockholders to approve at our annual meeting to be held on November 26, 2025, the 2025 Equity Incentive Plan (the “2025 Plan”), with a maximum of 50,000,000 shares available for issuance. No grants have been made under the 2025 Plan.
v3.25.3
Summary of Significant Accounting Policies (Policies)
 9 Months Ended
Sep. 30, 2025
Accounting Policies [Abstract]  
Use of Estimates

Use of Estimates

 

The preparation of interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the interim condensed consolidated financial statements and the notes thereto.

 

Significant estimates affecting amounts reported or disclosed in the interim condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items; the allowance for expected credit losses estimate; the assumptions used in estimating the fair value of convertible notes, preferred stock, warrants and purchase rights issued; the assumptions used in the valuation of inventory, intangible asset, and contingent liabilities; the useful lives and recoverability of long-lived assets; the assumptions used to estimate the amount due under the contingent Rush Royalty liability; and the valuation of deferred tax assets. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

 
Segment Reporting

Segment Reporting

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (CODM), the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. The Company’s CODM assesses performance and decides how to allocate resources for the Company’s one operating segment based on consolidated net loss that is reported on the interim condensed consolidated statements of operations. The Company has also evaluated the significant segment expenses incurred by the single segment that are regularly provided to the CODM. The significant segment expenses regularly provided to the CODM are consistent with those reported on the interim condensed consolidated statements of operations and include cost of goods sold, research and development, selling and marketing, and general and administrative. The CODM uses these expense categories, along with data on product sales, net, to make key operating decisions, such as the strategic direction of the Company, pursuing and/or approving product acquisitions, decisions about key personnel, and approving annual operating budgets. The Company manages assets on a consolidated basis as reported on the interim condensed consolidated balance sheets.

 
Concentrations of Credit Risk

Concentrations of Credit Risk

 

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the condensed consolidated balance sheets.

 

The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances on amounts in excess of federally insured limits due to the financial position of the depository institutions in which these deposits are held.

 

The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the U.S. and, expected to begin in the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies, mail-order specialty pharmacies and, in the UAE, its licensee Pharma 1. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. As of September 30, 2025 and December 31, 2024, based on the evaluation of these factors, the Company did not record an allowance for expected credit losses.

 

In the U.S., products are distributed primarily through three major distributors and mail-order pharmacies, which receive service fees calculated as a percentage of the gross sales and a fee-per-unit shipped, respectively. These entities are not obligated to purchase any set number of units; they distribute products on demand as orders are received.

 

For the three and nine months ended September 30, 2025, the Company’s three largest customers combined made up approximately 75% and 74% of its gross product sales, respectively. For the three and nine months ended September 30, 2024, the Company’s three largest customers combined made up approximately 80% and 79% of its gross product sales, respectively. As of September 30, 2025 and December 31, 2024, the Company’s three largest customers combined made up 83% and 89%, respectively, of its trade accounts receivable balance.

 

 
Significant Accounting Policies

Significant Accounting Policies

 

There have been no changes to the significant accounting policies that were described in Note 2 – Summary of Significant Accounting Policies of the 2024 Audited Financial Statements in the Company’s Annual Report.

 
Cash, Cash Equivalents and Restricted Cash

Cash, Cash Equivalents and Restricted Cash

 

Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit as described in Note 7- Commitments and Contingencies.

 
Net Loss Per Share

Net Loss Per Share

 

Basic net loss per share attributable to Common Stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. The net loss available to Common Stockholders is adjusted for amounts in accumulated deficit related to the deemed dividends triggered for certain financial instruments. Such adjustment was $0.1 million in each of the three and nine months ended September 30, 2025. Such adjustment was immaterial and $0.1 million in the three and nine months ended September 30, 2024, respectively. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and, therefore, basic and diluted net loss per share were the same for each of the three and nine months ended September 30, 2025 and 2024. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Common shares were calculated for the convertible preferred stock and the convertible debt using the if-converted method.

 

          
   September 30, 
   2025   2024 
Options to purchase Common Stock   3,372    3,747 
Warrants to purchase Common Stock   263,062,099    20,807,539 
Purchase rights to purchase Common Stock   1,508,548,899    1,529,448,899 
Convertible debt   2,923,775,388    2,577,050,313 
Series E-1 Shares   167,654,737    131,023,274 
Series F-1 Shares   1,706,493,507    1,528,571,429 
Series G-1 Shares   103,029,458    - 
Total(1)   6,672,567,460    5,786,905,201 

 

(1) The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted net loss per share as per GAAP, whereas the total Common Stock reserved for future issuance in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.

 
Recently Adopted Accounting Pronouncements

Recently Adopted Accounting Pronouncements

 

No significant new standards were adopted during the nine months ended September 30, 2025.

 

 
Recently Issued Accounting Pronouncements — Not Yet Adopted

Recently Issued Accounting Pronouncements — Not Yet Adopted

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standards setting bodies that are adopted as of the specified effective date.

 

In October 2023, the FASB issued Accounting Standards Update (ASU) 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, designed to clarify or improve disclosure and presentation requirements on a variety of topics and align the requirements in the FASB Accounting Standards Codification (ASC) with the SEC regulations. This guidance is effective for the Company no later than June 30, 2027. The Company is still evaluating the impact of ASU 2023-06.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes: Improvements to Income Tax Disclosures, addressing income tax disclosures, requiring entities to annually disclose specific categories in the rate reconciliation and provide additional information for certain reconciling items and categories. ASU 2023-09 will be effective for the Company beginning with the annual filing for the period ending December 31, 2025 and early adoption is allowed. The Company is still evaluating the impact of ASU 2023-09.

 

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which primarily requires disaggregation of specific expense categories in disclosures within the footnotes on an annual and interim basis. ASU 2024-03 is effective for the Company’s annual period ending December 31, 2027 and interim periods thereafter. Early adoption is permitted. In January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03. The Company is still evaluating the impacts of ASU 2024-03 and ASU 2025-01.

 

In November 2024, the FASB issued ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, designed to clarify the requirements for accounting for the settlement of a debt as an induced conversion versus as an extinguishment. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2024-04.

 

In July 2025, the FASB issued ASU 2025-05, Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, to provide a practical expedient related to the estimation of expected credit losses for current accounts receivable and current contract assets that arise from transactions accounted for under ASC 606. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2025-05.

 

The Company does not believe the impact of any other recently issued standards and any issued but not yet effective standards will have a material impact on its condensed consolidated financial statements upon adoption.
v3.25.3
Summary of Significant Accounting Policies (Tables)
 9 Months Ended
Sep. 30, 2025
Accounting Policies [Abstract]  
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share

 

          
   September 30, 
   2025   2024 
Options to purchase Common Stock   3,372    3,747 
Warrants to purchase Common Stock   263,062,099    20,807,539 
Purchase rights to purchase Common Stock   1,508,548,899    1,529,448,899 
Convertible debt   2,923,775,388    2,577,050,313 
Series E-1 Shares   167,654,737    131,023,274 
Series F-1 Shares   1,706,493,507    1,528,571,429 
Series G-1 Shares   103,029,458    - 
Total(1)   6,672,567,460    5,786,905,201 

 

(1) The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted net loss per share as per GAAP, whereas the total Common Stock reserved for future issuance in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.
v3.25.3
Debt (Tables)
 9 Months Ended
Sep. 30, 2025
Debt Disclosure [Abstract]  
Schedule of Cash payments Determined based Upon the Quarterly Global Net Revenue

 

Quarterly global net revenue   Quarterly cash payment
≤ $5.0 million   3% of such global net revenues
>$5.0 million and ≤ $7.0 million   3% on net revenue ≤ $5.0 million;
4% on the net revenue over $5.0 million
Greater than $7.0 million   3% on the net revenue ≤ $5.0 million;
4% on the net revenue over $5.0 million and up to $7.0 million;
5% on net revenue over $7.0 million
Schedule of Repurchase Price Reduction

The Fourth Amendment also granted the Company the ability to repurchase the principal amount and accrued and unpaid interest of the Baker Notes for up to a five-year period for the one-time Repurchase Price designated below:

 

Date of Notes’ Repurchase   Repurchase Price
On or prior to September 8, 2024   $14,000,000 (less Applicable Reductions)
September 9, 2024-September 8, 2025   $16,750,000 (less Applicable Reductions)
September 9, 2025-September 8, 2026   $19,500,000 (less Applicable Reductions)
September 9, 2026-September 8, 2027   $22,250,000 (less Applicable Reductions)
September 9, 2027-September 8, 2028   $25,000,000 (less Applicable Reductions)
Schedule of Interest Expense

Interest expense for the Adjuvant Notes consists of the following, and is included in convertible notes, net – Adjuvant on the condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024 and in other expense, net on the condensed consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

 

