16 unchanged sentences
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company has incurred significant losses and negative cash flows from operations and has limited capital resources to fund its ongoing operations that raise substantial doubt about its ability to continue as a going concern.
+Added: As discussed in Note 1 to the financial statements, the Company has incurred significant losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern.
Management’s plans in regard to these matters are also described in Note 1.
14 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Initial Accounting for the Warrant Exercise Inducement Transaction — Refer to “Note 6.
+Added: Critical Audit Matters
+Added: The critical audit matters communicated below are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing a separate opinion on the critical audit matters or on the accounts or disclosures to which they relate.
+Added: Initial Accounting for the July 2025 Underwritten Public Offering — Refer to “Note 2.
+Added: Summary of Significant Accounting Policies” and “Note 6.
Stockholders’ Equity” to the financial statements
Critical Audit Matter Description
−Removed: On July 21, 2024, the Company, entered into a warrant exercise inducement (the “Inducement”) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock (the “Series E-4 preferred stock”) which were convertible to 6,739,919 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $2.52 per share, in exchange for the Company’s issuance of new warrants (the “Inducement Warrants”), with varying termination dates and exercise prices.
−Removed: The Company received gross proceeds of $19.4 million and net proceeds of $17.5 million.
−Removed: As included in Note 6 to the financial statements, the Inducement Warrants were comprised of three separate tranches, each with a unique exercise price contractual term.
−Removed: Due to a cash settlement feature included in the Inducement Warrants that requires cash settlement in the event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance.
−Removed: As a result, and in accordance with the guidance in ASC 815, the Inducement Warrants issued in July 2024 were deemed to be liabilities and are adjusted to fair value each reporting period.
−Removed: We identified the assessment of the initial accounting for the warrant exercise inducement transaction as a critical audit matter because of the complexity in applying the accounting framework and the significant judgments made by management in the determination of the classification and valuation of the Inducement Warrants.
−Removed: This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the reasonableness of management’s classification, as well as the valuation of the Inducement Warrants.
+Added: As more fully described in Note 6 to the financial statements, on July 2, 2025, the Company completed an underwritten public offering for gross proceeds of approximately $6.9 million, prior to deducting underwriting commissions and offering expenses.
+Added: The offering was composed of shares of the Company’s common stock, pre-funded common stock purchase warrants (Pre-funded Warrants), and common warrants to purchase shares of the Company’s common stock (Common Warrants).
+Added: The Company determined that the Common Warrants and Pre-Funded Warrants met all of the criteria for equity classification and recorded them as a component of additional paid-in capital upon the closing of the transaction in July 2025.
+Added: We identified the assessment of the initial accounting for the Common Warrants and Pre-funded Warrants as a critical audit matter because of the complexity in applying the accounting framework and the significant judgments made by management in the determination of the classification of the warrants.
+Added: This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the reasonableness of management’s classification.
How the Critical Audit Matter Was Addressed in the Audit
−Removed: Our audit procedures related to the classification and valuation of the Inducement Warrants included the following, among others:
−Removed: ● We read the agreements associated with the Inducement Warrants and tested the accuracy and completeness of the significant terms identified by management for the purpose of determining the appropriate accounting treatment and classification of the Inducement Warrants.
−Removed: ● With the assistance of professionals in our firm having expertise in the accounting treatment for financial instruments, we evaluated the Company’s conclusions regarding the accounting treatment applied to the Inducement Warrants.
−Removed: ● With the assistance of our fair value specialists, we evaluated management’s valuation of the Inducement Warrants by:
−Removed: o Evaluating management’s use of the Monte Carlo simulation methodology
+Added: Our audit procedures related to the classification of the Common Warrants and Pre-funded Warrants included the following, among others:
+Added: ● We read the agreements associated with the Common Warrants and Pre-funded Warrants and tested the accuracy and completeness of the significant terms identified by management for the purpose of determining the appropriate accounting treatment and classification of the warrants.
+Added: ● With the assistance of professionals in our firm having expertise in the accounting treatment for financial instruments, we evaluated the Company’s conclusions regarding the accounting treatment applied to the Common Warrants and Pre-funded Warrants.
+Added: Initial Accounting for the October 2025 Warrant Inducement — Refer to “Note 2.
+Added: Summary of Significant Accounting Policies” and “Note 6.
+Added: Stockholders’ Equity” to the financial statements
+Added: Critical Audit Matter Description
+Added: As more fully described in Note 6 to the financial statements, on October 7, 2025, the Company entered into warrant exercise inducement offer letters with certain holders of certain existing warrants, pursuant to which the holders agreed to exercise for cash their existing warrants in exchange for the Company’s agreement to issue two new warrants for each warrant exercised (October 2025 Inducement Warrants).
+Added: The gross proceeds to the company from the warrant exercises and new warrant issuances was approximately $5.8 million, prior to deducting placement agent fees and offering expenses.
+Added: The Company determined that the October 2025 Inducement Warrants met all of the criteria for equity classification and recorded them as a component of additional paid-in capital upon the closing of the transaction in October 2025.
+Added: We identified the assessment of the initial accounting for the October 2025 Inducement Warrants as a critical audit matter because of the complexity in applying the accounting framework and the significant judgments made by management in the determination of the classification and valuation of the securities.
+Added: This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the reasonableness of management’s classification, as well as the valuation of the securities.
+Added: How the Critical Audit Matter Was Addressed in the Audit
+Added: Our audit procedures related to the classification and valuation of the October 2025 Inducement Warrants included the following, among others:
+Added: ● We read the agreements associated with the October 2025 Inducement Warrants and tested the accuracy and completeness of the significant terms identified by management for the purpose of determining the appropriate accounting treatment and classification of the warrants.
