Core Insights - CEL-SCI Corporation is scheduled to present its strategic roadmap for Multikine at the LD Micro "Main Event" Investor Conference on October 21, 2025 [1][2] Company Overview - CEL-SCI Corporation is a clinical stage cancer immunotherapy company focused on enhancing the immune system's ability to target tumors before surgical interventions [3] - The company operates in Vienna, Virginia, and near Baltimore, Maryland [5] Product Information - Multikine (Leukocyte Interleukin, Injection) is a first-line cancer therapy that has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck [4] - The FDA has approved CEL-SCI to conduct a confirmatory Registration Study for Multikine, which will enroll 212 patients with newly diagnosed locally advanced resectable head and neck cancer [4] - The target patient population for this study is estimated to represent about 100,000 patients annually [4]

Core Viewpoint - CEL-SCI Corporation is set to present its strategic roadmap for the development of Multikine at the LD Micro "Main Event" Investor Conference on October 21, 2025 [1][2]. Company Overview - CEL-SCI Corporation is a clinical stage cancer immunotherapy company focused on enhancing the immune system's ability to target tumors before surgical interventions [3]. - The company operates in Vienna, Virginia, and near Baltimore, Maryland [5]. Product Information - Multikine (Leukocyte Interleukin, Injection) is a first-line cancer therapy that has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck [4]. - A completed randomized controlled Phase 3 study involving 928 patients has led to FDA approval for a confirmatory Registration Study, which will enroll 212 patients with newly diagnosed locally advanced resectable head and neck cancer [4]. - The target patient population for this study is approximately 100,000 patients annually, specifically those with no lymph node involvement and low PD-L1 tumor expression [4].

Core Insights - Several small-cap stocks experienced significant gains in after-hours trading, driven by strategic updates, leadership changes, and pipeline developments, indicating renewed investor interest [1] Adaptimmune Therapeutics plc (ADAP) - ADAP's stock surged 30% in after-hours trading, reaching $0.2020 after a 98% gain during the regular session, closing at $0.16 [2] - The company reported a net loss of $30.3 million for Q2 2025, with total revenue of $13.7 million, primarily from product sales of TECELRA, which saw over 150% growth compared to Q1 [3] - In August, Adaptimmune sold several cell therapies to US WorldMeds for $55 million upfront, with potential future milestone payments of up to $30 million, allowing the company to repay its debt and restructure [4] Butterfly Network Inc. (BFLY) - BFLY's stock rose 10.58% in after-hours trading to $2.09, following a 15.95% increase during the regular session [4] - The company was recognized in TIME's list of the World's Top HealthTech Companies for 2025, and appointed a new Chief Technology Officer, enhancing its focus on innovation [5] - A recent study confirmed that Butterfly-enabled POCUS programs significantly reduce hospital stays and costs, validating its clinical impact [5] Aquestive Therapeutics Inc. (AQST) - AQST's stock increased 7.69% in after-hours trading to $5.32, continuing a year-to-date rise of nearly 39% [6] - The FDA confirmed it will not require an advisory committee meeting for AQST's NDA for Anaphylm, streamlining the regulatory process with a PDUFA date set for January 2026 [7] - The company secured a $75 million strategic funding agreement to support the potential launch of Anaphylm, reinforcing its commercial readiness [7] ALX Oncology Holdings Inc. (ALXO) - ALXO's stock rose 9.17% in after-hours trading to $1.19, following a 3.81% increase during the regular session [8] - Insider buying activity, particularly by CEO Jason Lettmann, who purchased 92,233 shares, has boosted investor confidence [9] - The company's lead candidate, Evorpacept, is in multiple Phase 1 and Phase 2 trials across various cancers, collaborating with major partners [9] Ekso Bionics Holdings Inc. (EKSO) - EKSO's stock increased 5.37% in after-hours trading to $4.51, following a 9.74% gain during the regular session [10] - The company's inclusion in the NVIDIA Connect Program has spotlighted its efforts to integrate AI into its technologies [11] - EKSO launched Virtual eksoUniversity to support continuing education for physical therapists, potentially broadening adoption of its rehabilitation devices [11] CEL-SCI Corp. (CVM) - CVM's stock rose 5.27% in after-hours trading to $9.39, after a 1.02% increase during the regular session [12] - The company completed a $10 million public offering to support ongoing clinical and regulatory efforts [13] - CEL-SCI filed for Breakthrough Medicine Designation in Saudi Arabia for its lead candidate, Multikine, which could expedite patient access and reimbursement [13]

PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) 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](index=28&type=chunk)[58](index=58&type=chunk) - 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](index=29&type=chunk)[30](index=30&type=chunk) - The Company has incurred recurring losses from operations, leading to substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk)[58](index=58&type=chunk) [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) 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](index=7&type=chunk) - 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](index=8&type=chunk)[9](index=9&type=chunk) [Condensed Statements of Operations (Nine Months Ended June 30, 2025 and 2024)](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20%28Nine%20Months%29) 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 **$(19.31) million** in 2025 for the nine-month period[11](index=11&type=chunk) - Net loss per common share improved significantly from **$(12.51)** in 2024 to **$(6.34)** in 2025, despite an increase in weighted average common shares outstanding[11](index=11&type=chunk) [Condensed Statements of Operations (Three Months Ended June 30, 2025 and 2024)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20%28Three%20Months%29) 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 **$(5.66) million** in 2025 for the three-month period[13](index=13&type=chunk) - Net loss per common share improved from **$(4.18)** in 2024 to **$(1.36)** in 2025, despite a significant increase in weighted average common shares outstanding[13](index=13&type=chunk) [Condensed Statements of Stockholders' Equity](index=4&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) 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](index=15&type=chunk)[17](index=17&type=chunk) - 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](index=9&type=chunk) [Condensed Statements of Cash Flows](index=5&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) 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](index=21&type=chunk) - Cash and cash equivalents at the end of the period increased significantly from **$384,652** in 2024 to **$1,792,856** in 2025[21](index=21&type=chunk) [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) 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](index=28&type=chunk)[58](index=58&type=chunk) - 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](index=29&type=chunk)[30](index=30&type=chunk) - The Company continues to fund operations primarily through equity and debt financings, with significant capital needs for Multikine development and clinical trials[56](index=56&type=chunk)[57](index=57&type=chunk) [A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=A.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) 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](index=26&type=chunk) - 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](index=29&type=chunk)[30](index=30&type=chunk) - 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](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) [B. LIQUIDITY](index=10&type=section&id=B.%20LIQUIDITY) 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](index=56&type=chunk)[58](index=58&type=chunk) - Plans to raise additional capital include corporate partnerships, debt, and/or equity financings, relying on past success and positive Phase 3 Multikine data[57](index=57&type=chunk) [C. STOCKHOLDERS' EQUITY](index=11&type=section&id=C.%20STOCKHOLDERS%27%20EQUITY) 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](index=62&type=chunk) - 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](index=68&type=chunk) [D. RELATED PARTY TRANSACTIONS](index=13&type=section&id=D.%20RELATED%20PARTY%20TRANSACTIONS) 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](index=77&type=chunk) - During the nine months ended June 30, 2024, officers and directors purchased **1,933** shares of restricted common stock for approximately **$80,620**[77](index=77&type=chunk) - 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](index=78&type=chunk) [E. NOTES PAYABLE](index=13&type=section&id=E.%20NOTES%20PAYABLE) 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](index=79&type=chunk) [F. COMMITMENTS AND CONTINGENCIES](index=13&type=section&id=F.%20COMMITMENTS%20AND%20CONTINGENCIES) 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](index=80&type=chunk)[81](index=81&type=chunk) - 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](index=83&type=chunk) - 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](index=84&type=chunk) [G. PATENTS](index=15&type=section&id=G.%20PATENTS) 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](index=89&type=chunk) - 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](index=89&type=chunk) [H. LOSS PER COMMON SHARE](index=15&type=section&id=H.%20LOSS%20PER%20COMMON%20SHARE) 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](index=91&type=chunk)[93](index=93&type=chunk) [I. SUBSEQUENT EVENTS](index=16&type=section&id=I.%20SUBSEQUENT%20EVENTS) 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](index=94&type=chunk) - On July 14, 2025, the Company sold **1,500,000** shares of common stock for gross proceeds of approximately **$5.7 million**[95](index=95&type=chunk) - On July 25, 2025, the CEO and a director purchased **32,116** shares of restricted common stock for approximately **$219,995**[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=97&type=chunk)[98](index=98&type=chunk) - 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](index=102&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - 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](index=103&type=chunk)[133](index=133&type=chunk) - 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](index=145&type=chunk) [Company Overview](index=16&type=section&id=Company%20Overview) 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](index=97&type=chunk) - Its