                 
   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2025   2024   2025    2024 
Coupon interest  $599   $556   $1,763   $1,637 
Amortization of issuance costs   -    -    -    28 
Total  $599   $556   $1,763   $1,665 
Schedule of SSNs and Warrants

Summary of SSNs and Warrants at Issuance (December 2022 to September 2023 and April to June 2025):

 

   Principal At Issuance   Net Proceeds Before Issuance                
Notes  (in
Thousands)		   costs (in
Thousands)		   Common
Warrants		   Preferred
Shares		  

Original

Maturity Date

 

Current

Maturity Date

  
December 2022 Notes(4)  $2,308   $1,500    369,230    70 - Series D    12/21/2025(4)  12/1/2026  
February 2023 Notes(1)(4)   1,385    900    653,538    -   2/17/2026(4)  12/1/2026  
March 2023 Notes(4)   600    390    240,000    -   3/17/2026(4)  12/1/2026  
March 2023 Notes(2)(4)   538    350    258,584    -   3/20/2026(4)  12/1/2026  
April 2023 Notes(4)   769    500    615,384    -   3/6/2026(4)  12/1/2026  
July 2023 Notes(4)   1,500    975    1,200,000    -   3/6/2026(4)  12/1/2026  
August 2023 Notes(4)   1,000    650    799,999    -   8/4/2026(4)  12/1/2026  
September 2023 Notes(3)(4)   2,885    1,875    26,997,041    -   9/26/2026(4)  12/1/2026  
Aditxt April Note   2,308    1,500    149,850,150    -   4/8/2028   4/8/2028  
Aditxt June Note   1,423    925    92,407,592    -   6/26/2028   6/26/2028  
Total Offerings  $14,716   $9,565    273,391,518               

 

(1) Warrants include 99,692 issued to the placement agent.
(2) Warrants include 43,200 issued to the placement agent.
(3) Warrants include 22,189,349 common warrants at $0.13 per share at issuance and 4,807,692 pre-funded warrants exercisable at $0.001 per share.
(4) As described above, for accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs. The maturity date under the Exchanged SSNs is December 1, 2026.
v3.25.3
Balance Sheet Details (Tables)
 9 Months Ended
Sep. 30, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Schedule of Inventories

Inventories consist of the following (in thousands):

    

   September 30, 2025   December 31, 2024 
Raw materials  $

134

   $350 
Work in process   

792

    982 
Finished goods   

758

    245 
Total  $

1,684

   $1,577 
Schedule of Prepaid and Other Current Assets

Prepaid and other current assets consist of the following (in thousands):

  

   September 30, 2025   December 31, 2024 
Insurance  $

650

   $391 
Prescription Drug User Fee Act (PDUFA) fees   

-

    606 
Outside service retainers   

70

    160 
Short-term deposits   

127

    127 
Other   

112

    175 
Total  $959   $1,459 
Schedule of Property and Equipment Net

Property and equipment, net, consists of the following (in thousands):

    

   Useful Life   September 30, 2025   December 31, 2024 
Research equipment   5 years   $

96

   $585 
Computer equipment and software   3 years    34    145 
Construction in-process   -    402    429 
 Property and equipment, gross        532    1,159 
Less: accumulated depreciation        (112)   (701)
Total, net       $420   $458 
Schedule of Intangible Assets, Net

Intangible asset, net, acquired in July 2024, consists of the following (in thousands):

    

   Useful Life  September 30, 2025   December 31, 2024 
Intellectual property  16 years  $

6,267

   $10,216 
Less: accumulated amortization      (1,029)   (619)
Total, net     $5,238   $9,597 
Schedule of Accrued Expenses

Accrued expenses consist of the following (in thousands):

    

   September 30, 2025   December 31, 2024 
Clinical trial related costs  $

-

   $2,498 
Accrued royalty   39    1,976 
Accrued compensation for non-employee directors   697    505 
Other   627    530 
Total  $1,363   $5,509 
v3.25.3
Fair Value of Financial Instruments (Tables)
 9 Months Ended
Sep. 30, 2025
Short-Term Debt [Line Items]  
Schedule of Fair Value of Derivative Liabilities

The following tables summarize the Company’s derivative liabilities as of September 30, 2025 and December 31, 2024 as discussed in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (in thousands):

   

   Fair Value     
   September 30, 2025   December 31, 2024   Leveling 
Purchase rights  $

1,140

   $1,359    Level 3 
Total derivative liabilities  $1,140   $1,359      
Schedule of Change in Fair Value of Level 3 Financial Liabilities

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes, SSNs, and Aditxt Notes measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):

    

  

Baker Notes

(Assigned to

Future Pak;

Note 4)

  

Total SSNs

and Aditxt Notes
(Note 4)

   Total 
Balance at June 30, 2025  $14,609   $172   $14,781 
Extinguishment/conversion   -    (16)   (16)
Payments   (143)   -    (143)
Change in fair value presented in the condensed consolidated statements of operations   708    -    708 
Change in fair value presented in the condensed consolidated statements of comprehensive operations   -    4,162    4,162 
Balance at September 30, 2025  $15,174   $4,318   $19,492 

 

  

Baker Notes

(Assigned to

Future Pak;

Note 4)

  

Total SSNs

and Aditxt Notes
(Note 4)

   Total 
Balance at December 31, 2024  $13,801   $1,173   $14,974 
Balance at issuance   -    129    129 
Extinguishment/conversion   -    (16)   (16)
Payments   (391)   -    (391)
Change in fair value presented in the condensed consolidated statements of operations   708    -    708 
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,056    3,032    4,088 
Balance at September 30, 2025  $15,174   $4,318   $19,492 

 

The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):

 

   Baker Notes
(Assigned to
Future Pak;
Note 4)		   Total SSNs
(Note 4)		   Total 
Balance at June 30, 2024  $12,280   $959   $13,239 
Balance at issuance   12,280    -    12,280 
Extinguishment/conversion   (12,280)   -    (12,280)
Payments   (125)   -    (125)
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,721    (652)   1,069 
Balance at September 30, 2024  $13,876   $307   $14,183 

 

  

Baker Notes

(Assigned to
Future Pak;

Note 4)

   Total SSNs
(Note 4)		   Total 
Balance at December 31, 2023  $13,510   $1,221   $14,731 
Balance at issuance   24,670    -    24,670 
Extinguishment/conversion   (25,790)   (51)   (25,841)
Payments   (378)   -    (378)
Change in fair value presented in the condensed consolidated statements of comprehensive operations   1,864    (863)   1,001 
Balance at September 30, 2024  $13,876   $307   $14,183 

 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):

 

   Purchase Rights  

Derivative

Liabilities Total

 
Balance at June 30, 2025  $3   $3 
Exercises   

-

   - 
Change in fair value presented in the condensed consolidated statements of operations   1,137    1,137
Balance at September 30, 2025  $1,140   $1,140 

 

   Purchase Rights  

Derivative

Liabilities Total

 
Balance at December 31, 2024  $1,359   $1,359 
Exercises   (1)   (1)
Change in fair value presented in the condensed consolidated statements of operations   (218)   (218)
Balance at September 30, 2025  $1,140   $1,140 

 

The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):

 

   Purchase Rights   Derivative
Liabilities
Total		 
Balance at June 30, 2024  $942   $942 
Exercises   (11)   (11)
Change in fair value presented in the condensed consolidated statements of operations   (769)   (769)
Balance at September 30, 2024  $162   $162 

 

   Purchase Rights   Derivative
Liabilities
Total		 
Balance at December 31, 2023  $1,926   $1,926 
Balance at issuance   3,300    3,300 
Exercises   (168)   (168)
Change in fair value presented in the condensed consolidated statements of operations   (4,896)   (4,896)
Balance at September 30, 2024  $162   $162 
Convertible Debt [Member]  
Short-Term Debt [Line Items]  
Schedule of Fair Value of Derivative Liabilities

The following tables summarize the Company’s debt instruments as of September 30, 2025 and December 31, 2024, respectively (in thousands):

    

    Principal     Accrued     Net Carrying     Fair Value  
As of September 30, 2025   Amount     Interest     Amount     Amount     Leveling  
Baker Notes(1)(2)   $ 117,634     $ -     $ 117,634     $ 15,174       Level 3  
Adjuvant Notes(3)     22,500       9,667       32,167        N/A       N/A  
December 2022 Notes(1) (4)     629        -       629        233        Level 3  
February 2023 Notes (1) (4)     946        -       946        350        Level 3  
March 2023 Notes (1) (4)     1,100        -       1,100        407        Level 3  
April 2023 Notes (1) (4)     707        -       707        262        Level 3  
July 2023 Notes (1) (4)     1,380        -       1,380        511        Level 3  
August 2023 Notes (1) (4)     963        -       963        357        Level 3  
September 2023 Notes (1) (4)     3,283        -       3,283        1,215        Level 3  
Aditxt Notes(1)     3,850        -       3,850        983        Level 3  
Totals   $ 152,992     $ 9,667     $ 162,659     $ 19,492       N/A  

 

   Principal   Accrued   Net Carrying   Fair Value 
As of December 31, 2024  Amount   Interest   Amount   Amount   Leveling 
Baker Notes(1)(2)  $109,488   $-   $109,488   $13,801    Level 3 
Adjuvant Notes(3)   22,500    8,269    30,769    N/A     N/A 
December 2022 Notes(1) (4)   973    -    973    118    Level 3 
February 2023 Notes (1) (4)   980    -    980    120    Level 3 
March 2023 Notes (1) (4)   1,209    -    1,209    147    Level 3 
April 2023 Notes (1) (4)   883    -    883    108    Level 3 
July 2023 Notes (1) (4)   1,322    -    1,322    161    Level 3 
August 2023 Notes (1) (4)   1,119    -    1,119    136    Level 3 
September 2023 Notes (1) (4)   3,147    -    3,147    383    Level 3 
Totals  $141,621   $8,269   $149,890   $14,974    N/A 

 

(1) These liabilities are/were carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest was included in the determination of fair value. The related debt issuance costs were expensed.

