Item 1. Financial Statements
Item 1. Financial Statements
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
12,554,289
$
23,288,607
Prepaid expenses and other current assets
1,067,409
961,665
Total current assets
13,621,698
24,250,272
Property, plant & equipment, net
595,271
757,121
Operating lease right-of-use asset
380,841
436,874
Other long-term assets
29,780
29,780
TOTAL ASSETS
$
14,627,590
$
25,474,047
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities
$
4,014,682
$
7,585,340
Warrant liability
801,650
1,718,000
Lease liability, current
96,034
84,417
Total current liabilities
4,912,366
9,387,757
Lease liability, net of current portion
335,895
409,586
TOTAL LIABILITIES
5,248,261
9,797,343
COMMITMENTS AND CONTINGENCIES (Note 7)
MEZZANINE EQUITY:
Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2025 and December 31, 2024
1,382,023
1,382,023
STOCKHOLDERS’ EQUITY:
Series E-2 preferred stock, 1,225 shares authorized; 35.60 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
520,778
520,778
Common stock, $ 0.00001 par value; 170,000,000 shares authorized; 3,192,040 and 1,535,996 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
32
15
Additional paid-in capital
271,314,776
261,116,351
Accumulated deficit
( 263,838,280 )
( 247,342,463 )
Total stockholders’ equity
7,997,306
14,294,681
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
14,627,590
$
25,474,047
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
OPERATING EXPENSES:
Research and development
$
2,523,305
$
5,493,496
$
8,340,200
$
19,927,019
General and administrative
2,327,391
7,834,181
8,949,015
19,105,853
Total operating expenses
4,850,696
13,327,677
17,289,215
39,032,872
LOSS FROM OPERATIONS
( 4,850,696 )
( 13,327,677 )
( 17,289,215 )
( 39,032,872 )
OTHER INCOME (EXPENSE):
Warrant issuance expense
—
( 7,743,284 )
—
( 7,743,284 )
Gain (loss) on valuation of warrants
294,276
6,088,355
455,874
3,583,440
Interest income
112,543
317,887
337,525
966,643
Total other income (expense)
406,819
( 1,337,042 )
793,399
( 3,193,201 )
NET LOSS
$
( 4,443,877 )
$
( 14,664,719 )
$
( 16,495,816 )
$
( 42,226,073 )
NET LOSS PER SHARE — BASIC
$
( 1.41 )
$
( 11.18 )
$
( 7.82 )
$
( 36.35 )
NET LOSS PER SHARE — DILUTED
$
( 1.41 )
$
( 12.13 )
$
( 7.82 )
$
( 41.79 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC
3,162,040
1,311,197
2,108,234
1,161,681
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED
3,162,040
1,326,474
2,108,234
1,184,850
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
Series D Preferred
Total
Stock
Preferred Stock
Common Stock
Additional
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Shares
Par Amount
Paid-In Capital
Deficit
(Deficit) Equity
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
—
—
—
—
—
—
454,363
—
454,363
Conversion of pre-funded warrants into common shares
—
—
—
—
35,971
1
3,972,539
—
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
—
—
( 1,575.00 )
( 33,983,571 )
329,670
3
33,983,568
—
—
Exercise of warrants for common stock
—
—
—
—
18,239
—
2,298,143
—
2,298,143
Conversion of Series E-2 preferred stock into common stock
—
—
( 82.26 )
( 1,203,346 )
30,132
—
1,203,346
—
—
Net loss
—
—
—
—
—
—
—
( 26,641,983 )
( 26,641,983 )
Balance at March 31, 2024
111.11
1,382,023
867.50
17,067,715
1,105,482
11
224,836,369
( 229,403,000 )
12,501,095
Stock-based compensation
—
—
—
—
—
—
799,249
—
799,249
Conversion of Series E-3 preferred stock into common stock
—
—
( 427.50 )
( 9,224,112 )
89,482
1
9,224,111
—
—
Net loss
—
—
—
—
—
—
—
( 919,371 )
( 919,371 )
Balance at June 30, 2024
111.11
$
1,382,023
440.00
$
7,843,603
1,194,964
$
12
$
234,859,729
$
( 230,322,371 )
$
12,380,973
Stock-based compensation
—
—
—
—
—
—
1,534,054
—
1,534,054
Issuance of E-4 preferred stock net of issuance costs
—
