Non-consolidated Financial Results for the Fiscal Year Ended December 31, 2025

On February 6, 2026 Oncolys BioPharma reported Non-consolidated Financial Results for the Fiscal Year Ended December 31, 2025.

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(Press release, Oncolys BioPharma, FEB 6, 2026, View Source [SID1234669196])

Immutep Achieves 50% Enrolment in Global TACTI-004 (KEYNOTE-F91) Phase III Trial in 1L NSCLC

On February 6, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported it has achieved 50% of the patient enrolment target in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC).

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Immutep Chief Executive Officer, Marc Voigt, said, "The excellent pace of enrolment globally in the TACTI-004 trial speaks to the promise of efti and the need for more efficacious therapies in the first line setting for patients with advanced/metastatic non-small cell lung cancer. Our team continues to work hard to bring this innovative cancer immunotherapy to market and looks forward to delivering on additional important upcoming milestones ahead, including the futility analysis in the first quarter and completing patient enrolment in the third quarter this year."

The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC, one of the largest and deadliest indications in oncology, by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival.

The registrational TACTI-004 Phase III has enrolled 378 patients globally and enrolment continues its robust pace. Additionally, over 140 clinical sites are now activated across 27 countries. The futility analysis and completion of patient enrolment remain on track for the first quarter and the third quarter of CY2026, respectively.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, FEB 6, 2026, View Source;v=undefined [SID1234662513])

Akari Therapeutics to Participate in the Corporate Connect Webinar Series Virtual Conference Hosted by Webull Financial

On February 5, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, reported that it will participate in the Corporate Connect Webinar Series hosted by Webull Financial being held virtually February 10-11, 2026.

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As part of the presentation, Abizer Gaslightwala, Director, President and CEO of Akari Therapeutics, will provide a corporate overview highlighting the Company’s next-generation antibody drug conjugate platform and proprietary PH1 spliceosome-modulating payload. He will discuss Akari’s lead program, AKTX-101, a Trop2-targeting ADC designed to deliver PH1 directly to tumors with limited off-target effects, as well as ongoing IND-enabling activities targeting a first-in-human trial in late 2026 or early 2027. Mr. Gaslightwala will also provide a brief update on AKTX-102, an additional ADC program focused on GI and lung cancers.

Details of the presentation are as follows:
Date and Time: Tuesday, February 10, 2026 at 1:00 PM EST
Presenter: Abizer Gaslightwala, Director, President and CEO of Akari

(Press release, Akari Therapeutics, FEB 5, 2026, View Source [SID1234662500])

PhotonPharma Inc. Announces Recruitment for Phase 1 Clinical Trial of Innocell™ Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer

On February 5, 2026 PhotonPharma Inc., a biopharmaceutical company pioneering personalized cancer immunotherapies, reported that patient recruitment has opened for its Phase 1 clinical trial evaluating Innocell in patients with recurrent epithelial ovarian cancer. The trial for Innocell, the investigational product, is registered with ClinicalTrials.gov under identifier NCT06366490.

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The clinical trial, being conducted in collaboration with City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, represents a significant milestone in developing a novel therapeutic approach that harnesses patients’ own tumor cells to stimulate targeted immune responses against their cancer.

"We are excited to begin enrolling patients in this groundbreaking trial," said Raymond P. Goodrich, PhD, Chief Executive Officer and Chief Scientific Officer of PhotonPharma. "Innocell represents a fundamentally different approach to cancer immunotherapy, presenting the complete spectrum of tumor antigens to the immune system, potentially overcoming the challenge of tumor heterogeneity that limits the effectiveness of many existing treatments."

About the Clinical Trial

The Phase 1 study will assess the safety, tolerability, and immunogenicity of Innocell in patients with recurrent epithelial ovarian cancer. The trial is designed to evaluate real-time safety profiles and measure immunologic responses following treatment with the investigational autologous cellular immunotherapy.

Addressing a Critical Unmet Medical Need

Ovarian cancer represents a significant public health challenge, with approximately 20,000 new cases diagnosed annually in the United States and approximately 13,000 deaths per year. Approximately 70-80% of patients are diagnosed at Stage III or IV, and the five-year survival rate remains approximately 50%. Despite advances in surgical techniques and chemotherapy regimens, recurrence rates remain high, with approximately 50% of patients experiencing relapse within three to five years following initial treatment.

"Patients with recurrent ovarian cancer face limited curative treatment options. City of Hope is conducting translational research to address even the most challenging cancers," said Mihae Song, M.D., Assistant Professor, Division of Gynecologic Oncology, Department of Surgery at City of Hope and principal investigator for the trial. "PhotonPharma’s approach offers a promising new avenue that could potentially help these patients by activating their own immune systems to recognize and attack cancer cells."

The Innocell Technology Platform

Innocell is an autologous cellular immunotherapy that utilizes a proprietary photochemical inactivation process involving ultraviolet light and riboflavin (vitamin B2), the same technology platform originally developed for pathogen inactivation in blood products, currently used globally. This process renders tumor cells replication-incompetent while preserving their metabolic activity, and upregulating protein expression and antigen presentation capabilities.

The patented technology enables customized treatment within approximately one week at scale, significantly faster than many current autologous cell therapies. Following tumor harvest through surgery or biopsy, cells are treated with the photochemical inactivation process and combined with an adjuvant to enhance immune activation. The processed cells are then administered intradermally to stimulate comprehensive immune responses, including activation of both cellular (T-cell mediated) and humoral (antibody-mediated) immunity.

Trial Participation Information

Patients with recurrent epithelial ovarian cancer who are interested in learning more about participation in this clinical trial should contact City of Hope or visit ClinicalTrials.gov (NCT06366490) for detailed eligibility criteria and enrollment information. The study is seeking adult patients (≥18 years old) with recurrent epithelial ovarian cancer who have received at least 1 line of platinum-based systemic therapy and for whom single-agent therapy is appropriate as the next line of treatment.

(Press release, PhotonPharma, FEB 5, 2026, View Source [SID1234662518])

Allogene Therapeutics Announces Participation in Upcoming Investor Conferences

On February 5, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in two upcoming investor conferences in the first quarter of 2026.

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Citi’s 2026 Virtual Oncology Leadership Summit
Wednesday, February 18
9:15AM PT/12:15PM ET

TD Cowen 46th Annual Health Care Conference
Tuesday, March 3
8:50AM PT/11:50AM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, FEB 5, 2026, View Source [SID1234662502])