Audit Information |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Auditor [Table] | |
| Auditor Name | KPMG LLP |
| Auditor Firm ID | 185 |
| Auditor Location | Atlanta, Georgia |
Balance Sheets (Parentheticals) - $ / shares |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Balance Sheets [Abstract] | ||
| Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
| Common stock, authorized (in Shares) | 200,000,000 | 200,000,000 |
| Common stock, issued (in Shares) | 59,720,010 | 23,473,149 |
| Common stock, outstanding (in Shares) | 59,602,787 | 23,355,926 |
| Treasury stock, common shares (in Shares) | 117,223 | 117,223 |
Organization, Nature of Business, and Liquidity |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Organization, Nature of Business, and Liquidity [Abstract] | |
| Organization, Nature of Business, and Liquidity |
(1)
Organization, Nature of Business, and Liquidity
Organization and Nature of Business
Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical innovator, addressing significant unmet needs in women’s health worldwide, with a broad patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio, which are currently being commercialized in the U.S. and key international markets. The Company’s suite of products and U.S. product candidate address what the Company believes are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
Basis of Presentation
The Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United States of America (GAAP) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC).
Liquidity As of December 31, 2025, the Company has cash and cash equivalents of $9,266,353. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from domestic sales of FemaSeed and FemVue and international sales of FemBloc, FemaSeed and FemVue to support the Company’s commercial efforts and research and development activities, primarily focused on FemBloc. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the year ended December
31, 2025, the Company generated a net loss of $18,627,887. The Company expects
such losses to increase over the next few years as the Company commercializes
FemaSeed and its other products and advances FemBloc through clinical
development if and until FDA approval is received and is available to be
marketed in the U.S. The financial statements have
been prepared on a going-concern basis, which contemplates the realization of
assets and the satisfaction of liabilities in the normal course of business.
The Company has incurred net operating losses in every year since inception and
has an accumulated deficit as of December 31, 2025 of $145,826,144 and expects
to incur additional losses and negative operating cash flows for at least the
next twelve months. The Company’s ability to meet its obligations is dependent
upon its ability to generate sufficient cash flows from operations and future
financing transactions. Although management expects the Company will continue
as a going concern, there is no assurance that management’s plans will be
successful since the availability and amount of such funding is not certain.
Accordingly, substantial doubt exists about the Company’s ability to continue
as a going concern for at least one year from the issuance of these financial
statements. The accompanying financial statements do not include any
adjustments to reflect the possible future effects on the recoverability of
assets or the amounts and classifications of liabilities that may result from
the possible inability of the Company to continue as a going concern.
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Summary of Significant Accounting Policies |
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| Summary of Significant Accounting Policies |
(2)
Summary of Significant Accounting Policies
(a) Use of Estimates in Preparation of Financial Statements The preparation of financial
statements in conformity with U.S. generally accepted accounting principles
(GAAP) requires the Company to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most
significant estimates used in these financial statements include stock options,
warrants, conversion option and warrants liabilities, the valuation of useful
lives of property and equipment, and clinical trial cost accruals. Actual
results could differ from those estimates. (b) Certain Risks and Uncertainties
Products being developed by the Company, such as FemBloc, will require approval from the FDA or corresponding foreign regulatory agencies prior to commercial sales. FemBloc is approved in the European Union, UK and New Zealand. FemaSeed Intratubal Insemination is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. FemVue, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared and approved in Europe, UK, Canada, Japan, Israel, Australia and New Zealand. FemVue Controlled, a diagnostic solution for controlled contract delivery to evaluate fallopian tube status, is U.S. FDA-cleared. FemCerv, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemCath for selective fallopian tube evaluation is U.S. FDA-cleared and approved in Europe, Canada and Israel. FemChec, a companion diagnostic product for FemBloc’s ultrasound-based confirmation test, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. There can be no assurance the Company’s other products in development will receive the necessary approvals/ clearances. If the Company is denied regulatory approval/ clearance or approval/ clearance is delayed, it might have a materially adverse impact on the Company.
The medical device industry is characterized by frequent and extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often difficult to predict, and the outcome may be uncertain until the court has entered final judgment and all appeals are exhausted. The Company’s competitors may assert that its products or the use of its products are covered by United States or foreign patents held by them. If such relevant patents are upheld as valid and enforceable and the Company is found to infringe, the Company could be prevented from selling its products unless it can obtain a license to use technology or ideas covered by such patents or are able to redesign its products to avoid infringement. A license may not be available at all or on commercially reasonable terms, and it may not be able to redesign its products to avoid infringement.
The Company relies on some single source suppliers to provide certain components of its products commercially available and those under development. The Company purchases these components on a purchase order basis. If the Company overestimates its component requirements, it could have excess inventory, which would increase its costs and result in write‑downs harming its operating results. If the Company underestimates its requirements, it may not have an adequate supply, which could interrupt the manufacturing of its products.
(c) Fair Value of Financial Instruments
The Company applies a fair value hierarchy that requires the use of observable market data, when available, and prioritizes the inputs to valuation techniques used to measure fair value in the following categories:
Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets.
Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑based valuation techniques for which all significant assumptions are observable in the market.
Level 3 – Valuation is generated from model‑based techniques that use significant assumptions not observable in the market. These unobservable assumptions reflect the Company’s own estimates of assumptions market participants would use in pricing the asset or liability.
Certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and other liabilities approximate their fair value because of the short‑term maturity of these financial instruments.
(d) Cash and Cash Equivalents The Company considers all
highly liquid investments with an initial maturity of three months or less when
purchased to be cash equivalents. Cash equivalents consist of amounts invested
in money market mutual funds and are stated at fair value. See Note 2(t) for
information on concentration of credit risk. (e) Accounts Receivable The Company grants trade credit to customers in the normal course of business and does not require collateral or any other security to support its receivables. Management reviews its accounts receivable monthly for any collection issues. Potentially uncollectible accounts are written off to bad debt expense when it is determined that the likelihood a customer account is uncollectible is probable. As of December 31, 2025 and 2024, the Company’s reserves for uncollectible accounts were $14,013 and $10,000, respectively. Trade accounts receivable are recorded at the invoiced amount, net of allowance for credit loss and do not bear interest. Amounts collected on trade accounts receivable are included in net cash provided by operating activities in the statements of cash flows. (f) Inventories
Inventories are stated at the lower of cost or net realizable value. Cost, which includes amounts related to materials, labor and overhead, is determined on a first‑in, first‑out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.
Inventory stated at cost, consisted of the following as of December 31:
(g) Other Assets The Company has research tax credits that are available to the Company to offset future payroll withholding liabilities. As of December 31, 2025 and 2024, the total amount of these credits is $948,292 and $1,030,809, respectively. The Company has included these amounts on the accompanying balance sheets as follows as of December 31:
(h) Property and Equipment
Property and equipment are carried at cost less accumulated depreciation and, if applicable, impairment charges. Expenditures which materially increase value or extend useful lives of assets are capitalized, while maintenance and repairs which do not improve or extend the lives of the respective assets are charged to operations when incurred. Gains and losses on the retirement or disposal of individual assets are included in the results of operations. Depreciation and amortization are computed using the straight‑line method over estimated useful lives of assets as follows:
Depreciation expense for the years ended 2025 and 2024 was $295,859 and $277,178, respectively. In 2025, the Company disposed of property and equipment at an original cost of $296,338 with a net book value of $62,650, which is recorded in operating expenses on the statements of comprehensive loss. In 2024, the Company disposed of property and equipment at an original cost of $82,507 with a net book value of $676, which is recorded in operating expenses on the statements of comprehensive loss. (i) Impairment of Long-Lived Assets The Company reviews long‑lived assets, including property and equipment and definite lived intangibles, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the asset group may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset group and its eventual disposition is less than its carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of a long‑lived asset group exceeds its fair value. The Company has not recorded any impairment losses to date. (j) Leases The Company records operating leases as right-of-use assets and operating lease liabilities in its balance sheets for all operating leases with terms exceeding one year. Right-of-use assets represent the right to use an underlying asset for the lease term, including extension options considered reasonably certain to be exercised, and operating lease liabilities to make lease payments. Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term. To the extent that lease agreements do not provide an implicit rate, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of lease payments. The expense for operating lease payments is recognized on a straight-line basis over the lease term and is included in operating expenses in the Company’s statements of comprehensive loss. Non-lease components included in lease agreements are accounted for separately. The Company records finance leases as right-of-use assets and finance lease liabilities in its balance sheets for all finance leases with terms exceeding one year, similar to operating leases, and records interest expense and depreciation expense on the right-of-use asset in the statements of comprehensive loss. (k) Intangible Assets Intangible assets consist of patent and trademark application costs and related legal fees, carried at cost less accumulated amortization and, if applicable, impairment charges. Amortization is computed using the straight‑line method over a weighted-average useful life of three years and is recorded in depreciation and amortization expense within the results of operations. Intangible assets consist of the following as of December 31:
Amortization expense for intangible assets for the years ended December 31, 2025 and 2024 was $46,175 and $20,140, respectively. (l) Deferred Offering Costs
Deferred offering costs, which consist mainly of legal, consulting, and accounting fees directly attributable to a strategic financing transaction, are capitalized in accordance with Staff Accounting Bulletin (SAB) Topic 5.A Expenses of Offering, codified in Accounting Standards Codification (ASC) 340-10-S99-1 Other Assets and Deferred Costs.
During 2022, the Company
incurred $232,845 in deferred offering costs in connection with prospectuses
filed in July 2022, including an offering to sell up to $150 million in stock,
debt securities and warrants, and an Equity Distribution Agreement entered into
with Piper Sandler which included an at-the-market (ATM) facility. These
deferred offering costs were offset against the total proceeds from the issuance
of common stock available under the prospectuses. As of December 31, 2025, and 2024, the Company
offset $15,637 and $3,143, respectively of deferred offering costs in
connection with the gross proceeds issued under the prospectuses. The shelf
expired in 2025 and the remaining balance of $196,267 was expensed as other
expense in the statements of comprehensive loss. During 2025, the Company
incurred $73,785 in deferred offering costs in connection with a prospectus
filed in July 2025, including an offering to sell up to $150 million in stock,
debt securities and warrants. As of December 31, 2025, deferred offering costs
capitalized were $73,785 and are included in other assets in the accompanying
balance sheet. As of December 31, 2024, deferred offering costs capitalized
were $211,654 and are included in prepaid and other current assets in the
accompanying balance sheet. These costs will be offset against proceeds from the issuance of common stock sales and will be expensed if the prospectus is terminated or aborted. (m) Accrued Expenses
Accrued compensation costs include incentive compensation and unused paid time off. Accrued clinical trial expenses include research and development costs for third-party services, largely related to the Company’s clinical trials, which are estimated based upon the services provided but not yet invoiced. These costs, at times, may be a significant component of the research and development expenses and the Company makes estimates in determining the accrued expense each period. As actual costs become known, the Company adjusts its accrual. Other accrued expenses include director fees, taxes and other miscellaneous accrued expenses.
Accrued expenses consisted of the following as of December 31:
(n) Clinical Holdback As part of the regulatory
approval process for taking its products to market or conducting post-market
clinical studies to support marketing efforts for products with regulatory
clearance, the Company enters into certain Clinical Trial Agreements (CTAs) which
include, among other things, the compensation and payment schedule the
participating medical institutions and investigators will receive for all costs
in connection with the clinical trial (or study) under the terms of the CTA. As
individual participants are enrolled in the study by the participating medical
institution or investigator, the Company pays certain per study fees according
to the CTA for the duration of the trial. As invoices are received by the
Company from the medical institution or investigator, the Company retains any
agreed upon percentage of total invoiced costs, generally ranging between 5% -
15%, which is withheld from payment until the end of the study. These retained
amounts are recorded as clinical holdback, a liability, on the accompanying
balance sheets, and all expenses incurred in connection with these CTA
activities are expensed as services are provided, which are included as
research and development expenses on the accompanying statements of comprehensive
loss. (o) Convertible Notes The Company accounts
for its convertible notes based on an assessment of the convertible note terms
and applicable guidance ASC 470-20, Debt with Conversion and Other Options
(ASC 470-20) and ASC 815-40, Derivatives and Hedging—Contracts in Entity’s
Own Equity (ASC 815). The Company evaluates all features contained in
financing agreements to determine if there are any embedded derivatives that
require separate accounting from the underlying agreement. An embedded
derivative that requires separation is accounted for as a separate asset or
liability from the host agreement. The derivative asset or liability is
accounted for at fair value, with changes in fair value recognized in the
statement of comprehensive loss at each reporting period. The convertible notes were
recorded net of debt issuance costs and any discounts. The Company has
historically issued warrants in conjunction with issuing convertible notes (see
Note 7). Debt issuance costs are amortized over the term of the convertible
notes using the effective interest method in addition to the discount initially
recognized for the fair value of warrants issued. The amortization of debt
issuance costs and discount is included in interest expense in the statements
of comprehensive loss. If the debt is retired early, the associated debt
discount will be recognized immediately as interest expense in the statements
of comprehensive loss. (p) Common Stock Warrants The Company accounts for its
common stock warrants as equity-classified or liability-classified instruments
based on an assessment of the warrants’ specific terms and applicable
authoritative guidance in ASC 480, Distinguishing Liabilities from Equity
(ASC 480) and ASC 815. The assessment considers whether the warrants are (i)
freestanding financial instruments pursuant to ASC 480, (ii) meet the
definition of a liability pursuant to ASC 480, and (iii) meet all of the
requirements for equity classification under ASC 815, including whether the
warrants are indexed to the Company’s own common stock and whether the warrant
holders could potentially require “net cash settlement” in a circumstance
outside of the Company’s control, among other conditions for equity classification.
