AIM ImmunoTech Inc. (NYSE:AIM) Q1 2023 Earnings Conference Call May 16, 2023 8:30 AM ET Company Participants Thomas Equels - CEO Christopher McAleer - Ph.D. Scientific Officer Conference Call Participants James Molloy - Alliance Global Partners Ed Woo - Ascendiant Capital Markets Operator Hello, and welcome to the AIM ImmunoTech Quarterly Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] Note that this webcast is being reco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended March 31, 2023 Commission File Number: 001-27072 AIM IMMUNOTECH INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) Delaware 52-0845822 2117 SW Highway 484, Ocala FL 34473 (Address of principal executive ...

AIM ImmunoTech Inc. (NYSE:AIM) Q4 2022 Earnings Conference Call April 3, 2023 8:30 AM ET Company Participants Thomas Equels - CEO Chris McAleer - Ph.D. Scientific Officer Conference Call Participants Jason McCarthy - Maxim Ed Woo - Ascendiant Capital Markets Operator Hello, and welcome to the AIM ImmunoTech Inaugural Fiscal Year 2022 Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] Following the presentation, there will be ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 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 No. 001-27072 AIM IMMUNOTECH INC. (Exact name of registrant as specified in its charter) | Delaware | | 52-0845822 | | --- | --- | --- | ...

[PART I- FINANCIAL INFORMATION](index=3&type=section&id=PART%20I-%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's discussion, market risk, and internal controls [Financial Statements](index=3&type=section&id=ITEM%201%3A%20Financial%20Statements) AIM ImmunoTech reported a reduced net loss of **$8.67 million** for H1 2022, with total assets decreasing to **$50.88 million** [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets to **$50.88 million** by June 30, 2022, primarily due to reduced marketable securities Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $34,452 | $32,093 | | Marketable securities | $7,320 | $16,175 | | Total current assets | $46,045 | $50,213 | | Total assets | $50,884 | $57,699 | | **Liabilities & Equity** | | | | Total current liabilities | $1,368 | $673 | | Total liabilities | $2,104 | $820 | | Total stockholders' equity | $48,780 | $56,879 | | Total liabilities and stockholders' equity | $50,884 | $57,699 | [Consolidated Statements of Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company reported a net loss of **$8.67 million** for the six months ended June 30, 2022, an improvement from the prior year Consolidated Statements of Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $30 | $23 | $64 | $52 | | Research and development | $2,475 | $1,317 | $3,511 | $2,742 | | General and administrative | $2,181 | $2,145 | $4,253 | $4,256 | | Operating loss | $(4,695) | $(3,718) | $(7,847) | $(7,463) | | Net Loss | $(4,851) | $(5,876) | $(8,671) | $(9,455) | | Basic and diluted loss per share | $(0.10) | $(0.12) | $(0.18) | $(0.20) | [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity decreased to **$48.78 million** by June 30, 2022, primarily due to the net comprehensive loss - Total stockholders' equity decreased from **$56.88 million** at December 31, 2021, to **$48.78 million** at June 30, 2022. The decrease was primarily driven by the net comprehensive loss of **$8.67 million** for the six-month period[10](index=10&type=chunk) [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased to **$34.45 million** by June 30, 2022, despite net cash used in operating activities Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,071) | $(4,763) | | Net cash provided by (used in) investing activities | $7,375 | $(629) | | Net cash provided by financing activities | $55 | $8,033 | | Net increase in cash and cash equivalents | $2,359 | $2,641 | | Cash and cash equivalents at end of period | $34,452 | $41,142 | [Notes to Financial Statements](index=7&type=section&id=NOTES%20TO%20UNAUDITED%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) The notes detail the company's R&D focus on Ampligen, recent asset sales, and significant clinical trial agreements - The company is an immuno-pharma firm focused on R&D for cancer, viral diseases, and immune disorders. Its flagship products are **Ampligen® (rintatolimod)** and **Alferon N Injection®**. Ampligen is approved in Argentina for Chronic Fatigue Syndrome (CFS) but not in the U.S[14](index=14&type=chunk)[15](index=15&type=chunk) - Primary business focus is on Ampligen, with key development areas including pancreatic cancer, modifying tumor microenvironments, exploring antiviral activities, and treating ME/CFS and Post-COVID conditions[15](index=15&type=chunk)[16](index=16&type=chunk) - On March 3, 2022, AIM entered an agreement to sell its New Brunswick manufacturing facility for **$3.9 million**, while retaining some space for Alferon activity[18](index=18&type=chunk) - In April 2022, AIM executed a work order with Amarex Clinical Research for a Phase 2 trial in advanced pancreatic cancer (AMP-270), estimated to cost **$8.2 million** over 4.6 years. In June 2022, another work order was executed with Amarex for a Phase 2 trial in Post-COVID Conditions, estimated to cost **$4.4 million**[77](index=77&type=chunk)[78](index=78&type=chunk) - Subsequent