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, 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 001-11889 CEL-SCI CORPORATION Colorado State or other jurisdiction of incorporation | --- | |------ ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed financial statements for March 31, 2022 and 2021, covering balance sheets, operations, equity, and cash flows, with detailed accounting notes [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheets | Metric | March 31, 2022 (Unaudited) | September 30, 2021 | | :-------------------------- | :------------------------- | :----------------- | | Cash and cash equivalents | $34,282,872 | $36,060,148 | | Total current assets | $37,275,040 | $45,271,521 | | Total assets | $64,160,646 | $75,869,965 | | Total current liabilities | $4,474,285 | $3,937,067 | | Total liabilities | $19,033,098 | $19,335,739 | | Total stockholders' equity | $45,127,548 | $56,534,226 | [Condensed Statements of Operations (Six Months)](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20six%20months%20ended%20March%2031%2C%202022%20and%202021) Condensed Statements of Operations (Six Months) | Operating Expenses | 2022 | 2021 | | :-------------------------- | :------------- | :------------- | | Research and development | $12,606,984 | $10,636,274 | | General and administrative | $5,788,250 | $6,627,640 | | Total operating expenses | $18,395,234 | $17,263,914 | | Operating loss | $(18,395,234) | $(17,263,914) | | Net loss | $(18,606,098) | $(19,217,984) | | Net loss per common share | $(0.43) | $(0.49) | [Condensed Statements of Operations (Three Months)](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20three%20months%20ended%20March%2031%2C%202022%20and%202021) Condensed Statements of Operations (Three Months) | Operating Expenses | 2022 | 2021 | | :-------------------------- | :------------ | :------------- | | Research and development | $6,523,817 | $5,221,514 | | General and administrative | $3,028,042 | $3,311,484 | | Total operating expenses | $9,551,859 | $8,532,998 | | Operating loss | $(9,551,859) | $(8,532,998) | | Net loss | $(9,823,492) | $(11,281,120) | | Net loss per common share | $(0.23) | $(0.28) | [Condensed Statements of Stockholders' Equity](index=4&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity%20for%20the%20six%20months%20ended%20March%2031%2C%202022%20and%202021) Condensed Statements of Stockholders' Equity | Metric | October 1, 2021 | March 31, 2022 | | :----------------------------------- | :-------------- | :------------- | | Common Shares Outstanding | 43,207,183 | 43,304,602 | | Common Stock Amount | $432,072 | $433,046 | | Additional Paid-In Capital | $474,298,566 | $481,497,012 | | Accumulated Deficit | $(418,196,412) | $(436,802,510) | | Total Stockholders' Equity | $56,534,226 | $45,127,548 | - Key changes in stockholders' equity for the six months ended March 31, 2022, include warrant exercises of **$13,860**, equity-based compensation for employees of **$3,392,706**, and a net loss of **$(9,823,492)**[20](index=20&type=chunk)[21](index=21&type=chunk) [Condensed Statements of Cash Flows](index=5&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20March%2031%2C%202022%20and%202021) Condensed Statements of Cash Flows | Cash Flow Activity | Six Months Ended March 31, 2022 | Six Months Ended March 31, 2021 | | :---------------------------------- | :------------------------------ | :------------------------------ | | Net cash used in operating activities | $(7,537,608) | $(8,784,495) | | Net cash provided by (used in) investing activities | $5,578,398 | $(17,774,717) | | Net cash provided by financing activities | $181,934 | $17,481,637 | | Net decrease in cash and cash equivalents | $(1,777,276) | $(9,077,575) | | Cash and cash equivalents, end of period | $34,282,872 | $6,431,334 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements%20%28unaudited%29) - The financial statements are prepared assuming the Company will continue as a going concern, despite recurring losses, as management believes current cash on hand is sufficient for the next twelve months[31](index=31&type=chunk)[53](index=53&type=chunk) - CEL-SCI Corporation announced positive long-term 5-year overall survival (OS) benefit from its pivotal Phase 3 study for Multikine® in advanced head and neck cancer, showing a **14.1% absolute advantage** (62.7% vs 48.6%) in the treatment arm receiving Multikine followed by surgery and radiation[50](index=50&type=chunk)[112](index=112&type=chunk) - The Company plans to raise additional capital through warrant exercises, corporate partnerships, and debt/equity financings to fund operations and bring Multikine to market, citing a history of successful fundraising[51](index=51&type=chunk)[52](index=52&type=chunk) Equity Compensation Plan Summary (March 31, 2022) | Name of Plan | Total Shares Reserved | Shares Reserved for Outstanding Options | Shares Issued | Remaining Options/Shares | | :--------------------------- | :-------------------- | :-------------------------------------- | :------------ | :----------------------- | | Incentive Stock Option Plans | 138,400 | 76,829 | N/A | 213 | | Non-Qualified Stock Option Plans | 11,787,200 | 11,198,714 | N/A | 178,258 | | Stock Bonus Plans | 783,760 | N/A | 385,305 | 398,422 | | Stock Compensation Plans | 634,000 | N/A | 153,195 | 462,395 | | Incentive Stock Bonus Plan | 640,000 | N/A | 614,500 | 25,500 | Stock-Based Compensation Expense | Category | Six Months Ended March 31, 2022 | Six Months Ended March 31, 2021 | | :------------ | :------------------------------ | :------------------------------ | | Employees | $6,655,002 | $6,579,051 | | Non-employees | $402,270 | $552,664 | | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------ | :-------------------------------- | :-------------------------------- | | Employees | $3,392,706 | $3,282,742 | | Non-employees | $183,952 | $304,004 | Net Gain (Loss) on Warrant Liabilities | Period | 2022 | 2021 | | :-------------------------- | :---------- | :----------- | | Six Months Ended March 31 | $366,791 | $(2,108,181) | | Three Months Ended March 31 | $2,195 | $(3,041,017) | - As of March 31, 2022, there were no outstanding derivative instruments, down from **$437,380** at September 30, 2021, due to exercises and expirations[63](index=63&type=chunk)[88](index=88&type=chunk) Lease Financials (March 31, 2022) | Lease Type | Right of Use Asset (Net Book Value) | Lease Liability (Balance) | | :------------ | :---------------------------------- | :------------------------ | | Finance Lease | $11,800,000 | $14,000,000 | | Operating Lease | $2,000,000 | $2,100,000 | - The Company recorded a patent impairment charge of approximately **$31,000** for the six months ended March 31, 2022, compared to **$0** in the prior year. Amortization of patent costs was approximately **$27,000** for the same period[106](index=106&type=chunk) Loss Per Common Share | Metric | Six Months Ended March 31, 2022 | Six Months Ended March 31, 2021 | | :-------------------------------------- | :------------------------------ | :------------------------------ | | Net loss available to common shareholders | $(18,606,098) | $(19,303,763) | | Weighted average shares outstanding | 43,100,070 | 39,351,194 | | Basic and diluted loss per common share | $(0.43) | $(0.49) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and capital resources, highlighting Multikine Phase 3 trial results, capital needs, and operating expense changes - The Multikine Phase 3 study showed a robust and durable **14.1% absolute 5-year overall survival benefit** in the surgery + radiation arm for advanced head and neck cancer, exceeding the **10% target** for the overall study population. The Company plans to file for FDA approval for this specific patient population[112](index=112&type=chunk)[114](index=114&type=chunk) - The Company continues to rely on equity sales, convertible notes, and loans to finance operations due to ongoing R&D and lack of significant revenue, anticipating continued need for additional capital[118](index=118&type=chunk)[119](index=119&type=chunk) - Approximately **$63,000,000** in direct costs have been incurred for the Multikine Phase 3 clinical trial to date, with an estimated additional **$800,000** remaining for the trial and FDA report filing[122](index=122&type=chunk) - For the six months ended March 31, 2022, cash decreased by approximately **$7,900,000** (after T-bill maturity). Net cash used in operating activities was **$7,500,000**, offset by **$800,000** in landlord lease incentives and **$100,000** from warrant/option exercises[124](index=124&type=chunk) - Research and development expenses increased by approximately **$2,000,000 (19%)** for the six months ended March 31, 2022, primarily due to higher employee stock compensation, depreciation from manufacturing facility upgrades, and costs for potential commercial sale of Multikine, partially offset by decreased Phase 3 study costs[130](index=130&type=chunk) - General and administrative expenses decreased by approximately **$800,000 (13%)** for the six months ended March 31, 2022, mainly due to a **$1,000,000** decrease in employee stock compensation expense[132](index=132&type=chunk) - A **$400,000 gain** on derivative instruments was recorded for the six months ended March 31, 2022, a significant change from the **$2,100,000 loss** in the prior year, attributed to fluctuations in the Company's common stock price. All derivative warrants were exercised or expired by March 31, 2022[133](index=133&type=chunk) Research and Development Expenses by Project | Project | Six Months Ended March 31, 2022 | Six Months Ended March 31, 2021 | | :-------- | :------------------------------ | :------------------------------ | | MULTIKINE | $11,995,302 | $9,732,817 | | LEAPS | $611,682 | $903,457 | | TOTAL | $12,606,984 | $10,636,274 | [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 states that it does not believe it has any significant exposures to market risk - The Company does not believe it has any significant exposures to market risk[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls as of March 31, 2022, with no material changes in internal control over financial reporting - The Company's disclosure controls and procedures were evaluated and deemed effective as of March 31, 2022[146](index=146&type=chunk) - No material changes in the Company's internal control over financial reporting occurred during the quarter ended March 31, 2022[147](index=147&type=chunk) PART II. OTHER INFORMATION [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.) Reports unregistered restricted common stock issuance to consultants for investor relations services under Section 4(a)(2) of the Securities Act of 1933 - During the six months ended March 31, 2022, the Company issued **43,495 restricted shares** of common stock to consultants for investor relations services[150](index=150&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 company information[151](index=151&type=chunk) [Item 6. Exhibits](index=21&type=section&id=Item%206.%20Exhibits) Lists exhibits filed as part of the quarterly report, including required SEC certifications - Exhibits include Rule 13a-14(a) Certifications (Exhibit 31) and Section 1350 Certifications (Exhibit 32)[152](index=152&type=chunk) [Signatures](index=22&type=section&id=Signatures) Contains official signatures for the quarterly report, confirming submission under the Securities Exchange Act of 1934 - The report was signed by Geert Kersten, Principal Executive Officer and Principal Accounting and Financial Officer, on May 13, 2022[155](index=155&type=chunk)

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) CEL-SCI reported an $8.8 million net loss for Q4 2021, with total assets decreasing to $69.7 million and stockholders' equity to $51.4 million, raising going concern doubts Financial Position | Financial Metric | Dec 31, 2021 (Unaudited) | Sep 30, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $37,109,917 | $36,060,148 | | Total current assets | $41,867,261 | $45,271,521 | | Total assets | $69,671,739 | $75,869,965 | | **Liabilities & Equity** | | | | Total current liabilities | $3,333,495 | $3,937,067 | | Total liabilities | $18,320,284 | $19,335,739 | | Total stockholders' equity | $51,351,455 | $56,534,226 | Statement of Operations | Line Item | Three Months Ended Dec 31, 2021 | Three Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Research and development | $6,083,167 | $5,414,760 | | General and administrative | $2,760,208 | $3,316,156 | | **Operating loss** | **($8,843,375)** | **($8,730,916)** | | Gain on derivative instruments | $364,596 | $932,836 | | **Net loss** | **($8,782,606)** | **($7,936,864)** | | Net loss per common share (Basic & Diluted) | ($0.20) | ($0.21) | Cash Flow Activities | Cash Flow Activity | Three Months Ended Dec 31, 2021 | Three Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,805,946) | ($3,827,899) | | Net cash provided by (used in) investing activities | $6,112,223 | ($3,149,820) | | Net cash (used in) provided by financing activities | ($256,508) | $13,329,292 | | **Net increase in cash and cash equivalents** | **$1,049,769** | **$6,351,573** | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes disclose a going concern warning, positive Multikine Phase 3 results for FDA submission, and details on equity changes, derivative liabilities, related-party transactions, and lease commitments - The financial statements assume the Company will continue as a going concern, but recurring losses and future liquidity needs raise **substantial doubt** about this ability[24](index=24&type=chunk) - The Phase 3 study for Multikine showed a **14.1% absolute 5-year overall survival benefit** in a specific treatment arm, forming the basis for a planned FDA approval filing[44](index=44&type=chunk) - The company has significant lease commitments, including a finance lease for its manufacturing facility with a liability of approximately **$13.5 million** and operating leases with liabilities of approximately **$2.1 million** as of December 31, 2021[86](index=86&type=chunk)[93](index=93&type=chunk) - In December 2020, the company extended expiration dates of warrants held by the de Clara Trust and other officers, resulting in a deemed dividend and interest expense[80](index=80&type=chunk)[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses positive Multikine Phase 3 results, ongoing reliance on equity financing, a 12% increase in R&D expenses to $6.1 million, a 17% decrease in G&A expenses to $2.8 million, and critical accounting estimates for leases and stock compensation [Liquidity and Capital Resources](index=16&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity depends on external financing, with $62.6 million incurred for Multikine Phase 3, $4.8 million cash used in operations, and an $11.1 million manufacturing facility upgrade completed - The company announced positive results from its 9.5-year pivotal Phase 3 study for Multikine, showing a **14.1% absolute 5-year overall survival benefit** in the patient arm treated with Multikine followed by surgery and radiation[101](index=101&type=chunk) - The company has been dependent on proceeds from the sale of its securities to meet liquidity and capital requirements and anticipates this will continue, requiring additional capital for research efforts[109](index=109&type=chunk)[110](index=110&type=chunk) - During the three months ended December 31, 2021, the company used approximately **$4.8 million** in cash to fund regular operations, including its Phase 3 clinical trial[113](index=113&type=chunk) [Results of Operations](index=18&type=section&id=Results%20of%20Operations) R&D expenses increased 12% to $6.1 million due to stock compensation and depreciation, while G&A expenses decreased 17% to $2.8 million from reduced stock compensation - Research and development expenses increased by approximately **$0.7 million (12%) YoY**, driven by a **$0.6 million** increase in employee stock compensation and **$0.3 million** in depreciation, offset by a **$0.2 million** reduction in other R&D costs[118](index=118&type=chunk) - General and administrative expenses decreased by approximately **$0.6 million (17%) YoY**, largely due to a decrease in employee stock compensation costs[119](index=119&type=chunk) R&D Project Expenses | R&D Project | Expenses (Q1 FY2022) | Expenses (Q1 FY2021) | | :--- | :--- | :--- | | MULTIKINE | $5,791,419 | $5,011,950 | | LEAPS | $291,748 | $402,810 | | **TOTAL** | **$6,083,167** | **$5,414,760** | [Critical Accounting Estimates and Policies](index=18&type=section&id=Critical%20Accounting%20Estimates%20and%20Policies) Leases and stock-based compensation are critical accounting estimates requiring significant judgment for inputs like incremental borrowing rates, stock volatility, and expected option life - The company's most critical accounting estimates and policies are in the areas of leases and stock-based compensation[128](index=128&type=chunk) - Significant judgment is required to determine inputs for lease liabilities (e.g., incremental borrowing rate) and for share-based compensation models (e.g., volatility, expected life, and performance condition probabilities)[129](index=129&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 asserts it has no significant exposures to market risk - The Company does not believe that it has any significant exposures to market risk[131](index=131&type=chunk) [Item 4. Controls and Procedures](index=19&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes identified - The Chief Executive and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective as of December 31, 2021[132](index=132&type=chunk) - Management concluded that the Company's internal control over financial reporting was effective as of December 31, 2021, based on the criteria in the COSO Framework[135](index=135&type=chunk) - There were no changes in the Company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[136](index=136&type=chunk) PART II - OTHER INFORMATION [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=20&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued 18,020 restricted common shares to consultants for investor relations services, exempt from registration under Section 4(a)(2) of the Securities Act of 1933 - During the quarter, the Company issued **18,020 restricted shares of common stock** to consultants for investor relations services[139](index=139&type=chunk) - The issuance was exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as it was made to sophisticated investors without general solicitation[140](index=140&type=chunk) [Item 6. Exhibits](index=20&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO certifications and corporate governance documents incorporated by reference - The report includes a list of exhibits, notably the CEO certifications required under Rule 13a-14(a) and Section 1350[142](index=142&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, 2021. 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) | --- | --- | |----------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock CVM NYSE American Large accelerated filer ☐ Accelerated filer Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ Class of Stock No. Shares Outstanding Date Common 43,028,150 August 9, 2021 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly p ...

