Quarterly report [Sections 13 or 15(d)]

Summary of Significant Accounting Policies (Policies)

v3.26.3
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2026
Summary of Significant Accounting Policies  
Basis of Presentation

Basis of Presentation

The accompanying condensed interim consolidated financial statements are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”) for complete financial statements. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes as found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 18, 2026 (the “2025 Annual Report on Form 10-K”). In the opinion of management, the unaudited condensed interim consolidated financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The interim consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2025 balance sheet included herein was derived from the audited consolidated financial statements, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Pharmagesic, including Pharmagesic’s wholly owned subsidiary, Wex, and Wex’s wholly owned subsidiaries, IWT Bio, Inc. (“IWT”), Wex Medical Corporation (“WMC”), and Wex Medical Limited (“WML”). All intercompany accounts and transactions have been eliminated in consolidation. The Company has determined the functional currency of Pharmagesic, Wex, IWT, WMC and WML to be the Canadian dollar. The Company translates assets and liabilities of Pharmagesic, Wex, IWT, WMC and WML at exchange rates in effect at the balance sheet date with the resulting translation adjustments directly recorded as a separate component of accumulated other comprehensive income. Income and expense accounts are translated at average exchange rates for the period. Transactions which are not in the functional currency are remeasured into the functional currency and gains and losses resulting from the remeasurement are recorded in foreign currency exchange and other gain (loss), net.

Use of Estimates

Use of Estimates

The preparation of these interim condensed consolidated financial statements and accompanying notes in conformity with U.S. GAAP 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. The Company's significant estimates and assumptions include estimated work performed but not yet billed by contract manufacturers, engineers and research organizations, the valuation of equity and stock-based related instruments, the valuation allowance related to deferred taxes, the estimated fair value of the net assets acquired in connection with the business combination of Pharmagesic, including impairment of In-Process Research and Development and discount for lack of marketability, the estimated fair value of the contingent value rights (“CVRs”) given to common stockholders at the time of the business combination and subsequent reporting period assessments until the adoption of ASU 2025-07 discussed below, impairment considerations of intangible assets, the fair value of the preferred stock modification, and the fair value of the consideration provided in connection with the license agreement with Serpin Pharma. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates. Although the Company believes

that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Actual results could differ from those estimates.

Revenue Recognition

Revenue Recognition

The Company recognizes revenue from its contracts with customers under Financial Accounting Standards Board ASC 606, Revenue from Contracts with Customers. The Company’s revenue arrangements include license agreements where the Company is licensing product candidates to third parties for further development and commercialization. The Company’s license agreements include certain milestone payments as well as royalties based on future product sales. In determining the amount of revenue to be recognized under these agreements, the Company performs the following steps: (i) identifies the promised goods and services to be transferred in the contract, (ii) identifies the performance obligations, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations and (v) recognizes revenue as the performance obligations are satisfied.

The Company receives payments from its customers based on billing schedules established in the license agreement. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

Segment Information

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment. The segment consists of the development of clinical and preclinical product candidates focused on advancing novel therapeutics for pain and peripheral neuropathy associated with cancer. The Company’s chief operating decision maker (“CODM”) is the Chief Executive Officer.

The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the segment based on net loss, which is reported on the income statement as consolidated net loss. The measure of segment assets is reported on the condensed consolidated balance sheet as total consolidated assets.

To date, the Company has not generated any product revenue from its therapeutic development activities. During the three and nine months ended September 30, 2026, the Company recognized $100,000 of licensing revenue and cost of goods sold of $88,104 related to the out licensing of its IMC-1 and IMC-2 assets which are not related to the Company’s current primary therapeutic development activities. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seeks regulatory approval. As such, the CODM uses cash forecast models in deciding how to invest into the segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budget versus actual results is used in assessing performance of the segment and in establishing management’s compensation, along with cash forecast models.

Management considered whether the licensing arrangement represented a separate operating segment under ASC 280. Because the licensing activity does not constitute a separate business component for which discrete financial information is regularly available (not probable or predictable until received) and reviewed by the CODM and resource allocation decisions continue to be made on an entity-wide basis, management concluded that the Company continues to have a single operating and reportable segment as of September 30, 2026.

