VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting. Dear CEL-SCI Shareholders: Last year we successfully moved our investigational Multikine® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very diff ...

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the closing of its previously announced public offering of 3,875,000 shares of its common stock at a public offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The Company intends to use the net proceeds ...

[Item 1. Financial Information](index=3&type=section&id=Item%201.%20Financial%20Information) This section presents the company's unaudited condensed financial statements and accompanying notes for the period ended December 31, 2023 [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets%20at%20December%2031%2C%202023%20(unaudited)%20and%20September%2030%2C%202023) The company's condensed balance sheets show a decrease in total assets and stockholders' equity from September 30, 2023, to December 31, 2023, primarily driven by a reduction in cash and cash equivalents and an accumulated deficit | Metric | Dec 31, 2023 ($) | Sep 30, 2023 ($) | | :----------------------------- | :----------- | :----------- | | Cash and cash equivalents | $3,241,440 | $4,145,735 | | Total current assets | $6,154,453 | $6,918,420 | | Total assets | $28,710,215 | $30,528,250 | | Total current liabilities | $4,867,310 | $5,585,846 | | Total liabilities | $16,059,955 | $17,313,360 | | Total stockholders' equity | $12,650,260 | $13,214,890 | [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20three%20months%20ended%20December%2031%2C%202023%20and%202022%20(unaudited)) For the three months ended December 31, 2023, the company reported a reduced net loss compared to the same period in 2022, primarily due to lower operating expenses, particularly in research and development | Operating Expense | 2023 (3 months) ($) | 2022 (3 months) ($) | | :------------------------ | :-------------- | :-------------- | | Research and development | $4,352,509 | $5,392,546 | | General and administrative | $2,133,378 | $2,258,003 | | Total operating expenses | $6,485,887 | $7,650,549 | | Operating loss | $(6,485,887) | $(7,650,549) | | Net loss | $(6,709,524) | $(7,853,509) | | Net loss per common share – basic and diluted | $(0.14) | $(0.18) | [Condensed Statements of Stockholders' Equity](index=4&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20for%20the%20three%20months%20ended%20December%2031%2C%202023%20and%202022%20(unaudited)) Stockholders' equity decreased from **$13.2 million** at September 30, 2023, to **$12.7 million** at December 31, 2023, despite proceeds from common stock sales and equity-based compensation, primarily due to the net loss incurred during the period | Metric | Sep 30, 2023 ($) | Dec 31, 2023 ($) | | :-------------------------- | :----------- | :----------- | | Common Stock Shares | 47,422,304 | 50,018,601 | | Common Stock Amount | $474,223 | $500,186 | | Additional Paid-In Capital | $499,832,063 | $505,950,994 | | Accumulated Deficit | $(487,091,396) | $(493,800,920) | | Total Stockholders' Equity | $13,214,890 | $12,650,260 | - Proceeds from the sale of common stock during the three months ended December 31, 2023: **$4,980,000**[12](index=12&type=chunk) - Equity based compensation for employees during the three months ended December 31, 2023: **$1,383,909**[12](index=12&type=chunk) [Condensed Statements of Cash Flows](index=4&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20December%2031%2C%202023%20and%202022%20(unaudited)) Cash and cash equivalents significantly decreased by **$0.9 million** for the three months ended December 31, 2023, primarily due to cash used in operating activities, partially offset by proceeds from common stock issuance | Cash Flow Activity | 2023 (3 months) ($) | 2022 (3 months) ($) | | :------------------------------------ | :-------------- | :-------------- | | Net cash used in operating activities | $(4,887,928) | $(4,666,649) | | Net cash used in investing activities | $(64,861) | $(53,580) | | Net cash provided by financing activities | $4,048,494 | $65,410 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(904,295) | $(4,654,819) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $3,241,440 | $18,017,319 | [Notes to Condensed Financial Statements](index=5&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20(unaudited)) These notes provide critical context to the financial statements, detailing accounting policies, liquidity, equity changes, commitments, and going concern risk [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 basis of financial statement preparation, key accounting policies, and the company's going concern assessment - The accompanying condensed financial statements are unaudited and prepared in accordance with U.S. GAAP, with certain information and footnote disclosures omitted as per SEC rules for interim reports[21](index=21&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern due to recurring losses from operations and future liquidity needs[24](index=24&type=chunk) - Key accounting policies include cash and cash equivalents, property and equipment, supplies used for R&D and manufacturing, patents, leases, share-based compensation, research and development costs, net loss per common share, income taxes, and impairment of long-lived assets[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)[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) - The Company adopted ASU 2016-13 (Financial Instruments – Credit Losses) effective October 1, 2023, using a modified retrospective transition method, with no impact on its financial position, results of operations, or cash flows[39](index=39&type=chunk) [B. Liquidity](index=8&type=section&id=B.%20LIQUIDITY) The company's liquidity section details its historical funding sources, ongoing capital requirements, and the substantial doubt regarding its ability to continue as a going concern - The Company has incurred significant costs since inception for R&D, manufacturing, and clinical trials, funded primarily by proceeds from loans and the public/private sale of its securities[41](index=41&type=chunk) - Additional capital is required to continue efforts to bring Multikine to market, with plans to raise funds through corporate partnerships, debt, and/or equity financings[41](index=41&type=chunk)[42](index=42&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern due to recurring losses from operations and future liquidity needs[43](index=43&type=chunk) [C. Stockholders' Equity](index=8&type=section&id=C.%20STOCKHOLDERS'%20EQUITY) This section details changes in stockholders' equity, including common stock sales, equity compensation plans, stock option activity, and restricted share issuances - In November 2023, the Company sold **2,490,000** shares of common stock at **$2.00** per share, receiving approximately **$5.0 million** in aggregate gross proceeds[44](index=44&type=chunk) Equity Compensation Plan Shares Reserved (as of Dec 31, 2023) | Name of Plan | Shares Reserved | | :------------------------- | :-------------- | | Incentive Stock Option Plans | 138,400 | | Non-Qualified Stock Option Plans | 15,787,200 | | Stock Bonus Plans | 1,283,760 | | Stock Compensation Plans | 634,000 | | Incentive Stock Bonus Plan | 640,000 | Stock Option Activity (Three Months Ended Dec 31) | Activity | 2023 | 2022 | | :--------------- | :--- | :--- | | Options granted | - | 2,500 | | Options exercised | - | - | | Options forfeited | 11,000 | 96,832 | | Options expired | - | 45,400 | Share-Based Compensation Expense (Three Months Ended Dec 31) | Category | 2023 ($) | 2022 ($) | | :------------- | :----------- | :----------- | | Employees | $1,383,909 | $1,692,831 | | Non-employees | $218,386 | $148,858 | - No warrants recorded as equity were exercised during the three months ended December 31, 2023; however, **217,752** warrants were exercised in the same period of 2022 for **$447,291** in proceeds[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company issued **88,573** restricted common shares to consultants for services in Q4 2023, compared to **40,236** shares in Q4 2022[50](index=50&type=chunk) [D. Related Party Transactions](index=10&type=section&id=D.%20RELATED%20PARTY%20TRANSACTIONS) This section describes transactions with related parties, including the extension of Series RR warrants held by officers and a trust - No restricted shares of the Company's common stock were purchased by related parties during the three months ended December 31, 2023[54](index=54&type=chunk) - On October 28, 2022, the expiration date of the Series RR warrants, held by current officers (Geert Kersten, Patricia Prichep) and a trust (beneficiary Geert Kersten), was extended two years, resulting in an incremental cost of approximately **$172,000** recorded as a deemed dividend[55](index=55&type=chunk) [E. Commitments and Contingencies](index=10&type=section&id=E.%20COMMITMENTS%20AND%20CONTINGENCIES) This section outlines the company's contractual obligations, including a co-development agreement, finance leases, and operating leases - Under a co-development and revenue sharing agreement, Ergomed agreed to contribute up to **$12 million** towards the Company's Phase 3 Clinical Trial in the form of discounted clinical services, with approximately **$11.9 million** realized as of December 31, 2023[55](index=55&type=chunk) - The Company leases a manufacturing facility (San Tomas lease) classified as a finance lease, with a 20-year term expiring in October 2028, requiring annual base rent escalation of **3%**[56](index=56&type=chunk)[57](index=57&type=chunk) - A deposit of approximately **$2.3 million** was required in January 2023 for the San Tomas lease due to the Company falling below a stipulated cash threshold[58](index=58&type=chunk) Future Minimum Lease Payments Under Finance Leases (as of Dec 31, 2023) | Period | Amount ($) | | :-------------------------------- | :----------- | | Nine months ending Sep 30, 2024 | $1,995,000 | | Year ending Sep 30, 2025 | $2,741,000 | | Year ending Sep 30, 2026 | $2,832,000 | | Year ending Sep 30, 2027 | $2,923,000 | | Year ending Sep 30, 2028 | $3,015,000 | | Year ending Sep 30, 2029 | $252,000 | | Total future minimum lease obligation | $13,758,000 | - The Company leases two facilities under operating leases, with the office headquarters lease expiring in November 2025 and the research and development laboratory lease expiring in February 2032[60](index=60&type=chunk) Future Minimum Lease Payments on Operating Leases (as of Dec 31, 2023) | Period | Amount ($) | | :-------------------------------- | :----------- | | Nine months ending Sep 30, 2024 | $268,000 | | Year ending Sep 30, 2025 | $366,000 | | 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 | | Thereafter | $746,000 | | Total future minimum lease obligation | $2,523,000 | [G. Patents](index=11&type=section&id=G.