+Added: ● We evaluated the Company’s conclusions regarding the accounting treatment applied to the October 2025 Inducement Warrants.
+Added: ● With the assistance of our fair value specialists, we evaluated management’s valuation of the October 2025 Inducement Warrants by:
+Added: o Evaluating management’s use of the valuation methodology
o Testing the significant valuation assumptions, including the expected volatility, the risk-free interest rate, expected life and dividend yield
−Removed: o Independently calculating a fair value estimate for the Inducement Warrants and comparing our estimates to management’s estimates
+Added: o Independently calculating a fair value estimate for the October 2025 Inducement Warrants and comparing our estimates to management’s estimates
/s/ Deloitte & Touche LLP
23 unchanged sentences
111.11 shares issued and outstanding as of December 31, 2025 and 2024
−Removed: STOCKHOLDERS’ (DEFICIT) EQUITY:
+Added: STOCKHOLDERS’ EQUITY:
Series E-2 preferred stock, 1,225.00 shares authorized;
7 unchanged sentences
( 247,342,463 )
−Removed: Total stockholders’ (deficit) equity
−Removed: ( 15,158,968 )
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
+Added: Total stockholders’ equity
+Added: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
See accompanying notes to the consolidated financial statements.
12 unchanged sentences
( 7,743,284 )
−Removed: Gain (loss) on valuation of warrants
−Removed: ( 3,787,114 )
+Added: Gain on valuation of warrants
Interest income
Total other income (expense), net
−Removed: ( 3,869,967 )
LOSS BEFORE INCOME TAXES
18 unchanged sentences
( 202,761,017 )
−Removed: Stock-based compensation
−Removed: Exercise of warrants for common stock
−Removed: Issuance of Series E-2 preferred stock, net of issuance costs
−Removed: Conversion of preferred stock to common stock
( 15,158,968 )
−Removed: Reclassification of pre-funded warrants to liability
−Removed: ( 3,239,112 )
−Removed: ( 3,239,112 )
−Removed: ( 42,770,610 )
−Removed: ( 42,770,610 )
−Removed: Balance at December 31, 2023
−Removed: ( 202,761,017 )
−Removed: ( 15,158,968 )
Stock-based compensation
10 unchanged sentences
Stock option exercise into common stock
+Added: ( 44,581,446 )
+Added: ( 44,581,446 )
+Added: Balance at December 31, 2024
+Added: ( 247,342,463 )
+Added: Stock-based compensation
+Added: Issuance of common stock, net of issuance costs
+Added: Exercise of warrants for common stock, net of issuance costs
Retired shares
20 unchanged sentences
( 3,161,792 )
+Added: ( 1,593,305 )
Lease liability
6 unchanged sentences
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from issuance of stock and warrants, net of issuance costs
−Removed: Proceeds from exercise of warrants
+Added: Proceeds from exercise of warrants and new warrants, net of issuance costs
+Added: Proceeds from issuance of common stock, pre-funded warrants and common warrants, net of issuance costs
Cash provided by financing activities
13 unchanged sentences
Going Concern — As an emerging growth company, the Company has, by design, incurred significant recurring losses and used net cash in its operations since its inception as it devotes substantially all of its efforts towards researching, developing and seeking approval for its product candidates to be commercialized in the marketplace.
−Removed: As a result of these efforts, the Company had an accumulated deficit of approximately $ 247,342,000 as of December 31, 2024, and incurred a net loss of approximately $ 44,581,000 during the year ended December 31, 2024.
−Removed: The Company expects it will continue to generate significant losses and use net cash for the foreseeable future, until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace.
−Removed: While management believes one or more of the Company’s product candidates will be approved and successfully commercialized in the marketplace, no assurance can be provided any products will be approved or commercialized in a profitable manner.
−Removed: To fund its research, development, and approval efforts, the Company has been heavily dependent on funding from private investors and public stockholders since its inception through the issuance of securities, such as common stock, convertible preferred stock, and warrants (collectively referred to as outside capital).
−Removed: The Company expects to remain heavily dependent on outside capital to fund the Company’s operations for the foreseeable future until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace.
−Removed: While management believes additional outside capital will be secured as needed, no assurance can be provided that additional outside capital will be secured or secured on terms that are acceptable to the Company.
+Added: As a result of these efforts, the Company had an accumulated deficit of approximately $269,000,000 as of December 31, 2025, and incurred a net loss of approximately $21,791,000 and negative cash flows from operations of approximately $23,100,000 , during the year ended December 31, 2025.
+Added: The Company expects it will continue to generate significant losses and negative cash flows from operations for the foreseeable future, until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace.
+Added: While management believes one or more of the Company’s product candidates will be approved and successfully commercialized in the marketplace, no assurance can be provided that any products will be approved or commercialized in a profitable manner.
As of the date the accompanying consolidated financial statements were issued (the “issuance date”), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $ 9.7 million of unrestricted cash and cash equivalents.
−Removed: Absent further action taken by management to increase its liquidity the Company may be unable to fund its operations under normal course beyond the fourth quarter of 2025.
+Added: Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the third quarter of 2026.
+Added: These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: To fund its research, development, and approval efforts, the Company has been heavily dependent on funding from private investors and public stockholders since its inception through the issuance of securities, such as common stock, convertible preferred stock, and warrants (collectively “outside capital”).
+Added: The Company expects to remain heavily dependent on outside capital to fund the Company’s operations for the foreseeable future until such time that one or more of its product candidates are approved and successfully commercialized in the marketplace.
+Added: While management believes additional outside capital will be secured as needed, no assurance can be provided that it will be secured or on terms acceptable to the Company.
To improve the Company’s liquidity, management plans to secure additional outside capital via the sale of equity and/or debt securities or execute a strategic transaction.
1 unchanged sentence
While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date.