to the quarter end, the company became involved in legal proceedings related to a nomination notice from an activist stockholder, Jonathan Thomas Jorgl, seeking to change control of the Board[80](index=80&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=20&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) AIM ImmunoTech focuses on Ampligen development for oncology and viral diseases, reporting a reduced Q2 2022 net loss and sufficient liquidity [Overview](index=24&type=section&id=Overview) AIM ImmunoTech is an immuno-pharma company focused on R&D for cancers, viral diseases, and immune disorders, with Ampligen as its core - AIM ImmunoTech is an immuno-pharma company focused on R&D for therapeutics to treat cancers, viral diseases, and immune-deficiency disorders. Its main products are **Ampligen® (rintatolimod)** and **Alferon N Injection®**[107](index=107&type=chunk) - The company's primary strategic focus is on four key areas for Ampligen: a randomized controlled study in pancreatic cancer, evaluation in other cancers as a checkpoint inhibitor combination therapy, exploring its broad-spectrum antiviral potential, and its use as a treatment for ME/CFS and Post-COVID conditions[108](index=108&type=chunk)[109](index=109&type=chunk) - In March 2022, the FDA cleared the clinical hold on the company's Investigational New Drug (IND) application for a planned Phase 2 study of Ampligen in late-stage pancreatic cancer, allowing the study to proceed[111](index=111&type=chunk) [Product Portfolio](index=27&type=section&id=OUR%20PRODUCTS) The company's product portfolio includes **Ampligen®** for CFS and cancers, and **Alferon N Injection®** for external genital warts - **Ampligen® (rintatolimod):** A first-in-class dsRNA drug, approved in Argentina for severe Chronic Fatigue Syndrome (CFS) and under clinical development in the U.S. for various cancers and ME/CFS. It acts as a selective Toll-like Receptor 3 (TLR3) agonist[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) - **Alferon N Injection®:** An FDA-approved natural alpha interferon product for treating refractory or recurring external genital warts. It is the only natural-source, multi-species alpha interferon approved for sale in the U.S. and Argentina[122](index=122&type=chunk)[179](index=179&type=chunk) - The AMP-511 Expanded Access Program for Ampligen in ME/CFS was expanded to include patients with Post-COVID conditions. As of June 30, 2022, **11 patients** were enrolled, including **three with Post-COVID conditions**, with preliminary data showing a clinically significant decrease in fatigue[127](index=127&type=chunk) [Results of Operations](index=43&type=section&id=RESULTS%20OF%20OPERATIONS) The company reported a reduced net loss for Q2 and H1 2022, despite increased R&D costs driven by clinical trials Q2 2022 vs Q2 2021 Performance (in thousands) | Metric | Q2 2022 | Q2 2021 | Change | | :--- | :--- | :--- | :--- | | Revenues | $30 | $23 | +$7 | | R&D Costs | $2,475 | $1,317 | +$1,158 | | G&A Expenses | $2,181 | $2,145 | +$36 | | Net Loss | $(4,851) | $(5,876) | +$1,025 | | Loss Per Share | $(0.10) | $(0.12) | +$0.02 | Six Months 2022 vs 2021 Performance (in thousands) | Metric | H1 2022 | H1 2021 | Change | | :--- | :--- | :--- | :--- | | Revenues | $64 | $52 | +$12 | | R&D Costs | $3,511 | $2,742 | +$769 | | G&A Expenses | $4,253 | $4,256 | -$3 | | Net Loss | $(8,671) | $(9,455) | +$784 | | Loss Per Share | $(0.18) | $(0.20) | +$0.02 | - The increase in R&D costs for Q2 2022 was primarily due to a **$1.09 million** increase in clinical trial expenses, largely related to work with Amarex[205](index=205&type=chunk) - The decrease in net loss for Q2 2022 was mainly driven by a **$2.72 million** decrease in interest expense and finance costs, following the extinguishment of debt in 2021[201](index=201&type=chunk)[210](index=210&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$41.8 million** in cash and marketable securities as of June 30, 2022, sufficient for 24 months of operations - As of June 30, 2022, the company had approximately **$41.8 million** in cash, cash equivalents, and marketable securities, a decrease of about **$6.5 million** from December 31, 2021[227](index=227&type=chunk) - Net cash used in operating activities for the first six months of 2022 was approximately **$5.1 million**, compared to **$4.8 million** for the same period in 2021[225](index=225&type=chunk) - Management believes that current funds are adequate to meet operational cash needs and fund current clinical trials for approximately the next **twenty-four months**. An effective S-3 shelf registration statement is in place for potential future capital raises[228](index=228&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is classified as a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company defined by Rule 12b-2 of the Exchange Act, AIM ImmunoTech is not required to provide quantitative and qualitative disclosures about market risk[229](index=229&type=chunk) [Controls and Procedures](index=46&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Based on an evaluation performed by the CEO and CFO, the company's disclosure controls and procedures were deemed effective as of