SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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| Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Use of Estimates | Use of Estimates
The preparation of financial statements in conformity with U. S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.
The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax asset and related valuation allowance, and fair value of financial instruments.
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| Cash and Restricted Cash | Cash and Restricted Cash
As of June 30, 2026, and December 31, 2025, the Company held all its cash in banks in the United States of America. The Company considers investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of June 30, 2026, and December 31, 2025. Restricted cash consists of certificates of deposits held at banks as collateral for various purposes.
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| Debt issuance Costs and Debt discount | Debt issuance Costs and Debt discount
Issuance costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination of the instrument’s initial net carrying amount.
Debt issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.
If the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled debt restructuring.
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| Fair Value of Financial Instruments | Fair Value of Financial Instruments
The carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is 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 (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.
The three levels of the fair value hierarchy defined by ASC 820 are as follows:
The Company did not have any Level 1 or Level 2 assets or liabilities at June 30, 2026 and December 31, 2025.
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| Investment in equity securities | Investment in equity securities
The Company holds equity investments in GMP Bio and Lunai Bioworks Inc. that do not result in a controlling financial interest or significant influence. The Company has elected the fair value option under ASC 825, Financial Instruments. Consequently, these investment are carried at fair value on the unaudited Condensed Consolidated Balance Sheets, with all subsequent changes in fair value recognized immediately in earnings under ASC 321. Unrealized gains and losses resulting from changes in fair value are reported within other income (expense), net on the unaudited Condensed Consolidated Statements of Operations. Below is the change in the fair value of the Company’s equity investments for the six months ended June 30, 2026 and the Audited Consolidated Statements of Operations for the year ended December 31, 2025:
The table above sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level 3 fair value as of June 30, 2026 and December 31, 2025. During the year ended December 31, 2025, there was a change in the long-term value of the Company’s investment in equity securities of GMP Bio and as such has been recorded as above. No similar change in fair value has been recorded in the long-term value of the GMP Bio investment during the six months ended June 30, 2026 as the Company has not observed any qualitative conditions required to record any further changes to the fair value. For more information, see Change in Fair Value of Equity Securities of GMP Bio below.
In addition, the Company recorded a $1.1 million initial non-cash gain in exchange for a non-financial asset and a $0.3 million gain from the change in the fair value of the Company’s equity securities in Lunai received during the three and six months ended June 30, 2026. No similar gains were recorded during the comparable periods in prior year. For more information, see Note 9 – Lunai Bioworks Transactions below.
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| Change in Fair Value of Equity Securities of GMP Bio | Change in Fair Value of Equity Securities of GMP Bio
On March 31, 2022, the Company entered into the JV with Dragon, contributing a license agreement for rights to OT-101for the territory within the United States of America with Sapu Holdings, LLC, a wholly owned subsidiary of GMP Bio and a license agreement for rights to OT-101 for the rest of the world with GMP Bio. For more information on the JV and the related agreements, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 19, 2023. As of the effective date of the formation of the JV, the Company received a 45% ownership interest in the JV. The combined enterprise value of GMP Bio, on the date of the formation of the JV, was approximately $50.4 million, comprising of the fair value of the Company’s investment in GMP Bio of approximately $22.7 million and the total original capital contributions by Dragon Overseas of approximately $27.7 million. As of December 31, 2024, the carrying value of the Company’s investment in GMP Bio was approximately $22.7 million, which was included in Investment in GMP Bio at fair value on the unaudited condensed consolidated balance sheets.
The investment in GMP Bio has been accounted for under the fair value method of accounting. Similarly, during the year ended December 31, 2025, the Company determined that a remeasurement of its investment to fair value was appropriate. All the factors described below allowed the Company to form a basis for a triggering event of significant development for the JV and justified the JV, and consequently the Company, to reassess the fair value of the JV.
The JV’s principal activities centered on the commercialization of OT-101 for certain oncology indications in the US and looking at other territories as well. In March 2025, the JV successfully completed a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101, an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFβ2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”). The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors. The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified. Based on the favorable safety data, the JV plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers. The JV is also sponsoring investigator-initiated studies for OT-101 for other oncology indications including lung cancer (non-small cell lung cancer- NSCLC- and Mesothelioma.- MPM) and has started clinical development for OT-101 for pancreatic cancer. Over ten patent families have been filed exploiting the central role of TGFB2 as prognostic indicator for cancer survival and one patent family for the intracranial delivery device of brain cancer with issued patent in China and Germany.