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, 2021 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 | --- | --- | --- | |----------------------------------------------|-------------------- ...

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 December 31, 2020 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 | --- | --- | --- | |-----------------------------------------------------------|---- ...

PART I [Business Overview](index=3&type=section&id=ITEM%201.%20BUSINESS) CEL-SCI is a clinical-stage biotechnology company focused on developing immunotherapies for cancer and infectious diseases [Company Products](index=4&type=section&id=CEL-SCI%27S%20PRODUCTS) The company's pipeline focuses on Multikine for head and neck cancer and LEAPS technology for rheumatoid arthritis and COVID-19 - The company's primary focus is on two product development platforms: Multikine for head and neck cancer and the LEAPS technology for rheumatoid arthritis and COVID-19[22](index=22&type=chunk) [Multikine](index=4&type=section&id=MULTIKINE) Multikine, the lead immunotherapy for head and neck cancer, is in final statistical analysis of its pivotal Phase 3 trial - Multikine has been granted Orphan Drug designation by the FDA for neoadjuvant therapy in patients with SCCHN[28](index=28&type=chunk) - The pivotal Phase 3 study is fully enrolled with **928 patients** and reached the required **298 events** in late April 2020, moving it into the final analysis phase[13](index=13&type=chunk)[30](index=30&type=chunk) - As of September 30, 2020, direct costs for the Phase 3 trial totaled approximately **$58.9 million**, with an estimated **$5.9 million** in additional expenses expected for the remainder of the trial and FDA filing[33](index=33&type=chunk)[34](index=34&type=chunk) - CEL-SCI has exclusive marketing and distribution agreements for Multikine with Teva Pharmaceutical for Israel and Turkey, Orient Europharma for several Asian and Pacific countries, and Byron Biopharma for South Africa[36](index=36&type=chunk)[39](index=39&type=chunk)[44](index=44&type=chunk) [LEAPS Technology](index=7&type=section&id=LEAPS) The LEAPS platform develops immunotherapies, including LEAPS COV-19 for COVID-19 and CEL-4000 for rheumatoid arthritis - LEAPS COV-19, a therapeutic treatment candidate, achieved a statistically significant **40% survival rate** in transgenic mouse models challenged with SARS-CoV-2, compared to **0% survival** in control groups[17](index=17&type=chunk)[50](index=50&type=chunk) - The company was awarded a **$1.5 million** Phase 2 SBIR grant from the NIH to advance its LEAPS candidate for rheumatoid arthritis, CEL-4000, towards an IND application[15](index=15&type=chunk)[53](index=53&type=chunk) [Intellectual Property](index=9&type=section&id=INTELLECTUAL%20PROPERTY) Intellectual property protects Multikine and LEAPS via patents, with Multikine's manufacturing process as a trade secret Key Patent Expiration Dates | Technology | Jurisdiction | Expiration Year(s) | | :--- | :--- | :--- | | **Multikine** | U.S. | 2023 | | | Europe | 2025, 2026 | | **LEAPS** | U.S. | 2021, 2022, 2032 | | | Europe | 2029, 2034 | - The manufacturing process for Multikine, a complex biological product, is protected as a trade secret rather than by patent[69](index=69&type=chunk) [Manufacturing Facility](index=10&type=section&id=MANUFACTURING%20FACILITY) The dedicated Multikine manufacturing facility is expanding for commercial demand, with its lease expiring in 2028 - The company is expanding its manufacturing facility to meet expected demand for Multikine upon potential regulatory approval[73](index=73&type=chunk) - The lease on the manufacturing facility expires on **October 31, 2028**[74](index=74&type=chunk) [Government Regulation](index=10&type=section&id=GOVERNMENT%20REGULATION) Company products are subject to extensive FDA and global regulations, with Multikine holding Orphan Drug Designation - The FDA approval process for biologics involves multiple stages: preclinical testing, IND submission, three phases of clinical trials to establish safety and efficacy, and finally, a BLA submission for marketing approval[76](index=76&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) - Multikine has received Orphan Drug Status from the FDA, which can provide **seven years of market exclusivity** if it is the first product approved for its specific indication[104](index=104&type=chunk)[106](index=106&type=chunk) - Upon commercialization, the company will be subject to various healthcare laws, including the Anti-Kickback Statute and the False Claims Act, and will face challenges related to pricing and reimbursement from third-party payors[108](index=108&type=chunk)[111](index=111&type=chunk) [Risk Factors](index=15&type=section&id=ITEM%201B.