Lytix Biopharma (LYTIX) investor relations material

Executive summary

• FDA cleared the path for a registrational Phase III trial of ruxotemitide plus pembrolizumab in high-risk resectable melanoma, confirming a single well-controlled trial may support approval and NDA submission, with event-free survival as the primary endpoint.

• The company is advancing clinical programs, including strong progress in the NeoLIPA Phase II study (85% enrolled) and the upcoming ALETTA Phase II study, broadening the clinical evidence base.

• Leadership team strengthened with key hires, including a new COO and CBO, to support late-stage development, partnering, and business development.

• Partnership with Verrica Pharmaceuticals continues, with new Phase II data showing a 67% reduction in untreated BCC lesions and external validation of ruxotemitide’s systemic activity.

• Moderna’s and Merck’s success with personalized cancer vaccines in melanoma has improved sentiment for neoadjuvant immunotherapy approaches.

Financial highlights

• Total operating expenses for Q2 2026 were NOK 26.8 million, flat sequentially from Q1 2026; H1 2026 operating expenses totaled NOK 53.6 million.

• Direct R&D expenses were NOK 15.9 million in Q2 2026, reflecting close-out of ATLAS-IT-05 and Phase III preparation.

• Cash and short-term financial investments stood at NOK 91.4 million at the end of June 2026, down from NOK 120.2 million at the end of March.

• Loss for H1 2026 was NOK 52.6 million, with a basic and diluted loss per share of NOK 0.72.

• Operating cash outflow was approximately NOK 29 million per quarter, providing a cash runway of roughly three quarters at the current spend rate.

Outlook and guidance

• Registrational enabling work is advancing on plan, with protocol finalization, CRO evaluation, and site selection ongoing for the pivotal Phase III trial.

• NeoLIPA Phase II top-line results are expected in the second half of 2026; ALETTA Phase II study to start in early 2027, with first readouts potentially in 2028.

• The company is actively pursuing partnerships and evaluating equity financing to fund the Phase III trial and advance the pipeline.

• Cash runway extends into 2027, supporting ongoing and planned clinical activities.