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Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2025
Accounting Policies [Abstract]  
Reverse Stock Split [Policy Text Block]

Reverse Stock Split - On March 22, 2024, the Company completed a reverse stock split of all the issued and outstanding shares of the Company’s common stock at a ratio of 1 to 15. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. Certain amounts previously reported include rounding up of fractional shares as a result of the reverse stock split.

 

Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the US (US GAAP) for financial information, and in accordance with the rules and regulations of the US Securities and Exchange Commission (SEC) with respect to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of  December 31, 2024 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 21, 2025.

 

Consolidation, Policy [Policy Text Block]

Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the United States. In accordance with FASB ASC Topic 280, Segment Reporting, the Company views its operations and manages its business as one segment. As a result, the financial information disclosed herein represents all of the material financial information related to its principal operating segment.

 

Segment Reporting, Policy [Policy Text Block]

Segment Information - Management has determined that the Company operates in one reportable segment, which is the development and commercialization of drug products. The Company's chief operating decision maker (CODM) is its Chief Executive Officer and Chairman, who reviews financial information presented on a consolidated basis. The CODM primarily uses consolidated net loss, which is also reported on the Consolidated Statements of Operations and Comprehensive Loss as net loss, to assess financial performance and allocate resources. These financial metrics are used by the CODM to make key operating decisions, such as the assessment of segment performance and allocation of resources. The significant expense categories within net loss from operations that the CODM regularly reviews are research and development expenses and general and administrative expenses. The significant expense categories and subcategories are reported on the Consolidated Statements of Operations and Comprehensive Loss. Other expenses included in the Company’s net loss include change in fair value of warrant liabilities, other income (expense), interest income, net, and any additional non-operating expenses that are reported on the Consolidated Statements of Operations and Comprehensive Loss. 

 

Use of Estimates, Policy [Policy Text Block]

Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes. 

 

Going Concern Policy [Policy Text Block]

Going Concern and Liquidity - These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary equity financing to continue operations and the attainment of profitable operations. As of  September 30, 2025, the Company had an accumulated deficit of $221.6 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $6.7 million as of September 30, 2025 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company intends to seek additional funding through one or more of the following: a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can be no assurance that such events or a combination thereof can be achieved.

 

 In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID-19. The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter. The Company is not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures. The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security. The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation. The Company's expenses for the three and nine months ended September 30, 2025, were not material. The Company expensed approximately $0.1 million and $0.2 million in related general and administrative fees and expenses for the three and nine months ended September 30, 2024, respectively. The Company has not hit the retention limits, so no reimbursement is expected. Accordingly, the Company has not recorded any provision for insurance reimbursement as of September 30, 2025.

 

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash and Cash Equivalents - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains cash accounts principally at one financial institution in the US, which at times, may exceed the Federal Deposit Insurance Corporation’s limit. The Company has not experienced any losses from cash balances in excess of the insurance limit. The Company’s management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held. 

 

Goodwill and Intangible Assets, Intangible Assets, Policy [Policy Text Block]

Intangible Assets – Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. Acquired intangible assets identified as in-process research and development (IPR&D) assets, are considered indefinite lived until the completion or abandonment of the associated research and development efforts. If the associated research and development effort is abandoned, the related IPR&D assets will be written off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, which was completed as of September 30, 2025, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. The Company evaluates the recoverability of intangible assets periodically and takes into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented.

 

Prepaid Expenses and Other Current Assets [Policy Text Block]

Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):

 

  

September 30, 2025

  

December 31, 2024

 

Prepaid insurance

 $786  $554 

Vendor prepayments and deposits

  367   331 

Prepaid sponsored research

  23   11 

Related party receivables

  4   4 

Non-trade receivables

  2   16 

Total prepaid expenses and other current assets

 $1,182  $916 

 

Other Non-Current Assets [Policy Text Block]

Other Non-Current Assets - The Company provided a cash deposit on the MB-108 trial that is expected to be held as a prepayment until the end of the study in 2029.

 

Fair Value of Financial Instruments, Policy [Policy Text Block]

Fair Value of Financial Instruments - The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.

 

The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with US GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3).

 

Assets and liabilities recorded in the condensed consolidated balance sheets at fair value are categorized based on a hierarchy of inputs as follows:

 

Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities.

Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.

Level 3 – Unobservable inputs for the asset or liability.

 

The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note 4.

 

The following table provides the financial liabilities reported at fair value and measured on a recurring basis at September 30, 2025 and December 31, 2024 (table in thousands): 

 

Description

 

Fair Value

  

Level 1

  

Level 2

  

Level 3

 

Fair value of warrant liability as of September 30, 2025:

 $41,333  $  $  $41,333 

Fair value of warrant liability as of December 31, 2024:

 $  $  $  $ 

 

The table below of Level 3 liabilities (table in thousands) begins with the valuation as of the beginning of the third quarter and then is adjusted for changes in fair value that occurred during the third quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments. 