This assessment, which requires the use of professional judgment, is conducted
at the time of warrant issuance and as of each subsequent quarterly period end
date while the warrants are outstanding. For warrants that meet all of
the criteria for equity classification, the warrants are required to be
recorded as a component of additional paid-in capital, on the balance sheets at
the time of issuance. For warrants that do not meet all the criteria for equity
classification, the warrants are required to be recorded at their initial fair
value on the date of issuance and on each balance sheet date thereafter. The Company’s warrants liabilities are measured at fair value using a simulation model which takes
into account, as of the valuation date, factors including the current exercise
price, the expected life of the warrant, the current price of the Company's common
stock, the expected volatility, the risk-free interest rate for the term of the
warrant and the likelihood of achieving certain future milestone events and the
related impact to the price of the Company's common stock. The warrants liabilities are revalued at each reporting period and changes in fair value are
recognized in other (expense) income in the statements of comprehensive loss. The
selection of the appropriate valuation model and the inputs and assumptions
that are required to determine the valuation requires significant judgment and
requires management to make estimates and assumptions that affect the reported
amount of the related liability and reported amounts of the change in fair
value. Actual results could differ from those estimates, and changes in these
estimates are recorded when known. See
Note 7 for additional information on warrants issued by the Company. (q) Any Market Purchase Agreement (“AMPA”)
The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate accounting from the underlying agreement. An embedded derivative that requires separation is accounted for as a separate asset or liability from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the statement of comprehensive loss. The Company determined that certain features under the AMPA contained embedded derivatives. The derivative liability associated with the AMPA were deemed de minimus at both the issuance date and as of December 31, 2025.
(r) Revenue Recognition The Company’s policy is to recognize revenue when a customer obtains control of the promised goods under ASC 606, Revenue from Contracts with Customers. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods, and the Company has elected to exclude amounts collected from customers for all sales (and other similar) taxes from the transaction price. Revenue is recognized upon shipment of the Company’s goods based upon contractually stated pricing at standard payment terms typically ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. There was no revenue recognized during the years ended December 31, 2025 and 2024 from performance obligations satisfied or partially satisfied in prior periods. Additionally, there were no unsatisfied performance obligations as of December 31, 2025 and 2024. The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to the Company’s international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. As of December 31, 2025, the Company has not had a history of significant returns. The following table summarizes the Company’s sales by geographic region for the years ending December 31:
(s) License, Manufacturing, and Supply Agreements
The Company entered into a FemVue License, Manufacturing, and Supply Agreement with Bayer Yakuhin, Ltd., a wholly owned subsidiary of Bayer AG, in 2012. The Company sells products based on purchase orders provided by Bayer Yakuhin in accordance with their agreement. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
The Company entered in distributor agreements with Comercial Medico Quirurgica, SA (“Comercial”) and Durgalab in September 2024. The Company sells products based on purchase orders provided by Comercial and Durgalab in accordance with their agreements. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
The Company entered in a distributor agreement with Kebomed Europe AG (“Kebomed”) in September 2025. The Company sells products based on purchase orders provided by Kebomed in accordance with their agreement. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
(t) Concentration of Credit Risk The Company generates revenue from sales directly to U.S. customers and to the Company’s international distributors with all prices in U.S. dollars. For the year ended December 31, 2025, one customer accounted for revenues of 21% of total revenues. As of December 31, 2025, one customer had an accounts receivable balance of 76% of total receivables, which was paid subsequent to year end. No other customer had revenue or accounts receivable in excess of 10% of total receivables. For the year ended December 31, 2024, two customers accounted for revenues of 15% and 12% of total revenues. As of December 31, 2024, three customers had balances of 23%, 21% and 12% of total receivables. (u) Research and Development
The Company’s research and development expenses consist of engineering, product development, clinical, quality assurance and regulatory expenses and are expensed as incurred. These expenses include direct expenses related to employee compensation, including salary, benefits and stock-based compensation; expenses related to consulting fees, testing fees, materials, and supplies; and activities conducted by third-party service providers, which include the conducting of preclinical studies and clinical trials.
(v) Sales and Marketing
The Company’s sales and marketing expenses consist of direct expenses related to employee compensation, including salary, benefits and stock-based compensation, advertising and marketing, business development and travel.
(w) General and Administrative
The Company’s general and administrative expenses include accounting, human resources, and general corporate expenses. These expenses are primarily related to employee compensation, including salary, benefits, and stock‑based compensation. General corporate expenses generally relate to office rent, utilities, insurance, legal, and professional fees.
(x) Advertising Expense Advertising costs are expensed as incurred. Advertising costs were $262,270 and $360,958 for the years ended December 31, 2025 and 2024, respectively. They are reflected in sales and marketing expenses in the statements of comprehensive loss. (y) Stock-Based Compensation
The Company recognizes all employee and nonemployee stock-based compensation as a cost in the financial statements. Equity-classified awards are measured at the grant-date fair value of the award. The Company estimates grant-date fair value using the Black-Scholes option pricing model and records forfeitures as they are incurred. Details of the stock‑based compensation and accounting treatment are discussed in Note 10.
(z) Income Taxes
The Company utilizes the asset‑and‑liability method of accounting for income taxes as set forth in ASC 740, Income Taxes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, as well as the net operating loss, capital loss, and tax credit carryforwards. Valuation allowances are established against deferred tax assets if it is more likely than not that they will not be realized.
ASC 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard requires that the Company recognize in its financial statements the impact of a tax position if that position is more likely than not of being sustained on audit, based on the technical merits of the position. The Company has determined it had no unrecognized tax benefits as of December 31, 2025 and 2024.
As of December 31, 2025, the 2022 through 2025 tax years remain subject to examination by federal and most state tax authorities. The use of net operating losses generated in tax years prior to 2022 may also subject returns for those years to examination.
(aa) Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the cumulative dividends, if any. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss position of the Company.
(ab) Recently Issued Accounting Pronouncements – Recently Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning after December 15, 2024. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company adopted the ASU prospectively on January 1, 2025 and it did not have a material impact on its operations.
(ac)
Recently Issued Accounting Pronouncements – Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (Subtopic 220-40). The standard requires public business entities to disclose additional information about specific expense categories included in relevant income statement captions, including purchases of inventory, employee compensation, depreciation, amortization of intangible assets, and certain other expenses. The ASU 2024-03 is effective for the Company’s annual reporting periods beginning after December 15, 2026. Early adoption is permitted. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Management is currently assessing the impact of this standard on the Company’s financial statements and will adopt the ASU on January 1, 2027.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. The amendments clarify the applicability of the interim reporting guidance in Topic 270 and improve the navigability of interim disclosure requirements by providing a more comprehensive listing of disclosures required in interim financial statements. The ASU is effective for the Company’s interim periods in annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Management is currently assessing the impact of this standard on the Company’s financial statements and will adopt the ASU on January 1, 2028.
No other new accounting pronouncements not yet effective are expected to have a material impact on the Company’s financial statements.
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Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments |
(3)
Fair Value of Financial Instruments
The following
fair value hierarchy table presents information about the Company’s assets and
liabilities measured at fair value on a recurring basis:
The fair value of the AMPA
(see Note 9(f)) was measured at inception and at the December 31, 2025
reporting period using
Level 3 inputs. The fair value was deemed de minimis at both date of
issuance date and as of the December 31, 2025 reporting period. The fair value of the
Conversion Option liability and Warrants liabilities related to the 2025 Notes
(see Note 7b) were measured at inception and at the December 31, 2025 reporting
period. The change in fair value between the periods was recognized as gains in
other (expense) income in the statements of comprehensive loss and are
summarized below:
The December 31, 2025 fair
value of the Conversion Option liability and Warrants liabilities were
estimated using the Black-Scholes option pricing model Level 3 inputs, with the
following assumptions:
The valuations of the
Conversion Option liability and Warrants liabilities at issuance were
calibrated such that the aggregate fair values of all instruments issued
together (including the 2025 Notes which are not subsequently remeasured at
fair value) equaled total gross proceeds received of $12 million in the
November 2025 Financing (see Note 7). This calibration resulted in an expected
volatility assumption of 20% which was also used in the valuation as of
December 31, 2025. If the Company used the historical volatility of its common
stock as the expected volatility assumption, the estimated value of the
Conversion Option liability and Warrants liabilities would be higher. Similarly, the expected terms of the
Conversion Option and Warrants were based on the Company’s option to mandate
conversion of the Notes upon achieving certain milestones (see Note 7) as well
as the expectation that the Warrants will be exercised upon a significant
increase in the price of the Company’s common stock. If the Company used the contractual term of
the Conversion Option and Warrants as the expected term, the estimated value of
the Conversion Option liability and Warrants liabilities would be higher.
We review the fair value hierarchy classification of our applicable assets and liabilities on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification for certain financial assets or liabilities. During the year ended December 31, 2025, there were no transfers between Level 1, Level 2 and Level 3.
The carrying amounts of cash and cash
equivalents, accounts receivable, customer deposits, accounts payable and
accrued expenses approximate fair value due to their short-term nature. As of
December 31, 2025, the fair value of the 2025 notes (excluding the conversion
option, see Note 7b), calculated using a discounted cash flow analysis using
Level 3 inputs, was approximately $3.8 million. As of December 31, 2024, the
fair value of the Company’s 2023 Notes (see Note 7a), calculated using a discounted
cash flow analysis using Level 3 inputs, was approximately $6.5 million. The
Company uses a Black-Scholes option valuation model to determine the grant date
fair value of employee stock options which uses Level 2 inputs. See Note 10 for
a description of inputs used.
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Cash and Cash Equivalents |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Cash and Cash Equivalents [Abstract] | |
| Cash and Cash Equivalents |
(4)
Cash and Cash Equivalents
As of December 31, 2025 and 2024, money market funds included in cash and cash equivalents on the balance sheets were $7,110,655 and $3,451,761, respectively. The Company considers all highly-liquid investments with a remaining maturity of three months or less at the date of purchase to be cash.
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Commitments and Contingencies |
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| Commitments and Contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies |
(5)
Commitments and Contingencies
(a)
Operating Leases
As of December 31, 2025, the Company has the right of use for its facilities located in Suwanee, GA under a long-term operating lease agreement, as amended (Lease Agreement), which expires in . The Company has the option (Extension Option) to extend the term for one consecutive term of five years each at the greater of the then current prevailing rental rate or current base rent rate, as agreed by both parties, and upon certain terms and conditions. The Company must provide written notice of its intent to exercise this extension option at between nine and 12 months prior to the expiration date of . Under the terms of the lease agreement, the Company’s monthly rent is subject to increases on an annual basis. As of December 31, 2025, the Company’s monthly rent payment was $52,614. Operating right-of-use assets and lease liabilities consist of the following as of December 31:
As of December 31, 2025 and
2024, the weighted-average discount rate for all operating leases with initial
terms of more than one year was approximately 10% and the weighted-average
remaining term for operating leases was 3.3 years and 4.3 years, respectively. The operating lease agreement for the Company’s facility includes non-lease costs, such as common area maintenance, which are recorded as variable lease costs. Operating lease expenses are included in general and administrative expenses in the Company’s statements of comprehensive loss and are summarized as follows for the years ending December 31:
The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities with initial terms of more than twelve months as of December 31, 2025:
(b)
Clinical Trial Agreements (CTAs)
As part of the regulatory approval process for taking its products to market or conducting post-market clinical studies to support marketing efforts for products with regulatory clearance, the Company enters into a CTA to compensate each participating medical institution and investigator. Generally, upon executing a CTA with a participating medical institution or investigator, the Company pays a fee for institutional review board (IRB) approval that usually requires annual renewals and one-time site startup costs. As individual participants are enrolled in the clinical trial by the participating medical institution or investigator, the Company pays certain per subject fees according to the CTA for the duration of the trial. Expenses incurred in connection with these CTA activities are expensed as services are provided and are included in research and development expenses on the accompanying statements of comprehensive loss.
(c)
Legal Claims
Occasionally, the Company may be a party to legal claims or proceedings of which the outcomes are subject to significant uncertainty. In accordance with ASC 450, Contingencies, the Company will assess the likelihood of an adverse judgment for any outstanding claim as well as ranges of probable losses. When it has been determined that a loss is probable and the amount can be reasonably estimated, the Company will record a liability. For the years ended December 31, 2025 and 2024, there were no material legal contingencies requiring accrual or disclosure.
The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director who is or was serving at the Company’s request in such capacity. The Company entered into employment agreements with its officers, which provides for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained director and officer insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2025 and 2024.
|
Notes Payable |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Notes Payable [Abstract] | |
| Notes Payable |
(6)
Notes Payable
AFCO Credit Corporation (AFCO) In July 2025, the Company executed a promissory note with AFCO to finance certain insurance premiums totaling $367,450, requiring the Company to pay $31,672 in a down payment and make monthly installment payments. The annual interest rate was 7.44% and the monthly installment is $31,672, which represents principal and interest. The Note was paid in full without penalty in . Interest expense in connection with the AFCO Promissory Note was $8,614 for the year ended December 31, 2025.
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Convertible Notes with Warrants |
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| Convertible Notes with Warrants [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Convertible Notes with Warrants |
(7)
Convertible Notes with Warrants
(a) Convertible
Notes with Warrants (November 2023 Financing) On
November 21, 2023, the Company issued (i) senior unsecured convertible notes in
an aggregate principal amount of $6,850,000 (“2023 Notes”), convertible into
shares of common stock at a conversion price of $1.18 per share, (ii) Series A
Warrants to purchase up to an aggregate of 5,805,083 shares of common stock at
an exercise price of $1.18 per share, and (iii) Series B Warrants, together
with the Series A Warrants, and, together with the convertible notes, to
purchase up to an aggregate of 5,805,083 shares of common stock at an exercise
price of $1.475 per share. The financing resulted in aggregate gross proceeds
of $6,850,000, before $525,144 of issuance costs. The 2023 Notes accrued
interest at a rate of 6.0% per annum, payable annually, in cash or shares of
common stock at the Company’s option. In November 2024, the Company paid
$111,000 of accrued interest in cash and $300,000 accrued interest in 315,790
shares of common stock. In November 2025, the Company paid $407,841 in accrued
interest in 516,256 shares of common stock. As
noted above, the 2023 Notes were convertible into shares of common stock at the
election of the holder at any time at an initial conversion price of $1.18. The
conversion feature did not meet the requirements for separate accounting and
was not accounted for as a derivative instrument. As of December 31, 2024, the
2023 Convertible Notes had not been converted into shares of common stock. In
April 2025, $85,000 of convertible notes were converted into 72,033 shares of
common stock. The
2023 Notes matured on November 21, 2025, and were repaid in full by the Company
with proceeds from the November 2025 Financing discussed below. No gain or loss was recorded upon repayment
of the 2023 Notes. Warrants The Series A Warrants are exercisable immediately and expire five years from the date of issuance. The Company has the right to call the exercise of the Series A Warrants if the closing price of the common stock exceeds 200% of the Series A Exercise Price for 10 consecutive trading days and the daily dollar trading volume of the common stock exceeds $1,000,000 per day during the same period and certain equity conditions are satisfied. The Series B Warrants expired in .
