AIM ImmunoTech Builds Positive Momentum and Reiterates Focus on Driving Ampligen® Clinical Development Toward Pancreatic Cancer Approval
AIM ImmunoTech (NYSE American: AIM) has provided an update on its clinical development progress, focusing primarily on Ampligen® (rintatolimod) for pancreatic cancer treatment. The company reported positive mid-year data from its Phase 2 DURIPANC study combining Ampligen® with AstraZeneca's Imfinzi® (durvalumab), showing promising progression-free survival (PFS) and overall survival (OS) with no significant toxicity.
Key achievements include raising $8.0 million through a public equity offering, providing approximately 12 months of operational funding. The company has also secured multiple U.S. patents for Ampligen®, received U.S. and EU Orphan Drug designations for pancreatic cancer, and resumed trading on the NYSE American.
AIM ImmunoTech (NYSE American: AIM) ha fornito un aggiornamento sui progressi del suo sviluppo clinico, concentrandosi principalmente su Ampligen® (rintatolimod) per il trattamento del cancro al pancreas. L'azienda ha riportato dati positivi a metà anno dallo studio di Fase 2 DURIPANC che combina Ampligen® con Imfinzi® (durvalumab) di AstraZeneca, mostrando risultati promettenti in termini di sopravvivenza libera da progressione (PFS) e sopravvivenza globale (OS) senza tossicità significativa.
Tra i principali traguardi raggiunti vi è la raccolta di 8,0 milioni di dollari tramite un'offerta pubblica di azioni, garantendo circa 12 mesi di finanziamento operativo. L'azienda ha inoltre ottenuto diversi brevetti negli Stati Uniti per Ampligen®, ha ricevuto le designazioni di Farmaco Orfano negli USA e nell'UE per il cancro al pancreas e ha ripreso la negoziazione sul NYSE American.
AIM ImmunoTech (NYSE American: AIM) ha proporcionado una actualización sobre el progreso de su desarrollo clínico, enfocándose principalmente en Ampligen® (rintatolimod) para el tratamiento del cáncer de páncreas. La compañía reportó datos positivos a mitad de año del estudio de Fase 2 DURIPANC que combina Ampligen® con Imfinzi® (durvalumab) de AstraZeneca, mostrando una supervivencia libre de progresión (PFS) y supervivencia global (OS) prometedoras sin toxicidad significativa.
Los logros clave incluyen la recaudación de 8.0 millones de dólares mediante una oferta pública de acciones, proporcionando aproximadamente 12 meses de financiamiento operativo. La compañía también ha asegurado múltiples patentes en EE. UU. para Ampligen®, recibió designaciones de Medicamento Huérfano en EE. UU. y la UE para el cáncer de páncreas, y reanudó la cotización en NYSE American.
AIM ImmunoTech (NYSE American: AIM)는 임상 개발 진행 상황에 대한 업데이트를 제공했으며, 주로 췌장암 치료를 위한 Ampligen® (rintatolimod)에 집중했습니다. 회사는 AstraZeneca의 Imfinzi® (durvalumab)와 Ampligen®을 병용한 2상 DURIPANC 연구의 중간 연도 긍정적인 데이터를 보고했으며, 유의미한 독성 없이 유망한 무진행 생존율(PFS)과 전체 생존율(OS)을 나타냈습니다.
주요 성과로는 공개 주식 공모를 통해 800만 달러를 조달하여 약 12개월간의 운영 자금을 확보한 점이 있습니다. 또한 회사는 Ampligen®에 대해 미국 내 다수의 특허를 획득했으며, 췌장암에 대해 미국 및 유럽 연합에서 희귀 의약품 지정을 받았고 NYSE American에서 거래를 재개했습니다.
AIM ImmunoTech (NYSE American : AIM) a fourni une mise à jour sur ses progrès en développement clinique, en se concentrant principalement sur Ampligen® (rintatolimod) pour le traitement du cancer du pancréas. La société a rapporté des données positives à mi-parcours de son étude de phase 2 DURIPANC, combinant Ampligen® avec Imfinzi® (durvalumab) d'AstraZeneca, montrant des résultats prometteurs en survie sans progression (PFS) et en survie globale (OS) sans toxicité significative.
Les réalisations clés incluent la levée de 8,0 millions de dollars via une offre publique d'actions, fournissant environ 12 mois de financement opérationnel. La société a également obtenu plusieurs brevets américains pour Ampligen®, reçu les désignations de médicament orphelin aux États-Unis et dans l'UE pour le cancer du pancréas, et a repris la cotation sur le NYSE American.