 

Three Months Ended September 30, 2025

 

Warrant Liability Long-Term

 

Balance, June 30, 2025

 $16,830 

Warrants issued

  30,585 

Warrants exercised

  (4,491)

Change in fair value - net

  (1,591)

Balance, September 30, 2025

 $41,333 

 

The table below of Level 3 liabilities (table in thousands) begins with the valuation as of  December 31, 2024 and then is adjusted for changes in fair value that occurred during the nine months ended September 30, 2025. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and  may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.

 

Nine Months Ended September 30, 2025

 

Warrant Liability Long-Term

 

Balance, December 31, 2024

 $ 

Warrants issued

  46,855 

Warrants exercised

  (4,491)

Change in fair value - net

  (1,031)

Balance, September 30, 2025

 $41,333 

 

Earnings Per Share, Policy [Policy Text Block]

Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended September 30, 2025 and 2024, approximately 85.7 million and 4.8 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect. For the nine months ended September 30, 2025 and 2024, approximately 41.7 million and 2.7 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect.

 

Subsequent Events, Policy [Policy Text Block]

Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements. See Note 8. Subsequent Events included in these unaudited condensed financial statements.

 

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements - In November 2024 and January 2025, FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures, but expects additional disclosures upon adoption.

 

In December 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance is effective for the annual periods beginning after the year ended December 31, 2024. There was no material impact upon adoption of ASU 2023-09 on the Company's interim disclosures.

 

There are no other effective pronouncements, or pronouncements issued but not yet effective, if adopted, that would have a material effect on the accompanying financial statements.

 

Change in Accounting Policy - During the quarter ended September 30, 2025, the Company changed its accounting policy related to the classification of certain outstanding warrants. Prior to the change in accounting policy, the Company's policy was to account for warrants with a certain contingent settlement provision as liability warrants, initially measuring them at fair value on the date of issuance. The warrants were previously remeasured at fair value at the end of each reporting period, with the related liability reflected on the Company's balance sheet. The changes in fair value during each previous reporting period were recognized as a gain (loss) from change in fair value of warrant liability in the Company's condensed consolidated statement of operations. The Company has changed its policy and warrants that contain this certain contingent settlement provision will now be accounted as equity under ASC 815-40-15-7C through 15-7F and ASC 505. The Company concluded that accounting for its warrants as equity instruments is preferable under ASC 250, as equity classification better reflects the economic substance of the arrangement and enhances the clarity and consistency of the Company's financial reporting. As a result of this change in accounting policy, all warrants issued prior to 2025, and certain warrants issued in 2025, that were previously accounted for as liability awards due to the certain contingent settlement provision will now meet the equity classification criteria under ASC 815-40 and will be classified as equity instruments. The effects of the change in accounting policy from warrant liabilities to equity have been retrospectively applied to all periods presented in these condensed consolidated financial statements. Certain warrants issued in 2025 will continue to be classified as a liability as these warrants contain features other than the contingent settlement provision that cause liability classification. See also Note 4 - Warrants and Equity

 

As a result of the change in accounting policy, the Company adjusted accumulated deficit, and additional paid-in capital to reverse previously recorded mark-to-market fair value changes of the liability-classified warrants. Warrants classified as liability warrants were adjusted retrospectively from January 2017 to June 2025, and beginning balances have been adjusted for the policy change to equity warrant classifications. Accumulated deficit as of January 1, 2024, changed from $131.6 million, as reported under the liability classification, to $146.4 million under the equity classification.

 

The following financial statement line items were impacted by the change in accounting policy, as shown in the tables below (in thousands, except per common share data):

 
  

September 30, 2025

  

December 31, 2024

 
  

 

  

As Reported

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  Under Old Policy  Under New Policy  Change  Under Old Policy  Under New Policy  Change 

Condensed Consolidated Balance Sheets

                        

Warrant liability - long-term

 $48,660  $41,333  $(7,327) $5,229  $  $(5,229)

Total liabilities

  54,600   47,273   (7,327)  10,946   5,717   (5,229)

Additional paid-in capital

  162,337   194,631   32,294   159,384   183,690   24,306 

Accumulated deficit

  (196,589)  (221,556)  (24,967)  (153,367)  (172,444)  (19,077)

Total stockholders' equity (deficit)

  (34,247)  (26,920)  7,327   5,979   11,208   5,229 

Total liabilities and stockholders' equity (deficit)

  20,353   20,353      16,925   16,925    

 

  

March 31, 2025

  

June 30, 2025

 
  

As Reported

  

As Adjusted

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  

Under Old Policy

  

Under New Policy

  

Change

  

Under Old Policy

  

Under New Policy

  

Change

 

Condensed Consolidated Balance Sheets

                        

Warrant liability - long-term

 $13,749  $  $(13,749) $20,553  $16,973  $(3,580)

Total liabilities

  20,971   7,222   (13,749)  28,758   25,178   (3,580)

Additional paid-in capital

  159,869   192,163   32,294   160,286   192,580   32,294 

Accumulated deficit

  (159,803)  (178,348)  (18,545)  (167,443)  (196,157)  (28,714)

Total stockholders' equity (deficit)

