SAVARA INC, 10-K filed on 3/27/2025
Annual Report
v3.25.1
Document and Entity Information - USD ($)
 12 Months Ended
Dec. 31, 2024
Mar. 27, 2025
Jun. 30, 2024
Cover [Abstract]      
Document Type 10-K    
Amendment Flag false    
Document Period End Date Dec. 31, 2024    
Document Fiscal Year Focus 2024    
Document Fiscal Period Focus FY    
Entity Registrant Name Savara Inc.    
Entity Central Index Key 0001160308    
Current Fiscal Year End Date --12-31    
Entity Well-known Seasoned Issuer No    
Entity Current Reporting Status Yes    
Entity Interactive Data Current Yes    
Entity Voluntary Filers No    
Entity Filer Category Non-accelerated Filer    
Entity Small Business true    
Entity Emerging Growth Company false    
Entity Shell Company false    
Entity File Number 001-32157    
Entity Tax Identification Number 84-1318182    
Entity Address, Address Line One 1717 Langhorne Newtown Road    
Entity Address, Address Line Two Suite 300    
Entity Address, City or Town Langhorne    
Entity Address, State or Province PA    
Entity Address, Postal Zip Code 19047    
City Area Code 512    
Local Phone Number 614-1848    
Document Annual Report true    
Document Transition Report false    
ICFR Auditor Attestation Flag false    
Document Financial Statement Error Correction [Flag] false    
Entity Incorporation, State or Country Code DE    
Entity Common Stock, Shares Outstanding   172,633,140  
Entity Public Float     $ 544,458,670
Title of 12(b) Security Common Stock, par value $0.001 per share    
Trading Symbol SVRA    
Security Exchange Name NASDAQ    
Documents Incorporated by Reference Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Shareholders, scheduled to be held on June 5, 2025, are incorporated by reference into Part III of this Report.    
Auditor Firm ID 49    
Auditor Location Boston, Massachusetts    
Auditor Name RSM US LLP    
v3.25.1
Consolidated Balance Sheets - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 15,128 $ 26,585
Short-term investments 181,199 135,734
Prepaid expenses and other current assets 5,808 3,628
Total current assets 202,135 165,947
Property and equipment, net 165 270
In-process R&D 10,337 10,960
Other non-current assets 242 387
Total assets 212,879 177,564
Current liabilities:    
Accounts payable 4,545 3,504
Accrued expenses and other current liabilities 10,179 7,093
Total current liabilities 14,724 10,597
Long-term liabilities:    
Long-term debt 26,619 26,348
Other long-term liabilities 87 247
Total liabilities 41,430 37,192
Commitments and contingencies (Note 10)  
Stockholders’ equity:    
Common stock, $0.001 par value, 300,000,000 shares authorized as of December 31, 2024 and 2023; 172,423,223 and 138,143,545 shares issued and outstanding as of December 31, 2024 and 2023, respectively 173 140
Additional paid-in capital 661,276 533,872
Accumulated other comprehensive loss (750) (271)
Accumulated deficit (489,250) (393,369)
Total stockholders’ equity 171,449 140,372
Total liabilities and stockholders' equity $ 212,879 $ 177,564
v3.25.1
Consolidated Balance Sheets (Parenthetical) - $ / shares
Dec. 31, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 300,000,000 300,000,000
Common stock, shares issued 172,423,223 138,143,545
Common stock, shares outstanding 172,423,223 138,143,545
v3.25.1
Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Operating expenses:    
Research and development $ 78,029 $ 44,262
General and administrative 25,037 15,668
Depreciation and amortization 130 77
Total operating expenses 103,196 60,007
Loss from operations (103,196) (60,007)
Other income, net:    
Interest income, net 6,467 4,436
Foreign currency exchange gain 51 76
Tax credit income 797 797
Total other income, net 7,315 5,309
Net loss $ (95,881) $ (54,698)
Net loss per share:    
Basic $ (0.48) $ (0.33)
Diluted $ (0.48) $ (0.33)
Weighted-average common shares outstanding:    
Basic 198,191,936 165,204,652
Diluted 198,191,936 165,204,652
Other comprehensive income (loss):    
Gain (loss) on foreign currency translation $ (523) $ 133
Unrealized gain on short-term investments 44 201
Total comprehensive loss $ (96,360) $ (54,364)
v3.25.1
Consolidated Statements of Changes in Stockholders' Equity - USD ($)
$ in Thousands
Total
Registered Direct Offering [Member]
At the Market Offerings [Member]
Common Stock [Member]
Common Stock [Member]
Registered Direct Offering [Member]
Common Stock [Member]
At the Market Offerings [Member]
Additional Paid-in Capital [Member]
Additional Paid-in Capital [Member]
Registered Direct Offering [Member]
Additional Paid-in Capital [Member]
At the Market Offerings [Member]
Accumulated Deficit [Member]
Accumulated Other Comprehensive Income (Loss) [Member]
Beginning balances at Dec. 31, 2022 $ 107,778     $ 116     $ 446,938     $ (338,671) $ (605)
Beginning balance, shares at Dec. 31, 2022       114,046,345              
Issuance of common stock, net   $ 74,874 $ 8,831   $ 21 $ 2   $ 74,853 $ 8,829    
Issuance of common stock, net, shares         21,000,000 2,071,511          
Issuance of common stock upon exercise of stock options 283           283        
Issuance of common stock upon exercise of stock options, shares       245,786              
Issuance of common stock for settlement of RSUs       $ 1     (1)        
Issuance of common stock for settlement of RSUs, shares       1,062,000              
Repurchase of shares for minimum tax withholdings (1,208)           (1,208)        
Repurchase of shares for minimum tax withholdings,shares       (282,097)              
Stock-based compensation 4,178           4,178        
Foreign exchange translation adjustment 133                   133
Unrealized gain on short-term investments 201                   201
Net loss (54,698)                 (54,698)  
Ending balance at Dec. 31, 2023 $ 140,372     $ 140     533,872     (393,369) (271)
Ending balance, shares at Dec. 31, 2023 138,143,545     138,143,545              
Issuance of common stock, net   $ 93,798 $ 24,374   $ 26 $ 6   $ 93,772 $ 24,368    
Issuance of common stock, net, shares         26,246,720 6,038,650          
Issuance of common stock upon exercise of stock options $ 347           347        
Issuance of common stock upon exercise of stock options, shares 464,297     388,185              
Issuance of common stock for settlement of RSUs       $ 1     (1)        
Issuance of common stock for settlement of RSUs, shares 1,117,750     1,117,750              
Repurchase of shares for minimum tax withholdings $ (995)           (995)        
Repurchase of shares for minimum tax withholdings,shares       (286,627)              
Issuance of common stock upon exercise of prefunded Warrants,Shares       775,000              
Issuance of common stock upon exercise of prefunded Warrants 7           7        
Reimbursement of commissions from prior issuance of common stock upon at the market sales, net 46           46        
Stock-based compensation 9,860           9,860        
Foreign exchange translation adjustment (523)                   (523)
Unrealized gain on short-term investments 44                   44
Net loss (95,881)                 (95,881)  
Ending balance at Dec. 31, 2024 $ 171,449     $ 173     $ 661,276     $ (489,250) $ (750)
Ending balance, shares at Dec. 31, 2024 172,423,223     172,423,223              
v3.25.1
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Cash flows from operating activities:    
Net loss $ (95,881) $ (54,698)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 130 77
Reduction in the carrying value of right-of-use assets 145 98
Foreign currency loss   (76)
Amortization of debt issuance costs 271 271
Accretion on discount to short-term investments (5,442) (4,984)
Stock-based compensation 9,860 4,178
Changes in operating assets and liabilities:    
Prepaid expenses and other current assets (2,383) (456)
Non-current assets 11 (12)
Accounts payable and accrued expenses and other current liabilities 4,201 4,541
Net cash used in operating activities (89,088) (51,061)
Cash flows from investing activities:    
Purchase of property and equipment (25) (296)
Purchase of available-for-sale securities, net (204,916) (194,220)
Maturity of available-for-sale securities 165,000 137,400
Net cash used in investing activities (39,941) (57,116)
Cash flows from financing activities:    
Issuance of common stock and pre-funded warrants in underwritten offering, net of offering costs   74,874
Issuance of common stock issued in underwritten offering, net of offering costs 93,798  
Issuance of common stock upon exercise of prefunded warrants 7  
Issuance of common stock upon at the market offerings, net 24,374 8,831
Proceeds from exercise of stock options 347 283
Reimbursement of commissions from the prior issuance of common stock upon at the market sales, net 46  
Repurchase of shares for minimum tax withholdings (995) (1,208)
Net cash provided by financing activities 117,577 82,780
Effect of exchange rate changes on cash and cash equivalents (5) (118)
Decrease in cash and cash equivalents (11,457) (25,515)
Cash and cash equivalents beginning of period 26,585 52,100
Cash and cash equivalents end of period 15,128 26,585
Supplemental disclosure of cash flow information:    
Cash paid for interest $ 2,124 $ 2,040
v3.25.1
Cybersecurity Risk Management, Strategy, and Governance
 12 Months Ended
Dec. 31, 2024
Cybersecurity Risk Management, Strategy, and Governance [Line Items]  
Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block]

Item 1C. Cybersecurity.

Cyber Risk Management and Strategy

As part of our enterprise risk management program, we have implemented and maintain policies and processes to identify and mitigate risks posed by cybersecurity threats. Our policies and processes are based upon the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework, and we utilize technologies to help identify and manage potential cyber threats. We have also secured cyber-specific insurance coverage as part of our overall insurance portfolio.

We have engaged an independent, third-party services provider to assist in monitoring our information technology systems, as well as identifying, assessing, and mitigating the associated cyber risk. With that provider, we conduct periodic assessments of our information security program to evaluate the effectiveness of applicable security controls, which include penetration testing, vulnerability scanning, and red teaming. Our Chief Financial and Administrative Officer (“CF&AO”) reviews the results of those assessments with our third-party provider to reasonably address any identified potential gaps. We also utilize a range of tools and services to help ensure material threats are prevented or the risks of such threats are mitigated, which include, network and endpoint monitoring, system patching, user and server backups, annual awareness training, and periodic vulnerability evaluation. Management reviews monthly monitoring reports and meets with our third-party provider on a regular basis to review activities and debrief on any key IT-related issues.

We have an employee education program that includes annual training designed to raise awareness of cybersecurity threats, and we require employees to review and acknowledge our IT Security Policy on an annual basis. Additionally, we have adopted an IT Incident Response Plan that outlines the procedures to be followed in response to a data breach, whether internal or through a third-party, that are designed to help contain, assess, and respond to the incident and mitigate potential harm.

Our systems periodically experience directed attacks intended to lead to interruptions and delays in our operations as well as loss, misuse, or theft of information and other data, confidential information, or intellectual property. However, to date, these incidents have not had a material impact on our operations. Any significant disruption to our service or access to our systems could adversely affect our business and results of operation. Further, a penetration of our systems or a third-party’s systems or other misappropriation or misuse of information could subject us to business, regulatory, litigation, and reputation risk, which could have a negative effect on our business, financial condition and results of operations. See Risk Factors – Risks Related to Information Technology and Data Privacy.

Governance Related to Cybersecurity Risks

The Audit Committee of our Board of Directors is responsible for the general oversight of risks related to data privacy and cybersecurity. The Audit Committee periodically reviews the Company’s cybersecurity program with management, including (i) the adequacy of controls and security for the Company’s information technology systems and (ii) the Company’s response plan in the event of a security breach impacting those systems. Our CF&AO has primary responsibility for overseeing the day-to-day management of cybersecurity risks and has served in that role for three years. Our CF&AO oversees the policies and processes described above and provides the periodic management briefings to the Audit Committee, including any cybersecurity incidents and related responses. Further, at least annually, the Board of Directors receives updates of potential cybersecurity incidents, as well as the data privacy and compliance programs, and its members actively participate in discussions with management regarding cybersecurity risks.
Cybersecurity Risk Management Processes Integrated [Flag] true
Cybersecurity Risk Management Processes Integrated [Text Block] we have implemented and maintain policies and processes to identify and mitigate risks posed by cybersecurity threats. Our policies and processes are based upon the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework, and we utilize technologies to help identify and manage potential cyber threats.
Cybersecurity Risk Management Third Party Engaged [Flag] true
Cybersecurity Risk Third Party Oversight and Identification Processes [Flag] true
Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag] false
Cybersecurity Risk Board of Directors Oversight [Text Block]

The Audit Committee of our Board of Directors is responsible for the general oversight of risks related to data privacy and cybersecurity. The Audit Committee periodically reviews the Company’s cybersecurity program with management, including (i) the adequacy of controls and security for the Company’s information technology systems and (ii) the Company’s response plan in the event of a security breach impacting those systems. Our CF&AO has primary responsibility for overseeing the day-to-day management of cybersecurity risks and has served in that role for three years. Our CF&AO oversees the policies and processes described above and provides the periodic management briefings to the Audit Committee, including any cybersecurity incidents and related responses. Further, at least annually, the Board of Directors receives updates of potential cybersecurity incidents, as well as the data privacy and compliance programs, and its members actively participate in discussions with management regarding cybersecurity risks.
Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block] The Audit Committee of our Board of Directors is responsible for the general oversight of risks related to data privacy and cybersecurity.
Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block] The Audit Committee periodically reviews the Company’s cybersecurity program with management, including (i) the adequacy of controls and security for the Company’s information technology systems and (ii) the Company’s response plan in the event of a security breach impacting those systems.
Cybersecurity Risk Role of Management [Text Block] Our CF&AO has primary responsibility for overseeing the day-to-day management of cybersecurity risks and has served in that role for three years. Our CF&AO oversees the policies and processes described above and provides the periodic management briefings to the Audit Committee, including any cybersecurity incidents and related responses. Further, at least annually, the Board of Directors receives updates of potential cybersecurity incidents, as well as the data privacy and compliance programs, and its members actively participate in discussions with management regarding cybersecurity risks
Cybersecurity Risk Management Positions or Committees Responsible [Flag] true
Cybersecurity Risk Management Positions or Committees Responsible [Text Block] Our CF&AO has primary responsibility for overseeing the day-to-day management of cybersecurity risks and has served in that role for three years.
Cybersecurity Risk Management Expertise of Management Responsible [Text Block] Our CF&AO has primary responsibility for overseeing the day-to-day management of cybersecurity risks and has served in that role for three years. Our CF&AO oversees the policies and processes described above and provides the periodic management briefings to the Audit Committee, including any cybersecurity incidents and related responses
Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block] Further, at least annually, the Board of Directors receives updates of potential cybersecurity incidents, as well as the data privacy and compliance programs, and its members actively participate in discussions with management regarding cybersecurity risks.
Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag] true
v3.25.1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Pay vs Performance Disclosure    
Net Income (Loss) $ (95,881) $ (54,698)
v3.25.1
Insider Trading Arrangements
 3 Months Ended
Dec. 31, 2024
shares
Trading Arrangements, by Individual  
Material Terms of Trading Arrangement

Item 9B. Other Information:

Rule 10b5-1 Trading Plans

Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities terminated by our executive officers and directors during the quarter ended December 31, 2024, each of which was entered into and terminated during an open trading window and was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) (each, a Trading Plan).

 

Name and Title

 

Date of Adoption of Trading Plan

 

Scheduled Start Date of Trading Plan

 

Scheduled Expiration Date of Trading Plan

 

Maximum Shares Subject to Trading Plan

 

 

Date Plan Terminated (1)

Matthew Pauls
Chief Executive Officer and Chair of the Board of Directors

 

9/25/2024

 

12/26/2024

 

5/15/2025

 

 

150,000

 

 

12/2/2024

David Lowrance
Chief Financial and Administrative Officer

 

9/24/2024

 

12/26/2024

 

5/15/2025

 

 

85,000

 

 

12/2/2024

(1) Each Trading Plan was terminated prior to any sales being made pursuant to such Trading Plan.