primary product candidates are Multikine (for head and neck cancers) and L.E.A.P.S. technology (for rheumatoid arthritis)[98](index=98&type=chunk) - None of the Company's product candidates have received regulatory approval for sale, and their safety or efficacy has not been established[97](index=97&type=chunk) [MULTIKINE, THE PHASE III CLINICAL TRIAL RESULTS, AND PATH FORWARD](index=16&type=section&id=MULTIKINE%2C%20THE%20PHASE%20III%20CLINICAL%20TRIAL%20RESULTS%2C%20AND%20PATH%20FORWARD) 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](index=99&type=chunk) - 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](index=102&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - The FDA indicated CEL-SCI may proceed with a **212-patient** randomized controlled confirmatory registration study for Multikine in the target population[103](index=103&type=chunk)[133](index=133&type=chunk) - Multikine demonstrated statistically significant pre-surgical responses (reductions and/or downstages) and no demonstrable safety signals or toxicities across multiple clinical trials[111](index=111&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=141&type=chunk)[142](index=142&type=chunk)[144](index=144&type=chunk) - The estimated cost for the confirmatory registration study is approximately **$30 million**, requiring additional capital or long-term financing[145](index=145&type=chunk) - 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](index=146&type=chunk) [Results of Operations and Financial Condition](index=24&type=section&id=Results%20of%20Operations%20and%20Financial%20Condition) 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](index=149&type=chunk) - Non-cash expenses, including share-based compensation and depreciation/amortization, represent a significant portion of the operating loss[149](index=149&type=chunk) [Research and Development Expenses](index=24&type=section&id=Research%20and%20Development%20Expenses) 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](index=153&type=chunk) - 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](index=160&type=chunk) [General and Administrative Expenses](index=25&type=section&id=General%20and%20Administrative%20Expenses) 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](index=155&type=chunk) - 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](index=155&type=chunk) [Interest Expense, Net](index=25&type=section&id=Interest%20Expense%2C%20Net) 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](index=157&type=chunk) [Critical Accounting Estimates](index=25&type=section&id=Critical%20Accounting%20Estimates) 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](index=163&type=chunk)[164](index=164&type=chunk)[167](index=167&type=chunk) - Significant judgment is required in developing inputs and assumptions for these estimates, which can materially affect financial statements[162](index=162&type=chunk)[163](index=163&type=chunk)[166](index=166&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risks](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risks) 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](index=168&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=170&type=chunk) - 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](index=171&type=chunk) PART II [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) 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](index=173&type=chunk) - 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](index=174&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) 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](index=175&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) 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](index=27&type=section&id=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](index=178&type=chunk)

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 100 points on Monday [1] - Ultragenyx Pharmaceutical Inc. shares fell 8% to $27.15 after receiving a Complete Response Letter from the FDA for its gene therapy UX111 [1] Company-Specific Movements - MiNK Therapeutics, Inc. shares dropped 31% to $44.25 after a significant 730% increase on Friday due to a publication announcement [3] - Above Food Ingredients Inc. shares decreased 21.3% to $2.84 following a 134% rise on Friday after announcing a merger agreement [3] - Newegg Commerce, Inc. shares fell 11.3% to $43.66 after a 71% gain on Friday [3] - CEL-SCI Corporation shares declined 11% to $3.08 after an 8% drop on Friday, following a partnership announcement with a Saudi Arabian company [3] - Unusual Machines, Inc. shares slipped 8% to $11.13 after a 39% increase on Friday [3] - Gossamer Bio, Inc. shares fell 6.6% to $1.2700 after completing enrollment in a Phase 3 study for pulmonary arterial hypertension [3] - Gilat Satellite Networks Ltd. shares decreased 4.1% to $7.22 after announcing over $22 million in orders from satellite operators [3] - KalVista Pharmaceuticals, Inc. shares dipped 4% to $13.94 after reporting a wider-than-expected quarterly loss [3] - Apple Inc. shares fell 1% to $209.22 amid a significant management reshuffle, with CEO Tim Cook remaining in charge despite challenges [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to __________. Commission file number 1-11889 CEL-SCI CORPORATION Colorado 84-0916344 State or other jurisdiction incorporation (IRS) Employer Ide ...

