Lytix Biopharma

TekBot · mai 6, 2026, 5:01am

New Phase II Study Data from Lytix Biopharma’s Partner Verrica Pharmaceuticals to be Presented at SID 2026 Highlight Potential Abscopal Effects of Ruxotemitide in Basal Cell Carcinoma

Oslo, Norway, May 6, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) today announced that new Phase II clinical data on ruxotemitide, also known as VP-315, will be presented by its partner Verrica Pharmaceuticals Inc. (“Verrica”) at the 2026 Society for Investigative Dermatology SID) Annual Meeting, taking place May 13–16, 2026, in Chicago, Illinois.

The data suggests a potential abscopal effect of VP-315 in the treatment of basal cell carcinoma (BCC), as evidenced by reductions in the size of untreated, non-injected lesions.
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The Phase II data to be presented by Verrica showed:
• 14 untreated non-target lesions in 9 subjects demonstrated an overall 67% reduction in lesion size following treatment of treated lesions
• Reductions ranged from 50–100% in superficial lesions and 25–100% in nodular lesions
• Complete histologic clearance was observed in 21% of non-target lesions, corresponding to 3 of 14 lesions
• Reductions in tumor size were observed in all non-target lesion locations, including proximal, distal and contralateral to treated lesions
• No skip lesions were observed
• Non-serious local skin reactions were reported in 1 non-target lesion

The findings suggest that the therapeutic effects of VP-315 extended beyond treated lesions. Reductions in untreated non-target lesions suggest a potential abscopal effect consistent with broader immune activation within the tumor microenvironment of remote non-target lesions.

“These new data from Verrica further support the unique immune-activating mechanism of ruxotemitide,” said Øystein Rekdal, PhD, CEO of Lytix Biopharma. “The observed reductions in untreated non-target lesions are highly relevant to the broader clinical rationale for ruxotemitide, including its potential to target the cancer disease beyond the injected lesion.”

The SID data build on prior findings from Verrica’s Phase II BCC study, which has further validated ruxotemitide’s two-step mode of action:

Direct tumor cell disruption with release of tumor antigens and danger signals.

Subsequent immune activation, converting “cold or immunosuppressed” tumors into “hot,” immune-responsive lesions.

The data also support Lytix’s broader development strategy for ruxotemitide, including treatment settings where local tumor destruction and immune activation before surgery or other definitive intervention may provide meaningful clinical value.

Verrica is advancing VP-315 toward pivotal Phase III studies in BCC, while Lytix continues its broader oncology development strategy for ruxotemitide, including the NeoLIPA Phase II study in neoadjuvant melanoma with top line results expected 2H 2026.

Presentation details:
Poster title: VP-315 Demonstrates a Potential Abscopal Effect in Untreated Non-Target Basal Cell Carcinoma (BCC) Lesions
Poster number: LB1190
Category: Non-Melanoma Cancers and UV Biology/Injury
Presenter: Noah Rosenberg, M.D., Chief Medical Officer, Verrica Pharmaceuticals
Poster session: Friday, May 15, 2026, 4:30 p.m.–6:00 p.m.
Location: Salons B, C, D – Lower Level, Hilton Chicago

About ruxotemitide
Ruxotemitide is an investigational, first-in-class, oncolytic immunotherapy administered intratumorally, to disrupt tumor cell membranes, release tumor antigens, and activate local and systemic anti-tumor immune responses irrespective of tumor heterogeneity or PD-L1 status. Ruxotemitide is being studied in various tumor settings, including as a neoadjuvant therapy in resectable solid tumors, both as a monotherapy and in combination therapies.

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 mono- and combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.
Visit www.lytixbiopharma.com.

For further information, please contact:
Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@lytixbiopharma.com

Kilde

TekBot · mai 15, 2026, 8:17am

Lytix Biopharma: Invitation to the Q1 2026 Results Presentation

Oslo, Norway, May 15, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) will release its first quarter 2026 financial results on Thursday, May 21th, 2026.

Join us for a live webcast presentation featuring CEO Øystein Rekdal, CFO Gjest Breistein and CMO Karim Benhadji where they will discuss the results and provide key insights.
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Date: Thursday, May 21th, 2026
Time: 14:00 CET

Q&A Session:
We welcome your questions in advance. Please send them to post@lytixbiopharma.com, and they will be addressed during the Q&A session following the presentation.