%20PATENTS) This section details patent amortization expenses and estimated future amortization, noting no impairment during the period - No impairment of patent costs occurred during the three months ended December 31, 2023, or 2022[62](index=62&type=chunk) - Amortization expense for patents totaled approximately **$9,000** in Q4 2023 and **$10,000** in Q4 2022, with a weighted average amortization period of approximately **8 years**[62](index=62&type=chunk) Estimated Future Patent Amortization | Period | Amount ($) | | :-------------------------------- | :----------- | | Nine months ending Sep 30, 2024 | $23,000 | | Year ending Sep 30, 2025 | $29,000 | | Year ending Sep 30, 2026 | $25,000 | | Year ending Sep 30, 2027 | $22,000 | | Year ending Sep 30, 2028 | $19,000 | | Year ending Sep 30, 2029 | $16,000 | | Thereafter | $54,000 | | Total | $188,000 | [H. Loss Per Common Share](index=11&type=section&id=H.%20LOSS%20PER%20COMMON%20SHARE) This section presents the calculation of basic and diluted loss per common share, including anti-dilutive securities excluded from the calculation Loss Per Share – Basic and Diluted (Three Months Ended Dec 31) | Metric | 2023 | 2022 | | :------------------------------------ | :----------- | :----------- | | Net loss available to common ($) | $(6,709,524) | $(8,025,061) | | Weighted average shares outstanding | 48,470,600 | 43,440,387 | | Basic and diluted loss per common share ($) | $(0.14) | $(0.18) | Anti-Dilutive Securities Excluded from Diluted EPS (as of Dec 31) | Security Type | 2023 | 2022 | | :-------------------- | :----------- | :----------- | | Options and Warrants | 15,839,028 | 13,917,352 | | Unvested Restricted Stock | 147,250 | 149,250 | | Total | 15,986,278 | 14,066,602 | [J. Subsequent Events](index=12&type=section&id=J.%20SUBSEQUENT%20EVENTS) This section reports significant events occurring after the balance sheet date, including a recent common stock offering - On February 9, 2024, the Company sold **3,875,000** shares of common stock at a public offering price of **$2.00** per share, generating approximately **$7.8 million** in gross proceeds[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=12&type=section&id=Item%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial performance, liquidity, capital resources, and operational results for the period [Company Overview](index=12&type=section&id=Company%20Overview) CEL-SCI Corporation is a clinical-stage biotechnology company focused on developing immunotherapies, with its lead investigational therapy, Multikine, targeting head and neck cancers, and LEAPS technology for rheumatoid arthritis - CEL-SCI is a clinical-stage biotechnology company dedicated to research and development aimed at improving cancer and other disease treatments by utilizing the immune system[66](index=66&type=chunk) - The Company's primary product candidates are Multikine (Leukocyte Interleukin, Injection) for head and neck cancers and L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for rheumatoid arthritis[66](index=66&type=chunk)[69](index=69&type=chunk) - The global cancer immunotherapy market is expected to reach **USD $196.45 billion** by 2030, with a Compound Annual Growth Rate (CAGR) of **7.2%**[68](index=68&type=chunk) [Multikine and Phase III Clinical Trial Results](index=12&type=section&id=MULTIKINE%20AND%20THE%20PHASE%20III%20CLINICAL%20TRIAL%20RESULTS) Multikine, an investigational immunotherapy, showed significant survival benefits in a Phase III trial for a specific head and neck cancer population, leading to accelerated approval pathway pursuit - Multikine is unique among approved cancer immunotherapies as it is given first, right after diagnosis and before surgery, to incite a locoregional immune response against the tumor[68](index=68&type=chunk)[71](index=71&type=chunk) - The target patient population for Multikine includes treatment-naïve adult patients with resectable locally advanced primary squamous cell carcinoma of the head and neck (SCCHN) in the oral cavity or soft palate, who have no lymph node involvement (N0) and low PD-L1 tumor expression (TPS<10)[72](index=72&type=chunk)[86](index=86&type=chunk) - In the target population, Multikine cut the **5-year risk of death in half** versus the control group, increasing survival from **45% to 73%** at five years[87](index=87&type=chunk) - Multikine demonstrated a **28.6% absolute 5-year overall survival benefit** versus control (p=0.0015) and a hazard ratio of **0.349** (95% CIs [0.18, 0.66]) in the target population[77](index=77&type=chunk)[91](index=91&type=chunk) - Statistically significant pre-surgical responses (reductions of **30%+** or disease downstages) were observed in Multikine patients, and these responses were shown to lead to longer life[75](index=75&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk)[81](index=81&type=chunk) - No demonstrable safety signals or toxicities were observed in approximately **750** Multikine-treated subjects across multiple clinical trials, with no Multikine-related deaths[73](index=73&type=chunk) - CEL-SCI plans to seek immediate approval for Multikine through conditional/accelerated approval pathways in Europe, the UK, Canada, and the U.S., based on existing data and a planned confirmatory study[94](index=94&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - Multikine addresses a tremendous unmet need for improved survival in its target population, as current standard of care provides only about a **50/50** chance of surviving five years, and existing immunotherapies work best on high PD-L1 tumors or are given after surgery[98](index=98&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) The company relies on equity and debt financing, facing going concern doubts due to recurring losses, with cash decreasing by **$0.9 million** in Q4 2023 from operating activities - The Company has historically financed its operations through equity securities, convertible notes, loans, and research grants, and anticipates continued reliance on securities sales due to ongoing net operating losses[103](index=103&type=chunk)[104](index=104&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern due to recurring losses from operations and future liquidity needs[105](index=105&type=chunk) - Direct costs for the Phase 3 clinical trial and filing of the clinical study report totaled approximately **$64.5 million** as of December 31, 2023, with an estimated **$0.7 million** additional expenses for completion[106](index=106&type=chunk) - Cash and cash equivalents decreased by approximately **$0.9 million** during the three months ended December 31, 2023, primarily due to **$4.9 million** used in operating activities and **$0.4 million** in finance lease payments, partially offset by **$4.5 million** net proceeds from November 2023 financing[108](index=108&type=chunk) - During the three months ended December 31, 2022, cash decreased by approximately **$4.7 million**, primarily due to cash used to fund regular operations, including the Phase 3 clinical trial[109](index=109&type=chunk) [Results of Operations and Financial Condition](index=20&type=section&id=Results%20of%20Operations%20and%20Financial%20Condition) The company reported a net operating loss of **$6.5 million** for Q4 2023, a decrease from the prior year, primarily due to reduced research and development and general and administrative expenses - The Company incurred a net operating loss of approximately **$6.5 million** for the three months ended December 31, 2023, which included significant non-cash expenses such as **$1.6 million** in share-based compensation and **$1.0 million** in depreciation and amortization[111](index=111&type=chunk) - Research and development expenses decreased by approximately **$1.0 million (19%)** in Q4 2023 compared to Q4 2022, mainly due to lower costs for commercial sale preparation, Phase 3 study expenses, and employee stock compensation[112](index=112&type=chunk) - General and administrative expenses decreased by approximately **$0.1 million (6%)** in Q4 2023 compared to Q4 2022, primarily due to reduced consulting fees and employee stock compensation[113](index=113&type=chunk) - Net interest expense remained relatively constant at approximately **$0.2 million** for both the three months ended December 31, 2023, and 2022[114](index=114&type=chunk) [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses) R&D expenses for Q4 2023 totaled **$4.35 million**, primarily for Multikine, significantly reduced from Q4 2022, and contingent on capital and regulatory approvals Research and Development Expenses (Three Months Ended Dec 31) | Project | 2023 ($) | 2022 ($) | | :-------- | :----------- | :----------- | | MULTIKINE | $4,329,252 | $5,294,377 | | LEAPS | $23,257 | $98,169 | | TOTAL | $4,352,509 | $5,392,546 | - The extent of the Company's clinical trials and research programs is primarily based upon the amount of capital available and the extent of regulatory approvals, with the inability to conduct these preventing product commercialization[116](index=116&type=chunk) [Critical