[PART I FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q4 2024 condensed financial statements for CEL-SCI are presented, emphasizing going concern doubt [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) This section provides a summary of the company's financial position, detailing assets, liabilities, and stockholders' equity as of December 31, 2024, and September 30, 2024 Condensed Balance Sheet Summary | Metric | Dec 31, 2024 (Unaudited) | Sep 30, 2024 | | :-------------------------------- | :----------------------- | :------------- | | Total Assets | $25,698,787 | $26,991,766 | | Total Liabilities | $14,390,155 | $14,124,683 | | Total Stockholders' Equity | $11,308,632 | $12,867,083 | - Total assets decreased by approximately **$1.3 million** from September 30, 2024, to December 31, 2024, while total liabilities increased by approximately **$0.27 million**[6](index=6&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) - Total stockholders' equity decreased by approximately **$1.56 million**[6](index=6&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) This section outlines the company's financial performance for the three months ended December 31, 2024 and 2023, focusing on operating expenses, net loss, and loss per common share Condensed Statements of Operations (Three Months Ended December 31) | Metric | 2024 (Unaudited) | 2023 (Unaudited) | | :----------------------------------- | :--------------- | :--------------- | | Research and development | $4,430,063 | $4,352,509 | | General and administrative | $2,463,355 | $2,133,378 | | Total operating expenses | $6,893,418 | $6,485,887 | | Operating loss | $(6,893,418) | $(6,485,887) | | Net loss | $(7,073,062) | $(6,709,524) | | Net loss per common share – basic and diluted | $(0.11) | $(0.14) | | Weighted average common shares outstanding | 65,325,855 | 48,470,600 | - Net loss increased to **$7.07 million** in Q4 2024 from **$6.71 million** in Q4 2023[12](index=12&type=chunk) - Net loss per common share improved to **$(0.11)** from **$(0.14)** due to a significant increase in weighted average common shares outstanding (from **48.47 million** to **65.33 million**)[12](index=12&type=chunk) - Total operating expenses increased by approximately **$0.41 million** year-over-year[12](index=12&type=chunk) [Condensed Statements of Stockholders' Equity](index=4&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section details changes in stockholders' equity for the three months ended December 31, 2024, including common stock, additional paid-in capital, and accumulated deficit Condensed Statements of Stockholders' Equity (Three Months Ended December 31) | Metric | Sep 30, 2024 | Dec 31, 2024 | | :-------------------------- | :----------- | :----------- | | Common Stock Shares | 63,787,104 | 73,084,041 | | Common Stock Amount | $637,870 | $730,839 | | Additional Paid-In Capital | $526,241,074 | $531,662,716 | | Accumulated Deficit | $(514,011,861) | $(521,084,923) | | Total Stockholders' Equity | $12,867,083 | $11,308,632 | - Total stockholders' equity decreased from **$12.87 million** to **$11.31 million** during the three months ended December 31, 2024, primarily due to a net loss of **$7.07 million**, partially offset by proceeds from common stock sales (**$5.00 million**) and equity-based compensation[14](index=14&type=chunk) - Common stock shares outstanding increased significantly from **63,787,104** to **73,084,041**, driven by pre-funded warrant exercises and proceeds from the sale of common stock[14](index=14&type=chunk) [Condensed Statements of Cash Flows](index=4&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the company's cash flow activities for the three months ended December 31, 2024 and 2023, covering operating, investing, and financing activities Condensed Statements of Cash Flows (Three Months Ended December 31) | Cash Flow Activity | 2024 | 2023 | | :----------------------------------- | :----------- | :----------- | | Net cash used in operating activities | $(4,139,973) | $(4,887,928) | | Net cash used in investing activities | $(32,954) | $(64,861) | | Net cash provided by financing activities | $4,048,869 | $4,048,494 | | Net decrease in cash and cash equivalents | $(124,058) | $(904,295) | | Cash and cash equivalents, end of period | $4,614,115 | $3,241,440 | - Net cash used in operating activities decreased from **$4.89 million** in Q4 2023 to **$4.14 million** in Q4 2024[16](index=16&type=chunk)[17](index=17&type=chunk) - Net cash provided by financing activities remained stable at approximately **$4.05 million** in both periods[16](index=16&type=chunk)[17](index=17&type=chunk) - The net decrease in cash and cash equivalents significantly improved from **$(904,295)** in Q4 2023 to **$(124,058)** in Q4 2024[16](index=16&type=chunk)[17](index=17&type=chunk) [Notes to Condensed Financial Statements](index=5&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed financial statements, covering accounting policies, liquidity, equity, commitments, and contingencies [A. Basis of Presentation and Summary of Significant Accounting Policies](index=5&type=section&id=A.