 

(2) The Baker Notes principal amount includes $33.4 million and $24.9 million of interest paid in-kind as of September 30, 2025 and December 31, 2024, respectively.

 

(3) The Adjuvant Notes are recorded in the condensed consolidated balance sheets at their net carrying amount which includes principal and accrued interest.
   
(4) For accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs.
v3.25.3
Commitments and Contingencies (Tables)
 9 Months Ended
Sep. 30, 2025
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Lease Cost

Supplemental Financial Statement Information

 

     

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
Lease Cost (in thousands)  Classification  2025   2024   2025   2024 
Operating lease expense  Research and development  $

1

   $-   $

3

   $2 
Operating lease expense  Selling and marketing   11    40    86    135 
Operating lease expense  General and administrative   2    3    8    8 
Total     $14   $43   $97   $145 
Schedule of Lease Term and Discount Rate
Lease Term and Discount Rate  September 30, 2025   December 31, 2024 
Weighted Average Remaining Lease Term (in years)   1.65    0.77 
Weighted Average Discount Rate   12%   12%
Schedule of Operating Lease Maturities
Maturity of Operating Lease Liabilities (in thousands)  September 30, 2025 
Remainder of 2025 (3 months)  $34 
Year ending December 31, 2026   127 
Year ending December 31, 2027   52 
Total lease payments   213 
Less imputed interest   (17)
Total  $196 
Schedule of Supplement Cash Outflows in Operating Leases
         
   Nine Months Ended September 30, 
Other information (in thousands)  2025   2024 
Operating cash outflows in operating leases  $94   $218 
Non-cash addition to ROU assets and lease liabilities due to new leases  $201   $90 
v3.25.3
Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (Tables)
 9 Months Ended
Sep. 30, 2025
Equity [Abstract]  
Schedule of Warrants

 

Type of Warrants  Underlying Common Stock
to be Purchased		   Exercise Price   Issue Date  Exercise Period 
Common Warrants   888   $11,962.50   April 11, 2019   October 11, 2019 to April 11, 2026 
Common Warrants   1,480   $11,962.50   June 10, 2019   December 10, 2019 to June 10, 2026 
Common Warrants   8,003   $735.00   January 13, 2022   March 1, 2022 to March 1, 2027 
Common Warrants   8,303   $897.56   March 1, 2022   March 1, 2022 to March 1, 2027 
Common Warrants   6,666   $309.56   May 4, 2022   May 4, 2022 to May 4, 2027 
Common Warrants   894,194   $0.0154   May 24, 2022   May 24, 2022 to May 24, 2027 
Common Warrants   582,886   $0.0154   June 28, 2022   May 24, 2022 to June 28, 2027 
Common Warrants   49,227   $0.0154   December 21, 2022   December 21, 2022 to December 21, 2027 
Common Warrants   130,461   $0.0154   February 17, 2023   February 17, 2023 to February 17, 2028 
Common Warrants   258,584   $0.0154   March 20, 2023   March 20, 2023 to March 20, 2028 
Common Warrants   369,231   $0.0154   April 5, 2023   April 5, 2023 to April 5, 2028 
Common Warrants   349,463   $0.0154   July 3, 2023   July 3, 2023 to July 3, 2028 
Common Warrants   615,384   $0.0154   August 4, 2023   August 4, 2023 to August 4, 2028 
Common Warrants   12,721,893   $0.0154   September 27, 2023   September 27, 2023 to September 27, 2028 
Common Warrants   149,850,150   $0.0154   April 8, 2025   April 8, 2025 to April 8, 2030 
Common Warrants   92,407,592   $0.0154   June 26, 2025   June 26, 2025 to June 26, 2030 
Prefunded Common Warrants   4,807,694   $0.0010   September 27, 2023   September 27, 2023 to September 27, 2028 
Total   263,062,099              
Summary of Common Stock Reserved for Future Issuance

Common Stock reserved for future issuance is as follows in common equivalent shares as of September 30, 2025:

  

Common Stock issuable upon the exercise of stock options outstanding   3,372 
Common Stock issuable upon the exercise of Common Stock warrants   10,595,019 
Common Stock available for future issuance under the 2019 ESPP   509 
Common Stock available for future issuance under the Amended Inducement Plan   609 
Common Stock reserved for the exercise of purchase rights   741,490,642 
Common Stock reserved for the conversion of convertible notes   421,784,555 
Common Stock reserved for the conversion of series E-1 preferred stock   46,570,761 
Total Common Stock reserved for future issuance(1)   1,220,445,467 

 

(1) The potentially dilutive securities in Note 2 – Summary of Significant Accounting Policies includes all potentially dilutive securities that are not included in the diluted EPS as per U.S. GAAP, whereas the total Common Stock reserved for future issuance in the table above includes the shares that must legally be reserved based on the applicable instruments’ agreements.
v3.25.3
Stock-based Compensation (Tables)
 9 Months Ended
Sep. 30, 2025
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock-based Compensation Expense Related to Stock Options

 