The table below summarizes the significant expense categories regularly reviewed by the CODM for three and nine months ended September 30, 2026 and 2025:

​

​

​

​

​

​

​

​

​

​

​

​

​

​

Three Months Ended

  ​ ​ ​

Nine Months Ended

​

September 30, 

​

September 30, 

​

2026

  ​ ​ ​

2025

  ​ ​ ​

2026

  ​ ​ ​

2025

Revenue

​

​

​

​

​

​

​

​

​

​

​

Licensing revenue

$

100,000

​

$

—

​

$

100,000

​

$

—

Total revenue

​

100,000

​

​

—

​

​

100,000

​

​

—

Cost of goods sold

​

​

​

​

​

​

​

​

​

​

​

CVR Expense

​

88,104

​

​

—

​

​

88,104

​

​

—

Total cost of goods sold

​

88,104

​

​

—

​

​

88,104

​

​

—

Gross profit

​

11,896

​

​

—

​

​

11,896

​

​

—

Operating expenses:

​

​

​

​

​

​

​

​

​

​

​

Acquired in-process research and development

$

—

​

$

12,030,667

​

$

—

​

$

12,030,667

Clinical

​

2,370,512

​

​

1,849,009

​

​

6,481,927

​

​

5,296,325

Chemical, manufacturing and controls

​

546,247

​

​

303,144

​

​

1,317,103

​

​

997,181

Research and preclinical

​

2,594

​

​

20,344

​

​

(2,309)

​

​

52,572

Regulatory

​

8,308

​

​

10,092

​

​

27,633

​

​

37,378

Other research and development costs

​

425,316

​

​

308,086

​

​

1,444,921

​

​

1,114,160

Total research and development

​

3,352,977

​

​

14,521,342

​

​

9,269,275

​

​

19,528,283

General and administrative expenses

​

1,576,219

​

​

1,287,783

​

​

5,608,915

​

​

4,633,883

IPR&D impairment

​

—

​

​

—

​

​

9,190,897

​

​

—

Total operating expenses

$

4,929,196

​

$

15,809,125

​

$

24,069,087

​

$

24,162,166

Loss from operations

​

(4,917,300)

​

​

(15,809,125)

​

​

(24,057,191)

​

​

(24,162,166)

Sublease income

​

27,241

​

​

—

​

​

64,138

​

​

—

Loss on debt conversion with related party

​

—

​

​

—

​

​

—

​

​

(6,134,120)

Interest income, net

​

42,035

​

​

80,582

​

​

185,734

​

​

44,871

Exchange loss, net

 

(35,757)

​

 

(17,509)

​

 

(72,186)

​

 

(36,251)

Net loss before income taxes

$

(4,883,781)

​

$

(15,746,052)

​

$

(23,879,505)

​

$

(30,287,666)

Concentrations of Credit Risk

Concentrations of Credit Risk

Cash and cash equivalents are potentially subject to concentrations of credit risk. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and cash equivalents are held.

Fair Value Measurements

Fair Value Measurements

The fair value of the Company’s interim condensed consolidated financial instruments is determined and disclosed in accordance with the three-tier fair value hierarchy specified in ASC Topic 820, Fair Value Measurements. The Company is required to disclose the estimated fair value of its consolidated financial instruments. As of September 30, 2026 and December 31, 2025, the Company’s consolidated financial instruments included cash, miscellaneous receivables, accounts payable, and accrued expenses which all approximate their fair values. The Company determined that the fair value of the CVRs was immaterial on the date of issuance and December 31, 2025. See further discussion below under Recently Adopted Accounting Standards for current treatment of the CVRs. See also Notes 3, 6, 9, and 11 below.

Business Combinations

Business Combinations

The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations (ASC 805), which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired. If determined to be an asset acquisition, the Company accounts for the transaction in accordance with ASC 805, Business Combinations, and ASC Subtopic 730-10, Research and Development. If the assets acquired are in-process research and development assets that are to be used in a particular research and development project and have no alternative future use, under ASC Subtopic 730-10, Research and Development, these costs along with direct transaction costs are expensed immediately.

Cash and Cash Equivalents

Cash and Cash Equivalents

Cash and cash equivalents are maintained in bank deposit accounts and money market funds that are readily convertible into cash, which exceed the federally insured limits of $250,000.