Accounting Estimates](index=21&type=section&id=Critical%20Accounting%20Estimates) Management's financial reporting relies on critical accounting estimates for leases and share-based compensation, requiring significant judgment in valuation - Critical accounting estimates include inventory obsolescence, accruals, stock options, useful lives for depreciation and amortization of long-lived assets, right-of-use assets and lease liabilities, deferred tax assets, and the related valuation allowance[38](index=38&type=chunk) - Significant judgment is required for measuring finance and operating lease right-of-use assets and lease liabilities (determining estimated lease term and incremental borrowing rate) and for valuing stock options (using Black-Scholes and Monte-Carlo models with various judgmental assumptions)[120](index=120&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risks](index=21&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS) The Company assesses that it does not have any significant exposure to market risk - The Company does not believe that it has any significant exposure to market risk[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded disclosure controls were ineffective as of December 31, 2023, due to material weaknesses, with no material internal control changes during the quarter - The Company's Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were not effective as of December 31, 2023, due to material weaknesses described in the Annual Report on Form 10-K for the year ended September 30, 2023[124](index=124&type=chunk) - There were no changes in the Company's internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting during the three months ended December 31, 2023[125](index=125&type=chunk) [PART II](index=21&type=section&id=PART%20II) This section covers unregistered sales of equity securities, other information, and exhibits, concluding with the report's signatures [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=21&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q4 2023, the Company issued **88,573** restricted common shares to consultants for investor relations services, relying on Section 4(a)(2) exemption - During the three months ended December 31, 2023, the Company issued **88,573** restricted shares of common stock to consultants for investor relations services[127](index=127&type=chunk) - The Company relied upon the exemption provided by Section 4(a)(2) of the Securities Act of 1933 for the issuance of these shares[127](index=127&type=chunk) [Item 5. Other Information](index=22&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 December 31, 2023 - 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, 2023[129](index=129&type=chunk) [Item 6. Exhibits](index=22&type=section&id=Item%206.%20Exhibits) The report includes Rule 13a-14(a) Certifications and Section 1350 Certifications as exhibits Exhibits | Number | Exhibit | | :----- | :-------------------------- | | 31 | Rule 13a-14(a) Certifications | | 32 | Section 1350 Certifications | [Signatures](index=22&type=section&id=Signatures) The report was duly signed on February 14, 2024, by Geert Kersten, Principal Executive Officer and Principal Accounting and Financial Officer - The report was signed on behalf of CEL-SCI CORPORATION by Geert Kersten, Principal Executive Officer and Principal Accounting and Financial Officer, on February 14, 2024[131](index=131&type=chunk)

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a Phase 3 cancer immunotherapy company, today announced the pricing of an offering of 3,875,000 shares of its common stock at an offering price of $2.00 per share, for gross proceeds of $7.75 million, before deducting underwriting discounts and offering expenses. All of the shares of common stock are being offered by the Company. The offering is expected to close on February 13, 2024, subject to satisfaction ...

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). According to the opinion letter: “The Paediatric Committee, having assessed the waiver application in accordance with Article 13 of Regulation (EC) No 1901/2006 as amended, recommends as set out in the appended summary report: ...

FORM 10-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under S ...

[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed financial statements, comprehensive notes, management's discussion and analysis, and disclosures on market risks and internal controls [Condensed Financial Statements](index=3&type=section&id=Condensed%20Financial%20Statements) This section presents the unaudited condensed financial statements for CEL-SCI Corporation, including balance sheets, statements of operations for three and nine months, statements of stockholders' equity, and statements of cash flows, providing a snapshot of the company's financial position and performance [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and equity at specific reporting dates Condensed Balance Sheets | Metric | June 30, 2023 (Unaudited) | September 30, 2022 | | :---------------------------------- | :-------------------------- | :------------------- | | **ASSETS** | | | | Cash and cash equivalents | $5,135,070 | $22,672,138 | | Total current assets | $7,731,746 | $25,435,916 | | Total assets | $32,318,968 | $50,523,706 | | **LIABILITIES & EQUITY** | | | | Total current liabilities | $5,292,473 | $4,663,751 | | Total liabilities | $17,529,569 | $18,360,499 | | Total stockholders' equity | $14,789,399 | $32,163,207 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $32,318,968 | $50,523,706 | - Total assets decreased by approximately **$18.2 million** from September 30, 2022, to June 30, 2023, primarily driven by a significant reduction in cash and cash equivalents[5](index=5&type=chunk) - Stockholders' equity decreased by approximately **$17.4 million**, indicating a decline in the company's net worth over the period[6](index=6&type=chunk) [Condensed Statements of Operations (Nine Months Ended June 30, 2023 and 2022)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20%28Nine%20Months%20Ended%20June%2030%2C%202023%20and%202022%29) This section details the company's revenues, expenses, and net loss for the nine-month periods ended June 30, 2023 and 2022 Condensed Statements of Operations (Nine Months Ended June 30, 2023 and 2022) | Metric | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------ | :------------------------------ | | Research and development expenses | $17,203,823 | $18,893,857 | | General and administrative expenses | $6,804,729 | $8,220,768 | | Total operating expenses | $24,008,552 | $27,114,625 | | Operating loss | $(24,008,552) | $(27,114,625) | | Net loss | $(24,563,599) | $(28,238,682) | | Net loss per common share – basic and diluted | $(0.57) | $(0.66) | | Weighted average common shares outstanding | 43,761,395 | 43,124,972 | - Net loss decreased by approximately **$3.67 million (13%)** for the nine months ended June 30, 2023, compared to the same period in 2022, primarily due to lower operating expenses and reduced interest expense[42](index=42&type=chunk) - Research and development expenses decreased by **9%** and general and administrative expenses decreased by **17%** year-over-year[42](index=42&type=chunk) [Condensed Statements of Operations (Three Months Ended June 30, 2023 and 2022)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20%28Three%20Months%20Ended%20June%2030%2C%202023%20and%202022%29) This section presents the company's revenues, expenses, and net loss for the three-month periods ended June 30, 2023 and 2022 Condensed Statements of Operations (Three Months Ended June 30, 2023 and 2022) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------- | :------------------------------- | | Research and development expenses | $5,727,789 | $6,286,873 | | General and administrative expenses | $2,453,968 | $2,432,518 | | Total operating expenses | $8,181,757 | $8,719,391 | | Operating loss | $(8,181,757) | $(8,719,391) | | Net loss | $(8,367,281) | $(9,632,584) | | Net loss per common share – basic and diluted | $(0.19) | $(0.23) | | Weighted average common shares outstanding | 44,254,363 | 43,174,775 | - Net loss for the three months ended June 30, 2023, decreased by approximately **$1.27 million (13%)** compared to the same period in 2022[43](index=43&type=chunk) - Research and development expenses decreased by **9%** while general and administrative expenses remained consistent year-over-year for the quarter[43](index=43&type=chunk) [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in the company's equity components, including common stock, additional paid-in capital, and accumulated deficit Condensed Statements of Stockholders' Equity | Metric | September 30, 2022 | June 30, 2023 | | :-------------------------------- | :----------------- | :----------------- | | Common Shares Outstanding | 43,448,317 | 44,748,437 | | Common Stock Amount | $434,484 | $447,484 | | Additional Paid-In Capital | $486,625,816 | $493,802,607 | | Accumulated Deficit | $(454,897,093) | $(479,460,692) | | Total Stockholders' Equity | $32,163,207 | $14,789,399 | - Total stockholders' equity decreased from **$32.16 million** at September 30, 2022, to **$14.79 million** at June 30, 2023, primarily due to accumulated net losses[9](index=9&type=chunk)[44](index=44&type=chunk) - The company issued additional common shares through warrant exercises, 401(k) contributions, stock/options for non-employee services, and a public offering, increasing common shares outstanding and additional paid-in capital[9](index=9&type=chunk)[44](index=44&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the nine-month periods Condensed Statements of Cash Flows | Metric | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(17,803,797) | $(13,327,230) | | Net cash (used in) provided by investing activities | $(361,892) | $5,507,433 | | Net cash provided by (used in) financing activities | $628,621 | $(166,678) | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(17,537,068) | $(7,986,475) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $5,135,070 | $28,073,673 | - Net cash used in operating activities increased by approximately **$4.48 million (34%)** in the nine months ended June 30, 2023, compared to the prior year[11](index=11&type=chunk) - Cash and cash equivalents significantly decreased by **$17.54 million**, resulting in an ending balance of **$5.14 million** as of June 30, 2023[11](index=11&type=chunk) [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes provide detailed explanations of the accounting policies, significant estimates, and specific financial statement line items, including liquidity concerns, equity transactions, fair value measurements, related party agreements, commitments, patent amortization, and loss per share calculations [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) This section outlines the principles used in preparing the financial statements and summarizes the key accounting policies adopted by the company - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP, with certain information and footnote disclosures omitted as permitted by SEC rules for interim reports[23](index=23&type=chunk) - The Company's ability to continue as a going concern is in substantial doubt due to recurring operating losses and future liquidity needs[24](index=24&type=chunk)[37](index=37&type=chunk) - Key accounting policies include recording property and equipment at cost and depreciating over 5-7 years, capitalizing patent expenditures and amortizing over 17 years or useful life, and recognizing lease liabilities based on incremental borrowing rates[26](index=26&type=chunk)[27](index=27&type=chunk)[52](index=52&type=chunk) - Stock-based compensation is measured at fair value on the grant date using the Black-Scholes model for options with service conditions and Monte Carlo simulation for awards with performance/market conditions[32](index=32&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) [B. Liquidity](index=9&type=section&id=B.%20Liquidity) This section addresses the company's ability to meet its short-term and long-term financial obligations and its plans for future capital raising - Due to recurring losses and future capital requirements, there is substantial doubt about the Company's ability to continue as a going concern[37](index=37&type=chunk)[60](index=60&type=chunk) - The Company plans to raise additional capital through corporate partnerships, debt, and/or equity financings, citing past success and positive Phase 3 study results for Multikine as reasons for optimism[61](index=61&type=chunk) - Failure to raise necessary funds may lead to curtailment of operations[61](index=61&type=chunk) [C. Stockholders' Equity](index=9&type=section&id=C.%20Stockholders%27%20Equity) This section details transactions affecting the company's equity, including stock sales, equity compensation, and warrant activities [Proceeds from the Sale of Common Stock](index=9&type=section&id=Proceeds%20from%20the%20Sale%20of%20Common%20Stock) This section reports on the capital raised through the issuance and sale of common stock - In April 2023, the Company sold **794,117 shares** of common stock at **$1.70 per share**, generating approximately **$1.2 million** in aggregate proceeds[38](index=38&type=chunk) - The underwriters fully exercised their 30-day option in May 2023, purchasing an additional **119,117 shares** for approximately **$190,000**[90](index=90&type=chunk) [Equity Compensation](index=10&type=section&id=Equity%20Compensation) This section details the company's stock option activity, including grants, exercises, forfeitures, and expirations Equity Compensation Activity | Metric | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | | :---------------- | :------------------------------ | :------------------------------ | | Options granted | 6,500 | 1,975,250 | | Options exercised | - | 6,500 | | Options forfeited | 179,832 | 20,166 | | Options expired | 58,787 | 13,614 | - In November 2021, **250,000 performance-based stock options** were granted to officers, vesting upon FDA approval of Multikine in specific regions; no compensation cost was recognized as of June 30, 2023, due to the uncertainty of the performance condition[91](index=91&type=chunk) [Stock-Based Compensation Expense](index=10&type=section&id=Stock-Based%20Compensation%20Expense) This section presents the expenses recognized for stock-based awards granted to employees and non-employees Stock-Based Compensation Expense | Category | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | | :----------- | :------------------------------ | :------------------------------ | | Employees | $4,976,338 | $9,102,774 | | Non-employees | $473,723 | $603,147 | | **Total** | **$5,450,061** | **$9,705,921** | | | | | | Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :----------- | :------------------------------- | :------------------------------- | | Employees | $1,540,219 | $2,447,772 | | Non-employees | $188,001 | $200,877 | | **Total** | **$1,728,220** | **$2,648,649** | - Total stock-based compensation expense for employees and non-employees decreased significantly for both the nine-month and three-month periods ended June 30, 2023, compared to the prior year[92](index=92&type=chunk) [Warrants and Non-Employee Options](index=11&type=section&id=Warrants%20and%20Non-Employee%20Options) This section provides details on outstanding warrants and options issued to non-employees, including their terms and exercise activity Outstanding Warrants and Non-Employee Options | Warrant/Options | Issue Date | Shares Issuable | Exercise Price | Expiration Date | | :---------------- | :--------- | :-------------- | :------------- | :-------------- | | Series N | 8/18/2008 | 85,339 | $3.00 | 8/18/2024 | | Series UU | 6/11/2018 | 93,603 | $2.80 | 6/30/2024 | | Series X | 1/13/2016 | 120,000 | $9.25 | 7/13/2024 | | Series Y | 2/15/2016 | 26,000 | $12.00 | 8/15/2024 | | Series MM | 6/22/2017 | 333,432 | $1.86 | 6/22/2024 | | Series NN | 7/24/2017 | 200,087 | $2.52 | 7/24/2024 | | Series RR | 10/30/2017 | 234,009 | $1.65 | 10/30/2024 | | Consultant Options | 7/28/2017 | 10,000 | $2.18 | 7/27/2027 | - As of June 30, 2023, no derivative liabilities were outstanding, compared to **$366,791** in net gain on warrant liabilities for the nine months ended June 30, 2022[69](index=69&type=chunk)[96](index=96&type=chunk)[106](index=106&type=chunk) - During the nine months ended June 30, 2023, **217,752 equity warrants** (Series RR and SS) were exercised for gross proceeds of **$447,291**[98](index=98&type=chunk) - The expiration date of Series RR warrants was extended by two years in October 2022, resulting in an incremental cost of approximately **$172,000** recorded as a deemed dividend[100](index=100&type=chunk)[106](index=106&type=chunk) - The Company issued **115,321 restricted common shares** to consultants for services during the nine months ended June 30, 2023, with a weighted average grant date fair value of **$2.45**[75](index=75&type=chunk) [D. Fair Value Measurements](index=12&type=section&id=D.%20Fair%20Value%20Measurements) This section describes the company's methodology for measuring fair value and the classification of financial instruments within the fair value hierarchy - The Company classifies fair value balances using a three-level hierarchy, prioritizing observable inputs (Level 1) and giving lowest priority to unobservable inputs (Level 3)[77](index=77&type=chunk)[79](index=79&type=chunk) - As of June 30, 2023, and September 30, 2022, the Company did not have any Level 3 derivative instruments[80](index=80&type=chunk) [E. Related Party Transactions](index=13&type=section&id=E.%20Related%20Party%20Transactions) This section discloses transactions and agreements with parties that have a special relationship with the company [Clinical Research Agreement](index=13&type=section&id=Clinical%20Research%20Agreement) This section details the co-development and revenue sharing agreement for the company's Phase 3 Clinical Trial - Under a co-development and revenue sharing agreement, Ergomed agreed to contribute up to **$12 million** towards the Company's Phase 3 Clinical Trial in exchange for milestone and royalty payments[107](index=107&type=chunk)[156](index=156&type=chunk) - Approximately **$11.8 million** of Ergomed's committed **$12 million** contribution has been realized as of June 30, 2023, recorded as a credit to research and development expense[107](index=107&type=chunk)[156](index=156&type=chunk) [F. Commitments and Contingencies](index=13&type=section&id=F.%20Commitments%20and%20Contingencies) This section outlines the company's contractual obligations and potential liabilities arising from various agreements and legal matters [Lease Agreements](index=14&type=section&id=Lease%20Agreements) This section provides details on the company's finance and operating lease obligations and related assets - The net book value of finance lease right-of-use assets was approximately **$9.6 million** and finance lease liabilities were approximately **$12.1 million** as of June 30, 2023[83](index=83&type=chunk) - Total cash paid for finance leases was approximately **$1.9 million** for both nine-month periods ended June 30, 2023 and 2022[83](index=83&type=chunk) - The Company deposited approximately **$2.3 million** with its landlord in January 2023 due to falling below a stipulated cash threshold for the San Tomas lease[109](index=109&type=chunk) - Operating lease right-of-use assets were approximately **$1.7 million** and operating lease liabilities were approximately **$1.9 million** as of June 30, 2023[112](index=112&type=chunk) [G. Patents](index=15&type=section&id=G.%20Patents) This section reports on patent-related expenses, including impairment charges and amortization costs - No patent impairment charges were recorded for the nine or three months ended June 30, 2023, compared to **$31,000** for the nine months ended June 30, 2022[113](index=113&type=chunk) - Amortization of patent costs totaled approximately **$29,000** for the nine months ended June 30, 2023, and **$9,000** for the three months ended June 30, 2023[113](index=113&type=chunk) [H. Loss Per Common Share](index=15&type=section&id=H.