—
1,610.00
15,914,632
—
—
—
—
15,914,632
Conversion of Series E-2 preferred stock into common stock
—
—
( 87.90 )
( 1,285,851 )
32,198
—
1,285,851
—
—
Conversion of Series E-4 preferred stock into common stock
—
—
( 896.00 )
( 8,856,840 )
125,030
1
8,856,839
—
—
Stock option exercise into common stock
—
—
—
—
26
—
—
—
—
Net loss
—
—
—
—
—
—
—
( 14,664,719 )
( 14,664,719 )
Balance at September 30, 2024
111.11
$
1,382,023
1,066.10
$
13,615,544
1,352,218
$
13
$
246,536,473
$
( 244,987,090 )
$
15,164,940
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
—
—
—
—
—
—
562,737
—
562,737
Net loss
—
—
—
—
—
—
—
( 6,604,029 )
( 6,604,029 )
Balance at March 31, 2025
111.11
$
1,382,023
35.60
$
520,778
1,535,996
$
15
$
261,679,088
$
( 253,946,492 )
$
8,253,389
Stock-based compensation
—
—
—
—
—
—
565,391
—
565,391
Exercise of warrants for common stock, net of issuance costs (Note 2)
—
—
—
—
276,044
3
2,714,140
—
2,714,143
Net loss
—
—
—
—
—
—
—
( 5,447,911 )
( 5,447,911 )
Balance at June 30, 2025
111.11
$
1,382,023
35.60
$
520,778
1,812,040
$
18
$
264,958,619
$
( 259,394,403 )
$
6,085,012
Stock-based compensation
—
—
—
—
—
—
567,788
—
567,788
Issuance of common stock and pre-funded warrants, net of issuance costs
—
—
—
—
1,045,000
11
5,788,369
—
5,788,380
Exercise of prefunded warrants for common stock
—
—
—
—
335,000
3
—
—
3
Net loss
—
—
—
—
—
—
—
( 4,443,877 )
( 4,443,877 )
Balance at September 30, 2025
111.11
$
1,382,023
35.60
$
520,778
3,192,040
$
32
$
271,314,776
$
( 263,838,280 )
7,997,306
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
Table of Contents
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Nine Months Ended
September 30,
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 16,495,816 )
$
( 42,226,073 )
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization
164,136
223,082
Stock-based compensation expense
1,695,916
2,787,666
Warrant issuance expense
—
7,743,284
Change in operating lease right-of-use asset
56,033
48,117
Change in fair value of warrants
( 455,874 )
( 3,583,440 )
Changes in:
Prepaid expenses and other current assets
( 105,744 )
( 747,593 )
Lease liability
( 62,074 )
( 40,232 )
Accounts payable and accrued liabilities
( 3,570,658 )
( 874,334 )
Cash used in operating activities
( 18,774,081 )
( 36,669,523 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant & equipment
—
( 42,909 )
Cash used in investing activities
—
( 42,909 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants, net of issuance costs (Note 2)
2,251,380
61,410,815
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs (Note 2)
5,788,380
—
Issuance of common stock in connection with exercise of pre-funded warrants
3
—
Cash provided by financing activities
8,039,763
61,410,815
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
( 10,734,318 )
24,698,383
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
23,288,607
9,564,988
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$
12,554,289
$
34,263,371
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Settlement of warrants to equity
$
462,760
$
7,410,000
Conversion of preferred stock to common stock
$
—
$
54,553,720
The accompanying notes are an integral part of these condensed consolidated financial statements.
8
Table of Contents
CELLECTAR BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. NATURE OF BUSINESS AND ORGANIZATION
Cellectar Biosciences, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, leveraging the Company’s 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 $ 263,838,000 as of September 30, 2025, and incurred a net loss of approximately $ 16,496,000 during the nine months ended September 30, 2025. 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. 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.
