Core Insights - AIM ImmunoTech Inc. is making significant progress in its clinical development programs, particularly in the high-value pancreatic cancer sector, highlighting the potential for collaboration with big pharmaceutical companies and commercialization opportunities [1][2] Financial Highlights - As of September 30, 2024, AIM reported cash, cash equivalents, and marketable securities totaling $7.2 million [4] - Research and development expenses for Q3 2024 were $1.4 million, a decrease from $2.7 million in Q3 2023 [4] - General and administrative expenses were $3.1 million for Q3 2024, down from $5.4 million in the same period of 2023 [4] - The net loss from operations for Q3 2024 was $3.7 million, or $0.06 per share, compared to a net loss of $7.8 million, or $0.16 per share, for Q3 2023 [4] Conference Call and Webcast - The company will host a conference call and webcast on November 15, 2024, at 8:30 AM ET to discuss its Q3 2024 operational and financial results [6][7]

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 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 Commission File Number: 001-27072 AIM IMMUNOTECH INC. (Exact name of registrant as specified in its charter) | --- | --- | --- | --- | |--------------------------------------------------------------- ...

OCALA, Fla., Nov. 06, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), announced today that management will host a conference call and webcast to discuss the Company’s Q3 2024 operational and financial results on Friday, November 15, 2024 at 8:30 AM ET. The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conferenc ...

SINGAPORE, Oct. 15, 2024 (GLOBE NEWSWIRE) -- BitFuFu Inc., (“BitFuFu” or “the Company”) (NASDAQ: FUFU), a fast-growing digital asset mining service and world-leading cloud-mining service provider, today announced that it will attend the AIM Summit Dubai 2024, which will take place from October 21 to 22, 2024, at Jumeirah Emirates Towers. Representing BitFuFu at the event will be Ms. Calla Zhao, Chief Financial Officer of BitFuFu, and Ms. Celine Lu, Director of BitFuFu. Attendees are invited to meet the BitF ...

OCALA, Fla., Oct. 03, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. patent No. 12,102,649, covering both compositions and methods comprising the Company’s drug Ampligen® in the treatment of endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. Endometriosis is a disease in w ...

OCALA, Fla., Sept. 27, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Thomas K. Equels, Chief Executive Officer of AIM will participate in a Virtual Investor CEO Connect segment on Wednesday, October 2, 2024 at 4:00 PM ET. As part of the event, Mr. Equels will provide a brief presentation, followed by an interactive Q&A session. Investors and interested parties will have the opportunity to submit questions live during the event. Questions can ...

Data demonstrate compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through Ampligen Additional commentary published discussing the potential of Ampligen and two other drugs OCALA, Fla., Aug. 20, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced the official print publication of the data analysis from a long-term Early Access Program (“EAP”) studying the company’s drug Ampligen® (rintatolimod) for the treatment of advanced pancreatic ...

Financial Data and Key Metrics Changes - As of June 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling $10.1 million, which is deemed sufficient to fund operations through multiple upcoming key milestones [18] - Research and development expenses for Q2 2024 were $1.1 million, down from $3 million in Q2 2023, while for the six months ending June 30, 2024, expenses were $3.1 million compared to $5 million for the same period in 2023 [18] - General and administrative expenses for Q2 2024 were $2.6 million, consistent with Q2 2023, while for the six months ending June 30, 2024, expenses increased to $6.4 million from $4.8 million in the same period of 2023 [19] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs in oncology, particularly in pancreatic and ovarian cancer, with promising preclinical data showing Ampligen's potential in combination therapies [6][7] - The DURIPANC trial, which combines Ampligen with AstraZeneca's durvalumab for metastatic pancreatic cancer, has completed safety evaluations and is moving forward with patient enrollment [9][10] - In the advanced recurrent ovarian cancer trial, the clinical benefit rate has exceeded 60%, leading to a decision to wrap up enrollment earlier than planned [14] Market Data and Key Metrics Changes - The company is collaborating with major pharmaceutical companies, including AstraZeneca and Merck, to enhance its clinical studies and expand its market reach [20] - The company is actively engaging with patient advocacy groups to better understand patient needs and improve trial designs, particularly for post-COVID conditions [16] Company Strategy and Development Direction - The company emphasizes transparency and stakeholder engagement through initiatives like the CEO Corner program, aimed at providing updates and gathering feedback [8] - The strategic focus is on advancing clinical trials and leveraging partnerships with leading cancer research institutions to enhance the development of Ampligen [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Ampligen to unlock significant value for stakeholders, including patients and investors [19] - The company acknowledges the challenges in the micro-cap biotech sector but remains optimistic about its cash position and upcoming milestones [18] Other Important Information - The company is awaiting biomarker data to refine its patient targeting for future trials, with plans to submit a preliminary regulatory package to the FDA in Q4 [17] Q&A Session Summary Question: What is the status of the clinical trials? - The DURIPANC trial is progressing with safety evaluations completed, and patient enrollment is ongoing for the next dosing level [9] Question: How is the company managing its financials in the current environment? - The company has a sufficient cash position to fund operations through key milestones, with reduced R&D expenses compared to the previous year [18][19]