+Added: As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
In the event management’s plans are not effectively implemented, the Company will be required to seek other alternatives which may include, among others, the sale of assets, discontinuance of certain operations, a wind-down of operations and return of capital to stockholders, and/or filing for bankruptcy protection.
−Removed: These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: The accompanying financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates it will be able to realize assets and settle liabilities and commitments in the normal course of business for the foreseeable future.
−Removed: Accordingly, the accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
+Added: The accompanying consolidated financial statements are prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
+Added: The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
5 unchanged sentences
requires management to make estimates and judgments that may affect the reported amounts of assets, liabilities and expenses and disclosure of contingent assets and liabilities.
−Removed: On an on-going basis, management evaluates its estimates including those related to
−Removed: potential accrued liabilities, valuation of warrant and equity-based instruments, and share-based compensation.
+Added: On an on-going basis, management evaluates its estimates including those related to potential accrued liabilities, valuation of warrant and equity-based instruments, and share-based compensation.
Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
27 unchanged sentences
There were no uncertain tax positions that require accrual to or disclosure in the consolidated financial statements as of December 31, 2025 and 2024.
−Removed: Fair Value of Financial Instruments The guidance under FASB ASC Topic 825, Financial Instruments , requires disclosure of the fair value of certain financial instruments.
+Added: Fair Value of Financial Instruments — The guidance under ASC Topic 825, Financial Instruments, requires disclosure of the fair value of certain financial instruments.
Financial instruments in the accompanying consolidated financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable, accrued liabilities, warrant liabilities and long-term obligations.
The carrying amount of cash equivalents, prepaid expenses, other current assets, accounts payable and accrued liabilities approximate their fair value as a result of their short-term nature.
−Removed: 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 applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”).
−Removed: The assessment considers whether the warrants are freestanding
−Removed: 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 common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification.
+Added: 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 applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and Hedging.
+Added: 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 common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification.
This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
9 unchanged sentences
As of December 31, 2025 and 2024, uninsured cash balances totaled approximately $ 12,946,000 and $ 22,837,000 , respectively.
−Removed: Government Assistance — For the fiscal year beginning January 1, 2022, management adopted ASU 2021-10, Government Assistance (Topic 832), which aims to provide increased transparency by requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements.
+Added: Government Assistance — In accordance with ASC 832, Government Assistance, the Company discloses certain types of government assistance they receive in the notes to the financial statements.
Reimbursements of eligible expenditures pursuant to government assistance programs are recorded as reductions of operating costs when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and when the reimbursement has been claimed.
5 unchanged sentences
The funding allows for an expansion from Part 1a into the Part 1b portion of the ongoing Phase 1 pediatric study.
−Removed: During the twelve months ended December 31, 2024, the Company received approximately $ 602,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses.
+Added: During the twelve months ended December 31, 2025, the Company received $ 0 in NCI grant funding under the grants described above.
During the twelve months ended December 31, 2024, the Company received approximately $ 602,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses.
−Removed: Recently Issued Accounting Pronouncements Not Yet Adopted — In December 2023, the FASB issued Accounting Standards Update (ASU) No.
−Removed: 2023-09, Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures, which is intended to enhance the transparency and decision usefulness of income tax disclosures.
−Removed: Public business entities are required to adopt this standard for annual fiscal periods beginning after December 15, 2024, and early adoption is permitted.
−Removed: The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures.
−Removed: In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40):
−Removed: Disaggregation of Income Statement Expenses.
−Removed: The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement.
−Removed: This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with
−Removed: early adoption permitted.
−Removed: The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.
+Added: Recently Issued Accounting Pronouncements Not Yet Adopted — In November 2025, the FASB issued ASU No.
+Added: 2025-11, Interim Reporting (Topic 270):
+Added: Narrow-Scope Improvements , which introduced new guidance on disclosures to provide clarity about the current requirements for interim reporting.
+Added: This guidance is effective for the Company for interim reporting periods within annual reporting periods beginning after December 15, 2027.
+Added: The Company is currently evaluating the impact ASU 2025-11 will have on its consolidated financial statements.
+Added: In October 2025, the FASB issued ASU No.
+Added: 2025-10, Government Grants (Topic 832):
+Added: Accounting for Government Grants Received by Business Entities , which introduced authoritative guidance on the accounting for government grants received by business entities.
+Added: This guidance is effective for the Company for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods.
+Added: The Company is currently evaluating the impact ASU 2025-10 will have on its consolidated financial statements.
The Company evaluates all ASUs issued by the FASB for consideration of their applicability to the financial statements.
The Company has assessed all ASUs issued but not yet adopted and concluded that those not disclosed are not relevant to the Company or are not expected to have a material impact.
−Removed: Recently Adopted Accounting Pronouncements — In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280).
−Removed: The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements.
−Removed: The Company adopted this ASU retrospectively.
−Removed: In accordance with Fair Value Measurements and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value:
+Added: Recently Adopted Accounting Pronouncements — In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures .
+Added: This standard increases the transparency and decision usefulness of income tax disclosures for investors by requiring information to better assess how an entity’s operations and related tax risks, planning, and operational opportunities affect its tax rate and prospects for future cash flows.
+Added: This standard requires entities to provide enhanced disclosures related to the income tax rate reconciliation and income taxes paid.
+Added: This standard is effective for all entities that are subject to Topic 740, Income Taxes for annual periods beginning after December 15, 2024, but early adoption is permitted.
+Added: The Company adopted this standard in fiscal year 2025, utilizing the retrospective application as permitted in the standard.
+Added: In accordance with ASC 820, Fair Value Measurements and Disclosures, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value:
Input prices quoted in an active market for identical financial assets or liabilities.
