AIM ImmunoTech Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
AIM ImmunoTech (NYSE: AIM) has reported its Q4 and full year 2024 financial results, highlighting progress in its Ampligen clinical development programs. The company ended 2024 with $4.0 million in cash and investments, down from $13.1 million in 2023. Financial metrics show reduced expenses, with R&D costs decreasing to $6.2 million from $10.9 million and G&A expenses dropping to $13.7 million from $21.1 million year-over-year.
Key developments include the advancement of the DURIPANC Phase 1b/2 trial combining Ampligen with AstraZeneca's Imfinzi for late-stage pancreatic cancer, and upcoming milestones in multiple clinical trials through 2026. The company is also pursuing studies in refractory melanoma, triple negative breast cancer, and advanced recurrent ovarian cancer, with several trials being partially funded by collaborators including AstraZeneca and Merck.
AIM ImmunoTech (NYSE: AIM) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nei suoi programmi di sviluppo clinico di Ampligen. L'azienda ha chiuso il 2024 con 4,0 milioni di dollari in contante e investimenti, in calo rispetto ai 13,1 milioni di dollari del 2023. Le metriche finanziarie mostrano una riduzione delle spese, con i costi di R&S che sono diminuiti a 6,2 milioni di dollari rispetto ai 10,9 milioni dell'anno precedente e le spese generali e amministrative che sono scese a 13,7 milioni di dollari dai 21,1 milioni dell'anno precedente.
Sviluppi chiave includono l'avanzamento della fase 1b/2 della sperimentazione DURIPANC che combina Ampligen con l'Imfinzi di AstraZeneca per il cancro pancreatico in fase avanzata, e traguardi imminenti in diversi studi clinici fino al 2026. L'azienda sta anche perseguendo studi su melanoma refrattario, cancro al seno triplo negativo e cancro ovarico ricorrente avanzato, con diversi trial parzialmente finanziati da collaboratori tra cui AstraZeneca e Merck.
AIM ImmunoTech (NYSE: AIM) ha reportado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en sus programas de desarrollo clínico de Ampligen. La compañía terminó 2024 con 4,0 millones de dólares en efectivo e inversiones, una disminución desde los 13,1 millones de dólares en 2023. Las métricas financieras muestran una reducción en los gastos, con los costos de I+D disminuyendo a 6,2 millones de dólares desde 10,9 millones y los gastos generales y administrativos cayendo a 13,7 millones de dólares desde 21,1 millones en comparación con el año anterior.
Los desarrollos clave incluyen el avance del ensayo DURIPANC de fase 1b/2 que combina Ampligen con el Imfinzi de AstraZeneca para el cáncer de páncreas en etapa avanzada, y hitos próximos en múltiples ensayos clínicos hasta 2026. La compañía también está llevando a cabo estudios sobre melanoma refractario, cáncer de mama triple negativo y cáncer de ovario recurrente avanzado, con varios ensayos parcialmente financiados por colaboradores, incluidos AstraZeneca y Merck.
AIM ImmunoTech (NYSE: AIM)는 2024년 4분기 및 연간 재무 결과를 보고하며 Ampligen 임상 개발 프로그램에서의 진전을 강조했습니다. 이 회사는 2024년을 400만 달러의 현금 및 투자로 마감했으며, 이는 2023년의 1310만 달러에서 감소한 수치입니다. 재무 지표는 비용 감소를 보여주며, 연구개발 비용은 1090만 달러에서 620만 달러로 감소하고, 일반 관리 비용은 2110만 달러에서 1370만 달러로 감소했습니다.
주요 개발 사항으로는 말기 췌장암을 위한 Ampligen과 AstraZeneca의 Imfinzi를 결합한 DURIPANC 1b/2상 시험의 진행이 포함되며, 2026년까지 여러 임상 시험에서의 주요 이정표가 예정되어 있습니다. 회사는 또한 난치성 흑색종, 삼중 음성 유방암 및 고급 재발성 난소암에 대한 연구를 진행하고 있으며, 여러 시험이 AstraZeneca와 Merck를 포함한 협력자들에 의해 부분적으로 자금을 지원받고 있습니다.
AIM ImmunoTech (NYSE: AIM) a publié ses résultats financiers pour le quatrième trimestre et l'année complète 2024, mettant en avant les progrès réalisés dans ses programmes de développement clinique d'Ampligen. L'entreprise a terminé 2024 avec 4,0 millions de dollars en liquidités et investissements, en baisse par rapport à 13,1 millions de dollars en 2023. Les indicateurs financiers montrent une réduction des dépenses, les coûts de R&D ayant diminué à 6,2 millions de dollars contre 10,9 millions de dollars et les dépenses générales et administratives passant de 21,1 millions de dollars à 13,7 millions de dollars d'une année sur l'autre.
Les développements clés incluent l'avancement de l'
AIM ImmunoTech (NYSE: AIM) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seinen Ampligen-Entwicklungsprogrammen hervorgehoben. Das Unternehmen schloss das Jahr 2024 mit 4,0 Millionen Dollar in bar und Investitionen, ein Rückgang von 13,1 Millionen Dollar im Jahr 2023. Die finanziellen Kennzahlen zeigen reduzierte Ausgaben, wobei die F&E-Kosten auf 6,2 Millionen Dollar von 10,9 Millionen Dollar gesenkt wurden und die allgemeinen und administrativen Ausgaben auf 13,7 Millionen Dollar von 21,1 Millionen Dollar im Jahresvergleich sanken.
