AIM ImmunoTech Reports Third Quarter 2025 Financial Results and Highlights Continued Progress Across Pipeline with Strategic Focus on Pancreatic Cancer Clinical Program

On November 18, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported a business update and announced its financial results for the third quarter 2025.

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"The third quarter was marked by solid and positive clinical and operational execution. Our clinical, manufacturing and regulatory teams are heavily focused on moving Ampligen down a pathway toward eventual FDA approval as part of a combination therapy for pancreatic cancer. We recently reported positive mid-year safety and efficacy data in the ongoing DURIPANC clinical trial combining Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi – or durvalumab – in the treatment of metastatic pancreatic cancer and, as an important inflection point, we will release a year-end update by the end of the current quarter. While we have more work ahead, the foundation we are building gives us confidence in our ability to deliver long-term value," commented AIM Chief Executive Officer Thomas K. Equels.

Additional Recent Highlights

Announced the presentation of data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), conducted by the University of Pittsburgh Medical Center at the 40th Annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting;
Granted European Patent No. 4,096,675, titled "Compositions for Treating LONG COVID," covering compositions of matter of AIM’s proprietary dsRNAs including, for example, Ampligen for use in the treatment of Long COVID;
Secured patent in Japan through 2039 for novel cancer therapy combining Ampligen with checkpoint inhibitors;
Peer-reviewed article published in Journal for ImmunoTherapy of Cancer (JITC) providing evidence of a positive combination effect of Ampligen and interferon-alpha on tumor growth and subsequent subject survival;
Presented latest positive progress from Ampligen clinical programs in pancreatic cancer at the 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care hosted by and at Poland’s National Institute of Oncology in Warsaw, Poland.
For more information, please visit the Company’s website at aimimmuno.com.

Summary of Financial Highlights for Third Quarter 2025

As of September 30, 2025, AIM reported cash, cash equivalents and marketable investments of $2.4 million.
Research and development expenses for the three months ended September 30, 2025 were approximately $607,000, compared to $1.4 million for the same period in 2024.
General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2025, compared to $3.1 million for the same period 2024.
The net loss from operations for the three months ended September 30, 2025 was approximately $(3.3 million), or $(1.57) per share, compared to $(3.7 million), or $(6.00) per share, for the three months ended September 30, 2024. This net loss includes non-recurring expenses. The Company expects a monthly burn rate of approximately ~ $550,000 while continuing operational efficiencies and a focused allocation of resources. This burn rate differs from the net loss above, as the net loss includes non-cash items and accounting adjustments, whereas burn rate isolates true operating cash outflows.
Please refer to the full September 30, 2025 Form 10-Q for complete details.

On November 17, 2025, AIM filed an extension with the SEC, giving the Company an additional five days to timely file its September 30, 2025 Form 10-Q. That 10-Q was subsequently filed yesterday.

(Press release, AIM ImmunoTech, NOV 18, 2025, View Source [SID1234660048])

GRAIL to Present at Piper Sandler 37th Annual Healthcare Conference

On November 18, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that company management will present at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, Dec. 2 at 3:00 p.m. ET.

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Live and replay webcasts may be accessed in the investor relations section of GRAIL’s website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after the event.

(Press release, Grail, NOV 18, 2025, View Source [SID1234660064])

ALX Oncology to Present at Upcoming Investor Conferences

On November 18, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that ALX Oncology leadership will participate in both the Jefferies Global Healthcare Conference in London and Piper Sandler 37th Annual Global Healthcare Conference in New York.

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The details of the meetings are as follows:

Jefferies Global Healthcare Conference in London

Format: Fireside Chat
Date: Wednesday, November 19, 2025
Time: 11:30 AM GMT / 6:30 AM EST
Location: London, UK
Webcast link: Available here

Piper Sandler 37th Annual Global Healthcare Conference

Format: Fireside Chat
Date: Wednesday, December 3, 2025
Time: 9:30 AM EST
Location: New York, NY
Webcast link: Available here

The webcasts of the Jefferies London and Piper Sandler fireside chats can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. Replays of the webcasts will be archived for up to 90 days following the fireside chat dates.

(Press release, ALX Oncology, NOV 18, 2025, View Source [SID1234660049])

BioCytics Successfully Completes a Key Regulatory Milestone with Recent FDA INTERACT Meeting

On November 18, 2025 BioCytics reported they successfully reached a regulatory milestone for de-risking clinical development plans with a productive FDA INTERACT meeting during which they discussed manufacturing immune cell therapies at the point of care.

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This INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting is a first step in getting feedback from the FDA regarding the feasibility of BioCytics’ cell therapy platform development plans. By accepting this meeting and reviewing the plans, the FDA is indicating that BioCytics’ immuno-oncology tumor treatment protocol efforts, the first of which is called BioCytics Immune Fraction #1 (BCyIF-1), show enough pre-clinical scientific potential to warrant continued research development and upscaling manufacturing efforts. This milestone feedback from the FDA speaks volumes for BioCytics’ work towards a future Investigational New Drug (IND) submission. It solidifies plans of getting to first-in-human clinical trials in 2027, with the ultimate goal of treating solid tumors.

Dr. John Powderly, Oncologist and President of BioCytics said "We are delighted to have received insightful feedback from the FDA regarding development of BioCytics BCyIF-1, a cellular therapy to be manufactured at the point of care. The FDA’s willingness to review our pre-clinical research data and hold the INTERACT meeting with us results in substantially reduced regulatory risk as we move towards a future IND. It is fantastic to have our early research validated and to be able to enter confidently into our IND-enabling and manufacturing efforts."

(Press release, BioCytics, NOV 18, 2025, View Source [SID1234660065])

Can-Fite: 9-Year Survival with Complete Cure in an Advanced Liver Cancer Patient Treated with Namodenoson

On November 18, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment.

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The patient, who suffered from advanced liver cancer, was enrolled in Can-Fite’s completed Phase II study and continues to be treated with Namodenoson through a compassionate use program. Nine years following treatment, the patient remains cancer-free and meets the definition of a complete responder based on the disappearance of ascites, normal liver function, and good quality of life.

Can-Fite is currently enrolling patients in Israel, Europe, and the U.S. for a pivotal Phase III clinical study of Namodenoson for patients with advanced hepatocellular carcinoma (HCC), the common form of liver cancer, as a 2nd or 3rd line treatment. The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

"With Namodenoson’s potent anti-cancer activity, along with its excellent tolerability, we aim to deliver longer survival for patients and hope to see outcomes that mirror the exceptional 9 year response achieved by the long-treated patient from our prior Phase II study. Namodenoson’s highly selective action against tumor cells, combined with its protection of healthy liver tissue, has the potential to make our Phase III trial especially promising," stated Prof. Pnina Fishman, Can-Fite CSO & Chairperson.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

(Press release, Can-Fite BioPharma, NOV 18, 2025, View Source [SID1234660050])