June 30, 2022. There were no material changes to internal controls over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2022[230](index=230&type=chunk) - No material changes were made to the company's internal controls over financial reporting during the six months ended June 30, 2022[231](index=231&type=chunk) [Part II – OTHER INFORMATION](index=46&type=section&id=Part%20II%20%E2%80%93%20OTHER%20INFORMATION) This section details legal proceedings, risk factors, and a comprehensive list of exhibits filed with the Form 10-Q [Legal Proceedings](index=46&type=section&id=ITEM%201%3A%20Legal%20Proceedings) The company is involved in legal proceedings with an activist stockholder, Jonathan Thomas Jorgl, who attempted to nominate two directors to the board. The company rejected the nomination, leading to lawsuits filed by both AIM and Mr. Jorgl - The company refers to Note 15 (Subsequent Events) for a description of pending material legal proceedings involving an activist stockholder's attempt to nominate directors[232](index=232&type=chunk)[353](index=353&type=chunk) [Risk Factors](index=46&type=section&id=ITEM%201A%3A%20Risk%20Factors) The primary risk factor highlighted is the ongoing situation with an activist stockholder. This conflict could lead to a costly and distracting proxy contest, divert management's attention, create uncertainty about the company's future direction, and potentially cause stock price volatility - A key risk is the potential negative impact from actions by activist investors, specifically a stockholder who has purported to nominate two new directors to the three-member board[234](index=234&type=chunk) - The company has initiated a lawsuit against the activist and related individuals, and the activist has sued the company in return. This legal battle and potential proxy contest could be costly, time-consuming, and divert management's attention from business operations[235](index=235&type=chunk)[236](index=236&type=chunk) - Uncertainty from the activist situation could harm relationships with strategic partners, disrupt clinical trials, and make it difficult to retain qualified personnel[237](index=237&type=chunk) [Exhibits](index=48&type=section&id=ITEM%206%3A%20Exhibits) This section provides a comprehensive list of all exhibits filed with the Form 10-Q, including corporate governance documents, securities agreements, material contracts, and certifications from the CEO and CFO - This section lists all exhibits filed with the Form 10-Q, incorporating by reference numerous historical agreements and filing new certifications and amendments[240](index=240&type=chunk)

Part I - Financial Information [Financial Statements](index=2&type=section&id=ITEM%201%3A%20Financial%20Statements) Unaudited Q1 2022 financial statements report a net loss of $3.82 million and total assets of $54.16 million Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $28,989 | $32,093 | | Marketable securities | $15,554 | $16,175 | | Assets held for sale | $3,900 | $— | | Total current assets | $50,380 | $50,213 | | Total assets | $54,155 | $57,699 | | **Liabilities & Equity** | | | | Total current liabilities | $766 | $673 | | Total liabilities | $854 | $820 | | Total stockholders' equity | $53,301 | $56,879 | Consolidated Statements of Comprehensive Loss (in thousands, except per share data) | Metric | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | Total Revenues | $33 | $28 | | Research and development | $1,036 | $1,424 | | General and administrative | $2,072 | $2,112 | | Operating loss | $(3,152) | $(3,745) | | Net Loss | $(3,820) | $(3,579) | | Basic and diluted loss per share | $(0.08) | $(0.08) | Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three months ended March 31, 2022 | Three months ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(2,758) | $(3,045) | | Net cash (used in)/provided by investing activities | $(346) | $523 | | Net cash provided by financing activities | $— | $12,794 | | Net (decrease) increase in cash | $(3,104) | $10,272 | [Note 1: Business and Basis of Presentation](index=6&type=section&id=Note%201%3A%20Business%20and%20Basis%20of%20Presentation) AIM ImmunoTech develops Ampligen for cancers and viral diseases, shifting manufacturing to CMOs after facility sale - The company's flagship products are **Ampligen® (rintatolimod)** and Alferon N Injection, with Ampligen approved in Argentina for severe Chronic Fatigue Syndrome (CFS) but not yet in the United States[16](index=16&type=chunk) - AIM's primary business focus is on Ampligen, with key development areas including pancreatic cancer, other cancers as combination therapy, antiviral activities, and ME/CFS and Post-COVID conditions[16](index=16&type=chunk) - AIM agreed to sell its New Brunswick manufacturing facility for **$3.9 million**, shifting production of Ampligen API to Contract Manufacturing Organizations (CMOs)[18](index=18&type=chunk)[19](index=19&type=chunk) [Note 3: Equity-Based Compensation](index=7&type=section&id=Note%203%3A%20Equity-Based%20Compensation) Q1 2022 saw **300,000 options** granted, with compensation expense of **$242,000** and **$729,000** unrecognized cost - During the three months ended **March 31, 2022**, **300,000 options** were granted, compared