18 unchanged sentences
July 2024 Warrants
−Removed: As part of the July 2024 inducement financing the Company issued Tranche A, B, and C warrants (the Inducement Warrants) to purchase shares of common stock (see Note 2).
−Removed: The fair value of the Inducement Warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model.
+Added: As part of the July 2024 financing the Company issued Tranche A, B, and C warrants (the 2024 Warrants) to purchase shares of common stock (see Note 2).
+Added: The fair value of the 2024 warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model.
The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes.
1 unchanged sentence
The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained.
−Removed: The quantitative elements associated with the inputs impacting the fair value measurement of the Inducement Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
+Added: The quantitative elements associated with the inputs impacting the fair value measurement of the 2024 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
The risk-free interest rate is determined by reference to the U.S.
2 unchanged sentences
Expected volatility was determined based upon the historical volatility of the Company’s common stock.
−Removed: The Inducement Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 12,000,000 and $ 1,200,000 as of July 21, 2024, the date of issuance, and December 31, 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
−Removed: The following table summarizes the modified option-pricing assumptions used on December 31, 2024, and July 21, 2024:
+Added: The 2024 Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 180,000 and $ 1,200,000 as of December 31, 2025, and December 31, 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
+Added: The following table summarizes the modified option-pricing assumptions used on December 31, 2025 and 2024:
+Added: 110.00 - 117.00
+Added: 80.60 - 104.00
Risk-free interest rate
1 unchanged sentence
September 2023 Warrants
−Removed: As part of the September 2023 financing the Company issued Tranche A and Tranche B warrants (the 2023 Warrants) to purchase shares of preferred stock which, on an as-converted basis, represented an aggregate of 21,025,641 shares of common stock.
−Removed: The fair value of the Tranche A and B warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model.
−Removed: The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes.
−Removed: Under both models, assumptions and estimates are used to value the preferred stock warrants.
−Removed: The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained.
−Removed: The quantitative elements associated with the inputs impacting the fair value measurement of the 2023 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
+Added: The fair value of the 2023 Warrants was determined by utilizing a Black-Scholes option-pricing model.
+Added: The quantitative elements associated with the inputs impacting the fair value measurement of the 2023 Warrants include the value per share of the underlying common stock, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
The risk-free interest rate is determined by reference to the U.S.
2 unchanged sentences
Expected volatility was determined based upon the historical volatility of the Company’s common stock.
−Removed: As previously described, all of the Tranche A warrants were exercised in January 2024.
−Removed: Additionally, in July 2024, the holders of the Tranche B warrants exercised all but 105.00 of the Tranche B warrants outstanding.
−Removed: As a result, those warrants were marked-to-market on July 21, 2024, the date of the exercise and subsequent settlement.
−Removed: The 2023 Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 26,000 and $ 4,200,000 as of December 31, 2024 and December 31, 2023, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
−Removed: They continue to be classified as a liability due to a cash settlement feature in the agreement.
−Removed: The following table summarizes the modified option-pricing assumptions used on December 31, 2024 and December 31, 2023:
+Added: These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized.
+Added: The 2023 Warrants are classified within the Level 3 hierarchy because of the nature of the valuation technique utilized, and had a fair value of $ 5,000 and $ 26,000 as of December 31, 2025 and 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
+Added: The following table summarizes the modified option-pricing assumptions used on December 31, 2025 and 2024:
+Added: 100.17 - 125.50
Risk-free interest rate
Expected life (years)
−Removed: At the time the Tranche A warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-3 preferred stock and the trading price of the stock when the warrants were exercised, was determined to be $ 4,800,000 .
−Removed: At the time the Tranche B warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-4 preferred stock, as adjusted by the inducement offering terms, and the trading price of the stock when the warrants were exercised, was determined to be $ 2,610,000 .
−Removed: Due to the settlement of these warrants, the corresponding liability was reclassified to equity in accordance with ASC 815.
October 2022 Warrants
−Removed: In October 2022 the Company issued a total of 5,151,098 common warrants that are immediately exercisable with a five-year life and a strike price of $ 1.96 for shares of common stock (the 2022 Common Warrants), and 1,875,941 pre-funded warrants (the 2022 Pre-Funded Warrants) to acquire shares of common stock (see Note 6).
−Removed: The 2022 Pre-Funded Warrants were all exercised prior to December 31, 2024.
The fair value of the 2022 Common Warrants was determined by utilizing a Black-Scholes option-pricing model.
−Removed: The quantitative elements associated with the inputs impacting the fair value measurement of the 2022 Common Warrants include the value per share of the underlying common stock, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
+Added: The quantitative elements associated with the inputs impacting the fair value measurement of the 2022 Common Warrants include the value per share
+Added: of the underlying common stock, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares.
The risk-free interest rate is determined by reference to the U.S.
3 unchanged sentences
These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized.
+Added: The 2022 Common Warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized, and had a fair value of $ 41,000 and $ 462,000 as of December 31, 2025, and December 31, 2024, respectively, which is included in the warrant liability caption on the accompanying balance sheets.