                 
   Three Months Ended
September 30,		   Nine Months Ended
September 30,		 
   2025   2024   2025   2024 
Research and development  $-   $5   $1   $31 
Selling and marketing   2    18    7    77 
General and administrative   21    180    116    551 
Total  $23   $203   $124   $659 
v3.25.3
Description of Business and Basis of Presentation (Details Narrative) - USD ($)
$ / shares in Units, $ in Millions
Sep. 30, 2025
Apr. 22, 2025
Jan. 06, 2025
Accounting Policies [Abstract]      
Working capital deficit $ 70.3    
Accumulated deficit $ 900.2    
Share price   $ 0.01 $ 0.01
v3.25.3
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares
 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total [1] 6,672,567,460 5,786,905,201
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 3,372 3,747
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 263,062,099 20,807,539
Rights [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 1,508,548,899 1,529,448,899
Convertible Debt Securities [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 2,923,775,388 2,577,050,313
Series E- 1 Shares [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 167,654,737 131,023,274
Series F-1 Shares [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 1,706,493,507 1,528,571,429
Series G-1 Shares [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 103,029,458
[1] The potentially dilutive securities in the table above include all potentially dilutive securities that are not included in the diluted net loss per share as per GAAP, whereas the total Common Stock reserved for future issuance in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit includes the shares that must legally be reserved based on the applicable instruments’ agreements.
v3.25.3
Summary of Significant Accounting Policies (Details Narrative)
$ in Millions
 3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2025
USD ($)
Sep. 30, 2024
Sep. 30, 2025
USD ($)
Integer
Sep. 30, 2024
Dec. 31, 2024
Product Information [Line Items]          
Number of operating segment | Integer     1    
Down round feature, decrease in net income (loss) to common shareholder, amount | $ $ 0.1   $ 0.1    
Revenue Benchmark [Member] | Three Largest Customers Combined [Member] | Customer Concentration Risk [Member]          
Product Information [Line Items]          
Concentration risk, percentage 75.00% 80.00% 74.00% 79.00%  
Accounts Receivable [Member] | Three Largest Customers Combined [Member] | Customer Concentration Risk [Member]          
Product Information [Line Items]          
Concentration risk, percentage     83.00%   89.00%
v3.25.3
Revenue (Details Narrative) - USD ($)
$ in Millions
 9 Months Ended
Sep. 30, 2025
Dec. 31, 2024
Trade Accounts Receivable [Member]    
RevenueFromContractWithCustomerLineItem [Line Items]    
Product revenue variable consideration liability current $ 0.1 $ 0.3
Other Current Liabilities [Member]    
RevenueFromContractWithCustomerLineItem [Line Items]    
Product revenue variable consideration liability current $ 8.0 $ 7.2
Minimum [Member]    
RevenueFromContractWithCustomerLineItem [Line Items]    
Payment term 31 days  
Maximum [Member]    
RevenueFromContractWithCustomerLineItem [Line Items]    
Payment term 66 days  
v3.25.3
Schedule of Cash payments Determined based Upon the Quarterly Global Net Revenue (Details)
 1 Months Ended
Sep. 30, 2023
= $5.0 million [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 3% of such global net revenues
>$5.0 million and = $7.0 million [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 3% on net revenue ≤ $5.0 million
>$5.0 million and = $7.0 million [Member] | Quarterly Cash Payment [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 4% on the net revenue over $5.0 million
Greater than $7.0 million [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 3% on the net revenue ≤ $5.0 million
Greater than $7.0 million [Member] | Quarterly Cash Payment [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 4% on the net revenue over $5.0 million and up to $7.0 million
Greater than $7.0 million [Member] | Quarterly Cash Payment [Member]  
Short-Term Debt [Line Items]  
Quarterly cash payment 5% on net revenue over $7.0 million
v3.25.3
Schedule of Repurchase Price Reduction (Details) - Baker Notes [Member]
Sep. 08, 2023
USD ($)
On Or Prior To September 8, 2024 [Member]  
Debt Instrument [Line Items]  
Debt instrument, repurchase amount $ 14,000,000
September 9, 2024 - September 8, 2025 [Member]  
Debt Instrument [Line Items]  
Debt instrument, repurchase amount 16,750,000
September 9, 2025 - September 8, 2026 [Member]  
Debt Instrument [Line Items]  
Debt instrument, repurchase amount 19,500,000
September 9, 2026 - September 8, 2027 [Member]  
Debt Instrument [Line Items]  
Debt instrument, repurchase amount 22,250,000
September 9, 2027 - September 8, 2028 [Member]  
Debt Instrument [Line Items]  
Debt instrument, repurchase amount $ 25,000,000
v3.25.3
Schedule of Interest Expense (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Debt Disclosure [Abstract]        
Coupon interest $ 599 $ 556 $ 1,763 $ 1,637
Amortization of issuance costs 28
Total $ 599 $ 556 $ 1,763 $ 1,665
v3.25.3
Schedule of SSNs and Warrants (Details) - USD ($)
 9 Months Ended
Jun. 26, 2025
Sep. 30, 2025
Dec. 31, 2024
Short-Term Debt [Line Items]      
Principal At Issuance $ 1,000    
Gross proceeds before issuance costs $ 650    
Preferred Shares   0 0
December 2022 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1]   $ 2,308,000  
Gross proceeds before issuance costs [1]   $ 1,500,000  
Warrants at issued (common stock) [1]   369,230  
Preferred Shares [1]   70  
Maturity date [1]   Dec. 21, 2025  
Current Maturity Date [1]   Dec. 01, 2026  
February 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1],[2]   $ 1,385,000  
Gross proceeds before issuance costs [1],[2]   $ 900,000  
Warrants at issued (common stock) [1],[2]   653,538  
Maturity date [1]   Feb. 17, 2026  
Current Maturity Date [1],[2]   Dec. 01, 2026  
March 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1]   $ 600,000  
Gross proceeds before issuance costs [1]   $ 390,000  
Warrants at issued (common stock) [1]   240,000  
Maturity date [1]   Mar. 17, 2026  
Current Maturity Date [1]   Dec. 01, 2026  
March Two 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1],[3]   $ 538,000  
Gross proceeds before issuance costs [1],[3]   $ 350,000  
Warrants at issued (common stock) [1],[3]   258,584  
Maturity date [1],[3]   Mar. 20, 2026  
Current Maturity Date [1],[3]   Dec. 01, 2026  
April 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1]   $ 769,000  
Gross proceeds before issuance costs [1]   $ 500,000  
Warrants at issued (common stock) [1]   615,384  
Maturity date [1]   Mar. 06, 2026  
Current Maturity Date [1]   Dec. 01, 2026  
July 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1]   $ 1,500,000  
Gross proceeds before issuance costs [1]   $ 975,000  
Warrants at issued (common stock) [1]   1,200,000  
Maturity date [1]   Mar. 06, 2026  
Current Maturity Date [1]   Dec. 01, 2026  
August 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1]   $ 1,000,000  
Gross proceeds before issuance costs [1]   $ 650,000  
Warrants at issued (common stock) [1]   799,999  
Maturity date [1]   Aug. 04, 2026  
Current Maturity Date [1]   Dec. 01, 2026  
September 2023 Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance [1],[4]   $ 2,885,000  
Gross proceeds before issuance costs [1],[4]   $ 1,875,000  
Warrants at issued (common stock) [4]   26,997,041  
Maturity date [1],[4]   Sep. 26, 2026  
Current Maturity Date [1],[4]   Dec. 01, 2026  
Aditxt April Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance   $ 2,308,000  
Gross proceeds before issuance costs   $ 1,500,000  
Warrants at issued (common stock)   149,850,150  
Maturity date   Apr. 08, 2028  
Current Maturity Date   Apr. 08, 2028  
Aditxt June Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance   $ 1,423,000  
Gross proceeds before issuance costs   $ 925,000  
Warrants at issued (common stock)   92,407,592  
Maturity date   Jun. 26, 2028  
Current Maturity Date   Jun. 26, 2028  
Senior Subordinated Notes [Member]      
Short-Term Debt [Line Items]      
Principal At Issuance   $ 14,716,000  
Gross proceeds before issuance costs   $ 9,565,000  
Warrants at issued (common stock)   273,391,518  
[1] As described above, for accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs. The maturity date under the Exchanged SSNs is December 1, 2026.
[2] Warrants include 99,692 issued to the placement agent.
[3] Warrants include 43,200 issued to the placement agent.
[4] Warrants include 22,189,349 common warrants at $0.13 per share at issuance and 4,807,692 pre-funded warrants exercisable at $0.001 per share.
v3.25.3
Schedule of SSNs and Warrants (Details) (Parenthetical) - $ / shares
Sep. 30, 2025
Jun. 26, 2025
Sep. 30, 2023
Mar. 31, 2023
Feb. 28, 2023
Short-Term Debt [Line Items]          
Number of shares to purchase capital stock 263,062,099        
Warrants exercise price $ 0.18 $ 0.0154      
December 2022 to September 2023 and April to June 2025 [Member] | Common Warrant [Member]          
Short-Term Debt [Line Items]          
Warrants     22,189,349    
Warrants exercise price     $ 0.13    
December 2022 to September 2023 and April to June 2025 [Member] | Pre-Funded Warrants [Member]          
Short-Term Debt [Line Items]          
Warrants     4,807,692    
Warrants exercise price     $ 0.001    
Placement Agent [Member] | December 2022 to September 2023 and April to June 2025 [Member]          
Short-Term Debt [Line Items]          
Number of shares to purchase capital stock       43,200 99,692
v3.25.3
Debt (Details Narrative) - USD ($)
 1 Months Ended 3 Months Ended 6 Months Ended 9 Months Ended
Jun. 26, 2025
Apr. 10, 2025
Nov. 08, 2024
Jul. 23, 2024
Sep. 08, 2023
Mar. 07, 2023
Dec. 19, 2022
Sep. 15, 2022
Apr. 04, 2022
Mar. 21, 2022
Nov. 20, 2021
Oct. 14, 2020
Jun. 09, 2020
Apr. 24, 2020
Apr. 23, 2020
Jun. 30, 2024
Sep. 30, 2023
Sep. 30, 2025
Sep. 30, 2024
Jun. 30, 2025
Sep. 30, 2025
Sep. 30, 2024
Aug. 22, 2025
Apr. 08, 2025
Mar. 31, 2025
Dec. 31, 2024
Mar. 31, 2024
Feb. 26, 2024
Dec. 31, 2023
Dec. 21, 2023
Dec. 11, 2023
Jun. 30, 2023
Dec. 31, 2022
Sep. 30, 2022
Jun. 30, 2022
Dec. 15, 2021
Debt Instrument [Line Items]                                                                        
Principal amount $ 1,000                                                                      
Warrants to purchase of common stcok                                   263,062,099     263,062,099                              
Warrant exercise price per share $ 0.0154                                 $ 0.18     $ 0.18                              
Interest expense                                         $ 1,760,000 $ 1,673,000                            
Proceeds from issuance of sale of equity                     $ 50,000,000                                                  
Debt covenant, cumulative net sales requirement                                 $ 100,000,000.0                             $ 100,000,000.0        
Exercise price per share                                   $ 0.0154     $ 0.0154                              
Debt instrument periodic payment           $ 92,700,000                                                            
Cumulative net sales         $ 100,000,000                                                              
Accrued interest percentage         10.00%                                                              
Interest revenue expenses net                                 1,000,000.0       $ 1,000,000.0                              
