Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements.
FINANCIAL STATEMENTS
INDEX TO FINANCIAL STATEMENTS FOR CELLECTAR BIOSCIENCES, INC.
Page
Report of Independent Registered Public Accounting Firm ( Deloitte & Touche LLP , Morristown, New Jersey , PCAOB ID No. 34 )
71
Consolidated Balance Sheets as of December 31, 2025 and 2024
74
Consolidated Statements of Operations for the Years Ended December 31, 2025 and 2024
75
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years Ended December 31, 2025 and 2024
76
Consolidated Statements of Cash Flows for the Years Ended December 31, 2025 and 2024
77
Notes to Consolidated Financial Statements
78
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Cellectar Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Cellectar Biosciences, Inc. and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, statements of convertible preferred stock and stockholders’ equity (deficit), and cash flows, for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. 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. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
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. 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.
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Initial Accounting for the July 2025 Underwritten Public Offering — Refer to “Note 2. Summary of Significant Accounting Policies” and “Note 6. Stockholders’ Equity” to the financial statements
Critical Audit Matter Description
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. 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). 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.
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. 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
Our audit procedures related to the classification of the Common Warrants and Pre-funded Warrants included the following, among others:
● 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.
● 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.
Initial Accounting for the October 2025 Warrant Inducement — Refer to “Note 2. Summary of Significant Accounting Policies” and “Note 6. Stockholders’ Equity” to the financial statements
Critical Audit Matter Description
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). 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. 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.
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. 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.
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How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the classification and valuation of the October 2025 Inducement Warrants included the following, among others:
● 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.
● We evaluated the Company’s conclusions regarding the accounting treatment applied to the October 2025 Inducement Warrants.
● With the assistance of our fair value specialists, we evaluated management’s valuation of the October 2025 Inducement Warrants by:
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
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
Morristown, New Jersey
March 4, 2026
We have served as the Company’s auditor since 2024.
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CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
December 31,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
13,196,033
$
23,288,607
Prepaid expenses and other current assets
842,432
961,665
Total current assets
14,038,465
24,250,272
Property, plant & equipment, net
549,405
757,121
Operating lease right-of-use asset
360,671
436,874
Other long-term assets
29,780
29,780
TOTAL ASSETS
$
14,978,321
$
25,474,047
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities
$
4,423,548
$
7,585,340
Warrant liability
226,000
1,718,000
Lease liability, current
100,189
84,417
Total current liabilities
4,749,737
9,387,757
Lease liability, net of current portion
309,397
409,586
TOTAL LIABILITIES
5,059,134
9,797,343
COMMITMENTS AND CONTINGENCIES (Note 10)
MEZZANINE EQUITY:
Series D convertible preferred stock, 111.11 shares authorized; 111.11 shares issued and outstanding as of December 31, 2025 and 2024
1,382,023
1,382,023
STOCKHOLDERS’ EQUITY:
Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 and 35.60 shares issued and outstanding as of December 31, 2025 and 2024, respectively
520,778
520,778
Common stock, $ 0.00001 par value; 170,000,000 shares authorized; 4,240,129 and 1,535,996 shares issued and outstanding as of December 31, 2025 and 2024, respectively
42
15
Additional paid-in capital
277,149,844
261,116,351
Accumulated deficit
( 269,133,500 )
( 247,342,463 )
Total stockholders’ equity
8,537,164
14,294,681
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
14,978,321
$
25,474,047
See accompanying notes to the consolidated financial statements.
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CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended December 31,
2025
2024
OPERATING EXPENSES:
Research and development
$
11,498,761
$
26,136,246
General and administrative
11,481,083
25,641,452
Total operating expenses
22,979,844
51,777,698
LOSS FROM OPERATIONS
( 22,979,844 )
( 51,777,698 )
OTHER INCOME (EXPENSE):
Warrant issuance expense
—
( 7,743,284 )
Gain on valuation of warrants
753,707
13,794,683
Interest income
435,100
1,210,853
Total other income (expense), net
1,188,807
7,262,252
LOSS BEFORE INCOME TAXES
( 21,791,037 )
( 44,515,446 )
INCOME TAX PROVISION (BENEFIT)
—
66,000
NET LOSS
$
( 21,791,037 )
$
( 44,581,446 )
NET LOSS PER SHARE — BASIC
$
( 8.35 )
$
( 36.52 )
NET LOSS PER SHARE — DILUTED
$
( 8.35 )
$
( 41.89 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC
2,608,317
1,220,749
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED
2,608,317
1,238,125
See accompanying notes to the consolidated financial statements.