No other Company directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarter ended December 31, 2024.
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
Rule 10b5-1 Arrangement Modified false
Non-Rule 10b5-1 Arrangement Modified false
Matthew Pauls [Member]  
Trading Arrangements, by Individual  
Name Matthew Pauls
Title Chief Executive Officer and Chair of the Board of Directors
Rule 10b5-1 Arrangement Adopted true
Adoption Date 9/25/2024
Rule 10b5-1 Arrangement Terminated true
Termination Date 12/2/2024 [1]
Expiration Date 5/15/2025
Arrangement Duration 233 days
Aggregate Available 150,000
David Lowrance [Member]  
Trading Arrangements, by Individual  
Name David Lowrance
Title Chief Financial and Administrative Officer
Rule 10b5-1 Arrangement Adopted true
Adoption Date 9/24/2024
Rule 10b5-1 Arrangement Terminated true
Termination Date 12/2/2024 [1]
Expiration Date 5/15/2025
Arrangement Duration 234 days
Aggregate Available 85,000
[1] Each Trading Plan was terminated prior to any sales being made pursuant to such Trading Plan.
v3.25.1
Description of Business and Basis of Presentation
 12 Months Ended
Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Description of Business and Basis of Presentation

1. Description of Business and Basis of Presentation

Description of Business

Savara Inc. (together with its subsidiaries “Savara,” the “Company,” “we” or “us”) is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s sole program, molgramostim inhalation solution ("MOLBREEVI" or "molgramostim"), is an investigational inhaled biologic, specifically an inhaled granulocyte-macrophage colony-stimulating factor ("GM-CSF") in Phase 3 development for autoimmune pulmonary alveolar proteinosis (“aPAP”). The Company and its wholly-owned domestic and foreign subsidiaries operate in one segment with its principal office in Langhorne, Pennsylvania, though a significant portion of employees work remotely.

Since inception, Savara has devoted its efforts and resources to identifying and developing its product candidates, recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operations and has no product revenue from inception to date. The Company has not yet commenced commercial operations.

Basis of Presentation

The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (the “FASB”).
v3.25.1
Summary of Significant Accounting Policies
 12 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S. dollars. These financial statements include the accounts of the Company and its wholly-owned subsidiaries. The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated other comprehensive loss. All intercompany transactions and accounts have been eliminated in consolidation.

Liquidity

As of December 31, 2024, the Company had an accumulated deficit of approximately $489.3 million. The Company used cash from operations of approximately $89.1 million for the year ended December 31, 2024. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Although the Company has sufficient capital to fund many of its planned activities, it may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, its product candidate and begin to commercialize any approved product.

The Company is currently focused on the development of MOLBREEVI for the treatment of aPAP and believes such activities will result in the continued incurrence of significant research and development and other expenses related to this program. If the Company’s product candidate does not gain regulatory approval or, if approved, fails to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand, short-term investments, and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances with partner companies. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders.

The Company had cash and cash equivalents of $15.1 million and short-term investments of $181.2 million as of December 31, 2024, which is sufficient to fund the Company's operations for at least the next twelve months subsequent to the issuance date of its consolidated financial statements for the year ended December 31, 2024. The Company may continue to raise additional capital as needed through the issuance of additional equity securities and potentially through borrowings and strategic alliances with partner companies. However, if such additional financing is not available timely and at adequate levels, the Company may need to reevaluate its long-term operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company currently maintains depository accounts and has a debt facility with Silicon Valley Bank, an FDIC insured entity. In order to mitigate risks associated with our banking deposits, the Company maintains a significant portion of its liquidity in U.S. Treasury money market funds and other short-term investments with custodial services provided by U.S. Bank, N.A. and FNZ, refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates.

Risks and Uncertainties

The product candidate being developed by the Company requires approval from the U.S. Food and Drug Administration (the “FDA”) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidate will receive the necessary approvals. If the Company is denied regulatory approval of its product candidate, or if approval is delayed, it will have a material adverse impact on the Company’s business, results of operations, and financial position.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

Cash and Cash Equivalents

Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value.

Short-term Investments

The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive loss within stockholders’ equity.

The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. We review investments for impairment whenever the fair value of an available-for-sale security is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or noncredit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to net loss, and noncredit-related impairment is recognized in other comprehensive (loss) income, net of taxes. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Refer to Note 5. Short-term Investments for additional discussion.

Concentration of Credit Risk

We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalents and marketable securities with a limited number of financial institutions. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash and cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets.

Research and Development Costs

The Company records the costs associated with research, nonclinical and clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third party service providers, including contract research and manufacturing organizations.

The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on

estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the trial duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Refer to Note 4. Accrued Expenses and Other Current Liabilities for additional discussion.

License and Collaboration Agreements

From time to time the Company enters, and may continue to enter, into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company may be required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products, and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the underlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred.

Acquired In-Process Research and Development

In accordance with ASC Topic 350, Intangibles – Goodwill and Other, the Company's acquired IPR&D is determined to have an indefinite life and, therefore, is not amortized. Instead, it is tested for impairment annually and between annual tests if the Company becomes aware of an event or a change in circumstances that would indicate the carrying value may be impaired.

With respect to the impairment testing of acquired IPR&D, ASU 2011-08, Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment, and ASU 2012-02, Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment, provides for a two-step impairment process with the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to the determination that it is more-likely-than not (that is, a likelihood of more than 50%) that acquired IPR&D is impaired. If the Company chooses to first assess qualitative factors and it determines that it is more-likely-than not acquired IPR&D is not impaired, the Company is not required to take further action to test for impairment.

When the Company performs a quantitative assessment of acquired IPR&D, it compares its carrying value to its estimated fair value to determine whether an impairment exists. Due to a lack of Level 1 or Level 2 inputs, the Multi-Period Excess Earnings Method (“MPEEM”), which is a form of the income approach, was used to estimate the fair value of acquired IPR&D when performing a quantitative assessment. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. The Company evaluates potential impairment of its acquired IPR&D annually on September 30th, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired.

Our determinations as to whether, and if so, the extent to which acquired IPR&D become impaired are highly judgmental and, in the case of applying the MPEEM approach to estimate fair value, are based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use of the acquired assets, development of our acquired assets or our overall business strategy, and regulatory, market, and economic environment and trends.

If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a non-cash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. Refer to Note 8.

Leases

The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits in accordance with ASU 2016-02, Leases (Topic 842), as codified in ASC 842, Leases. Lease right-of-use assets and liabilities are initially recorded on the lease commencement date based on the present value of lease payments over the lease term. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Leases may include renewal, purchase, or termination options that can extend or shorten the term of the lease. The exercise of those options is at the Company's sole discretion and is evaluated at inception and throughout the contract to determine if a modification of the lease term is required.

In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and liability. Rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations and comprehensive loss.

The Company has made an accounting policy election providing that leases with an initial term of 12 months or less are not recorded as a lease right-of-use asset and corresponding liability in accordance with ASC 842, Leases; those lease payments are recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. Refer to Note 10. Commitments – Operating Leases for additional discussion.

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years. Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. Refer to Note 6. Property and Equipment, Net for additional discussion.

Patents and Intellectual Property

As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property.

Fair Value of Financial Instruments

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.

The three tiers are defined as follows:

•
Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
•
Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
•
Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The Company’s financial instruments consist primarily of cash, cash equivalents, short term investments, accounts payable, and accrued liabilities. The Company’s cash, cash equivalents, accounts payable, and accrued liabilities

approximate fair value due to their relatively short maturities. Refer to Note 8. Fair Value Measurements for additional discussion.

Revenue Recognition

The Company records revenue based on a five-step model in accordance with ASC 606, Revenue from Contracts with Customers. To date, the Company has not generated any product revenue. The Company’s ability to generate product revenues, which the Company expects to commence in the upcoming year(s), if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates.

Net Loss per Share

Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Refer to Note 13. Net Loss per Share for additional discussion.

Stock-Based Compensation

The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period. Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. In addition, the Company accounts for any modifications to stock-based awards in accordance with ASC Topic 718, Compensation – Stock Compensation. Refer to Note 11. Stock-Based Compensation for additional discussion.

Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more-likely-than not to be realized. Refer to Note 12. Income Taxes for additional discussion.

Recent Accounting Pronouncements

In November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"), to provide more disaggregated expense information about a public entity’s reportable segments. The amendments in this update should be applied retrospectively and are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. As of January 1, 2024, we have adopted ASU 2023-07 which did not have a material impact on the Company's consolidated financial statements and additional required disclosures have been included in Note 13. Segment Reporting.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"), to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The amendments in this update should be applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.

In March 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses ("ASU 2024-03"), to improve the disclosures about a public business entity’s expenses and to provide more detailed information about the types of expenses in commonly presented expense captions. The amendments in this update should be applied either prospectively or retrospectively, and are effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.
v3.25.1
Prepaid Expenses and Other Current Assets
 12 Months Ended
Dec. 31, 2024
Prepaid Expense and Other Assets, Current [Abstract]  
Prepaid Expenses and Other Current Assets

3. Prepaid Expenses and Other Current Assets

Prepaid expenses, consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Prepaid contracted research and development costs

 

$

4,179

 

 

$

2,167

 

R&D tax credit receivable

 

 

768

 

 

 

814

 

VAT receivable

 

 

275

 

 

 

191

 

Prepaid insurance

 

 

131

 

 

 

176

 

Deposits and other

 

 

455

 

 

 

280

 

Total prepaid expenses and other current assets

 

$

5,808

 

 

$

3,628

 

 

Prepaid Contracted Research and Development Costs

As of December 31, 2024, Prepaid contracted research and development costs are primarily comprised of contractual prepayments associated with the Company's clinical trial for MOLBREEVI for the treatment of aPAP and for CMC related activities. This includes prepaid amounts paid under agreements with CROs, CMOs, and other outside service providers that provide services in connection with the Company's research and development activities.

R&D Tax Credit Receivable

The Company has recorded a Danish R&D tax credit receivable earned by its subsidiary, Savara ApS, as of December 31, 2024. Under Danish tax law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds. During the year ended December 31, 2023, the Company generated a Danish R&D tax credit receivable of $0.8 million which was received in the fourth quarter of 2024. During the year ended December 31, 2024, the Company generated a Danish R&D tax credit receivable of $0.8 million which is expected to be received in the fourth quarter of 2025.

v3.25.1
Accrued Expenses and Other Current Liabilities
 12 Months Ended
Dec. 31, 2024
Payables and Accruals [Abstract]  
Accrued Expenses and Other Current Liabilities

4. Accrued Expenses and Other Current Liabilities

Accrued expenses and other liabilities, consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Accrued compensation

 

$

5,017

 

 

$

4,046

 

Accrued contracted research and development costs

 

 

3,912

 

 

 

2,166

 

Accrued general and administrative costs

 

 

1,134

 

 

 

738

 

Lease liability

 

 

116

 

 

 

143

 

Total accrued expenses and other current liabilities

 

$

10,179

 

 

$

7,093

 

 

Accrued Compensation

As of December 31, 2024, Accrued compensation includes amounts to be paid to employees for salary, vacation and non-equity performance-based compensation. At the end of any period, the amount accrued for such compensation may vary due to many factors including, but not limited to, timing of payments to employees and vacation usage.

Accrued Contracted Research and Development Costs

As of December 31, 2024, Accrued contracted research and development costs are primarily comprised of costs associated with MOLBREEVI for the treatment of aPAP, including expenses resulting from obligations under agreements with CROs, CMOs, and other outside service providers that provide services in connection with the Company's research and development activities.
v3.25.1
Short-term Investments
 12 Months Ended
Dec. 31, 2024
Investments, Debt and Equity Securities [Abstract]  
Short-term Investments

5. Short-term Investments

Short-term Investments in Available-for-Sale Securities

The Company’s investment policy seeks to preserve capital and maintain sufficient liquidity to meet operational and other needs of the business. The following table summarizes, by major security type, the Company’s investments (in thousands):

 

As of December 31, 2024

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

$

180,961

 

 

$

255

 

 

$

(17

)

 

$

181,199

 

Total short-term investments

 

$

180,961

 

 

$

255

 

 

$

(17

)

 

$

181,199

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

$

135,541

 

 

$

194

 

 

$

(1

)

 

$

135,734

 

Total short-term investments

 

$

135,541

 

 

$

194

 

 

$

(1

)

 

$

135,734

 

 

The Company has classified its investments as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive loss in the consolidated balance sheet. Classification as short-term or long-term is based upon whether the maturity of the debt securities is less than or greater than twelve months, as further discussed in Note 8. Fair Value Measurements.

There were no significant realized gains or losses related to investments for the years ended December 31, 2024 and 2023.
v3.25.1
Property and Equipment, Net
 12 Months Ended
Dec. 31, 2024
Property, Plant and Equipment [Abstract]  
Property and Equipment, Net

6. Property and Equipment, Net

Property and equipment, net consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Research and development equipment

 

$

1,102

 

 

$

1,102

 

Equipment

 

 

772

 

 

 

737

 

Furniture and fixtures

 

 

120

 

 

 

110

 

Leasehold improvements

 

 

333

 

 

 

333

 

Total property and equipment

 

 

2,327

 

 

 

2,282

 

Less accumulated depreciation

 

 

(2,162

)

 

 

(2,012

)

Property and equipment, net

 

$

165

 

 

$

270

 

 

Depreciation expense for the years ended December 31, 2024 and 2023 was minimal.
v3.25.1
Debt Facility
 12 Months Ended
Dec. 31, 2024
Debt Disclosure [Abstract]  
Debt Facility

7. Debt Facility

On April 21, 2022, the Company and its subsidiary, Aravas Inc. (“Aravas”) entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”), as co-borrowers with Silicon Valley Bank, a division of First Citizens BancShares, as lender (the “Lender”) which provides for a $26.5 million term loan facility.

Pursuant to the Amended Loan Agreement, the loan has an interest-only monthly payment through April 21, 2026 (the “Interest-Only Period”) and thereafter equal monthly installments of principal plus interest over 12 months until April 21, 2027 (the “Maturity Date”). However, the Company may elect to extend the Interest-Only Period until the Maturity Date if it maintains cash and cash equivalents equal to at least 1.75 times the outstanding principal amount of the loan during the fifth year. If the Interest-Only Period is extended, all principal and unpaid interest is due and payable on the Maturity Date.

The loan bears interest at a floating rate equal to the greater of (i) 3% and (ii) the prime rate reported in The Wall Street Journal, minus a spread of 0.5%. The Company is obligated to pay customary closing fees and a final payment of 2.75% of the principal amount advanced under the facility. The Company may currently prepay the loan in whole or in part at any time without penalty or prepayment fee.

The Lender was granted a perfected first priority lien in all of the Company's assets with a negative pledge on intellectual property. The Amended Loan Agreement contains customary affirmative and negative covenants, including among others, covenants that limit the Company's and its subsidiaries’ ability to dispose of assets, permit a change in control, merge or

consolidate, make acquisitions, incur indebtedness, grant liens, make investments, make certain restricted payments, and enter into transactions with affiliates, in each case subject to certain exceptions.

Additionally, the Amended Loan Agreement contains an affirmative covenant providing that if the Company’s balance of cash and cash equivalents falls below $40.0 million, the Company is required to maintain cash and cash equivalents equal to at least (i) six months of operating expenses and (ii) 1.2 times the outstanding principal amount of the loan (or 1.75 in the final year of the loan if the Interest-Only Period is extended). The Company was obligated to issue warrants to purchase shares of its common stock as part of the initial funding of the loan, as further described in Note 9. Stockholders’ Equity.

Approximately $0.1 million of fees paid to the Lender were capitalized and will be amortized over the term of the Amended Loan Agreement. Expenses paid to third parties associated with the Amended Loan Agreement were immediately expensed and recorded in the Interest income (expense) line item in our consolidated statement of operations.