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the preparation basis for the unaudited financial statements and summarizes the key accounting policies adopted by the company - The financial statements are unaudited and prepared in accordance with U.S. GAAP, with certain disclosures omitted as permitted by SEC rules, and management believes they contain all necessary adjustments for fair presentation[21](index=21&type=chunk)[22](index=22&type=chunk) - Due to recurring losses and future liquidity needs, there is substantial doubt about the Company's ability to continue as a going concern[24](index=24&type=chunk) - Key accounting policies include cash and cash equivalents, property and equipment, R&D and manufacturing supplies, patents, leases (ASC 842), share-based compensation (ASC 718), net loss per common share (ASC 260), concentration of credit risk, income taxes (ASC 740), impairment of long-lived assets (ASC 360-10), and fair value measurements (ASC 820)[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - The Company is evaluating the impact of new accounting pronouncements: ASU 2023-07 (Segment Reporting), ASU 2023-09 (Income Tax Disclosures), SEC Climate Disclosure Rules (currently stayed), and ASU 2024-03 (Expense Disaggregation Disclosures)[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk) [B. Liquidity](index=9&type=section&id=B.%20Liquidity) This section discusses the company's ability to meet its short-term and long-term financial obligations, highlighting funding sources and going concern considerations - The Company has incurred significant costs for R&D, facilities, and clinical trials, funded primarily by loans and securities sales, and requires additional capital to bring Multikine to market[48](index=48&type=chunk) - Plans to raise additional capital through corporate partnerships, debt, and/or equity financings, citing past success and Multikine's Phase 3 survival benefit, though timely or acceptable financing is not assured[49](index=49&type=chunk) - Recurring losses and future liquidity needs create substantial doubt about the Company's ability to continue as a going concern[50](index=50&type=chunk) [C. Stockholders' Equity](index=9&type=section&id=C.%20Stockholders'%20Equity) This section details transactions affecting stockholders' equity, including common stock sales, warrant issuances, and share-based compensation expenses - In December 2024, the Company sold **7,552,500** common shares and pre-funded warrants for approximately **$4.4 million** net of issuance costs, with pre-funded warrants classified as permanent equity[51](index=51&type=chunk)[52](index=52&type=chunk) - In November 2023, the Company sold **2,490,000** common shares for approximately **$4.5 million** net of issuance costs[53](index=53&type=chunk) - In October 2024, **1,000,000** shares of common stock were issued to Ergomed Group Limited for services, recognized as unvested and forfeitable for accounting purposes[54](index=54&type=chunk) Share-Based Compensation Expense (Three Months Ended December 31) | Category | 2024 | 2023 | | :----------- | :--------- | :--------- | | Employees | $711,381 | $1,383,909 | | Non-employees | $396,839 | $218,386 | | Total | $1,108,220 | $1,602,295 | - During Q4 2024, **8,577,500** pre-funded warrants were issued, and **1,450,000** were exercised[57](index=57&type=chunk)[58](index=58&type=chunk)[61](index=61&type=chunk) - **500,000** options were issued to a consultant[57](index=57&type=chunk)[58](index=58&type=chunk)[61](index=61&type=chunk) Warrants and Non-Employee Options Outstanding (December 31, 2024) | Warrant/Options | Shares Issuable | Exercise Price | Expiration Date | | :---------------- | :-------------- | :------------- | :-------------- | | Series N | 85,339 | $3.00 | 8/18/2026 | | Series UU | 93,603 | $2.80 | 6/30/2026 | | Series X | 120,000 | $9.25 | 7/13/2026 | | Series Y | 26,000 | $12.00 | 8/15/2026 | | Series MM | 333,432 | $1.86 | 6/22/2026 | | Series NN | 200,087 | $2.52 | 7/24/2026 | | Series RR | 234,009 | $1.65 | 10/30/2026 | | Pre-Funded | 8,577,500 | $0.0001 | N/A | | Consultant Options | 610,000 | $0.70 - $2.18 | 7/27/2027 - 11/1/2034 | [D. Related Party Transactions](index=11&type=section&id=D.%20Related%20Party%20Transactions) This section discloses any transactions between the company and its related parties during the reporting periods - There were no related party transactions during the three months ended December 31, 2024 and 2023[63](index=63&type=chunk) [E. Commitments and Contingencies](index=11&type=section&id=E.