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CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
Series D Preferred Stock
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Shares
Par Amount
Capital
Deficit
Equity (Deficit)
Balance at December 31, 2023
111.11
$
1,382,023
319.76
$
4,677,632
691,470
$
7
$
182,924,410
$
( 202,761,017 )
$
( 15,158,968 )
Stock-based compensation
—
—
—
—
—
—
4,272,780
—
4,272,780
Exercise of pre-funded warrants into common shares
—
—
—
—
35,971
—
3,972,540
—
3,972,540
Exercise of warrants for preferred stock, net of issuance costs (Note 2)
—
—
2,205.00
47,577,000
—
—
—
—
47,577,000
Conversion of Series E-3 preferred stock into common stock
—
—
( 2,205.00 )
( 47,577,000 )
461,538
5
47,576,995
—
—
Exercise of warrants for common stock
—
—
—
—
18,239
—
2,298,143
—
2,298,143
Conversion of Series E-2 preferred stock into common stock
—
—
( 284.00 )
( 4,156,854 )
104,088
1
4,156,853
—
—
Issuance of E-4 preferred stock net of issuance costs
—
—
1,610.00
15,914,632
—
—
—
—
15,914,632
Conversion of Series E-4 preferred stock into common stock
—
—
( 1,610.00 )
( 15,914,632 )
224,664
2
15,914,630
—
—
Stock option exercise into common stock
—
—
—
—
26
—
—
—
—
Net loss
—
—
—
—
—
—
—
( 44,581,446 )
( 44,581,446 )
Balance at December 31, 2024
111.11
$
1,382,023
35.60
$
520,778
1,535,996
$
15
$
261,116,351
$
( 247,342,463 )
$
14,294,681
Stock-based compensation
—
—
—
—
—
—
2,263,703
—
2,263,703
Issuance of common stock, net of issuance costs
—
—
—
—
1,045,000
11
5,788,369
—
5,788,380
Exercise of warrants for common stock, net of issuance costs
—
—
—
—
1,659,138
16
7,981,421
—
7,981,437
Retired shares
—
—
—
—
( 5 )
—
—
—
—
Net loss
—
—
—
—
—
—
—
( 21,791,037 )
( 21,791,037 )
Balance at December 31, 2025
111.11
$
1,382,023
35.60
$
520,778
4,240,129
$
42
$
277,149,844
$
( 269,133,500 )
$
8,537,164
See accompanying notes to the consolidated financial statements.
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CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended
December 31,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 21,791,037 )
$
( 44,581,446 )
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization
213,597
291,653
Stock-based compensation
2,263,704
4,272,780
Loss on disposal of assets
—
145,726
Warrant issuance expense
—
7,743,284
Change in fair value of warrants
( 753,707 )
( 13,794,683 )
Change in operating lease right-of-use asset
76,202
65,409
Changes in:
Prepaid expenses and other assets
119,233
( 73,440 )
Accounts payable and accrued liabilities
( 3,161,792 )
( 1,593,305 )
Lease liability
( 84,417 )
( 58,979 )
Cash used in operating activities
( 23,118,217 )
( 47,583,001 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant & equipment
( 5,880 )
( 104,195 )
Cash used in investing activities
( 5,880 )
( 104,195 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants and new warrants, net of issuance costs
7,243,143
61,410,815
Proceeds from issuance of common stock, pre-funded warrants and common warrants, net of issuance costs
5,788,380
—
Cash provided by financing activities
13,031,523
61,410,815
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
( 10,092,574 )
13,723,619
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
23,288,607
9,564,988
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$
13,196,033
$
23,288,607
SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION
Conversion of preferred stock to common stock
$
—
$
67,648,487
Settlement of warrants to equity
$
738,325
$
12,608,199
See accompanying notes to the consolidated financial statements.
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CELLECTAR BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE OF BUSINESS AND ORGANIZATION
Cellectar Biosciences, Inc. (Cellectar or the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, leveraging our proprietary phospholipid drug conjugate™ (PDC™) delivery platform that specifically targets cancer cells and delivers improved efficacy and better safety as a result of fewer off-target effects.