The following table summarizes the assumptions used at each financial reporting date:
1 unchanged sentence
Expected life (years)
−Removed: The following table summarizes the changes in the fair market value of the warrants which are classified within the Level 3 fair value hierarchy, inclusive of all Preferred and Common Warrants, excluding the Pre-Funded Common Warrants:
−Removed: Fair value of Level 3 liabilities as of December 31, 2023
+Added: The following table summarizes the changes in the fair market value of all warrants which are classified within the Level 3 fair value hierarchy for the years ended December 31, 2025 and 2024:
+Added: Beginning warrant fair value
Change in warrant fair value
1 unchanged sentence
Issuance of July 2024 inducement warrants
−Removed: Settlement of 2023 Tranche A Warrants to equity
+Added: Settlement of warrants to equity
( 1,174,945 )
−Removed: Settlement of 2023 Tranche B Warrants to equity
( 7,410,000 )
1 unchanged sentence
( 1,225,676 )
−Removed: December 31, 2024, fair value of Level 3 liabilities
+Added: Ending warrant fair value
PROPERTY, PLANT & EQUIPMENT
6 unchanged sentences
( 1,186,000 )
+Added: ( 1,024,000 )
Property, plant & equipment, net
7 unchanged sentences
STOCKHOLDERS’ EQUITY
+Added: October 2025 Warrant Inducement
+Added: On October 7, 2025, the Company entered into warrant exercise inducements with certain holders of certain existing warrants, which were originally issued on October 25, 2022, July 21, 2024, and July 2, 2025, pursuant to which the holders agree to exercise for cash their existing warrants to purchase 1,048,094 shares of the Company’s common stock, at an exercise price of $ 5.25 per share, and pay $ 0.125 per new warrant, in exchange for the Company’s agreement to issue two new warrants for each warrant exercised.
+Added: In connection with the exercise of these warrants, the Company issued new warrants (the October 2025 Inducement Warrants) in two different series:
+Added: the Series I Inducement Warrants and the Series II Inducement Warrants.
+Added: Each Inducement Warrant is immediately exercisable at an exercise price of $ 6.00 per share.
+Added: The Series I Inducement Warrants will expire on October 8, 2030, and the Series II Inducement Warrants will expire on April 8, 2027.
+Added: The investors paid $ 0.125 for each October 2025 Inducement Warrant.
+Added: The gross proceeds to the Company from the warrant exercises and new warrant issuance was approximately $ 5.8 million, prior to deducting placement agent fees and offering expenses.
+Added: Based upon an evaluation utilizing the criteria in ASC 480, Distinguishing Liabilities from Equity, the company concluded that the Common Warrants do not meet any of the conditions necessary to be classified as a liability.
+Added: Furthermore, based upon an assessment utilizing ASC 815, Derivatives and Hedging, the Common Warrants meet all the necessary criteria to be classified as permanent equity.
+Added: July 2025 Underwritten Public Offering
+Added: On July 2, 2025, the Company completed an underwritten public offering for gross proceeds of approximately $ 6.9 million, prior to deducting underwriting commissions and offering expenses.
+Added: The offering was composed of (i) 1,045,000 Class A Units (which includes 180,000 Class A Units issued pursuant to the Underwriter’s exercise of the over-allotment option in full) with each Class A Unit consisting of (a) one share of common stock and (b) one common warrant to purchase one share of common stock (the Common Warrants), and (ii) 335,000 Class B Units with each Class B Unit consisting of (a) one pre-funded common stock purchase warrant to purchase one share of common stock (Pre-funded Warrants) and (b) one Common Warrant.
+Added: The price per Class A Unit is $ 5.00 and the price per Class B Unit is $ 4.99999 (collectively, the Offering).
+Added: The Common Warrants have an exercise price of $ 5.25 per share, are exercisable upon issuance, and have a term expiring five years from issuance.
+Added: Based upon an evaluation utilizing the criteria in ASC 480, Distinguishing Liabilities from Equity, the company concluded that the Common Warrants do not meet any of the conditions necessary to be classified as a liability.
+Added: Furthermore, based upon an assessment utilizing ASC 815, Derivatives and Hedging, the Common Warrants meet all the necessary criteria to be classified as permanent equity.
+Added: The Company also issued 82,800 common stock purchase warrants (representative warrants) to the underwriter upon the closing of the July 2025 offering.
+Added: The representative warrants have an exercise price equal to $ 7.75 per share of common stock, were exercisable immediately upon issuance and have a term expiring five years from issuance.
+Added: 2025 Reverse Stock Split
+Added: At the annual stockholders’ meeting held on June 23, 2025, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse split of the Company’s common stock at a ratio between one-for- ten (1:10) to one-for- thirty (1:30) in order to satisfy requirements for the continued listing of the Company’s common stock on Nasdaq.
+Added: The board of directors authorized the 1:
+Added: 30 ratio of the reverse split on June 18, 2025, and effective at the close of business on June 24, 2025, the Company’s certificate of incorporation was amended to effect a 1:
+Added: 30 reverse split of the Company’s common stock (the Reverse Stock Split).
+Added: The Reverse Stock Split did not impact authorized shares.
+Added: The accompanying consolidated financial statements and notes to consolidated financial statements give retroactive effect to the Reverse Stock Split for all periods presented.
+Added: June 2025 Warrant Inducement
+Added: On June 6, 2025, the Company entered into definitive agreements for investors to immediately exercise certain outstanding warrants to purchase an aggregate of 276,044 shares of common stock, issued by the company on June 5, 2020, October 25, 2022, and July 21, 2024 (the Existing Warrants), at a reduced exercise price of $ 9.123 per share.
+Added: The shares of common stock issuable upon exercise of the Existing Warrants are all registered, or their resale is registered, pursuant to effective registration statements.
+Added: The Company did not issue any new warrants as part of the agreements.
+Added: The gross proceeds to the Company from the exercise of the Existing Warrants was approximately $ 2.5 million, prior to deducting placement agent fees and offering expenses.
July 2024 Warrant Inducement
−Removed: On July 21, 2024, the Company, entered into a warrant exercise inducement (the “Inducement”) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock, par value $ 0.00001 per share (the “Series E-4 preferred stock”) which were convertible to 6,739,919 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $ 2.52 per share, in exchange for the Company’s issuance of new warrants (the “Inducement Warrants”), with varying termination dates and exercise prices.