The Series A Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock from which they are issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.
The Series A and Series B
Warrants were valued using the Black-Scholes option pricing model with the
following assumptions:
The
November 2023 Financing proceeds of $6,850,000 net of $525,144 in issuance costs
were allocated to the convertible notes and Series A and Series B Warrants
using the relative fair value method. The proceeds allocated to the warrants
was $2,219,165 and was recorded as a component of stockholders’ equity. For the year ended December 31, 2025, the Company recognized total interest expense on the 2023 Notes of $1,794,113, including coupon interest expense of $363,315, amortization of debt discount and issuance costs of $1,430,798. For the year ended December 31, 2024, the Company recognized total interest expense on the convertible notes of $1,603,575, including coupon interest expense of $411,001 amortization of debt discount and issuance costs of $1,192,574. The effective interest rate for the discount amortization was 32.3%. The Notes and accrued interest, net of unamortized discount costs was $47,841 and $5,406,228 as of December 31, 2025 and 2024, respectively. See Note 3 for further detail regarding fair value of the 2023 Notes. (b) Convertible Notes with Warrants
(November 2025 Financing) In November 2025, the Company
issued (i) senior secured convertible notes (“2025 Notes”) in an aggregate
principal amount of $12,000,000, convertible into shares of 16,378,563 common
stock at a conversion price of $0.73 per share, (ii) Series A-1 Warrants to
purchase up to an aggregate of 16,378,563 shares of common stock at an exercise
price of $0.81 per share, subject to adjustments, (iii) Series B-1 Warrants to
purchase an aggregate of 16,378,563 shares of common stock at an exercise price
of $0.92 per share, subject to adjustments, and (iv) Series C-1 Warrants to
purchase an aggregate of 16,378,563 shares of common stock at an exercise price
of $1.10 per share, subject to adjustments (Series A-1 Warrants, Series B-1
Warrants and Series C-1 Warrants are collectively the “Warrants”). The
financing resulted in aggregate gross proceeds of $12,000,000, before $718,528
of issuance costs. The 2025 Notes accrue interest at a rate of 8.5% per annum, payable annually in-kind by increasing the principal balance outstanding. The Company granted a security interest in
substantially all of its assets to the holders of the 2025 Notes. The 2025 Notes mature in . The Company has a call option where it may voluntarily redeem the 2025 Notes after and from Note issuance at 112% of the then-outstanding principal. The 2025 Notes are convertible into shares of common stock at the election of the holder at any time (“Conversion Option”) at an initial conversion price of $0.73 (“Conversion Price”). The Conversion Price is adjustable proportionally for certain events including stock splits, reverse stock splits and stock dividends (each a “Share Combination Event”). Additionally, upon a Share Combination Event, the conversion price will also be further adjusted to the lowest dollar volume-weighted average price (VWAP) of the Company’s common stock during the five-day period following any Share Combination Event, but only if the conversion price (after the standard proportional adjustment) is higher than the market price. The Company may require
conversion of the 2025 Notes, in whole or in part, if at any time (i) a
Registration Statement is effective, (ii) for the immediately preceding thirty
(30) consecutive trading days, the VWAP has exceeded 450% of the then-effective
Conversion Price on each such trading day, (iii) the total daily trading volume
of the Common Stock is at least $1,500,000.00, and (iv) certain equity
conditions are satisfied (effective registration statement is available,
sufficient authorized shares are available, etc.). The holders of the 2025
Notes may require prepayment of principal and accrued interest upon certain
Events of Default (failure to timely pay amounts owed under the 2025 Notes,
failure to deliver shares upon conversion of the 2025 Notes or exercise of the
related Warrants, failure to maintain an effective registration statement
related to the common shares underlying the 2025 Notes and related Warrants,
etc.), and the Company must redeem the 2025 Notes if involuntary bankruptcy
proceedings are initiated against the Company and not dismissed within 60 days
or if the Company voluntarily initiates bankruptcy. Additionally, in the event
of Fundamental Transaction, the Company must redeem the 2025 Notes, and if the
Fundamental Transaction occurs in the first 5 years of note issuance, the
redemption will include a premium.
If the Company offers future rights such as convertible securities, options, or warrants to purchase common stock to common stockholders (“Purchase Rights”), the holder/investor of the 2025 Notes are likewise entitled to receive such Purchase Rights as if the Notes were converted and the corresponding shares of common stock were outstanding.
As of December 31, 2025, the 2025 Notes have not been converted into shares of common stock. Warrants The Series A-1 Warrants are exercisable immediately and expire ten years from the date of issuance. The Series B-1 Warrants are exercisable immediately and expire at the earlier of (i) the anniversary of the issuance of the Warrants, or (ii) 45 days after the Company discloses two consecutive quarters of at least $3.25 million in sales. The Series C-1 Warrants are exercisable immediately and expire at the earlier of (i) the anniversary of the issuance of the Warrants, or (ii) 45 days after the Company discloses FDA approval of FemBloc. The exercise price of the Warrants are adjustable proportionally in the event of a Share Combination Event. Additionally, similar to the Conversion Option in the 2025 Notes, upon a Share Combination Event, the exercise prices of the Warrants will also be further adjusted to the lowest VWAP of the Company’s common stock during the five-day period following any Share Combination Event, but only if the exercise price (after the standard proportional adjustment) is higher than the market price. The number of Warrants exercisable will also be adjusted such that the aggregate exercise price remains constant.
In the event of a Fundamental Transaction within the Company’s control, the holders of the Warrants are entitled to put the unexercised portion of the Warrants to the Company in exchange for cash at their then Black-Scholes value. If the Fundamental Transaction is outside of the Company’s control, the holders of the Warrants may receive consideration for the unexercised portion of the Warrants equal to the then Black-Scholes value in the same form (cash or equity) as other common shareholders pursuant to the Fundamental Transaction.
If the Company offers future rights such as convertible securities, options, or warrants to purchase common stock to common stockholders (“Purchase Rights”), the holders of the Warrants are likewise entitled to receive such Purchase Rights as if the Warrant were exercised and the corresponding shares of common stock were outstanding.
As of December 31, 2025 the Warrants have not been exercised. The 2025 Notes
and Warrants are freestanding financial instruments that are legally detachable
and separately exercisable. Due to the adjustments to the conversion price of
the 2025 Notes and the exercise prices of the Warrants upon a Share Combination
Event beyond a standard proportional adjustment (but only if the market price
of the Company’s common stock is lower than the Conversion Price of the 2025
Notes or exercise prices of the Warrants) and due to the requirement that
shareholder approval be obtained for conversion and exercises that would exceed
19.99% of the outstanding shares of the Company, both the Conversion Option and
the Warrants were determined to be not indexed to the Company’s common stock.
As a result, at issuance, the Conversion Option was bifurcated from the 2025
Notes, and both the Conversion Option and Warrants were recognized as
derivative liabilities on the Company’s balance sheet. The Conversion Option
and Warrants will be remeasured at fair value every reporting period. The Notes
will be accreted to their maturity value based on the effective interest
method. The accretion is recorded as a credit to interest expense and was
($43,748) for the year ended December 31, 2025. The effective interest rate of
the 2025 Notes is approximately 21.9%. See Note 3 for
further detail regarding fair value of the 2025 Notes, Conversion Option and
Warrants liabilities. The following summarizes the carrying values of the November
2025 and November 2023 Convertible Notes as of December 31, 2025 and 2024:
No amounts
are due under the 2025 Notes until they mature in November 2035. In March 2026, the Company modified the 2025
Notes and related Warrants to remove the non-standard adjustment to the
conversion price and exercise prices upon a Share Combination Event (See Note
16).
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| Income Taxes [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Taxes | (8) Income
Taxes The
Company adopted ASU 2023-09, Income Taxes (Topic 740):
Improvements to Income Tax Disclosures on January 1, 2025 on a prospective
basis. Accordingly, the presentation of certain prior year disclosures below
differs from 2025 disclosures. Income
tax expense consists of the following:
The
current tax provisions and deferred tax provisions, as reflected in the
financial statements are as follows as of December 31, 2024:
As further described in Note
2, Summary of Significant Accounting Policies, the Company has elected
to prospectively adopt the guidance in ASU No. 2023-09, Income Taxes (Topic
740): Improvements to Income Taxes Disclosures, or ASU 2023-09. The
following table is a reconciliation of the federal statutory rate to the
Company’s effective rate for the year ended December 31, 2025:
The following is a
reconciliation of income tax expense at the statutory federal income tax rate
and income taxes as for the year ended December 31, 2024 in accordance with
guidance prior to the adoption of ASU 2023-09:
Under the prospective
adoption of ASU 2023-09, income taxes paid by jurisdiction as of December 31,
2025, are as follows:
Deferred tax assets
(liabilities) consisted of the following as of December 31, 2025 and 2024:
Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amount of assets and liabilities
for financial reporting purposes and the amounts used for income tax purposes,
and the Company is required to reduce its deferred tax assets by a valuation
allowance if it is more likely than not that some or all of its deferred tax
assets will not be realized. Management must use judgment in assessing the
potential need for a valuation allowance, which requires an evaluation of both
negative and positive evidence. The weight given to the potential effect of
negative and positive evidence should be commensurate with the extent to which
it can be objectively verified. In determining the need for and amount of the
valuation allowance, if any, the Company assesses the likelihood that it will
be able to recover its deferred tax assets using historical levels of income,
estimates of future income and tax planning strategies. As a result of
historical cumulative losses, the Company determined that, based on all
available evidence, there was substantial uncertainty as to whether it will
recover recorded net deferred taxes in future periods. Accordingly, the Company
recorded a valuation allowance against all of its net deferred tax assets as of
December 31, 2025 and 2024. The change in valuation allowance was $4,191,880 and
$4,776,250 for the years ended December 31, 2025 and 2024, respectively. Beginning on January 1, 2022, the Tax Cuts and Jobs Act,
enacted in December 2017, eliminated the option to deduct research and
development expenditures in the current period and requires taxpayers to
capitalize and amortize U.S.-based and non-U.S. based research and development
expenditures over five and fifteen years, respectively. This legislation does
not impact the Company’s current tax obligations. As
of December 31, 2025 and 2024,
respectively, the Company has $120,129,845 and $104,880,492 of federal net
operating loss carryforwards and $4,139,328 and $3,723,817 of federal research
and experimentation tax credits, respectively, and state net operating loss
carryforwards of $20,275,840 and $17,675,024, respectively. The utilization of
such net operating loss carryforwards and the realization of tax benefits in
future years depend predominately upon having taxable income. Under the
provisions of the Internal Revenue Code, certain substantial changes in the
Company’s ownership may result in a limitation on the amount of net operating
loss carryforwards and tax credit carryforwards that may be used in future
years. The
Company’s net operating losses may be subject to Section 382 of the Internal
Revenue Code which provide for a limitation on the annual use of net operating
losses following certain ownership changes that could limit the Company’s
ability to utilize these carryforwards. The Company has completed an analysis
covering the period February 19, 2004 through December 31, 2018, to determine
if such ownership changes have occurred and concluded it was more likely than
not that there were changes in ownership during the period, with the most
recent change of ownership occurring on December 16, 2016. Further analyses
will be performed prior to recognizing the benefits of any losses or credits in
the financial statements, and the Company is in the process of determining the
limitations that Section 382 will have on the Company’s net operating loss
carryforwards and research credits. In general, the annual use limitation
equals the aggregate value of the Company’s stock at the time of the ownership
change multiplied by a specified tax-exempt interest rate. The following schedule
indicates the expiration year, as of December 31, for the Company’s federal net
operating loss carryforwards available to future years without taking into
account any Section 382 limitations as of December 31, 2025:
The FASB issued
authoritative guidance on accounting for uncertainty in income taxes, which
clarifies the accounting for income taxes, by prescribing a minimum recognition
threshold that a tax position is required to meet before recognition in the
financial statements. The guidance also provides direction on recognition,
measurement, classification, interest, and penalties, accounting in interim
periods, disclosure, and transition. Management has determined there are no
uncertain tax positions. Accordingly, these financial statements do not include
any adjustments or disclosures related to uncertain tax positions.