Webcast Details:
The presentation and Q&A session will be conducted in English. You can view the live event by registering here: Lytix Biopharma Webcast Q1 2026

Missed the Live Session?
A recording of the presentation will be available shortly after the event on our financial reports page: https://www.lytixbiopharma.com/financial-reports

For more information, please contact:
Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@lytixbiopharma.com

About Lytix:
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 mono- and combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.
For more information, visit www.lytixbiopharma.com.

Kilde

TekBot · mai 21, 2026, 5:00am

Lytix Biopharma Q1 2026: Clinical Development Priorities On Track as Registrational Path Planning Advances

Oslo, Norway, May 21, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) today releases its results for the first quarter of 2026.

Lytix continued to execute on its established development strategy during the first quarter and post-quarter-end period, with progress across its lead asset ruxotemitide and broader oncolytic molecule platform. Clinical development priorities for 2026 and 2027 remain on track, with registrational path planning advancing for ruxotemitide in neoadjuvant melanoma.
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Ruxotemitide is supported by a strong and consistent clinical foundation across melanoma and basal cell carcinoma, including evidence of local tumor killing, systemic immune activation, durable responses, and a manageable safety profile. The Company is focused on advancing ruxotemitide toward its next stage of development through disciplined clinical planning, regulatory engagement, and continued execution.

Q1 2026 highlights and developments

The NeoLIPA Phase II neoadjuvant melanoma study continued to progress:
– 20 of 27 patients enrolled as of May 2026
– A new clinical site opened at Haukeland to support continued enrollment momentum and reduce execution risk
– Top-line results remain expected in the second half of 2026
New ATLAS-IT-05 data were presented at the American Association for Cancer Research (AACR) Annual Meeting on April 20, 2026 in San Diego. Ruxotemitide continued to demonstrate clinical and strategic relevance in advanced melanoma:
– Tumor shrinkage was observed in distant, non-treated lesions in patients who had failed prior immunotherapy
– Durable responses and disease control were observed in difficult-to-treat melanoma
– Overall survival data further supported the clinical profile of ruxotemitide in combination with pembrolizumab
Additional ATLAS-IT-05 data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 30, 2026 in Chicago
Verrica Pharmaceuticals presented new data for ruxotemitide (VP-315), on May 15, 2026 at the Investigative Dermatology Annual Meeting in Chicago
Cash and short-term financial investments amounted to NOK 120 million as of March 31, 2026
Total operating expenses amounted to NOK 26.8 million for the first quarter of 2026

Ruxotemitide remains Lytix’s lead development priority. The Company is advancing the asset in neoadjuvant melanoma through the NeoLIPA study and structured planning for a potential registrational study. In parallel, Verrica Pharmaceuticals continue preparations for a registrational Phase 3 trial with ruxotemitide as a non-surgical treatment for basal cell carcinoma.

Lytix is continuing to advance LTX-401, its proprietary preclinical oncolytic small molecule designed for deep-seated tumors. The Company is evaluating the optimal clinical development strategy for LTX-401 and continues to pursue partnering discussions to support future value creation.

Webcast details
The results will be presented in a webcast with CEO Øystein Rekdal, CFO Gjest Breistein and CMO Karim Benhadji today.

Date: Thursday, May 21, 2026
Time: 14:00 CET

Questions may be submitted in advance to: post@lytixbiopharma.com

The presentation and Q&A session will be conducted in English. You can view the live event by registering here: Lytix Biopharma Webcast Q1 2026

A recording will be available after the event at:
Lytix Biopharma | Oncolytic Immunotherapy

For more information, please contact:
Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@lytixbiopharma.com

About Lytix:
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 combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.

For more information, visit www.lytixbiopharma.com

Kilde

Hotdog · mai 22, 2026, 6:42am

Basistilfelle NOK14 (NOK13)

Vi øker sannsynligheten for godkjenning av ruxotemitide i neoadjuvant melanom noe. Vi gjør ellers begrensede endringer. Dette resulterer i en økning av vårt basistilfelle med NOK1 til NOK14. En positiv NeoLIPA-avlesning og starten av fase III i BCC kan drive aksjekursen.

https://www.redeye.se/research/1168567/lytix-biopharma-q1-review-improved-melanoma-outlook?utm_source=report&utm_medium=email&notificationId=1d2aadc3-2788-495a-b599-6211e9f585d9

TekBot · juni 1, 2026, 5:05am

Lytix Biopharma Reports Phase II Data in Melanoma and Triple-Negative Breast Cancer for Ruxotemitide (LTX-315) in Combination with Pembrolizumab

Oslo, Norway, 1 June 2026 - Lytix Biopharma ASA (“Lytix” or the “Company”), a clinical-stage immuno-oncology company developing novel intratumoral cancer therapies, today announced that clinical data evaluating intratumoral ruxotemitide (LTX-315) in combination with pembrolizumab in patients with advanced melanoma and metastatic triple-negative breast cancer (TNBC) has been presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, USA.