Property and Equipment

Property and Equipment

Property and equipment are carried at acquisition cost less accumulated depreciation, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable as described further under the heading "Impairment of Long-Lived Assets" below.

Depreciation and amortization are computed using the straight-line method based on the estimated useful lives of the related assets. Leasehold improvements are amortized over the term of the lease. Office equipment and furniture are depreciated over five years and computer software and equipment are depreciated over two years.

When an asset is disposed of, the associated cost and accumulated depreciation is removed from the related accounts on the Company’s consolidated balance sheet with any resulting gain or loss included in the Company's consolidated statement of operations.

Indefinite-Lived Intangible Assets

Indefinite-Lived Intangible Assets

Indefinite-lived intangible assets consist of In-Process Research and Development (“IPR&D”). The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination and for subsequent annual impairment testing. The projections used in this valuation approach are based on many factors, such as relevant market size, the estimated probability of regulatory success rates, anticipated patent protection, expected pricing, expected treated population, and estimated payments. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate.

Intangible assets with indefinite useful lives, including IPR&D, are tested for impairment whenever events or changes in circumstances indicate that the asset may be impaired and, at a minimum, annually. An entity may first perform a qualitative assessment to determine whether it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount. If, based on the qualitative assessment, the entity concludes that it is not more likely than not that the asset is impaired, no further testing is required.

The impairment test for indefinite-lived intangible assets consists of comparing the asset's fair value with its carrying amount. If the carrying amount exceeds fair value, an impairment loss is recognized for the amount of the excess. In evaluating whether an indefinite-lived intangible asset may be impaired, the Company considers various factors, including recent clinical data, expected growth rates, the cost of equity and debt capital, general economic conditions, industry outlook and market performance, and historical and forecasted financial results.

The Company performs its annual impairment assessment of indefinite-lived intangible assets, including IPR&D, on October 1 of each year and more frequently if events or changes in circumstances indicate that the asset may be impaired. The impairment test consists of a comparison of the asset's estimated fair value to its carrying value. If the carrying value exceeds the estimated fair value, the Company records an impairment charge equal to the excess.

The Company estimates the fair value of its IPR&D assets using a discounted cash flow methodology, which requires management to make significant estimates and assumptions, including the timing and costs required to complete development activities, the probability and timing of regulatory approval, future revenues and operating cash flows from the underlying asset, and the selection of an appropriate discount rate. Changes in these estimates and assumptions could have a material impact on the determination of fair value and the amount of any impairment charge.

During the first and second quarters of 2026, the Company's market capitalization declined below its stockholders' equity, which management determined represented an impairment indicator. Accordingly, the Company performed an interim impairment assessment of its indefinite-lived intangible assets as of June 30, 2026. Based on the results of that assessment, the Company concluded that the carrying value of the IPR&D asset related to CINP exceeded its estimated fair value and recognized a net non-cash impairment charge of $6.7 million during the three months ended June 30, 2026. The impairment consisted of a $9.2 million non-cash charge that was partially offset by a $2.5 million reduction in the related deferred tax liability. The impairment charge had no impact on the Company's liquidity, cash flows, or cash runway.

As of September 30, 2026, the Company's market capitalization remained below its stockholders' equity and management therefore performed an additional interim impairment assessment of its indefinite-lived intangible assets. The Company performed sensitivity analyses around certain key assumptions used in its fair value estimate of the IPR&D asset. Because the Company determined that the decline in its stock price during the third quarter of 2026 was influenced by market volatility and may not have been indicative of a sustained decrease in enterprise value, management evaluated market capitalization using various averaging periods, including 30-day, 60-day and 90-day average closing stock prices. The Company also evaluated the sensitivity of the estimated fair value to changes in the discount rate and the control premium utilized in reconciling enterprise value to fair value. Based on the results of that assessment, including updated projected cash flows for the underlying asset and consideration of the volatility in the Company's stock price during the third quarter of 2026, management concluded that the estimated fair value of the cancer related pain (“CRP”) IPR&D asset exceeded its carrying value as of September 30, 2026. Accordingly, no additional impairment charge was recognized during the three months ended September 30, 2026.