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 (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 additional outside capital will be secured, or secured on terms that are acceptable to the Company.
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 $ 15.6 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. 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. 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 the Company or its assets, a merger or other strategic business combination, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.
These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. 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. Accordingly, the accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties.
The condensed consolidated financial statements have been prepared by Cellectar Biosciences, Inc. in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Management believes the disclosures made in this document are adequate with respect to interim reporting requirements.
9
Table of Contents
The accompanying Condensed Consolidated Balance Sheet as of December 31, 2024, has been derived from the Company’s audited financial statements. The accompanying Condensed Consolidated Balance Sheet as of September 30, 2025, and the Condensed Consolidated Statements of Operations, Cash Flows, and the Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the nine months ended September 30, 2025 and 2024, and the related interim information contained within the Notes to the Condensed Consolidated Financial Statements, have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions, rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information. Accordingly, they do not include all the information and the notes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments which are of a nature necessary for the fair presentation of the Company’s consolidated financial position as of September 30, 2025, and consolidated results of its operations, cash flows, and stockholders’ equity for the nine months ended September 30, 2025 and 2024. The results for the nine months ended September 30, 2025, are not necessarily indicative of future results.
These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company’s Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 13, 2025.
Principles of Consolidation — The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. The Company consists of one reportable segment.
Use of Estimates — The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of the warrant liability, the valuation of debt and equity instruments, the valuation of stock options issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.
Property, Plant & Equipment — Property, plant & equipment are stated at cost. Depreciation 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 represents the full term of the lease at the time the leasehold improvements were capitalized. The Company’s only long-lived assets are property, plant & equipment and right-of-use (ROU) assets. Periodically, and at a minimum annually, the Company 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 did not experience any events or changes in circumstances that indicate the carrying amount of the assets may not be recoverable as of September 30, 2025. There were no fixed asset impairment charges recorded during the nine months ended September 30, 2025 or 2024.
Right-of-Use Asset and Lease Liabilities — The Company accounts for all material leases in accordance with FASB Accounting Standards Codification (ASC) Topic 842, Leases. ROU Assets are amortized over their estimated useful life, which represents the full term of the lease (see Note 8).
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 forfeitures for awards that are not performance-based, is recognized on a straight-line basis over the service period of the award, which in the three and nine months ended September 30, 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.
10
Table of Contents
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 gross 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 not to meet a more-likely-than-not threshold would be recorded as tax expense in the current year. There are no uncertain tax positions that require accrual to or disclosure in the financial statements as of September 30, 2025 and December 31, 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 financial statements consist of cash equivalents, prepaid expenses and other assets, accounts payable and accrued liabilities, and long-term obligations. The carrying amount of cash equivalents, prepaid expenses, other current assets and accounts payable approximate their fair value as a result of their short-term nature (see Notes 2 and 3).
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 fundamental transaction 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 (see Note 2). If the warrants are liability-classified, valuation changes, as well as the cost to issue the warrants, are included in Other Income (Expense) in the financial statements (see Note 3). 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 (particularly if there is a cash settlement aspect), whether they contain characteristics that are predominantly debt-like or equity-like, whether they 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 September 30, 2025 and December 31, 2024 is on deposit in interest-bearing accounts with well-established financial institutions. At times, such amounts may exceed the FDIC insurance limits. As of September 30, 2025, and December 31, 2024, uninsured cash balances totaled approximately $ 12,098,000 and $ 22,837,000 , respectively.
Government Assistance — 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 . In September 2021, the Company was granted 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 through a second grant 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 Phase 1a into Phase 1b of the ongoing pediatric study.
11
Table of Contents
During the three months ended September 30, 2025 and 2024, the Company received approximately $ 0 and $ 137,000 in NCI grant funding under the grants described above, respectively, all of which was reported as a reduction of research and development expenses.
During the nine months ended September 30, 2025 and 2024, the Company received approximately $ 0 and $ 602,000 in NCI grant funding under the grants described above, respectively, all of which was reported as a reduction of research and development expenses.
