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

LYTIXRegulatoriskt pressmeddelande2026-11-13 07:00
Läs börsmeddelandet
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:
o All patients enrolled
o In the evaluable population, the pathological complete response (pCR) rate met
the protocol's prespecified success criterion of at least 40%.
o No new safety signals were identified
o 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-rep
orts

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.
cations and treatment settings\, both as monotherapy and in combination\
therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.\