Interest amount                                         1,100,000                              
Accumulated other comprehensive income                                   $ (5,731,000) $ (3,291,000)   $ (6,485,000) $ (6,681,000)                            
Debt Instrument, Debt Default, Description of Notice of Default     the Notices (the Third Amended Notice of Default) which added new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.                                                                  
Common stock, par value                                   $ 0.0001     $ 0.0001         $ 0.0001             $ 0.0001      
Original principal and accrued interest amount                                   $ 1,200,000     $ 1,200,000                              
Preferred stock, par value                                   $ 0.0001     $ 0.0001   $ 0.0001     $ 0.0001                   $ 0.0001
Series G1 shares deemed dividends                                   $ 400,000                                    
Issuance of debt $ 650                                                                      
Warrants purchase                                   263,062,099     263,062,099                              
Debt instrument, description                                         The Aditxt April Notes’ and the Aditxt June Notes’ interest rates are subject to increase to 12% upon an event of default and they have no Company right to prepayment prior to maturity; however, the Company has the option to redeem the respective notes at a redemption premium of 32.5%. Aditxt can also require the Company to redeem the notes a) at the respective premium rate tied to the occurrence of certain subsequent transactions, and b) in the event of subsequent placements (as defined). Also, pursuant to the terms of the respective SPAs, Aditxt has certain rights to participate in subsequent issuances of the Company’s securities, subject to certain exceptions, and the shares of Company Common Stock underlying the Aditxt April Offering and the Aditxt June Offering are unregistered. Additionally, the conversion rate and warrant strike price are subject to adjustment upon the issuance of other securities (as defined) below the stated conversion rate and strike price at issuance.                              
Short term debt                               $ 400,000       $ 400,000                                
Series F-1 Convertible Preferred Stock [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Preferred stock, par value                                                             $ 0.0001          
Share conversion price                               $ 0.0154   $ 0.0154     $ 0.0154                   $ 0.0635          
Series A One Preferred Stock[Member]                                                                        
Debt Instrument [Line Items]                                                                        
Warrants outstanding                                   26,280     26,280         26,280                    
Common Stock [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Warrants to purchase up                                                           9,972,074            
Conversion of redeemable preferred stock, shares                                                           613            
Warrants outstanding                               82,828,686   123,956,354 100,328,686 118,656,354 123,956,354 100,328,686     113,356,354 113,356,354 48,710,395   20,007,799              
Common Stock Agreements [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Aggregate purchase price   $ 13,000,000.0                                                                    
Original principal and accrued interest amount                                   $ 400,000     $ 400,000                              
Securities Purchase Agreements [Member] | Common Stock [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Converted shares                                         584,994,694                              
Security Purchase Agreement [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Principal amount $ 1,400,000                                             $ 2,300,000                        
Warrants to purchase of common stcok 92,407,592                                             149,850,150                        
Debt instrument interest rate effective percent 8.00%                                                                      
Common stock, par value $ 0.0001                                             $ 0.0001                        
Exercise price $ 0.0154                                                                      
Offering costs $ 2,400,000                                                                      
Insurance Premium Finance Agreement [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Annual interest rate                               857.00%       782.00%                                
June 2022 Baker Warrants [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Warrants to purchase of common stcok                     582,886                                                  
Warrant exercise price per share                     $ 93.75                                                  
Baker Warrants [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Warrant exercise price per share                                   $ 0.0154     $ 0.0154                              
Senior Subordinated Notes [Member] | Security Purchase Agreement [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Interest rate 8.00%                                                                      
Warrants purchase 242,257,742                                                                      
Baker Bros. Notes [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Class of warrant or right vesting term                         5 years                                              
Debt instrument, term               2 years                                                        
Debt instrument conversion price per share                     $ 4,575                                                  
Conversion price as a percentage of lowest stock price                     115.00%                                                  
Conversion price threshold percentage                   100.00%                                                    
Convertible debt       $ 12,300,000                           $ 18,509,000     $ 18,509,000         $ 14,974,000   $ 13,500,000                
Accumulated other comprehensive income       $ 100,000                                                                
Baker Bros. Notes [Member] | Convertible Notes Payable [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Principal amount                             $ 25,000,000.0                                          
Debt instrument, term                             5 years                                          
Debt instrument term with no prepayment                             3 years                                          
Debt instrument conversion rate                             10.00%                                          
Debt instrument interest rate effective percent                             10.00%                                          
Interest expense                                   2,900,000 $ 2,700,000   8,500,000 $ 7,800,000                            
Written notice period                           10 days                                            
Debt instrument, benchmark price per share                           $ 9,356.25                                            
Debt instrument conversion price per share                           $ 4,575                                            
Baker Bros. Notes [Member] | Convertible Notes Payable [Member] | Debt Instrument, Redemption, Period Two [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument, redemption price, percentage                           100.00%                                            
Baker Bros. Notes [Member] | Convertible Notes Payable [Member] | Debt Instrument, Redemption, Period One [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument, redemption price, percentage                           110.00%                                            
Baker Bros. Notes [Member] | Baker Second Closing Notes [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Principal amount                         $ 25,000,000.0                                              
Warrants to purchase of common stcok                         2,731                                              
Warrant exercise price per share                         $ 4,575                                              
Second Baker Amendment [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument conversion price per share                   $ 725.81                                                    
Debt covenant, cumulative net sales requirement                                 $ 100,000,000.0                                      
Conversion price threshold percentage                   100.00%                                                    
Proceeds from issuance of common stock                   $ 20,000,000                                                    
Second Baker Amendment [Member] | Baker Warrants [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Warrant exercise price per share                                                                   $ 93.75    
Third Baker Amendment [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument conversion price per share               $ 26.25                                                        
Secured Creditor Forbearance Agreement [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument indebtedness amount             $ 5,000,000.0                                                          
Short-term Convertible Notes [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Convertible debt                                   15,200,000     15,200,000                              
Principal and accrued interest                                   $ 117,600,000     $ 117,600,000         109,500,000                    
Convertible notes payable                                                   13,800,000                    
Adjuvant Notes [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument interest rate effective percent                                   7.50%     7.50%                              
Debt instrument conversion price per share                 $ 678.49                 $ 0.0154     $ 0.0154                              
Conversion price as a percentage of lowest stock price                 100.00%                                                      
Convertible debt                                   $ 32,167,000     $ 32,167,000         30,769,000                    
Converted shares                                         2,088,759,258                              
Restricted cash                                   25,000,000.0     $ 25,000,000.0                              
Adjuvant Notes [Member] | Short-term Convertible Notes [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Convertible debt                                   32,200,000     $ 32,200,000         30,800,000                    
Adjuvant Notes [Member] | Convertible Notes Payable [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Principal amount                       $ 25,000,000.0                                                
Debt instrument, term                       5 years                                                