Recently Issued Accounting Pronouncements Not Yet Adopted — In December 2023, the FASB issued Accounting Standards Update (ASU) No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures, which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 15, 2024, and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. 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. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating this guidance to determine the impact it may have on its condensed 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.
Recently Adopted Accounting Pronouncements — In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). 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. The Company adopted this ASU on December 31, 2024 and the prior year to date period has been presented on a comparative basis (see Note 9).
2. STOCKHOLDERS’ 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 gross proceeds to the company from the underwritten public offering was approximately $ 6.9 million, prior to deducting placement agent fees and offering expenses. 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
12
Table of Contents
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.
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
13
Table of Contents
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 September 30, 2025.
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 September 30, 2025, there remain 123,609 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 September 30, 2025:
Number of Common
Shares Issuable
Upon Exercise of
Outstanding
Exercise
Offering
Warrants
Price
Expiration Date
2025 July Common Warrants
1,380,000
$
5.25
July 2, 2030
2025 Representative Warrants
82,800
$
7.75
July 2, 2030
2024 Tranche A Warrants
158,728
$
75.60
July 21, 2029
2024 Tranche B Warrants
149,107
$
120.00
July 21, 2029
2024 Tranche C Warrants
75,912
$
165.00
July 21, 2029
2023 Tranche B Preferred Warrants
14,652
$
143.25
September 8, 2028
2022 Common Warrants
123,609
$
58.80
October 25, 2027
Total
1,984,808
The 2025 July Common Warrants and Representative Warrants are classified as equity. All other warrants in the table above are liability classified.
3. FAIR VALUE
In accordance with the Fair Value Measurements and Disclosures Topic of 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:
● 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. As of September 30, 2025, the Company does no t have any Level 1 or Level 2 liabilities.
14
Table of Contents
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 $ 600,000 and $ 1,200,000 as of September 30, 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 September 30, 2025 and December 31, 2024:
September 30,
December 31,
2025
2024
Volatility
110.00 - 114.00
%
80.60 - 104.00
%
Risk-free interest rate
3.60 - 3.80
%
3.50 - 4.20
%
Expected life (years)
3.30 - 4.10
0.50 - 4.80
Dividend
0
%
0
%
September 2023 Warrants
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 $ 15,000 and $ 26,000 as of September 30, 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 September 30, 2025 and December 31, 2024:
September 30,
December 31,
2025
2024
Volatility
100.17 - 104.80
%
105
%
Risk-free interest rate
3.61 - 3.89
%
4.20 - 4.30
%
Expected life (years)
2.94 - 3.44
0.80 - 4.20
Dividend
0
%
0
%
15
Table of Contents
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 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 following table summarizes the assumptions used at each financial reporting date:
September 30,
December 31,
2025
2024
Volatility
135.00
%
117.50
%
Risk-free interest rate
3.60
%
4.27
%
Expected life (years)
2.1
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 nine months ended September 30, 2025 and 2024:
2025
2024
Beginning warrant fair value
$
1,718,000
$
13,131,691
Change in warrant fair value
127,710
( 4,566,773 )
Issuance of July 2024 inducement warrants
—
12,000,000
Settlement of warrants to equity
( 1,044,060 )
( 7,410,000 )
Exercise of October 2022 warrants
—
( 1,225,676 )
Ending warrant fair value
$
801,650
$
11,929,242
4. STOCK-BASED COMPENSATION
Accounting for Stock-Based Compensation
2021 Stock Incentive Plans
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.
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 233,333 to 312,296 .
16
Table of Contents
The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Employee and director stock option grants:
Research and development
$
104,830
$
309,933
$
308,193
$
453,158
General and administrative
462,958
1,224,121
1,387,723
2,334,508
Total stock-based compensation
$
567,788
$
1,534,054
$
1,695,916
$
2,787,666
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 is 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 applies 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 records stock-based compensation expense only for those awards that are expected to vest and accounts for forfeitures as they occur.
Dividends. The Company has not historically recorded dividends related to stock options.
Exercise prices for all grants made during the nine months ended September 30, 2025 and September 30, 2024, were equal to the market value of the Company’s common stock on the date of grant.