to none in the same period of **2021**[23](index=23&type=chunk) - Stock-based compensation expense was approximately **$242,000** for **Q1 2022**, compared to **$526,000** for **Q1 2021**[27](index=27&type=chunk) [Note 14: Research, Consulting and Supply Agreements](index=19&type=section&id=Note%2014%3A%20Research%20%2C%20Consulting%20and%20Supply%20Agreements) Key R&D agreements include a Phase 1 Ampligen study and a **$8.2 million** Phase 2 pancreatic cancer trial - In April **2022**, AIM executed a work order with Amarex Clinical Research LLC to manage the **AMP-270** Phase 2 clinical trial for advanced pancreatic cancer, anticipated to cost approximately **$8.2 million** and take about 4.6 years to complete[85](index=85&type=chunk) - The company has an ongoing agreement with Polysciences Inc for the manufacture of polymer precursors to Ampligen and paid them **$51,390** for the period ended **March 31, 2022**[84](index=84&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Ampligen's strategic focus, **Q1 2022** net loss of **$3.8M**, and **$44.5M** liquidity [Overview](index=22&type=section&id=Overview) AIM ImmunoTech prioritizes Ampligen clinical trials for pancreatic cancer, ME/CFS, and Post-COVID conditions - The company is prioritizing clinical activities for Ampligen in pancreatic cancer, ME/CFS, and Post-COVID conditions, with the goal of conducting trials that could support future NDAs[108](index=108&type=chunk) - In March **2022**, the **FDA** cleared the company's Investigational New Drug (IND) application for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer[109](index=109&type=chunk) - The company is exploring Ampligen's broad-spectrum antiviral capabilities, with a focus on proving its concept against COVID-19 and its variants[111](index=111&type=chunk) [Our Products](index=24&type=section&id=OUR%20PRODUCTS) Company's platform features Ampligen (CFS approved in Argentina) and Alferon N Injection (production on hold) - **Ampligen** is approved for sale in Argentina for severe Chronic Fatigue Syndrome (CFS) and is an experimental drug in the U.S undergoing development for cancers and ME/CFS[119](index=119&type=chunk) - The **AMP-511** open-label expanded access program for Ampligen in severely debilitated CFS patients is ongoing and has been expanded to include patients with Post-COVID conditions, with **11 patients** enrolled as of **March 31, 2022**[123](index=123&type=chunk) - Alferon N Injection is the only natural-source, multi-species alpha interferon approved for sale in the U.S for refractory or recurring external genital warts, but production is currently on hold[129](index=129&type=chunk) [Immuno-Oncology](index=28&type=section&id=Immuno-Oncology) Ampligen's immuno-oncology focus includes **FDA**-cleared Phase 2 pancreatic cancer trial and promising ovarian data - The **FDA** has cleared the company to proceed with a Phase 2 study (**AMP-270**) of Ampligen for locally advanced or metastatic late-stage pancreatic cancer[138](index=138&type=chunk) - Interim results from a Phase 2 study in advanced recurrent ovarian cancer showed a clinical response rate of **61%** among **13 evaluable patients**[134](index=134&type=chunk) - A Phase 1 study in Stage 4 Metastatic Triple Negative Breast Cancer met its primary endpoint, demonstrating an increase in immune markers like CD8 T-cells in the tumor microenvironment[136](index=136&type=chunk) [Results of Operations](index=39&type=section&id=RESULTS%20OF%20OPERATIONS) **Q1 2022** net loss increased to **$3.82 million**, primarily due to a **$0.93 million** loss on investments Q1 2022 vs Q1 2021 Financial Performance (in thousands) | Metric | Q1 2022 | Q1 2021 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $(3,820) | $(3,579) | $(241) | | Revenues | $33 | $28 | $5 | | R&D Costs | $1,036 | $1,424 | $(388) | | G&A Expenses | $2,072 | $2,112 | $(40) | | Production Costs | $77 | $237 | $(160) | - The increase in net loss was primarily due to a **$934,000** loss on investments in **Q1 2022**, compared to none in **Q1 2021**[190](index=190&type=chunk)[197](index=197&type=chunk) - Research and Development (R&D) costs decreased by **$388,000**, largely due to a decrease in clinical trial activity compared to the prior year[194](index=194&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) As of **March 31, 2022**, AIM had **$44.5 million** in liquidity, sufficient for the next **24 months** of operations - As of **March 31, 2022**, the company had approximately **$44.5 million** in cash, cash equivalents, and marketable securities[203](index=203&type=chunk) - Management believes current funds are adequate to meet anticipated operational cash needs for approximately the next **twenty-four months**[204](index=204&type=chunk) - Cash provided by financing activities was **$0** in **Q1 2022**, a decrease of **$12.8 million** from **Q1 2021**, which included proceeds from the sale of stock[202](index=202&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Company holds **$44.5 million** in liquidity, investing excess cash in conservative instruments to manage market risk - The company had approximately **$44.5 million** in cash, cash equivalents, and marketable securities as of **March 31, 