ImPact Biotech Announces Completion of Treatment in Phase 3 ENLIGHTED Trial of Padeliporfin VTP in LG-UTUC and Positive Regulatory Updates

– Successful treatment of 91 patients with consistent safety and efficacy results observed to date; interim data to be presented at ESMO Congress in October 2026 –

– Written feedback from FDA following pre-NDA meeting acknowledge the potential clinical meaningfulness of Padeliporfin VTP in LG-UTUC and support path to NDA submission in 2027 –

– Expanded access program (EAP) discussions with the FDA are currently underway to expand patient reach and support real-world clinical use –

TEL AVIV, Israel, Sept. 09, 2026 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, today announced the completion of treatment for all required patients enrolled in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC). Completion of treatment, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the Company's planned reporting of topline data and anticipated NDA submission in 2027.

“The completion of treatment for all required patients in the Phase 3 ENLIGHTED trial represents a major milestone towards our goal of delivering a next-generation treatment option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “Preliminary clinical data to date show encouraging complete response rates, durability of response, and a consistent safety profile, further supporting Padeliporfin VTP’s potential to provide a minimally invasive, organ-sparing treatment option in LG-UTUC. This, alongside the existing dataset for Padeliporfin across solid tumor indications, gives us confidence in its potential to shift the treatment paradigm for these difficult-to-treat diseases and improve patient outcomes.”

Following ImPact’s positive pre-NDA meeting in April 2026, “the FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporfin-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area.” The agency has confirmed the registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer for submission in LG-UTUC in 2027.

Additionally, the Company has engaged in discussions with the FDA regarding a potential expanded access program (EAP) for eligible patients with LG-UTUC in the US. The program would enable access to Padeliporfin VTP to qualifying patients prior to potential regulatory approval.

“With treatment now complete in the Phase 3 ENLIGHTED trial and following positive recent interactions with the FDA, our focus remains on bringing Padeliporfin VTP to patients as efficiently as possible,” said Barak Palatchi, Chief Executive Officer of ImPact Biotech. “The FDA’s feedback further supports our confidence in the program and its path toward regulatory submission. Recognizing the significant unmet need among LG-UTUC patients, the potential for an expanded access program for Padeliporfin VTP underscores our commitment to expanding patient access and supporting treating physicians. We look forward to reporting topline results and advancing towards regulatory submission in 2027, while evaluating strategic commercialization opportunities to maximize patient reach.”

ImPact plans to present interim data from the Phase 3 ENLIGHTED trial in LG-UTUC at the ESMO Congress taking place from October 23-27, 2026 in Madrid.

ePoster Title: Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial
Presenter: Asaf Shvero, M.D., Department of Urology, Sheba Medical Center
Poster Number: 4860eTiP
Category: Urothelial Cancer

About ENLIGHTED

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact enrolled 91 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy was performed, via an ureteroscopy which applied a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) was achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

About ImPact Biotech
ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a Phase 1 light dose escalation study in unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com.

Contacts

Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com