Summary of Carrying Value

The following table summarizes the components of the long-term debt carrying value, which approximates the fair value (in thousands):

 

Future minimum payments due during the year ended December 31,

 

 

 

2025

 

$

-

 

2026

 

 

17,667

 

2027

 

 

9,562

 

Total future minimum payments

 

 

27,229

 

Unamortized end of term charge

 

 

(333

)

Debt issuance costs

 

 

(253

)

Debt discount related to warrants

 

 

(24

)

Total debt

 

 

26,619

 

Current portion of long-term debt

 

 

—

 

Long-term debt

 

$

26,619

 
v3.25.1
Fair Value Measurements
 12 Months Ended
Dec. 31, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements

8. Fair Value Measurements

The Company measures and reports certain financial instruments at fair value on a recurring basis and evaluates its financial instruments subject to fair value measurements on a recurring and nonrecurring basis to determine the appropriate level in which to classify them in each reporting period.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The Company determined that certain investments in debt securities classified as available-for-sale securities were Level 1 financial instruments.

Additional investments in corporate debt securities, commercial paper, and asset-backed securities are considered Level 2 financial instruments because the Company has access to quoted prices but does not have visibility to the volume and frequency of trading for all of these investments. For the Company’s investments, a market approach is used for recurring fair value measurements and the valuation techniques use inputs that are observable, or can be corroborated by observable data, in an active marketplace.

The fair value of these instruments as of December 31, 2024 and 2023 was as follows (in thousands):

 

 

 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

As of December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

13,802

 

 

$

—

 

 

$

—

 

 

$

13,802

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

 

181,199

 

 

 

—

 

 

 

—

 

 

 

181,199

 

As of December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

17,270

 

 

$

—

 

 

$

—

 

 

$

17,270

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

 

135,734

 

 

 

—

 

 

 

—

 

 

 

135,734

 

 

The Company did not transfer any assets measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during the years ended December 31, 2024 and 2023.

Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis

Certain assets and liabilities are measured at fair value on a nonrecurring basis. These assets and liabilities are not measured at fair value on an ongoing basis but are subject to fair value adjustments annually or whenever events or circumstances indicate that the carrying value of those assets may not be recoverable. These assets and liabilities can include acquired IPR&D and other long-lived assets that are written down to fair value if they are impaired.

As of December 31, 2024 and 2023, the Company had IPR&D of approximately $10.3 million and $11.0 million, respectively. For the years ended December 31, 2024 and 2023, the Company experienced a decrease of approximately $0.6 million and an increase of approximately $0.3 million, respectively, in the carrying value of IPR&D, which was due to foreign currency translation.
v3.25.1
Stockholders’ Equity
 12 Months Ended
Dec. 31, 2024
Equity [Abstract]  
Stockholders’ Equity

9. Stockholders’ Equity

Underwritten Offering of Common Stock

July 2024

On July 1, 2024, the Company sold an aggregate of 26,246,720 shares of the Company’s common stock, par value $0.001 per share, pursuant to an underwritten offering of its common stock (the "July 2024 Offering") at an offering price of $3.81 per share. The July 2024 Offering was made pursuant to the Registration Statement on Form S-3 (File No. 333-279274), which was filed with the SEC on May 9, 2024 and declared effective on May 21, 2024 (the "2024 Registration Statement"), and a prospectus supplement filed with the SEC on June 28, 2024. The July 2024 Offering resulted in net proceeds of $93.8 million after taking into consideration underwriter commissions, legal fees, and other customary closing costs, as follows (in thousands):

 

Financial instruments

 

Proceeds

 

Common stock

 

$

100,000

 

Offering expenses

 

 

(6,201

)

Net proceeds

 

$

93,799

 

 

July 2023

On July 17, 2023, the Company sold (i) an aggregate of 21,000,000 shares of the Company’s common stock for $3.00 per share which represented a 1% premium over the closing price on that date and (ii) pre-funded warrants to purchase an aggregate of 5,666,667 shares of the Company's common stock at an exercise price of $0.001 per share (the “2023 Pre-Funded Warrants”) for $2.999 per warrant pursuant to an underwritten offering (the “July 2023 Offering”).

The Company determined that the securities issued in the July 2023 Offering were free-standing and that the 2023 Pre-Funded Warrants meet the equity classification requirements pursuant to ASC 480, Distinguishing Liability from Equity, ASC 815, Derivatives and Hedging and Subtopic 815-40, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The 2023 Pre-Funded Warrants were sold at the same price as the underlying common stock, less $0.001 (which represents the exercise price of the warrants).

The July 2023 Offering resulted in net proceeds to the Company of approximately $74.9 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses, as follows (in thousands):

 

Financial instruments

 

Proceeds

 

Common stock

 

$

63,000

 

2023 Pre-funded warrants

 

 

16,994

 

Total

 

 

79,994

 

Offering expenses

 

$

(5,120

)

Net proceeds

 

$

74,874

 

 

 

 

Evercore Common Stock Sales Agreement

On July 6, 2021, the Company entered into a Common Stock Sales Agreement with Evercore Group L.L.C. (“Evercore”), as sales agent (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Evercore, shares of Savara’s common stock, par value $0.001 per share (the “Shares”), having an aggregate offering price of not more than $100.0 million. The Sales Agreement was effective on July 16, 2021, the date the Company’s Registration Statement on Form S-3 (File No. 333-257709) (the “2021 Registration Statement”), filed with the SEC on July 6, 2021, was declared effective by the SEC. From July 16, 2021 through May 20, 2024, Shares were sold pursuant to the 2021 Registration Statement. Since May 21, 2024, the Shares have been offered and sold pursuant to the 2024 Registration Statement. Subject to the terms and conditions of the Sales Agreement, Evercore will use commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided Evercore with customary indemnification rights, and Evercore will be entitled to a commission at a fixed commission rate equal to 3% of the gross proceeds per Share sold. Sales of the Shares, if any, under the Sales Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement.

During the year ended December 31, 2024 and 2023, the Company sold 6,038,650 shares of the Company’s common stock resulting in net proceeds of $24.4 million and 2,071,511 shares of common stock resulting in net proceeds of $8.8 million to a single institutional investor pursuant to the Sales Agreement, respectively.

Common Stock

The Company’s amended and restated certificate of incorporation, as amended, authorizes the Company to issue 301,000,000 shares of capital stock, consisting of 300,000,000 shares of common stock with $0.001 par value per share and 1,000,000 shares of preferred stock with $0.001 par value per share.

The following is a summary of the Company’s common stock at December 31, 2024 and 2023:

 

 

 

December 31

 

 

 

2024

 

 

2023

 

Common stock authorized

 

 

300,000,000

 

 

 

300,000,000

 

Common stock outstanding

 

 

172,423,223

 

 

 

138,143,545

 

 

The Company’s shares of common stock reserved for issuance as of December 31, 2024 and 2023 were as follows:

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

April 2017 Warrants

 

 

24,725

 

 

 

24,725

 

June 2017 Warrants

 

 

41,736

 

 

 

41,736

 

December 2018 Warrants

 

 

11,332

 

 

 

11,332

 

2017 Pre-funded Warrants

 

 

—

 

 

 

775,000

 

Pre-funded PIPE Warrants

 

 

5,780,537

 

 

 

5,780,537

 

2021 Pre-funded Warrants

 

 

32,175,172

 

 

 

32,175,172

 

2023 Pre-funded Warrants

 

 

5,666,667

 

 

 

5,666,667

 

Stock options outstanding

 

 

13,554,621

 

 

 

9,633,067

 

Issued and non-vested RSUs

 

 

4,677,500

 

 

 

3,488,250

 

Total shares reserved

 

 

61,932,290

 

 

 

57,596,486

 

 

Warrants

The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2024:

 

Expiration Date

 

Shares Underlying
Outstanding Warrants

 

 

Exercise Price

 

April 2027

 

 

24,725

 

 

$

2.87

 

June 2027

 

 

41,736

 

 

$

2.87

 

December 2028

 

 

11,332

 

 

$

2.87

 

None

 

 

43,622,376

 

 

$

0.001

 

 

 

 

43,700,169

 

 

 

 

 

Accumulated Other Comprehensive Income (Loss) Information

The components of accumulated other comprehensive income (loss) as of the dates indicated and the change during the period were (in thousands):

 

 

 

Foreign Exchange Translation Adjustment

 

 

Unrealized Gain (Loss) on ST Investments

 

 

Total Accumulated Other Comprehensive Income (Loss)

 

Balance, December 31, 2022

 

$

(594

)

 

$

(11

)

 

$

(605

)

Change

 

 

133

 

 

 

201

 

 

 

334

 

Balance, December 31, 2023

 

$

(461

)

 

 

190

 

 

$

(271

)

Change

 

 

(523

)

 

 

44

 

 

 

(479

)

Balance, December 31, 2024

 

$

(984

)

 

$

234

 

 

$

(750

)
v3.25.1
Commitments
 12 Months Ended
Dec. 31, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments

10. Commitments

Operating Leases

The Company is obligated under an operating lease, as amended, for commercial real estate located in Langhorne, Pennsylvania, the Company’s headquarters. On February 28, 2023, the Company entered into the first amendment (the “Lease Amendment”) to its existing lease agreement, dated July 7, 2021 and which originally commenced on October 1, 2021. The Lease Amendment commenced on July 1, 2023, continues through June 30, 2026, or an additional thirty-six months, expands the existing office space, and increases the average monthly rent to approximately $14.5 thousand, paid over monthly installments during the Lease Amendment term.

As of December 31, 2024, the carrying value of the right-of-use assets for the operating lease was $0.2 million, which is reflected in Other non-current assets and the carrying value of the lease liabilities for the operating lease increased to $0.3 million, of which approximately $0.2 million related to the current portion of the lease liabilities is recorded in Accrued expenses and other current liabilities and approximately $0.1 million related to the non-current portion of the lease liabilities is recorded in Other long-term liabilities.

The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of December 31, 2024 (in thousands):

 

Year ending December 31,

 

 

 

2025

 

$

160

 

2026

 

 

87

 

Total future minimum lease payments

 

$

247

 

Less imputed interest

 

 

(17

)

Total

 

$

230

 

 

Operating cash flows from operating leases

 

$

172

 

Weighted-average remaining lease term (in months) - operating leases

 

 

18

 

Weighted-average discount rate - operating leases

 

 

7.8

%

 

Manufacturing and Other Commitments and Contingencies

The Company is subject to various royalties and manufacturing and development payments related to its product candidate, MOLBREEVI. Under a manufacture and supply agreement with an active pharmaceutical ingredients (“API”) manufacturer for MOLBREEVI, as amended, the Company must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by the Company from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, the Company shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country of products containing API supplied by the API manufacturer.

Additionally, the Company is subject to a purchase requirement under which for ten years following the date of receipt of approval by a regulatory authority of the first regulatory filing for the marketing and sale of the first product containing the API in any country, the Company will purchase from the API manufacturer the API required to produce a percentage of such product it sells each year (the “Purchase Requirement”); provided, however, that the Purchase Requirement will no longer apply if (i) the price charged by the API manufacturer exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) API manufacturer at any time fails to materially fulfill a purchase order of the Company.

The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer MOLBREEVI. In addition to these milestones, the Company will owe a royalty of three-and one-half percent (3.5%) to the manufacturer of the nebulizer based on net sales.

The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands):

Manufacturing, Development, and Other Contingent Milestone Payments (in thousands):

 

 

 

December 31, 2024

 

MOLBREEVI manufacturer:

 

 

 

Achievement of certain milestones related to validation of API and regulatory approval of
    MOLBREEVI

 

$

320

 

MOLBREEVI nebulizer manufacturer:

 

 

 

Achievement of various development activities and regulatory approval of nebulizer
    utilized to administer MOLBREEVI

 

 

521

 

Total manufacturing and other commitments

 

$

841

 

 

The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of December 31, 2024.

Further, in February 2024, the Company entered into a master services agreement with an additional manufacturer to provide development and manufacturing services related to API for the Company’s MOLBREEVI product candidate in accordance with the terms of separate scope of work agreements and to perform a manufacturing campaign for process performance qualification of the API of MOLBREEVI. Under that master services agreement, work orders and subsequent change orders, the Company is currently obligated to pay the second source manufacturer, in total, estimated fees of $24.7 million of which $15.9 million has been recognized as expense during the year ended December 31, 2024. No expense was recognized in relation to this master services agreement during the year ended December 31, 2023. These costs are subject to various cancellation fees ranging from ten percent (10%) to one hundred percent (100%) of the cost of the respective activity based upon the timing of the commencement date and status of the activity.

Contract Research

As part of its development of MOLBREEVI for the treatment of aPAP, the Company entered into a Master Services Agreement (“MSA”) with Parexel International (IRL) Limited (“Parexel”) pursuant to which Parexel will provide contract research services related to clinical trials. Contemporaneously with entering the MSA, a work order was executed with Parexel, under which they will provide services related to the IMPALA-2 trial. Under that work order and subsequent change orders, the Company is obligated to pay Parexel service fees, pass-through expenses, and investigator fees estimated to be approximately $48.5 million over the course of the IMPALA-2 clinical trial and trial close-out activities of which $9.2 million and $10.8 million has been recognized as expense during the years ended December 31, 2024 and 2023, respectively.

In the second quarter of 2024, the Company initiated an open-label, multicenter clinical trial of MOLBREEVI in pediatric subjects with aPAP ("IMPACT") under a separate work order with Parexel. Pursuant to the IMPACT trial, Parexel currently

has the opportunity to earn up to approximately $4.8 million in various milestone payments primarily dependent upon patient enrollment, site management, project oversight and the compliance with defined study protocols of which $1.3 million was recognized in the year ended December 31, 2024. No expense was recognized in relation to this work order during the year ended December 31, 2023.

Risk Management

The Company maintains various forms of insurance that the Company's management believes are adequate to reduce the exposure to these risks to an acceptable level.

Employment Agreements

On December 8, 2020, the Company entered into an employment agreement with the Chief Executive Officer ("CEO"), as amended and restated on December 13, 2022, whereby the CEO is entitled to payments and benefits upon certain events. Upon (i) termination without cause, (ii) termination due to the CEO’s death or disability, or (iii) the CEO’s resignation for good reason, the CEO is entitled to receive (i) a lump sum payment equal to 18 months of base salary, (ii) a lump sum payment equal to 100% of his target bonus, (iii) a pro-rated portion of the unpaid target bonus based upon the number of days he was employed by the Company during the relevant performance period, (iv) reimbursement for continued coverage under medical benefit plans for 18 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 18 month anniversary of the termination date or (y) the original expiration date.

Upon a termination other than for cause, death or disability or upon resignation for good reason within three months prior to or 12 months following a change in control, the CEO is entitled to receive (i) a lump sum payment of an amount equal to 24 months of base salary, (ii) 100% of the unpaid target bonus, (iii) a pro-rated portion of the unpaid target bonus based on the number of days he was employed by the Company during the relevant performance period, (iv) reimbursement for continued coverage under medical benefit plans for 24 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 24-month anniversary of the termination date or (y) the original expiration date.

Each of the Company’s Chief Financial & Administrative Officer (“CFO”), Chief Medical Officer (“CMO”), Chief Operating Officer ("COO"), Chief Business Officer ("CBO"), and Chief Commercial Officer ("CCO") is entitled to payments and benefits if the CFO, CMO, COO, CBO, or CCO, respectively, is (i) terminated without cause, (ii) terminated due to death or disability, or (iii) resigns for good reason, which includes (i) a lump sum payment equal to 12 months of base salary and a pro-rated portion of their unpaid bonus, (ii) reimbursement for continued coverage under medical benefit plans for 12 months or until covered under a separate plan from another employer, and (iii) accelerated vesting of outstanding non-vested Company equity awards equal to 12 months. Upon a termination other than for cause, death or disability or upon resignation for good reason within three months prior to or 12 months following a change in control, the CFO, CMO, COO, CBO, or CCO is entitled to receive (i) a lump sum payment of an amount equal to 18 months of base salary, plus 100% of their target bonus, plus a pro-rated portion of their unpaid target bonus, (ii) a lump sum payment equal to the amount required to continue coverage under medical benefit plans for 18 months, and (iii) the immediate and full vesting of outstanding non-vested options at the time of such termination.
v3.25.1
Stock-Based Compensation
 12 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [Abstract]  
Stock-Based Compensation

11. Stock-Based Compensation

A. Equity Incentive Plans

The Company’s 2024 Omnibus Incentive Plan (the “2024 Plan”) was adopted by the Company’s board of directors in March 2024, was approved by the Company’s stockholders on June 6, 2024, and became effective on June 7, 2024. The 2024 Plan was intended to replace the Company’s Amended and Restated 2015 Omnibus Incentive Plan (the “2015 Plan”), and upon the effectiveness of the 2024 Plan, no further grants may be made under the 2015 Plan. All outstanding awards under the 2015 Plan will continue in accordance with the 2015 Plan and any award agreement executed in connection with such outstanding awards. The 2024 Plan provides for the grant of stock options (both incentive stock options and non-statutory stock options), stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance units, shares, and other stock-based awards. Stock-based awards are subject to terms and conditions established by the board of directors or the compensation committee of the board of directors. As of December 31, 2024, the number of shares of common stock available for grant under the 2024 Plan was 7,153,602 shares.