2022**[206](index=206&type=chunk) [Controls and Procedures](index=43&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Disclosure controls were effective as of **March 31, 2022**, with no material changes to internal controls during **Q1** - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **March 31, 2022**[207](index=207&type=chunk) - No changes were made in internal controls over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, the controls[208](index=208&type=chunk) Part II - Other Information [Legal Proceedings](index=43&type=section&id=ITEM%201%3A%20Legal%20Proceedings) No new legal proceedings were reported during **Q1 2022**, referring to the **2021 10-K** for existing matters - Nothing new to report regarding legal proceedings during the quarter ended **March 31, 2022**[209](index=209&type=chunk) [Risk Factors](index=43&type=section&id=ITEM%201A%3A%20Risk%20Factors) This section refers readers to the comprehensive risk factor discussion in the **2021** Annual Report on Form **10-K** - The report refers readers to the "Item 1A. Risk Factors" section in the Annual Report on Form **10-K** for the year ended **December 31, 2021**, for a comprehensive discussion of potential risks[210](index=210&type=chunk) [Exhibits](index=44&type=section&id=ITEM%206%3A%20Exhibits) This section lists all exhibits filed with the Form **10-Q**, including corporate governance and material agreements - The exhibits section lists numerous agreements, including those related to stock offerings, clinical trials, manufacturing, and executive employment, as well as required Sarbanes-Oxley certifications[213](index=213&type=chunk)[233](index=233&type=chunk)

[PART I](index=4&type=section&id=PART%20I) [Business](index=4&type=section&id=ITEM%201.%20Business) AIM ImmunoTech is an immuno-pharma company developing therapeutics for cancers, viral diseases, and immune disorders, primarily focusing on Ampligen for various clinical applications [Our Products](index=13&type=section&id=OUR%20PRODUCTS) - Ampligen® (rintatolimod) is a first-in-class macromolecular dsRNA drug. It is **approved in Argentina** for severe Chronic Fatigue Syndrome (CFS) and is under clinical development in the U.S. for certain cancers and ME/CFS. It has received **Orphan Drug Designation** from the FDA and EMA for several indications[44](index=44&type=chunk)[45](index=45&type=chunk) - Alferon N Injection® is the only natural-source, multi-species alpha interferon **approved in the U.S. and Argentina** for treating refractory or recurring external genital warts caused by HPV[55](index=55&type=chunk) - The company is conducting an open-label **expanded access protocol (AMP-511)** for Ampligen, providing safety data for its use in CFS patients. This program was expanded in **October 2020** to include patients with Post-COVID chronic fatigue-like symptoms[50](index=50&type=chunk) [Patents and Non-Patent Exclusivity Rights](index=16&type=section&id=PATENTS%20AND%20NON-PATENT%20EXCLUSIVITY%20RIGHTS) - As of **December 31, 2021**, the company holds **44 patents worldwide** with **39 additional patent applications pending**[58](index=58&type=chunk) - In **February 2020**, **three provisional patent applications** were filed related to Ampligen's use against SARS-CoV-2, covering its potential as a therapy/prophylaxis, its role in a universal coronavirus vaccine, and a high-volume manufacturing process[58](index=58&type=chunk) - Ampligen has been granted U.S. **patents** for novel formulations, extending protection until at least **2029**. It also has **Orphan Drug Status** from the FDA for CFS, HIV/AIDS, renal cell carcinoma, pancreatic cancer, and malignant melanoma, providing **seven years of market exclusivity** post-approval for each indication[61](index=61&type=chunk)[62](index=62&type=chunk) [Research and Development](index=17&type=section&id=RESEARCH%20AND%20DEVELOPMENT) - The company's R&D focus is on developing new drug therapies for immune-based disorders, including cancer and CFS. The SARS-CoV-2 pandemic has led to a **widened focus** on potential prophylactic and therapeutic applications for COVID-19 and its long-term effects[65](index=65&type=chunk) - AIM is advancing Ampligen in immuno-oncology, particularly as an adjuvant to modify the tumor microenvironment and enhance responses to checkpoint inhibitors, in collaboration with institutions like the **University of Pittsburgh**[66](index=66&type=chunk) [Manufacturing](index=27&type=section&id=MANUFACTURING) - Ampligen is **approved for commercial distribution in Argentina** for CFS. The company has engaged **Contract Manufacturing Organizations (CMOs)** like Jubilant HollisterStier and Pharmaceutics International Inc. (Pii) for 'Fill & Finish' services to enhance production capacity and provide redundancy[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - In **March 2022**, the company entered an agreement to sell its New Brunswick, NJ manufacturing facility for **$3.9 million**. Future production of Ampligen Active Pharmaceutical Ingredient (API) will rely on one or more CMOs[106](index=106&type=chunk)[107](index=107&type=chunk) - Commercial sales of Alferon N Injection are **on hold** until new batches are produced and released by the FDA. The company is not