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Stockholders' Equity |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Stockholders’ Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stockholders' Equity | (9) Stockholders’
Equity The Company’s Board of
Directors approved in January 2017 the Tenth Amended and Restated Certificate
of Incorporation authorizing the Company to issue for all classes of stock
169,000,000 shares at $0.001 par value per share, of which 95,853,558 shares were
designated common stock and 73,146,442 shares were designated Preferred Stock. In June 2021, the
Company issued 2,650,000 shares of common stock in connection with the
Company’s IPO of its common stock at $13.00 per share. Net proceeds to the
Company, after deducting underwriting discounts, commissions, and legal
expenses, was $31,613,500. Offering costs incurred by the Company were
$2,016,143, which include legal expenses incurred and paid by the underwriters
of $425,000. Immediately prior to the closing of the IPO, all of the
convertible Series A preferred stock and redeemable convertible Series B and
Series C preferred stock automatically converted into 8,116,343 shares of
common stock. The Company filed an
Eleventh Amended and Restated Certificate of Incorporation (the “Amended and
Restated Certificate”) with the Secretary of State of the State of Delaware in
connection with the completion of the IPO on June 22, 2021. The Amended and Restated
Certificate amends and restates the Company’s existing certificate of
incorporation in its entirety to, among other things: (i) authorize 200,000,000
shares of common stock; (ii) eliminate all references to the
previously-existing series of preferred stock (Series A, B and C); and (iii)
authorize 10,000,000 shares of undesignated preferred stock that may be issued
from time to time by the Board in one or more series. On July
1, 2022, we entered into an Equity Distribution Agreement (the “Equity
Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler” or the
“Sales Agent”) and filed a related prospectus establishing an “at-the-market”
facility, pursuant to which we may offer and sell shares of our common stock
from time to time through the Sales Agent. In October 2023, the Sales Agent was
authorized to sell shares for aggregate proceeds up to $16.7 million at current
market prices until all shares are sold. During the year ended December 31, 2025,
we sold approximately 5.6 million shares of common stock for aggregate proceeds
of $7.0 million. In December 2025, we filed a new prospectus pursuant to which
we may sell up to $9.8 million under the Equity Distribution Agreement. In
July 2025, the Company filed a prospectus to sell up to $150 million in stock,
debt securities and warrants. As of December 31,
2025, the amount we are authorized to sell is subject to baby-shelf
limitations. The Company may only offer one-third of the public float during
and trailing twelve-month period. Based on our public float, as of the date of
the filing of this Annual Report on Form 10-K, we are only permitted to utilize
a shelf registration statement, including the registration statement under
which our at the market offering is operated, subject to Instruction I.B.6 to
Form S-3, which is referred to as the “baby shelf” rule. For so long as our
public float is less than $75.0 million, we may not sell more than the
equivalent of one-third of our public float during any 12 consecutive months
pursuant to the baby shelf rules. (a) Common
Stock The holders of the
common stock shall have the exclusive right to vote for the election of
directors and on all other matters requiring stockholder action, each
outstanding share entitling the holder thereof to one vote on each matter
properly submitted to the stockholders of the Company for their vote; provided,
however, that, except as otherwise required by law, holders of common stock, as
such, shall not be entitled to vote on any amendment to the Amended and
Restated Certificate (or on any amendment to a certificate of designations of
any series of preferred stock) that alters or changes the powers, preferences,
rights or other terms of one or more outstanding series of preferred stock if
the holders of such affected series of preferred stock are entitled to vote,
either separately or together with the holders of one or more other such
series, on such amendment pursuant to this Amended and Restated Certificate (or
pursuant to a certificate of designations of any series of preferred stock). Dividends may be
declared and paid or set apart for payment upon the common stock out of any
assets or funds of the Company legally available for the payment of dividends,
but only when and as declared by the Board of Directors or any authorized
committee thereof. In the event of our
liquidation or dissolution, the holders of common stock are entitled to receive
proportionately the Company’s net assets available for distribution to
stockholders after the payment of all debts and other liabilities and subject
to the prior rights of any outstanding preferred stock. Holders of common stock
have no preemptive, subscription, redemption, or conversion rights. (b) Convertible
Preferred Stock As of December 31, 2025,
no shares of convertible preferred stock have been issued and/or outstanding,
and no dividends have been declared or paid since inception. (c) Redeemable
Convertible Preferred Stock As of December 31, 2025,
no shares of redeemable convertible preferred stock have been issued and/or
outstanding, and no dividends have been declared or paid since inception. (d) Preferred
Stock Under the terms of the
Amended and Restated Certificate, the Company’s Board of Directors is
authorized to direct the Company to issue shares of preferred stock in one or
more series without stockholder approval. The Board of Directors has the
discretion to determine the rights, preferences, privileges and restrictions,
including voting rights, dividend rights, conversion rights, redemption
privileges and liquidation preferences, of each series of preferred stock. The purpose of
authorizing the Board of Directors to issue preferred stock and determine its
rights and preferences is to eliminate delays associated with a stockholder
vote on specific issuances. The issuance of preferred stock, while providing
flexibility in connection with possible acquisitions, future financings, and
other corporate purposes, could have the effect of making it more difficult for
a third-party to acquire, or could discourage a third-party from seeking to
acquire, a majority of the outstanding voting stock. As of December 31, 2025
and 2024, no shares of preferred stock are outstanding. (e) June
2025 Financing In June 2025, the Company
sold 3,600,000 shares of common stock in an underwritten public offering at
$0.85 per share. The Company also sold 1,686,275 shares of common stock in a
separate concurrent private placement at a price of $0.85 per share to certain
existing institutional stockholders and a price of $1.02 per share to certain
directors and officers. The offering resulted in aggregate gross proceeds of
$4,510,001, before $804,940 of transaction costs. Additionally,
common warrants to purchase 105,726 shares of common stock were issued to the
underwriter as a commission for services performed. The underwriter warrants
are exercisable beginning December 2, 2025, have a 5-year term and an exercise
price of $1.0625 per share. The warrants are classified as a component of
permanent equity because they are freestanding financial instruments that are
legally detachable and separately exercisable from the shares of common stock
from which they are issued, are immediately exercisable, do not embody an obligation
for the Company to repurchase its shares and permit the holders to receive a
fixed number of shares of common stock upon exercise. The warrants were valued
at $56,035 using Black-Scholes assumptions. As of December 31, 2025, 105,726
underwriter warrants remain outstanding. (f) Any Market Purchase Agreement (“AMPA”) On June 30, 2025, the Company
entered into an Any Market Purchase Agreement (“Purchase Agreement” or “AMPA”) with
Alumni Capital LP (“Alumni”) whereby the Company has the right, but not
obligation, to sell to Alumni up to an aggregate of $10 million in shares of common
stock in a series of purchases until December 31, 2026. The Company may elect
that Alumni purchase up to $1 million in shares of common stock (or up to $5
million if mutually agreed) at either (i) the lowest traded price for four
previous business days, multiplied by 90% or (ii) up to the lesser of (a) $1
million in shares of common stock or (b) 100% of the average daily trading
volume of common stock for previous two business days at lowest daily dollar
volume-weighted-average price, multiplied by 97%. The Company is limited to
issuances to Alumni or 19.99% of the shares of common stock outstanding
immediately prior to the execution of the Purchase Agreement. The Purchase
Agreement allows the Company to raise equity on a periodic basis at its
discretion depending on a variety of factors including market conditions, the
trading price of the common stock, and use of proceeds for operating
activities. Due to certain pricing and settlement provisions, the Purchase
Agreement includes an embedded put option contract. The Company accounts for
the Purchase Agreement as a derivative, with a fair value remeasured each reporting period. The difference between
the discounted purchase price and fair value of the shares will be expensed in
the period the transaction occurs as a non-cash, nonoperating financing cost. See Note 3 for further detail regarding fair value of the AMPA. The Company incurred a 2% commitment fee of $200,000
and an additional $86,295 in expenses as of December 31, 2025, which are
included as other expense in the statements of comprehensive loss. (g) August 2025 Financing On August 25, 2025, the
Company entered into a securities purchase agreement pursuant to which the
Company sold (i) 10,434,586 shares of common stock in a public offering and to
certain Company officers, (ii) pre-funded warrants to purchase 11,750,000 shares
of common stock, and (iii) common warrants to purchase 22,184,586 shares of
common stock. Additionally, common warrants to purchase 443,692 shares of
common stock were issued to the underwriter as compensation for services
performed. The pre-funded warrants,
common warrants and underwriter warrants were exercisable immediately following
the closing date of the offering. The pre-funded warrants have an unlimited
term and an exercise price of $0.0001 per share. The common warrants have a
5-year term and an exercise price of $0.36 per share, except for common
warrants sold to certain Company officers, which have an exercise price of
$0.5151 per share. The underwriter warrants have a 5-year term and exercise
price of $0.45 per share. The offering resulted in aggregate gross proceeds of
$7,998,826, before $930,132 of transaction costs. The pre-funded warrants and
common warrants are classified as a component of permanent equity because they
are freestanding financial instruments that are legally detachable and
separately exercisable from the shares of common stock with which they were issued,
are immediately exercisable, do not embody an obligation for the Company to
repurchase its shares, and permit the holders to receive a fixed number of
shares of common stock upon exercise. The common stock was valued
at $3,770,001, based on the Company’s stock price. The pre-funded warrants and
common warrants were valued at $4,230,000 and $5,324,301, respectively, using
the following Black-Scholes assumptions:
The net proceeds of
$7,068,694 were allocated to the common stock, pre-funded warrants and common
warrants using the relative fair value method and were recorded to
stockholders’ equity. As of December 31, 2025, 6,750,000
pre-funded warrants, 12,965,476 common warrants and 443,692 placement agent
warrants remain outstanding. (h) Warrants
As of December 31, 2025,
the Company has warrants outstanding to purchase shares of common stock, which
are all exercisable in whole or in part, with expiration dates as follows:
In
April 2025, 55,177 warrants to purchase shares of common stock expired. (i) Dividends
As of December 31, 2025,
no dividends have been declared or paid since inception.
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Equity Incentive Plans |
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| Equity Incentive Plans [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity Incentive Plans | (10) Equity
Incentive Plans (a) Stock
Option Plans – Prior to the IPO Prior to the IPO in June
2021, the Company maintained two equity incentive plans, the 2004 Stock
Incentive Plan, as amended, or 2004 Plan, and the 2015 Stock-Based Incentive
Compensation Plan, or 2015 Plan, which provided the Company’s employees,
non-employee directors, consultants and independent contractors the opportunity
to participate in the equity appreciation of the business through the receipt
of stock options to purchase shares of common stock. New grants ceased being
made under the 2004 Plan upon the adoption of the 2015 Plan; however,
outstanding stock options under the 2004 Plan may continue to be exercised in
accordance with their terms. The Company adopted the 2015 Plan in April 2015,
which contains substantially similar terms and conditions as the 2004 Plan. The
2015 Plan initially had 1,176,681 shares of common stock reserved for issuance
under the 2015 Plan and was administered by the compensation committee of the
Board of Directors. Upon the closing of the IPO, no further awards will be made
under the 2015 Plan; however, outstanding stock options under the 2015 Plan may
continue to be exercised in accordance with their terms. (b) Stock
Option Plans – Post the IPO In June
2021, in connection with the IPO, the 2021 Equity Incentive Plan (2021 Plan)
became effective, which was adopted by the Board of Directors in February 2021
and approved by stockholders in March 2021. The 2021 Plan is
administered by our compensation committee. Under the 2021 Plan, the
Company may grant awards in respect of shares of common stock to employees,
consultants, and non-employee directors pursuant to option awards, stock
appreciation right, or SAR, awards, restricted stock awards, restricted stock
unit, or RSU, awards, performance stock awards, performance stock unit, or PSU,
awards, and other stock-based awards. The total number of
shares of common stock available for awards under the 2021 Plan is 1,111,111,
provided that such number shall be automatically increased on each January 1,
beginning on January 1, 2022, by 4% of the outstanding number of shares of common
stock on the immediately preceding December 31 or such lesser number of shares
as determined by the Board of Directors. The aggregate number of shares of our
common stock that will be available for issuance under awards granted pursuant
to the 2021 Plan shall also be increased by the number of shares underlying the
portion of an award granted under the 2015 Plan that is cancelled, terminated
or forfeited or lapses after the effective date of the 2021 Plan. No more than
1,111,111 shares of common stock issued under the 2021 Plan may be issued
pursuant to the exercise of incentive stock options (ISO), provided that such
number shall be automatically increased on each January 1, beginning on January
1, 2022, by the lesser of 4% of the outstanding number of shares of common
stock on the immediately preceding December 31 or 555,555 shares of common
stock. Shares of common stock issued by us in connection with the assumption or
substitution of outstanding grants or under certain stockholder approved plans
from an acquired company shall not reduce the number of shares of common stock
available for awards under the 2021 Plan. Shares of common stock underlying the
portion of an award that is forfeited or otherwise terminated for any reason
whatsoever, in any case, without the issuance of shares of common stock, will
be added back to the number of shares of common stock available for grant under
the 2021 Plan. No non-employee director may be granted awards under the 2021
Plan in any one calendar year covering a number of shares of common stock that
have a fair market value on the grant date in excess of $350,000 in the first
calendar year of such non-employee director’s initial service as a non-employee
director and $200,000 in any other calendar year of such non-employee
director’s service as a non-employee director. Options granted under
the 2021 Plan may be either ISOs or non-qualified stock options. The price at
which shares of common stock may be purchased upon exercise shall be determined
by the compensation committee but shall not be less than the fair market value
of one share of common stock on the date of grant, or, in the case of an ISO
granted to a stockholder, less than 110% of the fair market value
of a share of common stock on the date of grant. The compensation committee may
grant options that have a term of up to 10 years, or, in the case of an ISO
granted to a stockholder, five years. The award agreement shall
specify the exercise price, term, vesting requirements, including any
performance goals, and any other terms and conditions applicable to the granted
option. Unless otherwise provided in an award agreement or an effective
employment, consulting, severance or similar agreement with us or a subsidiary,
upon a participant’s termination of service for any reason, the unvested portion
of each award of options granted generally will be forfeited with no
compensation due to the participant. Activity under the stock
option plans was as follows:
The
intrinsic value represents the amount by which the market price of the
underlying stock at December 31, 2025 exceeds the exercise price of an option.
Stock options granted
under the 2021 Plan for the years ended December 31, 2025 and 2024 were as
follows:
The Black-Scholes
weighted-average assumptions for all stock option awards granted during 2025
and 2024 were as follows:
The intrinsic values
represent the dollar value of the exercised stock options whereby the fair
market value of the underlying common stock exceeded the exercise price of the
stock option as of the exercise date. There were
no options exercised during 2025 and 2024. The options outstanding
and vested and currently exercisable by exercise prices as of December 31, 2025
were as follows:
As of
December 31, 2025, the total number of shares of common stock reserved for
future awards under the 2021 Plan is 3,701,726.
(c)
Inducement Grants
Since 2023, the Company has granted 250,000 inducement grants, a stock option grant to certain employees for the right to purchase shares, which were approved by the Compensation Committee. The inducement grants vest in equal installments over four years provided the employee remains employed by the Company on the vesting date. The inducement grants are summarized as follows:
(d)
Valuation
The Company uses the Black‑Scholes option pricing model to determine the fair value of stock awards granted to employees and non-employees. The determination of the fair value of share‑based payment awards granted using a pricing model is affected by the Company’s stock price as well as the assumptions regarding a number of complex and subjective variables as follows:
(i)
Expected Term
The expected term of stock options represents the period where the stock options are expected to remain outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term for all options granted by using the simplified method provided by Compensation—Stock Compensation (Topic 718): Improvements to Accounting for Stock Compensation (ASC 718), which calculates the expected term as the average of the time-to-vesting and the contractual life of the options. The contractual term for options awarded since inception is 10 years for employees and non-employees.
(ii)
Risk‑Free Interest Rate
The risk‑free interest rate is based on U.S. Treasury zero‑coupon issues with remaining terms similar to the expected term on the options.
(iii)
Dividend Yield
The Company has not declared or paid any cash dividends from inception through December 31, 2025 and does not plan to pay any cash dividends in the foreseeable future, and, therefore, used an expected dividend yield of zero in the valuation model.