+Added: On July 21, 2024, the Company, entered into a warrant exercise inducement (the Inducement) with certain holders of its September 2023 Tranche B warrants, pursuant to which the holders agreed to exercise the warrants to purchase 1,610 shares of the Company’s Series E-4 Convertible Voting Preferred Stock, par value $ 0.00001 per share (the Series E-4 preferred stock) which is convertible to 224,663 shares of the Company’s common stock in the aggregate, at a reduced, as-converted common stock price of $ 75.60 per share, in exchange for the Company’s issuance of new warrants (the July 2024 Inducement Warrants), with varying termination dates and exercise prices.
The Company received gross proceeds of $ 19.4 million and net proceeds of $ 17.5 million.
−Removed: The Inducement Warrants have the following terms:
+Added: The July 2024 Inducement Warrants have the following terms:
● The 2024 Tranche A warrants have an exercise price of $ 75.60 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that the FDA has assigned a Prescription Drug User Fee Act goal date for review of iopofosine I 131, and (ii) July 21, 2029.
1 unchanged sentence
● The 2024 Tranche C warrants have an exercise price of $ 165.00 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement that it has recorded quarterly gross revenues from sales of iopofosine I 131 in the United States in excess of $ 10 million and (ii) July 21, 2029.
−Removed: Due to a cash settlement feature that requires cash settlement in the event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance.
+Added: ● The July 2024 Inducement Warrants do not qualify under the equity classification guidance because of a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders.
As a result, and in accordance with the guidance in ASC 815, the warrants issued in July 2024 are deemed to be liabilities.
All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period.
+Added: In accordance with the guidance above, the Company recorded the July 2024 Inducement Warrants and preferred stock at their respective fair values.
See Note 3 for the related valuation.
−Removed: In accordance with the guidance above, the Company recorded the Inducement Warrants and preferred stock at their respective fair values.
−Removed: Utilizing valuation techniques described in Note 3, the Company computed the fair value of the Inducement Warrants as $ 12.0 million and recorded the preferred stock at approximately $ 15.9 million, which represented its fair value of $ 17.0 million less allocated issuance costs.
−Removed: The value of the preferred stock and Inducement Warrants sold exceeded the proceeds received by the Company and the fair value of the Tranche B warrants that were exercised in the transaction, which was approximately $ 2.6 million at the time of exercise.
−Removed: The value in excess of the net proceeds and the fair value of the Tranche B warrants of approximately $ 7.7 million is reflected in Other Expense.
−Removed: As of December 31, 2024, all of the Series E-4 preferred stock issued in the July 2024 financing has been converted into 6,739,919 shares of common stock.
September 2023 Private Placement
On September 8, 2023, in a private placement with certain institutional investors, the Company issued 1,225 shares of Series E-1 preferred stock, along with Tranche A warrants to purchase 2,205 shares of Series E-3 preferred stock and Tranche B warrants to purchase 1,715 shares of Series E-4 preferred stock.
−Removed: Shares of Series E preferred stock were issued at a fixed price of $ 20,000 per share, resulting in gross proceeds of $ 24.5 million and net proceeds of approximately $ 22.2 million after placement agent fees and other customary expenses.
−Removed: The conversion prices for the preferred stock are as follows:
−Removed: for the Series E-1 or E-2 preferred stock, $ 1.82 per share of common stock, or a total of 13,461,538 shares of common stock;
−Removed: for the Series E-3 preferred stock, $ 3.185 per share of common stock, or a total of 13,846,154 shares of common stock;
−Removed: and for the Series E-4 preferred stock, $ 4.7775 per share of common stock, or a total of 7,179,487 shares of common stock, in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization.
−Removed: The warrants were exercisable as follows:
−Removed: ● Tranche A warrants, for an aggregate exercise price of $ 44.1 million, exercisable for Series E-3 preferred stock until the earlier of September 6, 2026, or 10 trading days after the Company’s announcement of positive topline data from the Waldenstrom’s macroglobulinemia CLOVER WaM pivotal trial;
−Removed: ● Tranche B warrants, for an aggregate exercise price of $ 34.3 million, exercisable for Series E-4 preferred stock until the earlier of September 6, 2028, or 10 days following the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131.
−Removed: As of December 31, 2023, the Tranche A and Tranche B warrants did not qualify as derivatives;
−Removed: however, they did not meet the requirements necessary to be considered indexable in the Company’s stock.
−Removed: As a result, and in accordance with the guidance in FASB ASC 815, the warrants were deemed to be liabilities.
−Removed: As of September 30, 2024, the Tranche B warrants do not qualify as derivatives and meet the requirements necessary to be considered indexable in the Company’s stock.
−Removed: However, due to a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance.
−Removed: As a result, and in accordance with the guidance in ASC 815, the Tranche B warrants continue to be deemed liabilities.
+Added: The Series E-1 preferred stock automatically converted either to Series E-2 preferred or common stock upon stockholder approval, which occurred on October 25, 2023.
+Added: The July 2024 Warrant Inducement described above resulted in 105.000 Tranche B warrants remaining outstanding, which are convertible into 14,652 shares of common stock.
+Added: The Tranche B warrants do not qualify as derivatives;
+Added: however, they also do not meet the requirements necessary to be considered indexable in the Company’s stock.
+Added: As a result, and in accordance with the guidance in ASC 815 , the warrants are deemed to be liabilities.
All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period.
−Removed: As discussed above, the majority of the Tranche B warrants were exercised in July 2024.
See Note 3 for the related valuation.
−Removed: When issued, the Series E-1 preferred stock had a redemption feature;
−Removed: therefore, it was classified as mezzanine equity as of September 30, 2023.
−Removed: The Series E-1 preferred stock also had a liquidation preference, which was calculated as an amount per share equal to the greater of (i) two times (2X) the Original Per Share Price, together with any declared, unpaid dividends, or (ii) such amount per share as would have been payable had all shares of Series E-1 preferred stock been converted into Common Stock immediately prior to such Liquidation.
