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AIM ImmunoTech Completes cGMP Manufacturing of Clinical Vials of Ampligen®

Key Takeaway: AIM ImmunoTech has successfully completed the cGMP manufacturing of 9,042 clinical vials of its product candidate, Ampligen (rintatolimod). This milestone is crucial for the company's development and commercial strategies as they advance their pipeline targeting various cancers and viral diseases. Ampligen is currently being evaluated in multiple clinical trials at major cancer research centers.
Price reaction · baseline $0.4044 (2024-05-03 close) · hit pre-market · 1 other AIM headline(s) in the window, move may be shared
day 0 close
+3.8%
day 1
+5%
day 3 · peak
+7.9%

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful completion of cGMP manufacturing of clinical vials.
  • Ampligen is being developed for important cancers and viral diseases.
  • AIM's operational focus on production supports clinical and commercial strategies.
  • The company is advancing its pipeline with ongoing clinical trials.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+20%
120-day peak, hindsight
Typical move
16.5%
average across 4 past catalysts
Cash runway
~6 mo
High dilution risk
Lead asset
poly I-poly C12U
Phase 2 · HIV Seropositivity

Full Press Release Details

OCALA, Fla., May 06, 2024 — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the successfully completion of cGMP manufacturing of 9,042 clinical vials of Ampligen ® (rintatolimod), AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
AIM Chief Executive Officer Thomas K. Equels commented, “We remain focused on operational execution and the successful continued production of our commercial-sized manufacturing process for Ampligen represents a critical component of our overall development, commercial and business development strategies. This is an important milestone as we look to advance our pipeline and work toward clinical and commercial success. Our record of successful manufacturing is both important as we seek commercial partners, as well as for establishing Ampligen reserves for ongoing and upcoming clinical trials.”
Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country.
Ampligen has had a series of clinical trial advances in 2024. Read a recent update on AIM’s active clinical study program .
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.

Frequently Asked Questions

What is Ampligen used for?

Ampligen is being developed for the treatment of various cancers and viral diseases.

How many clinical vials of Ampligen were manufactured?

AIM ImmunoTech manufactured 9,042 clinical vials of Ampligen.

What does cGMP stand for?

cGMP stands for current Good Manufacturing Practice.

What is the significance of this manufacturing milestone?

This milestone is critical for AIM's development and commercial strategies.

Last updated: May 6, 2024