%20Loss%20Per%20Common%20Share) This section details the calculation of basic and diluted loss per common share for the reporting periods Loss Per Common Share | Metric | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------ | :------------------------------ | | Net loss available to common shareholders | $(24,735,151) | $(28,533,091) | | Weighted average shares outstanding | 43,761,395 | 43,124,972 | | Basic and diluted loss per common share | $(0.57) | $(0.66) | | | | | | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :------------------------------------------ | :------------------------------- | :------------------------------- | | Net loss available to common shareholders | $(8,367,281) | $(9,926,993) | | Weighted average shares outstanding | 44,254,363 | 43,174,775 | | Basic and diluted loss per common share | $(0.19) | $(0.23) | - Potentially dilutive shares (options, warrants, unvested restricted stock) were excluded from diluted EPS calculations for all periods as their inclusion would be anti-dilutive[85](index=85&type=chunk)[114](index=114&type=chunk) [J. Subsequent Events](index=16&type=section&id=J.%20Subsequent%20Events) This section discloses significant events that occurred after the balance sheet date but before the financial statements were issued - On July 17, 2023, the Company sold **2,500,000 shares** of common stock at **$2.00 per share**, generating approximately **$4.6 million** in aggregate net proceeds[115](index=115&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 management's perspective on the company's financial performance and condition, highlighting the progress of its lead immunotherapy Multikine, liquidity challenges, and key factors influencing operating results and accounting estimates [Overview](index=16&type=section&id=Overview) This section provides a general summary of the company's business, key product developments, and strategic direction - The Company completed its 9.5-year pivotal Phase 3 study for Multikine in advanced head and neck cancer, showing a **14.1% absolute 5-year overall survival benefit** in the surgery plus radiation treatment arm (**62.7% vs. 48.6%** for control)[137](index=137&type=chunk)[138](index=138&type=chunk) - The overall study did not meet its primary endpoint of a **10% improvement** in overall survival when both treatment arms (radiation and chemoradiation) were combined, as chemotherapy negated Multikine's immunological effect[117](index=117&type=chunk) - Commercialization of Multikine in Canada may be possible as early as 2024, with the Company preparing an application for Notice of Compliance with Conditions (NOCC) approval as advised by Health Canada[119](index=119&type=chunk) - The Company is also developing LEAPS (Ligand Epitope Antigen Presentation System) technology, with CEL-4000 as a lead peptide-based immunotherapy for rheumatoid arthritis in pre-clinical development[139](index=139&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding sources, and future capital requirements to support its operations and development activities - The Company has historically financed operations through equity issuances, convertible notes, loans, and research grants, and anticipates continued reliance on these methods due to ongoing net operating losses[121](index=121&type=chunk)[141](index=141&type=chunk) - Cash and cash equivalents decreased by approximately **$17.5 million** during the nine months ended June 30, 2023, primarily due to **$17.8 million** used in operations, including a **$2.3 million** landlord deposit[143](index=143&type=chunk) - The Company incurred approximately **$64.3 million** in direct costs for the Phase 3 clinical trial as of June 30, 2023, with an estimated **$0.7 million** remaining[142](index=142&type=chunk) - The Company will need to raise additional capital to continue research efforts and achieve regulatory approval, with no assurance of obtaining sufficient funds on acceptable terms[155](index=155&type=chunk) [Results of Operations and Financial Condition](index=17&type=section&id=Results%20of%20Operations%20and%20Financial%20Condition) This section analyzes the company's financial performance, including operating expenses, net interest expense, and derivative gains, for the reporting periods - Net operating loss for the nine months ended June 30, 2023, was approximately **$24.0 million**, including **$5.0 million** in stock-based employee compensation and **$3.0 million** in depreciation and amortization[125](index=125&type=chunk) Operating Expenses and Other Items | Expense Category | Nine Months Ended June 30, 2023 | Nine Months Ended June 30, 2022 | Change ($) | Change (%) | | :----------------------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Research and Development | $17,203,823 | $18,893,857 | $(1,689,034) | -9% | | General and Administrative | $6,804,729 | $8,220,768 | $(1,416,039) | -17% | | Net Interest Expense | $(493,522) | $(1,460,055) | $966,533 | -66% | | Derivative Gains | $0 | $366,791 | $(366,791) | -100% | - The decrease in R&D expenses was primarily due to a **$2.3 million** decrease in employee stock compensation and an **$0.8 million** decrease in Phase 3 study expenses, partially offset by a **$1.3 million** increase in commercialization preparation costs[159](index=159&type=chunk) - Net interest expense decreased by approximately **$1.0 million**, mainly due to **$0.7 million** in interest expense from warrant modifications in the prior year and **$0.3 million** more interest income in the current period[160](index=160&type=chunk) [Critical Accounting Estimates and Policies](index=19&type=section&id=Critical%20Accounting%20Estimates%20and%20Policies) This section highlights the accounting policies and estimates that require significant judgment and can materially impact the financial statements - Critical accounting estimates include those related to leases (lease term, incremental borrowing rate) and stock-based compensation (Black-Scholes model assumptions, Monte-Carlo simulation for performance-based options)[149](index=149&type=chunk)[163](index=163&type=chunk) - Management's judgments, estimates, and assumptions in these areas significantly affect the reported financial condition and results of operations[162](index=162&type=chunk)[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risks](index=19&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[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=19&type=section&id=Item%204.%20Controls%20and%20Procedures) This section addresses the effectiveness of the Company's disclosure controls and procedures and internal control over financial reporting, noting material weaknesses identified in the prior annual report [Evaluation of Disclosure Controls and Procedures](index=19&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on the assessment of the effectiveness of the company's disclosure controls and procedures - The Company's CEO and CFO concluded that disclosure controls and procedures were not effective as of June 30, 2023, due to material weaknesses previously described in the Annual Report on Form 10-K for September 30, 2022[152](index=152&type=chunk)[164](index=164&type=chunk) [Changes in Internal Control over Financial Reporting](index=19&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section discloses any material changes in the company's internal control over financial reporting during the reporting period - No changes in internal control over financial reporting occurred during the three months ended June 30, 2023, that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[153](index=153&type=chunk) [PART II. OTHER INFORMATION](index=19&type=section&id=PART%20II%20OTHER%20INFORMATION) This section includes disclosures on unregistered sales of equity securities, a list of exhibits, and the report's signatures [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=19&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the issuance of unregistered equity securities, specifically restricted common stock to consultants for investor relations services, and affirms compliance with Securities Act exemptions - During the nine months ended June 30, 2023, the Company issued **115,321 restricted shares** of common stock to consultants for investor relations services[153](index=153&type=chunk) - The issuance relied on the exemption provided by Section 4(a)(2) of the Securities Act of 1933, with shares acquired by sophisticated investors for their own accounts and bearing a restricted legend[166](index=166&type=chunk) [Item 6. Exhibits](index=20&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including certifications from the Principal Executive Officer and Principal Financial Officer - Exhibits include Rule 13a-14(a)/15d-14(a) Certifications from the Principal Executive Officer (31.1) and Principal Financial Officer (31.2), and Section 1350 Certifications (32)[154](index=154&type=chunk)[167](index=167&type=chunk) [Signatures](index=20&type=section&id=Signatures) The report is duly signed on behalf of CEL-SCI Corporation by its Principal Executive Officer, Geert Kersten, who also serves as the Principal Accounting and Financial Officer - The report was signed by Geert Kersten, Principal Executive Officer, on August 10, 2023, who also serves as the Principal Accounting and Financial Officer[168](index=168&type=chunk)

Summary of Significant Accounting Policies: Cash and Cash Equivalents – Cash and cash equivalents consist principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months to be cash and cash equivalents. U.S. Treasury Bills – U.S. Treasury Bills ("T-bills") are highly liquid short-term investments with maturity dates of greater than 3 months, but less than one year. These investments ar ...