In addition to OT-101, the JV has developed a nanoparticle platform (“Nano Platform”) that entails the formulation of products in new nanoparticle sizes. The JV anticipates that the Nano Platform may offer superior platform for the absorption of water insoluble drugs across a broad spectrum of cancers. The JV is working on improved formulations for OT-101 with new nanoparticle sizes. In addition, the JV has identified five additional compounds as product candidates on the Nano Platform, including the following:
The DeciparticleTM platform has proven robust and is being expand to other drug candidates through partnering. The platform is protected by more than 15 patent families covering chemical composition, manufacturing, and method of use.
The JV built a GMP manufacturing facility in San Diego, California (the “San Diego Facility”). In late 2024, the San Diego Facility was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. A significant portion of the manufacturing for the Nano Platform, including the development of Phase I clinical trial materials, is conducted at the San Diego Facility. Evaluation of larger commercial scale manufacturing is ongoing.
In early 2025, the Company entered into a strategic partnership with Shanghai Medicilon, Inc. (“Medicilon”) to access its industry-leading rapid IND development platform to support up to 20 IND projects, including INDs developed by the JV. All six of the compounds that the JV is developing are planned to be initiated under these INDs, and are focused on next-generation anticancer agents.
During the year ended December 31, 2025, GMP Bio completed an independent third-party valuation by an offshore independent valuation firm, which preliminarily estimated the potential value of the drug pipeline under development at approximately $2.3 billion. This valuation was a non-binding, forward-looking, and based upon a number of assumptions including the successful achievement of clinical, regulatory, and commercial milestones. That valuation was interpreted not to be a current measure of fair value under U.S. GAAP. Although no assurances can be given, GMP Bio currently intends to conduct an initial public offering of the JV, at a future date, on either the Hong Kong Exchange or other stock exchange. For more information on the JV, refer to Note 6 of the unaudited Notes to the unaudited Condensed Consolidated Financial Statements.
The Company then conducted its own independent assessment of the valuation of the JV. The basis for the valuation was reliance on the valuation report of the third party offshore valuation firm, including the financial projection, risks and parameters of assessment as done by the offshore independent valuation firm, and then applying additional independent parameters, like discounts for lack of marketability and lack of control, and other standard discounts, required to adhere to the ASC-compliant standards as generally used in the United States. The Company hired the services of an independent, ASC-compliant valuation firm to review, perform and validate the assumptions considered by the Company and provide an ASC-compliant valuation of the JV under U.S. GAAP standards. The valuation conducted by the independent ASC-compliant valuation firm of the JV was based on various methods compliant with ASC and U. S. GAAP to derive the fair value. The Company then utilized the fair value of GMP Bio, as assessed by the ASC-compliant valuation firm, attributed the ownership percentage of the Company in GMP Bio, to ascertain the Company’s interest in GMP Bio and recorded the resulting gain to the investment in GMP Bio at fair value. As the circumstances related to the JV have not materially changed since December 31, 2025, the Company assessed and determined that no additional fair value adjustment was required during the six months ended June 30, 2026, and hence, the Company has not recorded a change in value of the Company’s interest in the JV. The Company will appropriately adjust the fair value of the interest of the Company’s interest in the JV at the end of future reporting periods and when key value inflection points are met.
As many of the inputs considered for the purpose of the valuation are unobservable inputs including, but not limited to, the potential revenue projections, the probability of success, the conduct of the clinical trials under accelerated timelines of approvals by the territorial regulatory bodies similar to the 505(b)(2) pathway under the US FDA regulations, the timing of completion of the clinical trials and approvals of the products, timing of product launches, estimates for working capital, additional research and development and general and administrative expenses, estimated tax rates, interest rates of potential debt and many others. The fair value of the Company’s investment was determined in accordance with ASC 820 Fair Value Measurement and is classified within Level 3 of the fair value hierarchy due to the use of significant unobservable inputs. The valuation was performed with the assistance of an independent third-party valuation specialist and utilized an income approach (discounted cash flow method) and market-based approach (guideline public company multiples) and recent transactions, where available, to corroborate the results of the income approach. The final value was then arrived at by calculating the average of the values under the two approaches. The income approach of valuation incorporates assumptions that market participants would use in pricing the asset, including estimates of future financial performance and the selection of an appropriate discount rate. As the circumstances related to the JV have not materially changed since December 31, 2025, and June 30, 2026, the Company assessed and determined that no additional fair value adjustment was required and hence, the Company has not recorded a change in value of the Company’s interest in the JV.
Fair Value Hierarchy – GMP Bio
The Company’s investment in the JV is classified within Level 3 of the fair value hierarchy under ASC 820 Fair Value Measurement due to the use of significant unobservable inputs, including projected cash flows and discount rates.