−Removed: While the Series E - 1 preferred was outstanding, this resulted in both the Tranche A and Tranche B warrants being considered puttable by virtue of the liquidation preference impacting the disposition of these warrants in the
−Removed: event of a liquidation.
−Removed: In accordance with the guidance in ASC 480, a puttable warrant is deemed to be a liability.
−Removed: These features only applied to the Series E-1 preferred stock when it was outstanding;
−Removed: upon stockholder approval of the transaction, which was obtained by the Company at a special meeting of stockholders held on October 25, 2023, the Series E-1 preferred stock immediately converted into either Series E-2 preferred stock and/or common stock, dependent upon the beneficial ownership position of the holder.
−Removed: The net proceeds from the September 2023 Private Placement were allocated first to the fair value of the Tranche A and Tranche B warrants, which had a fair value upon issuance of $ 4,800,000 , with the remainder, or $ 17,820,000 , allocated to the Series E-1 preferred stock.
−Removed: Upon stockholder approval of the transaction, the entire amount that had been assigned to mezzanine equity was reclassified to Series E-2 preferred stock and is a component of permanent equity, as is reflected in the financial statements.
−Removed: As a result of the stockholder approval, Series E-1 preferred stock was fully extinguished in accordance with the terms of the financing.
−Removed: The outstanding shares of Series E preferred stock were classified as permanent equity upon issuance.
−Removed: Series E preferred stock is convertible to common stock at the request of the holder, subject to the holder not exceeding certain beneficial ownership percentages as stipulated in the financing agreement.
−Removed: Subsequent to the issuance of the Series E-2 preferred stock and prior to December 31, 2023, preferred holders converted 905.24 shares of preferred stock into 9,947,684 shares of common stock at the stated rate of $ 1.82 per common share, resulting in 319.76 shares of Series E - 2 preferred stock outstanding as of December 31, 2023.
−Removed: During the twelve months ended December 31, 2024, 284.16 shares of Series E-2 preferred stock were converted into 3,122,637 shares of common stock.
−Removed: There remain 35.60 shares of Series E-2 preferred stock outstanding as of December 31, 2024.
−Removed: In January 2024, the Company released topline data from its pivotal, Phase 2b CLOVER WaM trial.
−Removed: In accordance with the terms of the Tranche A warrant, the warrants’ expiration accelerated to 10 trading days after the topline data release.
−Removed: Warrant holders exercised the Tranche A warrants in their entirety, resulting in the Company issuing 2,205.00 shares of Series E-3 preferred stock, which were convertible to common stock at the stated rate of $ 3.185 per share, and receiving gross proceeds of $ 44.1 million and net proceeds of $ 42.8 million (see Note 3).
−Removed: As of December 31, 2024, all of the Series E-3 preferred stock has been converted into 13,846,141 shares of common stock.
+Added: There are 35.60 shares of Series E-2 preferred stock outstanding as of December 31, 2025.
October 2022 Public Offering and Private Placement
−Removed: On October 25, 2022, the Company completed a registered direct offering of 3,275,153 shares of the Company’s common stock at $ 2.085 per share and warrants to purchase up to an aggregate of 3,275,153 shares of common stock in a concurrent private placement priced at-the-market under Nasdaq rules.
−Removed: In a separate concurrent private placement transaction, the Company offered and sold pre-funded warrants to purchase an aggregate of 1,875,945 shares of common stock and warrants to purchase an aggregate of 1,875,945 shares of common stock.
−Removed: The warrants are immediately exercisable at an exercise price of $ 1.96 per share and will expire on the fifth anniversary of the closing date.
−Removed: Each pre-funded warrant had a purchase price of $ 2.08499 , is immediately exercisable at an exercise price of $ 0.00001 per share and will not expire until exercised in full.
−Removed: The registered direct offering and private placements resulted in total gross proceeds of approximately $ 10.7 million with net proceeds to the Company of approximately $ 9.6 million after deducting estimated offering expenses.
−Removed: During the twelve months ended December 31, 2024, 1,079,132 pre-funded warrants, which was the entirety of the quantity still outstanding, were converted into 1,079,132 shares of common stock, and 547,177 warrants issued in October 2022 were exercised for net proceeds of approximately $ 1.1 million.
−Removed: There were no such conversions or exercises in the twelve months ended December 31, 2023.
+Added: On October 25, 2022, the Company completed a registered direct offering and concurrent private placement transaction.
+Added: As of December 31, 2025, there remain 75,939 warrants outstanding that are immediately exercisable at an exercise price of $ 58.80 per share and will expire on the fifth anniversary of the closing date.
+Added: Due to a cash settlement feature, the warrants are liability classified.
+Added: See Note 3 for the related valuation.
The following table summarizes information with regard to outstanding warrants to purchase stock as of December 31, 2025:
2 unchanged sentences
Expiration Date
+Added: 2025 October Series I Common Warrants
+Added: October 8, 2030
+Added: 2025 October Series II Common Warrants
+Added: April 8, 2027
+Added: 2025 July Common Warrants
+Added: 2025 Representative Warrants
2024 Tranche A Warrants
8 unchanged sentences
October 25, 2027
−Removed: June 2020 Series H Common Warrants
−Removed: All warrants in the table above are liability-classified.
+Added: The 2025 October Series I and Series II Common Warrants, the 2025 July Common Warrants, and the 2025 Representative Warrants are classified as equity.
+Added: All other warrants in the table above are liability classified.
STOCK-BASED COMPENSATION
15 unchanged sentences
No dividends have been recorded historically.
−Removed: At the annual meeting of stockholders held on June 14, 2024, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under the 2021 Stock Incentive Plan by 7,000,000 to 9,368,900 .