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. 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. 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. 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. 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. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern.
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”). 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. 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. Management also plans to preserve liquidity, as needed, by implementing temporary cost-saving measures. 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. 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.
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. 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.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The accompanying consolidated financial statements reflect the application of certain accounting policies, as described in this note and elsewhere in the notes to the consolidated financial statements.
Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All inter-company accounts and transactions have been eliminated in consolidation. The Company consists of one reportable segment.
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Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. 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. 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. Actual results may differ from those estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Cash and Cash Equivalents — All short-term investments purchased with original maturities of three months or less are considered to be cash equivalents.
Property, Plant & Equipment — Property, plant & equipment are stated at cost. Depreciation on property and equipment is provided using the straight-line method over the estimated useful lives of the assets ( 3 to 10 years ). Leasehold improvements are depreciated over 64 months (their estimated useful life), which represented the full term of the lease at the time the leasehold improvements were capitalized. Our only long-lived assets are property, equipment and Right-of-Use (ROU) assets. The Company periodically, and at a minimum annually, evaluates long-lived assets for potential impairment. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. Such analyses necessarily involve judgement. The Company recorded disposal charges of approximately $ 0 and $ 146,000 during the years ended December 31, 2025 and 2024, respectively.
Right-of-Use Asset and Lease Liability — The Company accounts for all material leases in accordance with FASB Accounting Standards Codification (ASC) Topic 842, Leases . ROU assets are recognized over their estimated useful life, which represents the full term of the lease. See Note 11.
Stock-Based Compensation — The Company uses the Black-Scholes option-pricing model to calculate the grant-date fair value of stock option awards. The resulting compensation expense, net of expected forfeitures, for awards that are not performance-based, is recognized on a straight-line basis over the service period of the award, which for 2025 and 2024 ranged from twelve months to three years .
Research and Development — Research and development costs are expensed as incurred. The Company recognizes cost reimbursements from government grants when it is probable that the Company will comply with the conditions attached to the grant arrangement and the grant proceeds will be received. Government grants are recognized on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, when government grants are related to reimbursements for operating expenses, the government grants are recognized as a reduction of the related expense.
Income Taxes — Income taxes are accounted for using the liability method of accounting. Under this method, deferred tax assets and liabilities are determined based on temporary differences between the financial statement basis and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more-likely-than-not that some portion of the deferred tax assets will not be realized. Management has provided a full valuation allowance against the Company’s net deferred tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine whether the tax positions are more-likely-than-not to be sustained by the applicable tax authority. Tax positions deemed to not meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There were no uncertain tax positions that require accrual to or disclosure in the consolidated financial statements as of December 31, 2025 and 2024.
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. See Note 3 .
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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. 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. For equity-classified warrants, the fair value is not remeasured. For warrants that are liability-classified, changes in fair value, as well as the cost to issue the warrants, are included in Other Income (Expense) in the accompanying Consolidated Statements of Operations. If these instruments are initially classified as either liabilities or equity and a subsequent assessment determines that the classification has changed, the Company reflects that change in the financial statements.
Preferred Stock — The Company accounts for preferred stock based upon their specific terms and the authoritative guidance in ASC 480 and ASC 815, including whether they are freestanding instruments, whether any redemption or conversion aspects exist and how they are required to be settled (for example, if there are features that may require cash settlement), contain characteristics that are predominantly debt-like or equity-like, have embedded derivatives, and if they have redemption features. Based upon analysis of these criteria, the preferred stock will be classified as either debt, temporary (or “mezzanine”) equity, or permanent equity. The resultant classification is then evaluated quarterly to determine whether any change to the classification is required.
Concentration of Credit Risk — Financial instruments that subject the Company to credit risk consist of cash and cash equivalents on deposit with financial institutions. The Company’s excess cash as of December 31, 2025 and 2024, is on deposit in interest-bearing accounts with well-established financial institutions. At times, such amounts may exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits. As of December 31, 2025 and 2024, uninsured cash balances totaled approximately $ 12,946,000 and $ 22,837,000 , respectively.