AIM ImmunoTech (NYSE American: AIM) hat ein Update zu seinem klinischen Entwicklungsfortschritt gegeben, wobei der Schwerpunkt hauptsächlich auf Ampligen® (Rintatolimod) zur Behandlung von Bauchspeicheldrüsenkrebs liegt. Das Unternehmen berichtete positive Halbjahresdaten aus der Phase-2-Studie DURIPANC, die Ampligen® in Kombination mit AstraZenecas Imfinzi® (Durvalumab) verwendet, und zeigte vielversprechende progressionsfreie Überlebensraten (PFS) sowie Gesamtüberleben (OS) ohne signifikante Toxizität.
Zu den wichtigsten Erfolgen zählt die Beschaffung von 8,0 Millionen US-Dollar durch ein öffentliches Aktienangebot, was etwa 12 Monate Betriebskapital sichert. Das Unternehmen hat zudem mehrere US-Patente für Ampligen® erhalten, die Orphan-Drug-Zulassungen für Bauchspeicheldrüsenkrebs in den USA und der EU erhalten und den Handel an der NYSE American wieder aufgenommen.
- Positive Phase 2 DURIPANC study results showing favorable PFS and OS with no significant toxicity
- Secured $8.0 million in funding providing 12-month operational runway
- Obtained multiple U.S. patents for Ampligen manufacturing and combination therapy
- Received U.S. and EU Orphan Drug designations for pancreatic cancer
- Successfully resumed NYSE American listing
- Limited cash runway of only 12 months
- Company faced previous listing status challenges
Insights
AIM ImmunoTech shows promising Phase 2 pancreatic cancer results while securing funding and patents, though specifics on efficacy metrics remain limited.
AIM ImmunoTech is building momentum in its pursuit of developing Ampligen® for pancreatic cancer treatment. The company reported a mid-year update from its Phase 2 DURIPANC study showing positive signs with no significant toxicity and superior progression-free survival (PFS) and overall survival (OS) when combining Ampligen® with AstraZeneca's Imfinzi®.
The company has strengthened its financial position by closing an
Beyond financial improvements, AIM has secured several regulatory achievements that enhance their intellectual property position: new U.S. patents for Ampligen manufacturing methods and for combining Ampligen with PD-L1 inhibitors, plus U.S. and EU Orphan Drug designations for pancreatic cancer. The company has also regained its NYSE American listing, improving market visibility.
While the press release touts "superior" survival metrics, it notably lacks specific quantitative data on efficacy endpoints or patient numbers. This limited disclosure makes it difficult to assess the true clinical significance of the reported positive signals. Additionally, the Phase 2 status indicates that even with promising results, the company still faces significant regulatory hurdles before potential approval.
Primary focus on pancreatic cancer
Mid-year report of Ampligen® (rintatolimod) in combination with AstraZeneca’s Imfinzi® (durvalumab) for the treatment of pancreatic cancer demonstrates positive signs of both no significant toxicity and superior PFS and OS
Bolstered cash position provides runway to fund operations for approximately 12 months
OCALA, Fla., Aug. 04, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted recent key financial milestones and firmly stated its focus on advancing clinical trials of Ampligen® for the treatment of pancreatic cancer, with the ultimate goal of achieving drug approval.
AIM ImmunoTech CEO Thomas K. Equels stated, “We have emerged strong despite significant macro, sector and market-related headwinds. Our perseverance, dedication to patients, belief in the potential of Ampligen and commitment to all stakeholders have enabled us to successfully navigate through an extremely challenging period. With our regained listing status, the closing of a significant equity financing and the continued advancement of our pipeline and strengthened patent estate, we are well poised to build momentum and drive value for all stakeholders.
“Our growing body of positive data with Ampligen has provided the opportunity to focus our resources and priorities to our lead indication in pancreatic cancer. We believe establishing a clear path to registration and the execution of our clinical and regulatory initiatives will unlock the full potential of this important asset and shareholder value,” added Equels.
Significant Achievements
- Resumed trading on the NYSE American;
- Closed public equity offering, raising
$8.0 million in gross proceeds, which is expected to fund operations for approximately 12 months; - Reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen® (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the “DURIPANC” study) (See: NCT05927142);
- Granted U.S. patent covering methods of manufacturing therapeutic dsRNA, including Ampligen;
- Granted U.S. patent for Ampligen in combination with PD-L1 drugs for the treatment of cancer;
- Granted U.S. and EU Orphan Drug designations for pancreatic cancer;
- Ampligen oncology data presented at scientific congresses including the Annual Meeting of the American Association of Immunologists and U.S.-Poland Science and Technology Symposium 2025;
For more information, please visit the Company’s website at aimimmuno.com.
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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy in pancreatic cancer. 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.
Investor Contact: JTC Team, LLC Jenene Thomas 908.824.0775 AIM@jtcir.com
FAQ
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