currently manufacturing Alferon N Injection and has no definitive timetable to resume production[108](index=108&type=chunk) [Licensing/Collaborations/Joint Ventures](index=28&type=section&id=LICENSING%2FCOLLABORATIONS%2FJOINT%20VENTURES) - The company's strategy is to **license Ampligen** and/or form **collaborations or joint ventures** with partners who have the capability to gain approval and commercialize the product globally. Ideal partners would have strong global/regional experience, robust commercial infrastructure, and a therapeutic area fit[109](index=109&type=chunk) [Marketing/Distribution](index=28&type=section&id=MARKETING%2FDISTRIBUTION) - AIM has an **exclusive sales, marketing, and distribution agreement** with **GP Pharm** for Ampligen in Argentina and other Latin American countries, which was extended until **May 2024**[110](index=110&type=chunk) - The company has an agreement with **myTomorrows** to manage an **Early Access Program (EAP)** for Ampligen in Europe, Turkey, and Canada for ME/CFS and pancreatic cancer patients. This agreement was automatically extended in **May 2021**[111](index=111&type=chunk)[113](index=113&type=chunk) [Competition](index=29&type=section&id=COMPETITION) - Major pharmaceutical competitors for Ampligen include **Pfizer**, **GlaxoSmithKline**, **Merck & Co.**, **Novartis**, and **AstraZeneca**. Biotech competitors include **Baxter International** and **Genta**[115](index=115&type=chunk) - When Alferon N Injection sales resume, it may compete with **Merck & Co.'s Intron® A**[115](index=115&type=chunk) [Government Regulation](index=29&type=section&id=GOVERNMENT%20REGULATION) - The company's products are subject to **rigorous regulation** by governmental authorities in the U.S. (**FDA**) and foreign countries. New drug products require extensive pre-clinical and clinical testing for clearance, a process that demands substantial resources[116](index=116&type=chunk) [Human Capital](index=29&type=section&id=HUMAN%20CAPITAL) - As of **December 31, 2021**, the company had **21 full-time** and **two part-time employees**. Five are engaged in R&D, clinical, and manufacturing, while **18** perform administrative, regulatory, financial, and investor relations functions. The company has **no union employees**[118](index=118&type=chunk) [Risk Factors](index=30&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant risks including COVID-19 impacts, financing needs, substantial losses, uncertain regulatory approvals, manufacturing reliance, and stock price volatility - The COVID-19 pandemic could **adversely impact business**, including delays in clinical trial enrollment and operations, and has already delayed the commercial launch in Argentina[120](index=120&type=chunk)[121](index=121&type=chunk) - The company may **require additional financing** to fund its projects, as it does not generate material revenues and had an accumulated deficit of approximately **$359.087 million** as of **December 31, 2021**[123](index=123&type=chunk)[126](index=126&type=chunk) - The company's drugs are investigational and subject to a **lengthy and uncertain regulatory approval process** with the FDA and other global authorities. The FDA issued a Complete Response Letter for the Ampligen NDA for CFS in **2013**, requiring at least one additional clinical trial[127](index=127&type=chunk)[130](index=130&type=chunk) - Manufacturing risks include the **halt of Alferon N Injection sales** due to lack of inventory, reliance on a limited number of raw material suppliers for Ampligen, and the need to engage CMOs for API production following the sale of the New Brunswick facility[159](index=159&type=chunk)[161](index=161&type=chunk)[163](index=163&type=chunk) [Properties](index=44&type=section&id=ITEM%202.%20Properties) The company's principal offices are leased, and its New Brunswick, NJ manufacturing facility was sold for $3.9 million in March 2022 after being re-purchased in May 2021 - The principal executive office is located in **Ocala, FL**, and the finance/HR office is in **Riverton, NJ**, both under lease agreements[195](index=195&type=chunk) - In **March 2022**, the company agreed to sell its New Brunswick, NJ property for **$3.9 million**. This facility was re-purchased in **May 2021** after being sold in a sale-and-leaseback transaction in **March 2018**[195](index=195&type=chunk)[196](index=196&type=chunk) [Legal Proceedings](index=44&type=section&id=ITEM%203.%20Legal%20Proceedings) The company is involved in a breach of contract lawsuit against BioLife, with a counterclaim of $96,676, currently in discovery with a trial anticipated in late 2022 - AIM commenced a breach of contract action against BioLife in **December 2017**. BioLife has filed a counterclaim for **$96,676**. The parties are engaged in discovery, with a trial anticipated in **late 2022**[197](index=197&type=chunk) [PART II](index=46&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=46&type=section&id=ITEM%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on NYSE American under 'AIM', with approximately 150 holders of record as of March 25, 2022, and no cash dividends paid recently as earnings are retained for operations - The company's common stock is listed on the **NYSE