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. The determination of the amount of the claim, and accordingly the receivable amount, requires management to make calculations based on its interpretation of eligible expenditures in accordance with the terms of the programs. The reimbursement claims submitted by the Company are subject to review by the relevant government agencies . The Company currently has a cancer treatment research award through the National Cancer Institute (NCI) totaling approximately $ 2.0 million over a period of approximately three years . In September 2022, the Company was awarded $ 1.98 million in additional grant funding to expand the Company’s ongoing Phase 1 study of iopofosine I 131 in children and adolescents with inoperable relapsed or refractory high-grade gliomas (HGGs). The grant was awarded by the NCI based upon the initial signals of efficacy in the Phase 1 study, which is an international, open-label, dose escalation, safety study. The funding allows for an expansion from Part 1a into the Part 1b portion of the ongoing Phase 1 pediatric study.
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.
Recently Issued Accounting Pronouncements Not Yet Adopted — In November 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements , which introduced new guidance on disclosures to provide clarity about the current requirements for interim reporting. This guidance is effective for the Company for interim reporting periods within annual reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact ASU 2025-11 will have on its consolidated financial statements.
In October 2025, the FASB issued ASU No. 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities , which introduced authoritative guidance on the accounting for government grants received by business entities. 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. The Company is currently evaluating the impact ASU 2025-10 will have on its consolidated financial statements.
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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.
Recently Adopted Accounting Pronouncements — In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . 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. This standard requires entities to provide enhanced disclosures related to the income tax rate reconciliation and income taxes paid. 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. The Company adopted this standard in fiscal year 2025, utilizing the retrospective application as permitted in the standard. See Note 8.
3. FAIR VALUE
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:
● Level 1: Input prices quoted in an active market for identical financial assets or liabilities.
● Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets, and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data.
● Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of cash and cash equivalents approximates fair value as maturities are less than three months. The carrying amounts reported for other current financial assets and liabilities approximate fair value because of their short-term nature.
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period, pursuant to the policy described in Note 2. This determination requires significant judgments be made. The following table summarizes the conclusions reached as of December 31, 2025 and 2024 for financial instruments measured at fair value on a recurring basis.
Balance
Level 1
Level 2
Level 3
December 31, 2025
Cash and cash equivalents
$
13,196,033
$
13,196,033
$
—
$
—
Total assets
$
13,196,033
$
13,196,033
$
—
$
—
Warrant liability
$
226,000
$
—
$
—
$
226,000
Total liabilities
$
226,000
$
—
$
—
$
226,000
December 31, 2024
Cash and cash equivalents
$
23,288,607
$
23,288,607
$
—
$
—
Total assets
$
23,288,607
$
23,288,607
$
—
$
—
Warrant liability
$
1,718,000
$
—
$
—
$
1,718,000
Total liabilities
$
1,718,000
$
—
$
—
$
1,718,000
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July 2024 Warrants
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). 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. Under both models, assumptions and estimates are used to value the warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. 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. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock.
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.
The following table summarizes the modified option-pricing assumptions used on December 31, 2025 and 2024:
December 31,
December 31,
2025
2024
Volatility
110.00 - 117.00
%
80.60 - 104.00
%
Risk-free interest rate
3.50 - 3.80
%
3.50 - 4.20
%
Expected life (years)
3.30 - 4.10
0.50 - 4.80
Dividend
0
%
0
%
September 2023 Warrants
The fair value of the 2023 Warrants was determined by utilizing a Black-Scholes option-pricing model. 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. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized.
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.
The following table summarizes the modified option-pricing assumptions used on December 31, 2025 and 2024:
December 31,
December 31,
2025
2024
Volatility
100.17 - 125.50
%
105
%
Risk-free interest rate
3.55 - 3.89
%
4.20 - 4.30
%
Expected life (years)
2.69 - 3.44
0.80 - 4.20
Dividend
0
%
0
%
October 2022 Warrants
The fair value of the 2022 Common Warrants was determined by utilizing a Black-Scholes option-pricing model. The quantitative elements associated with the inputs impacting the fair value measurement of the 2022 Common Warrants include the value per share
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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. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0 % dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized.