The Company’s 2021 Inducement Equity Incentive Plan (the “Inducement Plan”) was adopted by the Company’s board of directors in May 2021 and subsequently amended to increase the shares available for grant. The Inducement Plan provides for the grant of non-statutory stock options, restricted stock, RSUs, stock appreciation rights, performance units, and performance shares. Each award under the Inducement Plan is intended to qualify as an employment inducement grant in accordance with Nasdaq Listing Rule 5635(c)(4). As of December 31, 2024, the number of shares of common stock available for grant under the Inducement Plan was 1,272,799 shares. Under the Inducement Plan and 2024 Plan, stock option grants typically vest quarterly over four years and expire ten years from the grant date and restricted stock unit grants typically cliff vest after two years.

The Savara Inc. Stock Option Plan (the “2008 Plan”) was adopted in 2008, and the Company no longer issues awards under the 2008 Plan. As of December 31, 2024, the Company had options outstanding to purchase 139,332 shares of common stock under the 2008 Plan. The outstanding awards granted under the 2008 Plan are fully vested and generally have a maximum contractual term of ten years.

B. Stock Options and Restricted Stock Units

The Company values stock options using the Black-Scholes-Merton option pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility, and dividend yield. The risk-free interest rate assumption is based upon observed interest rates for constant maturity U.S. Treasury securities consistent with the expected term of the Company’s employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on historical volatilities for publicly traded stock of comparable companies over the estimated expected life of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the future, consistent with the Company’s history of not paying dividends. The valuation of stock options is also impacted by the valuation of common stock.

Restricted stock units are valued at the closing market price of the Company’s common stock on the date of grant.

C. Fair Value Assumptions for the Equity Incentive Plans

The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2024 and 2023:

 

 

 

2024

 

2023

Risk-free interest rate

 

3.58% - 4.55%

 

3.37% - 4.80%

Expected term (years)

 

6.06 - 9.26

 

6.06

Expected volatility

 

90.9% - 114.6%

 

91.2% - 97.84%

Dividend yield

 

0%

 

0%

 

D. Stock-Based Award Activity

The following tables provide a summary for stock option and RSU activity for the year ended December 31, 2024:

Stock Options:

 

 

 

Shares Underlying Option Awards

 

 

Weighted-Average Exercise Price

 

 

Weighted-Average Remaining Contractual Life

 

 

Aggregate Intrinsic Value (in 000's)

 

Outstanding at December 31, 2023

 

 

9,633,067

 

 

$

2.42

 

 

 

7.94

 

 

$

25,392

 

Granted

 

 

4,573,000

 

 

 

3.47

 

 

 

6.08

 

 

 

 

Exercised

 

 

(464,297

)

 

 

1.49

 

 

 

 

 

$

1,327

 

Expired/cancelled/forfeited

 

 

(187,149

)

 

 

1.78

 

 

 

 

 

 

 

Outstanding at December 31, 2024

 

 

13,554,621

 

 

$

2.79

 

 

 

7.89

 

 

$

11,586

 

Options exercisable at December 31, 2024

 

 

6,220,508

 

 

$

2.47

 

 

 

6.29

 

 

$

8,728

 

 

The weighted-average grant date fair values for the Company’s stock options granted during the years ended December 31, 2024 and 2023 were $3.47 per share and $2.79 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2024 was $18.4 million, which will be recognized over a weighted-average period of approximately 3.5 years.

During the years ended December 31, 2024 and 2023, the Company did not grant any options to purchase shares of common stock to non-employees. The Company recorded a minimal amount of stock-based compensation expense for options issued to non-employees for the years ended December 31, 2024 and 2023, respectively.

RSUs:

 

 

 

Shares
Underlying
Option Awards

 

 

Weighted-Average Grant Date Fair Value

 

Outstanding at December 31, 2023

 

 

3,488,250

 

 

$

3.36

 

Granted

 

 

2,409,500

 

 

 

3.58

 

Vested

 

 

(1,117,750

)

 

 

1.81

 

Expired/cancelled/forfeited

 

 

(102,500

)

 

 

—

 

Outstanding at December 31, 2024

 

 

4,677,500

 

 

$

3.83

 

The total compensation cost related to unvested RSUs not yet recognized as of December 31, 2024 was $11.7 million, which will be recognized over a weighted-average period of 1.4 years.

E. Stock-Based Compensation

Stock-based compensation expense is included in the following line items in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Research and development

 

$

4,453

 

 

$

1,470

 

General and administrative

 

 

5,407

 

 

 

2,708

 

Total stock-based compensation

 

$

9,860

 

 

$

4,178

 
v3.25.1
Income Taxes
 12 Months Ended
Dec. 31, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

12. Income Taxes

The components of loss before income taxes for the years ended December 31, 2024 and 2023 are as follows (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Domestic

 

$

(63,256

)

 

$

(40,834

)

Foreign

 

 

(32,625

)

 

 

(13,864

)

Total

 

$

(95,881

)

 

$

(54,698

)

 

The Company did not record a federal tax benefit or expense for the years ended December 31, 2024 and 2023. The Company recorded a minimal state provision for income taxes for the year ended December 31, 2024 and no state provision for income taxes for the year ended December 31, 2023 due to revenues below the minimum tax threshold. The components of the income tax expense are as follows for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Current:

 

 

 

 

 

 

Federal

 

$

—

 

 

$

—

 

State

 

 

9

 

 

 

—

 

Foreign

 

 

—

 

 

 

—

 

Total Current

 

 

9

 

 

 

—

 

Deferred:

 

 

 

 

 

 

Federal

 

 

—

 

 

 

—

 

State

 

 

—

 

 

 

—

 

Foreign

 

 

—

 

 

 

—

 

Total Deferred

 

 

—

 

 

 

—

 

Total income tax expense

 

$

9

 

 

$

—

 

 

A reconciliation of the expected income tax results computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Income tax benefit computed at federal statutory tax rate

 

$

(20,135

)

 

$

(11,487

)

State taxes, net of federal

 

 

7

 

 

 

—

 

Change in valuation allowance

 

 

29,911

 

 

 

18,957

 

Orphan drug & research credits generated

 

 

(9,659

)

 

 

(6,998

)

Impact of foreign operations

 

 

(338

)

 

 

(136

)

Foreign deferred tax asset - true up

 

 

(750

)

 

 

(1,124

)

Actualization and deferred tax asset - true up

 

 

(214

)

 

 

—

 

Imputed interest

 

 

1,498

 

 

 

1,309

 

Permanent differences

 

 

(311

)

 

 

(537

)

Other

 

 

—

 

 

 

16

 

Total

 

$

9

 

 

$

—

 

 

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. The Company has established a valuation allowance due to uncertainties regarding the realization of deferred tax assets based upon the Company’s lack of earnings history. During the years ended December 31, 2024 and 2023, the valuation allowance increased by $33.5 million and $23.0 million, respectively.

Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Deferred tax liabilities:

 

 

 

 

 

 

ROU assets

 

$

67

 

 

$

108

 

Other

 

 

687

 

 

 

783

 

Total deferred tax liabilities

 

 

754

 

 

 

891

 

Deferred tax assets:

 

 

 

 

 

 

Net operating loss carryforwards

 

 

58,384

 

 

 

44,731

 

Intangible assets

 

 

379

 

 

 

1,398

 

Amortization

 

 

1,263

 

 

 

1,400

 

Credit carryforwards

 

 

22,624

 

 

 

12,965

 

Section 174 research and development expenses

 

 

20,058

 

 

 

11,638

 

ROU liabilities

 

 

56

 

 

 

108

 

Depreciation

 

 

272

 

 

 

245

 

Accrued liabilities & other

 

 

5,074

 

 

 

2,304

 

Total deferred tax assets

 

 

108,110

 

 

 

74,789

 

Subtotal

 

 

107,356

 

 

 

73,898

 

Valuation allowance

 

 

(107,356

)

 

 

(73,898

)

Net deferred taxes

 

$

—

 

 

$

—

 

 

The Company completed a Section 382 analysis to determine the amount of losses that are currently available for potential offset against future taxable income. Based on the analysis, it was determined that the utilization of the Company's NOLs and tax credit carryforwards generated in tax periods up to and including December 2019 are substantially limited and may result in the expiration of such carryforwards prior to utilization. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of 5% shareholders in the stock of a corporation by more than 50 percentage points in the aggregate over a three-year period. Since the Company's formation, it has raised capital through public and private issuance of common stock on several occasions which have ultimately resulted in multiple changes in ownership, as defined by Section 382. As of December 31, 2024 and 2023, the Company still has $52.4 million of federal Section 382 NOLs, collectively, which are included in the federal NOL carryforwards below, that are severely limited in future years.

As of December 31, 2024 and 2023, the Company had foreign NOL carryforwards of approximately $137.7 million and $96.0 million, respectively, which have an indefinite carryforward period. After taking the Section 382 limitations discussed into account, as of December 31, 2024 and 2023, the Company had NOLs for federal income tax purposes of approximately $126.0 million and $109.4 million, respectively. Federal NOL carryforwards of $5.2 million begin to expire in 2037, with $120.8 million not having an expiration date. As of December 31, 2024 and 2023, the Company had state NOL

carryforwards of approximately $25.0 million and $9.5 million, respectively. The state NOL carryforwards begin to expire in 2038.

As of December 31, 2024 and 2023, the Company also had available research and orphan drug tax credit carryforwards for federal income tax purposes of approximately $22.1 million and $12.5 million, respectively. If not utilized, these carryforwards expire at various dates beginning in 2039. As of December 31, 2024 and 2023, the Company had state research and development tax credit carryforwards of approximately $0.5 million and $0.5 million, respectively, which will begin to expire in 2034 if not utilized.

The Company applies the accounting guidance in ASC 740 Income Taxes related to accounting for uncertainty in income taxes. The Company’s reserves related to taxes are based on a determination of whether, and how much of, a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. As of December 31, 2024 and 2023, the Company had no unrecognized tax benefits. During the years ended December 31, 2024 and 2023, the Company had no interest and penalties related to income taxes.

The Company files income tax returns in the U.S. federal, state, and foreign jurisdictions. As of December 31, 2024, the statute of limitations for assessment by the Internal Revenue Service (“IRS”) is open for the 2020 and subsequent tax years, although carryforward attributes that were generated for tax years prior to then may still be adjusted upon examination by the IRS if they either have been, or will be, used in a future period. The 2019 and subsequent tax years remain open and subject to examination by the state taxing authorities. The 2020 and subsequent tax years remain open and subject to examination by the foreign taxing authorities. There are currently no federal, state, or foreign income tax audits in progress.
v3.25.1
Segment Reporting
 12 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
Segment Reporting

13. Segment Reporting

We follow the accounting guidance of ASC Topic 280, Segment Reporting, which establishes standards for companies to report in their financial statement information about operating segments, products, services, geographic areas, and major customers. Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available that is regularly evaluated by the Company’s chief operating decision-makers in deciding how to allocate resources and assess performance. The Company’s chief operating decision maker (“CODM”) has been identified as the Chief Executive Officer, who reviews consolidated results including operating expenses and operating losses at a consolidated level only. The Company and its CODM do not distinguish between potential markets for the purpose of making decisions about resource allocation and performance assessment of its sole pre-revenue development program, MOLBREEVI, for the treatment of aPAP. Therefore, the Company has only one operating segment and one reportable segment, specialty pharmaceuticals within the respiratory system. The Company's only significant long-lived asset, IPR&D, is located in Denmark, and the Company currently does not generate any revenues and its operating expenses and losses are viewed on a consolidated basis by the CODM. Therefore, no geographical segments are presented. In addition to the significant expense categories included on the Company's consolidated statements of operations, refer below for disaggregated amounts that comprise research and development expenses and the segment net loss (in thousands):

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Research and development operating costs and expenses excluding
   non-cash stock-based compensation:

 

 

 

 

 

 

Primary program research and development expenses (a)

 

$

59,325

 

 

$

32,535

 

Other research and development expenses:

 

 

 

 

 

 

Payroll and benefits

 

 

11,933

 

 

 

9,023

 

Occupancy and other overhead and operating costs

 

 

2,318

 

 

 

1,234

 

Total other research and development expenses

 

 

14,251

 

 

 

10,257

 

Research and development operating costs and expenses excluding
   non-cash stock-based compensation:

 

 

73,576

 

 

 

42,792

 

General and administrative expense excluding non-cash stock-based
   compensation

 

 

19,630

 

 

 

12,960

 

Other segment income (expense), net (b)

 

 

2,675

 

 

 

(1,054

)

Segment net loss

 

$

(95,881

)

 

$

(54,698

)

 

(a)
Primary program research and development expenses are comprised primarily of costs paid to third parties for clinical trials and product development manufacturing, nonclinical, regulatory, and quality assurance activities, and the portion of related research and development expenses incurred by our collaborators and third-party service providers, including contract research and manufacturing organizations that we are obligated to reimburse.
(b)
Other segment income (expense), net includes interest income, interest expense, foreign currency exchange gain or loss, depreciation and amortization, non-cash stock-based compensation and tax credit income.
v3.25.1
Net Loss Per Share
 12 Months Ended
Dec. 31, 2024
Earnings Per Share [Abstract]  
Net Loss Per Share

14. Net Loss per Share

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding. Diluted net loss per share is computed similarly to basic net loss per share except the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted net loss per share is the same as basic net loss per common share since the effects of potentially dilutive securities are antidilutive.

As of December 31, 2024 and 2023, potentially dilutive securities include:

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Awards under equity incentive plan

 

 

13,554,621

 

 

 

9,633,067

 

Non-vested restricted shares and restricted stock units

 

 

4,677,500

 

 

 

3,488,250

 

Warrants to purchase common stock

 

 

77,793

 

 

 

77,793

 

Total

 

 

18,309,914

 

 

 

13,199,110

 

The following table calculates basic net loss per share of common stock and diluted net loss per share of common stock for the years ended December 31, 2024 and 2023 (in thousands, except share and per share amounts):

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Net loss

 

$

(95,881

)

 

$

(54,698

)

Net loss attributable to common stockholders

 

$

(95,881

)

 

$

(54,698

)

Undistributed earnings and net loss attributable to
   common stockholders, basic and diluted

 

$

(95,881

)

 

$

(54,698

)

Weighted-average common shares outstanding, basic
   and diluted

 

 

198,191,936

 

 

 

165,204,652

 

Basic and diluted net loss per share

 

$

(0.48

)

 

$

(0.33

)
v3.25.1
Employee Benefits
 12 Months Ended
Dec. 31, 2024
Retirement Benefits [Abstract]  
Employee Benefits

15. Employee Benefits

The Company offers a defined contribution 401(k) plan for its employees. Employees are eligible to participate in the plan beginning on the first day following the three month anniversary date of hire. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation. The Company makes discretionary contributions to the 401(k) plan equal to 100 percent of each employee’s pretax contributions up to the IRS annual contribution limit. The Company’s total contributions to the 401(k) plan were $0.6 million and $0.5 million for the years ended December 31, 2024 and 2023, respectively.
v3.25.1
Subsequent Events
 12 Months Ended
Dec. 31, 2024
Subsequent Events [Abstract]  
Subsequent Events

16. Subsequent Events

The Company has evaluated subsequent events through the date these consolidated financial statements were issued. The Company determined there were no events, other than as described below, that required disclosure or recognition in these condensed consolidated financial statements.

