Lytix Biopharma AS said the U.S. Food and Drug Administration raised no objections to its proposed Phase III trial design for ruxotemitide in combination with pembrolizumab for high-risk resectable melanoma, clearing a key regulatory hurdle.
The company’s shares rose 4.83% to $8.24 following the disclosure, which follows interim data from an investigator-led Phase II study showing an 88% overall pathological response rate in the first nine evaluable patients. The trial, led by Dr. Henrik Jespersen at The Norwegian Radium Hospital, reported a 55% major pathological response and 44% complete pathological response, with no relapses observed at the time of analysis.
Lytix’s Chief Executive Øystein Rekdal said the FDA feedback "clears the path to a registrational Phase III study" of the combination therapy. Chief Medical Officer Karim Benhadji noted the agency raised no objections to the trial’s randomized, open-label design, the primary endpoint of event-free survival, or the use of pembrolizumab as a single-agent comparator. The FDA also indicated that a single well-controlled trial may suffice for registration, pending the totality of data submitted in the New Drug Application.
Operating expenses totaled NOK 26.8 million in the second quarter, unchanged from the prior quarter, while the company reported a net loss of NOK 52.6 million for the first half of 2026. Cash and short-term investments stood at NOK 91.4 million as of June 30, down from NOK 120.2 million at the end of March, reflecting an operating cash outflow of approximately NOK 29 million per quarter. The current cash position supports a runway of roughly three quarters.
The company maintains revenue projections of $3.52 million for fiscal 2026 and $8.31 million for 2027, while total liabilities declined to NOK 13.7 million from NOK 19.8 million at year-end 2025. Lytix’s cash position comprises NOK 29 million in cash and NOK 62.4 million in short-term financial investments.
Separately, Verrica Pharmaceuticals completed Phase II testing of ruxotemitide (VP-315) in basal cell carcinoma, reporting a 67% reduction in untreated non-target lesions and complete histological clearance in 21% of cases. Verrica has not set a specific start date for its Phase III program, which remains in planning stages. Lytix’s LTX-401 is in late-stage preclinical development with a planned clinical entry in 2027.
The company also highlighted investigator-initiated studies evaluating ruxotemitide combinations in melanoma and triple-negative breast cancer, with pooled data presented at recent medical conferences. Chief Financial Officer Gjest Breistein said the company’s spending in the first half of 2026 "bought regulatory clarity on the fastest available route to registration."