The poster, entitled “Safety and Efficacy of Intratumoral (IT) Ruxotemitide (LTX-315) in Combination with Pembrolizumab in Patients with Unresectable Advanced Melanoma or Triple Negative Breast Cancer (TNBC),” presents pooled data from two open-label Phase II studies of intratumoral ruxotemitide plus pembrolizumab in patients with advanced melanoma who had progressed following prior anti PD-1/PD-L1 therapy and in patients with metastatic TNBC.
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Key efficacy observations from the pooled analysis include:
• Antitumor activity was observed in heavily pretreated patients with advanced melanoma and metastatic TNBC, two populations with limited therapeutic options.
• Durable responses was obtained in melanoma patients in the context of prior PD-1/PD-L1-refractory disease.
• Systemic activity was noted, including tumor regression in non-injected lesions, supporting the potential of ruxotemitide to induce broader immune activation following local intratumoral administration.
• The safety profile observed across the studies was broadly consistent with the known effects of intratumoral immunotherapy and pembrolizumab, and the combination was manageable.

The poster was presented by Prof. Aurélien Marabelle of Gustave Roussy, France, a senior clinical investigator in cancer immunotherapy with dedicated expertise in intratumoral treatment approaches. Prof. Marabelle leads clinical and translational work focused on immune-targeted therapies and intratumoral immunotherapy and serves on the Board of Directors of the Society for Immunotherapy of Cancer (SITC).

“The pooled Phase II data show that intratumoral ruxotemitide in combination with pembrolizumab was generally manageable and demonstrated antitumor activity in two difficult-to-treat patient populations: advanced melanoma after prior anti-PD-1/PD-L1 therapy and metastatic triple-negative breast cancer,” said Prof. Aurélien Marabelle of Gustave Roussy, France. “The observation of durable responses in melanoma, disease stabilization across both studies and activity in non-injected lesions supports further clinical evaluation of this intratumoral immunotherapy approach, including in earlier treatment settings.”

“These Phase II data represent an important step in building the clinical rationale for ruxotemitide as a differentiated intratumoral immunotherapy,” said Øystein Rekdal, Chief Executive Officer of Lytix Biopharma. “Our ambition is to use local tumor destruction to initiate broader systemic antitumor immunity and thereby improve the depth and durability of responses to checkpoint inhibition. The ASCO findings strengthen our conviction that ruxotemitide should be advanced into earlier treatment settings, where immune activation may have the greatest potential to change patient outcomes.”

About Ruxotemitide (LTX-315)
Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for intratumoral administration. The molecule disrupts tumor cells locally, leading to the release of tumor antigens and danger-associated molecular signals that may activate systemic antitumor immune responses. This mechanism has the potential to convert immunologically “cold” tumors into “hot” tumors and enhance responses to checkpoint inhibitor therapies.

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.

For more information, visit www.lytixbiopharma.com.

Kilde

TekBot · juli 23, 2026, 12:16pm

Lytix Biopharma ASA: Grant of share options to management and key personnel

Oslo, Norway – 23 July 2026 – Lytix Biopharma ASA (the “Company”) announces that the Board of Directors has approved the grant of 1,230,400 share options under the Company’s long-term incentive program.

Key terms of the grants
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• Each option gives the holder the right to acquire one share in the Company at an exercise price of NOK 9.26, corresponding to the closing price of the Company’s shares on Euronext Growth Oslo on 22 July 2026.
• No consideration is payable for the grant of the options. The applicable exercise price must be paid upon exercise.
• A total of 845,900 options are subject to the Company’s standard four-year vesting schedule. Of these options, 25% will vest 12 months after the date of grant, while the remaining 75% will vest in equal monthly instalments over the following 36 months, subject to the option holder’s continued employment or engagement with the Company.
• The 384,500 options granted to Karim Benhadji are subject to a 36-month linear vesting schedule commencing in September 2025. In recognition of services provided since the commencement of the vesting period, 117,000 options are deemed vested on the date of grant. The remaining 267,500 options will vest in monthly instalments through August 2028, subject to his continued engagement with the Company.
• All options expire five years after the date of grant.