PART I. FINANCIAL INFORMATION This section presents the Company's condensed financial statements, including balance sheets, statements of operations, stockholders' equity, cash flows, detailed notes, and management's discussion and analysis [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$44.56 million** by December 31, 2022, driven by reduced cash and prepaid expenses, with corresponding declines in liabilities and stockholders' equity | Metric | Dec 31, 2022 (Unaudited) ($) | Sep 30, 2022 ($) | | :-------------------------- | :----------------------- | :----------- | | **Assets** | | | | Cash and cash equivalents | $18,017,319 | $22,672,138 | | Total current assets | $20,404,330 | $25,435,916 | | Total assets | $44,557,737 | $50,523,706 | | **Liabilities** | | | | Total current liabilities | $4,741,941 | $4,663,751 | | Total liabilities | $17,966,116 | $18,360,499 | | **Stockholders' Equity** | | | | Total stockholders' equity | $26,591,621 | $32,163,207 | [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) The Company reported a net loss of **$7.85 million** for the three months ended December 31, 2022, an improvement from the prior year, due to reduced operating expenses and no derivative gains | Metric | 3 months ended Dec 31, 2022 ($) | 3 months ended Dec 31, 2021 ($) | | :----------------------------------- | :-------------------------- | :-------------------------- | | Research and development | $5,392,546 | $6,083,167 | | General and administrative | $2,258,003 | $2,760,208 | | Total operating expenses | $7,650,549 | $8,843,375 | | Operating loss | $(7,650,549) | $(8,843,375) | | Gain on derivative instruments | - | $364,596 | | Net loss | $(7,853,509) | $(8,782,606) | | Net loss per common share – basic | $(0.18) | $(0.20) | | Weighted average common shares outstanding - basic | 43,440,387 (Shares) | 43,077,961 (Shares) | [Condensed Statement of Stockholders' Equity](index=4&type=section&id=Condensed%20Statement%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to **$26.59 million** by December 31, 2022, primarily due to a net loss, partially offset by warrant exercises and equity compensation | Metric | Sep 30, 2022 ($) | Dec 31, 2022 ($) | | :--------------------------------------- | :------------- | :------------- | | Common Shares | 43,448,317 (Shares) | 43,725,636 (Shares) | | Common Stock Amount | $434,484 | $437,256 | | Additional Paid-In Capital | $486,625,816 | $488,904,967 | | Accumulated Deficit | $(454,897,093) | $(462,750,602) | | Total Stockholders' Equity | $32,163,207 | $26,591,621 | | Net loss (3 months ended Dec 31, 2022) | - | $(7,853,509) | | Warrant exercises (3 months ended Dec 31, 2022) | - | $447,291 | | Equity based compensation - employees (3 months ended Dec 31, 2022) | - | $1,703,931 | [Condensed Statements of Cash Flows](index=5&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash and cash equivalents decreased by **$4.65 million** to **$18.02 million** for the three months ended December 31, 2022, driven by operating activities, partially offset by financing | Cash Flow Activity | 3 months ended Dec 31, 2022 ($) | 3 months ended Dec 31, 2021 ($) | | :------------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(4,666,649) | $(4,805,946) | | Net cash (used in) provided by investing activities | $(53,580) | $6,112,223 | | Net cash provided by (used in) financing activities | $65,410 | $(256,508) | | NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | $(4,654,819) | $1,049,769 | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $18,017,319 | $37,109,917 | | Non-Cash Investing and Financing Activities | 2022 ($) | 2021 ($) | | :------------------------------------------ | :-------- | :------ | | Property and equipment included in current liabilities | $105,318 | $469,005 | | Prepaid consulting services paid with issuance of common stock | $91,623 | $233,753 | | Cash paid for interest | $277,853 | $290,212 | [Notes to Condensed Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section details the Company's accounting policies, liquidity, equity changes, fair value measurements, related party transactions, commitments, patents, and loss per share calculations [A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=6&type=section&id=A.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This section outlines the basis of financial statement presentation and summarizes key accounting policies, including cash, investments, property, R&D, patents, stock-based compensation, leases, and derivatives - The unaudited condensed financial statements contain all necessary adjustments for fair presentation and should be read in conjunction with the annual report on Form 10-K for the year ended September 30, 2022[49](index=49&type=chunk) - There is **substantial doubt** about the Company's ability to continue as a going concern due to recurring losses and future liquidity needs[50](index=50&type=chunk) - Key accounting policies include: cash and cash equivalents (highly liquid investments < 3 months maturity), U.S. Treasury Bills (highly liquid, >3 months but <1 year maturity, recorded at **fair value**), property and equipment (straight-line depreciation 5-7 years), R&D and manufacturing supplies (recorded at cost, expensed when used), patents (capitalized, amortized over shorter of useful/legal life, impairment recognized if future undiscounted cash flows are less than **carrying value**)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - Stock-based compensation for equity awards is measured at **fair value** on grant date using Black-Scholes or Monte Carlo simulation, expensed over the service period[56](index=56&type=chunk)[57](index=57&type=chunk)[67](index=67&type=chunk)[69](index=69&type=chunk) - Leases are accounted for under ASC 842, recognizing right-of-use assets and lease liabilities for contracts conveying control over identified assets; short-term leases (**12 months or less**) are not reflected on the balance sheet[62](index=62&type=chunk) - Derivative instruments are recognized as assets or liabilities at **fair value**, with gains or losses recognized in earnings, in accordance with ASC 815[64](index=64&type=chunk) [B. LIQUIDITY](index=8&type=section&id=B.%20LIQUIDITY) This section addresses significant R&D and clinical trial costs, ongoing capital requirements, and substantial doubt about the Company's ability to continue as a going concern - The Company has incurred significant costs for technology acquisition, R&D, administrative costs, facility expansion, and clinical trials, funded primarily by loans and public/private sale of securities[88](index=88&type=chunk) - Additional capital is required to finance the Company through marketing approval, with plans to raise funds through warrant exercises, corporate partnerships, and debt/equity financings[74](index=74&type=chunk) - There is **substantial doubt** about the Company's ability to continue as a going concern due to recurring losses and future liquidity needs, with no assurance of successful fundraising on acceptable terms[75](index=75&type=chunk)[88](index=88&type=chunk) - The full impact of the COVID-19 pandemic on the Company's financial condition, liquidity, and future operations remains **uncertain**, with management actively monitoring risks[89](index=89&type=chunk) [C. STOCKHOLDERS' EQUITY](index=8&type=section&id=C.%20STOCKHOLDERS'%20EQUITY) This section details changes in stockholders' equity, including equity compensation plans, stock option activity, restricted stock issuances, warrant exercises, and derivative instrument impact Equity Compensation Plan | Equity Compensation Plan | Total Shares Reserved Under Plans (Shares) | | :----------------------------- | :-------------------------------- | | Incentive Stock Option Plans | 138,400 | | Non-Qualified Stock Option Plans | 13,787,200 | | Stock Bonus Plans | 783,760 | | Stock Compensation Plans | 634,000 | | Incentive Stock Bonus Plan | 640,000 | Stock Option Activity | Stock Option Activity | 3 months ended Dec 31, 2022 (Options) | 3 months ended Dec 31, 2021 (Options) | | :-------------------- | :-------------------------- | :-------------------------- | | Options granted | 2,500 | 251,000 | | Options exercised | - | 6,500 | | Options forfeited | 96,832 | 13,000 | | Options expired | 45,400 | - | - During the three months ended December 31, 2022, **40,236 shares** of restricted common stock were issued to consultants for services, with a weighted average grant date fair value of **$2.53 per share**, compared to **18,020 shares** issued at **$9.93 per share** in 2021[12](index=12&type=chunk)[146](index=146&type=chunk) - Stock-based compensation expense for consulting agreements was approximately **$149,000** in Q4 2022, down from **$218,000** in Q4 2021[117](index=117&type=chunk) - On October 28, 2022, the expiration date of Series RR warrants was extended by **two years**, resulting in an incremental cost of approximately **$172,000**, recorded as a deemed dividend[96](index=96&type=chunk)[102](index=102&type=chunk) Warrants Exercised (Equity) | Warrants Exercised (Equity) | 3 months ended Dec 31, 2022 (Warrants) | Proceeds (2022) ($) | 3 months ended Dec 31, 2021 (Warrants) | Proceeds (2021) ($) | | :-------------------------- | :-------------------------- | :-------------- | :-------------------------- | :-------------- | | Series RR | 17,752 | $29,291 | - | - | | Series SS | 200,000 | $418,000 | - | - | | Series NN | - | - | 4,500 | $11,340 | | Series TT | - | - | 10,000 | $22,400 | | Series CC | - | - | 15,205 | $76,000 | | Total | 217,752 | $447,291 | 29,705 | $109,740 | - No warrant liabilities were outstanding during the three months ended December 31, 2022, compared to a net gain on warrant liabilities of **$364,596** in 2021[11](index=11&type=chunk)[182](index=182&type=chunk) [D. FAIR VALUE MEASUREMENTS](index=11&type=section&id=D.