On July 25, 2025 PDX Pharma reported it has successfully met the Year 1 milestones of its Phase II SBIR grant (R44CA285233) from the National Cancer Institute (NCI) for the development of PETTRA (PLK1 and EGFR Targeted Therapy and Radiation Sensitizer) for lung cancer treatment (Press release, PDX Pharmaceuticals, JUL 25, 2025, View Source [SID1234654548]). As a result, the NCI has issued a Notice of Award for approximately $1.09 million, bringing the total grant funding to $2.4 million. We thank the NCI for its continued support, as well as our dedicated staff and collaborators at OHSU, who worked tirelessly to achieve the project milestones. PETTRA demonstrated superior efficacy compared to the standard of care (SOC) in a metastatic non-small cell lung cancer (NSCLC) mouse model and exhibited strong synergy with radiation therapy. In the final phase of the project, we will conduct additional PK/PD and safety studies of PETTRA, advancing it toward clinical trials as both a monotherapy and a radiation sensitizer.

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On July 25, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place in Berlin, Germany from October 17-21 (Press release, Agenus, JUL 25, 2025, View Source [SID1234654537]). The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation Details:

1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors

Presenting Author:
Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA

Mini Oral Session:

Investigational Immunotherapy

Session Date:

Friday, October 17, 2025

Session Time:

2:00-3:00 PM CEST / 8:00-9:30 AM EDT

Location:

Hall 5.2

Abstract Number:

3220

2.

Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial

Presenting Author: Dr. David O’Malley; The Ohio State University Comprehensive Cancer Center- OH, USA
Session Date:

Saturday, October 18, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

2952

Poster Number:

1164P

3.

Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer

Presenting Author:

Dr. Marwan Fakih; City of Hope- CA, USA

Session Date:

Sunday, October 19, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

6197

Poster Number:

851P

4.

Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA)

Presenting Author:

Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center – Poland

Session Date:

Monday, October 20, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

7273

Poster Number:

1662P

On July 25, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany (Press release, Taiho, JUL 25, 2025, View Source [SID1234654536]).

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The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease.

"We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year’s ESMO (Free ESMO Whitepaper) Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need."

The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025.

Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations
Abstract Number: 3778
Session Name: Mini oral session 1: NSCLC metastatic
Session Type: Mini Oral Presentation
Session Date: Oct. 19, 2025
Session Time: 8:30 to 10 a.m. CEST

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On July 25, 2025 Servier reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy (Press release, Servier, JUL 25, 2025, View Source [SID1234654535]).

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The marketing authorization application for VORANIGO will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 member states of the EU. Decisions by the EC are also applicable in Norway, Liechtenstein, and Iceland.

"Today’s recommendation for EU approval brings us one step closer to offering VORANIGO to patients in the EU with Grade 2 IDH-mutant glioma who have historically had limited treatment options for this relentless disease," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "We look forward to continuing conversations with the EMA and other regulatory bodies around the world to introduce VORANIGO as a potential new standard of care for patients with IDH-mutant gliomas."

The CHMP opinion is based on the positive results of the Phase 3 INDIGO trial, a global Phase 3 randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent Grade 2 glioma with an IDH1/2 mutation who have undergone surgery as their only treatment. Results were presented during the plenary session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published simultaneously in The New England Journal of Medicine.

VORANIGO was approved by the United States Food and Drug Administration (FDA) in August 2024 after being granted Fast Track, Breakthrough and Orphan Drug Designations and receiving Priority Review. VORANIGO has also been granted marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, and Switzerland. Servier has also submitted marketing authorization applications in the United Kingdom, Japan and various other regions, and reviews by the appropriate health authorities are ongoing.

The use of VORANIGO is investigational in the EU and is not yet approved.

On July 25, 2025 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company formed under the laws of the British Virgin Islands, with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, reported its financial results for the fiscal year ended March 31, 2025 (Press release, Portage Biotech, JUL 25, 2025, View Source [SID1234654534]).

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Financial Results from Year Ended March 31, 2025

The Company incurred a net loss of approximately $6.8 million during the fiscal year ended March 31, 2025 ("Fiscal 2025"), which includes approximately $0.2 million of net non-cash expenses. This compares to a net loss of approximately $75.4 million during the fiscal year ended March 31, 2024 ("Fiscal 2024"), which included approximately $60.9 million of net non-cash expenses. Net loss decreased by approximately $68.6 million year-over-year, which is primarily due to lower non-cash losses attributable to full impairment of the Company’s identifiable intangible assets, goodwill, and certain investments as of March 31, 2024.

Operating expenses, including research and development ("R&D") costs and general and administrative ("G&A") expenses, were $7.4 million in the Fiscal 2025, down from $18.2 million in the Fiscal 2024, a decrease of $10.8 million, as detailed below.