Notwithstanding the results of the September 30, 2026 impairment assessment, the IPR&D asset remains subject to significant estimation uncertainty. The Company expects to report clinical results from its CINP program during the fourth quarter of 2026. These clinical results are expected to provide important information regarding the future development and commercialization prospects of the IPR&D asset and may significantly impact management's estimates of future cash flows and fair value. Positive clinical results could support the

recoverability of the IPR&D asset's carrying value, while unfavorable clinical results could result in a decline in estimated fair value and may require the Company to recognize an additional impairment charge in future periods.

Accordingly, the IPR&D asset remains at risk of future impairment. Events and circumstances that could result in a future impairment charge include, but are not limited to, (i) a sustained decline in the Company's stock price or market capitalization, including declines in average market capitalization measures over extended periods; (ii) increases in discount rates resulting from changes in market conditions, interest rates or company-specific risk factors; (iii) changes in assumptions regarding control premiums or other valuation inputs; (iv) adverse clinical trial results, including the anticipated fourth-quarter 2026 CINP data readout; (v) delays in, or failure to obtain, regulatory approval; (vi) unfavorable changes in projected cash flows, development costs or commercialization assumptions; and (vii) the emergence of competing therapies or changes in the standard of care for chemotherapy-induced neuropathic pain. If one or more of these events occur, the Company could be required to recognize additional material non-cash impairment charges in future periods.

No impairment of indefinite-lived intangible assets was recognized during the year ended December 31, 2025.

Goodwill

Goodwill

Goodwill represents the excess of the purchase consideration transferred over the fair value of the net assets acquired in business combinations accounted for under the acquisition method of accounting. The Company's acquired intangible assets primarily consisted of IPR&D, which was recorded as an indefinite-lived intangible asset on the accompanying condensed consolidated balance sheet. A deferred tax liability was recognized for the difference between the fair value of the acquired IPR&D and its tax basis, with a corresponding amount recognized as goodwill.

Goodwill is not amortized but is tested at the reporting unit level annually on October 1 and between annual tests whenever events or changes in circumstances indicate that the carrying amount of a reporting unit may exceed its fair value. The Company may first perform a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, no further testing is required.

During the first and second quarter of 2026, the Company's market capitalization declined below its stockholders' equity, which management determined represented a triggering event. As a result, the Company performed a quantitative goodwill impairment assessment as of June 30, 2026. The Company estimated the fair value of its reporting unit using a combination of income and market approaches, including the application of an estimated control premium. Based on the results of this assessment, the Company concluded that the fair value of the reporting unit exceeded its carrying amount and, accordingly, no goodwill impairment was recognized.

As of September 30, 2026, the Company's market capitalization remained below its stockholders' equity. Management therefore considered whether additional indicators of impairment existed and evaluated the carrying value of the reporting unit. Based on this evaluation, including consideration of the volatility in the Company's stock price during the third quarter of 2026 and the results of its updated fair value analyses, management concluded that the fair value of the reporting unit continued to exceed its carrying amount. Accordingly, no goodwill impairment was recognized during the three or nine months ended September 30, 2026.

Although management concluded that the fair value of the reporting unit exceeded its carrying amount as of September 30, 2026, the excess has declined since the Company's most recent annual impairment assessment. As a result, goodwill remains at risk of future impairment. The fair value estimate is sensitive to changes in key assumptions, including projected cash flows, forecasted revenues, the timing and probability of

regulatory approvals, expected development costs, and discount rates. A sustained decline in the Company's stock price or market capitalization, unfavorable changes in clinical or regulatory expectations, adverse changes in market conditions, or reductions in projected cash flows could materially reduce the estimated fair value of the reporting unit. If actual results differ from management's estimates or if market conditions deteriorate, the Company could be required to recognize a material non-cash goodwill impairment charge in future periods.

Operating Lease Right-of-use Asset and Lease Liability

Operating Lease Right-of-use Asset and Lease Liability

The Company accounts for leases under ASC 842, Leases. Operating leases are included in “Right-of-use assets” within the Company’s condensed consolidated balance sheets and represent the Company’s right to use an underlying asset for the lease term. The Company’s related obligation to make lease payments is included in “Lease liability” and “Lease liability, net of current portion” within the Company’s condensed consolidated balance sheets. Operating lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The ROU assets are tested for impairment according to ASC 360, Property, Plant, and Equipment (“ASC 360”). Leases with an initial term of 12 months or less are not recorded on the balance sheet and are recognized as lease expense on a straight-line basis over the lease term.