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:
December 31,
December 31,
2025
2024
Volatility
147.20
%
117.50
%
Risk-free interest rate
3.47
%
4.27
%
Expected life (years)
1.80
2.80
Dividend
0
%
0
%
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:
2025
2024
Beginning warrant fair value
$
1,718,000
$
13,131,691
Change in warrant fair value
( 317,055 )
( 14,778,015 )
Issuance of July 2024 inducement warrants
—
12,000,000
Settlement of warrants to equity
( 1,174,945 )
( 7,410,000 )
Exercise of October 2022 warrants
—
( 1,225,676 )
Ending warrant fair value
$
226,000
$
1,718,000
4. PROPERTY, PLANT & EQUIPMENT
Property, plant & equipment consisted of the following as of December 31:
2025
2024
Office and laboratory equipment
$
1,421,000
$
1,467,000
Computer software
4,000
4,000
Leasehold improvements
310,000
310,000
Total property, plant & equipment
1,735,000
1,781,000
Less– accumulated depreciation and amortization
( 1,186,000 )
( 1,024,000 )
Property, plant & equipment, net
$
549,000
$
757,000
For the years ended December 31, 2025 and 2024, the Company recorded approximately $ 214,000 and $ 292,000 of fixed asset depreciation and amortization expense, respectively.
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5. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
Accounts payable and accrued liabilities consist of the following as of December 31:
2025
2024
Accounts payable
$
1,441,000
$
4,105,000
Incentive compensation
1,090,000
611,000
Clinical project costs
1,079,000
1,339,000
Professional fees
315,000
219,000
Other
499,000
1,311,000
$
4,424,000
$
7,585,000
6. STOCKHOLDERS’ EQUITY
October 2025 Warrant Inducement
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. In connection with the exercise of these warrants, the Company issued new warrants (the October 2025 Inducement Warrants) in two different series: the Series I Inducement Warrants and the Series II Inducement Warrants. Each Inducement Warrant is immediately exercisable at an exercise price of $ 6.00 per share. The Series I Inducement Warrants will expire on October 8, 2030, and the Series II Inducement Warrants will expire on April 8, 2027. The investors paid $ 0.125 for each October 2025 Inducement Warrant. 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. 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. 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.
July 2025 Underwritten Public Offering
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. 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. The price per Class A Unit is $ 5.00 and the price per Class B Unit is $ 4.99999 (collectively, the Offering). 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. 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. 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. The Company also issued 82,800 common stock purchase warrants (representative warrants) to the underwriter upon the closing of the July 2025 offering. 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.
2025 Reverse Stock Split
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. The board of directors authorized the 1: 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: 30 reverse split of the Company’s common stock (the Reverse Stock Split). The Reverse Stock Split did not impact authorized shares. The accompanying consolidated financial statements and notes to consolidated financial statements give retroactive effect to the Reverse Stock Split for all periods presented.
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June 2025 Warrant Inducement
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. 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. The Company did not issue any new warrants as part of the agreements. 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
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.
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.
● The 2024 Tranche B warrants have an exercise price of $ 120.00 and expire at the earlier of (i) ten (10) trading days following the date of the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131, and (ii) July 21, 2029.
● 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.
● 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. 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.
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.
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.
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. The Tranche B warrants do not qualify as derivatives; however, they also do not meet the requirements necessary to be considered indexable in the Company’s stock. 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. See Note 3 for the related valuation.
There are 35.60 shares of Series E-2 preferred stock outstanding as of December 31, 2025.
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October 2022 Public Offering and Private Placement
On October 25, 2022, the Company completed a registered direct offering and concurrent private placement transaction. 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. Due to a cash settlement feature, the warrants are liability classified. 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:
Number of Common
Shares Issuable
Upon
Exercise of
Outstanding
Exercise
Offering
Warrants
Price
Expiration Date
2025 October Series I Common Warrants
1,048,094
$
6.00
October 8, 2030
2025 October Series II Common Warrants
1,048,094
$
6.00
April 8, 2027
2025 July Common Warrants
436.000
$
5.25
July 2, 2030
2025 Representative Warrants
82,800
$
7.75
July 2, 2030
2024 Tranche A Warrants
114,773
$
75.60
July 21, 2029
2024 Tranche B Warrants
139,877
$
120.00
July 21, 2029
2024 Tranche C Warrants
72,663
$
165.00
July 21, 2029
2023 Tranche B Preferred Warrants
14,652
$
143.25
September 8, 2028
2022 Common Warrants
75,939
$
58.80
October 25, 2027
Total
3,032,892
The 2025 October Series I and Series II Common Warrants, the 2025 July Common Warrants, and the 2025 Representative Warrants are classified as equity. All other warrants in the table above are liability classified.
