CEL-SCI (CVM) - 2025 Q3 - Quarterly Report

PART I FINANCIAL INFORMATION Item 1. Financial Statements This section presents CEL-SCI Corporation's unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, alongside disclosures of a reverse stock split and going concern warning - The Company's financial statements are prepared on a going concern basis, despite recurring losses, and do not include adjustments that might result from the outcome of this uncertainty[28][58] - A 1-for-30 reverse stock split was approved by shareholders on May 19, 2025, and became effective on May 20, 2025, retroactively adjusting all share and per-share data[29][30] - The Company has incurred recurring losses from operations, leading to substantial doubt about its ability to continue as a going concern[28][58] Condensed Balance Sheets Presents the company's financial position, highlighting significant decreases in cash, total assets, and stockholders' equity Condensed Balance Sheet Highlights | Metric | June 30, 2025 (Unaudited) | September 30, 2024 | | :-------------------------------- | :-------------------------- | :------------------- | | Cash and cash equivalents | $1,792,856 | $4,738,173 | | Total current assets | $2,622,529 | $6,055,678 | | Total assets | $20,336,199 | $26,991,766 | | Total current liabilities | $5,616,048 | $4,615,779 | | Total liabilities | $13,311,259 | $14,124,683 | | Total stockholders' equity | $7,024,940 | $12,867,083 | - Cash and cash equivalents decreased by approximately 62% from $4.74 million at September 30, 2024, to $1.79 million at June 30, 2025[7] - Total assets decreased by approximately 24.7% from $26.99 million to $20.34 million, while total stockholders' equity decreased by approximately 45.3% from $12.87 million to $7.02 million[8][9] Condensed Statements of Operations (Nine Months Ended June 30, 2025 and 2024) Details the company's financial performance over nine months, showing a reduced net loss and improved loss per share despite increased shares outstanding Condensed Statements of Operations (Nine Months) | Metric | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------ | :------------------------------ | | Research and development | $12,184,276 | $13,684,204 | | General and administrative | $6,592,128 | $6,547,866 | | Total operating expenses | $18,776,404 | $20,232,070 | | Operating loss | $(18,776,404) | $(20,232,070) | | Net loss | $(19,310,155) | $(20,810,973) | | Net loss per common share – basic and diluted | $(6.34) | $(12.51) | | Weighted average common shares outstanding | 3,046,400 | 1,715,982 | - Net loss decreased by approximately 7.2% from $(20.81) million in 2024 to $(19.31) million in 2025 for the nine-month period[11] - Net loss per common share improved significantly from $(12.51) in 2024 to $(6.34) in 2025, despite an increase in weighted average common shares outstanding[11] Condensed Statements of Operations (Three Months Ended June 30, 2025 and 2024) Presents the company's quarterly financial performance, indicating a notable reduction in net loss and improved loss per share Condensed Statements of Operations (Three Months) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $3,739,948 | $4,703,160 | | General and administrative | $1,748,935 | $1,967,075 | | Total operating expenses | $5,488,883 | $6,670,235 | | Operating loss | $(5,488,883) | $(6,670,235) | | Net loss | $(5,664,704) | $(6,856,558) | | Net loss per common share – basic and diluted | $(1.36) | $(4.18) | | Weighted average common shares outstanding | 4,150,702 | 1,799,813 | - Net loss decreased by approximately 17.4% from $(6.86) million in 2024 to $(5.66) million in 2025 for the three-month period[13] - Net loss per common share improved from $(4.18) in 2024 to $(1.36) in 2025, despite a significant increase in weighted average common shares outstanding[13] Condensed Statements of Stockholders' Equity Outlines changes in stockholders' equity, primarily driven by net losses and common stock issuances, alongside a significant increase in outstanding shares Stockholders' Equity Changes (Nine Months Ended June 30, 2025) | Item | Amount | | :------------------------------------------ | :------------- | | Balance, September 30, 2024 | $12,867,083 | | Proceeds from the sale of common stock | $7,560,300 | | Equity based compensation - employees | $1,470,491 | | Share issuance costs | $(1,661,622) | | Net loss | $(19,310,155) | | Balance, June 30, 2025 | $7,024,940 | - Total stockholders' equity decreased from $12.87 million at September 30, 2024, to $7.02 million at June 30, 2025, primarily due to net losses, partially offset by proceeds from common stock sales[15][17] - The number of common shares issued and outstanding significantly increased from 2,126,682 at September 30, 2024, to 5,321,341 at June 30, 2025[9] Condensed Statements of Cash Flows Presents the company's cash flow activities, showing a decrease in cash used in operations and an increase in end-of-period cash and equivalents Condensed Statements of Cash Flows (Nine Months) | Cash Flow Activity | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(12,449,214) | $(13,994,501) | | Net cash used in investing activities | $(32,954) | $(88,333) | | Net cash provided by financing activities | $9,536,851 | $10,321,752 | | Net decrease in cash and cash equivalents | $(2,945,317) | $(3,761,083) | | Cash