American** under the symbol **AIM**[199](index=199&type=chunk) - As of **March 25, 2022**, there were approximately **150 holders of record** of the Common Stock[200](index=200&type=chunk) - The company has **not paid any cash dividends recently** and does not intend to, instead retaining earnings for business operations[201](index=201&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=ITEM%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2021, the company's net loss increased to $19.1 million due to debt extinguishment and R&D expenses, with cash decreasing to $48.3 million, though current funds are deemed adequate for the next 24 months Financial Performance Comparison (2021 vs. 2020) | Metric | 2021 (in thousands) | 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | **Net Loss** | **$19,127** | **$14,400** | **$4,727 (Increase)** | | Revenues | $135 | $163 | -$28 (Decrease) | | R&D Costs | $7,672 | $5,720 | $1,952 (Increase) | | G&A Expenses | $8,672 | $8,654 | $18 (Increase) | | Loss on Debt Extinguishment | $2,701 | -$142 (Gain) | $2,843 (Increase in Loss) | | **Net Loss Per Share** | **$(0.40)** | **$(0.45)** | **N/A** | - The increase in net loss was primarily driven by a **$2.7 million loss** on the extinguishment of debt related to the repurchase of the manufacturing facility and a **$2.0 million increase** in R&D expenses for company-sponsored clinical trials[207](index=207&type=chunk)[211](index=211&type=chunk)[216](index=216&type=chunk) Liquidity and Capital Resources - As of **December 31, 2021**, the company had approximately **$48.3 million** in cash, cash equivalents, and marketable securities, a **decrease of $6.1 million** from year-end **2020**[223](index=223&type=chunk) Cash Flow Summary (2021 vs. 2020) | Cash Flow Activity | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | **Net Cash Used in Operating Activities** | **($13,965)** | **($10,368)** | | Net Cash Used in Investing Activities | ($631) | ($9,164) | | Net Cash Provided by Financing Activities | $8,188 | $56,563 | - Management believes that current funds are **adequate** to meet operational cash needs and fund clinical trials for approximately the **next twenty-four months**[224](index=224&type=chunk) Critical Accounting Policies - Key critical accounting policies include the assessment of long-lived assets for impairment and the valuation of redeemable warrants[226](index=226&type=chunk) - The company uses a **Monte Carlo Simulation** to recompute the fair value of redeemable warrants quarterly. This valuation uses **Level 3 inputs**, which are highly subjective and require significant judgment, particularly regarding the probability of a 'Fundamental Transaction'[230](index=230&type=chunk) [Controls and Procedures](index=52&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) As of December 31, 2021, the company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective, and internal control over financial reporting was effective with no material weaknesses identified - Management, including the CEO and CFO, evaluated disclosure controls and procedures and concluded they were **effective** as of **December 31, 2021**[233](index=233&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company maintained **effective internal control over financial reporting** as of **December 31, 2021**, with **no material weaknesses identified**[236](index=236&type=chunk) [PART III](index=54&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=54&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's leadership includes CEO Thomas K. Equels and Chairman William M. Mitchell, with governance overseen by various committees including Audit, Scientific Advisory, Disclosure Controls, and Executive, alongside a Code of Ethics - Key executive officers include **Thomas K. Equels (CEO)**, **Peter W. Rodino III (COO)**, and **Ellen M. Lintal (CFO)**. The Board of Directors is chaired by **William M. Mitchell, M.D., Ph.D.**[239](index=239&type=chunk) - The Board has determined that director **Stewart L. Appelrouth** qualifies as an **'audit committee financial expert'**[256](index=256&type=chunk) - The company maintains several governance committees, including an **Audit Committee**, **Scientific Advisory Board (SAB)**, **Disclosure Controls Committee (DCC)**, and an **Executive Committee**, each with specific oversight responsibilities[257](index=257&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) [Executive Compensation](index=58&type=section&id=ITEM%2011.