AIM ImmunoTech Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Rhea-AI Summary

AIM ImmunoTech Inc. reports financial results for 2023, highlighting positive data and milestones achieved in various clinical studies. The company aims to create stockholder value through operational, clinical, and regulatory initiatives. Key highlights include positive findings in treating pancreatic cancer and Post-COVID fatigue, as well as bolstering intellectual property. Financially, the company reported $13.1 million in cash and investments, with increased R&D and administrative expenses compared to the previous year.

Insights

Medical Research Analyst

The recent update from AIM ImmunoTech Inc. regarding the Ampligen studies suggests potential advancements in therapeutic applications for various conditions, including cancer and Post-COVID fatigue. The completion of the AMP-518 Clinical Study and the publication of positive findings in a reputable journal like Clinical Cancer Research are significant. These developments could lead to increased interest from the medical community and investors, especially given the ongoing demand for effective cancer treatments and the emerging need to address Post-COVID conditions.

From a research perspective, the combination of Ampligen with an anti-PD-L1 antibody represents a novel approach in oncology, potentially offering a new avenue for cancer treatment. The issuance of a key U.S. patent for this combination therapy could provide AIM ImmunoTech with a competitive edge and a level of market exclusivity, which is important for the company's valuation and attractiveness to potential partners.

Financial Analyst

The financials indicate a significant increase in both research and development expenses and general and administrative expenses year over year. This uptick in spending is likely attributed to the company's intensified efforts in clinical trials and expansion of its intellectual property portfolio. While the company's cash reserves have decreased, this is not uncommon for biotech firms in development stages. Stakeholders should monitor the burn rate and future funding requirements, considering the potential need for additional capital to support ongoing and upcoming trials.

Investors should also consider the implications of the upcoming pipeline milestones, as positive results could lead to stock volatility. However, the inherent risks of clinical trials mean that outcomes are uncertain and this should be factored into any investment considerations. The company's ability to manage costs and successfully navigate the regulatory landscape will be critical for its financial health and stock performance.

Market Research Analyst

AIM ImmunoTech's focus on high-value indications like cancer and Post-COVID conditions taps into substantial markets with significant unmet needs. The emphasis on Ampligen's potential and the strategic IP developments could resonate well with investors looking for growth opportunities in the biotech sector. The market's response to the reported data and clinical progress will depend on the perceived viability of Ampligen as a treatment option and its ability to secure regulatory approvals.

Moreover, the company's proactive dissemination of information through scientific publications and conference calls is a positive sign of transparency, which can foster investor confidence. The anticipated milestones and subsequent data publications could serve as catalysts for market interest, potentially influencing the company's stock trajectory in the mid to long term.

Year marked by growing body of promising data demonstrating Ampligen’s potential to address multiple high-value indications

Company to host conference call and webcast today, April 2^nd at 8:30 AM ET

OCALA, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the full year 2023 and provided a business update. As previously announced, the Company will host a conference call and webcast today, Tuesday, April 2, 2024, at 8:30 AM ET (details below).

“AIM reported positive data across many fronts in 2023 and the first quarter of 2024. We intend to build on this momentum throughout the year, as we focus on the execution of our operational, clinical and regulatory initiatives. My goal is to create stockholder value in the near- and long-term as positive data continues to come in,” commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

• Announced in March 2024 the publication of positive findings from Early Access Program evaluating Ampligen in the treatment of pancreatic cancer in the prestigious journal Clinical Cancer Research
• AMP-518 Clinical Study: Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue
  • Last subject treated and study completed in November 2023
  • Reported positive topline results in February 2024, offering preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
• Bolstered intellectual property estate with November 2023 issuance of key U.S. patent for Ampligen in combination with an anti-PD-L1 antibody — such as AstraZeneca’s Imfinzi^® (durvalumab) — for the treatment of cancer
• DURIPANC Clinical Study: Phase 1b/2 clinical trial combining AIM’s Ampligen with Imfinzi^® for the treatment of pancreatic cancer
  • Opened for enrollment and enrolled first subject in January 2024 at Erasmus Medical Center (“Erasmus MC”)
  • First subject dosed in February 2024 at Erasmus MC

Expected Upcoming Pipeline Milestones

Q2 2024

• Post-COVID Conditions (AMP-518) – Final dataset
• Advanced Recurrent Ovarian Cancer – Protocol-planned interim results

2024

• Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First subject dosed
• Publications of data in scientific journals

Summary of Financial Highlights for Fiscal Year 2023

• As of December 31, 2023, AIM reported cash, cash equivalents and marketable investments of $13.1 million, compared to $34.2 million as of December 31, 2022.
• Research and development expenses for the year ended December 31, 2023, were $10.9 million, compared to $7.0 million for the year ended December 31, 2022.
• General and administrative expenses for the year ended December 31, 2023, were $21.1 million, compared to $13.1 million for the year ended December 31, 2022.
  

Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and webcast to discuss the operational and financial results today, April 2, 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 conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen^® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

FAQ

What are the recent highlights for AIM ImmunoTech Inc. (AIM)?

Recent highlights include positive findings in treating pancreatic cancer and Post-COVID fatigue, as well as bolstering intellectual property with a key U.S. patent issuance.

What are the expected upcoming pipeline milestones for AIM ImmunoTech Inc. (AIM)?

Expected upcoming milestones include final dataset for Post-COVID Conditions, protocol-planned interim results for Advanced Recurrent Ovarian Cancer, and dosing of the first subject for Locally Advanced Pancreatic Adenocarcinoma.

What are the financial highlights for AIM ImmunoTech Inc. (AIM) for fiscal year 2023?

AIM reported $13.1 million in cash and investments, with $10.9 million in research and development expenses and $21.1 million in general and administrative expenses for 2023.

When is the conference call and webcast scheduled for AIM ImmunoTech Inc. (AIM)?

The conference call and webcast are scheduled for April 2, 2024, at 8:30 AM ET, hosted by AIM's leadership team.