and cash equivalents, end of period | $1,792,856 | $384,652 | - Net cash used in operating activities decreased by approximately 11% from $(13.99) million in 2024 to $(12.45) million in 2025[21] - Cash and cash equivalents at the end of the period increased significantly from $384,652 in 2024 to $1,792,856 in 2025[21] Notes to Condensed Financial Statements Provides detailed explanations and disclosures supporting the condensed financial statements, including accounting policies, liquidity, equity, and subsequent events - The Company's financial statements are prepared on a going concern basis, despite recurring losses, and do not include adjustments that might result from the outcome of this uncertainty[28][58] - A 1-for-30 reverse stock split was approved by shareholders on May 19, 2025, and became effective on May 20, 2025, retroactively adjusting all share and per-share data[29][30] - The Company continues to fund operations primarily through equity and debt financings, with significant capital needs for Multikine development and clinical trials[56][57] A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Outlines the basis for financial statement preparation, significant accounting policies, and the impact of a recent reverse stock split and new accounting pronouncements - The financial statements are unaudited and prepared in accordance with U.S. GAAP, with certain disclosures omitted per SEC rules for interim reports[26] - A 1-for-30 reverse stock split was enacted on May 20, 2025, retroactively adjusting all share and per-share data, and reclassifying $909,021 from common stock to additional paid-in capital[29][30] - New accounting pronouncements (ASU 2023-07, ASU 2023-09, SEC climate disclosure rules, ASU 2024-03) are being evaluated for their potential impact on future disclosures[52][53][54][55] B. LIQUIDITY Addresses the company's liquidity challenges, including recurring losses and the need for additional capital to fund operations and Multikine development - The Company has incurred significant recurring losses and requires additional capital to continue Multikine development and operations, leading to substantial doubt about its ability to continue as a going concern[56][58] - Plans to raise additional capital include corporate partnerships, debt, and/or equity financings, relying on past success and positive Phase 3 Multikine data[57] C. STOCKHOLDERS' EQUITY Details the changes in stockholders' equity, including proceeds from common stock sales, share-based compensation, and the classification of pre-funded warrants Proceeds from Common Stock Sales (Nine Months Ended June 30, 2025) | Offering Date | Shares Sold | Offering Price per Share | Net Proceeds (approx.) | | :------------ | :---------- | :----------------------- | :--------------------- | | May 2025 | 2,000,000 | $2.50 | $4.5 million | | March 2025 | 133,750 (common) + 399,584 (pre-funded warrants) | $4.80 (common), $4.797 (warrant) | $2.1 million | | December 2024 | 251,750 (common) + 285,917 (pre-funded warrants) | $9.30 (common), $9.297 (warrant) | $4.4 million | Share-Based Compensation Expense (Nine Months Ended June 30) | Category | 2025 | 2024 | | :--------- | :----------- | :----------- | | Employees | $1,470,491 | $3,544,569 | | Non-employees | $587,285 | $600,841 | | Total | $2,057,776 | $4,145,410 | - Pre-funded warrants from March 2025 and December 2024 offerings were classified as permanent equity[62] - Total share-based compensation expense decreased by approximately 50% for the nine months ended June 30, 2025, compared to the same period in 2024[68] D. RELATED PARTY TRANSACTIONS Reports on related party transactions, including officer and director stock purchases and warrant expiration date extensions - No related party transactions occurred during the nine months ended June 30, 2025[77] - During the nine months ended June 30, 2024, officers and directors purchased 1,933 shares of restricted common stock for approximately $80,620[77] - Warrant expiration dates for Series UU, X, Y, N, MM, NN, and RR were extended by 24 months on May 4, 2024, resulting in an incremental cost of approximately $0.7 million recorded as a deemed dividend[78] E. NOTES PAYABLE Details a short-term promissory note agreement entered into and fully repaid during the period - The Company entered into a $350,000 promissory note agreement on May 8, 2025, bearing 10% interest, which was fully repaid by June 30, 2025[79] F. COMMITMENTS AND CONTINGENCIES Outlines contractual obligations, including clinical development services, finance lease liabilities, and a significant lease deposit - The Company engaged Ergomed Clinical Research, Inc. for clinical development services for an upcoming confirmatory registration study, incurring approximately $0.7 million in R&D expenses as of June 30, 2025[80][81] - Finance lease right-of-use assets decreased from $7.4 million to $6.0 million, and finance lease liabilities decreased from $10.0 million to $8.5 million between September 30, 2024, and June 30, 2025[83] - A $2.3 million deposit was made to the San Tomas lease landlord on January 11, 2023, due to falling below a stipulated cash threshold[84] G. PATENTS Reports on patent-related activities, including abandonments, resulting impairment losses, and amortization costs - During the nine months ended June 30, 2025, the