Lytix Biopharma Q2 2026: FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma, Marking Defining Milestone
Oslo, Norway, August 27, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) today reported second quarter and first half 2026 results, highlighted by a defining regulatory milestone: No objection from the U.S. Food and Drug Administration (FDA) on the registrational study design for ruxotemitide in combination with pembrolizumab in high-risk resectable melanoma, removing a key source of uncertainty on the path to full approval.
The FDA feedback, announced in a separate release earlier today, marks a major milestone in the ruxotemitide program and gives Lytix a clear regulatory pathway toward full approval. Lytix is continuing to advance preparations for the registrational study while actively pursuing partnerships to fund and execute the study and evaluate alternative options to advance the program. Supported by continued progress across its pipeline and a strengthened leadership team, Lytix enters the second half of 2026 from a meaningfully de-risked position and with strong momentum.
“This FDA feedback is a defining milestone for our ruxotemitide program. It removes a key source of regulatory uncertainty and gives us clarity on the path to full approval,” said Øystein Rekdal, Ph. D., CEO of Lytix Biopharma. “We are continuing to advance preparations for the registrational study, and given its scale, we are also actively pursuing the right partner to support it through to potential regulatory approval and bring this program to patients.”
The Company’s second quarter 2026 results and developments will be presented in a live webcast with CEO Øystein Rekdal, CFO Gjest Breistein, CMO Karim Benhadji and CBO Timothy Herpin today at 14:00 CET.
Q2 2026 highlights and developments and post-quarter • Lytix received feedback from the U.S. Food and Drug Administration (FDA) post quarter on the registrational study design for ruxotemitide in combination with pembrolizumab, supporting a potential path to full regulatory approval. • The NeoLIPA Phase II neoadjuvant melanoma study continued to progress: o 85% of planned patients enrolled as of August 2026 o Top-line results remain expected in the second half of 2026 • Lytix partnered with a leading investigator on ALETTA, an investigator-initiated, multi-arm Phase II study of ruxotemitide in combination with ipilimumab and nivolumab in resectable stage III melanoma, conducted independently by the Netherlands Cancer Institute (NKI) and the European Institute of Oncology (IEO). The study includes a randomized comparison of ipilimumab and nivolumab with and without ruxotemitide in IFN-γ-low patients, with 47 patients in the Lytix-relevant arm, and is expected to start in early 2027. • Final Phase II results were presented at the AACR Annual Meeting 2026 in San Diego on April 20, 2026. • Aggregate ATLAS-IT-03/ATLAS-IT-05 data were presented at the ASCO Annual Meeting on May 30, 2026, in Chicago. • LTX-401 continued to advance through pre-clinical development. • Leadership team was strengthened with two key hires: Renée Christine Amundsen joined as Chief Operating Officer, and Timothy F. Herpin, Ph.D., M.B.A., joined as Chief Business Officer on a fractional basis. • Verrica Pharmaceuticals has stated they continue to prepare for a Phase III program for ruxotemitide (VP-315) in basal cell carcinoma, including CRO selection and manufacturing of Phase III clinical supplies. • Cash and short-term financial investments amounted to NOK 91.4 million as of June 30, 2026 (NOK 120 million Q1 2026). • Total operating expenses amounted to NOK 26.8 million for the second quarter of 2026 (NOK 5.15 million, Q2 2025).
Lytix enters the second half of 2026 from a meaningfully de-risked position, with FDA feedback on the registrational study design secured, a strengthened organization, and a clear regulatory path to approval. Consistent with its capital-efficient, partnership-driven strategy, the Company continues to advance registrational-enabling activities while pursuing partnering discussions and evaluating alternative options to advance the program. In parallel, is advancing LTX-401 toward a clinical entry in 2027. The Company has the financial flexibility to execute this strategy and remains confident in its path forward.
The interim report has been prepared in accordance with IAS 34 and includes financial information for the second quarter and the first half of 2026.
Webcast details: Date: Thursday, August 27, 2026 Time: 14:00 CET Questions may be submitted in advance to: post@lytixbiopharma.com
The presentation and subsequent Q&A session will be conducted in English and can be viewed live by registering here: https://qcnl.tv/p/wFBmNeuCBCK8I_UvrCJ8Dg
A recording of the presentation will be made available after the webcast at: https://www.lytixbiopharma.com/investors/reports-and-presentations/financial-reports
The interim report for the first half of 2026 and the second quarter presentation are available on the Company’s website.
For further information, please contact: Gjest Breistein, CFO gjest.breistein@lytixbiopharma.com +47 952 60 512
About Lytix Biopharma Based in Oslo, Norway, Lytix Biopharma is a clinical-stage biotech company with a highly differentiated oncolytic molecule platform based on world-leading research in host-defense peptide-derived molecules. Lytix Biopharma's lead product, ruxotemitide (formerly LTX-315), is a first-in-class oncolytic molecule representing a new approach to maintaining durable anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that work across multiple cancer indications and treatment settings, both as monotherapy and in combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.