Loan Agreement

On March 26, 2025 (the “Closing Date”), the Company, as borrower, entered into a Loan and Security Agreement (the “Hercules Loan Agreement”) with the lenders party thereto (the “Lenders”) and Hercules Capital, Inc., as administrative agent and collateral agent (the “Agent”). The Hercules Loan Agreement provides for the Company to borrow up to $200 million of term loans (the “Term Loan”).

 

The initial advance of $30 million under the Hercules Loan Agreement was drawn on the Closing Date and used to repay all outstanding obligations under the Company’s prior term loan with Silicon Valley Bank, described in Footnote 7. Debt Facility, to pay the Company’s expenses in connection with the Hercules Loan Agreement, and for general corporate purposes. The Company may draw further Term Loans in the following tranches: (i) subject to FDA approval of the Company’s MOLBREEVI product candidate for the treatment of aPAP (the “Approval Milestone”), (a) up to $40 million on or prior to March 15, 2026 and (b) up to $40 million on or prior to December 15, 2026; (ii) subject to the Company achieving a trailing six months net product revenue from the sale of MOLBREEVI of at least seventy-five percent of an agreed upon revenue plan for any reporting period following March 31, 2027 (the “Revenue Milestone”), up to $20 million on or prior to December 31, 2027; and (iii) subject to approval by the Lenders’ investment committees, up to $70 million.

The Term Loan will mature April 1, 2030 (the “Maturity Date”). The Term Loan bears interest at a floating rate equal to (i) the greater of (a) the prime rate reported in The Wall Street Journal or (b) 6.0%, plus (ii) 1.45%, or, subject to the Company meeting the Revenue Milestone, 1.20% after the full fiscal quarter following such achievement. The Term Loan has an interest-only monthly payment through March 2028 (the “Interest-Only Period”), and beginning April 1, 2028, requires equal monthly installments of principal plus interest until the Maturity Date. If the Company achieves the Approval Milestone, the Interest-Only period will extend until the Maturity Date.

The Company's obligations under the Hercules Loan Agreement are secured, subject to customary permitted liens and other agreed-upon exceptions, by a first-priority perfected security interest in all of the tangible and intangible assets of the Company, other than intellectual property, on which there is a negative pledge. The Hercules Loan Agreement includes customary affirmative and negative covenants, repayment and prepayment terms, representations and warranties, and events of default.

The Hercules Loan Agreement contains an affirmative covenant requiring the Company to maintain unrestricted cash under an account control agreement equal to 50% of the outstanding principal of the Term Loan beginning April 1, 2026 (the “Cash Requirement”), which will decrease to 35% upon achievement of the Revenue Milestone and compliance with the Conditional Minimum Revenue Covenant (defined below). However, if the Approval Milestone has not been achieved, the Cash Requirement increases to 70% of the outstanding principal until the Approval Milestone is achieved. Notwithstanding the foregoing, the Cash Requirement will not apply during any period when the Company’s market capitalization exceeds $600 million.

Additionally, if the Company draws more than $50 million under the Term Loan, beginning nine months after achievement of the Approval Milestone, the Company will be required to have achieved, and to maintain, trailing six months of net product revenue of at least (i) 65% of a provided sales forecast or (ii) $100 million (“Conditional Minimum Revenue Covenant”). If the Company raises at least $75 million in net cash proceeds from the issuance of equity and/or upfront business development proceeds before June 30, 2026, the Conditional Minimum Revenue Covenant will not apply until 15 months after achievement of the Approval Milestone. Notwithstanding the foregoing, the Conditional Minimum Revenue Covenant will not apply during any period when the Company’s market capitalization exceeds $500 million and the Company maintains minimum unrestricted cash under an account control agreement equal to 50% of the outstanding principal amount of the Term Loan.
v3.25.1
Summary of Significant Accounting Policies (Policies)
 12 Months Ended
Dec. 31, 2024
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (the “FASB”).
Principles of Consolidation

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S. dollars. These financial statements include the accounts of the Company and its wholly-owned subsidiaries. The financial statements of the Company’s wholly-owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated other comprehensive loss. All intercompany transactions and accounts have been eliminated in consolidation.

Liquidity

Liquidity

As of December 31, 2024, the Company had an accumulated deficit of approximately $489.3 million. The Company used cash from operations of approximately $89.1 million for the year ended December 31, 2024. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Although the Company has sufficient capital to fund many of its planned activities, it may need to continue to raise additional capital to further fund the development of, and seek regulatory approvals for, its product candidate and begin to commercialize any approved product.

The Company is currently focused on the development of MOLBREEVI for the treatment of aPAP and believes such activities will result in the continued incurrence of significant research and development and other expenses related to this program. If the Company’s product candidate does not gain regulatory approval or, if approved, fails to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand, short-term investments, and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances with partner companies. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders.

The Company had cash and cash equivalents of $15.1 million and short-term investments of $181.2 million as of December 31, 2024, which is sufficient to fund the Company's operations for at least the next twelve months subsequent to the issuance date of its consolidated financial statements for the year ended December 31, 2024. The Company may continue to raise additional capital as needed through the issuance of additional equity securities and potentially through borrowings and strategic alliances with partner companies. However, if such additional financing is not available timely and at adequate levels, the Company may need to reevaluate its long-term operating plans. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company currently maintains depository accounts and has a debt facility with Silicon Valley Bank, an FDIC insured entity. In order to mitigate risks associated with our banking deposits, the Company maintains a significant portion of its liquidity in U.S. Treasury money market funds and other short-term investments with custodial services provided by U.S. Bank, N.A. and FNZ, refer to Note 5. Short-term Investments and Note 8. Fair Value Measurements.

Use of Estimates

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates.
Risks and Uncertainties

Risks and Uncertainties

The product candidate being developed by the Company requires approval from the U.S. Food and Drug Administration (the “FDA”) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidate will receive the necessary approvals. If the Company is denied regulatory approval of its product candidate, or if approval is delayed, it will have a material adverse impact on the Company’s business, results of operations, and financial position.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

Cash and Cash Equivalents

Cash and Cash Equivalents

Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value.
Short-term Investments

Short-term Investments

The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of Accumulated other comprehensive loss within stockholders’ equity.

The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. We review investments for impairment whenever the fair value of an available-for-sale security is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or noncredit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to net loss, and noncredit-related impairment is recognized in other comprehensive (loss) income, net of taxes. The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Refer to Note 5. Short-term Investments for additional discussion.
Concentration of Credit Risk

Concentration of Credit Risk

We are subject to credit risk from our portfolio of cash equivalents and marketable securities. These investments were made in accordance with our investment policy which specifies the categories, allocations, and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. We maintain our cash and cash equivalents and marketable securities with a limited number of financial institutions. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash and cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets.
Research and Development Costs

Research and Development Costs

The Company records the costs associated with research, nonclinical and clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third party service providers, including contract research and manufacturing organizations.

The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on

estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the trial duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Refer to Note 4. Accrued Expenses and Other Current Liabilities for additional discussion.
License and Collaboration Agreements

License and Collaboration Agreements

From time to time the Company enters, and may continue to enter, into license and collaboration agreements with third parties whereby the Company purchases the rights to develop, market, sell and/or distribute the underlying pharmaceutical products or drug candidates. Pursuant to these agreements, the Company may be required to make up-front payments, milestone payments contingent upon the achievement of certain pre-determined criteria, royalty payments based on specified sales levels of the underlying products, and/or certain other payments. Up-front payments are either expensed immediately as research and development or capitalized. The determination to capitalize amounts related to licenses is based on management’s judgments with respect to stage of development, the nature of the rights acquired, alternative future uses, developmental and regulatory issues and challenges, the net realizable value of such amounts based on projected sales of the underlying products, the commercial status of the underlying products, and/or various other competitive factors. Milestone payments made prior to regulatory approval are generally expensed as incurred and milestone payments made subsequent to regulatory approval are generally capitalized as an intangible asset. Royalty payments are expensed as incurred. Other payments made pursuant to license and collaboration agreements, which are generally related to research and development activities, are expensed as incurred.
Acquired In-Process Research and Development

Acquired In-Process Research and Development

In accordance with ASC Topic 350, Intangibles – Goodwill and Other, the Company's acquired IPR&D is determined to have an indefinite life and, therefore, is not amortized. Instead, it is tested for impairment annually and between annual tests if the Company becomes aware of an event or a change in circumstances that would indicate the carrying value may be impaired.

With respect to the impairment testing of acquired IPR&D, ASU 2011-08, Intangibles – Goodwill and Other (Topic 350): Testing Goodwill for Impairment, and ASU 2012-02, Intangibles – Goodwill and Other (Topic 350): Testing Indefinite-Lived Intangible Assets for Impairment, provides for a two-step impairment process with the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to the determination that it is more-likely-than not (that is, a likelihood of more than 50%) that acquired IPR&D is impaired. If the Company chooses to first assess qualitative factors and it determines that it is more-likely-than not acquired IPR&D is not impaired, the Company is not required to take further action to test for impairment.

When the Company performs a quantitative assessment of acquired IPR&D, it compares its carrying value to its estimated fair value to determine whether an impairment exists. Due to a lack of Level 1 or Level 2 inputs, the Multi-Period Excess Earnings Method (“MPEEM”), which is a form of the income approach, was used to estimate the fair value of acquired IPR&D when performing a quantitative assessment. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s projected incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life. The Company evaluates potential impairment of its acquired IPR&D annually on September 30th, utilizing a qualitative approach and determining if it was more-likely-than not that the fair value was impaired.

Our determinations as to whether, and if so, the extent to which acquired IPR&D become impaired are highly judgmental and, in the case of applying the MPEEM approach to estimate fair value, are based on significant assumptions regarding our projected future financial condition and operating results, changes in the manner of our use of the acquired assets, development of our acquired assets or our overall business strategy, and regulatory, market, and economic environment and trends.

If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a non-cash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. Refer to Note 8.

Fair Value Measurements – Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis for additional discussion.
Manufacturing and Other Commitments and Contingencies

Manufacturing and Other Commitments and Contingencies

The Company is subject to various royalties and manufacturing and development payments related to its product candidate, MOLBREEVI. Under a manufacture and supply agreement with an active pharmaceutical ingredients (“API”) manufacturer for MOLBREEVI, as amended, the Company must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by the Company from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, the Company shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country of products containing API supplied by the API manufacturer.

Additionally, the Company is subject to a purchase requirement under which for ten years following the date of receipt of approval by a regulatory authority of the first regulatory filing for the marketing and sale of the first product containing the API in any country, the Company will purchase from the API manufacturer the API required to produce a percentage of such product it sells each year (the “Purchase Requirement”); provided, however, that the Purchase Requirement will no longer apply if (i) the price charged by the API manufacturer exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) API manufacturer at any time fails to materially fulfill a purchase order of the Company.

The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer MOLBREEVI. In addition to these milestones, the Company will owe a royalty of three-and one-half percent (3.5%) to the manufacturer of the nebulizer based on net sales.

The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands):

Manufacturing, Development, and Other Contingent Milestone Payments (in thousands):

 

 

 

December 31, 2024

 

MOLBREEVI manufacturer:

 

 

 

Achievement of certain milestones related to validation of API and regulatory approval of
    MOLBREEVI

 

$

320

 

MOLBREEVI nebulizer manufacturer:

 

 

 

Achievement of various development activities and regulatory approval of nebulizer
    utilized to administer MOLBREEVI

 

 

521

 

Total manufacturing and other commitments

 

$

841

 

 

The milestone commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of December 31, 2024.

Further, in February 2024, the Company entered into a master services agreement with an additional manufacturer to provide development and manufacturing services related to API for the Company’s MOLBREEVI product candidate in accordance with the terms of separate scope of work agreements and to perform a manufacturing campaign for process performance qualification of the API of MOLBREEVI. Under that master services agreement, work orders and subsequent change orders, the Company is currently obligated to pay the second source manufacturer, in total, estimated fees of $24.7 million of which $15.9 million has been recognized as expense during the year ended December 31, 2024. No expense was recognized in relation to this master services agreement during the year ended December 31, 2023. These costs are subject to various cancellation fees ranging from ten percent (10%) to one hundred percent (100%) of the cost of the respective activity based upon the timing of the commencement date and status of the activity.
R&D Tax Credit Receivable

R&D Tax Credit Receivable

The Company has recorded a Danish R&D tax credit receivable earned by its subsidiary, Savara ApS, as of December 31, 2024. Under Danish tax law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds. During the year ended December 31, 2023, the Company generated a Danish R&D tax credit receivable of $0.8 million which was received in the fourth quarter of 2024. During the year ended December 31, 2024, the Company generated a Danish R&D tax credit receivable of $0.8 million which is expected to be received in the fourth quarter of 2025.

Leases

Leases

The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset's economic benefits in accordance with ASU 2016-02, Leases (Topic 842), as codified in ASC 842, Leases. Lease right-of-use assets and liabilities are initially recorded on the lease commencement date based on the present value of lease payments over the lease term. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term. Leases may include renewal, purchase, or termination options that can extend or shorten the term of the lease. The exercise of those options is at the Company's sole discretion and is evaluated at inception and throughout the contract to determine if a modification of the lease term is required.

In addition to rent, the leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a right-of-use asset and liability. Rent expense is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations and comprehensive loss.

The Company has made an accounting policy election providing that leases with an initial term of 12 months or less are not recorded as a lease right-of-use asset and corresponding liability in accordance with ASC 842, Leases; those lease payments are recognized in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term. Refer to Note 10. Commitments – Operating Leases for additional discussion.
Property and Equipment

Property and Equipment

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which range from three to five years. Repairs and maintenance that do not improve or extend the useful life of the respective asset are charged to expense as incurred. Refer to Note 6. Property and Equipment, Net for additional discussion.
Patents and Intellectual Property

Patents and Intellectual Property

As the Company’s products are currently under research and development and are not currently approved for market, costs incurred in connection with patent applications are expensed as incurred due to the uncertainty of the future economic benefits of the underlying patents and intellectual property.
Fair Value of Financial Instruments

Fair Value of Financial Instruments

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.

The three tiers are defined as follows:

•
Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
•
Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
•
Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The Company’s financial instruments consist primarily of cash, cash equivalents, short term investments, accounts payable, and accrued liabilities. The Company’s cash, cash equivalents, accounts payable, and accrued liabilities

approximate fair value due to their relatively short maturities. Refer to Note 8. Fair Value Measurements for additional discussion.
Revenue Recognition

Revenue Recognition

The Company records revenue based on a five-step model in accordance with ASC 606, Revenue from Contracts with Customers. To date, the Company has not generated any product revenue. The Company’s ability to generate product revenues, which the Company expects to commence in the upcoming year(s), if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates.
Net Loss per Share

Net Loss per Share

Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Refer to Note 13. Net Loss per Share for additional discussion.
Stock-Based Compensation

Stock-Based Compensation

The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period. Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. In addition, the Company accounts for any modifications to stock-based awards in accordance with ASC Topic 718, Compensation – Stock Compensation. Refer to Note 11. Stock-Based Compensation for additional discussion.
Income Taxes

Income Taxes

The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more-likely-than not to be realized. Refer to Note 12. Income Taxes for additional discussion.
Recent Accounting Pronouncements

Recent Accounting Pronouncements

In November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"), to provide more disaggregated expense information about a public entity’s reportable segments. The amendments in this update should be applied retrospectively and are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. As of January 1, 2024, we have adopted ASU 2023-07 which did not have a material impact on the Company's consolidated financial statements and additional required disclosures have been included in Note 13. Segment Reporting.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"), to require disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The amendments in this update should be applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.