%20FAIR%20VALUE%20MEASUREMENTS) This section defines fair value measurement principles, outlines the fair value hierarchy, and confirms the absence of Level 3 derivative instruments - Fair value is determined as the price to sell an asset or transfer a liability in an orderly transaction between market participants, generally using the **income approach**[98](index=98&type=chunk) - The fair value hierarchy prioritizes inputs: **Level 1** (quoted prices in active markets), **Level 2** (observable inputs other than quoted prices), and **Level 3** (unobservable inputs reflecting management's assumptions)[99](index=99&type=chunk)[118](index=118&type=chunk) - As of December 31, 2022, and September 30, 2022, the Company did not have any derivative instruments classified as **Level 3** in the fair value hierarchy[119](index=119&type=chunk)[121](index=121&type=chunk) [E. RELATED PARTY TRANSACTIONS](index=12&type=section&id=E.%20RELATED%20PARTY%20TRANSACTIONS) This section details co-development and revenue sharing agreements with Ergomed, including their **$12 million** contribution to the Phase 3 Clinical Trial and related R&D expenses - Under co-development and revenue sharing agreements, Ergomed agreed to contribute up to **$12 million** towards the Phase 3 Clinical Trial in discounted clinical services, in exchange for milestone and royalty payments[103](index=103&type=chunk)[194](index=194&type=chunk) - Approximately **$11.8 million** of Ergomed's committed **$12 million** contribution has been realized as of December 31, 2022[194](index=194&type=chunk) - The Company recorded approximately **$0.1 million** and **$0.2 million** (net of Ergomed's discount) as R&D expense related to Ergomed's services for the three months ended December 31, 2022 and 2021, respectively[103](index=103&type=chunk) [F. COMMITMENTS AND CONTINGENCIES](index=12&type=section&id=F.%20COMMITMENTS%20AND%20CONTINGENCIES) This section outlines the Company's lease obligations for manufacturing and R&D facilities, including finance and operating lease liabilities and future payment schedules - The Company leases a manufacturing facility (San Tomas lease) for a **20-year term**, expiring October 2028, with annual base rent escalating at **3%**[105](index=105&type=chunk)[175](index=175&type=chunk) - The facility was upgraded for potential commercial production of Multikine, with the landlord financing **$2.4 million**[175](index=175&type=chunk) - As of December 31, 2022, the net book value of finance lease right-of-use assets was approximately **$10.5 million**, and the finance lease liability was approximately **$12.9 million**[104](index=104&type=chunk) - The weighted average discount rate is **8.45%** with a weighted average time to maturity of **5.08 years**[104](index=104&type=chunk) Finance Lease Payments (as of Dec 31, 2022) | Finance Lease Payments (as of Dec 31, 2022) | Amount ($) | | :------------------------------------------ | :------------ | | Nine months ending September 30, 2023 | $1,937,000 | | Year ending September 30, 2024 | $2,655,000 | | Year ending September 30, 2025 | $2,741,000 | | Year ending September 30, 2026 | $2,832,000 | | Year ending September 30, 2027 | $2,923,000 | | Year ending September 30, 2028 | $3,015,000 | | Thereafter | $252,000 | | Total future minimum lease obligation | $16,355,000 | | Less imputed interest | $(3,446,000) | | Net present value of finance lease obligations | $12,909,000 | - The Company leases two facilities under operating leases, with the R&D laboratory lease renewed until February 29, 2032[149](index=149&type=chunk) - As of December 31, 2022, the net book value of operating lease right-of-use assets was approximately **$1.8 million**, and the operating lease liability was approximately **$2.0 million**[149](index=149&type=chunk) - The weighted average discount rate is **9.10%** with a weighted average time to maturity of **7.6 years**[149](index=149&type=chunk) Operating Lease Payments (as of Dec 31, 2022) | Operating Lease Payments (as of Dec 31, 2022) | Amount ($) | | :-------------------------------------------- | :------------ | | Nine months ending September 30, 2023 | $262,000 | | Year ending September 30, 2024 | $357,000 | | Year ending September 30, 2025 | $366,000 | | Year ending September 30, 2026 | $287,000 | | Year ending September 30, 2027 | $277,000 | | Year ending September 30, 2028 | $285,000 | | Thereafter | $1,040,000 | | Total future minimum lease obligation | $2,874,000 | | Less imputed interest | $(893,000) | | Net present value of operating lease obligation | $1,981,000 | [G. PATENTS](index=13&type=section&id=G.%20PATENTS) This section details patent impairment charges and amortization expenses, along with estimated future patent amortization expenses - During the three months ended December 31, 2022, the Company recorded **$0** in patent impairment charges, compared to **$31,000** in 2021[150](index=150&type=chunk) - Amortization of patent costs totaled approximately **$10,000** in 2022 and **$14,000** in 2021[150](index=150&type=chunk) Estimated Future Patent Amortization Expense | Estimated Future Patent Amortization Expense | Amount ($) | | :------------------------------------------- | :----------- | | Nine months ending September 30, 2023 | $28,000 | | Year ending September 30, 2024 | $30,000 | | Year ending September 30, 2025 | $28,000 | | Year ending September 30, 2026 | $24,000 | | Year ending September 30, 2027 | $21,000 | | Year ending September 30, 2028 | $17,000 | | Thereafter | $54,000 | | Total | $202,000 | [H. LOSS PER COMMON SHARE](index=14&type=section&id=H.%20LOSS%20PER%20COMMON%20SHARE) This section explains the calculation of basic and diluted loss per common share and lists anti-dilutive securities - Basic loss per share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares outstanding; diluted loss per share excludes **anti-dilutive securities**[151](index=151&type=chunk) Loss Per Share Metric | Loss Per Share Metric | 3 months ended Dec 31, 2022 ($) | 3 months ended Dec 31, 2021 ($) | | :---------------------------------------- | :-------------------------- | :-------------------------- | | Net loss available to common shareholders - basic | $(8,025,061) | $(8,782,606) | | Weighted average shares outstanding - basic | 43,440,387 (Shares) | 43,077,961 (Shares) | | Basic loss per common share | $(0.18) | $(0.20) | | Diluted loss earnings per common share | $(0.18) | $(0.20) | Anti-Dilutive Securities (as of Dec 31) | Anti-Dilutive Securities (as of Dec 31) | 2022 (Securities) | 2021 (Securities) | | :-------------------------------------- | :----------- | :----------- | | Options and Warrants | 13,917,352 | 10,477,966 | | Unvested Restricted Stock | 149,250 | 151,250 | | Total | 14,066,602 | 10,629,216 | [I. New Accounting Pronouncements](index=7&type=section&id=I.%20New%20Accounting%20Pronouncements) This section discusses the adoption of new accounting standards, ASU 2020-06 and ASU 2019-12, and their immaterial impact on the Company's financial statements - The Company adopted ASU 2020-06 (Debt with Conversion and Other Options) effective October 1, 2021, with **no financial impact** in the period of adoption[65](index=65&type=chunk)[66](index=66&type=chunk) - The Company adopted ASU 2019-12 (Income Taxes) effective October 1, 2021, with **no impact** on its financial statements[86](index=86&type=chunk) - The Company has considered all recently issued accounting pronouncements and does not believe their adoption will have a **material impact** on its financial statements[73](index=73&type=chunk) [J. SUBSEQUENT EVENTS](index=14&type=section&id=J.