AIM ImmunoTech Reports First Quarter 2024 Financial Results and Provides Corporate Update
AIM ImmunoTech reported its Q1 2024 financial results, showing a net loss of $5.8 million, or $0.12 per share, compared to $3.7 million, or $0.08 per share, in Q1 2023. Cash reserves are at $10.9 million. The company highlighted progress in its Ampligen clinical programs, including positive interim data in ovarian cancer and the completion of cGMP manufacturing of 9,000 vials. AIM also announced that the first dose in a Phase 1b/2 study for late-stage pancreatic cancer was well-tolerated. Upcoming milestones include final data for Post-COVID Conditions in Q2 2024. AIM will host a conference call today, May 16, 2024, to discuss these results.
- Completed cGMP manufacturing of 9,000 clinical vials of Ampligen.
- First dose level in Phase 1b/2 pancreatic cancer study is well-tolerated.
- Reported 45% Objective Response Rate in ovarian cancer trial with Ampligen and pembrolizumab.
- Total Clinical Benefit Rate of 55% in ovarian cancer trial.
- Median Progression-Free Survival of 7.8 months in ovarian cancer trial.
- Cash reserves at $10.9 million.
- Net loss from operations increased to $5.8 million in Q1 2024 from $3.7 million in Q1 2023.
- General and administrative expenses rose to $3.8 million from $2.3 million year-over-year.
- Research and development expenses remained stable at $2.0 million, reflecting no significant decrease in costs.
AIM ImmunoTech's first quarter financial results show a notable increase in general and administrative expenses to
For long-term viability, investors should evaluate the potential revenue from Ampligen and ongoing clinical trials. While the increase in expenses might be concerning, the positive clinical data and manufacturing milestones could justify the spending if these lead to successful commercialization or partnerships.
The latest clinical developments for Ampligen are promising, particularly in the oncology domain. The 45% Objective Response Rate (ORR) in the phase 2 trial for recurrent ovarian cancer is a significant indicator of potential efficacy, notably when combined with pembrolizumab and cisplatin. The reported Clinical Benefit Rate of 55% further emphasizes the drug’s potential in improving patient outcomes. However, it’s important to remain cautious about over-optimism; while initial data is encouraging, the final results and larger sample sizes will provide a clearer picture.
In terms of the regulatory pathway, watching the progress of Phase 1b/2 trials for pancreatic cancer and Phase 2 trials for ovarian cancer will be crucial. Investors should be aware that positive interim results are a good sign, but not a guarantee of final approval or market success.
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, May 16, at 8:30 AM ET
OCALA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the first quarter 2024. As previously announced, the Company will host a conference call and webcast today, Thursday, May 16, 2024, at 8:30 AM ET (details below).
“AIM is making fundamental progress across our clinical development programs and continues to be encouraged by Ampligen’s potential. We recently reported encouraging top-line data across our pipeline. We also recently completed cGMP manufacturing of 9,000 vials of Ampligen. Both of these successes are extremely important as we seek commercial partners. We remain focused on the continued execution of our operational, clinical and regulatory initiatives and seek to generate — through such progress — a basis for increased stockholder value,” commented AIM Chief Executive Officer Thomas K. Equels.
Recent Highlights
- Completed cGMP manufacturing of clinical vials of Ampligen
- Announced first dose level is generally well-tolerated in Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer
- Announced appointment of Charles Lapp, MD as a Consulting Medical Officer for AIM’s ME/CFS and Long COVID programs
- Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer:
- In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of
45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. Objective Response Rate includes complete response and partial response to treatment. There was a total Clinical Benefit Rate of55% when including patients who experienced stable disease. Researchers also reported a median Progression-Free Survival of 7.8 months.
- In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of
- Released multiple CEO Corner segments highlighting Company news and clinical programs
Expected Upcoming Pipeline Milestones
Q2 2024
- Final dataset for Post-COVID Conditions (AMP-518)
2024
- Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First Subject Dosed
- Publications of data in scientific journals
Summary of Financial Highlights for First Quarter 2024
- As of March 31, 2024, AIM reported cash, cash equivalents and marketable securities of
$10.9 million . - Research and development expenses for the three months ended March 31, 2024, were
$2.0 million , compared to$2.1 million for the same period in 2023. - General and administrative expenses were
$3.8 million for the three months ended March 31, 2024, compared to$2.3 million for the same period 2023. - The net loss from operations for the three months March 31, 2024, was
$5.8 million , or$0.12 per share, compared to$3.7 million , or$0.08 per share, for the three months ended March 31, 2023.
Please refer to the full 10-Q for complete details.
Conference Call and Webcast Details
As previously announced, the Company will host a conference call and webcast to discuss the Company’s Q1 2024 operational and financial results today, May 16, 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. 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.
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