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])

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])

On November 17, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for the detection of clear cell renal cell carcinoma (ccRCC). The Fast Track designation was granted based on the potential of ITM-94 as a more effective, non-invasive diagnostic agent designed to improve outcomes for people living with ccRCC, a condition with high unmet medical need1.

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"The FDA’s Fast Track designation is a validation of ITM-94’s potential to aid in the non-invasive diagnosis of renal cell carcinoma," said Dr. Celine Wilke, chief medical officer of ITM. "We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well. This news highlights the innovation within our pipeline and the important role an effective diagnostic can play in cancer treatment."

ITM-94 is a gallium-68-radiolabeled PET imaging agent and, together with radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), comprise a first-in-class, peptide-based theranostic pair. The theranostic pair targets carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-94 is currently being evaluated in Part D of the ongoing Phase 1/2 clinical trial for its effectiveness to accurately detect ccRCC in patients with indeterminate renal masses (IDRM) when compared to CT/MRI imaging, with histopathological confirmation of diagnosis. Secondary endpoints include assessments of the imaging agent’s sensitivity, specificity and Positive Predictive Value (PPV) and Negative Predictive Value (NPV) compared to histology.

FDA Fast Track designation is designed to facilitate the development and expedite the review of new diagnostics and therapies that are intended to treat serious or life-threatening conditions and have the potential to address an unmet medical need. Programs granted this designation are eligible for more frequent communications with the FDA during clinical development and for accelerated approval and/or priority review over standard reviews if relevant criteria are met.

About the Phase 1/2 ITM-91/ITM-94 Trial
The multi-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In the first-in-human part of the trial (Part A), ITM-94 has demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC1. Part B is currently assessing increasing doses of the therapeutic agent, ITM-91, in ccRCC patients whose tumors show CAIX expression as evidenced by uptake of the imaging tracer, ITM-94. Based on the recommended dose and treatment schedule obtained from Part B, expansion Part C of the trial will evaluate the safety and preliminary efficacy of ITM-91 in patients with ccRCC, and potentially other CAIX-expressing tumor types. Part D is evaluating the effectiveness of ITM-94 in classifying indeterminate renal masses, such as ccRCC.

(Press release, ITM Isotopen Technologien Munchen, NOV 17, 2025, View Source [SID1234661165])

On November 17, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering a novel cancer therapy, reported that the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2 inhibitor.

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This milestone was achieved at START Madrid/Fundación Jiménez Díaz University Hospital, under the supervision of Dr. Victor Moreno, Director of Clinical Research and Principal Investigator. Dr. Moreno commented: "I am pleased that our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited, and we look forward to continuing collaborating with One-carbon Therapeutics."

"Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies," said Ana Slipicevic, Chief Executive Officer of One-carbon Therapeutics. "TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible."

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and a dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway – TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells, while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first in human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, NOV 17, 2025, View Source [SID1234661124])

On November 17, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported that the first patient has been dosed in its ANK-101-004 clinical trial (NCT07027514). This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%.

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"While there has been considerable progress in the treatment of lung cancer many patients do not respond to current approaches", said Thomas Marron, MD, PhD, Director of the Early Phase Trials Unit at the Tisch Cancer Institute at Mount Sinai and Chief Medical Officer of OCCAM Immune and the principal investigator of the study. "The potential use of anchored IL-12 to drive better responses without adding appreciable toxicity could be an important advance for patients."

"Tolododekin alfa has already demonstrated objective responses as a single agent in patients with anti-PD-1-refractory cancers in phase 1 trials", stated Howard L. Kaufman, MD. CEO at Ankyra Therapeutics, "and now we have an opportunity to test tolododekin in patients with advanced lung cancer." Ankyra is working with OCCAM Immune at Mount Sinai in support of Ankyra the LANTERN clinical trial, which is evaluating ANK-101 in combination with PD-1 blockade in patients with first- and second-line NSCLC. Through state-of-the-art immune profiling, OCCAM Immune aims to generate a comprehensive immune atlas to correlate immune modulation with therapeutic efficacy and disease progression, advance biomarker discovery and deepen mechanistic insights into Ankyra’s novel therapeutic approach.

The ANK-101-004 (LANTERN) trial will be conducted at several institutions, including, Icahn School of Medicine at Mount Sinai, Roswell Park Cancer Institute, Mayo Clinic, Moffitt Cancer Center, The University of Chicago, Community Health Network, The University of Miami Sylvester Comprehensive Cancer Center, Karmanos Cancer Institute, FirstHealth of the Carolinas, and OSF Saint Francis Medical Center with additional sites expected as well.

About Tolododekin alfa (ANK-101)

Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 17, 2025, View Source [SID1234660046])