(iv)
Expected Volatility
Expected volatility measures the amount that a stock price has fluctuated or is expected to fluctuate during a period. The Company determines volatility based on an analysis of comparable companies.
(v)
Forfeitures
The Company accounts for forfeitures as they occur.
(e)
Employee Stock Purchase Plan (ESPP)
In June 2021, in connection with the IPO, the ESPP became effective upon adoption by the Board of Directors in February 2021 and the stockholders approved the 2021 ESPP in March 2021. The ESPP is administered by the compensation committee.
The total number of shares of common stock available for purchase under the ESPP is 166,666, provided that such number is automatically increased on January 1 of each calendar year, from January 1, 2022 through January 1, 2031 by the least of (i) 1.0% of the total number of shares of common stock outstanding on December 31 of the immediately preceding calendar year, (ii) 222,222 shares of common stock or (iii) a number determined by the board of directors that is less than the foregoing clauses (i) and (ii). Under the ESPP, the Company may specify offerings with durations of not more than 27 months and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of common stock will be purchased for employees participating in the offering. An offering may be terminated under certain circumstances. No employee may purchase more than 12,254 shares of common stock under the ESPP during any offering period. Unless otherwise determined by the board of directors, shares of common stock will be purchased for accounts of employees participating in the ESPP at a price per share equal to the lower of (i) 85% of the fair market value of a share of common stock on the last date of an offering period or (ii) 85% of the fair market value of a share of common stock on the first day of such offering period. As of December 31, 2025, 234,801 shares of common stock have been purchased under the ESPP to date, and the total number of shares of common stock reserved for future awards under the ESPP is 618,735.
(f)
Stock‑Based Compensation Expense
Stock‑based compensation expense recognized is based on the value of the portion of stock option awards that is ultimately expected to vest on a straight-line basis. Stock‑based compensation expense recognized in the Company’s statements of comprehensive loss during the years ended December 31, 2025, and 2024 includes compensation expense for stock‑based awards based on the fair value estimated in accordance with the provisions of ASC 718.
The following table shows the stock-based compensation expense related to vested stock option grants to employees and non-employees awarded under the stock plans and inducement grants by financial statement line item on the accompanying statements of comprehensive loss:
As of December 31, 2025, the
remaining amount of stock‑based compensation expense that is expected to be
recognized in future periods for employees and non-employees is $1,138,799
which includes $155,222 of compensation expense to be recognized upon achieving
a certain performance condition. The $983,577 of unrecognized expense is
expected to be recognized over a weighted-average period of 2.5 years.
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Retirement Plan |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Retirement Plan [Abstract] | |
| Retirement Plan |
(11)
Retirement Plan
The Company has a 401(k) defined contribution plan covering substantially all employees, meeting certain eligibility requirements. The Company has no required matching or other contribution requirements. For the years ended December 31, 2025 and 2024, the Company contributed $122,917 and $97,876 of voluntary employer matching contributions.
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Related-Party Transactions |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Related-Party Transactions [Abstract] | |
| Related-Party Transactions |
(12)
Related‑Party Transactions
In November 2023, the Company
issued unsecured convertible notes and accompanying Series A and Series B
Warrants (see Note 7a). The transaction included issuance of a $5 million
convertible note and 4,237,288 Series A and 4,237,288 Series B Warrants to
PharmaCyte Biotech, Inc. The interim CEO, President and Director of PharmaCyte
Biotech, Inc., Joshua Silverman, served on the Company’s board of directors until
March 2026. The Series B Warrants expired in . In November 2024, the Company paid PharmaCyte accrued interest on the convertible note of
$300,000 in equity of 315,790 common shares. In November 2025, the Company paid
PharmaCyte accrued interest on the convertible note of $300,000 in equity of
379,747 common shares. In November 2025, the convertible notes principal
balance of $5 million was repaid at maturity. No amounts were due to Pharmacyte
as of December 31, 2025. Convertible notes of $5M and accrued interest of
$32,500 were due to Pharmacyte as of December 31, 2024. In the June 2025 Financing (see Note 9e), certain executive officers and a director of the Company of the purchased an aggregate of 98,040 shares of the Company’s common stock in a private placement at a price of $1.02 per share, for total gross proceeds of $100,001. Other investors in the private placement purchased common stock at a discounted price of $0.85 per share. No amounts were due to or from these related parties in connection with this transaction as of December 31, 2025. In the August 2025 Financing (see Note 9g), certain executive officers of the Company purchased 87,363 common shares, with a common warrant, with a combined price of $0.5151. Gross proceeds from the transaction totaled $45,001. The price equaled the market price of the Company’s stock on the applicable purchase date. The common warrants have a 5-year term and an exercise price of $0.5151 per share. The warrants remain outstanding as of December 31, 2025. No amounts were due to or from these related parties in connection with this transaction as of December 31, 2025. In the November 2025 Financing (see Note 7b), certain executive officers and a director of the Company purchased senior secured convertible notes with a combined principal balance of $100,000, convertible into common shares at a price of $0.73 per share. Additionally, in connection with the convertible notes, the officers and director were issued 136,488 Series A-1 Warrants, 136,488 Series B-1 Warrants and 136,488 Series C-1 Warrants at conversion exercise prices of $0.81, $0.92 and $1.10 per share, respectively. As of December 31, 2025, $100,000 in convertible notes were due to the officers and director, in addition to accrued interest of $1,251. All A-1, B-1 and C-1 warrants issued to the officers and director remain outstanding as of December 31 2025. During the years ended December 31, 2025 and 2024, a family member of the CEO was employed and earned total cash compensation of $196,000 and $168,000, respectively. The compensation paid is consistent with market standards for comparable positions.
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Net Loss per Share Attributable to Common Stockholders |
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| Net Loss per Share Attributable to Common Stockholders [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss per Share Attributable to Common Stockholders |
(13)
Net Loss per Share Attributable to Common Stockholders
The following table sets forth the computation of the basic and diluted net loss per share for the years ended December 31:
Since the shares underlying the November 2025 pre-funded warrants were issuable for little consideration of $0.0001 per share, they were considered outstanding for both basic and diluted loss per share from the date of issuance. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because they would be anti-dilutive for the years ended December 31:
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Segment Reporting |
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| Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Segment Reporting |
(14)
Segment Reporting
In accordance with FASB ASC Topic 280, Segment Reporting, the Company has determined that it operates as a business segment, which is the development and commercialization of therapeutic and diagnostic products that service women’s reproductive health needs (infertility and permanent birth control). The determination of a single business segment is consistent with the financial information regularly provided to the Company’s chief operating decision maker (“CODM”). As a reportable segment entity, the Company’s segment performance measure is net loss attributable to shareholders. The measurement of segment assets is reported on the balance sheet as total assets. The Company’s CODM is its Chief Executive Officer and Chief Financial Officer, who together review and evaluate net income for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. Significant segment expenses, as provided to the CODM are as follows:
1 Other research and development expenses include clinical affairs, regulatory, manufacturing and quality assurance expenses. |
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Other Expense, net |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Other Expense, net [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Expense, net |
(15)
Other Expense, net
The company incurred the following Other Expense, net for the years ended December 31, 2025 and 2024:
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Subsequent Events |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Subsequent Events [Abstract] | |
| Subsequent Events |
(16)
Subsequent Events
In February and March 2026,
the Company sold 623,911 shares under the at-the-market facility, resulting in
gross cash proceeds of $352,922. In February 2026, $76,452 of the 2025 Notes and accrued interest were converted into 103,429 shares of common stock. In March 2026, the Company
modified the 2025 Notes and related Warrants to remove the non-standard
adjustment to the conversion price and exercise prices, respectively, upon a
Share Combination Event. As
consideration for this modification, the Company issued the holders of the 2025
Notes and related Warrants new Series D-1 Warrants which allow the holders to
purchase an aggregate number of 16,378,563 shares of the Company’s common
stock. The exercise price of the Series
D-1 Warrants is $0.58 per share, and the Warrants expire in March 2029.
|
Pay vs Performance Disclosure - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Pay vs Performance Disclosure | ||
| Net Income (Loss) | $ (18,627,887) | $ (18,816,628) |
Insider Trading Arrangements |
3 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Trading Arrangements, by Individual | |
| Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Rule 10b5-1 Arrangement Terminated | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
Cybersecurity Risk Management and Strategy Disclosure |
12 Months Ended |
|---|---|
Dec. 31, 2025 | |
| Cybersecurity Risk Management, Strategy, and Governance [Line Items] | |
| Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block] | Risk Management and Strategy We employ a cybersecurity program which we believe is appropriate for the potential of cybersecurity threats faced by us and is built upon a set of policies, procedures and standards supported by training and education. Our information systems employ local and cloud storage and recovery services from various third parties. We have established processes to assess, identify, and manage risks from cybersecurity threats as part of our broader enterprise-wide risk management system and processes and engaged third-party consultants to assess and gather threat intelligence and cyber risk trends and conduct assessments and testing of our cybersecurity procedures and protections, which is reported to and overseen by our Board of Directors through our Audit Committee, along with our executive management.
Our cybersecurity program focuses on all areas of our business, including cloud-based environments, devices used by employees and contractors, facilities, networks, applications, vendors, disaster recovery, business continuity and controls and safeguards enabled through business processes and tools. We continuously monitor for unauthorized access to our information technology systems and identify potential security threats through various automated detection solutions. To protect the security of our information infrastructure and protect our systems and information from unauthorized access, we draw on the knowledge and insights of an external information technology consultant who acts as our primary IT administrator and employ an array of third-party tools and technologies. We also maintain cybersecurity insurance to cover us for costs and expenses we may incur due to a cybersecurity incident.
As of the date of this Annual Report, we have not encountered any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of operations, or financial condition. For more information on our cybersecurity related risks, see “General Risks Factors” included elsewhere in this Annual Report on Form 10-K.
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| Cybersecurity Risk Management Processes Integrated [Flag] | true |
| Cybersecurity Risk Management Processes Integrated [Text Block] | We employ a cybersecurity program which we believe is appropriate for the potential of cybersecurity threats faced by us and is built upon a set of policies, procedures and standards supported by training and education. Our information systems employ local and cloud storage and recovery services from various third parties. We have established processes to assess, identify, and manage risks from cybersecurity threats as part of our broader enterprise-wide risk management system and processes and engaged third-party consultants to assess and gather threat intelligence and cyber risk trends and conduct assessments and testing of our cybersecurity procedures and protections, which is reported to and overseen by our Board of Directors through our Audit Committee, along with our executive management.
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| Cybersecurity Risk Management Third Party Engaged [Flag] | true |
| Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] | false |
| Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Text Block] | we have not encountered any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company, including its business strategy, results of operations, or financial condition. |
| Cybersecurity Risk Board of Directors Oversight [Text Block] | Governance and Role of Management and the Board Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. The Chief Financial Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly. The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls. The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. We have not experienced any cybersecurity threats or incidents that have had a material impact on our business to date.
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| Cybersecurity Risk Management Positions or Committees Responsible [Flag] | true |
| Cybersecurity Risk Management Positions or Committees Responsible [Text Block] | Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. |
| Cybersecurity Risk Role of Management [Text Block] | Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. The Chief Financial Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly. The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls. The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. |
| Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] | Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. The Chief Financial Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly. The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls. The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. |
| Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block] | Our Chief Financial Officer leads our cybersecurity program and reports directly, with respect to cybersecurity incidents, to the Board of Directors and the Audit Committee, which is the principal committee charged with the Board’s risk management oversight, including cybersecurity risks. The Chief Financial Officer briefs the Board and Audit Committee on the effectiveness of our cybersecurity program quarterly. The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls. The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. |
| Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag] | true |
| Cybersecurity Risk Management Expertise of Management Responsible [Text Block] | The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls |
| Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block] | The Chief Financial Officer oversees the operation of our cybersecurity program and has over 30 years of executive experience overseeing risk management and internal controls. The Chief Financial Officer is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through the Financial Officer’s oversight of the Company’s information technology function. |
Accounting Policies, by Policy (Policies) |
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| Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Organization and Nature of Business | Organization and Nature of Business
Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a leading biomedical innovator, addressing significant unmet needs in women’s health worldwide, with a broad patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio, which are currently being commercialized in the U.S. and key international markets. The Company’s suite of products and U.S. product candidate address what the Company believes are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm.
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| Basis of Presentation | Basis of Presentation
The Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United States of America (GAAP) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC).
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| Liquidity | Liquidity As of December 31, 2025, the Company has cash and cash equivalents of $9,266,353. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from domestic sales of FemaSeed and FemVue and international sales of FemBloc, FemaSeed and FemVue to support the Company’s commercial efforts and research and development activities, primarily focused on FemBloc. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted. For the year ended December
31, 2025, the Company generated a net loss of $18,627,887. The Company expects
such losses to increase over the next few years as the Company commercializes
FemaSeed and its other products and advances FemBloc through clinical
development if and until FDA approval is received and is available to be
marketed in the U.S. The financial statements have
been prepared on a going-concern basis, which contemplates the realization of
assets and the satisfaction of liabilities in the normal course of business.
The Company has incurred net operating losses in every year since inception and
has an accumulated deficit as of December 31, 2025 of $145,826,144 and expects
to incur additional losses and negative operating cash flows for at least the
next twelve months. The Company’s ability to meet its obligations is dependent
upon its ability to generate sufficient cash flows from operations and future
financing transactions. Although management expects the Company will continue
as a going concern, there is no assurance that management’s plans will be
successful since the availability and amount of such funding is not certain.
Accordingly, substantial doubt exists about the Company’s ability to continue
as a going concern for at least one year from the issuance of these financial
statements. The accompanying financial statements do not include any
adjustments to reflect the possible future effects on the recoverability of
assets or the amounts and classifications of liabilities that may result from
the possible inability of the Company to continue as a going concern.
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| Use of Estimates in Preparation of Financial Statements | (a) Use of Estimates in Preparation of Financial Statements The preparation of financial
statements in conformity with U.S. generally accepted accounting principles
(GAAP) requires the Company to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most
significant estimates used in these financial statements include stock options,
warrants, conversion option and warrants liabilities, the valuation of useful
lives of property and equipment, and clinical trial cost accruals. Actual
results could differ from those estimates.
