Lytix Biopharma ASA

Lytix Biopharma Q3 2026: Positive NeoLIPA Results Strengthen Basis for Phase III in Melanoma

Källa: Cision
Positiv

Sammanfattning

Lytix Biopharma rapporterar positiva topplinjeresultat från Fas II NeoLIPA-studien för ruxotemitide i neoadjuvant melanom, vilket uppfyller primärt effektmål. FDA har även gett positiv feedback gällande Fas III-studiedesignen.

Analys

Bolaget presenterar positiva topplinjeresultat från Fas II NeoLIPA-studien som uppfyllt sitt primära effektmål (pCR >= 40%). Detta, tillsammans med FDA:s bekräftelse att en Fas III-studie kan vara tillräcklig för godkännande och att de inte har några invändningar mot studiedesignen, stärker bolagets position för marknadsintroduktion i USA. Förberedelser för Fas III och en ny Fas II-studie (ALETTA) pågår, vilket indikerar en tydlig framåtrörelse. De finansiella resultaten visar på en minskad kassa och fortsatt förlust, men kassaflödesförbränningen minskade något jämfört med tidigare kvartal.
Se relaterad nyhet

VD-ord

optimistisk · PDF

Fas II-studien NeoLIPA uppnådde primärt effektmål. FDA har bekräftat att en Fas III-studie kan räcka för amerikanskt godkännande. Bolaget söker partnerskap för att finansiera Fas III.

Utsikter: FDA har bekräftat att en Fas III-studie kan räcka för amerikanskt marknadsgodkännande av ruxotemitid i kombination med pembrolizumab för neoadjuvant behandling av melanom.

Nyckeltal

pCR rate in evaluable population
>= 40%
Cash and short-term financial investments Q3 2026
NOK 67.3 million
Cash and short-term financial investments Q2 2026
NOK 91.4 million
Total operating expenses Q3 2026
NOK 27.9 million
Loss for the period Q3 2026
NOK 26.1 million
Cash burn Q3 2026
NOK 24.1 million

Insikter

  • • De positiva studieresultaten och FDA:s feedback är en stark katalysator för bolaget.
  • • Förberedelserna för Fas III och ALETTA-studien indikerar en tydlig framåtrörelse.
  • • Den ökade kostnaden för FoU reflekterar förberedelserna för den kommande Fas III-studien.
Fundamental påverkan
Positiv

Positiva kliniska resultat och regulatorisk feedback stärker potentialen för framtida marknadsintroduktion och därmed bolagets långsiktiga värde.

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Oslo, Norway, November 13, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) today reported third quarter 2026 results, highlighted by the Phase II NeoLIPA study of ruxotemitide in neoadjuvant melanoma meeting its primary endpoint.

The NeoLIPA result, together with the FDA’s earlier no-objection to the proposed registrational study design, strengthens the basis for moving into Phase III. The proposed study will evaluate ruxotemitide combined with pembrolizumab compared with pembrolizumab alone, given before surgery in melanoma patients at high risk of recurrence. Work on the study protocol and the selection of a CRO and clinical sites is progressing. In parallel, ALETTA, a multi-arm Phase II study of ruxotemitide in combination with ipilimumab and nivolumab in resectable stage III melanoma, is on track to begin in early 2027.

“NeoLIPA meeting its primary endpoint, together with the FDA’s feedback, moves ruxotemitide a significant step closer to a registrational study in neoadjuvant melanoma. We look forward to presenting the top-line results in a late-breaking oral presentation at ESMO Immuno-Oncology in London on December 15, 2026” said Øystein Rekdal, Ph.D., CEO of Lytix Biopharma.

The Company’s third quarter 2026 results and developments will be presented in a live webcast with CEO Øystein Rekdal, PhD; CFO Gjest Breistein; and CMO Karim Benhadji, MD today at 14:00 CET.

Q3 2026 highlights and developments and post-quarter

  • FDA feedback outlines the path to US market approval: the FDA has confirmed that a single well-designed Phase III study may be sufficient to apply for  approval in the US, depending on the overall results, and raised no objection to the proposed study design
  • The NeoLIPA Phase II neoadjuvant melanoma study met its primary endpoint:
    • All patients enrolled
    • In the evaluable population, the pathological complete response (pCR) rate met the protocol’s prespecified success criterion of at least 40%.
    • No new safety signals were identified
    • NeoLIPA Phase II results will be presented in a late-breaking oral presentation at the ESMO Immuno-Oncology & Advanced Therapies Congress in London on December 15, 2026.
  • ALETTA, a multi-arm Phase II study of ruxotemitide in combination with ipilimumab and nivolumab in resectable stage III melanoma, led by Prof. Christian Blank across multiple European clinical sites, is on track to begin in early 2027
  • Preparations for the Phase III study are underway, including work on the study protocol and the selection of a CRO and clinical sites
  • Following positive results in Phase 2, Verrica is exploring a proof-of-concept study of ruxotemitide (VP-315) in Gorlin syndrome, an inherited condition marked by a high number of BCCs and repeated surgery
  • According to Verrica a proof-of-concept study in Gorlin syndrome could clarify VP-315's role in multiple-lesion BCC in addition to the ongoing BCC program
  • LTX-401 continued to advance through pre-clinical development.
  • Cash and short-term financial investments amounted to NOK 67.3 million as of September 30, 2026 (NOK 91.4 million as of June 30, 2026)
  • Total operating expenses amounted to NOK 27.9 million for the third quarter of 2026 (NOK 24.3 million, Q3 2025)
  • Direct R&D expenses of NOK 14.3 million were the largest cost component, reflecting preparation for the planned registrational trial
  • Loss for the period was NOK 26.1 million for the third quarter of 2026 (NOK 23.3 million, Q3 2025)
  • Cash burn was NOK 24.1 million in Q3 2026, down from approximately NOK 29 million in each of the first two quarters of 2026.

Lytix enters the final weeks of 2026 with strong forward momentum: a positive Phase II result in neoadjuvant melanoma, FDA feedback on the path to approval, and Phase III preparations well underway. The next key milestones are the presentation of full NeoLIPA data and the start of ALETTA in early 2027, with LTX-401 also being prepared for clinical entry.

The interim report has been prepared in accordance with IAS 34 and includes financial information for the third quarter of 2026.

Webcast details: Date: Friday, November 13, 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/7YpgKFsTuKpxolSOKBNeSw

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 third quarter of 2026 and the third 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.

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