R&D expenses decreased by approximately $9.4 million, or approximately 75%, from approximately $12.5 million in Fiscal 2024, to approximately $3.1 million in Fiscal 2025. The decrease was primarily attributable to clinical trial costs (principally CRO-related), which decreased by approximately $3.4 million, from $5.2 million in Fiscal 2024 to $1.8 million in Fiscal 2025, due to the decision to pause enrollment in our sponsored clinical trials in the third and fourth quarters of Fiscal 2024. Manufacturing-related costs decreased by $1.6 million from $1.8 million in Fiscal 2024, compared to $0.2 million in Fiscal 2025, related to the iNKT and adenosine clinical trials. During Fiscal 2024, we deprioritized development of the iNKT program and closed the related clinical trial. In August 2024, we temporarily paused enrollment in the PORT-6 arm of the study. Enrollment resumed in March 2025 with the initiation of the final dose escalation cohort. Non-cash share-based compensation expense allocable to R&D decreased by $1.4 million, from $1.4 million in Fiscal 2024, compared to nil in Fiscal 2025, as the relevant share options fully vested by Fiscal 2024 and no new share option awards were allocable to R&D during Fiscal 2025. Payroll-related expenses decreased by $0.9 million from $1.6 million in Fiscal 2024 to $0.7 million in Fiscal 2025; the decrease in salaries is primarily due to reduced headcount. R&D services decreased by $0.5 million due to the pause of medical writing, analysis, and clinical studies at the beginning of Fiscal 2025. Scientific consulting fees decreased by approximately $0.6 million from $0.8 million in Fiscal 2024 to $0.2 million in Fiscal 2025 to reflect the decrease in activity year-over-year. Additionally, in Fiscal 2024, we incurred a one-time milestone payment of $0.5 million for dosing our first adenosine patients, and finally, $0.5 million in fees paid with respect to the transition of the iNKT study prior to discontinuing the study in Fiscal 2024.

G&A expenses decreased by approximately $1.4 million, or approximately 24.9%, from approximately $5.7 million in Fiscal 2024, to approximately $4.3 million in Fiscal 2025. The decreases are attributable to decreases in: non-cash share-based compensation expense allocable to G&A expenses by $0.9 million, from $1.2 million in Fiscal 2024 to $0.3 million in Fiscal 2025, primarily due to the vesting of certain share options granted in prior years fully vesting by Fiscal 2024 and lower fair value associated with more recent grants; professional fees by $0.7 million, from $2.3 million in Fiscal 2024, compared to $1.6 million in Fiscal 2025, primarily due to decline in public relations and accounting services related expenses; directors’ fees by $0.1 million, from $0.3 million in Fiscal 2024, compared to $0.2 million Fiscal 2025 due to the adoption of a new director compensation policy in March 2025; and general office related supplies and expenses by $0.1 million, from $0.2 million in Fiscal 2024, compared to $0.1 million in Fiscal 2025. These decreases were offset to some extent by an increase in payroll-related and consulting expenses by $0.4 million from $0.9 million in Fiscal 2024 to $1.3 million in Fiscal 2025 primarily attributable to $0.2 million in retention payments to an employee and a consultant included in payroll expenses allocable to general and administrative expenses.

The primary reasons for the year-over-year differences in the Company’s pre-tax items of income and expense were substantially non-cash in nature, aggregating approximately $0.6 million net gain in Fiscal 2025 compared to approximately $67.7 million net loss in Fiscal 2024. The net gain in year over year were attributable to $0.9 million net gain from the settlement and release of obligations and liabilities under the Master Services Agreement between iOx and Parexel partially offset to some extent by the $0.4 million non-cash loss from the change in the fair value of certain warrants accounted for as liabilities, issued in connection with a private placement offering in October 2023 in Fiscal 2025. In Fiscal 2024, the recognized full impairment of the carrying value of in-process research and development of $57.9 million for iOx and $23.6 million for Tarus, as well as a $1.0 million loss on the impairment of the Company’s investment in Stimunity and the Stimunity convertible note. These expenses were partially offset by the non-cash gains from the decrease in the fair value of the deferred purchase price payable to the former Tarus shareholders and the deferred obligation for the iOx milestone, totaling $11.3 million. These losses were offset to some extent by a $0.7 million gain on the sale of Intensity shares, accounted for under fair value through other comprehensive income (FVOCI), which had a carrying value of $2.1 million and a $2.4 million loss during Fiscal 2024 from the Company’s equity financing in October 2023, representing the excess of the fair value of certain warrants over the net proceeds. Additionally, a $6.9 million non-cash gain was recognized from the change in the fair value of certain warrants accounted for as liabilities issued in connection with this equity offering.

Additionally, the Company recognized a non-cash net deferred income tax benefit of $10.5 million in Fiscal 2024, compared to a non-cash net deferred income tax benefit of $3 thousand in Fiscal 2025. The benefit in Fiscal 2024 was primarily attributable to the tax effect of the non-cash impairment loss on IPR&D for iOx, partially offset by the derecognition of previously recognized losses.

As of March 31, 2025, the Company had cash and cash equivalents of approximately $1.7 million and total current liabilities of approximately $1.1 million.