On November 18, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of a narrative review by leading interventional radiologists and oncologists from multiple institutions. The review, titled "Treatment of Liver Metastases from Uveal Melanoma with Percutaneous Hepatic Perfusion," was published in the Journal of Vascular and Interventional Radiology (JVIR) and provides a comprehensive overview of percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s HEPZATO KIT. The article highlights PHP’s rationale, technique, patient selection, clinical outcomes, and future research directions, emphasizing its role as an FDA-approved liver-directed therapy for unresectable hepatic metastases from uveal melanoma (UM) with limited extrahepatic disease.

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"The publication of this expert narrative review in JVIR features the growing clinical evidence and consensus supporting the use of PHP as a key treatment option for patients with liver-dominant metastatic uveal melanoma," said Gerard Michel, Chief Executive Officer of Delcath Systems. "By consolidating insights from leading specialists, this review reinforces the value of HEPZATO KIT in achieving meaningful tumor responses and survival benefits while preserving quality of life. We are encouraged by the highlighted potential for broader applications and combinations with systemic therapies, which align with our ongoing efforts to advance interventional oncology."

The narrative review synthesizes data from prospective and retrospective studies from leading centers in the US and Europe, collectively demonstrating objective response rates of 36%-72%, median overall survival of 15-20 months, and disease control rates up to 89%. Key highlights include:

PHP’s suitability for multifocal, bilobar UM liver metastases, delivering high-dose chemotherapy with extracorporeal filtration to minimize systemic toxicity
Short-stay hospital admissions with discharge within 24 hours
Advantages over other liver-directed therapies, such as reduced risk of hepatic fibrosis compared to radioembolization in whole-liver treatments
Quality of life data showing no long-term decline, with scores returning to baseline by Day 28 post-procedure
Ongoing research into immunotherapy combinations and expansion to other metastatic cancers like breast and colorectal

(Press release, Delcath Systems, NOV 18, 2025, View Source [SID1234660051])

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])

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])