Wichtige Entwicklungen umfassen den Fortschritt der DURIPANC Phase 1b/2 Studie, die Ampligen mit AstraZenecas Imfinzi für fortgeschrittenen Bauchspeicheldrüsenkrebs kombiniert, sowie bevorstehende Meilensteine in mehreren klinischen Studien bis 2026. Das Unternehmen verfolgt auch Studien zu refraktärem Melanom, triple-negativem Brustkrebs und fortgeschrittenem rezidivierenden Eierstockkrebs, wobei mehrere Studien teilweise von Partnern wie AstraZeneca und Merck finanziert werden.
- Multiple ongoing clinical trials partially funded by major partners AstraZeneca and Merck
- Significant reduction in operating expenses: R&D down 43% and G&A down 35% year-over-year
- Expansion of patent portfolio for Ampligen
- Cash position decreased 69% from $13.1M to $4.0M year-over-year
- Most major trial results and milestones are 12-18 months away
Insights
AIM ImmunoTech's financial position reveals significant challenges amid clinical progress. The company's
This financial reality creates tension with the company's ambitious 18-month clinical roadmap. The cash position appears insufficient to fully fund all planned development activities through mid-2026 without additional capital. While partnerships with AstraZeneca and Merck provide valuable validation and partial funding for specific trials, these collaborations likely won't eliminate the need for additional financing.
The cost reductions could signal improved operational efficiency but warrant monitoring for potential impact on clinical execution. With multiple trials progressing and a market capitalization of approximately
AIM's Ampligen (rintatolimod) development program demonstrates strategic positioning across multiple high-value oncology indications, with pancreatic cancer as the clear priority. The advancement to Phase 2 in the DURIPANC trial combining Ampligen with AstraZeneca's Imfinzi represents significant progress in targeting pancreatic ductal adenocarcinoma—a notoriously treatment-resistant cancer with dismal survival rates and massive unmet need.
The company's diversified approach spans multiple indications including triple-negative breast cancer, refractory melanoma, and recurrent ovarian cancer—creating multiple potential value-inflection points. The collaborations with AstraZeneca and Merck add considerable validation to Ampligen's mechanism as a TLR-3 agonist potentially capable of enhancing immune checkpoint inhibitor efficacy.
However, investors should recognize the extended development timeline ahead, with most milestone completions projected into 2026. The pancreatic cancer trial completion timeline of Q2/Q3 2026 for last patient enrollment means definitive efficacy data remains distant. Historical success rates for Phase 2 oncology trials hover around 30-35%, underscoring the speculative nature of current programs despite their promising scientific rationale.
The planned investigation into Ampligen combined with FluMist for influenza represents an interesting pipeline expansion with potentially faster development timelines than oncology indications, though commercial potential likely remains secondary to cancer applications. Overall, AIM presents multiple shots on goal in high-value indications, but with extended timelines to potential commercialization.
Continued execution across Ampligen® (rintatolimod) clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer space
Expected milestones over the course of the next 18 months provide significant value-driving opportunities, including some trials being partially funded by collaborators AstraZeneca (pancreatic cancer) and Merck (advanced ovarian cancer)
Company to host conference call and webcast on Tuesday, April 1st at 8:30 AM ET
OCALA, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the fourth quarter and full year 2024 and provided a business update. The Company will host a conference call and webcast on Tuesday, April 1, 2025 at 8:30 AM ET (details below).
“Our team made significant strides in advancing our development programs along with our collaborators over the course of 2024. As we look ahead, we will continue to execute our corporate and clinical strategies to further establish the foundation upon which we can secure the successful future of AIM and our drug Ampligen for the treatment of major-market unmet medical needs. We are focused on the successful execution of a number of key milestones expected over the course of the next 18 months with the goal of building long-term stockholder value,” commented AIM Chief Executive Officer Thomas K. Equels.
Recent Highlights
- Announced plans to conduct clinical study of the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza (bird flu); Paul Goepfert, MD, of the University of Alabama-Birmingham, has agreed to act as the Principal Investigator for the study.
- Announced Ted D. Kellner and David Chemerow as new members of AIM’s Board of Directors.
- Erasmus Medical Center Safety Committee granted approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”).
- Commenced dosing in Phase 2 of the Phase 1b/2 DURIPANC clinical trial for treatment of late-stage pancreatic cancer.
- Announced the final clinical study results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) were published to ClinicalTrials.gov (See: NCT05592418).
- Expanded patent portfolio with a U.S. compositions and methods patent for Ampligen for the treatment of endometriosis and a Netherlands compositions and methods patent covering Ampligen for use in the Post-COVID condition of fatigue.
- Announced publication of data from Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating a combination therapy using Ampligen in early-stage triple-negative breast cancer (TNBC) in The Journal for ImmunoTherapy of Cancer.
Expected Upcoming, Value-Driving Milestones
Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center
- Q2/Q3 2026: Last patient enrolled in Phase 2
Refractory Melanoma
Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute
- H1 2025: First patient dosed
Stage 4 Triple Negative Breast Cancer
Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute
- Q2 2026: Expected completion of enrollment
Advanced Recurrent Ovarian Cancer
Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck
- H1 2025: Completion of study, publication of data
Summary of Financial Highlights for Fiscal Year 2024
- As of December 31, 2024, AIM reported cash, cash equivalents and marketable investments of
$4.0 million , compared to$13.1 million as of December 31, 2023. - Research and development expenses for the year ended December 31, 2024, were
$6.2 million , compared to$10.9 million for the year ended December 31, 2023. - General and administrative expenses for the year ended December 31, 2024, were
$13.7 million , compared to$21.1 million for the year ended December 31, 2023.
Please refer to the full 10-K for complete details.
Conference Call and Webcast Details
The Company will host a conference call and webcast to discuss the Company’s Q4/FY2024 operational and financial results on Tuesday, April 1, 2025 at 8:30 AM ET.
The call will be hosted by Thomas K. Equels, Chief Executive Officer of AIM. 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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a prophylactic or therapy for any indication. 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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