%20SUBSEQUENT%20EVENTS) This section reports a subsequent event where the Company deposited **$2.3 million** to its landlord due to falling below a stipulated cash threshold - On January 11, 2023, the Company was required to deposit approximately **$2.3 million** to its landlord for falling below the stipulated cash threshold in accordance with the San Tomas lease[15](index=15&type=chunk) - This amount will be included in current assets until the minimum cash balance is met and the deposit is returned[15](index=15&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 the Company's financial condition, operational results, and liquidity for the three months ended December 31, 2022, including clinical trial progress and funding strategies [Overview](index=14&type=section&id=Overview) This overview details the completion of the Multikine Phase 3 study, its survival benefits, the impact of chemotherapy, and the development of LEAPS technology - The Company completed its **9.5-year pivotal Phase 3 study** for Multikine® (Leukocyte Interleukin, Injection) in advanced head and neck cancer (SCCHN)[8](index=8&type=chunk) - The Phase 3 study showed a long-term **5-year overall survival (OS) benefit of 14.1%** for the Multikine treatment arm followed by surgery and radiation (**62.7% vs. 48.6%** for control), with **no safety issues**; this benefit was **robust, durable, and increased over time**[8](index=8&type=chunk)[131](index=131&type=chunk) - When chemotherapy was added to the treatment arm, the immunological effect of Multikine was **negated**, leading to the combined study not achieving its primary endpoint of a **10% improvement** in overall survival[154](index=154&type=chunk) - The Company is also developing LEAPS (Ligand Epitope Antigen Presentation System) technology, investigating CEL-4000 as a potential therapeutic vaccine for **rheumatoid arthritis**[187](index=187&type=chunk) - All projects are under development, and the Company cannot predict when it will generate revenue from product sales[156](index=156&type=chunk) [Liquidity and Capital Resources](index=15&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the Company's historical financing, ongoing capital needs for clinical trials, cash flow changes, and the necessity of raising additional capital - Since inception, operations have been financed through equity securities, convertible notes, loans, and research grants; the Company anticipates continued net operating losses and will rely on these financing vehicles[133](index=133&type=chunk) - The Company has incurred approximately **$64.2 million** in direct costs for the Phase 3 clinical trial and filing as of December 31, 2022, with an estimated additional **$0.6 million** needed for completion[134](index=134&type=chunk) - During the three months ended December 31, 2022, cash decreased by approximately **$4.7 million**, primarily due to **$4.7 million** used in regular operations, including the Phase 3 clinical trial[135](index=135&type=chunk) - The Company incurred a net operating loss of approximately **$7.7 million** for the three months ended December 31, 2022, including significant non-cash expenses like **$1.7 million** in stock-based employee compensation and **$1.0 million** in depreciation and amortization[160](index=160&type=chunk) - Prepaid expenses decreased by approximately **$0.2 million (29%)** at December 31, 2022, compared to September 30, 2022, mainly due to a decrease in prepaid stock compensation to non-employees[159](index=159&type=chunk) - The Company will need to raise additional capital or secure long-term financing to continue research and development efforts, with **no assurance** of obtaining sufficient funds[157](index=157&type=chunk) [Results of Operations and Financial Condition](index=16&type=section&id=Results%20of%20Operations%20and%20Financial%20Condition) This section analyzes changes in research and development, general and administrative expenses, derivative gains, and net interest expense for the three months ended December 31, 2022 Research and Development Expenses | Research and Development Expenses | 3 months ended Dec 31, 2022 ($) | 3 months ended Dec 31, 2021 ($) | | :-------------------------------- | :-------------------------- | :-------------------------- | | MULTIKINE | $5,294,377 | $5,791,419 | | LEAPS | $98,169 | $291,748 | | TOTAL | $5,392,546 | $6,083,167 | - Research and development expenses decreased by approximately **$0.7 million (11%)** in Q4 2022 compared to Q4 2021, primarily due to a **$0.9 million** decrease in employee stock compensation and a **$0.4 million** decrease in Phase 3 clinical study costs, partially offset by increases in commercial preparation costs (**$0.4 million**) and other R&D costs (**$0.2 million**)[138](index=138&type=chunk) - General and administrative expenses decreased by approximately **$0.5 million (18%)** in Q4 2022 compared to Q4 2021, mainly due to a **$0.7 million** decrease in employee stock compensation costs, offset by a **$0.2 million** increase in other G&A costs[178](index=178&type=chunk) - The Company recorded derivative gains of approximately **$0 million** in Q4 2022, a decrease from **$0.4 million** in Q4 2021, due to fluctuations in the common stock share price affecting the fair value of derivative liabilities[161](index=161&type=chunk) - Net interest expense remained relatively constant at approximately **$0.2 million** in Q4 2022 and **$0.3 million** in Q4 2021, primarily consisting of interest paid on lease liabilities[139](index=139&type=chunk) [Critical Accounting Estimates and Policies](index=17&type=section&id=Critical%20Accounting%20Estimates%20and%20Policies) This section highlights critical accounting estimates for lease assets and liabilities, requiring judgment in lease terms and borrowing rates, and share-based compensation valuation - Critical accounting estimates include the measurement of finance and operating lease right-of-use assets and lease liabilities, which require judgment in determining estimated lease terms and incremental borrowing rates[165](index=165&type=chunk)[179](index=179&type=chunk) - Share-based compensation cost for employees is measured at fair value using the Black-Scholes option pricing model (requiring assumptions like volatility and expected option life) or Monte-Carlo simulation for performance-based options (requiring estimates of performance/market conditions)[165](index=165&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risks](index=17&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risks) The Company assesses its market risk exposure and concludes that it does not have any significant market risk - The Company does not believe that it has any **significant exposure to market risk**[196](index=196&type=chunk) [Item 4. Controls and Procedures](index=17&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of December 31, 2022, due to material weaknesses, with no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=17&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The CEO and CFO determined that the Company's disclosure controls and procedures were **not effective** as of December 31, 2022, due to previously identified material weaknesses - The Company's Chief Executive and Chief Financial Officer concluded that the Company's disclosure controls and procedures were **not effective** as of December 31, 2022, due to **material weaknesses** described in the Annual Report on Form 10-K for the year ended September 30, 2022[166](index=166&type=chunk) [Changes in Internal Control over Financial Reporting](index=17&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in the Company's internal control over financial reporting occurred during the three months ended December 31, 2022 - There were **no changes** in the Company's internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting during the three months ended December 31, 2022[190](index=190&type=chunk) PART II This section covers unregistered sales of equity securities and lists exhibits filed with the quarterly report [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=17&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company issued **40,236 restricted common shares** to consultants for investor relations services during the three months ended December 31, 2022, under a Section 4(a)(2) exemption - During the three months ended December 31, 2022, the Company issued **40,236 restricted shares** of common stock to consultants for investor relations services[146](index=146&type=chunk) - The issuance relied on the exemption provided by **Section 4(a)(2)** of the Securities Act of 1933, with shares acquired by sophisticated investors for their own accounts, without general solicitation, and bearing a restricted legend[169](index=169&type=chunk) [Item 6. Exhibits](index=18&type=section&id=Item%206.%20Exhibits) This section provides a list of exhibits filed with the quarterly report | Number | Exhibit | | :----- | :------ | | 31 | Rule 13a-14(a) Certifications | | 32 | Section 1350 Certifications | [Signatures](index=18&type=section&id=Signatures) The report was signed by Geert Kersten, Principal Executive Officer of CEL-SCI Corporation, on **February 14, 2023** - The report was signed by Geert Kersten, Principal Executive Officer, on **February 14, 2023**[170](index=170&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, 2022. 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 (Exact name of registrant as specified in its charter) | --- | --- | |----------------------------- ...