Allocation of the options
The following primary insiders have been granted options:
• Karim Benhadji, Chief Medical Officer, 384,500 options
• Renée Amundsen, Chief Operating Officer, 769,000 options

In addition, 76,900 options have been granted to a key employee who is not a primary insider.

Please refer to the notification forms appended hereto for further information regarding the option grants to primary insiders of the Company.

For further information, please contact:
Gjest Breistein, CFO
E-mail: gjest.breistein@lytixbiopharma.com

This information is subject to disclosure under section 5-12 of the Norwegian Securities Trading Act and article 19 of the Market Abuse Regulation.

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.

For more information, visit www.lytixbiopharma.com.

Kilde

TekBot · august 18, 2026, 8:32am

Lytix Biopharma Strengthens Business Development Leadership with Appointment of Timothy Herpin as Chief Business Officer

OSLO, Norway, 18 August 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”), a clinical-stage immuno-oncology company developing novel intratumoral cancer therapies, today announced the appointment of Timothy F. Herpin, Ph.D., M.B.A., as Chief Business Officer. Herpin will serve on a fractional basis effective 17 August 2026.

The appointment strengthens the Company’s global business development and partnering capabilities as Lytix advances its clinical programs and seeks strategic partnerships across its portfolio.
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Herpin brings more than 25 years of experience in pharmaceutical and biotechnology business development, spanning licensing, co-development and co-commercialization partnerships, mergers and acquisitions, and portfolio strategy across oncology and other therapeutic areas.

“We are in an important phase for Lytix as we advance ruxotemitide and build the partnerships required to realize the full value of our portfolio,” said Øystein Rekdal, Chief Executive Officer of Lytix Biopharma. “Tim brings extensive transaction experience, a strong international network and a deep understanding of how to position innovative oncology assets for potential partners. His appointment strengthens our ability to move partnering discussions from initial engagement through diligence, negotiation and execution.”

As Chief Business Officer, Herpin will lead Lytix’s global business development and partnering activities. Working closely with the CEO, management team and Board of Directors, he will develop and execute the Company’s partnering strategy.

Prior to joining Lytix, Herpin founded Anza Advisors, where he provides fractional Chief Business Officer services to biotechnology companies. He previously served as Chief Business Officer of Santa Ana Bio, where he led business development ,contributing to raise a $125 million Series B financing, and of Caribou Biosciences, where he helped shape the company’s strategy for a portfolio of allogeneic CAR-T cell therapies. He also spent five years as Vice President and Head of Transactions, Business Development at AstraZeneca, leading licensing, M&A and partnering transactions across oncology and other disease areas. During his career, Herpin also held senior business development roles at Johnson & Johnson and Bristol Myers Squibb.

“I am pleased to join Lytix at this point in the Company’s development,” said Herpin. “Lytix has built a differentiated immuno-oncology portfolio supported by encouraging clinical and scientific evidence. I look forward to working with the team to strengthen the Company’s partnering strategy, engage relevant global companies and advance discussions toward value-creating transactions.”

About Lytix
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 mono- and combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX. For more information, visit www.lytixbiopharma.com.

Kilde

TekBot · august 21, 2026, 5:31am

Lytix Biopharma: Invitation to the Q2 2026 Results Presentation

Oslo, Norway, August 20, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) will release its second quarter 2026 financial results on Thursday, August 27th, 2026.

Join us for a live webcast presentation featuring CEO Øystein Rekdal, CFO Gjest Breistein, CBO Timothy Herpin, and CMO Karim Benhadji where they will present the quarterly update and provide key insights.
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Date: Thursday, August 27th, 2026
Time: 14:00 CET

Q&A Session:
We welcome your questions in advance. Please send them to post@lytixbiopharma.com, and they will be addressed during the Q&A session following the presentation.

Webcast Details:
The presentation and Q&A session will be conducted in English. You can view the live event by registering here: Lytix Biopharma Webcast Q2 2026

Missed the Live Session?
A recording of the presentation will be available shortly after the event on our financial reports page: Lytix Biopharma | Oncolytic Immunotherapy

For more information, please contact:
Gjest Breistein, CFO
+47 952 60 512
gjest.breistein@lytixbiopharma.com

About Lytix
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 mono- and combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX. For more information, visit www.lytixbiopharma.com.