In March 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses ("ASU 2024-03"), to improve the disclosures about a public business entity’s expenses and to provide more detailed information about the types of expenses in commonly presented expense captions. The amendments in this update should be applied either prospectively or retrospectively, and are effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. We began an assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.
v3.25.1
Prepaid Expenses and Other Current Assets (Tables)
 12 Months Ended
Dec. 31, 2024
Prepaid Expense and Other Assets, Current [Abstract]  
Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses, consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Prepaid contracted research and development costs

 

$

4,179

 

 

$

2,167

 

R&D tax credit receivable

 

 

768

 

 

 

814

 

VAT receivable

 

 

275

 

 

 

191

 

Prepaid insurance

 

 

131

 

 

 

176

 

Deposits and other

 

 

455

 

 

 

280

 

Total prepaid expenses and other current assets

 

$

5,808

 

 

$

3,628

 

 
v3.25.1
Accrued Expenses and Other Current Liabilities (Tables)
 12 Months Ended
Dec. 31, 2024
Payables and Accruals [Abstract]  
Summary of Accrued Expenses and Other Current Liabilities

Accrued expenses and other liabilities, consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Accrued compensation

 

$

5,017

 

 

$

4,046

 

Accrued contracted research and development costs

 

 

3,912

 

 

 

2,166

 

Accrued general and administrative costs

 

 

1,134

 

 

 

738

 

Lease liability

 

 

116

 

 

 

143

 

Total accrued expenses and other current liabilities

 

$

10,179

 

 

$

7,093

 
v3.25.1
Short-term Investments (Tables)
 12 Months Ended
Dec. 31, 2024
Investments, Debt and Equity Securities [Abstract]  
Summary of Major Security Type of Investments The following table summarizes, by major security type, the Company’s investments (in thousands):

 

As of December 31, 2024

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

$

180,961

 

 

$

255

 

 

$

(17

)

 

$

181,199

 

Total short-term investments

 

$

180,961

 

 

$

255

 

 

$

(17

)

 

$

181,199

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

Amortized Cost

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair Value

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

$

135,541

 

 

$

194

 

 

$

(1

)

 

$

135,734

 

Total short-term investments

 

$

135,541

 

 

$

194

 

 

$

(1

)

 

$

135,734

 

 
v3.25.1
Property and Equipment, Net (Tables)
 12 Months Ended
Dec. 31, 2024
Property, Plant and Equipment [Abstract]  
Property and Equipment, Net

Property and equipment, net consisted of (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Research and development equipment

 

$

1,102

 

 

$

1,102

 

Equipment

 

 

772

 

 

 

737

 

Furniture and fixtures

 

 

120

 

 

 

110

 

Leasehold improvements

 

 

333

 

 

 

333

 

Total property and equipment

 

 

2,327

 

 

 

2,282

 

Less accumulated depreciation

 

 

(2,162

)

 

 

(2,012

)

Property and equipment, net

 

$

165

 

 

$

270

 

 
v3.25.1
Debt Facility (Tables)
 12 Months Ended
Dec. 31, 2024
Debt Disclosure [Abstract]  
Carrying Value and Future Minimum Payments

The following table summarizes the components of the long-term debt carrying value, which approximates the fair value (in thousands):

 

Future minimum payments due during the year ended December 31,

 

 

 

2025

 

$

-

 

2026

 

 

17,667

 

2027

 

 

9,562

 

Total future minimum payments

 

 

27,229

 

Unamortized end of term charge

 

 

(333

)

Debt issuance costs

 

 

(253

)

Debt discount related to warrants

 

 

(24

)

Total debt

 

 

26,619

 

Current portion of long-term debt

 

 

—

 

Long-term debt

 

$

26,619

 
v3.25.1
Fair Value Measurements (Tables)
 12 Months Ended
Dec. 31, 2024
Fair Value Disclosures [Abstract]  
Summary of Fair Value of Financial Instruments

The fair value of these instruments as of December 31, 2024 and 2023 was as follows (in thousands):

 

 

 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

As of December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

13,802

 

 

$

—

 

 

$

—

 

 

$

13,802

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

 

181,199

 

 

 

—

 

 

 

—

 

 

 

181,199

 

As of December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

17,270

 

 

$

—

 

 

$

—

 

 

$

17,270

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government securities

 

 

135,734

 

 

 

—

 

 

 

—

 

 

 

135,734

 

 
v3.25.1
Stockholders’ Equity (Tables)
 12 Months Ended
Dec. 31, 2024
Equity [Abstract]  
Summary of Net Proceeds After Taking Into Consideration Underwriter Commissions, Legal Fees, and Other Customary Closing Costs The July 2024 Offering resulted in net proceeds of $93.8 million after taking into consideration underwriter commissions, legal fees, and other customary closing costs, as follows (in thousands):

 

Financial instruments

 

Proceeds

 

Common stock

 

$

100,000

 

Offering expenses

 

 

(6,201

)

Net proceeds

 

$

93,799

 
Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses

The July 2023 Offering resulted in net proceeds to the Company of approximately $74.9 million, after deducting final underwriting discounts, commissions, and other estimated offering expenses, as follows (in thousands):

 

Financial instruments

 

Proceeds

 

Common stock

 

$

63,000

 

2023 Pre-funded warrants

 

 

16,994

 

Total

 

 

79,994

 

Offering expenses

 

$

(5,120

)

Net proceeds

 

$

74,874

 
Summary of Company's Common Stock

The following is a summary of the Company’s common stock at December 31, 2024 and 2023:

 

 

 

December 31

 

 

 

2024

 

 

2023

 

Common stock authorized

 

 

300,000,000

 

 

 

300,000,000

 

Common stock outstanding

 

 

172,423,223

 

 

 

138,143,545

 

 
Company's Shares of Common Stock Reserved for Issuance

The Company’s shares of common stock reserved for issuance as of December 31, 2024 and 2023 were as follows:

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

April 2017 Warrants

 

 

24,725

 

 

 

24,725

 

June 2017 Warrants

 

 

41,736

 

 

 

41,736

 

December 2018 Warrants

 

 

11,332

 

 

 

11,332

 

2017 Pre-funded Warrants

 

 

—

 

 

 

775,000

 

Pre-funded PIPE Warrants

 

 

5,780,537

 

 

 

5,780,537

 

2021 Pre-funded Warrants

 

 

32,175,172

 

 

 

32,175,172

 

2023 Pre-funded Warrants

 

 

5,666,667

 

 

 

5,666,667

 

Stock options outstanding

 

 

13,554,621

 

 

 

9,633,067

 

Issued and non-vested RSUs

 

 

4,677,500

 

 

 

3,488,250

 

Total shares reserved

 

 

61,932,290

 

 

 

57,596,486

 

 
Summary of Outstanding Warrants for Company's Common Stock

The following table summarizes the outstanding warrants for the Company’s common stock as of December 31, 2024:

 

Expiration Date

 

Shares Underlying
Outstanding Warrants

 

 

Exercise Price

 

April 2027

 

 

24,725

 

 

$

2.87

 

June 2027

 

 

41,736

 

 

$

2.87

 

December 2028

 

 

11,332

 

 

$

2.87

 

None

 

 

43,622,376

 

 

$

0.001

 

 

 

 

43,700,169

 

 

 

 

 
Components of Accumulated Other Comprehensive Income (Loss)

The components of accumulated other comprehensive income (loss) as of the dates indicated and the change during the period were (in thousands):

 

 

 

Foreign Exchange Translation Adjustment

 

 

Unrealized Gain (Loss) on ST Investments

 

 

Total Accumulated Other Comprehensive Income (Loss)

 

Balance, December 31, 2022

 

$

(594

)

 

$

(11

)

 

$

(605

)

Change

 

 

133

 

 

 

201

 

 

 

334

 

Balance, December 31, 2023

 

$

(461

)

 

 

190

 

 

$

(271

)

Change

 

 

(523

)

 

 

44

 

 

 

(479

)

Balance, December 31, 2024

 

$

(984

)

 

$

234

 

 

$

(750

)
v3.25.1
Commitments (Tables)
 12 Months Ended
Dec. 31, 2024
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities

Year ending December 31,

 

 

 

2025

 

$

160

 

2026

 

 

87

 

Total future minimum lease payments

 

$

247

 

Less imputed interest

 

 

(17

)

Total

 

$

230

 
Schedule of Lease Cost and Other Information

Operating cash flows from operating leases

 

$

172

 

Weighted-average remaining lease term (in months) - operating leases

 

 

18

 

Weighted-average discount rate - operating leases

 

 

7.8

%

 
Schedule of Manufacturing Commitments and Contigencies

The following table summarizes manufacturing commitments and contingencies as of the period indicated (in thousands):

Manufacturing, Development, and Other Contingent Milestone Payments (in thousands):

 

 

 

December 31, 2024

 

MOLBREEVI manufacturer:

 

 

 

Achievement of certain milestones related to validation of API and regulatory approval of
    MOLBREEVI

 

$

320

 

MOLBREEVI nebulizer manufacturer:

 

 

 

Achievement of various development activities and regulatory approval of nebulizer
    utilized to administer MOLBREEVI

 

 

521

 

Total manufacturing and other commitments

 

$

841

 
v3.25.1
Stock-Based Compensation (Tables)
 12 Months Ended
Dec. 31, 2024
Share-Based Payment Arrangement [Abstract]  
Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees

The following table summarizes the assumptions used for estimating the fair value of stock options granted to employees for the years ended December 31, 2024 and 2023:

 

 

 

2024

 

2023

Risk-free interest rate

 

3.58% - 4.55%

 

3.37% - 4.80%

Expected term (years)

 

6.06 - 9.26

 

6.06

Expected volatility

 

90.9% - 114.6%

 

91.2% - 97.84%

Dividend yield

 

0%

 

0%

 
Summary of Stock Option Activity and RSU Activity

The following tables provide a summary for stock option and RSU activity for the year ended December 31, 2024:

Stock Options:

 

 

 

Shares Underlying Option Awards

 

 

Weighted-Average Exercise Price

 

 

Weighted-Average Remaining Contractual Life

 

 

Aggregate Intrinsic Value (in 000's)

 

Outstanding at December 31, 2023

 

 

9,633,067

 

 

$

2.42

 

 

 

7.94

 

 

$

25,392

 

Granted

 

 

4,573,000

 

 

 

3.47

 

 

 

6.08

 

 

 

 

Exercised

 

 

(464,297

)

 

 

1.49

 

 

 

 

 

$

1,327

 

Expired/cancelled/forfeited

 

 

(187,149

)

 

 

1.78

 

 

 

 

 

 

 

Outstanding at December 31, 2024

 

 

13,554,621

 

 

$

2.79

 

 

 

7.89

 

 

$

11,586

 

Options exercisable at December 31, 2024

 

 

6,220,508

 

 

$

2.47

 

 

 

6.29

 

 

$

8,728

 

 

The weighted-average grant date fair values for the Company’s stock options granted during the years ended December 31, 2024 and 2023 were $3.47 per share and $2.79 per share, respectively. The total compensation cost related to non-vested stock options not yet recognized as of December 31, 2024 was $18.4 million, which will be recognized over a weighted-average period of approximately 3.5 years.

During the years ended December 31, 2024 and 2023, the Company did not grant any options to purchase shares of common stock to non-employees. The Company recorded a minimal amount of stock-based compensation expense for options issued to non-employees for the years ended December 31, 2024 and 2023, respectively.

RSUs:

 

 

 

Shares
Underlying
Option Awards

 

 

Weighted-Average Grant Date Fair Value

 

Outstanding at December 31, 2023

 

 

3,488,250

 

 

$

3.36

 

Granted

 

 

2,409,500

 

 

 

3.58

 

Vested

 

 

(1,117,750

)

 

 

1.81

 

Expired/cancelled/forfeited

 

 

(102,500

)

 

 

—

 

Outstanding at December 31, 2024

 

 

4,677,500

 

 

$

3.83

 
Stock-based Compensation Expense included in Accompanying Consolidated Statements of Operations and Comprehensive Loss

Stock-based compensation expense is included in the following line items in the accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Research and development

 

$

4,453

 

 

$

1,470

 

General and administrative

 

 

5,407

 

 

 

2,708

 

Total stock-based compensation

 

$

9,860

 

 

$

4,178

 
v3.25.1
Income Taxes (Tables)
 12 Months Ended
Dec. 31, 2024
Income Tax Disclosure [Abstract]  
Components of Loss Before Income Taxes

The components of loss before income taxes for the years ended December 31, 2024 and 2023 are as follows (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Domestic

 

$

(63,256

)

 

$

(40,834

)

Foreign

 

 

(32,625

)

 

 

(13,864

)

Total

 

$

(95,881

)

 

$

(54,698

)

 
Components of Income Tax Expense The components of the income tax expense are as follows for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Current:

 

 

 

 

 

 

Federal

 

$

—

 

 

$

—

 

State

 

 

9

 

 

 

—

 

Foreign

 

 

—

 

 

 

—

 

Total Current

 

 

9

 

 

 

—

 

Deferred:

 

 

 

 

 

 

Federal

 

 

—

 

 

 

—

 

State

 

 

—

 

 

 

—

 

Foreign

 

 

—

 

 

 

—

 

Total Deferred

 

 

—

 

 

 

—

 

Total income tax expense

 

$

9

 

 

$

—

 

 
Reconciliation of Expected Income Tax

A reconciliation of the expected income tax results computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2024 and 2023 (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Income tax benefit computed at federal statutory tax rate

 

$

(20,135

)

 

$

(11,487

)

State taxes, net of federal

 

 

7

 

 

 

—

 

Change in valuation allowance

 

 

29,911

 

 

 

18,957

 

Orphan drug & research credits generated

 

 

(9,659

)

 

 

(6,998

)

Impact of foreign operations

 

 

(338

)

 

 

(136

)

Foreign deferred tax asset - true up

 

 

(750

)

 

 

(1,124

)

Actualization and deferred tax asset - true up

 

 

(214

)

 

 

—

 

Imputed interest

 

 

1,498

 

 

 

1,309

 

Permanent differences

 

 

(311

)

 

 

(537

)

Other

 

 

—

 

 

 

16

 

Total

 

$

9

 

 

$

—

 

 
Significant Components of Deferred Tax Assets and Liabilities

Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands):

 

 

 

December 31,

 

 

 

2024

 

 

2023

 

Deferred tax liabilities:

 

 

 

 

 

 

ROU assets

 

$

67

 

 

$

108

 

Other

 

 

687

 

 

 

783

 

Total deferred tax liabilities

 

 

754

 

 

 

891

 

Deferred tax assets:

 

 

 

 

 

 

Net operating loss carryforwards

 

 

58,384

 

 

 

44,731

 

Intangible assets

 

 

379

 

 

 

1,398

 

Amortization

 

 

1,263

 

 

 

1,400

 

Credit carryforwards

 

 

22,624

 

 

 

12,965

 

Section 174 research and development expenses

 

 

20,058

 

 

 

11,638

 

ROU liabilities

 

 

56

 

 

 

108

 

Depreciation

 

 

272

 

 

 

245

 

Accrued liabilities & other

 

 

5,074

 

 

 

2,304

 

Total deferred tax assets

 

 

108,110

 

 

 

74,789

 

Subtotal

 

 

107,356

 

 

 

73,898

 

Valuation allowance

 

 

(107,356

)

 

 

(73,898

)

Net deferred taxes

 

$

—

 

 

$

—

 
v3.25.1
Segment Reporting (Tables)
 12 Months Ended
Dec. 31, 2024
Segment Reporting [Abstract]  
Schedule of Disaggregated Research and Development Expenses and Segment Net Loss In addition to the significant expense categories included on the Company's consolidated statements of operations, refer below for disaggregated amounts that comprise research and development expenses and the segment net loss (in thousands):

 

 

 

Year Ended December 31,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Research and development operating costs and expenses excluding
   non-cash stock-based compensation:

 

 

 

 

 

 

Primary program research and development expenses (a)

 

$

59,325

 

 

$

32,535

 

Other research and development expenses:

 

 

 

 

 

 

Payroll and benefits

 

 

11,933

 

 

 

9,023

 

Occupancy and other overhead and operating costs

 

 

2,318

 

 

 

1,234

 

Total other research and development expenses

 

 

14,251

 

 

 

10,257

 

Research and development operating costs and expenses excluding
   non-cash stock-based compensation:

 

 

73,576

 

 

 

42,792

 

General and administrative expense excluding non-cash stock-based
   compensation

 

 

19,630

 

 

 

12,960

 

Other segment income (expense), net (b)

 

 

2,675

 

 

 

(1,054

)

Segment net loss

 

$

(95,881

)

 

$

(54,698

)

 