Debt instrument conversion rate                                         7.50%                              
Debt instrument conversion price per share               $ 26.25       $ 6,843.75                                                
Debt covenant, cumulative net sales requirement                                                               $ 100,000,000.0     $ 100,000,000.0  
Common stock, par value                       0.0001                                                
Debt instrument weighted average price per share                 $ 18,750     $ 18,750                                                
Debt instrument weighted average period                 30 days                                                      
Debt instrument convertible exchange percentage               10.00%                                                        
Debt conversion converted instrument amount               $ 2,900,000                                                        
Converted shares               109,842                                                        
Convertible debt current principal amount                                   22,500,000     $ 22,500,000         22,500,000                    
Convertible debt current accrued interest                                   $ 9,700,000     $ 9,700,000         $ 8,300,000                    
Adjuvant Notes [Member] | Convertible Notes Payable [Member] | Maximum [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Debt instrument convertible beneficial ownership limitation                       19.99%                                                
A80 Senior Subordinated Notes Due 2025 Issued December2022 [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Redemption premium percentage                                                                 32.50%      
A80 Senior Subordinated Notes Due 2025 Issued December2022 [Member] | Unsecured Debt [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Interest rate                                                                 8.00%      
Interest rate increase                                                                 12.00%      
Aditxt Note [Member] | Common Stock [Member]                                                                        
Debt Instrument [Line Items]                                                                        
Converted shares                                         250,021,436                              
v3.25.3
Schedule of Inventories (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Raw materials $ 134 $ 350
Work in process 792 982
Finished goods 758 245
Total $ 1,684 $ 1,577
v3.25.3
Schedule of Prepaid and Other Current Assets (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Insurance $ 650 $ 391
Prescription Drug User Fee Act (PDUFA) fees 606
Outside service retainers 70 160
Short-term deposits 127 127
Other 112 175
Total $ 959 $ 1,459
v3.25.3
Schedule of Property and Equipment Net (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Property, Plant and Equipment [Line Items]    
 Property and equipment, gross $ 532 $ 1,159
Less: accumulated depreciation (112) (701)
Total, net 420 458
Equipment [Member]    
Property, Plant and Equipment [Line Items]    
 Property and equipment, gross $ 96 585
Useful Life 5 years  
Computer Equipment and Software [Member]    
Property, Plant and Equipment [Line Items]    
 Property and equipment, gross $ 34 145
Useful Life 3 years  
Construction in Progress [Member]    
Property, Plant and Equipment [Line Items]    
 Property and equipment, gross $ 402 $ 429
v3.25.3
Schedule of Intangible Assets, Net (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Intellectual property $ 6,267 $ 10,216
Intellectual Property useful life 16 years  
Less: accumulated amortization $ (1,029) (619)
Total, net $ 5,238 $ 9,597
v3.25.3
Schedule of Accrued Expenses (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Clinical trial related costs $ 2,498
Accrued royalty 39 1,976
Accrued compensation for non-employee directors 697 505
Other 627 530
Total $ 1,363 $ 5,509
v3.25.3
Balance Sheet Details (Details Narrative) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Dec. 31, 2024
Jul. 14, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]            
Amortization expense $ 80 $ 301 $ 410 $ 301    
Amortization expense, remainder of 2025 100   100      
Intangible asset fully amortized $ 400   $ 400      
Intangible assets expected remaining useful life     14 years 10 months 24 days      
Intangible asset net         $ 5,900 $ 16,100
Intangible asset, adjustment     $ 3,900      
v3.25.3
Schedule of Fair Value of Financial Liabilities (Details) - USD ($)
Sep. 30, 2025
Jun. 26, 2025
Dec. 31, 2024
Jul. 23, 2024
Feb. 26, 2024
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount   $ 1,000      
Accrued Interest $ 2,500,000        
Convertible Debt [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount 152,992,000   $ 141,621,000    
Accrued Interest 9,667,000   8,269,000    
Net Carrying Amount 162,659,000   149,890,000    
Fair Value Amount 19,492,000   14,974,000    
Baker Bros. Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Fair Value Amount 18,509,000   14,974,000 $ 12,300,000 $ 13,500,000
Baker Bros. Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [1],[2] 117,634,000   109,488,000    
Accrued Interest [1],[2]      
Net Carrying Amount [1],[2] 117,634,000   109,488,000    
Fair Value Amount [1],[2] 15,174,000   13,801,000    
Adjuvant Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Fair Value Amount 32,167,000   30,769,000    
Adjuvant Notes [Member] | Convertible Debt [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Accrued Interest [3] 9,667,000   8,269,000    
Net Carrying Amount [3] 32,167,000   30,769,000    
Principal Amount [3] 22,500,000   22,500,000    
December 2022 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4] 2,308,000        
December 2022 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 629,000   973,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 629,000   973,000    
Fair Value Amount [2],[5] 233,000   118,000    
February 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4],[6] 1,385,000        
February 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 946,000   980,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 946,000   980,000    
Fair Value Amount [2],[5] 350,000   120,000    
March 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4] 600,000        
March 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 1,100,000   1,209,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 1,100,000   1,209,000    
Fair Value Amount [2],[5] 407,000   147,000    
April 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4] 769,000        
April 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 707,000   883,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 707,000   883,000    
Fair Value Amount [2],[5] 262,000   108,000    
July 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4] 1,500,000        
July 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 1,380,000   1,322,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 1,380,000   1,322,000    
Fair Value Amount [2],[5] 511,000   161,000    
August 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4] 1,000,000        
August 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 963,000   1,119,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 963,000   1,119,000    
Fair Value Amount [2],[5] 357,000   136,000    
September 2023 Notes [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [4],[7] 2,885,000        
September 2023 Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2],[5] 3,283,000   3,147,000    
Accrued Interest [2],[5]      
Net Carrying Amount [2],[5] 3,283,000   3,147,000    
Fair Value Amount [2],[5] 1,215,000   $ 383,000    
Aditxt Notes [Member] | Convertible Debt [Member] | Fair Value, Inputs, Level 3 [Member]          
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]          
Principal Amount [2] 3,850,000        
Accrued Interest [2]        
Net Carrying Amount [2] 3,850,000        
Fair Value Amount [2] $ 983,000        
[1] The Baker Notes principal amount includes $33.4 million and $24.9 million of interest paid in-kind as of September 30, 2025 and December 31, 2024, respectively.
[2] These liabilities are/were carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest was included in the determination of fair value. The related debt issuance costs were expensed.
[3] The Adjuvant Notes are recorded in the condensed consolidated balance sheets at their net carrying amount which includes principal and accrued interest.
[4] As described above, for accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs. The maturity date under the Exchanged SSNs is December 1, 2026.
[5] For accounting purposes, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs.
[6] Warrants include 99,692 issued to the placement agent.
[7] Warrants include 22,189,349 common warrants at $0.13 per share at issuance and 4,807,692 pre-funded warrants exercisable at $0.001 per share.
v3.25.3
Schedule of Fair Value of Financial Liabilities (Details) (Parenthetical) - USD ($)
$ in Millions
 9 Months Ended 12 Months Ended
Sep. 30, 2025
Dec. 31, 2024
Baker Notes [Member] | Convertible Debt [Member]    
Short-Term Debt [Line Items]    
Interest paid in kind $ 33.4 $ 24.9
v3.25.3
Schedule of Fair Value of Derivative Liabilities (Details) - USD ($)
$ in Thousands
Sep. 30, 2025
Dec. 31, 2024
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Derivative liabilities $ 1,140 $ 1,359
Fair Value, Inputs, Level 3 [Member]    
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]    
Derivative liabilities $ 1,140 $ 1,359
v3.25.3
Schedule of Change in Fair Value of Level 3 Financial Liabilities (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Jun. 30, 2025
Mar. 31, 2025
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2025
Sep. 30, 2024
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Change in fair value presented in the condensed consolidated statements of operations $ (1,845)     $ 769     $ (490) $ 4,896
Change in fair value presented in the condensed consolidated statements of comprehensive operations (4,162) $ (573) $ 647 (1,069) $ (256) $ 324 (4,088) (1,001)
Long-Term Debt [Member] | Fair Value, Inputs, Level 3 [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance 14,781   14,974 13,239   14,731 14,974 14,731
Balance at issuance       12,280     129 24,670
Extinguishment/conversion (16)     (12,280)     (16) (25,841)
Payments (143)     (125)     (391) (378)
Change in fair value presented in the condensed consolidated statements of operations 708           708  
Change in fair value presented in the condensed consolidated statements of comprehensive operations 4,162     1,069     4,088 1,001
Ending balance 19,492 14,781   14,183 13,239   19,492 14,183
Long-Term Debt [Member] | Baker Notes Assigned To Aditxt Notes [Member] | Fair Value, Inputs, Level 3 [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance 14,609   13,801 12,280   13,510 13,801 13,510
Balance at issuance       12,280     24,670
Extinguishment/conversion     (12,280)     (25,790)
Payments (143)     (125)     (391) (378)
Change in fair value presented in the condensed consolidated statements of operations 708           708  
Change in fair value presented in the condensed consolidated statements of comprehensive operations     1,721     1,056 1,864
Ending balance 15,174 14,609   13,876 12,280   15,174 13,876
Long-Term Debt [Member] | Total Offerings And Aditxt Notes [Member] | Fair Value, Inputs, Level 3 [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance 172   1,173       1,173  