Kilde

TekBot · august 26, 2026, 3:02pm

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
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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.

Kilde

polygon · august 26, 2026, 3:29pm

En stor randomisert fase II med ordentlig statistikk - det var positivt! Nå får man forhåpentligvis endelig et ordentlig svar på om LTX-315 funker i føflekkreft.

Lite info om den studien foreløpig, men jeg fant denne posten på Linkedin. Man har tydeligvis slitt med finansieringen, noe som forhåpentligvis er løst nå. Designet virker temmelig avansert på sliden der:

Newcomer · august 26, 2026, 3:52pm

Var det denne studien Verrica egentlig skulle finansiere?

Timm · august 26, 2026, 6:10pm

Boms · august 26, 2026, 6:36pm

@polygon Er 47 pasienter nok til å få tydelige nok svar? I mitt hode som ikke har rørt statistikk pensumet i dette årtusenet, høres det litt tynt ut, og det gjøres kanskje ikke noe lettere av at det er forskjeller i de andre armene også??

polygon · august 26, 2026, 7:39pm

Vanskelig å mene noe definitivt før man får sett designet, men når alle de 47 tydeligvis er selektert for de samme biomarkørene (som man jo må tolke “arm” i entall til) og om de kan sammenlignes med minst like mange i en kontrollarm så er det ganske sterk statistikk ja. LTX-315 må ha veldig tydelig effekt for å få lav p-verdi, men dette er en helt ny sjanse i selskapet og legemiddelets (lange) historie for å få vist nettopp det.

TekBot · august 27, 2026, 4:55am

FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma

Oslo, Norway, August 27, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”), a clinical-stage immuno-oncology company developing novel intratumoral cancer therapies, today announced feedback from its July meeting with the U.S. Food and Drug Administration (FDA) on the planned registrational trial of ruxotemitide (LTX-315) in combination with pembrolizumab in high-risk resectable melanoma.

The FDA raised no objection to Lytix’s proposed randomized Phase III trial of neoadjuvant ruxotemitide plus pembrolizumab versus pembrolizumab alone, with event-free survival (EFS) as the primary endpoint. The FDA also confirmed that a single well-controlled trial may support a New Drug Application, depending on the totality of the data generated.
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The FDA feedback follows previously reported interim data from NeoLIPA, an ongoing investigator-initiated Phase 2 study of neoadjuvant ruxotemitide in combination with pembrolizumab. Among the first 9 evaluable patients, 88% achieved an overall pathological response, including 55% with a major pathological response and 44% with a complete pathological response, with no relapses reported at the time of the analysis. Top-line results are expected in the second half of 2026.

“This constructive feedback from the FDA on our registrational study design removes a key source of uncertainty as we look toward a registrational trial. I want to thank our clinical, regulatory, and scientific teams for the work that went into this program over many years,” Øystein Rekdal, Ph.D., CEO of Lytix, commented.

Lytix will continue preparations for the registrational study within its existing capital-efficient plan, and recently appointed Timothy F. Herpin, Ph.D., M.B.A., as Chief Business Officer on a fractional basis to lead partnership discussions. “With a defined regulatory pathway and a well-supported combination approach with pembrolizumab now in hand, we are well positioned to actively pursue partnerships to fund and execute the study and evaluate alternative options to advance the program,” added Rekdal.

About Ruxotemitide (LTX-315)
Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for intratumoral administration. The molecule disrupts tumor cells locally, leading to the release of tumor antigens and danger signals that may activate systemic antitumor immune responses. This mechanism has the potential to convert immunologically “cold” tumors into “hot” tumors and enhance responses to checkpoint inhibitor therapies.

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.

For further information, please contact:
Gjest Breistein, CFO
gjest.breistein@lytixbiopharma.com
+47 952 60 512

Kilde

TekBot · august 27, 2026, 5:01am

Lytix Biopharma Q2 2026: FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma, Marking Defining Milestone

Oslo, Norway, August 27, 2026 – Lytix Biopharma ASA (“Lytix” or the “Company”) today reported second quarter and first half 2026 results, highlighted by a defining regulatory milestone: No objection from the U.S. Food and Drug Administration (FDA) on the registrational study design for ruxotemitide in combination with pembrolizumab in high-risk resectable melanoma, removing a key source of uncertainty on the path to full approval.