The fair value measurement was determined on a recurring basis as of June 30, 2026, and December 31, 2025. There were no transfers between Levels 1, 2, or 3 during the period.
The following table presented the fair value of the Company’s investment in the JV by level within the fair value hierarchy as June 30, 2026:
Quantitative Information about significant unobservable inputs (Level 3):
The projected revenue growth rates reflected an initial period of accelerated growth associated with the commercialization and market adoption of one product followed by additional products, subsequently followed by a gradual decline as the business matures and reaches a more stable and then stagnant growth phase as generics enter the market. The pharmaceutical industry often exhibits a financial profile characterized by initially negative EBIT margins, transitioning to high or blockbuster EBIT margins over financial projections. This J-curve trajectory is driven by extreme R&D costs, long development timelines and regulatory protection for a successful drug. The discount rate of 21.4% reflects management’s estimate of the JV’s weighted-average cost of capital, considering its early-stage nature, which to a great extent is mitigated by the expedited regulatory pathway to approval that the Company is planning under the 505(b)(2), for all the market risk, and company-specific risk factors. The significant unobservable inputs used in the fair value measurement are inherently uncertain and reflect management’s judgment about the assumptions market participants would use in pricing the asset. The terminal growth rate reflects long-term expectations for the business beyond the projection period. Increases (decreases) in revenue growth rates, EBIT margins, or terminal growth rates could result in a higher (lower) fair value, while increases (decreases) in the discount rate would result in a lower (higher) fair value.
Sensitivity and Measurement Uncertainty
The fair value of the Company’s investment in the JV is based on significant unobservable inputs and, as a result, is subject to substantial measurement uncertainty. Changes in key assumptions could result in a materially different fair value. For example, a 100 basis point increase in the discount rate could result in a decrease in the estimated fair value of approximately $120 million. The valuation is derived from projected future cash flows, which are inherently uncertain and subject to change due to, among other factors:
Given the early-stage nature of the JV and the absence of an active market for its equity interests, the fair value measurement is particularly sensitive to changes in key assumptions, including projected revenue growth rates, profitability, and the discount rate. Accordingly, actual results could differ materially from those reflected in the valuation, and such differences could have a material impact on the Company’s financial position and results of operations in future periods. The valuation does not represent a guaranteed realizable value and may differ significantly from amounts that could be realized in an actual transaction.
Restrictions on Transfer
The Company’s ownership interest in the Joint Venture is subject to certain contractual restrictions on transfer under the JV Agreement. In accordance with ASU 2022-03 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, such restrictions were considered in the determination of fair value.
Concentration of Credit Risk
The Company does not believe that it is exposed to significant concentrations of credit risk related to its investment in the Joint Venture.
Additional Considerations
The fair value of the Company’s investment reflects its 45% ownership interest and may differ from a pro rata share of the JV’s enterprise value due to factors such as lack of control and marketability. Discounts for lack of control and marketability were applied because the valuation was performed on a non-controlling, non-marketable basis, consistent with ASC 820 fair value. ASC 820 reflects a market participant perspective at the enterprise level. While the applied methods (discounted cash flow and Guideline Public Company) already incorporate risk and marketability assumptions, the Company conservatively applied the control and marketability discounts to the valuation. The valuation does not represent a guaranteed realizable value and may differ significantly from amounts that could be realized in an actual transaction.
Fair Value Hierarchy – Lunai
The Company’s equity investment in Lunai is classified within Level 3 of the fair value hierarchy under ASC 820 Fair Value Measurement due to the use of significant unobservable inputs, including lack of marketability and liquidity conditions and contractual limitation conditions. The fair value of the investment is determined using a market approach that considers the quoted market price of Lunai’s publicly traded common stock, adjusted to reflect the specific rights, preferences, and restrictions associated with the Series B preferred stock. Because significant unobservable inputs are used in determining fair value, the investment is classified as a Level 3 asset within the fair value hierarchy. The Company received convertible preferred stock of Lunai, with a stated value of $12.5 million. For financial reporting, the fair value of these shares was determined using a market approach based on the market capitalization value of the underlying common stock on an as-converted basis. This baseline value was then adjusted downward to reflect significant unobservable inputs, specifically a discount for lack of marketability and discounts for contractual restrictions.
The fair value measurement was determined as of June 30, 2026 only, as no similar transactions were recorded during the year ended December 31, 2025. There were no transfers between Levels 1, 2, or 3 during the period.