– Continued execution across Ampligen® clinical development programs and growing body of positive data in multiple high-value indications – Company to host conference call and webcast today, August 16th at 8:30 AM ET OCALA, Fla., Aug. 16, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the second quarter 2024. As previously announced, the Company will host a conference call and webcast today, Friday, August 16, 2024, at 8:30 ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the six months ended June 30, 2024 [Financial Statements](index=3&type=section&id=ITEM%201%3A%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of comprehensive loss, changes in stockholders' equity, and cash flows, with detailed accompanying notes Condensed Consolidated Balance Sheet Highlights (Unaudited) | Metric | June 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $3,554 | $5,439 | | Total Assets | $15,715 | $19,381 | | Total Liabilities | $9,613 | $9,147 | | Total Stockholders' Equity | $6,102 | $10,234 | Consolidated Statements of Comprehensive Loss Highlights (Unaudited) | Metric (in thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $50 | $42 | $90 | $91 | | Research and development | $1,145 | $2,953 | $3,096 | $5,005 | | Net Loss | $(1,836) | $(4,909) | $(7,653) | $(8,570) | | Basic and diluted loss per share | $(0.03) | $(0.10) | $(0.15) | $(0.18) | Consolidated Statements of Cash Flows Highlights (Unaudited) | Metric (in thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,823) | $(5,838) | | Net cash provided by (used in) investing activities | $668 | $(282) | | Net cash provided by financing activities | $5,270 | $105 | | Net decrease in cash and cash equivalents | $(1,885) | $(6,015) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's focus on Ampligen development, significant financing activities, R&D expenses for clinical trials, and subsequent corporate governance changes - The company's primary focus is on the research and development of therapeutics for cancers, viral diseases, and immune-deficiency disorders, with flagship products **Ampligen (rintatolimod)** and **Alferon N Injection**[15](index=15&type=chunk) - On February 16, 2024, the company entered into a Note Purchase Agreement with Streeterville Capital LLC, receiving **$2,500,000** in exchange for an unsecured promissory note[77](index=77&type=chunk) - On May 31, 2024, the company entered into a Securities Purchase Agreement with a single accredited investor, issuing **5,640,958 shares and warrants**, raising approximately **$2.05 million** in gross proceeds[57](index=57&type=chunk) - The company has significant R&D agreements with Amarex Clinical Research for managing a **Phase 2 pancreatic cancer trial (AMP-270)** and a **Phase 2 trial for Post-COVID Conditions**[90](index=90&type=chunk)[92](index=92&type=chunk) - Subsequent to the quarter end, the company amended its 2018 Equity Incentive Plan, adopted amended bylaws following a court ruling, and amended employment agreements for its CEO and another executive[101](index=101&type=chunk)[102](index=102&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=29&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, strategic direction, and liquidity, focusing on Ampligen's clinical development and funding for future operations [Overview](index=30&type=section&id=Overview) This section outlines AIM's immuno-pharma business, prioritizing Ampligen's clinical trials for pancreatic cancer, ME/CFS, and Post-COVID conditions, supported by recent financing agreements - The company is prioritizing clinical activities for **pancreatic cancer, ME/CFS, and Post-COVID conditions**, with the goal of conducting trials that support future NDA submissions to the FDA or EMA[114](index=114&type=chunk)[116](index=116&type=chunk) - The **Phase 2 AMP-270 clinical trial for locally advanced pancreatic cancer** is actively recruiting patients, following FDA clearance[118](index=118&type=chunk)[160](index=160&type=chunk) - The company completed a **Phase 2 study (AMP-518) for Post-COVID conditions**, with topline data reported in February 2024[125](index=125&type=chunk)[181](index=181&type=chunk) - AIM entered into a purchase agreement with Atlas Sciences for an **equity line of credit of up to $15 million**, providing flexible access to capital[131](index=131&type=chunk)[132](index=132&type=chunk) - In May 2024, the company raised gross proceeds of approximately **$2.05 million** through a securities purchase agreement with a single accredited investor[142](index=142&type=chunk)[143](index=143&type=chunk) [Results of Operations](index=48&type=section&id=RESULTS%20OF%20OPERATIONS) This section provides a comparative financial analysis, highlighting a significant decrease in net loss for Q2 2024 and the first six months, primarily due to reduced R&D costs and an insurance recovery Q2 Financial Comparison (in thousands) | Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $(1,836) | $(4,909) | $3,073 (Decrease) | | R&D Costs | $1,145 | $2,953 | $(1,808) | | G&A Expenses | $2,591 | $2,550 | $41 | | Interest and Other Income | $2,580 | $318 | $2,262 | Six-Month Financial Comparison (in thousands) | Metric | H1 2024 | H1 2023 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $(7,653) | $(8,570) | $917 (Decrease) | | R&D Costs | $3,096 | $5,005 | $(1,909) | | G&A Expenses | $6,406 | $4,841 | $1,565 | - The decrease in R&D costs for both the three and six-month periods was primarily due to a reduction in expenses for **outside contractors and clinical studies**[226](index=226&type=chunk)[237](index=237&type=chunk) - The increase in G&A expenses for the six-month period was mainly driven by a **$1.4 million increase in legal professional fees**[238](index=238&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company held approximately $10.1 million in cash, which management deems sufficient for the next 24 months, bolstered by recent financing activities - As of June 30, 2024, the company had approximately **$10.1 million** in cash, cash equivalents, and marketable securities[243](index=243&type=chunk) - Management believes current funds are sufficient to meet operational cash needs and fund current clinical trials for approximately the **next twenty-four months**[245](index=245&type=chunk) - Cash provided by financing activities for H1 2024 was **$5.27 million**, a significant increase from $105,000 in H1 2023, due to proceeds from a note payable (**$2.37M**), stock sales (**$0.86M**), and warrant issuance (**$2.05M**)[242](index=242&type=chunk) - The company has multiple avenues for future funding, including an **Equity Distribution Agreement (EDA)**, an **equity line of credit with Atlas**, and an effective **S-3 shelf registration statement**[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=55&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, AIM ImmunoTech is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[254](index=254&type=chunk) [Controls and Procedures](index=55&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal controls - Based on an evaluation, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective as of June 30, 2024**[255](index=255&type=chunk) - No changes were made in internal controls over financial reporting during the six months ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[256](index=256&type=chunk) [PART II - OTHER INFORMATION](index=55&type=section&id=Part%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, other corporate information, and a list of exhibits filed with the report [Legal Proceedings](index=55&type=section&id=ITEM%201%3A%20Legal%20Proceedings) This section updates on key legal cases, including sanctions in *AIM v. Tudor* and the *Kellner v. AIM* ruling on bylaws and nominations - In the *AIM ImmunoTech, Inc. v. Tudor, et al.* case, the District Court sanctioned the company and its counsel, leading to judgments for attorneys' fees totaling **$293,409**, which AIM has filed a notice of appeal for[258](index=258&type=chunk) - In *Kellner v. AIM ImmunoTech Inc.*, the Delaware Supreme Court affirmed in part and reversed in part a lower court opinion, finding certain bylaws legally invalid but not requiring action on Kellner's rejected nominations due to **'deceptive conduct'** by the nominating group[260](index=260&type=chunk)[261](index=261&type=chunk) - Following the Supreme Court's decision, the company's board revised the bylaws to address the deficiencies, and the court denied Kellner's subsequent motion for reargument and attorneys' fees[261](index=261&type=chunk) [Risk Factors](index=57&type=section&id=ITEM%201A%3A%20Risk%20Factors) This section refers readers to the comprehensive risk factors detailed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - The company refers to the 'Risk Factors' section in its Annual Report on Form 10-K for the year ended December 31, 2023, for a discussion of factors that could materially affect its business[264](index=264&type=chunk) [Other Information](index=57&type=section&id=ITEM%205%3A%20Other%20Information) This section details the adoption of amended bylaws and revisions to employment agreements for the CEO and another executive, adjusting their short-term compensation - On July 31, 2024, the company adopted **Restated and Amended Bylaws** to address issues deemed unenforceable or invalid by the Delaware Supreme Court[268](index=268&type=chunk) - The employment agreements for CEO Thomas K. Equels and executive Peter W. Rodino III were amended, revising their short-term compensation to include a mix of **base salary and company common stock**[270](index=270&type=chunk)[271](index=271&type=chunk) [Exhibits](index=58&type=section&id=ITEM%206%3A%20Exhibits) This section lists all exhibits filed with the 10-Q report, including corporate governance documents, financial agreements, and required certifications - The list of exhibits includes key corporate governance and financial documents, such as the **Amended and Restated By-Laws**, a **Securities Purchase Agreement from May 2024**, and **amendments to executive employment agreements**[274](index=274&type=chunk)