7. STOCK-BASED COMPENSATION
Accounting for Stock-Based Compensation
2021 Stock Incentive Plan
The Company maintains the 2021 Stock Incentive Plan (the “2021 Plan”). The Company utilizes stock-based compensation incentives as a component of its employee and non-employee director and officer compensation philosophy. A committee of the Board of Directors determines the terms of the awards granted and may grant various forms of equity-based incentive compensation. Currently, these incentives consist principally of stock options and restricted shares. All outstanding awards under the 2015 Stock Incentive Plan (the “2015 Plan”) remained in effect according to the terms of the 2015 Plan. Any shares that are currently available under the 2015 Plan and any shares underlying 2015 Plan awards which are forfeited, cancelled, reacquired by the Company or otherwise terminated are added to the shares available for grant under the 2021 Plan.
Under the current stock option award program, all options become exercisable between one and three years after issuance and expire after ten years. The fair value of each stock option award is estimated on the grant date using the Black-Scholes option-pricing model. Volatility is based on the Company’s historical common stock volatility. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time. The expected term of stock options granted is based on an estimate of when options will be exercised in the future. Forfeitures are recorded as they occur. No dividends have been recorded historically.
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During the twelve months ended December 31, 2025 and 2024, stock options granted were 77,331 and 102,116 , respectively. The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants:
Twelve Months Ended
December 31,
2025
2024
Employee and director stock option and stock grants:
Research and development
$
413,022
$
3,486,168
General and administrative
1,850,682
786,612
Total stock-based compensation
$
2,263,704
$
4,272,780
In December 2023, the Company granted 92,533 contingent, non-statutory stock option awards at an exercise price of $ 78.90 per share to employees and directors, and in March 2024 the Company granted 6,666 contingent, non-statutory stock option awards at an exercise price of $ 108.90 and $ 100.50 per share to our employees. Each of these grants was contingent on approval of an increase in the shares available in the 2021 Stock Incentive Plan that was approved by the stockholders at the annual meeting of stockholders held on June 14, 2024. In accordance with the removal of the contingency, the Company began recognizing the expense for these awards in June 2024.
Assumptions Used in Determining Fair Value
Valuation and amortization method . The fair value of each stock award is estimated on the grant date using the Black-Scholes option-pricing model. The estimated fair value of employee stock options is amortized to expense using the straight-line method over the required service period which is generally the vesting period. The estimated fair value of the non-employee options is amortized to expense over the period during which a non-employee is required to provide services for the award (usually the vesting period).
Volatility. The Company estimates volatility based on the Company’s historical volatility since its common stock has been publicly traded.
Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption.
Expected term . The expected term of stock options granted is based on an estimate of when options will be exercised in the future. The Company applied the simplified method of estimating the expected term of the options, as described in the SEC’s Staff Accounting Bulletins 107 and 110, as the historical experience is not indicative of the expected behavior in the future. The expected term, calculated under the simplified method, is applied to groups of stock options that have similar contractual terms. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted. The Company applied the simplified method to non-employees who have a truncation of term based on termination of service and utilizes the contractual life of the stock options granted for those non-employee grants which do not have a truncation of service.
Forfeitures. The Company only records stock-based compensation expense for those awards that are expected to vest. The Company accounts for forfeitures as they occur.
Dividends. The Company has not historically issued dividends.
Summary. The following table summarizes the assumptions used for stock options granted to employees and directors in the periods indicated:
Year Ended December 31,
2025
2024
Volatility
100.17
%
82.13
%
Risk-free interest rate
4.37
%
4.21 - 4.64
%
Expected life (years)
6.0
6.0
Dividend
0
%
0
%
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Exercise prices for all grants made during the twelve months ended December 31, 2025 and 2024 were equal to the market value of the Company’s common stock on the date of grant.
Stock Option Activity
A summary of stock option activity is as follows:
Number of
Shares
Issuable
Weighted
Upon
Average
Exercise
Weighted
Remaining
of
Average
Contracted
Aggregate
Outstanding
Exercise
Term in
Intrinsic
Options
Price
Years
Value
Outstanding as of December 31, 2023
78,397
$
163.80
8.64
$
1,682,667
Granted
102,116
$
81.60
Expired
( 53 )
$
600.00
Forfeited
( 27,503 )
$
75.30
Exercised
( 55 )
$
50.40
Outstanding as of December 31, 2024
152,902
$
123.00
7.37
$
—
Granted
77,331
$
8.70
Expired
( 18,066 )
$
125.25
Outstanding as of December 31, 2025
212,167
$
80.47
5.35
$
—
Exercisable as of December 31, 2025
113,080
$
129.93
$
—
Unvested as of December 31, 2025
99,087
$
24.03
$
—
The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. At December 31, 2025, we had 100,651 shares available for grant under the 2021 Option Plan.