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| Certain Risks and Uncertainties | (b) Certain Risks and Uncertainties
Products being developed by the Company, such as FemBloc, will require approval from the FDA or corresponding foreign regulatory agencies prior to commercial sales. FemBloc is approved in the European Union, UK and New Zealand. FemaSeed Intratubal Insemination is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. FemVue, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared and approved in Europe, UK, Canada, Japan, Israel, Australia and New Zealand. FemVue Controlled, a diagnostic solution for controlled contract delivery to evaluate fallopian tube status, is U.S. FDA-cleared. FemCerv, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel and New Zealand. FemCath for selective fallopian tube evaluation is U.S. FDA-cleared and approved in Europe, Canada and Israel. FemChec, a companion diagnostic product for FemBloc’s ultrasound-based confirmation test, is U.S. FDA-cleared and approved in Europe, UK, Canada, Israel, Australia and New Zealand. There can be no assurance the Company’s other products in development will receive the necessary approvals/ clearances. If the Company is denied regulatory approval/ clearance or approval/ clearance is delayed, it might have a materially adverse impact on the Company.
The medical device industry is characterized by frequent and extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often difficult to predict, and the outcome may be uncertain until the court has entered final judgment and all appeals are exhausted. The Company’s competitors may assert that its products or the use of its products are covered by United States or foreign patents held by them. If such relevant patents are upheld as valid and enforceable and the Company is found to infringe, the Company could be prevented from selling its products unless it can obtain a license to use technology or ideas covered by such patents or are able to redesign its products to avoid infringement. A license may not be available at all or on commercially reasonable terms, and it may not be able to redesign its products to avoid infringement.
The Company relies on some single source suppliers to provide certain components of its products commercially available and those under development. The Company purchases these components on a purchase order basis. If the Company overestimates its component requirements, it could have excess inventory, which would increase its costs and result in write‑downs harming its operating results. If the Company underestimates its requirements, it may not have an adequate supply, which could interrupt the manufacturing of its products.
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| Fair Value of Financial Instruments | (c) Fair Value of Financial Instruments
The Company applies a fair value hierarchy that requires the use of observable market data, when available, and prioritizes the inputs to valuation techniques used to measure fair value in the following categories:
Level 1 – Valuation is based upon quoted prices for identical instruments traded in active markets.
Level 2 – Valuation is based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑based valuation techniques for which all significant assumptions are observable in the market.
Level 3 – Valuation is generated from model‑based techniques that use significant assumptions not observable in the market. These unobservable assumptions reflect the Company’s own estimates of assumptions market participants would use in pricing the asset or liability.
Certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable and other liabilities approximate their fair value because of the short‑term maturity of these financial instruments.
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| Cash and Cash Equivalents | (d) Cash and Cash Equivalents The Company considers all
highly liquid investments with an initial maturity of three months or less when
purchased to be cash equivalents. Cash equivalents consist of amounts invested
in money market mutual funds and are stated at fair value. See Note 2(t) for
information on concentration of credit risk.
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| Accounts Receivable | (e) Accounts Receivable The Company grants trade credit to customers in the normal course of business and does not require collateral or any other security to support its receivables. Management reviews its accounts receivable monthly for any collection issues. Potentially uncollectible accounts are written off to bad debt expense when it is determined that the likelihood a customer account is uncollectible is probable. As of December 31, 2025 and 2024, the Company’s reserves for uncollectible accounts were $14,013 and $10,000, respectively. Trade accounts receivable are recorded at the invoiced amount, net of allowance for credit loss and do not bear interest. Amounts collected on trade accounts receivable are included in net cash provided by operating activities in the statements of cash flows.
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| Inventories | (f) Inventories
Inventories are stated at the lower of cost or net realizable value. Cost, which includes amounts related to materials, labor and overhead, is determined on a first‑in, first‑out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.
Inventory stated at cost, consisted of the following as of December 31:
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| Other Assets | (g) Other Assets The Company has research tax credits that are available to the Company to offset future payroll withholding liabilities. As of December 31, 2025 and 2024, the total amount of these credits is $948,292 and $1,030,809, respectively. The Company has included these amounts on the accompanying balance sheets as follows as of December 31:
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| Property and Equipment | (h) Property and Equipment
Property and equipment are carried at cost less accumulated depreciation and, if applicable, impairment charges. Expenditures which materially increase value or extend useful lives of assets are capitalized, while maintenance and repairs which do not improve or extend the lives of the respective assets are charged to operations when incurred. Gains and losses on the retirement or disposal of individual assets are included in the results of operations. Depreciation and amortization are computed using the straight‑line method over estimated useful lives of assets as follows:
Depreciation expense for the years ended 2025 and 2024 was $295,859 and $277,178, respectively. In 2025, the Company disposed of property and equipment at an original cost of $296,338 with a net book value of $62,650, which is recorded in operating expenses on the statements of comprehensive loss. In 2024, the Company disposed of property and equipment at an original cost of $82,507 with a net book value of $676, which is recorded in operating expenses on the statements of comprehensive loss.
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| Impairment of Long-Lived Assets | (i) Impairment of Long-Lived Assets The Company reviews long‑lived assets, including property and equipment and definite lived intangibles, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the asset group may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset group and its eventual disposition is less than its carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of a long‑lived asset group exceeds its fair value. The Company has not recorded any impairment losses to date.
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| Leases | (j) Leases The Company records operating leases as right-of-use assets and operating lease liabilities in its balance sheets for all operating leases with terms exceeding one year. Right-of-use assets represent the right to use an underlying asset for the lease term, including extension options considered reasonably certain to be exercised, and operating lease liabilities to make lease payments. Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term. To the extent that lease agreements do not provide an implicit rate, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of lease payments. The expense for operating lease payments is recognized on a straight-line basis over the lease term and is included in operating expenses in the Company’s statements of comprehensive loss. Non-lease components included in lease agreements are accounted for separately. The Company records finance leases as right-of-use assets and finance lease liabilities in its balance sheets for all finance leases with terms exceeding one year, similar to operating leases, and records interest expense and depreciation expense on the right-of-use asset in the statements of comprehensive loss.
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| Intangible Assets | (k) Intangible Assets Intangible assets consist of patent and trademark application costs and related legal fees, carried at cost less accumulated amortization and, if applicable, impairment charges. Amortization is computed using the straight‑line method over a weighted-average useful life of three years and is recorded in depreciation and amortization expense within the results of operations. Intangible assets consist of the following as of December 31:
Amortization expense for intangible assets for the years ended December 31, 2025 and 2024 was $46,175 and $20,140, respectively.
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| Deferred Offering Costs | (l) Deferred Offering Costs
Deferred offering costs, which consist mainly of legal, consulting, and accounting fees directly attributable to a strategic financing transaction, are capitalized in accordance with Staff Accounting Bulletin (SAB) Topic 5.A Expenses of Offering, codified in Accounting Standards Codification (ASC) 340-10-S99-1 Other Assets and Deferred Costs.
During 2022, the Company
incurred $232,845 in deferred offering costs in connection with prospectuses
filed in July 2022, including an offering to sell up to $150 million in stock,
debt securities and warrants, and an Equity Distribution Agreement entered into
with Piper Sandler which included an at-the-market (ATM) facility. These
deferred offering costs were offset against the total proceeds from the issuance
of common stock available under the prospectuses. As of December 31, 2025, and 2024, the Company
offset $15,637 and $3,143, respectively of deferred offering costs in
connection with the gross proceeds issued under the prospectuses. The shelf
expired in 2025 and the remaining balance of $196,267 was expensed as other
expense in the statements of comprehensive loss. During 2025, the Company
incurred $73,785 in deferred offering costs in connection with a prospectus
filed in July 2025, including an offering to sell up to $150 million in stock,
debt securities and warrants. As of December 31, 2025, deferred offering costs
capitalized were $73,785 and are included in other assets in the accompanying
balance sheet. As of December 31, 2024, deferred offering costs capitalized
were $211,654 and are included in prepaid and other current assets in the
accompanying balance sheet. These costs will be offset against proceeds from the issuance of common stock sales and will be expensed if the prospectus is terminated or aborted.
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| Accrued Expenses | (m) Accrued Expenses
Accrued compensation costs include incentive compensation and unused paid time off. Accrued clinical trial expenses include research and development costs for third-party services, largely related to the Company’s clinical trials, which are estimated based upon the services provided but not yet invoiced. These costs, at times, may be a significant component of the research and development expenses and the Company makes estimates in determining the accrued expense each period. As actual costs become known, the Company adjusts its accrual. Other accrued expenses include director fees, taxes and other miscellaneous accrued expenses.
Accrued expenses consisted of the following as of December 31:
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| Clinical Holdback | (n) Clinical Holdback As part of the regulatory
approval process for taking its products to market or conducting post-market
clinical studies to support marketing efforts for products with regulatory
clearance, the Company enters into certain Clinical Trial Agreements (CTAs) which
include, among other things, the compensation and payment schedule the
participating medical institutions and investigators will receive for all costs
in connection with the clinical trial (or study) under the terms of the CTA. As
individual participants are enrolled in the study by the participating medical
institution or investigator, the Company pays certain per study fees according
to the CTA for the duration of the trial. As invoices are received by the
Company from the medical institution or investigator, the Company retains any
agreed upon percentage of total invoiced costs, generally ranging between 5% -
15%, which is withheld from payment until the end of the study. These retained
amounts are recorded as clinical holdback, a liability, on the accompanying
balance sheets, and all expenses incurred in connection with these CTA
activities are expensed as services are provided, which are included as
research and development expenses on the accompanying statements of comprehensive
loss.
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| Convertible Notes | (o) Convertible Notes The Company accounts
for its convertible notes based on an assessment of the convertible note terms
and applicable guidance ASC 470-20, Debt with Conversion and Other Options
(ASC 470-20) and ASC 815-40, Derivatives and Hedging—Contracts in Entity’s
Own Equity (ASC 815). The Company evaluates all features contained in
financing agreements to determine if there are any embedded derivatives that
require separate accounting from the underlying agreement. An embedded
derivative that requires separation is accounted for as a separate asset or
liability from the host agreement. The derivative asset or liability is
accounted for at fair value, with changes in fair value recognized in the
statement of comprehensive loss at each reporting period. The convertible notes were
recorded net of debt issuance costs and any discounts. The Company has
historically issued warrants in conjunction with issuing convertible notes (see
Note 7). Debt issuance costs are amortized over the term of the convertible
notes using the effective interest method in addition to the discount initially
recognized for the fair value of warrants issued. The amortization of debt
issuance costs and discount is included in interest expense in the statements
of comprehensive loss. If the debt is retired early, the associated debt
discount will be recognized immediately as interest expense in the statements
of comprehensive loss.
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| Common Stock Warrants | (p) Common Stock Warrants The Company accounts for its
common stock warrants as equity-classified or liability-classified instruments
based on an assessment of the warrants’ specific terms and applicable
authoritative guidance in ASC 480, Distinguishing Liabilities from Equity
(ASC 480) and ASC 815. The assessment considers whether the warrants are (i)
freestanding financial instruments pursuant to ASC 480, (ii) meet the
definition of a liability pursuant to ASC 480, and (iii) meet all of the
requirements for equity classification under ASC 815, including whether the
warrants are indexed to the Company’s own common stock and whether the warrant
holders could potentially require “net cash settlement” in a circumstance
outside of the Company’s control, among other conditions for equity classification.
This assessment, which requires the use of professional judgment, is conducted
at the time of warrant issuance and as of each subsequent quarterly period end
date while the warrants are outstanding. For warrants that meet all of
the criteria for equity classification, the warrants are required to be
recorded as a component of additional paid-in capital, on the balance sheets at
the time of issuance. For warrants that do not meet all the criteria for equity
classification, the warrants are required to be recorded at their initial fair
value on the date of issuance and on each balance sheet date thereafter. The Company’s warrants liabilities are measured at fair value using a simulation model which takes
into account, as of the valuation date, factors including the current exercise
price, the expected life of the warrant, the current price of the Company's common
stock, the expected volatility, the risk-free interest rate for the term of the
warrant and the likelihood of achieving certain future milestone events and the
related impact to the price of the Company's common stock. The warrants liabilities are revalued at each reporting period and changes in fair value are
recognized in other (expense) income in the statements of comprehensive loss. The
selection of the appropriate valuation model and the inputs and assumptions
that are required to determine the valuation requires significant judgment and
requires management to make estimates and assumptions that affect the reported
amount of the related liability and reported amounts of the change in fair
value. Actual results could differ from those estimates, and changes in these
estimates are recorded when known. See
Note 7 for additional information on warrants issued by the Company.
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| Any Market Purchase Agreement (“AMPA”) | (q) Any Market Purchase Agreement (“AMPA”)
The Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate accounting from the underlying agreement. An embedded derivative that requires separation is accounted for as a separate asset or liability from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the statement of comprehensive loss. The Company determined that certain features under the AMPA contained embedded derivatives. The derivative liability associated with the AMPA were deemed de minimus at both the issuance date and as of December 31, 2025.
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| Revenue Recognition | (r) Revenue Recognition The Company’s policy is to recognize revenue when a customer obtains control of the promised goods under ASC 606, Revenue from Contracts with Customers. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods, and the Company has elected to exclude amounts collected from customers for all sales (and other similar) taxes from the transaction price. Revenue is recognized upon shipment of the Company’s goods based upon contractually stated pricing at standard payment terms typically ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. There was no revenue recognized during the years ended December 31, 2025 and 2024 from performance obligations satisfied or partially satisfied in prior periods. Additionally, there were no unsatisfied performance obligations as of December 31, 2025 and 2024. The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to the Company’s international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. As of December 31, 2025, the Company has not had a history of significant returns. The following table summarizes the Company’s sales by geographic region for the years ending December 31:
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| License, Manufacturing, and Supply Agreements | (s) License, Manufacturing, and Supply Agreements
The Company entered into a FemVue License, Manufacturing, and Supply Agreement with Bayer Yakuhin, Ltd., a wholly owned subsidiary of Bayer AG, in 2012. The Company sells products based on purchase orders provided by Bayer Yakuhin in accordance with their agreement. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
The Company entered in distributor agreements with Comercial Medico Quirurgica, SA (“Comercial”) and Durgalab in September 2024. The Company sells products based on purchase orders provided by Comercial and Durgalab in accordance with their agreements. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
The Company entered in a distributor agreement with Kebomed Europe AG (“Kebomed”) in September 2025. The Company sells products based on purchase orders provided by Kebomed in accordance with their agreement. Control and risk of ownership transfer at the time of shipment and the Company records revenue at that time.