%20Commitments%20and%20Contingencies) This section outlines the company's contractual obligations and potential liabilities, including lease agreements and clinical development service contracts - The Company entered into an agreement with Ergomed Clinical Research, Inc. in August 2024 for clinical development services, incurring approximately **$0.7 million** in R&D expenses as of December 31, 2024[64](index=64&type=chunk) - The Company leases a manufacturing facility (San Tomas lease) with a 20-year term expiring in October 2028, and other smaller finance leases[65](index=65&type=chunk)[67](index=67&type=chunk) - The net book value of finance lease right-of-use assets was approximately **$6.9 million**, and the finance lease liability was approximately **$9.5 million** as of December 31, 2024[65](index=65&type=chunk)[67](index=67&type=chunk) - Operating lease right-of-use assets were approximately **$1.4 million**, and operating lease liabilities were approximately **$1.6 million** as of December 31, 2024[68](index=68&type=chunk)[70](index=70&type=chunk) - The Company also made a **$2.3 million** deposit for the San Tomas lease in January 2023[68](index=68&type=chunk)[70](index=70&type=chunk) Future Minimum Lease Payments Under Finance Leases (as of December 31, 2024) | Period | Amount | | :-------------------------- | :----------- | | Nine months ending Sep 30, 2025 | $2,065,000 | | Year ending Sep 30, 2026 | $2,838,000 | | Year ending Sep 30, 2027 | $2,929,000 | | Year ending Sep 30, 2028 | $3,021,000 | | Year ending Sep 30, 2029 | $255,000 | | Total future minimum lease obligation | $11,108,000 | | Net present value of financing lease obligations | $9,486,000 | Future Minimum Lease Payments Under Operating Leases (as of December 31, 2024) | Period | Amount | | :-------------------------- | :----------- | | Nine months ending Sep 30, 2025 | $276,000 | | Year ending Sep 30, 2026 | $287,000 | | Year ending Sep 30, 2027 | $277,000 | | Year ending Sep 30, 2028 | $285,000 | | Year ending Sep 30, 2029 | $294,000 | | Year ending Sep 30, 2030 | $303,000 | | Thereafter | $443,000 | | Total future minimum lease obligation | $2,165,000 | | Net present value of operating lease obligations | $1,599,000 | [G. Patents](index=12&type=section&id=G.%20Patents) This section details the company's patent activities, including abandonments, impairment losses, and amortization expenses - During Q4 2024, the Company abandoned three patents, resulting in an impairment loss of **$9,541**[73](index=73&type=chunk) - Patent amortization for the period was approximately **$8,000**[73](index=73&type=chunk) Estimated Future Patent Amortization | Period | Amount | | :-------------------------- | :------- | | Nine months ending Sep 30, 2025 | $21,000 | | Year ending Sep 30, 2026 | $25,000 | | Year ending Sep 30, 2027 | $22,000 | | Year ending Sep 30, 2028 | $18,000 | | Year ending Sep 30, 2029 | $16,000 | | Year ending Sep 30, 2030 | $14,000 | | Thereafter | $32,000 | | Total | $148,000 | [H. Loss Per Common Share](index=13&type=section&id=H.%20Loss%20Per%20Common%20Share) This section explains the calculation of basic and diluted net loss per common share and lists anti-dilutive securities excluded from the calculation - Basic and diluted net loss per common share is calculated by dividing net loss by the weighted average common shares outstanding, with potentially dilutive shares excluded if anti-dilutive[75](index=75&type=chunk) Loss Per Share Reconciliation (Three Months Ended December 31) | Metric | 2024 | 2023 | | :----------------------------------- | :----------- | :----------- | | Net loss available to common shareholders | $(7,073,062) | $(6,709,524) | | Weighted average shares outstanding | 65,325,855 | 48,470,600 | | Basic and diluted loss per common share | $(0.11) | $(0.14) | Anti-Dilutive Securities Excluded from Diluted EPS (as of December 31) | Security Type | 2024 | 2023 | | :-------------------- | :----------- | :----------- | | Options and Warrants | 17,837,177 | 15,839,028 | | Unvested Common Stock | 1,000,000 | - | | Unvested Restricted Stock | 144,250 | 147,250 | | Total | 18,981,427 | 15,986,278 | [J. Subsequent Events](index=13&type=section&id=J.