As of September 30, 2026 and December 31, 2025, the Company’s operating lease ROU assets and corresponding short-term and long-term lease liabilities primarily relate to the operating lease for an office in Vancouver, British Columbia, that was acquired as part of the Combination with Pharmagesic. The office lease expires on August 31, 2028.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

In accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets, the Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable (i.e., impaired). Once an impairment is determined, the actual impairment recognized is the difference between the carrying amount and the fair value (less costs to sell for assets to be disposed of) as estimated using one of the following approaches: income, cost, and/or market. Fair value using the income approach is determined primarily using a discounted cash flow model that uses the estimated cash flows associated with the asset or asset group under review, discounted at a rate commensurate with the risk involved. Fair value utilizing the cost approach is determined based on the replacement cost of the asset reduced for, among other things, depreciation and obsolescence. Fair value utilizing the market approach benchmarks the fair value against the carrying amount.

Redeemable and Convertible Preferred Stock

Redeemable and Convertible Preferred Stock

The Company applies ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ (deficit) equity. See Note 11 to these condensed consolidated financial statements.

Warrants

Warrants

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and in accordance with the Financial Accounting Standards

Board (“FASB”) ASC 480 and ASC 815 “Derivatives and Hedging” ("ASC 815"). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance.

For issued warrants that meet all of the criteria for equity classification, the warrants are recorded as a component of additional paid in capital at the time of issuance. For issued warrants that do not meet all the criteria for equity classification, the warrants are recorded at their initial fair value of the date of issuance, and each balance sheet date thereafter. Changes in the estimated fair value of liability classified warrants are recognized as a non-cash gain or loss on the consolidated statements of operations. Costs associated with issuing the warrants classified as derivative liabilities are charged to operations when the warrants are issued.

Net Income (Loss) per Common Share Applicable to Common Stockholders

Net Income (Loss) per Common Share Applicable to Common Stockholders

The Company uses the two-class method to compute net income per common share during periods the Company realizes net income and has securities outstanding that entitle the holder to participate in dividends and earnings of the Company. In addition, the Company analyzes the potential dilutive effect of outstanding participating securities under the "if-converted" method when calculating diluted earnings per share and reports the more dilutive of the approaches (two class or "if-converted"). The two-class method is not applicable during periods with a net loss, as the holders of participating securities have no obligation to fund losses.

Basic and Diluted Net Loss per Share

Basic and Diluted Net Loss per Share

Basic net loss per common share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during the period including shares issuable for little to no consideration upon the exercise of certain equity-classified warrants. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period increased by the number of additional common shares that would have been outstanding if all potential common shares had been issued and were dilutive. However, potentially dilutive securities are excluded from the computation of diluted EPS to the extent that their effect is anti-dilutive. For the three and nine months ended September 30, 2026 and 2025, the Company had options to purchase 1,857,927 and 188,130 shares of Common Stock, respectively, warrants to purchase 4,386,892 and 7,755 shares of Common Stock, respectively, and preferred shares which may convert into none and 27,434,704 shares, of Common Stock, respectively, outstanding that were anti-dilutive.

Recently Adopted Accounting Standards and Recent Accounting Pronouncements

Recently Adopted Accounting Standards

In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. ASU 2025-07 refines the scope of derivative accounting under Topic 815 for certain non-exchange-traded arrangements whose settlement is based on the operations or activities of one of the parties to the contract. The ASU also clarifies the accounting for certain share-based noncash consideration received from a customer under Topic 606. The amendments in ASU 2025-07 are effective for annual periods beginning after December 15, 2026, and interim periods within those annual periods. Early adoption is permitted, including adoption in an interim period. The Company early adopted ASU 2025-07 as of April 1, 2026, on a modified retrospective basis. In October 2024, the Company issued CVRs to its shareholders that entitle holders to receive a portion of future cash proceeds, if any, related to the licensing of certain assets. In April 2026, the Company entered into a license agreement related to the underlying assets (the PRIDCor License Agreement). The Company has determined that each of the contingent payment streams under that agreement, if and when received, would constitute a Milestone Payment under the CVR Agreement, with 87.75% of any gross amount received payable to CVR Holders. Cash payments under the license agreement remain contingent upon future events specific to the agreement and the underlying