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| Concentration of Credit Risk | (t) Concentration of Credit Risk The Company generates revenue from sales directly to U.S. customers and to the Company’s international distributors with all prices in U.S. dollars. For the year ended December 31, 2025, one customer accounted for revenues of 21% of total revenues. As of December 31, 2025, one customer had an accounts receivable balance of 76% of total receivables, which was paid subsequent to year end. No other customer had revenue or accounts receivable in excess of 10% of total receivables. For the year ended December 31, 2024, two customers accounted for revenues of 15% and 12% of total revenues. As of December 31, 2024, three customers had balances of 23%, 21% and 12% of total receivables.
|
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| Research and Development | (u) Research and Development
The Company’s research and development expenses consist of engineering, product development, clinical, quality assurance and regulatory expenses and are expensed as incurred. These expenses include direct expenses related to employee compensation, including salary, benefits and stock-based compensation; expenses related to consulting fees, testing fees, materials, and supplies; and activities conducted by third-party service providers, which include the conducting of preclinical studies and clinical trials.
|
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| Sales and Marketing | (v) Sales and Marketing
The Company’s sales and marketing expenses consist of direct expenses related to employee compensation, including salary, benefits and stock-based compensation, advertising and marketing, business development and travel.
|
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| General and Administrative | (w) General and Administrative
The Company’s general and administrative expenses include accounting, human resources, and general corporate expenses. These expenses are primarily related to employee compensation, including salary, benefits, and stock‑based compensation. General corporate expenses generally relate to office rent, utilities, insurance, legal, and professional fees.
|
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| Advertising Expense | (x) Advertising Expense Advertising costs are expensed as incurred. Advertising costs were $262,270 and $360,958 for the years ended December 31, 2025 and 2024, respectively. They are reflected in sales and marketing expenses in the statements of comprehensive loss.
|
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| Stock-Based Compensation | (y) Stock-Based Compensation
The Company recognizes all employee and nonemployee stock-based compensation as a cost in the financial statements. Equity-classified awards are measured at the grant-date fair value of the award. The Company estimates grant-date fair value using the Black-Scholes option pricing model and records forfeitures as they are incurred. Details of the stock‑based compensation and accounting treatment are discussed in Note 10.
|
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| Income Taxes | (z) Income Taxes
The Company utilizes the asset‑and‑liability method of accounting for income taxes as set forth in ASC 740, Income Taxes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, as well as the net operating loss, capital loss, and tax credit carryforwards. Valuation allowances are established against deferred tax assets if it is more likely than not that they will not be realized.
ASC 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The standard requires that the Company recognize in its financial statements the impact of a tax position if that position is more likely than not of being sustained on audit, based on the technical merits of the position. The Company has determined it had no unrecognized tax benefits as of December 31, 2025 and 2024.
As of December 31, 2025, the 2022 through 2025 tax years remain subject to examination by federal and most state tax authorities. The use of net operating losses generated in tax years prior to 2022 may also subject returns for those years to examination.
|
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| Net Loss per Share Attributable to Common Stockholders | (aa) Net Loss per Share Attributable to Common Stockholders
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the cumulative dividends, if any. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss position of the Company.
|
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| Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted | (ab) Recently Issued Accounting Pronouncements – Recently Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for the Company’s annual reporting periods beginning after December 15, 2024. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Early adoption is permitted. The Company adopted the ASU prospectively on January 1, 2025 and it did not have a material impact on its operations.
(ac)
Recently Issued Accounting Pronouncements – Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (Subtopic 220-40). The standard requires public business entities to disclose additional information about specific expense categories included in relevant income statement captions, including purchases of inventory, employee compensation, depreciation, amortization of intangible assets, and certain other expenses. The ASU 2024-03 is effective for the Company’s annual reporting periods beginning after December 15, 2026. Early adoption is permitted. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Management is currently assessing the impact of this standard on the Company’s financial statements and will adopt the ASU on January 1, 2027.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. The amendments clarify the applicability of the interim reporting guidance in Topic 270 and improve the navigability of interim disclosure requirements by providing a more comprehensive listing of disclosures required in interim financial statements. The ASU is effective for the Company’s interim periods in annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The ASU may be applied either with a prospective method or a fully retrospective method of transition. Management is currently assessing the impact of this standard on the Company’s financial statements and will adopt the ASU on January 1, 2028.
No other new accounting pronouncements not yet effective are expected to have a material impact on the Company’s financial statements.
|
Summary of Significant Accounting Policies (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventory Stated at Cost, Net of Reserve | Inventory stated at cost, consisted of the following as of December 31:
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| Other Assets | The Company has included these amounts on the accompanying balance sheets as follows as of December 31:
|
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| Estimated Useful Lives of Assets | Depreciation and amortization are computed using the straight‑line method over estimated useful lives of assets as follows:
|
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| Intangible Assets | Intangible assets consist of the following as of December 31:
|
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| Accrued Expenses | Accrued expenses consisted of the following as of December 31:
|
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| Sales by Geographic Region | The following table summarizes the Company’s sales by geographic region for the years ending December 31:
|
Fair Value of Financial Instruments (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Financial Instruments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value of Assets and Liabilities Measured on Recurring Basis | The following
fair value hierarchy table presents information about the Company’s assets and
liabilities measured at fair value on a recurring basis:
|
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| Fair Value of Conversion Option Liability and Warrants Liabilities | The change in fair value between the periods was recognized as gains in
other (expense) income in the statements of comprehensive loss and are
summarized below:
|
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| Fair Value Estimated Using Black-Scholes Option Pricing Model | The December 31, 2025 fair
value of the Conversion Option liability and Warrants liabilities were
estimated using the Black-Scholes option pricing model Level 3 inputs, with the
following assumptions:
|
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Commitments and Contingencies (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments and Contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Operating Right-of-Use Assets and Lease Liabilities | Operating right-of-use assets and lease liabilities consist of the following as of December 31:
|
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| Lease Cost | Operating lease expenses are included in general and administrative expenses in the Company’s statements of comprehensive loss and are summarized as follows for the years ending December 31:
|
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| Undiscounted Cash Payment Obligations | The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities with initial terms of more than twelve months as of December 31, 2025:
|
Convertible Notes with Warrants (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Convertible Notes with Warrants [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Warrant and Black-Scholes Warrant Assumptions | The Series A and Series B
Warrants were valued using the Black-Scholes option pricing model with the
following assumptions:
|
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| Convertible Notes Payable | The following summarizes the carrying values of the November
2025 and November 2023 Convertible Notes as of December 31, 2025 and 2024:
|
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Income Taxes (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Taxes [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income tax expense | Income
tax expense consists of the following:
The
current tax provisions and deferred tax provisions, as reflected in the
financial statements are as follows as of December 31, 2024:
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| Reconciliation of Income Tax Expense at Statutory Federal Income Tax Rate and Income Taxes | The
following table is a reconciliation of the federal statutory rate to the
Company’s effective rate for the year ended December 31, 2025:
The following is a
reconciliation of income tax expense at the statutory federal income tax rate
and income taxes as for the year ended December 31, 2024 in accordance with
guidance prior to the adoption of ASU 2023-09:
|
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| Income Taxes Paid | Under the prospective
adoption of ASU 2023-09, income taxes paid by jurisdiction as of December 31,
2025, are as follows:
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| Components of Deferred Tax Assets (Liabilities) | Deferred tax assets
(liabilities) consisted of the following as of December 31, 2025 and 2024:
|
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| Federal Net Operating Loss Carryforwards Available to Future Years | The following schedule
indicates the expiration year, as of December 31, for the Company’s federal net
operating loss carryforwards available to future years without taking into
account any Section 382 limitations as of December 31, 2025:
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Stockholders' Equity (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stockholders’ Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Warrants Valuation Assumptions | The pre-funded warrants and
common warrants were valued at $4,230,000 and $5,324,301, respectively, using
the following Black-Scholes assumptions:
|
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| Warrants Outstanding to Purchase Shares of Common Stock | As of December 31, 2025,
the Company has warrants outstanding to purchase shares of common stock, which
are all exercisable in whole or in part, with expiration dates as follows:
|
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Equity Incentive Plans (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity Incentive Plans [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock Option Plan Activity | Activity under the stock
option plans was as follows:
|
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| Black-Scholes Weighted Average Assumptions | The Black-Scholes
weighted-average assumptions for all stock option awards granted during 2025
and 2024 were as follows:
|
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| Options Outstanding and Vested and Currently Exercisable by Exercise Prices | The options outstanding
and vested and currently exercisable by exercise prices as of December 31, 2025
were as follows:
|
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| Share-based Compensation Expense | The following table shows the stock-based compensation expense related to vested stock option grants to employees and non-employees awarded under the stock plans and inducement grants by financial statement line item on the accompanying statements of comprehensive loss:
|
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| 2021 Stock Option Plan [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity Incentive Plans [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock Option Plan Activity | Stock options granted
under the 2021 Plan for the years ended December 31, 2025 and 2024 were as
follows:
|
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| Inducement Grants [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity Incentive Plans [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock Option Plan Activity | The inducement grants are summarized as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss per Share Attributable to Common Stockholders (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net loss per share for the years ended December 31:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Computations of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because they would be anti-dilutive for the years ended December 31:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Significant Segment Expenses | Significant segment expenses, as provided to the CODM are as follows:
1 Other research and development expenses include clinical affairs, regulatory, manufacturing and quality assurance expenses. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Expense, net (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Expense, net [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Expense, Net | The company incurred the following Other Expense, net for the years ended December 31, 2025 and 2024:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Nature of Business, and Liquidity (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Organization, Nature of Business, and Liquidity [Abstract] | ||
| Cash and cash equivalents | $ 9,266,353 | $ 3,451,761 |
| Net loss | (18,627,887) | (18,816,628) |
| Accumulated deficit | $ (145,826,144) | $ (127,198,257) |
Summary of Significant Accounting Policies - Inventory Stated at Cost, Net of Reserve (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Summary of Significant Accounting Policies [Abstract] | ||
| Materials | $ 2,060,521 | $ 1,308,863 |
| Work in progress | 1,266,542 | 982,630 |
| Finished goods | 2,413,186 | 754,830 |
| Inventory | $ 5,740,249 | $ 3,046,323 |
Summary of Significant Accounting Policies - Other Assets (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Summary of Significant Accounting Policies [Abstract] | ||
| Prepaid and other current assets | $ 249,394 | $ 315,897 |
| Other long-term assets | 698,898 | 714,912 |
| Research tax credits available to the Company | $ 948,292 | $ 1,030,809 |
Summary of Significant Accounting Policies - Estimated Useful Lives of Assets (Details) |
Dec. 31, 2025 |
|---|---|
| Office Equipment [Member] | |
| Summary of Significant Accounting Policies [Abstract] | |
| Estimated useful lives of assets | 5 years |
| Furniture and Fixtures [Member] | |
| Summary of Significant Accounting Policies [Abstract] | |
| Estimated useful lives of assets | 7 years |
| Machinery and Equipment [Member] | Minimum [Member] | |
| Summary of Significant Accounting Policies [Abstract] | |