%20RISK%20FACTORS) The company faces significant risks including financial losses, Multikine dependence, high costs, and regulatory and IP challenges - The company has incurred net losses of approximately **$384 million** since inception and expects to continue incurring losses, raising substantial doubt about its ability to continue as a going concern without additional capital[128](index=128&type=chunk)[135](index=135&type=chunk) - The business is heavily dependent on the success of Multikine, its only product in late-stage clinical development; failure to obtain regulatory approval or commercialize Multikine would materially harm the company[118](index=118&type=chunk)[130](index=130&type=chunk) - The COVID-19 pandemic has caused business disruptions, including delays in the Phase 3 trial data lock and the expansion of the manufacturing facility[125](index=125&type=chunk) - The company's bylaws include fee-shifting and exclusive forum provisions that may discourage shareholder litigation[170](index=170&type=chunk)[175](index=175&type=chunk) - Intellectual property risks include the potential for patents to not provide adequate protection and the reliance on trade secrets for manufacturing, which are vulnerable to disclosure[267](index=267&type=chunk)[271](index=271&type=chunk) [Properties](index=35&type=section&id=ITEM%202.%20PROPERTIES) CEL-SCI leases corporate, lab, and a 73,000 sq ft manufacturing facility, which is being upgraded for Multikine production Leased Properties | Property | Location | Size (sq. ft.) | Lease Expiration | | :--- | :--- | :--- | :--- | | **Office Space** | Vienna, VA | N/A | Nov 30, 2025 | | **Laboratory** | Baltimore, MD | 17,900 | Feb 28, 2022 | | **Manufacturing Facility** | Near Baltimore, MD | 73,000 | Oct 31, 2028 | - The manufacturing facility is undergoing an upgrade estimated to cost **$10.5 million** to prepare for potential commercial production of Multikine; the landlord has contingently agreed to finance the final **$2.4 million** of these costs[287](index=287&type=chunk) [Legal Proceedings](index=36&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company reported no material pending legal proceedings - Not applicable[288](index=288&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Not applicable[289](index=289&type=chunk) PART II [Market for Common Equity and Related Stockholder Matters](index=36&type=section&id=ITEM%205.%20MARKET%20FOR%20CEL-SCI%27S%20COMMON%20EQUITY%20AND%20RELATED%20STOCKHOLDER%20MATTERS.) CEL-SCI's common stock trades on NYSE American; no dividends are paid or planned, with historical price data provided - The company's common stock trades on the NYSE American under the symbol **"CVM"**[290](index=290&type=chunk) - CEL-SCI has not paid and does not plan to pay any dividends on its common stock in the foreseeable future[292](index=292&type=chunk) Quarterly Common Stock Price Range (High/Low) | Quarter Ended | High ($) | Low ($) | | :--- | :--- | :--- | | 9/30/2020 | 15.10 | 11.29 | | 6/30/2020 | 18.00 | 9.64 | | 3/31/2020 | 17.80 | 6.35 | | 12/31/2019 | 9.74 | 6.00 | | 9/30/2019 | 9.93 | 5.80 | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=37&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) FY2020 net loss increased to $30.3 million due to higher operating expenses; the company relies on equity financing and faces going concern doubts [Results of Operations](index=37&type=section&id=Results%20of%20Operations) FY2020 saw increased R&D and G&A expenses, leading to a net loss of $30.3 million, up from $22.1 million in FY2019 Year-over-Year Financial Performance (in millions) | Metric | FY 2020 | FY 2019 | Change (%) | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $17.8 | $12.7 | +41% | | **G&A Expenses** | $11.7 | $8.0 | +46% | | **Operating Loss** | ($29.0) | ($20.2) | +44% | | **Net Loss** | ($30.3) | ($22.1) | +37% | R&D Expenses by Project | Project | 2020 | 2019 | | :--- | :--- | :--- | | Multikine | $16,146,248 | $11,623,050 | | LEAPS | $1,694,042 | $1,036,237 | | **Total** | **$17,840,290** | **$12,659,287** | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company relies on equity financing, with $15.5 million cash as of FY2020, facing significant capital commitments and going concern doubts - The company raised net proceeds of approximately **$25.8 million** in FY2020 and **$14.8 million** in FY2019 through stock sales and warrant/option exercises[312](index=312&type=chunk) - In December 2020 (subsequent to year-end), the company raised an additional **$13.6 million** in net proceeds from a public stock offering[312](index=312&type=chunk)[590](index=590&type=chunk) - The company's auditor has issued an opinion with an explanatory paragraph expressing substantial doubt about its ability to continue as a going concern[330](index=330&type=chunk) - Future capital needs include an estimated **$5.9 million** for the remainder of the Phase 3 trial and clinical study report, plus an estimated **$7.4 million** to complete the manufacturing facility upgrade[327](index=327&type=chunk)[329](index=329&type=chunk) [Controls and Procedures](index=42&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) A material weakness in internal controls over financial reporting, due to an ASC 842 ROU asset error, rendered disclosure controls ineffective - A material weakness was identified in internal control over financial reporting[348](index=348&type=chunk) - The weakness stemmed from an error in calculating the right-of-use (ROU) asset under ASC 842, which understated the opening finance ROU asset and stockholders' equity by approximately **$2.04 million** as of October 1, 2019[348](index=348&type=chunk) - As a result of the material weakness, management concluded that disclosure controls and procedures were not effective as of September 30, 2020[344](index=344&type=chunk)[353](index=353&type=chunk) PART III [Directors and Executive Officers](index=43&type=section&id=ITEM%2010.%20DIRECTORS%20AND%20EXECUTIVE%20OFFICERS%20OF%20THE%20REGISTRANT) This section details the company's directors and executive officers, highlighting their backgrounds and the board's independent members Officers and Directors | Name | Position | | :--- | :--- | | Geert R. Kersten, Esq. | Director, Chief Executive and Financial Officer | | Patricia B. Prichep | Senior Vice President of Operations | | Dr. Eyal Talor | Chief Scientific Officer | | Dr. Daniel H. Zimmerman | Senior Vice President of Research, Cellular Immunology | | John Cipriano | Senior Vice President of Regulatory Affairs | | Dr. Peter R. Young | Director | | Bruno Baillavoine | Director | | Robert Watson | Director | - The Board of Directors includes three independent directors: Dr. Peter R. Young, Bruno Baillavoine, and Robert Watson[372](index=372&type=chunk) [Executive Compensation](index=46&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Executive compensation includes salary and stock options, with CEO Geert Kersten's FY2020 total compensation at $3.3 million, and performance-based options granted Executive Compensation Summary (FY 2020) | Name | Position | Salary ($) | Option Awards ($) | Total Comp ($) | | :--- | :--- | :--- | :--- | :--- | | Geert R. Kersten | CEO & CFO | 756,102 | 2,492,320 | 3,335,103 | | Patricia B. Prichep | SVP, Operations | 366,722 | 1,212,480 | 1,610,633 | | Dr. Eyal Talor | CSO | 308,250 | 1,212,480 | 1,539,561 | - In April 2020, the company granted **1.872 million** performance-based stock options to officers and directors from the 2020 Non-Qualified Stock Option Plan; these options vest upon achieving stock price targets ranging from **$20 to $40 per share** or the filing of a marketing application for Multikine[418](index=418&type=chunk)[545](index=545&type=chunk) - Key executives have employment agreements with change-in-control provisions, providing for lump-sum payments of **18 