The following table presented the fair value of the Company’s equity investment in Lunai Bioworks by level within the fair value hierarchy as of June 30, 2026:
Quantitative Information about significant unobservable inputs (Level 3)
The Company first attributed a portion of the value of the market capitalization of Lunai common stock, based on a fully diluted basis including the preferred shares and common shares. The market capitalization of Lunai was the only observable input available and used in the fair market value of the Company’s investment in preferred shares of Lunai Bioworks.
The Company then considered the below factors that impacted the liquidity and marketability of the underlying equity interest along with existing contractual restrictions associated with the Lunai Preferred Stock on the date of the closing of the Lunai transaction and then on June 30, 2026.
Sensitivity and Measurement Uncertainty
The fair value of the Company’s investment in Lunai is based on significant unobservable inputs and, as a result, is subject to substantial measurement uncertainty. Changes in key assumptions could result in a different fair value. For example, a 10 percent increase in the discount rate could result in a decrease in the estimated fair value of approximately $0.1 million.
Lack of liquidity and marketability
The Company’s ownership of the convertible preferred shares of Lunai, even if converted into common shares of Lunai, is faced with liquidity and marketability limitations. The common stock of Lunai is fairly thinly traded. Further the preferred shares have Rule 144 restrictions and are restricted in book entry form, have no DTC eligibility, require shareholders’ approval prior to conversion amongst other conditions. The Company attributed a 35% discount due to all these factors.
Contractual Risks
The Company believes that it is exposed to certain concentrations of credit risk related to its investment in the Lunai preferred shares, such as beneficial ownership limitation, suspended conversion, cancellation of the shares if there were an IP clawback, cancellation of shares in the event of indemnification claims among other conditions. The Company attributed a 10% discount for these limitations
Based on the above limitations, the Company recorded an initial fair value of $1.1 million for the investment in Lunai on the date of the Lunai merger transaction and further recorded a gain in the value of $0.3 million in the three and six months ended June 30, 2026, based on changes to the fair value inputs. The Company will continue to record the fair value of its investment in future periods on a similar basis and report the change a in fair value through the unaudited condensed consolidated statement of operations.
For more information on Lunai, refer to Note 9 – Lunai Bioworks Transactions to these Notes to the unaudited Condensed Consolidated Financial Statements below.
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| Derivative Liability Related to 2019 Bridge Financing | Derivative Liability Related to 2019 Bridge Financing
The Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), consisting of conversion feature derivatives at June 30, 2026 and December 31, 2025, and are Level 3 fair value measurements. The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 for the below periods:
As of June 30, 2026 and December 31, 2025, the Company estimated the fair value of the conversion feature derivatives embedded in the convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consist, in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate fair value of the derivatives as of June 30, 2026 and December 31, 2025:
A contingent consideration liability of $2,625,000 for shares of the Company, issuable to PointR’s shareholders recorded and associated with the PointR Merger, is also classified as Level 3 fair value measurements. The Company initially recorded the contingency based on a valuation conducted by a third-party valuation expert. The valuation was based on a probability of the completion of certain milestones by PointR for the shareholders to earn additional shares. The Company evaluated the probability of the earning of the milestones and concluded that the probability of achievement of the milestones had not changed, primarily due to the shifting of focus by the Company to develop AI technologies for the COVID-19 pandemic as well as other AI technologies. As such, the Company did not record any change to the valuation as of June 30, 2026.
If and when the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period when the transfers occur. For the periods ended June 30, 2026 and June 30, 2025, there were no transfers of financial assets or financial liabilities between the hierarchy levels.
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| Net Income (Loss) Per Share |
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. For the three months ended June 30, 2026, we included of Common Stock Equivalents related to the convertible notes, to the weighted average Common Stock, as we reported a gain of approximately $ million during such period. For the three months ended June 30, 2025, we included of Common Stock Equivalents, related to the convertible notes, to the weighted average Common Stock, as we reported a gain of approximately $ million during such period.
For the six months ended June 30, 2026 and 2025, respectively, equivalent shares of the Common Stock were included as the Company incurred losses during the said periods, because addition of such stock equivalents in the computation would have been anti-dilutive.
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| Stock-Based Compensation |
The Company applies the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options, in the statements of operations.
For stock options issued, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.
For warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments, the Company records stock compensation expense and an addition to additional paid in capital. If the warrants are deemed to be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.
For shares issued in connection with provision of services, the Company estimates the cost of the shares at the price of the Company’s stock on the date of issuance and records that cost as a stock-based compensation cost.