| Estimated useful lives of assets | 5 years |
| Machinery and Equipment [Member] | Maximum [Member] | |
| Summary of Significant Accounting Policies [Abstract] | |
| Estimated useful lives of assets | 7 years |
Summary of Significant Accounting Policies - Intangible Assets (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Summary of Significant Accounting Policies [Abstract] | ||
| Cost | $ 1,869,257 | $ 1,755,009 |
| Accumulated amortization | (1,734,343) | (1,689,091) |
| Net book value | $ 134,914 | $ 65,918 |
Summary of Significant Accounting Policies - Accrued Expenses (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Summary of Significant Accounting Policies [Abstract] | ||
| Incentive and other compensation costs | $ 870,910 | $ 650,768 |
| Clinical trial costs | 259,293 | 354,762 |
| Director fees | 71,250 | 70,000 |
| Other | 64,320 | 75,519 |
| Accrued expenses | $ 1,265,773 | $ 1,151,049 |
Summary of Significant Accounting Policies - Sales by Geographic Region (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Summary of Significant Accounting Policies [Abstract] | ||
| Sales | $ 2,293,313 | $ 1,629,108 |
| U.S. [Member] | ||
| Summary of Significant Accounting Policies [Abstract] | ||
| Sales | 1,393,555 | 1,073,508 |
| International [Member] | ||
| Summary of Significant Accounting Policies [Abstract] | ||
| Sales | $ 899,758 | $ 555,600 |
Fair Value of Financial Instruments (Details) |
1 Months Ended | 12 Months Ended | ||
|---|---|---|---|---|
|
Nov. 21, 2023
USD ($)
|
Nov. 30, 2025
USD ($)
|
Dec. 31, 2025
USD ($)
|
Dec. 31, 2024
USD ($)
|
|
| Fair Value of Financial Instruments [Abstract] | ||||
| Proceeds from November 2025 convertible notes | $ 12,000,000 | $ 0 | ||
| November 2025 Financing [Member] | ||||
| Fair Value of Financial Instruments [Abstract] | ||||
| Proceeds from November 2025 convertible notes | $ 12,000,000 | |||
| 2023 Notes [Member] | ||||
| Fair Value of Financial Instruments [Abstract] | ||||
| Proceeds from November 2025 convertible notes | $ 6,850,000 | |||
| Level 3 [Member] | November 2025 Financing [Member] | ||||
| Fair Value of Financial Instruments [Abstract] | ||||
| Fair value of notes | $ 3,800,000 | |||
| Level 3 [Member] | 2023 Notes [Member] | ||||
| Fair Value of Financial Instruments [Abstract] | ||||
| Fair value of notes | $ 6,500,000 | |||
| Expected Volatility [Member] | Conversion Option Liability [Member] | November 2025 Financing [Member] | ||||
| Fair Value of Financial Instruments [Abstract] | ||||
| Warrants, measurement input | 20 | |||
Fair Value of Financial Instruments - Fair Value of Assets and Liabilities Measured on Recurring Basis (Details) - Level 3 [Member] - Recurring [Member] |
Dec. 31, 2025
USD ($)
|
|---|---|
| Fair Value of Financial Instruments [Abstract] | |
| AMPA liability | $ 0 |
| Conversion Option liability | 2,014,000 |
| Warrants liabilities | $ 4,943,000 |
Fair Value of Financial Instruments - Fair Value of Conversion Option Liability and Warrants Liabilities (Details) |
12 Months Ended |
|---|---|
|
Dec. 31, 2025
USD ($)
| |
| Fair Value of Conversion Option Liability [Member] | |
| Fair Value of Financial Instruments [Abstract] | |
| Fair value at issuance | $ 2,517,000 |
| Change in fair value (gain) | (503,000) |
| Balance | 2,014,000 |
| Fair Value of Warrants Liabilities [Member] | |
| Fair Value of Financial Instruments [Abstract] | |
| Fair value at issuance | 5,674,000 |
| Change in fair value (gain) | (731,000) |
| Balance | $ 4,943,000 |
Cash and Cash Equivalents (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Money Market Funds [Member] | Level 1 [Member] | ||
| Cash and Cash Equivalents [Abstract] | ||
| Cash and cash equivalents | $ 7,110,655 | $ 3,451,761 |
Commitments and Contingencies (Details) |
12 Months Ended | |
|---|---|---|
|
Dec. 31, 2025
USD ($)
Option
|
Dec. 31, 2024 |
|
| Commitments and Contingencies [Abstract] | ||
| Lease expiration date | Apr. 30, 2029 | |
| Number of extension option for operating lease term (in Option) | Option | 1 | |
| Extension period for lease | 5 years | |
| Payments for rent (in Dollars) | $ | $ 52,614 | |
| Weighted average discount rate | 10.00% | 10.00% |
| Weighted average remaining lease terms | 4 years 3 months 18 days | 3 years 3 months 18 days |
| Minimum [Member] | ||
| Commitments and Contingencies [Abstract] | ||
| Written notice to exercise extension option | 9 months | |
| Maximum [Member] | ||
| Commitments and Contingencies [Abstract] | ||
| Written notice to exercise extension option | 12 months |
Commitments and Contingencies - Operating Right-of-Use Assets and Lease Liabilities (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Commitments and Contingencies [Abstract] | ||
| Lease right-of-use assets | $ 1,297,121 | $ 1,805,543 |
| Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Lease right-of-use assets | Lease right-of-use assets |
| Lease liabilities – current portion | $ 487,624 | $ 517,967 |
| Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Lease liabilities – current portion | Lease liabilities – current portion |
| Lease liabilities – long-term portion | $ 1,030,476 | $ 1,518,100 |
| Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Lease liabilities – long-term portion | Lease liabilities – long-term portion |
| Total | $ 1,518,100 | $ 2,036,067 |
Commitments and Contingencies - Lease Cost (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Commitments and Contingencies [Abstract] | ||
| Operating lease cost | $ 619,796 | $ 619,796 |
| Short-term lease cost | 7,765 | 7,765 |
| Variable lease cost | 139,646 | 148,109 |
| Total | $ 767,207 | $ 775,670 |
Commitments and Contingencies - Undiscounted Cash Payment Obligations (Details) |
Dec. 31, 2025
USD ($)
|
|---|---|
| Commitments and Contingencies [Abstract] | |
| 2026 | $ 654,514 |
| 2027 | 680,694 |
| 2028 | 707,922 |
| 2029 | 243,835 |
| 2030 | 0 |
| Total undiscounted lease payments -operating leases | 2,286,965 |
| Less: imputed interest | (768,865) |
| Lease liability | 1,518,100 |
| Less: current portion of lease liability | (487,624) |
| Lease liability, less current portion | $ 1,030,476 |
Notes Payable (Details) - AFCO Credit Corporation [Member] - Promissory Notes [Member] - USD ($) |
1 Months Ended | 12 Months Ended |
|---|---|---|
Jul. 31, 2025 |
Dec. 31, 2025 |
|
| Notes Payable [Abstract] | ||
| Proceeds to pay insurance premiums | $ 367,450 | |
| Down payments | $ 31,672 | |
| Interest rate | 7.44% | |
| Frequency of installment payments | monthly | |
| Monthly principal and interest payments | $ 31,672 | |
| Maturity date of loan | Nov. 30, 2025 | |
| Interest expense on loan | $ 8,614 |
Convertible Notes with Warrants - Convertible Notes Payable (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Convertible Notes with Warrants [Abstract] | ||
| Less unamortized discount and debt issuance costs | $ (8,953,275) | $ (1,443,772) |
| Total Convertible Notes Payable | 3,178,864 | 5,406,228 |
| Convertible Notes Payable, short term | 0 | (5,406,228) |
| Convertible Notes Payable | $ 3,178,864 | 0 |
| Convertible Notes [Member] | November 2025 Financing [Member] | ||
| Convertible Notes with Warrants [Abstract] | ||
| Stated interest rate | 6.00% | |
| Notes principal balance | $ 0 | 6,850,000 |
| Convertible Notes Payable | $ 47,841 | 5,406,228 |
| Convertible Notes [Member] | November 2025 Financing [Member] | ||
| Convertible Notes with Warrants [Abstract] | ||
| Stated interest rate | 8.50% | |
| Notes principal balance | $ 12,000,000 | 0 |
| PIK [Member] | November 2025 Financing [Member] | ||
| Convertible Notes with Warrants [Abstract] | ||
| Notes principal balance | $ 132,139 | $ 0 |
Income Taxes (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Income Taxes [Abstract] | ||
| Change in valuation allowance | $ 4,191,880 | |
| Change in valuation allowance | 4,205,724 | $ 4,776,250 |
| Net operating loss carry forwards | 120,129,845 | |
| Research and experimentation tax credits | 4,139,328 | 3,839,058 |
| Federal [Member] | ||
| Income Taxes [Abstract] | ||
| Net operating loss carry forwards | 120,129,845 | 104,880,492 |
| Research and experimentation tax credits | 4,139,328 | 3,723,817 |
| State [Member] | ||
| Income Taxes [Abstract] | ||
| Net operating loss carry forwards | $ 20,275,840 | $ 17,675,024 |
Income Taxes - Income tax expense (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Current tax expense | ||
| Federal | $ 0 | $ 0 |
| State and local | 1,297 | 9,602 |
| Total current tax expense provision | 1,297 | 9,602 |
| Deferred tax expense | ||
| Federal | (4,205,724) | (4,433,940) |
| State and local | 13,844 | (342,310) |
| Total deferred tax expense provision | (4,191,880) | 0 |
| Valuation allowance change | 4,191,880 | |
| Total income tax expense | ||
| Federal | 0 | |
| State and local | 1,297 | |
| Total income tax expense provision (in Dollars) | 1,297 | 9,602 |
| Valuation allowance change | $ 4,205,724 | $ 4,776,250 |
Income Taxes - Income Taxes Paid (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | $ 6,806 | |
| Total income taxes paid | 6,806 | $ 5,708 |
| U.S. Federal [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 0 | |
| New York [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 2,000 | |
| California [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 1,600 | |
| New Hampshire [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 1,100 | |
| Georgia [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 1,000 | |
| New Jersey [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 500 | |
| Massachusetts [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | 456 | |
| Other states [Member] | ||
| Income Taxes [Abstract] | ||
| Total U.S. State and Local | $ 150 | |
Income Taxes - Components of Deferred Tax Assets (Liabilities) (Details) - USD ($) |
Dec. 31, 2025 |
Dec. 31, 2024 |
|---|---|---|
| Deferred tax asset arising from | ||
| Net operating loss carryforwards | $ 26,318,782 | $ 23,030,273 |
| Accrued expenses (compensation) | 109,914 | 138,806 |
| Intangibles | 98,355 | 93,426 |
| Property and equipment | 67,159 | 80,313 |
| Research and development expense capitalization | 3,835,472 | 3,326,621 |
| Research and development tax credits | 4,139,328 | 3,839,058 |
| Share-based compensation expense | 375,773 | 257,891 |
| Lease liabilities | 344,986 | 471,733 |
| Other | 10,796 | 5,210 |
| Deferred tax asset | 35,300,565 | 31,243,331 |
| Deferred tax liability arising from: | ||
| Uniform capitalization | 0 | (11,092) |
| Right-of-use assets | (294,769) | (418,323) |
| Deferred tax liability | (294,769) | (429,415) |
| Valuation allowance | 35,005,796 | 30,813,916 |
| Net deferred tax asset | $ 0 | $ 0 |
Equity Incentive Plans - Stock Option Granted (Details) - 2021 Stock Option Plan [Member] - shares |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Equity Incentive Plans [Abstract] | ||
| Granted (in Shares) | 1,639,915 | 1,359,821 |
| Employees [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Granted (in Shares) | 1,569,515 | 1,286,921 |
| Nonemployee [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Granted (in Shares) | 70,400 | 72,900 |
Equity Incentive Plans - Black-Scholes Weighted Average Assumptions (Details) - $ / shares |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| 2021 Equity Plan [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Fair Value of Awards (in Dollars per share) | $ 0.83 | $ 0.91 |
| Grant Price (in Dollars per share) | $ 1.08 | $ 1.07 |
| Expected term (in years) | 6 years 14 days | 6 years 2 months 12 days |
| Risk‑free interest rate | 4.34% | 4.04% |
| Dividend yield | 0.00% | 0.00% |
| Expected volatility | 91.17% | 109.61% |
| Inducement Grant [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Fair Value of Awards (in Dollars per share) | $ 0.69 | $ 0.94 |
| Grant Price (in Dollars per share) | $ 0.9 | $ 1.1 |
| Expected term (in years) | 6 years 3 months | 6 years 3 months |
| Risk‑free interest rate | 4.03% | 4.10% |
| Dividend yield | 0.00% | 0.00% |
| Expected volatility | 88.50% | 109.64% |
Equity Incentive Plans - Share-based Compensation Expense (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Equity Incentive Plans [Abstract] | ||
| Stock-based compensation expense | $ 790,145 | $ 444,147 |
| Research and Development [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Stock-based compensation expense | 224,714 | 179,911 |
| Sales and Marketing [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Stock-based compensation expense | 52,537 | 48,379 |
| General and Administrative [Member] | ||
| Equity Incentive Plans [Abstract] | ||
| Stock-based compensation expense | $ 512,894 | $ 215,857 |
Retirement Plan (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Retirement Plan [Abstract] | ||
| Contributions by employer | $ 122,917 | $ 97,876 |
Net Loss per Share Attributable to Common Stockholders (Details) - Pre-funded Warrants [Member] |
1 Months Ended |
|---|---|
|
Nov. 30, 2025
$ / shares
| |
| Net Loss per Share Attributable to Common Stockholders [Abstract] | |
| Basic loss per share (in Dollars per share) | $ 0.0001 |
| Diluted loss per share (in Dollars per share) | $ 0.0001 |
Net Loss per Share Attributable to Common Stockholders - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Net Loss per Share Attributable to Common Stockholders [Abstract] | ||
| Net loss attributable to common stockholders, basic | $ (18,627,887) | $ (18,816,628) |
| Net loss attributable to common stockholders, diluted | $ (18,627,887) | $ (18,816,628) |
| Weighted average common shares and pre-funded warrants outstanding - basic (in Shares) | 39,549,218 | 22,267,695 |
| Weighted average common shares and pre-funded warrants outstanding - diluted (in Shares) | 39,549,218 | 22,267,695 |
| Net loss per share attributable to common stockholders, basic (in Dollars per share) | $ (0.47) | $ (0.85) |
| Net loss per share attributable to common stockholders, diluted (in Dollars per share) | $ (0.47) | $ (0.85) |
Segment Reporting (Details) |
12 Months Ended |
|---|---|
|
Dec. 31, 2025
Segment
| |
| Segment Reporting [Abstract] | |
| Number of operating segments | 1 |
| Number of reportable segments | 1 |
Segment Reporting - Segment Reporting (Details) - Business Segment [Member] - USD ($) |
12 Months Ended | |||
|---|---|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|||
| Segment Reporting [Abstract] | ||||
| Sales | $ 2,293,313 | $ 1,629,108 | ||
| Cost of sales (excluding depreciation expense) | 872,400 | 544,903 | ||
| Research and development expense | 2,072,771 | 2,217,610 | ||
| Other research and development expenses | [1] | 5,504,933 | 5,998,933 | |
| Total research and development expense | 7,577,704 | 8,216,543 | ||
| Sales and marketing expense | 4,443,807 | 4,030,150 | ||
| General and administrative expense | 6,646,037 | 6,325,999 | ||
| Depreciation and amortization expense | 342,034 | 297,318 | ||
| Total operating expenses | 19,009,582 | 18,870,010 | ||
| Total other expense, net | (1,037,921) | (1,021,221) | ||
| Loss before income taxes | (18,626,590) | (18,807,026) | ||
| Income tax expense | 1,297 | 9,602 | ||
| Net loss | $ (18,627,887) | $ (18,816,628) | ||
| ||||
Other Expense, net - Other Expense, Net (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Dec. 31, 2025 |
Dec. 31, 2024 |
|
| Other Expense, net [Abstract] | ||
| Interest income | $ 101,760 | $ 582,354 |
| Amortization of debt issuance costs and discount for 2025 and 2023 notes | (1,387,050) | (1,192,574) |
| Interest expense | (504,069) | (411,001) |
| Debt issuance costs for AMPA | (286,295) | 0 |
| Change in fair value of Conversion Option liability | 503,000 | 0 |
| Change in fair value of Warrants liabilities | 731,000 | 0 |
| Other expenses | (196,267) | 0 |
| Total other expense, net | $ (1,037,921) | $ (1,021,221) |
Subsequent Events (Details) - Subsequent Events [Member] - USD ($) |
1 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Feb. 28, 2026 |
|
| Convertible Notes [Member] | ||
| Subsequent Events [Abstract] | ||
| Amount of convertible notes converted in to common stock (in Dollars) | $ 76,452 | |
| Common Stock [Member] | ||
| Subsequent Events [Abstract] | ||
| Number of shares issued upon conversion of convertible notes (in Shares) | 103,429 | |
| Series D-1 Warrants [Member] | ||
| Subsequent Events [Abstract] | ||
| Warrants purchase shares of common stock | 16,378,563 | |
| Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per share) | $ 0.58 | |
| At-the-Market Facility [Member] | ||
| Subsequent Events [Abstract] | ||
| Sale of common stock (in Shares) | 623,911 | 623,911 |
| Gross cash proceeds (in Dollars) | $ 352,922 | $ 352,922 |