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. 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. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2024, was $ 110.70 and $ 65.70 , respectively.
The weighted average grant date fair value of options forfeited during the years ended December 31, 2025 and 2024, was $ 60.65 and $ 53.10 , respectively. The number of options vested during the years ended December 31, 2025 and December 31, 2024, was 33,156 and 80,295 , respectively. The number of options unvested at December 31, 2025 and December 31, 2024, was 99,087 and 55,130 , respectively.
As of December 31, 2025, there was approximately $ 5,470,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize approximately $ 1,969,000 , $ 1,820,000 , and $ 1,681,000 during 2026, 2027 and 2028, respectively. The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future.
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8. INCOME TAXES
2025
2024
Tax provision (benefit)
Current
Federal
$
—
$
—
State
—
66,000
Total current
—
66,000
Deferred
Federal
( 5,245,000 )
( 16,106,000 )
State
( 1,609,000 )
( 3,458,000 )
Total deferred
( 6,854,000 )
( 19,564,000 )
Change in valuation allowance
6,854,000
19,564,000
Total
$
—
$
66,000
Deferred tax assets consisted of the following as of December 31:
2025
2024
Deferred tax assets
Federal net operating loss
$
61,791,000
$
47,909,000
Federal research and development tax credit carryforwards
22,530,000
21,359,000
State net operating losses and tax credit carryforwards
14,935,000
10,191,000
Capitalized research and development expenses
9,632,000
22,658,000
Stock-based compensation expense
5,092,000
5,072,000
Other
457,000
419,000
Total deferred tax assets
114,437,000
107,608,000
Deferred tax liabilities
Depreciable assets
( 98,000 )
( 123,000 )
Total deferred tax liabilities
( 98,000 )
( 123,000 )
Net deferred tax assets
114,339,000
107,485,000
Less- valuation allowance
( 114,339,000 )
( 107,485,000 )
Total deferred tax assets
$
—
$
—
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A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows:
Year ended December 31,
2025
2024
Income tax benefit using U.S. federal statutory rate
$
( 4,605,000 )
21.00
%
$
( 9,357,000 )
21.00
%
State income taxes
$
( 122,000 )
0.56
%
$
136,000
( 0.31 )
%
Permanent nondeductible items
$
—
0.00
%
$
—
0.00
%
Federal tax credits
Orphan Drug Credit
$
( 1,176,000 )
5.36
%
$
( 4,582,000 )
10.28
%
Research and development credits
$
6,000
( 0.03 )
%
$
( 811,000 )
1.82
%
Change in valuation allowance
$
5,401,000
( 24.63 )
%
$
16,113,000
( 36.15 )
%
Nontaxable or nondeductible items
Warrant cost/Revaluation
$
( 130,000 )
0.59
%
$
( 1,276,000 )
2.86
%
Share-based compensation
$
617,000
( 2.81 )
%
$
—
—
Other
$
4,000
( 0.02 )
%
$
40,000
( 0.09 )
%
Other
$
5,000
( 0.02 )
%
$
( 197,000 )
0.44
%
Total
$
—
( 0.00 )
%
$
66,000
( 0.15 )
%
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. Federal NOLs generated as of December 31, 2017, will expire in 2025 through 2037 , while NOLs generated during 2018 and later will be carried forward indefinitely until utilized. As of December 31, 2025, the Company had state NOL carryforwards of approximately $ 203,341,000 . State NOL carryforwards will expire in 2030 through 2045 .
In July 2025, the OBBBA was signed into law. 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. ASC 740 requires that the effect of changes in tax rates and laws be recognized in the period in which the legislation is enacted. 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 . As of December 31, 2025, the Company also had state credit carryforwards of approximately $ 781,000 which will expire in 2025 through 2039 .
The Company had federal NOLs and R&D credit carryforwards of $ 274,000 and $ 50,000 , respectively, that expired in 2025 . 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. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances.
The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized. As a result of uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets. When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to the valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made.