Balance at issuance             129  
Extinguishment/conversion (16)           (16)  
Payments            
Change in fair value presented in the condensed consolidated statements of operations            
Change in fair value presented in the condensed consolidated statements of comprehensive operations 4,162           3,032  
Ending balance 4,318 172         4,318  
Long-Term Debt [Member] | Total Offerings [Member] | Fair Value, Inputs, Level 3 [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance       959   1,221   1,221
Balance at issuance            
Extinguishment/conversion             (51)
Payments            
Change in fair value presented in the condensed consolidated statements of comprehensive operations       (652)       (863)
Ending balance       307 959     307
Derivative Financial Instruments, Liabilities [Member] | Fair Value, Inputs, Level 3 [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance 3   1,359 942   1,926 1,359 1,926
Balance at issuance               3,300
Change in fair value presented in the condensed consolidated statements of operations 1,137     (769)     (218) (4,896)
Exercises     (11)     (1) (168)
Ending balance 1,140 3   162 942   1,140 162
Derivative Financial Instruments, Liabilities [Member] | Fair Value, Inputs, Level 3 [Member] | Rights [Member]                
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]                
Beginning balance 3   $ 1,359 942   $ 1,926 1,359 1,926
Balance at issuance               3,300
Change in fair value presented in the condensed consolidated statements of operations 1,137     (769)     (218) (4,896)
Exercises     (11)     (1) (168)
Ending balance $ 1,140 $ 3   $ 162 $ 942   $ 1,140 $ 162
v3.25.3
Fair Value of Financial Instruments (Details Narrative)
$ in Millions
Sep. 08, 2023
USD ($)
Sep. 30, 2025
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Earnout term 15 years  
Net revenue $ 10.0  
Cumulative net sales $ 100.0  
Baker Bros. Notes [Member] | Measurement Input Royalty Rate [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Interest rate   5.0
Baker Bros. Notes [Member] | Measurement Input, Discount Rate [Member]    
Fair Value Measurement Inputs and Valuation Techniques [Line Items]    
Interest rate   15.0
v3.25.3
Schedule of Lease Cost (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Loss Contingencies [Line Items]        
Operating lease expense $ 14 $ 43 $ 97 $ 145
Research and Development Expense [Member]        
Loss Contingencies [Line Items]        
Operating lease expense 1 3 2
Selling and Marketing Expense [Member]        
Loss Contingencies [Line Items]        
Operating lease expense 11 40 86 135
General and Administrative Expense [Member]        
Loss Contingencies [Line Items]        
Operating lease expense $ 2 $ 3 $ 8 $ 8
v3.25.3
Schedule of Lease Term and Discount Rate (Details)
Sep. 30, 2025
Dec. 31, 2024
Commitments and Contingencies Disclosure [Abstract]    
Weighted Average Remaining Lease Term (in years) 1 year 7 months 24 days 9 months 7 days
Weighted Average Discount Rate 12.00% 12.00%
v3.25.3
Schedule of Operating Lease Maturities (Details)
$ in Thousands
Sep. 30, 2025
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
Remainder of 2025 (3 months) $ 34
Year ending December 31, 2026 127
Year ending December 31, 2027 52
Total lease payments 213
Less imputed interest (17)
Total $ 196
v3.25.3
Schedule of Supplement Cash Outflows in Operating Leases (Details) - USD ($)
$ in Thousands
 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]    
Operating cash outflows in operating leases $ 94 $ 218
Non-cash addition to ROU assets and lease liabilities due to new leases $ 201 $ 90
v3.25.3
Commitments and Contingencies (Details Narrative)
 1 Months Ended 3 Months Ended 9 Months Ended
Oct. 13, 2025
Jun. 26, 2025
USD ($)
$ / shares
shares
Nov. 08, 2024
Sep. 27, 2024
Jan. 01, 2021
USD ($)
Jun. 30, 2024
Sep. 30, 2025
USD ($)
$ / shares
shares
Sep. 30, 2024
USD ($)
Sep. 30, 2025
USD ($)
Integer
$ / shares
shares
Sep. 30, 2024
USD ($)
Dec. 31, 2024
USD ($)
Dec. 31, 2019
Loss Contingencies [Line Items]                        
Total commitment amount                 $ 3,500,000      
Purchases under commitment             $ 400,000   800,000      
Expects to purchase, remainder of fiscal year             600,000   600,000      
Expects to purchase, next year             1,900,000   1,900,000      
Royalty payments                 0      
Royalty expense             100,000   100,000      
Contingent liability current             200,000   200,000   $ 700,000  
Contingent liability non current             5,400,000   $ 5,400,000   9,700,000  
Leased vehicles | Integer                 18      
Purchases             $ 300,000 $ 800,000 $ 1,100,000 $ 1,000,000.0    
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | shares             263,062,099   263,062,099      
Debt Instrument, Unamortized Discount   $ 650                    
Principle amount   $ 1,000                    
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares   $ 0.0154         $ 0.18   $ 0.18      
Accounts payable, trade             $ 3,100,000   $ 3,100,000      
Accrued expenses             $ 2,500,000   $ 2,500,000      
Percentage of accounts payable trade             75.00%   75.00%      
Contingency liability accrued             $ 400,000   $ 400,000   800,000  
Description of debt notice of default     the Notices (the Third Amended Notice of Default) which added new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.                  
Debt default longterm debt description of notice     the Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.                  
Accrued liabilities             1,363,000   1,363,000   5,509,000  
Contingent liabilities             1,900,000   1,900,000   900,000  
Accrued expenses                     1,900,000  
Refund amount                 900,000      
Maximum [Member]                        
Loss Contingencies [Line Items]                        
Contingent liabilities             2,300,000   2,300,000      
Additional gain             900,000   900,000      
Additional loss             $ 2,300,000   $ 2,300,000      
Future Pak LLC [Member]                        
Loss Contingencies [Line Items]                        
Description of debt notice of default       According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to $106.8 million. Pursuant to Section 5.7(b) of the Baker Bros. SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).                
Security Purchase Agreement [Member] | Senior Subordinated Notes [Member]                        
Loss Contingencies [Line Items]                        
Debt Instrument, Issued, Principal   $ 3,700,000                    
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | shares   242,257,742                    
Debt Instrument, Interest Rate, Stated Percentage   8.00%                    
Proceeds from Notes Payable   $ 2,400,000                    
Rush License Agreement [Member]                        
Loss Contingencies [Line Items]                        
Royalty expense               $ 200,000   $ 600,000    
Accrued liabilities                     $ 2,800,000  
Rush License Agreement [Member] | Minimum [Member]                        
Loss Contingencies [Line Items]                        
Royalty payments         $ 100,000              
Subsequent Event [Member]                        
Loss Contingencies [Line Items]                        
Merger agreement description (i) amend section 1.5 and 3.1(b)(ii) to update the definition of “Unconverted Company Preferred Stock” to include Series G-1 Shares; (ii) amend section 1.6 to update the definition of “Company Shareholder Approval” to include the outstanding shares of Company Common Stock (including all of the Company’s Preferred Stock, on the basis and to the extent it is permitted to so vote) entitled to vote thereon and each series of the Unconverted Company Preferred Stock; (iii) amend section 6.23 to clarify that the Company will assist in obtaining Exchange Agreements (as defined in the A&R Merger Agreement, as amended) to exchange Company convertible notes and purchase rights for an aggregate of not more than 89,021 shares of Parent Preferred Stock from the applicable Company shareholders; (iv) amend section 7.2(j) to change the number of dissenting shares to no more than 5,932,818 shares of Common Stock or 202 shares of Preferred Stock; (v) add a new section 7.2(k) to require waivers from each holder of the Company’s E-1 Convertible Preferred Stock, with respect to the last sentence of Section 2, the entirety of Section 6, any price adjustment provisions that may be triggered under Section 8(a)(ii), Section 12(c), and Section 12(d) of the Series E-1 Certificate of Designations; and (vi) to replace, in its entirety, the Certificate of Designations for Exchanged Parent Preferred Stock included as Exhibit C to the A&R Merger Agreement.                      
Lease Contract Term One [Member]                        
Loss Contingencies [Line Items]                        
Lease contract           24 months            
Operating lease extended term           12 months            
Lease Contract Term One [Member] | Vehicles [Member]                        
Loss Contingencies [Line Items]                        
Lease contract                       24 months
Lease Contract Term [Member] | Vehicles [Member]                        
Loss Contingencies [Line Items]                        
Lease contract                       36 months
v3.25.3
Schedule of Warrants (Details) - $ / shares
Jun. 26, 2025
Apr. 08, 2025
Sep. 27, 2023
Aug. 04, 2023
Jul. 03, 2023
Apr. 05, 2023
Mar. 20, 2023
Feb. 17, 2023
Dec. 21, 2022
Jun. 28, 2022
May 24, 2022
May 04, 2022
Mar. 01, 2022
Jan. 13, 2022
Jun. 10, 2019
Apr. 11, 2019
Sep. 30, 2025
Accumulated Other Comprehensive Income (Loss) [Line Items]                                  
Underlying common stock to be purchased                                 263,062,099
Warrants exercise price $ 0.0154                               $ 0.18
Common Warrants [Member]                                  
Accumulated Other Comprehensive Income (Loss) [Line Items]                                  
Underlying common stock to be purchased 92,407,592 149,850,150 12,721,893 615,384 349,463 369,231 258,584 130,461 49,227 582,886 894,194 6,666 8,303 8,003 1,480 888  
Warrants exercise price $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 0.0154 $ 309.56 $ 897.56 $ 735.00 $ 11,962.50 $ 11,962.50  
Warrants exercise period June 26, 2025 to June 26, 2030 April 8, 2025 to April 8, 2030 September 27, 2023 to September 27, 2028 August 4, 2023 to August 4, 2028 July 3, 2023 to July 3, 2028 April 5, 2023 to April 5, 2028 March 20, 2023 to March 20, 2028 February 17, 2023 to February 17, 2028 December 21, 2022 to December 21, 2027 May 24, 2022 to June 28, 2027 May 24, 2022 to May 24, 2027 May 4, 2022 to May 4, 2027 March 1, 2022 to March 1, 2027 March 1, 2022 to March 1, 2027 December 10, 2019 to June 10, 2026 October 11, 2019 to April 11, 2026  
Prefunded Common Warrants [Member]                                  
Accumulated Other Comprehensive Income (Loss) [Line Items]                                  
Underlying common stock to be purchased     4,807,694                            
Warrants exercise price     $ 0.0010                            
Warrants exercise period     September 27, 2023 to September 27, 2028                            
v3.25.3
Summary of Common Stock Reserved for Future Issuance (Details)
Sep. 30, 2025
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Common stock reserved upon exercise of stock options outstanding 3,372