Company abandoned four patents, resulting in an impairment loss of $13,312[89] - Patent amortization costs were approximately $22,000 for the nine months ended June 30, 2025, and $25,000 for the same period in 2024[89] H. LOSS PER COMMON SHARE Reconciles the calculation of basic and diluted loss per common share, noting the exclusion of anti-dilutive securities Loss Per Common Share Reconciliation | Metric | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------ | :------------------------------ | | Net loss available to common shareholders | $(19,310,155) | $(21,470,429) | | Weighted average shares outstanding | 3,046,400 | 1,715,982 | | Basic and diluted loss per common share | $(6.34) | $(12.51) | - Potentially dilutive shares (options, warrants, unvested restricted stock) were excluded from diluted EPS calculation as their effect would be anti-dilutive[91][93] I. SUBSEQUENT EVENTS Discloses significant events occurring after the reporting period, including new legislation, stock sales, and insider purchases - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, making permanent key elements of the Tax Cuts and Jobs Act, and the Company is evaluating its impact on financial statements[94] - On July 14, 2025, the Company sold 1,500,000 shares of common stock for gross proceeds of approximately $5.7 million[95] - On July 25, 2025, the CEO and a director purchased 32,116 shares of restricted common stock for approximately $219,995[95] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of CEL-SCI's business, focusing on its lead investigational therapy Multikine, its Phase III clinical trial results, and the path forward for regulatory approval. It also discusses the Company's liquidity, capital resources, and detailed results of operations, highlighting the ongoing need for financing due to recurring losses - CEL-SCI is a late clinical-stage biotechnology company focused on immunotherapy for cancer and other diseases, with lead product candidates Multikine (head and neck cancers) and L.E.A.P.S. technology (rheumatoid arthritis)[97][98] - Multikine's Phase III study in a target population (newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression) showed a 73% survival rate vs. 45% without Multikine at 5 years, with a Hazard ratio of 0.35[102][105][108][109] - The FDA indicated CEL-SCI may proceed with a 212-patient confirmatory registration study for Multikine in the target population, which accounts for approximately 100,000 patients worldwide per year[103][133] - The Company continues to face substantial doubt about its ability to continue as a going concern due to recurring operating losses and the need to raise approximately $30 million for the confirmatory registration study[145] Company Overview Introduces CEL-SCI Corporation as a late clinical-stage biotechnology company developing immunotherapies, with no products yet approved for sale - CEL-SCI Corporation is a late clinical-stage biotechnology company focused on developing immunotherapies for cancer and other diseases[97] - Its primary product candidates are Multikine (for head and neck cancers) and L.E.A.P.S. technology (for rheumatoid arthritis)[98] - None of the Company's product candidates have received regulatory approval for sale, and their safety or efficacy has not been established[97] MULTIKINE, THE PHASE III CLINICAL TRIAL RESULTS, AND PATH FORWARD Discusses Multikine's Phase III clinical trial results in head and neck cancer, highlighting significant survival benefits and the FDA-approved path for a confirmatory study - Multikine is an investigational immunotherapy for head and neck cancers, unique for being administered first, right after diagnosis, before other treatments[99] - In the target patient population (newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression), Multikine showed a 73% survival rate vs. 45% without Multikine at 5 years, with a Hazard ratio of 0.35[102][105][108][109] - The FDA indicated CEL-SCI may proceed with a 212-patient randomized controlled confirmatory registration study for Multikine in the target population[103][133] - Multikine demonstrated statistically significant pre-surgical responses (reductions and/or downstages) and no demonstrable safety signals or toxicities across multiple clinical trials[111][113][114][115] Liquidity and Capital Resources Addresses the company's financing strategies, ongoing capital needs for clinical studies, and recent cash flow changes - The Company has historically financed operations through equity securities, convertible notes, loans, and research grants, and anticipates continued reliance on these methods due to ongoing net operating losses[141][142][144] - The estimated cost for the confirmatory registration study is approximately $30 million, requiring additional capital or long-term financing[145] - Cash decreased by approximately $2.9 million during the nine months ended June 30, 2025, primarily due to $12.5 million in operating activities and $1.5 million in finance lease payments, partially offset by $11.0 million from financings[146] Results of Operations and Financial Condition Analyzes the company's financial performance, noting a decrease in net operating loss and the significant impact of non-cash expenses Net Operating Loss (Nine Months Ended June 30) | Metric | 2025 | 2024 | | :------------------- | :------------- | :------------- | | Net operating loss | $(18.8 million) | $(20.2 million) | | Share-based compensation | $2.1 million | $4.1 million | | Depreciation and amortization | $2.9 million | $3.0 million | - The net operating loss decreased by approximately $1.4 million for the nine months ended June 30, 2025, compared to the same period in 2024[149] - Non-cash expenses, including share-based compensation and depreciation/amortization, represent a significant portion of the operating loss[149] Research and Development Expenses Examines the changes in R&D expenses, primarily driven by a decrease in employee stock compensation, for Multikine and LEAPS programs Research and Development Expenses (Nine Months Ended June 30) | Category | 2025 (in thousands) | 2024 (in thousands) | | :------------------------------ | :------------------ | :------------------ | | Clinical trial expense | $554 | $547 | | Supplies & materials | $1,766 | $1,225 | | Personnel-related expenses | $4,558 | $4,534 | | Stock-based compensation | $567 | $2,488 | | Depreciation and amortization expense | $2,894 | $2,702 | | Other expenses | $1,845 | $2,188 | | Total research and development expenses | $12,184 | $13,684 | - Total R&D expenses decreased by approximately $1.5 million (11%) for the nine months ended June 30, 2025, primarily due to a $1.9 million decrease in employee stock compensation expense[153] - R&D expenses for Multikine were $12.69 million in 2025 (vs. $13.62 million in 2024), while LEAPS showed a credit of $(0.50) million in 2025 (vs. $0.07 million expense in 2024)[160] General and Administrative Expenses Reviews the stability of general and administrative expenses, noting offsetting changes in stock compensation, depreciation, and professional fees - General and administrative expenses remained constant at $6.6 million for the nine months ended June 30, 2025, compared to the prior year[155] - Key changes included a $0.2 million decrease in employee stock compensation and a $0.3 million decrease in depreciation/amortization, offset by a $0.2 million increase in legal/accounting fees and a $0.4 million increase in public relations costs[155] Interest Expense, Net Reports a decrease in net interest expense, primarily attributed to reduced principal balances on leases - Net interest expense decreased by approximately $0.1 million (9%) for the nine months ended June 30, 2025, primarily due to lower interest paid on leases as principal balances were reduced[157] Critical Accounting Estimates Identifies key accounting estimates, such as lease accounting and share-based compensation, which require significant management judgment - Critical accounting estimates include lease accounting (determining lease term and incremental borrowing rate) and share-based compensation (fair value calculation using Black-Scholes model and Monte Carlo simulation)[163][164][167] - Significant judgment is required in developing inputs and assumptions for these estimates, which can materially affect financial statements[162][163][166] Item 3. Quantitative and Qualitative Disclosures about Market Risks The Company states that it does not believe it has any significant exposure to market risk - The Company does not believe it has any significant exposure to market risk[168] Item 4. Controls and Procedures The Company's management, including the CEO and CFO, evaluated the effectiveness of its disclosure controls and procedures as of June 30, 2025, and concluded they were not effective due to material weaknesses identified in the prior annual report - The Company's disclosure controls and procedures were deemed not effective as of June 30, 2025, due to material weaknesses previously described in the Annual Report on Form 10-K for September 30, 2024[170] - No changes in internal control over financial reporting occurred during the nine months ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control[171] PART II Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. During the nine months ended June 30, 2025, CEL-SCI issued 6,821 restricted shares of common stock to consultants for investor relations services, relying on the Section 4(a)(2) exemption of the Securities Act of 1933 - The Company issued 6,821 restricted shares of common stock to consultants for investor relations services during the nine months ended June 30, 2025[173] - These issuances were made under the exemption provided by Section 4(a)(2) of the Securities Act of 1933, with no general solicitation and shares bearing a restricted legend[174] Item 5. Other Information No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the quarter ended June 30, 2025 - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarterly period ending June 30, 2025[175] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including Rule 13a-14(a) and Section 1350 Certifications Exhibits Filed | Number | Exhibit | | :----- | :-------------------------- | | 31 | Rule 13a-14(a) Certifications | | 32 | Section 1350 Certifications | Signatures The report is duly signed on behalf of CEL-SCI Corporation by its Principal Executive Officer, Geert Kersten, and Principal Financial Officer, Patricia Prichep, on August 14, 2025 - The report was signed by Geert Kersten, Principal Executive Officer, and Patricia Prichep, Principal Financial Officer, on August 14, 2025[178]