%20Executive%20Compensation) For fiscal year 2021, Named Executive Officers received total compensation including base salary, bonuses, and stock options, with new employment agreements established in March 2021 for the COO and CFO 2021 Summary Compensation Table for Named Executive Officers | Name & Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Thomas K. Equels** (CEO & President) | 2021 | 850,000 | 352,500 | 473,038 | 86,106 | **1,761,644** | | **Ellen Lintal** (CFO) | 2021 | 350,000 | 102,500 | 132,346 | 49,893 | **634,739** | | **Peter Rodino** (COO, General Counsel) | 2021 | 425,000 | 102,500 | 132,346 | 57,949 | **717,795** | - In **March 2021**, the company entered into new employment agreements with **Peter Rodino (3-year term)** and **Ellen Lintal (1-year term)**, establishing base salaries of **$425,000** and **$350,000**, respectively, plus performance-based bonuses and long-term stock option awards[265](index=265&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=68&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 25, 2022, all directors and executive officers collectively owned 1,606,385 shares, representing 0.034% of common stock, including options, with no individual owning 1% or more Security Ownership of Management (as of March 25, 2022) | Name | Shares Beneficially Owned | % of Shares Beneficially Owned | | :--- | :--- | :--- | | Thomas K. Equels (CEO) | 957,677 | <1% | | Peter W. Rodino III (COO) | 153,193 | <1% | | William M. Mitchell, M.D. (Chairman) | 156,474 | <1% | | Stewart L. Appelrouth (Director) | 241,126 | <1% | | Ellen Lintal (CFO) | 97,915 | <1% | | **All directors and executive officers as a group (5 persons)** | **1,606,385** | **0.034%** | [Principal Accountant Fees and Services](index=70&type=section&id=ITEM%2014.%20Principal%20Accountant%20Fees%20and%20Services) BDO USA, LLP's total fees increased to $485,000 in 2021 from $353,500 in 2020, primarily due to higher audit and new tax fees, all pre-approved by the Audit Committee Accountant Fees (2021 vs. 2020) | Fee Type | 2021 ($) | 2020 ($) | | :--- | :--- | :--- | | Audit Fees | 370,000 | 260,000 | | Audit-Related Fees | 42,000 | 93,500 | | Tax Fees | 73,000 | 0 | | All Other Fees | 0 | 0 | | **Total** | **485,000** | **353,500** | [PART IV](index=71&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=71&type=section&id=ITEM%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section indexes all exhibits filed with the 10-K report, including corporate governance documents, material contracts, and certifications, with financial statement schedules omitted as information is elsewhere - This section contains a comprehensive list of exhibits filed with the annual report, including the Certificate of Incorporation, bylaws, material contracts, employment agreements, and various certifications[312](index=312&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk) [Financial Statements](index=82&type=section&id=Financial%20Statements) [Report of Independent Registered Public Accounting Firm](index=83&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) BDO USA, LLP issued an unqualified audit opinion on AIM ImmunoTech's 2021 and 2020 financial statements, identifying the fair value calculation of redeemable warrants as a critical audit matter due to subjective Monte Carlo Simulation assumptions - The auditor, **BDO USA, LLP**, issued an **unqualified opinion**, stating the financial statements are fairly presented in accordance with U.S. GAAP[347](index=347&type=chunk) - A **Critical Audit Matter** was identified concerning the calculation of the fair value of redeemable warrants, due to the **subjective assumptions** (e.g., probability of a Fundamental Transaction, stock price volatility) used in the company's **Monte Carlo Simulation model**[351](index=351&type=chunk)[352](index=352&type=chunk) [Consolidated Balance Sheets](index=85&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2021, total assets decreased to $57.7 million from $64.6 million, total liabilities decreased to $0.8 million from $3.3 million, and total stockholders' equity decreased to $56.9 million from $61.3 million Consolidated Balance Sheet Data (as of Dec 31) | Account | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $32,093 | $38,501 | | Total current assets | $50,213 | $40,310 | | **Total Assets** | **$57,699** | **$64,584** | | Total current liabilities | $673 | $1,102 | | **Total Liabilities** | **$820** | **$3,290** | | **Total Stockholders' Equity** | **$56,879** | **$61,294** | [Consolidated Statements of Comprehensive Loss](index=86&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) For 2021, net loss increased to $19.1 million from $14.4 million in 2020, primarily due to higher operating expenses including asset impairment and debt extinguishment loss, partially offset by a gain from tax operating losses Consolidated Statements of Comprehensive Loss (for the year ended Dec 31) | Metric | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Total Revenues | $135 | $163 | | Total Costs and Expenses | $18,973 | $15,315 | | Operating Loss | ($18,838) | ($15,152) | | **Net Loss** | **($19,127)** | **($14,400)** | | **Basic and Diluted Loss Per Share** | **($0.40)** | **($0.45)** | [Consolidated Statements of Cash Flows](index=88&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For 2021, net cash used in operating activities increased to $14.0 million, while net cash from financing dropped to $8.2 million, resulting in a $6.4 million net decrease in cash, ending with $32.1 million Consolidated Statements of Cash Flows (for the year ended Dec 31) | Cash Flow Activity | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,965) | ($10,368) | | Net cash used in investing activities | ($631) | ($9,164) | | Net cash provided by financing activities | $8,188 | $56,563 | | **Net (decrease) increase in cash** | **($6,408)** | **$37,031** | | **Cash and cash equivalents at end of period** | **$32,093** | **$38,501** |