%20Subsequent%20Events) This section reports on events occurring after the balance sheet date that may require disclosure or adjustment to the financial statements - The Company has evaluated subsequent events through the filing date and found no events requiring disclosure[78](index=78&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses CEL-SCI's business, Multikine's Phase III results, future plans, and financial condition [Company Overview](index=14&type=section&id=Company%20Overview) This section introduces CEL-SCI Corporation as a late clinical-stage biotechnology company focused on developing immunotherapies for cancer and other diseases - CEL-SCI Corporation is a late clinical-stage biotechnology company focused on developing immunotherapies for cancer and other diseases[79](index=79&type=chunk) - The primary product candidates are Multikine (Leukocyte Interleukin, Injection) for head and neck cancers and L.E.A.P.S. technology for rheumatoid arthritis[79](index=79&type=chunk)[87](index=87&type=chunk) - None of the product candidates have received regulatory approval for sale, and their safety or efficacy has not been established[79](index=79&type=chunk) [Multikine, The Phase III Clinical Trial Results, and Path Forward](index=14&type=section&id=MULTIKINE,%20THE%20PHASE%20III%20CLINICAL%20TRIAL%20RESULTS,%20AND%20PATH%20FORWARD) This section details the Phase III clinical trial results for Multikine in head and neck cancer, its unique mechanism, target population, and the FDA-approved path for a confirmatory registration study - The global cancer immunotherapy market is projected to reach **$196.45 billion** by 2030, growing at a CAGR of **7.2%**[80](index=80&type=chunk) - Multikine is unique as a first-line investigational immunotherapy administered before standard of care (surgery) for newly diagnosed advanced primary head and neck cancer[80](index=80&type=chunk)[86](index=86&type=chunk) - The target population for Multikine is newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (via PET imaging) and low PD-L1 tumor expression (TPS<10 via biopsy), accounting for approximately **100,000** patients worldwide per year[81](index=81&type=chunk)[85](index=85&type=chunk)[88](index=88&type=chunk)[94](index=94&type=chunk) - In the target population, the Phase III study showed a **73% survival rate** with Multikine vs. **45%** without Multikine at 5 years, with a Hazard Ratio of **0.35** (95% CIs [0.19, 0.66])[84](index=84&type=chunk)[99](index=99&type=chunk)[102](index=102&type=chunk) - The FDA indicated in May 2024 that CEL-SCI may proceed with a confirmatory registration study for Multikine in the target population[85](index=85&type=chunk)[108](index=108&type=chunk) - Multikine demonstrated no demonstrable safety signals or toxicities in approximately **740** treated subjects across multiple clinical trials, with no Multikine-related deaths or delays in surgery[90](index=90&type=chunk) - Multikine induces pre-surgical responses (PSR: ≥30% tumor reduction; PSD: disease downstaging), with PSRs seen in **8.5%** of Multikine patients vs. none in control, and PSDs in **22%** of Multikine patients vs. **13%** in control across the whole Phase III trial[92](index=92&type=chunk)[93](index=93&type=chunk) - The confirmatory study will be a randomized controlled trial with two arms (Multikine + SOC vs. SOC alone), expected to initiate in Q1/Q2 2025 and reach full enrollment in Q2 2026[110](index=110&type=chunk) - Multikine addresses a significant unmet medical need, as current standard of care offers only about a **50%** chance of 5-year survival, which Multikine could increase to over **70%**, targeting patients with low PD-L1 expression underserved by existing immunotherapies like Keytruda and Opdivo[114](index=114&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) This section analyzes the company's financial resources, historical funding methods, and future capital needs, particularly for the Multikine confirmatory study, and addresses going concern issues - The Company has historically funded operations through equity, convertible notes, loans, and grants, and anticipates continued reliance on securities sales due to ongoing net operating losses[118](index=118&type=chunk)[119](index=119&type=chunk) - The estimated cost for the confirmatory registration study is approximately **$30 million**, necessitating additional capital or long-term financing[120](index=120&type=chunk) - Due to recurring losses and future liquidity needs, there is substantial doubt about the Company's ability to continue as a going concern[120](index=120&type=chunk) - In Q4 2024, cash decreased by approximately **$0.1 million**, driven by **$4.5 million** net proceeds from financing, offset by **$4.1 million** in operating activities and **$0.5 million** in finance lease payments[121](index=121&type=chunk) - In Q4 2023, cash decreased by approximately **$0.9 million**, with **$4.9 million** used in operations and **$0.4 million** in finance lease payments, offset by **$4.5 million** net proceeds from financing[122](index=122&type=chunk) [Results of Operations and Financial Condition](index=21&type=section&id=Results%20of%20Operations%20and%20Financial%20Condition) This section provides a detailed analysis of the company's financial performance, including operating losses, research and development expenses, and general and administrative