During the twelve months ended December 31, 2025 and 2024, stock options granted were 77,331 and 102,116 , respectively.
28 unchanged sentences
Year Ended December 31,
−Removed: 82.02 - 83.28
Risk-free interest rate
12 unchanged sentences
The weighted-average grant-date fair value of options granted during the years ended December 31, 2025 and 2024, was $ 21.30 and $ 73.50 , respectively.
−Removed: The total fair value of shares vested during the years ended December 31, 2024 and 2023, was $ 5,342,685 and $ 1,670,964 , respectively.
+Added: The total fair value of options vested during the years ended December 31, 2025 and 2024, was $ 2,039,819 and $ 5,342,685 , respectively.
The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2025, was $ 113.91 and $ 21.30 respectively.
37 unchanged sentences
federal statutory rate
+Added: ( 4,605,000 )
+Added: ( 9,357,000 )
State income taxes
1 unchanged sentence
Federal tax credits
+Added: Orphan Drug Credit
+Added: ( 1,176,000 )
+Added: ( 4,582,000 )
+Added: Research and development credits
Change in valuation allowance
+Added: Nontaxable or nondeductible items
+Added: Warrant cost/Revaluation
+Added: ( 1,276,000 )
+Added: Share-based compensation
As of December 31, 2025, the Company had federal net operating loss (NOL) carryforwards of approximately $ 109,370,000 generated as of December 31, 2017, and NOL carryforwards of approximately $ 184,873,000 after December 31, 2017.
2 unchanged sentences
State NOL carryforwards will expire in 2030 through 2045 .
+Added: In July 2025, the OBBBA was signed into law.
+Added: The OBBBA makes permanent or introduces certain changes to the Internal Revenue Code, including 100% bonus depreciation, the deductibility of business interest expense, and expensing of domestic research costs.
+Added: ASC 740 requires that the effect of changes in tax rates and laws be recognized in the period in which the legislation is enacted.
+Added: The impact of this change is primarily reflected in deferred taxes.
As of December 31, 2025, the Company had federal research and development (R&D) and orphan drug credit carryforwards of approximately $ 22,530,000 which will expire in 2025 through 2044 .
1 unchanged sentence
The Company had federal NOLs and R&D credit carryforwards of $ 274,000 and $ 50,000 , respectively, that expired in 2025 .
+Added: Additionally, $ 49,000 of WI R&D credits carryforward expired in 2025 .
The NOL, R&D and orphan drug credit carryforwards may have, or may become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions.
9 unchanged sentences
However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination.
+Added: Upon the adoption of ASU 2023-09 we are required to disclose income taxes paid, net of refunds for 2025.
+Added: All amounts for federal, state and foreign are zero for the year ended December 31, 2025.
NET LOSS PER SHARE
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period.
−Removed: The pre-funded warrants are considered common shares outstanding for the purposes of the basic net loss per share calculation due to the nominal cash consideration and lack of other contingencies for issuance of the underlying common shares.
+Added: The pre-funded warrants are considered common shares outstanding for the purposes of the basic net loss per share calculation to the nominal cash consideration and lack of other contingencies for issuance of the underlying common shares.
Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding.
Potential common stock equivalents consist of stock options, warrants, and convertible preferred shares.
−Removed: In accordance with ASC Topic 260, Earnings per Share, diluted earnings per share are the amount of earnings for the period available to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares
−Removed: outstanding during the reporting period.
+Added: In accordance with ASC Topic 260, Earnings per Share, diluted earnings per share are the amount of earnings for the period available to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares outstanding during the reporting period.
In the quarters ended June 30, 2024, and September 30, 2024, the common warrants issued in October 2022 were dilutive.
In all other periods presented, all outstanding warrants were antidilutive.
+Added: As a result, there is no difference between basic and diluted earnings per share for the year ended December 31, 2025.
Year ended December 31, 2024
19 unchanged sentences
The total expense charge related to the plan was approximately $ 1,510,000 .
−Removed: The remaining liability related to the plan as of December 31, 2024 was $ 1,180,000 .
+Added: There is no remaining liability related to the workforce reduction as of December 31, 2025.
Operating Lease Liability
In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (HQ Lease).
−Removed: The HQ Lease commenced upon completion of certain improvements in October 2018 and terminates in February 2024 with an option to extend the term of the lease for one additional 60 -month period.
+Added: The HQ Lease commenced upon completion of certain improvements in October 2018.
On December 30, 2022, the Company entered into an Amended Agreement of Lease, with CAMPUS 100 LLC (the “Landlord”).
1 unchanged sentence
The Company also has an option to extend the term of the Amended Lease for one additional 60 -month period.
−Removed: Under the terms of the Amended Lease, the Company’s previously paid security deposit of $ 75,000 was reduced to $ 23,566 and the aggregate rent due over the term of the Amended Lease is approximately $ 918,000 , which will be reduced to approximately $ 893,000 after certain rent abatements.
−Removed: The Company will also be required to pay its proportionate share of certain operating expenses
−Removed: and real estate taxes applicable to the leased premises.
+Added: Under the terms of the Amended Lease, the Company’s previously paid security deposit of $ 75,000 was reduced to $ 23,566 and the aggregate rent over the term of the Amended Lease is approximately $ 918,000 , which will be reduced to approximately $ 893,000 after certain rent abatements.
+Added: The Company will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises.
After certain rent abatements the rent is approximately $ 11,800 per month for the first year and then escalates thereafter by 2 % per year for the duration of the term.
26 unchanged sentences
Phase 1 study in pediatric tumors
+Added: Phase 1 study in Triple Negative Breast Cancer
Manufacturing and related costs
4 unchanged sentences
( 1,189,000 )
+Added: ( 7,196,000 )
Segment and consolidated net loss
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.