Common stock reserved upon exercise of common stock warrants 10,595,019
Common stock reserved for the exercise of purchase rights 741,490,642
Common stock reserved for the conversion of convertible notes 421,784,555
Common stock reserved for the conversion of series E-1 preferred stock 46,570,761
Total common stock reserved for future issuance 1,220,445,467 [1]
Employee Stock Purchase Plan 2019 [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Common stock available for future issuance 509
Amended Inducement Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Common stock available for future issuance 609
[1] The potentially dilutive securities in Note 2 – Summary of Significant Accounting Policies includes all potentially dilutive securities that are not included in the diluted EPS as per U.S. GAAP, whereas the total Common Stock reserved for future issuance in the table above includes the shares that must legally be reserved based on the applicable instruments’ agreements.
v3.25.3
Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (Details Narrative) - USD ($)
$ / shares in Units, $ in Millions
 1 Months Ended 3 Months Ended 6 Months Ended 9 Months Ended
Aug. 22, 2025
Dec. 21, 2023
Aug. 07, 2023
Sep. 15, 2022
May 31, 2024
Jun. 30, 2022
Sep. 30, 2025
Jun. 30, 2025
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Dec. 31, 2024
Sep. 30, 2025
Sep. 30, 2024
Jun. 26, 2025
Apr. 22, 2025
Apr. 08, 2025
Jan. 06, 2025
Dec. 11, 2023
Sep. 30, 2023
Sep. 14, 2023
Aug. 06, 2023
Dec. 31, 2022
May 31, 2022
Dec. 15, 2021
Jun. 30, 2020
Apr. 30, 2020
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock             263,062,099           263,062,099                            
Warrants exercise price             $ 0.18           $ 0.18   $ 0.0154                        
Common stock, par value             $ 0.0001         $ 0.0001 $ 0.0001                   $ 0.0001        
Exercise price                               $ 0.01   $ 0.01                  
Preferred stock, shares authorized             5,000,000         5,000,000 5,000,000                       5,000,000    
Preferred stock, par value $ 0.0001           $ 0.0001         $ 0.0001 $ 0.0001                       $ 0.0001    
Redemption premium percentage 25.00%                                                    
Deemed dividends             $ 0.1           $ 0.1                            
Shares issued             0         0 0                            
Common stock, shares authorized             3,000,000,000         3,000,000,000 3,000,000,000               3,000,000,000            
Series F-1 Convertible Preferred Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Shares issued upon conversion   613                                                  
Preferred stock, shares authorized                                     95,000                
Preferred stock, par value                                     $ 0.0001                
Redemption premium percentage                                     25.00%                
Share conversion price             $ 0.0154     $ 0.0154     $ 0.0154           $ 0.0635                
Shares issued   22,280                                                  
Shares issued for purchase rights   21,667                                                  
Series E-1 Convertible Preferred Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Preferred stock, shares authorized     10,000                                     2,300          
Preferred stock, par value     $ 0.0001                                                
Conversion price     $ 0.40                                                
Dividend rate description     The Series E-1 Shares were entitled to dividends at a rate of 10% per annum (which increased as per the provision below as of April 1, 2025) or 12% upon a triggering event. On the 18-month anniversary of the initial issuance date for the Series E-1 convertible preferred stock, the dividend rate increased by 30% and will remain at that rate until no E-1 Shares remain outstanding                                                
Redemption premium percentage     25.00%                                                
Debt Conversion, Original Debt, Amount     $ 1.8                                                
Debt Conversion, Converted Instrument, Shares Issued     1,800                                                
Share conversion price             0.0154           0.0154                            
Payments of Dividends                           $ 0.1                          
Series G-1 Convertible Preferred Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Exercise price $ 1,000                                                    
Preferred stock, par value $ 0.0001                                                    
Debt Conversion, Original Debt, Amount $ 1.6                                                    
Debt Conversion, Converted Instrument, Shares Issued 1,573                                                    
Share conversion price $ 0.0154                                                    
Debt Instrument, Repaid, Principal $ 0.1                                                    
Adjuvant and May 2022 Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Purchase rights       $ 24.7                                              
Warrant [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants exercise price             $ 0.0154           $ 0.0154                            
Common stock warrant outstanding             894,194           894,194                            
Warrants converted   9,972,074                                                  
Common Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Common stock warrant outstanding   9,972,074                                                  
Common stock issued upon exercise of purchase rights             5,300,000 5,300,000 17,500,000 24,350,000 17,725,000                                
Common Stock [Member] | Adjuvant and May 2022 Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Shares issued for purchase rights       942,080                                              
Underwritten Public Offering [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                               362,640      
Warrants exercise price                                               $ 93.75      
IPO [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                               205,360      
Warrants exercise price                                               $ 93.63      
Baker Warrants [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants exercise price             $ 0.0154           $ 0.0154                            
June 2022 Baker Warrants [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock           582,886                                          
Warrants exercise price           $ 93.75 $ 0.0154           $ 0.0154                            
Warrants term           5 years                                   5 years      
Common stock, par value           $ 0.0001                                          
June 2022 Baker Warrants [Member] | Minimum [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Beneficial ownership limitation percentage           4.99%                                          
June 2022 Baker Warrants [Member] | Maximum [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Beneficial ownership limitation percentage           19.99%                                          
Rights [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Increase in purchase rights outstanding                 0         1,161,636,815                          
Purchase rights outstanding             1,508,548,899           1,508,548,899                            
Rights [Member] | Common Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Common stock issued upon exercise of purchase rights             5,300,000   17,500,000       10,600,000 59,575,000                          
Baker Bros Purchase Agreement [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                                   2,731 2,731
Warrants exercise price                                                   $ 4,575 $ 4,575
Security Purchase Agreement [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                             92,407,592   149,850,150                    
Common stock, par value                             $ 0.0001   $ 0.0001                    
Exercise price                             $ 0.0154                        
Security Purchase Agreement [Member] | Aditxt Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock               242,257,742                                      
Exercise price               $ 0.0154                                      
Security Purchase Agreement [Member] | Warrant [Member] | Senior Subordinated Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants exercise price             $ 0.0154           $ 0.0154                            
Security Purchase Agreement [Member] | Warrant One [Member] | Senior Subordinated Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                       1,152,122              
Exercise price                                       $ 2.50              
Security Purchase Agreement [Member] | Warrant Two [Member] | Senior Subordinated Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                       2,615,383              
Warrants exercise price                                       $ 1.25              
Security Purchase Agreement [Member] | Warrant Three [Member] | Senior Subordinated Notes [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Warrants to purchase common stock                                       22,189,349              
Warrants exercise price                                       $ 0.13              
A&R Merger Agreement [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Proceeds from merger         $ 1.0                                            
A&R Merger Agreement [Member] | Series F-1 Convertible Preferred Stock [Member]                                                      
Class of Warrant or Right [Line Items]                                                      
Number of shares issued                       4,000                              
Share purchase price                       $ 4.0                              
Cash received recorded as additional paid-in-capital                       $ 5.0                              
v3.25.3
Schedule of Stock-based Compensation Expense Related to Stock Options (Details) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2025
Sep. 30, 2024
Sep. 30, 2025
Sep. 30, 2024
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total $ 23 $ 203 $ 124 $ 659
Research and Development Expense [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total 5 1 31
Selling and Marketing Expense [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total 2 18 7 77
General and Administrative Expense [Member]        
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]        
Total $ 21 $ 180 $ 116 $ 551
v3.25.3
Stock-based Compensation (Details Narrative)
$ in Millions
 9 Months Ended
Sep. 30, 2025
USD ($)
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Equity awards issued | shares 0
Share-Based Payment Arrangement, Option [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unrecognized stock-based compensation expense | $ $ 0.1
Weighted-average remaining period 2 months 12 days
v3.25.3
Subsequent Events (Details Narrative)
Oct. 03, 2025
shares
Subsequent Event [Member] | 2025 Equity Incentive Plan [Member]  
Subsequent Event [Line Items]  
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant 50,000,000