The FDA feedback, announced in a separate release earlier today, marks a major milestone in the ruxotemitide program and gives Lytix a clear regulatory pathway toward full approval. Lytix is continuing to advance preparations for the registrational study while actively pursuing partnerships to fund and execute the study and evaluate alternative options to advance the program. Supported by continued progress across its pipeline and a strengthened leadership team, Lytix enters the second half of 2026 from a meaningfully de-risked position and with strong momentum.
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“This FDA feedback is a defining milestone for our ruxotemitide program. It removes a key source of regulatory uncertainty and gives us clarity on the path to full approval,” said Øystein Rekdal, Ph. D., CEO of Lytix Biopharma. “We are continuing to advance preparations for the registrational study, and given its scale, we are also actively pursuing the right partner to support it through to potential regulatory approval and bring this program to patients.”

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

Q2 2026 highlights and developments and post-quarter
• Lytix received feedback from the U.S. Food and Drug Administration (FDA) post quarter on the registrational study design for ruxotemitide in combination with pembrolizumab, supporting a potential path to full regulatory approval.
• The NeoLIPA Phase II neoadjuvant melanoma study continued to progress:
o 85% of planned patients enrolled as of August 2026
o Top-line results remain expected in the second half of 2026
• Lytix partnered with a leading investigator on ALETTA, an investigator-initiated, multi-arm Phase II study of ruxotemitide in combination with ipilimumab and nivolumab in resectable stage III melanoma, conducted independently by the Netherlands Cancer Institute (NKI) and the European Institute of Oncology (IEO). The study includes a randomized comparison of ipilimumab and nivolumab with and without ruxotemitide in IFN-γ-low patients, with 47 patients in the Lytix-relevant arm, and is expected to start in early 2027.
• Final Phase II results were presented at the AACR Annual Meeting 2026 in San Diego on April 20, 2026.
• Aggregate ATLAS-IT-03/ATLAS-IT-05 data were presented at the ASCO Annual Meeting on May 30, 2026, in Chicago.
• LTX-401 continued to advance through pre-clinical development.
• Leadership team was strengthened with two key hires: Renée Christine Amundsen joined as Chief Operating Officer, and Timothy F. Herpin, Ph.D., M.B.A., joined as Chief Business Officer on a fractional basis.
• Verrica Pharmaceuticals has stated they continue to prepare for a Phase III program for ruxotemitide (VP-315) in basal cell carcinoma, including CRO selection and manufacturing of Phase III clinical supplies.
• Cash and short-term financial investments amounted to NOK 91.4 million as of June 30, 2026 (NOK 120 million Q1 2026).
• Total operating expenses amounted to NOK 26.8 million for the second quarter of 2026 (NOK 5.15 million, Q2 2025).

Lytix enters the second half of 2026 from a meaningfully de-risked position, with FDA feedback on the registrational study design secured, a strengthened organization, and a clear regulatory path to approval. Consistent with its capital-efficient, partnership-driven strategy, the Company continues to advance registrational-enabling activities while pursuing partnering discussions and evaluating alternative options to advance the program. In parallel, is advancing LTX-401 toward a clinical entry in 2027. The Company has the financial flexibility to execute this strategy and remains confident in its path forward.

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

Webcast details:
Date: Thursday, August 27, 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:
Lytix Biopharma Webcast Q2 2026

A recording of the presentation will be made available after the webcast at:
Lytix Biopharma | Oncolytic Immunotherapy

The interim report for the first half of 2026 and the second 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.

Kilde

polygon · august 27, 2026, 5:30am

Jaggu. Da mangler de bare en milliard eller noen som vil betale en milliard da. Skal være rimelig overbevisende data fra NeoLIPA for å få til det. Tror de trenger ALETTA også for å komme dit.

Dreamliner · august 27, 2026, 5:43am

Det er kombinasjonen med Keytruda de har diskutert med FDA. Ikke de to andre . Det var en overraskende melding.

polygon · august 27, 2026, 5:46am

Klar over det. Men CTLA-4 hemmer i tillegg til en PD-1 i en randomisert studie vil gi mye sterkere visshet om at LTX funker enn de signalene man får med PD-1 alene i en enarmet.

TekBot · september 2, 2026, 8:01pm