to 24 months of salary** upon resignation following a change in control[396](index=396&type=chunk)[404](index=404&type=chunk) [Security Ownership](index=52&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) This section details beneficial ownership of common stock, with CEO Geert R. Kersten as the largest insider shareholder at 7.3% Beneficial Ownership of Common Stock (as of Dec 1, 2020) | Owner | Shares Beneficially Owned | Percent of Class | | :--- | :--- | :--- | | Geert R. Kersten (CEO) | 2,949,013 | 7.3% | | All Officers and Directors as a Group (8 persons) | 5,262,784 | 12.43% | [Principal Accounting Fees and Services](index=53&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) This section discloses fees billed by BDO USA, LLP for audit and other professional services for fiscal years 2020 and 2019 Fees Billed by BDO USA, LLP | Fee Category | FY 2020 | FY 2019 | | :--- | :--- | :--- | | Audit Fees | $553,700 | $363,000 | | Audit Related Fees | - | - | | Tax Fees | - | - | Financial Statements [Report of Independent Registered Public Accounting Firm](index=57&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report includes a "Going Concern Uncertainty" paragraph, citing recurring losses and capital needs - The auditor's report contains a "Going Concern Uncertainty" paragraph, citing recurring losses and the need to raise additional capital as factors that raise substantial doubt about the company's ability to continue operations[450](index=450&type=chunk) [Financial Statements](index=58&type=section&id=Financial%20Statements) FY2020 financial statements show a net loss of $30.3 million, with $15.5 million in cash and $19.7 million in stockholders' equity Key Financial Data (as of and for the year ended September 30) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | **Statement of Operations:** | | | | Net Loss | $(30,255,244) | $(22,134,640) | | Net Loss Per Share | $(0.82) | $(0.71) | | **Balance Sheet:** | | | | Cash and cash equivalents | $15,508,909 | $8,444,774 | | Total Assets | $40,536,454 | $27,622,994 | | Total Liabilities | $20,809,780 | $22,489,327 | | Total Stockholders' Equity | $19,726,674 | $5,133,667 | [Notes to Financial Statements](index=61&type=section&id=Notes%20to%20Financial%20Statements) Notes detail going concern dependence, ASC 842 adoption and error correction, warrant and stock compensation plans, and major commitments - The company adopted the new lease accounting standard ASC 842 on October 1, 2019, resulting in the recognition of right-of-use assets and lease liabilities on the balance sheet; an error in the initial calculation understated the finance lease ROU asset and equity by approximately **$2.0 million**, which has been corrected[483](index=483&type=chunk)[485](index=485&type=chunk) - The company has a co-development and revenue sharing agreement with Ergomed, which contributes to the Phase 3 study costs in exchange for a percentage of future milestone and royalty payments; as of Sept 30, 2020, Ergomed's contribution in the form of discounted services totaled approximately **$11.1 million**[557](index=557&type=chunk) - The company has numerous series of outstanding warrants, many of which are treated as derivative liabilities and re-measured at fair value each period, causing fluctuations in the statement of operations[503](index=503&type=chunk)[511](index=511&type=chunk) - The company has contingent obligations with vendors, estimating it will incur an additional **$5.9 million** for the remainder of the Phase 3 clinical trial and the filing of the clinical study report with the FDA[570](index=570&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of Each Class Trading Symbol(s)Name of Each Exchange on Which Registered Common Stock CVM NYSE American Large accelerated filer ☐ Accelerated filer ☒ Non-accelerated filer ☐ Smaller reporting company ☒ Emerging growth company ☐ Class of Stock No. Shares Outstanding Date Common 38,624,084 August 5, 2020 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Class of Stock No. Shares Outstanding Date Common 37,633,894 May 5, 2020 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, 2020 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 CORPORA ...