(a)
Primary program research and development expenses are comprised primarily of costs paid to third parties for clinical trials and product development manufacturing, nonclinical, regulatory, and quality assurance activities, and the portion of related research and development expenses incurred by our collaborators and third-party service providers, including contract research and manufacturing organizations that we are obligated to reimburse.
(b)
Other segment income (expense), net includes interest income, interest expense, foreign currency exchange gain or loss, depreciation and amortization, non-cash stock-based compensation and tax credit income.
v3.25.1
Net Loss Per Share (Tables)
 12 Months Ended
Dec. 31, 2024
Earnings Per Share [Abstract]  
Schedule of Potentially Dilutive Securities

As of December 31, 2024 and 2023, potentially dilutive securities include:

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Awards under equity incentive plan

 

 

13,554,621

 

 

 

9,633,067

 

Non-vested restricted shares and restricted stock units

 

 

4,677,500

 

 

 

3,488,250

 

Warrants to purchase common stock

 

 

77,793

 

 

 

77,793

 

Total

 

 

18,309,914

 

 

 

13,199,110

 
Reconciles Basic Net Loss Per Share and Diluted Net Loss Per Share of Common Stock

The following table calculates basic net loss per share of common stock and diluted net loss per share of common stock for the years ended December 31, 2024 and 2023 (in thousands, except share and per share amounts):

 

 

 

Year ended December 31,

 

 

 

2024

 

 

2023

 

Net loss

 

$

(95,881

)

 

$

(54,698

)

Net loss attributable to common stockholders

 

$

(95,881

)

 

$

(54,698

)

Undistributed earnings and net loss attributable to
   common stockholders, basic and diluted

 

$

(95,881

)

 

$

(54,698

)

Weighted-average common shares outstanding, basic
   and diluted

 

 

198,191,936

 

 

 

165,204,652

 

Basic and diluted net loss per share

 

$

(0.48

)

 

