Lytix to Partner with Leading Investigator on ALETTA Study Testing Ruxotemitide in Combination with Ipilimumab and Nivolumab in Early-stage Resectable Melanoma

Oslo, Norway, August 26, 2026 - Lytix Biopharma ASA ("Lytix" or "the Company"), a clinical-stage immuno-oncology company developing novel intratumoral cancer therapies, today announces its collaboration in a new investigator-initiated Phase II study in melanoma (ALETTA) in Europe

Investigator-led study by Prof. Christian Blank, could deliver the first clinical validation of ruxotemitide beyond pembrolizumab, complementing the company's registrational path

The study, led by Prof. Christian Blank, MD, PhD, will investigate ruxotemitide (formerly LTX-315) in combination with ipilimumab plus nivolumab, a standard of care in early-phase melanoma patients alongside pembrolizumab.

"Our drug candidate has already shown preliminary positive effects in combination with pembrolizumab in our NeoLIPA study, and this new study gives us the opportunity to generate clinical evidence with the other standard of care backbone in neoadjuvant melanoma," said Øystein Rekdal, CEO of Lytix Biopharma. “Partnering with Prof. Blank, one of the true pioneers of neoadjuvant immunotherapy in melanoma, on a biomarker-defined study targeting patients who respond poorly to ipilimumab plus nivolumab today makes this an especially valuable addition to our evidence base."

The ALETTA study is a multi-arm Phase II study is evaluating ruxotemitide in patients with resectable stage III melanoma. The study is designed and conducted by the Netherlands Cancer Institute (NKI) and the European Institute of Oncology (IEO), and will be implemented together with each eight Dutch and Italiane melanoma expert centers, implying broad expertise for Lytix. The study will be led by Professor Christian Blank, MD, PhD, a globally recognized expert and pioneer in neoadjuvant immunotherapy for melanoma. His landmark OpACIN, OpACIN-neo, PRADO, DONIMI, and NADINA trials helped establish checkpoint inhibitor therapy before surgery as a new standard of care for patients with melanoma, and the background knowledge for personalized neoadjuvant immunotherapy, now tested in ALETTA.

Both neoadjuvant ipilimumab plus nivolumab and perioperative pembrolizumab are used today as standard of care options in neoadjuvant treatment of stage III melanoma. “By generating the first randomized, controlled clinical data on ruxotemitide added to ipilimumab plus nivolumab, ALETTA will complement the existing clinical evidence with pembrolizumab and strengthen the evidence for ruxotemitide across the two leading checkpoint inhibitor regimens used in melanoma. Patient enrollment in the ipilimumab/nivolumab plus ruxotemitide comparison is expected to begin in early 2027.

"Despite the progress made with checkpoint inhibitor combinations in stage III melanoma, patients with low interferon-gamma signatures continue to have substantially worse outcomes," said Prof. Christian Blank, MD, PhD, NKI and IEO. "The preclinical rationale for combining ruxotemitide with ipilimumab and nivolumab in this population is compelling, and I look forward to testing whether this combination can meaningfully improve pathological response rates for patients who are currently underserved by standard of care."

About the ALETTA Study ALETTA is an investigator-initiated, multi-arm Phase II study in patients with pathologically proven resectable stage III melanoma with at least one lymph node metastasis. The study is led by Prof. Christian Blank in The Netherlands and Italy is conducted as investigator initiated trial sponsored by the NKI and the IEO as delegated sponsor for Italy. The study includes a randomized comparison of ipilimumab and nivolumab alone versus ipilimumab and nivolumab plus ruxotemitide in patients with low interferon-gamma signatures alongside additional treatment arms. Total planned enrolment across the multi-arm study exceeds 260 patients, of which 47 will be randomized within the ipilimumab/nivolumab plus ruxotemitide comparison arm relevant to Lytix.

About Ruxotemitide (LTX-315) Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for intratumoral administration. The molecule killstumor cells locally, leading to the release of tumor antigens (mutated proteins) and danger signals that can activate systemic anti-tumor immune responses. This mechanism has the potential to convert immunologically “cold” (no or few immune cells) tumors into “hot” (immune cell infiltrated) tumors and enhance responses to checkpoint inhibitor therapies.

About Lytix Biopharma Lytix Biopharma is a clinical-stage biotech company based in Oslo, Norway, developing a highly differentiated oncolytic molecule platform based on world-leading research in host-defense peptide-derived molecules. The Company’s lead product, ruxotemitide (formerly LTX-315), is a first-in-class oncolytic molecule designed to induce durable anti-cancer immunity. Lytix has a pipeline of product candidates with potential applications across multiple cancer indications and treatment settings, both as mono- and combination therapy.

Lytix is listed on Euronext Growth Oslo under the ticker symbol LYTIX.