expenses - The Company incurred a net operating loss of approximately **$6.9 million** for the three months ended December 31, 2024, including **$1.1 million** in share-based compensation and **$1.0 million** in depreciation and amortization[124](index=124&type=chunk) Research and Development Expenses (Three Months Ended December 31) | Project | 2024 | 2023 | | :-------- | :----------- | :----------- | | MULTIKINE | $4,409,465 | $4,329,252 | | LEAPS | $20,598 | $23,257 | | TOTAL | $4,430,063 | $4,352,509 | - Research and development expenses remained constant at approximately **$4.4 million** in Q4 2024 compared to Q4 2023, with increases in clinical studies, supplies, and other R&D expenses offset by a decrease in employee stock compensation[125](index=125&type=chunk) - General and administrative expenses increased by approximately **$0.3 million (15%)** in Q4 2024, primarily due to a **$0.2 million** increase in non-employee stock compensation and public relations costs, partially offset by a decrease in employee stock compensation[126](index=126&type=chunk) - Net interest expense remained constant at approximately **$0.2 million** in both periods, primarily due to interest on lease liabilities[127](index=127&type=chunk) [Critical Accounting Estimates](index=22&type=section&id=Critical%20Accounting%20Estimates) This section identifies and explains the accounting estimates that require significant management judgment and have a material impact on the financial statements - Critical accounting estimates include Lease Accounting (determining lease term and incremental borrowing rate) and Share-based Compensation (fair value measurement using Black-Scholes model and Monte Carlo simulation for certain awards)[132](index=132&type=chunk)[133](index=133&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) - Management's judgment is crucial in developing inputs and assumptions for these estimates, which are based on historical experience, contract terms, industry trends, and external information[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risks](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risks) 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[137](index=137&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were ineffective as of December 31, 2024, due to material weaknesses - The Company's disclosure controls and procedures were not effective as of December 31, 2024, due to material weaknesses described in the Annual Report on Form 10-K for the year ended September 30, 2024[139](index=139&type=chunk) - No changes in internal control over financial reporting occurred during the three months ended December 31, 2024, that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[140](index=140&type=chunk) [PART II](index=23&type=section&id=PART%20II) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) CEL-SCI issued restricted common shares to consultants for investor relations, using Section 4(a)(2) exemption - During the three months ended December 31, 2024, the Company issued **154,615** restricted shares of common stock to consultants for investor relations services[142](index=142&type=chunk) - The issuance relied on the exemption provided by Section 4(a)(2) of the Securities Act of 1933, with recipients being sophisticated investors provided full information, and no general solicitation[143](index=143&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers - None of the Company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period ending December 31, 2024[144](index=144&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) Exhibits filed with Form 10-Q include Rule 13a-14(a) and Section 1350 certifications Exhibits Filed | Number | Exhibit | | :----- | :-------------------------- | | 31 | Rule 13a-14(a) Certifications | | 32 | Section 1350 Certifications | [Signatures](index=24&type=section&id=Signatures) The report is signed by CEL-SCI's Principal Executive and Financial Officers on February 14, 2025 - The report was signed by Geert Kersten, Principal Executive Officer, and Patricia Prichep, Principal Financial Officer, on February 14, 2025[149](index=149&type=chunk)

FORM 10-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024. (State or other jurisdiction of incorporation or organization) 8229 Boone Blvd., Suite 802 Vienna, Virginia 22182 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (703) 506-9460 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECUR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to ______________. | --- | --- | --- | |-----------------------------------------------------------|----------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to ______________. Commission File Number 001-11889 CEL-SCI CORPORATION State or other jurisdiction incorporation (IRS) Employer Identificat ...