$

(0.33

)
v3.25.1
Description of Business and Basis of Presentation - Additional Information (Detail)
 12 Months Ended
Dec. 31, 2024
USD ($)
Segment
Description Of Business And Basis Of Presentation [Line Items]  
Number of operating segments | Segment 1
Product [Member]  
Description Of Business And Basis Of Presentation [Line Items]  
Revenue from inception to date | $ $ 0
v3.25.1
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Summary Of Significant Accounting Policies [Line Items]    
Accumulated deficit $ (489,250) $ (393,369)
Cash from operations (89,088) (51,061)
Cash and cash equivalents 15,128 26,585
Short-term investments $ 181,199 $ 135,734
Cash and cash equivalents with original maturities three months or less  
Minimum [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Estimated useful lives of assets 3 years  
Maximum [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Estimated useful lives of assets 5 years  
ASC 2023-07    
Summary Of Significant Accounting Policies [Line Items]    
Change in Accounting Principle, Accounting Standards Update, Adopted true  
Change in Accounting Principle, Accounting Standards Update, Adoption Date Jan. 01, 2024  
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect true  
v3.25.1
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Prepaid Expense and Other Assets, Current [Abstract]    
Prepaid contracted research and development costs $ 4,179 $ 2,167
R&D tax credit receivable 768 814
VAT receivable 275 191
Prepaid insurance 131 176
Deposits and other 455 280
Total prepaid expenses and other current assets $ 5,808 $ 3,628
v3.25.1
Prepaid Expenses and Other Current Assets - Additional Information (Details) - Savara ApS [Member] - USD ($)
$ in Millions
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Prepaid Expenses And Other Current Assets [Line Items]    
Effective Income Tax Rate Reconciliation, Tax Credit, Research, Percent 22.00%  
Research and development tax credits receivable $ 0.8 $ 0.8
v3.25.1
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Payables and Accruals [Abstract]    
Accrued compensation $ 5,017 $ 4,046
Accrued contracted research and development costs 3,912 2,166
Accrued general and administrative costs 1,134 738
Lease liability 116 143
Total accrued expenses and other current liabilities $ 10,179 $ 7,093
v3.25.1
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost $ 180,961 $ 135,541
Gross Unrealized Gains 255 194
Gross Unrealized Losses (17) (1)
Fair Value 181,199 135,734
U.S. Government Securities [Member]    
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost 180,961 135,541
Gross Unrealized Gains 255 194
Gross Unrealized Losses (17) (1)
Fair Value $ 181,199 $ 135,734
v3.25.1
Short-term Investments - Additional Information (Detail) - USD ($)
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]    
Realized gains or losses on investments $ 0 $ 0
v3.25.1
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 2,327 $ 2,282
Less accumulated depreciation (2,162) (2,012)
Property and equipment, net 165 270
Research and Development Equipment [Member]    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 1,102 1,102
Equipment [Member]    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 772 737
Furniture and Fixtures [Member]    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 120 110
Leasehold Improvements [Member]    
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 333 $ 333
v3.25.1
Debt Facility - Additional Information (Detail) - Loan and Security Agreement [Member] - Silicon Valley Bank [Member] - Term Loan [Member] - USD ($)
$ in Millions
 12 Months Ended
Apr. 21, 2022
Dec. 31, 2024
Debt Instrument [Line Items]    
Loan agreement amendment date Apr. 21, 2022  
Principal amount $ 26.5  
Payments of Debt Issuance Costs   $ 0.1
Percentage of obligation to pay closing fees and final payment 2.75%  
Debt instrument payment description 1.75 Pursuant to the Amended Loan Agreement, the loan has an interest-only monthly payment through April 21, 2026 (the “Interest-Only Period”) and thereafter equal monthly installments of principal plus interest over 12 months until April 21, 2027 (the “Maturity Date”). However, the Company may elect to extend the Interest-Only Period until the Maturity Date if it maintains cash and cash equivalents equal to at least 1.75 times the outstanding principal amount of the loan during the fifth year. If the Interest-Only Period is extended, all principal and unpaid interest is due and payable on the Maturity Date.
Debt instrument principal and interest payment period 12 months  
Debt instrument, maturity rate range, end Apr. 21, 2027  
Frequency of principal plus interest repayment period equal monthly installments  
Interest rate, basis spread 0.50%  
Debt instrument, interest rate 3.00%  
Maximum [Member]    
Debt Instrument [Line Items]    
Debt instrument covenants cash and cash equivalents threshold limit $ 40.0  
v3.25.1
Debt Facility - Carrying Value and Future Minimum Payments (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Debt Disclosure [Abstract]    
2026 $ 17,667  
2027 9,562  
Total future minimum payments 27,229  
Unamortized end of term charge (333)  
Debt issuance costs (253)  
Debt discount related to warrants (24)  
Total debt 26,619  
Long-term debt $ 26,619 $ 26,348
v3.25.1
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
U.S. Treasury Money Market Funds [Member]    
Cash equivalents:    
Cash equivalents $ 13,802 $ 17,270
U.S. Government Securities [Member]    
Short-term investments:    
Short-term investments 181,199 135,734
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Money Market Funds [Member]    
Cash equivalents:    
Cash equivalents 13,802 17,270
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Government Securities [Member]    
Short-term investments:    
Short-term investments $ 181,199 $ 135,734
v3.25.1
Fair Value Measurements - Additional Information (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Fair Value Disclosures [Abstract]    
Fair value, assets, transfers into level 3, amount $ 0 $ 0
Fair value, assets, transfers out of level 3, amount 0 0
IPR&D 10,337 10,960
Increase (decrease) in carrying value of IPR&D due to foreign currency translation $ (600) $ 300
v3.25.1
Stockholders' Equity - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Thousands
 12 Months Ended
Jul. 01, 2024
Jul. 17, 2023
Jul. 16, 2021
Dec. 31, 2024
Dec. 31, 2023
Jul. 06, 2021
Class Of Warrant Or Right [Line Items]            
Net proceeds $ 100,000          
Net proceeds after taking into consideration underwriting commissions, legal fees, and other customary closing costs $ 93,799          
Net proceeds after deducting underwriting discounts commissions and offering expenses   $ 74,874        
Common stock, par value       $ 0.001 $ 0.001  
Common and preferred stock, shares authorized       301,000,000    
Common Stock, Shares Authorized       300,000,000 300,000,000  
Preferred stock, shares authorized       1,000,000    
Preferred stock, par value       $ 0.001    
Underwritten Offering of Common Stock [Member]            
Class Of Warrant Or Right [Line Items]            
Common stock, shares sold 26,246,720 21,000,000        
Common stock, sale of stock, price per share $ 0.001 $ 3        
Offering price per share $ 3.81          
Net proceeds after taking into consideration underwriting commissions, legal fees, and other customary closing costs $ 93,800          
Common stock, sale of stock, premium percentage   1.00%        
Common stock, pre-funded warrants to purchase   5,666,667        
Common Stock pre funded warrants exercise price   $ 0.001        
Common Stock pre funded warrants per warrant   $ 2.999        
Net proceeds after deducting underwriting discounts commissions and offering expenses   $ 74,900        
Common stock, par value   $ 0.001        
Evercore Group L.L.C., [Member]            
Class Of Warrant Or Right [Line Items]            
Common stock, shares sold       6,038,650 2,071,511  
Net proceeds       $ 24,400 $ 8,800  
Common stock, par value           $ 0.001
Common stock sales agreement, effective date     Jul. 16, 2021      
Sales commissions in fixed percentage of gross proceeds per share           3.00%
Evercore Group L.L.C., [Member] | Maximum [Member]            
Class Of Warrant Or Right [Line Items]            
Amount available to sell under equity program           $ 100,000
v3.25.1
Stockholders' Equity - Summary of Net Proceeds After Taking Into Consideration Underwriter Commissions, Legal Fees, and Other Customary Closing Costs (Details) - USD ($)
$ in Thousands
Jul. 01, 2024
Jul. 17, 2023
Equity [Abstract]    
Common stock $ 100,000  
Offering expenses (6,201) $ (5,120)
Net proceeds $ 93,799  
v3.25.1
Shareholders' Equity - Summary of Net Proceeds after Deducting Underwriting Discounts Commissions and Offering Expenses (Details) - USD ($)
$ in Thousands
Jul. 01, 2024
Jul. 17, 2023
Class of Warrant or Right [Line Items]    
Total common stock and pre-funded warrants   $ 79,994
Offering expenses $ (6,201) (5,120)
Net proceeds   74,874
Common Stock [Member]    
Class of Warrant or Right [Line Items]    
Total common stock and pre-funded warrants   63,000
2023 Pre-funded Warrants [Member]    
Class of Warrant or Right [Line Items]    
Total common stock and pre-funded warrants   $ 16,994
v3.25.1
Stockholders' Equity - Summary of Company's Common Stock (Detail) - shares
Dec. 31, 2024
Dec. 31, 2023
Equity [Abstract]    
Common stock authorized 300,000,000 300,000,000
Common stock outstanding 172,423,223 138,143,545
v3.25.1
Stockholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares
Dec. 31, 2024
Dec. 31, 2023
Class Of Warrant Or Right [Line Items]    
Total shares reserved 61,932,290 57,596,486
April 2017 Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 24,725 24,725
June 2017 Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 41,736 41,736
December 2018 Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 11,332 11,332
2017 Pre-Funded Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 0 775,000
Pre-Funded PIPE Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 5,780,537 5,780,537
2021 Pre-funded Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 32,175,172 32,175,172
2023 Pre-funded Warrants [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 5,666,667 5,666,667
Stock Options [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 13,554,621 9,633,067
Issued and nonvested RSUs [Member]    
Class Of Warrant Or Right [Line Items]    
Total shares reserved 4,677,500 3,488,250
v3.25.1
Stockholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail)
 12 Months Ended
Dec. 31, 2024
$ / shares
shares
Class Of Warrant Or Right [Line Items]  
Shares Underlying Outstanding Warrants 43,700,169
Exercise Price One [Member]  
Class Of Warrant Or Right [Line Items]  
Expiration Date 2027-04
Shares Underlying Outstanding Warrants 24,725
Exercise Price | $ / shares $ 2.87
Exercise Price Two [Member]  
Class Of Warrant Or Right [Line Items]  
Expiration Date 2027-06
Shares Underlying Outstanding Warrants 41,736
Exercise Price | $ / shares $ 2.87
Exercise Price Three [Member]  
Class Of Warrant Or Right [Line Items]  
Expiration Date 2028-12
Shares Underlying Outstanding Warrants 11,332
Exercise Price | $ / shares $ 2.87
Exercise Price Four [Member]  
Class Of Warrant Or Right [Line Items]  
Shares Underlying Outstanding Warrants 43,622,376
Exercise Price | $ / shares $ 0.001
Expiration Date None
v3.25.1
Stockholders' Equity - Components of Accumulated Other Comprehensive Income (Loss) (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Accumulated Other Comprehensive Income Loss [Line Items]    
Total Accumulated Other Comprehensive Income (Loss) $ (271) $ (605)
Change (479) 334
Total Accumulated Other Comprehensive Income (Loss) (750) (271)
Foreign Exchange Translation Adjustment [Member]    
Accumulated Other Comprehensive Income Loss [Line Items]    
Total Accumulated Other Comprehensive Income (Loss) (461) (594)
Change (523) 133
Total Accumulated Other Comprehensive Income (Loss) (984) (461)
Unrealized Gain (Loss) on ST Investments [Member]    
Accumulated Other Comprehensive Income Loss [Line Items]    
Total Accumulated Other Comprehensive Income (Loss) 190 (11)
Change 44 201
Total Accumulated Other Comprehensive Income (Loss) $ 234 $ 190
v3.25.1
Commitments - Additional Information (Detail) - USD ($)
 3 Months Ended 12 Months Ended
Feb. 28, 2023
Mar. 05, 2021
Jun. 30, 2024
Dec. 31, 2024
Dec. 31, 2023
Feb. 29, 2024
Commitments And Contingencies [Line Items]            
Maximum earnings in milestone payment     $ 4,800,000      
Amount recognized as expense under various milestone payments       $ 1,300,000 $ 0  
Operating lease, right-of -use asset       $ 200,000    
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]       Other non-current assets    
Estimated parexel service fees, pass through expenses, and investigator fees   $ 48,500,000        
Parexel service fees and pass through expenses and investigator fees recognized as expense       $ 9,200,000 10,800,000  
Operating lease liability increased amount       300,000    
Operating lease, liability, current portion       $ 200,000    
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]       Accrued expenses and other current liabilities    
Operating lease, liability, non-current portion       $ 100,000    
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]       Liabilities    
Estimated services fees       $ 15,900,000 $ 0 $ 24,700,000
Active Pharmaceutical Ingredients [Member]            
Commitments And Contingencies [Line Items]            
Agreement description       Under a manufacture and supply agreement with an active pharmaceutical ingredients (“API”) manufacturer for MOLBREEVI, as amended, the Company must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by the Company from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, the Company shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country of products containing API supplied by the API manufacturer.Additionally, the Company is subject to a purchase requirement under which for ten years following the date of receipt of approval by a regulatory authority of the first regulatory filing for the marketing and sale of the first product containing the API in any country, the Company will purchase from the API manufacturer the API required to produce a percentage of such product it sells each year (the “Purchase Requirement”); provided, however, that the Purchase Requirement will no longer apply if (i) the price charged by the API manufacturer exceeds a certain price charged by an alternative supplier, (ii) there is a shortage of supply, or (iii) API manufacturer at any time fails to materially fulfill a purchase order of the Company.    
Nebulizer [Member]            
Commitments And Contingencies [Line Items]            
Royalty percent on net sale       3.50%    
Second Source Member | Maximum [Member]            
Commitments And Contingencies [Line Items]            
Percentage of Cancellation Fees       100.00%    
Second Source Member | Minimum [Member]            
Commitments And Contingencies [Line Items]            
Percentage of Cancellation Fees       10.00%    
Lease Amendment [Member]            
Commitments And Contingencies [Line Items]            
Lease agreement date Jul. 07, 2021          
Lease originally commencement date Oct. 01, 2021          
Lease commencement date Jul. 01, 2023          
Lease expiration date Jun. 30, 2026          
Lease term 36 months          
Average increase in monthly rent $ 14,500          
CEO [Member]            
Commitments And Contingencies [Line Items]            
Employment agreement description       Upon (i) termination without cause, (ii) termination due to the CEO’s death or disability, or (iii) the CEO’s resignation for good reason, the CEO is entitled to receive (i) a lump sum payment equal to 18 months of base salary, (ii) a lump sum payment equal to 100% of his target bonus, (iii) a pro-rated portion of the unpaid target bonus based upon the number of days he was employed by the Company during the relevant performance period, (iv) reimbursement for continued coverage under medical benefit plans for 18 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 18 month anniversary of the termination date or (y) the original expiration date.    
Percentage of target bonus to be paid upon termination       100.00%    
CEO [Member] | Termination Other Than for Cause Death or Disability or Resignation for Good Reason [Member]            
Commitments And Contingencies [Line Items]            
Employment agreement description       Upon a termination other than for cause, death or disability or upon resignation for good reason within three months prior to or 12 months following a change in control, the CEO is entitled to receive (i) a lump sum payment of an amount equal to 24 months of base salary, (ii) 100% of the unpaid target bonus, (iii) a pro-rated portion of the unpaid target bonus based on the number of days he was employed by the Company during the relevant performance period, (iv) reimbursement for continued coverage under medical benefit plans for 24 months or until covered under a separate plan from another employer, and (v) the immediate and full vesting of outstanding non-vested Company equity awards. Additionally, all of the CEO’s outstanding stock options will be exercisable through the earlier of (x) the 24-month anniversary of the termination date or (y) the original expiration date.    
Chief Financial Officer (“CFO”) and Chief Medical Officer (“CMO”) [Member]            
Commitments And Contingencies [Line Items]            
Employment agreement description       Each of the Company’s Chief Financial & Administrative Officer (“CFO”), Chief Medical Officer (“CMO”), Chief Operating Officer ("COO"), Chief Business Officer ("CBO"), and Chief Commercial Officer ("CCO") is entitled to payments and benefits if the CFO, CMO, COO, CBO, or CCO, respectively, is (i) terminated without cause, (ii) terminated due to death or disability, or (iii) resigns for good reason, which includes (i) a lump sum payment equal to 12 months of base salary and a pro-rated portion of their unpaid bonus, (ii) reimbursement for continued coverage under medical benefit plans for 12 months or until covered under a separate plan from another employer, and (iii) accelerated vesting of outstanding non-vested Company equity awards equal to 12 months. Upon a termination other than for cause, death or disability or upon resignation for good reason within three months prior to or 12 months following a change in control, the CFO, CMO, COO, CBO, or CCO is entitled to receive (i) a lump sum payment of an amount equal to 18 months of base salary, plus 100% of their target bonus, plus a pro-rated portion of their unpaid target bonus, (ii) a lump sum payment equal to the amount required to continue coverage under medical benefit plans for 18 months, and (iii) the immediate and full vesting of outstanding non-vested options at the time of such termination.    
v3.25.1
Commitments - Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities (Detail)
$ in Thousands
Dec. 31, 2024
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2025 $ 160
2026 87
Total future minimum lease payments 247
Less imputed interest (17)
Operating lease, liability $ 230
v3.25.1
Commitments - Schedule of Lease Cost and Other Information (Detail)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
USD ($)
Leases [Abstract]  
Operating cash outflows from operating leases $ 172
Weighted-average remaining lease term (in months) - operating leases 18 months
Weighted-average discount rate - operating leases 7.80%
v3.25.1
Commitments - Schedule of Manufacturing Commitments and Contingencies (Detail)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
USD ($)
Commitments And Contingencies [Line Items]  
Total manufacturing and other commitments $ 841
Active Pharmaceutical Ingredients [Member]  
Commitments And Contingencies [Line Items]  
Achievement of certain milestones related to validation of API and regulatory approval of MOLBREEVI 320
Molbreevi Nebulizer Manufacturer [Member]  
Commitments And Contingencies [Line Items]  
Achievement of various development activities and regulatory approval of nebulizer utilized to administer MOLBREEVI $ 521
v3.25.1
Related Parties - Additional Information (Detail)
Dec. 31, 2024
shares
Related Party Transaction [Line Items]  
Warrants issued 43,700,169
v3.25.1
Stock-Based Compensation - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Millions
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Options granted to purchase common stock 4,573,000  
Options exercised to purchase common stock 464,297  
Non-Employees [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Options granted to purchase common stock 0 0
Stock Options [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Dividend yield 0.00%  
Weighted-average grant date fair value $ 3.47 $ 2.79
Total compensation cost not yet recognized $ 18.4  
Weighted-average period to be recognized 3 years 6 months  
RSUs [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Total compensation cost not yet recognized $ 11.7  
Weighted-average period to be recognized 1 year 4 months 24 days  
2008 Stock Option Plan [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Common stock shares purchased under stock option plan 139,332  
2008 Stock Option Plan [Member] | Maximum [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Contractual term 10 years  
2008 Stock Option Plan [Member] | Stock Options [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Issuance of stock based awards 0  
2021 Inducement Equity Incentive Plan [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Common stock shares available for grant 1,272,799  
2024 Omnibus Incentive Option Plan [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Common stock shares available for grant 7,153,602  
2008 Plan and 2024 Plan [Member] | Stock Options [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Contractual term 10 years  
Vesting period 4 years  
Vesting interval period quarterly  
2008 Plan and 2024 Plan [Member] | RSUs [Member] | Cliff Vest [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Vesting period 2 years  
v3.25.1
Stock-Based Compensation - Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted to Employees (Detail) - Employees [Member] - Equity Incentive Plans [Member]
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Risk-free interest rate, Minimum 3.58% 3.37%
Risk-free interest rate, Maximum 4.55% 4.80%
Expected term (years)   6 years 21 days
Expected volatility, Minimum 90.90% 91.20%
Expected volatility, Maximum 114.60% 97.84%
Dividend yield 0.00% 0.00%
Minimum [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected term (years) 6 years 21 days  
Maximum [Member]    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected term (years) 9 years 3 months 3 days  
v3.25.1
Stock-Based Compensation - Summary of Stock Option Activity and RSU Activity (Detail) - USD ($)
$ / shares in Units, $ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]    
Stock Options, Shares Underlying Option Awards, Outstanding at beginning balance 9,633,067  
Stock Options, Shares Underlying Option Awards, Granted 4,573,000  
Stock Options, Shares Underlying Option Awards, Exercised (464,297)  
Stock Options, Shares Underlying Option Awards, Expired/cancelled/forfeited (187,149)  
Stock Options, Shares Underlying Option Awards, Outstanding at ending balance 13,554,621 9,633,067
Stock Options, Shares Underlying Option Awards, Options exercisable 6,220,508  
Stock Options, Weighted-Average Exercise Price, beginning balance $ 2.42  
Stock Options, Weighted-Average Exercise Price, Granted 3.47  
Stock Options, Weighted-Average Exercise Price, Exercised 1.49  
Stock Options, Weighted-Average Exercise Price, Expired/cancelled/forfeited 1.78  
Stock Options, Weighted-Average Exercise Price, ending balance 2.79 $ 2.42
Stock Options, Weighted-Average Exercise Price, Options exercisable $ 2.47  
Stock Options, Weighted-Average Remaining Contractual Years 7 years 10 months 20 days 7 years 11 months 8 days
Stock Options, Weighted-Average Remaining Contractual Years, Granted 6 years 29 days  
Stock Options, Weighted-Average Remaining Contractual Years, Options exercisable 6 years 3 months 14 days  
Stock Options, Aggregate Intrinsic Value Outstanding $ 11,586 $ 25,392
Stock Options, Aggregate Intrinsic Value, Options exercised 1,327  
Stock Options, Aggregate Intrinsic Value, Options exercisable $ 8,728  
RSU's, Shares Underlying Option Awards, Beginning balance 3,488,250  
RSUs, Shares Underlying Option Awards, Granted 2,409,500  
RSUs, Shares Underlying Option Awards, Vested (1,117,750)  
RSUs, Shares Underlying Option Awards, Expired/cancelled/forfeited (102,500)  
RSU's, Shares Underlying Option Awards, Ending balance 4,677,500 3,488,250
RSU's Weighted-Average Grant Date Fair Value, Beginning balance $ 3.36  
RSU's Weighted-Average Grant Date Fair Value, Granted 3.58  
RSU's Weighted-Average Grant Date Fair Value, Vested 1.81  
RSU's Weighted-Average Grant Date Fair Value, Ending balance $ 3.83 $ 3.36
v3.25.1
Stock-Based Compensation - Stock-based Compensation Expense included in Accompanying Consolidated Statements of Operations and Comprehensive Loss (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]    
Total stock-based compensation $ 9,860 $ 4,178
Research and Development [Member]    
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]    
Total stock-based compensation 4,453 1,470
General and Administrative [Member]    
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]    
Total stock-based compensation $ 5,407 $ 2,708
v3.25.1
Income Taxes - Components of Loss Before Income Taxes (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest [Abstract]    
Domestic $ (63,256) $ (40,834)
Foreign (32,625) (13,864)
Total $ (95,881) $ (54,698)
v3.25.1
Income Taxes - Additional Information (Detail) - USD ($)
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Operating Loss Carryforwards [Line Items]    
Federal tax benefit related to deferred tax liability $ 0 $ 0
State provision for income taxes 9,000 0
(Decrease) increase in valuation allowance $ 33,500,000 23,000,000
Increase in shareholders ownership interest, percentage 5.00%  
Change in ownership interest, percentage points 0.50%  
Change in ownership interest period 3 years  
Research and orphan drug tax credit carry forwards $ 22,624,000 12,965,000
Net operating loss carryforwards 58,384,000 44,731,000
Foreign net operating loss carryforwards 137,700,000 96,000,000
State net operating loss carryforwards 25,000,000 9,500,000
Unrecognized tax benefits 0 0
Interest and penalties related to income taxes 0 0
Federal [Member]    
Operating Loss Carryforwards [Line Items]    
Net operating loss carryforwards 126,000,000 109,400,000
Research and orphan drug tax credit carry forwards 22,100,000 12,500,000
Net operating loss carryforwards $ 52,400,000 52,400,000
Tax credit carry forwards expiration beginning year 2039  
Operating loss carry forwards expiration beginning Year 2037  
Operating loss carry forwards with expiration date $ 5,200,000  
Operating loss carry forwards with no expiration date $ 120,800,000  
Federal [Member] | Internal Revenue Service ("IRS") [Member]    
Operating Loss Carryforwards [Line Items]    
Open tax year 2020  
State and Local Jurisdiction [Member]    
Operating Loss Carryforwards [Line Items]    
Tax credit carry forwards expiration beginning year 2034  
Operating loss carry forwards expiration beginning Year 2038  
State research and development tax credit carryforwards $ 500,000 $ 500,000
State of Texas [Member] | Internal Revenue Service ("IRS") [Member]    
Operating Loss Carryforwards [Line Items]    
Open tax year 2019  
Foreign Tax Authorities [Member] | Internal Revenue Service ("IRS") [Member]    
Operating Loss Carryforwards [Line Items]    
Open tax year 2020  
v3.25.1
Income Taxes - Components of Income Tax Expense (Detail) - USD ($)
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Current:    
State $ 9,000 $ 0
Total current 9,000  
Deferred:    
Federal 0 $ 0
Total income tax expense $ 9,000  
v3.25.1
Income Taxes - Reconciliation of Expected Income Tax (Detail) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Income Tax Disclosure [Abstract]    
Income tax benefit computed at federal statutory tax rate $ (20,135) $ (11,487)
State taxes, net of federal 7  
Change in valuation allowance 29,911 18,957
Orphan drug & research credits generated (9,659) (6,998)
Impact of foreign operations (338) (136)
Foreign deferred tax asset - true up (750) (1,124)
Actualization and deferred tax asset - true up (214)  
Imputed interest 1,498 1,309
Permanent differences (311) (537)
Other   $ 16
Total income tax expense $ 9  
v3.25.1
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($)
$ in Thousands
Dec. 31, 2024
Dec. 31, 2023
Deferred tax liabilities:    
ROU assets $ 67 $ 108
Other 687 783
Total deferred tax liabilities 754 891
Deferred tax assets:    
Net operating loss carryforwards 58,384 44,731
Intangible assets 379 1,398
Amortization 1,263 1,400
Credit carryforwards 22,624 12,965
Section 174 research and development expenses 20,058 11,638
ROU liabilities 56 108
Depreciation 272 245
Accrued liabilities & other 5,074 2,304
Total deferred tax assets 108,110 74,789
Subtotal 107,356 73,898
Valuation allowance $ (107,356) $ (73,898)
v3.25.1
Segment Reporting - Additional Information (Details)
 12 Months Ended
Dec. 31, 2024
Segment
Segment Reporting [Abstract]  
Number of operating segments 1
Number of reportable segments 1
Factors used to identify entitys reportable segments Segment Reporting, which establishes standards for companies to report in their financial statement information about operating segments, products, services, geographic areas, and major customers.
Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration] Chief Executive Officer [Member]
Segment Reporting, CODM, Profit (Loss) Measure, How Used, Description the Company currently does not generate any revenues and its operating expenses and losses are viewed on a consolidated basis by the CODM.
v3.25.1
Segment Reporting - Summary of Disaggregated Amounts Research and Development Expenses and Segment Net Loss (Details) - USD ($)
$ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Segment Reporting Information [Line Items]    
Primary program research and development expenses [1] $ 59,325 $ 32,535
Total other research and development expenses 14,251 10,257
Research and development operating costs and expenses excluding non-cash stock-based compensation 73,576 42,792
General and administrative expense excluding non-cash stock-based compensation 19,630 12,960
Other segment income (expense), net [2] 2,675 (1,054)
Net loss (95,881) (54,698)
Payroll and Benefits [Member]    
Segment Reporting Information [Line Items]    
Total other research and development expenses 11,933 9,023
Occupancy and Other Overhead and Operating Costs [Member]    
Segment Reporting Information [Line Items]    
Total other research and development expenses $ 2,318 $ 1,234
[1] Primary program research and development expenses are comprised primarily of costs paid to third parties for clinical trials and product development manufacturing, nonclinical, regulatory, and quality assurance activities, and the portion of related research and development expenses incurred by our collaborators and third-party service providers, including contract research and manufacturing organizations that we are obligated to reimburse.
[2] Other segment income (expense), net includes interest income, interest expense, foreign currency exchange gain or loss, depreciation and amortization, non-cash stock-based compensation and tax credit income.
v3.25.1
Net Loss Per Share - Schedule of Potentially Dilutive Securities (Detail) - shares
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Earnings Per Share Basic [Line Items]    
Potentially dilutive securities 18,309,914 13,199,110
Awards under Equity Incentive Plan [Member]    
Earnings Per Share Basic [Line Items]    
Potentially dilutive securities 13,554,621 9,633,067
Nonvested Restricted Shares and Restricted Stock Units [Member]    
Earnings Per Share Basic [Line Items]    
Potentially dilutive securities 4,677,500 3,488,250
Warrants to Purchase Common Stock [Member]    
Earnings Per Share Basic [Line Items]    
Potentially dilutive securities 77,793 77,793
v3.25.1
Net Loss Per Share - Reconciles Basic Net Loss Per Share and Diluted Net Loss Per Share of Common Stock (Detail) - USD ($)
$ / shares in Units, $ in Thousands
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Earnings Per Share [Abstract]    
Net loss $ (95,881) $ (54,698)
Net loss attributable to common stockholders (95,881) (54,698)
Undistributed earnings and net loss attributable to common stockholders, basic and diluted $ (95,881) $ (54,698)
Weighted Average Number of Shares Outstanding, Basic 198,191,936 165,204,652
Weighted Average Number of Shares Outstanding, Diluted 198,191,936 165,204,652
Net loss per share, Basic $ (0.48) $ (0.33)
Net loss per share, Diluted $ (0.48) $ (0.33)
v3.25.1
Employee Benefits (Additional Information) (Detail) - USD ($)
$ in Millions
 12 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Retirement Benefits [Abstract]    
Maximum discretionary contributions to 401(k) plan in percent of each employee 100.00%  
Contributions to 401(k) plan $ 0.6 $ 0.5