  42   13,791   13,749   (7,165)  (3,585)  3,580 

Total liabilities and stockholders' equity (deficit)

  21,013   21,013      21,593   21,593    

 

  Three Months Ended  Three Months Ended 
  

September 30, 2025

  

September 30, 2024

 
  

 

  

As Reported

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  

Under Old Policy

  

Under New Policy

  

Change

  

Under Old Policy

  

Under New Policy

  

Change

 

Condensed Consolidated Statement of Operations

      

Gain (loss) from change in fair value of warrant liability

 $(2,157) $1,591  $3,748  $(1,728) $  $1,728 

Transaction costs allocated to warrant liabilities

  (530)  (530)     (993)     993 

Loss on issuance of warrant liabilities

  (20,609)  (20,609)     (847)     847 

Net loss

  (29,147)  (25,399)  3,748   (10,592)  (7,024)  3,568 

Net loss per common share - basic and diluted

  (0.78)  (0.68)  0.10   (2.85)  (1.89)  0.96 

Other comprehensive income (loss)

  (29,153)  (25,405)  3,748   (10,578)  (7,010)  3,568 

 

  Nine Months Ended  Nine Months Ended 
  

September 30, 2025

  

September 30, 2024

 
  

 

  

As Reported

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  

Under Old Policy

  

Under New Policy

  

Change

  

Under Old Policy

  

Under New Policy

  

Change

 

Condensed Consolidated Statement of Operations

      

Gain (loss) from change in fair value of warrant liability

 $16,506  $1,031  $(15,475) $1,423  $  $(1,423)

Transaction costs allocated to warrant liabilities

  (3,525)  (1,737)  1,788   (993)     993 

Loss on issuance of warrant liabilities

  (38,760)  (30,962)  7,798   (847)     847 

Net loss

  (43,223)  (49,112)  (5,889)  (19,881)  (19,464)  417 

Net loss per common share - basic and diluted

  (2.08)  (2.36)  (0.28)  (6.83)  (6.69)  0.14 

Other comprehensive income (loss)

  (43,226)  (49,115)  (5,889)  (19,868)  (19,451)  417 

 

  

Three Months Ended

  

Three Months Ended

 
  

June 30, 2025

  

June 30, 2024

 
  

As Reported

  

As Adjusted

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  

Under Old Policy

  

Under New Policy

  

Change

  

Under Old Policy

  

Under New Policy

  

Change

 

Condensed Consolidated Statement of Operations

                        

Gain (loss) from change in fair value of warrant liability

 $9,609  $(560) $(10,169) $1,696  $  $(1,696)

Transaction costs allocated to warrant liabilities

  (1,207)  (1,207)            

Loss on issuance of warrant liabilities

  (10,352)  (10,352)            

Net loss

  (7,640)  (17,809)  (10,169)  (4,319)  (6,015)  (1,696)

Net loss per common share - basic and diluted

  (0.49)  (1.15)  (0.66)  (1.70)  (2.37)  (0.67)

Other comprehensive loss

  (7,640)  (17,809)  (10,169)  (4,311)  (6,007)  (1,696)

 

  

Six Months Ended

  

Six Months Ended

 
  

June 30, 2025

  

June 30, 2024

 
  

As Reported

  

As Adjusted

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  Under Old Policy  Under New Policy  Change  Under Old Policy  Under New Policy  Change 

Condensed Consolidated Statement of Operations

                        

Gain (loss) from change in fair value of warrant liability

 $18,663  $(560) $(19,223) $3,151  $  $(3,151)

Transaction costs allocated to warrant liabilities

  (2,995)  (1,207)  1,788          

Loss on issuance of warrant liabilities

  (18,150)  (10,352)  7,798          

Net loss

  (14,076)  (23,713)  (9,637)  (9,289)  (12,440)  (3,151)

Net loss per common share - basic and diluted

  (1.13)  (1.90)  (0.77)  (3.71)  (4.97)  (1.26)

Other comprehensive loss

  (14,073)  (23,710)  (9,637)  (9,290)  (12,441)  (3,151)

 

  

Three Months Ended

  

Three Months Ended

 
  

March 31, 2025

  

March 31, 2024

 
  

As Reported

  

As Adjusted

  

Effect of

  

As Reported

  

As Adjusted

  

Effect of

 
  

Under Old Policy

  

Under New Policy

  

Change

  

Under Old Policy

  

Under New Policy

  

Change

 

Condensed Consolidated Statement of Operations

                        

Gain from change in fair value of warrant liability

 $9,054  $  $(9,054) $1,455  $  $(1,455)

Transaction costs allocated to warrant liabilities

  (1,788)     1,788          

Loss on issuance of warrant liabilities

  (7,798)     7,798          

Net loss

  (6,436)  (5,904)  532   (4,970)  (6,425)  (1,455)

Net loss per common share - basic and diluted

  (0.69)  (0.63)  0.06   (2.02)  (2.61)  (0.59)

Other comprehensive loss

  (6,433)  (5,901)  532   (4,979)  (6,434)  (1,455)

 

The change in accounting policy did not have a material effect on the statement of cashflows for any current or prior period presented.