5. INCOME TAXES
The Company accounts for income taxes in accordance with the liability method of accounting. Deferred tax assets or liabilities are computed based on the difference between the financial statement and income tax basis of assets and liabilities, and net operating loss carryforwards (NOLs), using the enacted tax rates. Deferred income tax expense or benefit is based on changes in the asset or liability from period to period. The Company did not record a provision or benefit for federal, state or foreign income taxes for the nine months ended September 30, 2025 or 2024 because the Company has experienced losses on a tax basis since inception. Management has provided a full allowance against the value of its gross deferred tax assets considering the continuing losses and uncertainty associated with the utilization of the NOLs in the future.
The Company also accounts for the uncertainty in income taxes related to the recognition and measurement of a tax position taken or expected to be taken in an income tax return. The Company follows the applicable accounting guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition related to the uncertainty in income tax positions. No uncertain tax positions have been identified.
17
Table of Contents
6. 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 due 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 quarter ended September 30, 2024, the common warrants issued in October 2022 were dilutive. In all other periods presented, all outstanding warrants were antidilutive.
Periods ended September 30, 2024
Three Months
Nine Months
Net loss
$
( 14,664,719 )
$
( 42,226,073 )
Dilutive effect of warrant liability
( 1,428,355 )
( 7,283,786 )
Net loss allocated to common shares
$
( 16,093,074 )
$
( 49,509,859 )
Weighted average common shares outstanding - basic
1,311,197
1,161,681
Dilutive effect of warrant liability
15,277
23,169
Weighted average common shares outstanding - diluted
1,326,474
1,184,850
Net loss per share - diluted
$
( 12.13 )
$
( 41.79 )
The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would be antidilutive:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Warrants
1,984,808
680,426
1,984,808
680,426
Preferred shares on an as-converted-into-common-stock basis
16,743
200,522
16,743
200,522
Stock options
212,167
178,654
212,167
178,654
Total potentially dilutive shares
2,213,718
1,059,602
2,213,718
1,059,602
7. COMMITMENTS AND CONTINGENCIES
Legal
The Company may be involved in legal matters and disputes in the ordinary course of business. It is not anticipated that the outcome of such matters and disputes will materially affect the Company’s financial statements.
18
Table of Contents
8. 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 of the HQ Lease (Amended HQ Lease), with CAMPUS 100 LLC (the Landlord). Under the Amended HQ Lease, which was accounted for as a modification of the initial lease, 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, commencing on March 1, 2023 until April 30, 2029. The Company also has an option to extend the term of the Amended HQ Lease for one additional 60 -month period.
Under the terms of the Amended Lease, the Company Company’s previously paid security deposit of $ 75,000 will be 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. 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 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.
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 September 30, 2025:
Years ending December 31,
Remaining period of 2025
$
37,000
2026
150,000
2027
153,000
2028
156,000
Thereafter
52,000
Total undiscounted lease payments
548,000
Less: Imputed interest
( 115,000 )
Present value of lease liabilities
$
433,000
19
Table of Contents
9. OPERATING SEGMENT
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:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Research and development:
Phase 2 study in B-cell malignancies, including WM and MM
$
143,000
$
742,000
$
1,245,000
$
5,726,000
Phase 1 study in pediatric tumors
225,000
769,000
1,175,000
2,428,000
Phase 1 study in triple negative breast cancer
214,000
—
265,000
—
Manufacturing and related costs
1,195,000
2,469,000
2,776,000
8,410,000
Pre-clinical projects cost
72,000
49,000
724,000
101,000
General research and development costs
674,000
1,465,000
2,155,000
3,262,000
General and administrative
2,327,000
7,834,000
8,949,000
19,106,000
Other segment items
( 406,000 )
1,337,000
( 793,000 )
3,193,000
Segment and consolidated net loss
$
4,444,000
$
14,665,000
$
16,496,000
$
42,226,000
Other segment items consist of warrant issuance expense, (gain) loss on valuation of warrants, and interest income.
10. SUBSEQUENT EVENTS
On October 7, 2025, the Company entered into warrant exercise inducement offer letters 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 per 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.
20
Table of Contents
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.