receipts are not yet probable and reasonably estimable; accordingly, no CVR liability has been accrued. The adoption of ASU 2025-07 as of April 1, 2026 did not have a material impact on the Company’s condensed consolidated financial statements, as the Company had no derivative liabilities recognized at adoption. The Company concluded that as a result of the adoption of ASU 2025-07, the CVRs are no longer in the scope of ASC 815 and instead should be accounted for as potential liabilities under ASC 450.  During the three and nine months ended September 30, 2026, the Company received and recognized $100,000 in licensing revenue and a corresponding $88,104 in cost of goods sold related to the corresponding payment to the CVR Holders under the CVR Agreement and Rights Agent expenses. See Note 6 and Note 11 for further discussion.

Recent Accounting Pronouncements

In April 2026, the FASB issued ASU 2026-01, Equity (Topic): Initial Measurement of Paid-in-Kind Dividends on Equity-Classified Preferred Stock, which provides guidance on the initial measurement of paid-in-kind ("PIK") dividends on equity-classified preferred stock. The amendments require an entity to initially measure PIK dividends using the dividend rate specified in the applicable preferred stock agreement and are intended to reduce diversity in practice. The guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the effect of adopting this standard on its consolidated financial statements and related disclosures. The Company does not currently have any outstanding equity-classified preferred stock instruments with paid-in-kind dividend features and, therefore, does not expect the adoption of this guidance to have a material impact on its consolidated financial statements.

In December 2025, the FASB issued ASU 2025-12, Codification Improvements. The amendments in this update are effective for all entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance. If an entity adopts the amendments in this update in an interim period, it must adopt them as of the beginning of the annual reporting period that includes that interim reporting period. An entity may elect to early adopt the amendments on an issue-by-issue basis. An entity should apply the amendments in this update (except for the amendments to Topic 260, Earnings Per Share) using either (i) prospectively to all transactions recognized on or after the date that the entity first applies the amendments or (ii) retrospectively to the beginning of the earliest comparative period presented, and should adjust the opening balance of retained earnings as of the beginning of the earliest comparative period presented. For the amendments in this update to Topic 260, an entity should apply the amendments retrospectively to each prior reporting period presented in the period of adoption. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which improves disclosures about an entity’s expenses and addresses requests from investors for more detailed information about types of expenses including purchases of inventory, employee compensation, depreciation, amortization, and depletion, commonly presented in cost of sales, research and development and general and administrative expenses. In January 2025, the FASB issued ASU 2025-01 which revises the effective date of ASU 2024-03. Adoption of these new disclosure requirements is effective for public entities for annual reporting periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027 and early adoption is permitted.  The Company is currently evaluating the impact of this ASU on its consolidated financial statements.  

In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity, to improve the requirements for identifying the accounting acquirer in Topic 805, Business Combinations. The amendments in ASU 2025-03 revise current guidance for determining the accounting acquirer for a transaction effected primarily by exchanging equity interests in which the legal acquiree is a variable interest entity (“VIE”) that meets the definition of a business. The amendments require that an entity consider the same factors that are

currently required for determining which entity is the accounting acquirer in other acquisition transactions. Entities will be required to apply the new guidance prospectively to any acquisition transaction that occurs after the initial application date. Adoption of this guidance is effective for all entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods and early adoption is permitted as of the beginning of an interim or annual reporting period. The Company is currently evaluating the impact of this ASU on its consolidated financial statements.

Subsequent Event

Subsequent Event

Subsequent to September 30, 2026, on October 19, 2026, the Company entered into a securities subscription agreement (the “Subscription Agreement”) with its largest shareholder, Sealbond Limited (“Sealbond”). Pursuant to the terms of the Subscription Agreement, the Company issued an aggregate of 4,098,360 shares of Common Stock at a price of $1.22 per share (the “October 2026 Offering”) for gross proceeds to the Company of approximately $5 million. No warrants or other derivative securities were included in the transaction. The transaction closed on October 26, 2026. In addition to the Subscription Agreement, the Company entered into a registration rights agreement with Sealbond, whereby the Company agreed to register the shares issued in the private placement within 15 days following the date of the registration agreement.

On October 30, 2026, the Company filed a Form S-3 Registration Statement for the resale of 4,098,360 shares of the Company's Common Stock for the Sealbond private placement. At the time of this filing, the registration statement had not been declared effective.