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The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2025 or 2024, and does not anticipate having unrecognized tax benefits over the next twelve months. The Company is subject to audit by the Internal Revenue Service and state taxing authorities for tax periods commencing January 1, 2022, as a result of its NOLs. However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination.
Upon the adoption of ASU 2023-09 we are required to disclose income taxes paid, net of refunds for 2025. All amounts for federal, state and foreign are zero for the year ended December 31, 2025.
9. 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. 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. 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. 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
Net loss
$
( 44,581,446 )
Dilutive effect of warrant liability
( 7,283,786 )
Net loss allocated to common shares
$
( 51,865,232 )
Weighted average common shares outstanding - basic
1,220,749
Dilutive effect of warrant liability
17,376
Weighted average common shares outstanding - diluted
1,238,125
Net loss per share - diluted
$
( 41.89 )
The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would have been antidilutive:
Year Ended December 31,
2025
2024
Warrants
3,032,892
679,390
Stock options
212,167
152,902
Convertible preferred shares
16,743
16,743
Total potentially dilutive shares
3,261,802
849,035
10. COMMITMENTS AND CONTINGENCIES
Legal
The Company may be involved in legal matters and disputes in the ordinary course of business. We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements.
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Workforce Reduction
In December 2024, the Company implemented a workforce reduction plan impacting approximately 60 % of employees. The total expense charge related to the plan was approximately $ 1,510,000 . There is no remaining liability related to the workforce reduction as of December 31, 2025.
11. LEASES
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). 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”). Under the Amended Lease, which was accounted for as a modification of the initial lease, as the Company will continue to lease 3,983 square feet of rentable area on the second floor of a building located at 100 Campus Drive in Florham Park, New Jersey, for the period commencing on March 1, 2023, and ending on April 30, 2029. The Company also has an option to extend the term of the Amended Lease for one additional 60 -month period.
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. 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. The Company has not entered into any leases with related parties.
Discount Rate
The Company has determined an appropriate interest rate to be used in evaluating the present value of the Amended Lease liability considering factors such as the Company’s credit rating, borrowing terms offered by the U.S. Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term. The Company considers 14 % per annum as reasonable to use as the incremental borrowing rate for the purpose of calculating the liability under the Amended Lease. In conjunction with the June 2018 lease, the Company had previously used a 10 % per annum incremental borrowing rate.
Maturity Analysis of Short-Term and Operating Leases
The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of December 31, 2025:
Years ending December 31,
2026
$
150,000
2027
153,000
2028
155,000
2029
53,000
Total undiscounted lease payments
511,000
Less: Imputed interest
( 101,000 )
Present value of lease liabilities
$
410,000
12. EMPLOYEE RETIREMENT PLAN
The Company maintains a defined contribution plan under Section 401(k) of the Internal Revenue Code that allows eligible employees to contribute a portion of their annual compensation on a pre-tax basis. The Company has not made any matching contributions under this plan.
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13. OPERATING SEGMENT
The Company has one operating and reportable segment focused on utilizing its PDC platform to develop drugs for the treatment of cancer. The accounting policies of the single operating segment are the same as those of the Company. The chief operating decision maker is the Company’s president and CEO, who manages the Company’s operations on a consolidated basis, assesses performance for the operating segment and decides how to allocate resources based on consolidated operating expenses, which are reported in the consolidated statements of operations. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. Expenditures for additions to long-lived assets, which include purchases of property and equipment, are included in total consolidated assets reviewed by management and are reported on the consolidated statements of cash flows.
Management uses consolidated cash used in operations and budget-to-actual variances for consolidated net loss to assess the performance of the operating segment and evaluate performance and to allocate resources.
The following table presents certain financial data for the Company’s one reportable segment:
Year Ended December 31,
2025
2024
Research and development:
Phase 2 study in WM
$
1,308,000
$
7,422,000
Phase 1 study in pediatric tumors
1,345,000
3,040,000
Phase 1 study in Triple Negative Breast Cancer
933,000
—
Manufacturing and related costs
4,220,000
10,582,000
Pre-clinical projects costs
823,000
228,000
General research and development costs
2,870,000
4,864,000
General and administrative
11,481,000
25,641,000
Other segment items
( 1,189,000 )
( 7,196,000 )
Segment and consolidated net loss
$
21,791,000
$
44,581,000
Other segment items consist of warrant issuance expense, (gain) loss on valuation of warrants, and interest income.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.