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| Impairment of Long-Lived Assets | Impairment of Long-Lived Assets
The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets. For the three and six months ended June 30, 2026 and 2025, there were no impairment losses recognized for long-lived assets.
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| Intangible Assets | Intangible Assets
The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. If the intangible asset’s carrying amount exceeds its fair value, an impairment loss is recognized for the difference. For the three and six months ended June 30, 2026 and 2025, there were no impairment losses recognized for intangible assets. When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed.
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| Goodwill | Goodwill
Goodwill represents the excess of the purchase price of an acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level, or more frequently if events or changes in circumstances indicate that the asset might be impaired.
The goodwill impairment test may be initiated by performing an optional qualitative assessment to evaluate whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the qualitative assessment indicates that it is not more likely than not that the fair value is less than the carrying amount, further quantitative testing is not required. Otherwise, a quantitative impairment test is performed by comparing the fair value of the reporting unit with its carrying amount. If the carrying amount of the reporting unit exceeds its fair value, an impairment loss is recognized in an amount equal to that excess, limited to the total amount of goodwill allocated to that reporting unit. For the three and six months ended June 30, 2026, and 2025, no impairment was recognized toward goodwill. For more information on goodwill and impairment, refer to Note 3 to these Notes to the unaudited Condensed Consolidated Financial Statements.
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| Derivative Financial Instruments Indexed to the Company’s Common Stock | Derivative Financial Instruments Indexed to the Company’s Common Stock
We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants based on the price of our Common Stock as of December 31 each year, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Condensed Consolidated Statements of Operations.
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| Convertible Instruments | Convertible Instruments
The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging” (“ASC 815”).
ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible Debt Instrument.”
The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.
ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event occurs that is not within the entity’s control could or would require net cash settlement, then the contract shall be classified as an asset or a liability.
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| Variable Interest Entity (VIE) Accounting | Variable Interest Entity (VIE) Accounting
The Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements. At June 30, 2026 and December 31, 2025, the Company identified EdgePoint as the Company’s sole VIE. At June 30, 2026 and December 31, 2025, the Company’s ownership percentage of EdgePoint was 29%, respectively. The VIE’s net assets were less than $0.1 million at June 30, 2026 and December 31, 2025, respectively.
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| Investments - Equity Method | Investments - Equity Method
The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the unaudited condensed consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the result from other income. Refer to Note 6 to these Notes to the unaudited Condensed Consolidated Financial Statements.
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| Joint Venture agreement | Joint Venture agreement
We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.
We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.
To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.
To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non- managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.
We use the equity method of accounting for those arrangements where we exercise considerable influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our unaudited condensed consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our unaudited condensed consolidated balance sheet.
When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.
When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.
The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are not appropriately reflected in the market value or reflective of the true value of the development activities of the Company.
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| Revenue Recognition | Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers.
Under ASC 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step process: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company identifies the performance obligation(s) in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
While the Company entered into the transactions with Lunai and recorded service revenue of approximately $0.3 million, the Company does not anticipate generating revenues from rendering services to other third party customers for the development of certain drug products and/or in connection with certain out-licensing agreements, as least in the near future. In the case of services rendered for development of the drugs, revenue is recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period. In the case of out-licensing contracts, the Company records revenues either (i) upon achievement of certain pre-defined milestones when there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or (ii) upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.
The Company occasionally collects advance payments from customers toward commitments to provide services or performance obligations, in which case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.
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| Research & Development Costs | Research & Development Costs
In accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when incurred.
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| Recent Accounting Pronouncements | Recent Accounting Pronouncements
Recently Adopted
In December 2023, the FASB issued ASU 2023-09, “Improvements to Tax Disclosures” (Topic 740). The new guidance is intended to enhance the transparency and decision usefulness of income tax disclosures through changes to the rate reconciliation and the income taxes paid information disclosed. The ASU is effective prospectively for fiscal years beginning after December 15, 2024, with retrospective application and early adoption permitted. The Company adopted this ASU on a prospective basis as of December 31, 2025
Not Yet Adopted
In November 2024 and January 2025, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures” (Subtopic 220-40) “Disaggregation of Income Statement Expenses” and ASU 2025-01 “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures” (Subtopic 220-40): Clarifying the Effective Date”. The new guidance is intended to enhance transparency and disclosures by requiring public business entities to disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The ASU is effective for the first annual reporting periods after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is in the process of evaluating the impact that the adoption of this ASU will have on its financial statements and related disclosures.
All other newly issued, but not yet effective, accounting pronouncements have been deemed to be not applicable or immaterial to the Company. |
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