Lytix Biopharma Highlights Positive Data on LTX-315 in Collaboration with Verrica Pharmaceuticals at 2024 Fall Clinical Dermatology Conference

24 Oct 2024 14:11 CEST

Oslo, Norway, October 24, 2024 - Lytix Biopharma, a Norwegian immuno-oncology
company, today announces the acceptance of two abstracts showcasing positive
preliminary topline results from Part 2 of the Phase II clinical study of
LTX-315 (named VP-315 by Lytix’s licensing partner Verrica Pharmaceuticals) for
the treatment of basal cell carcinoma (BCC). BCC is the largest skin cancer
disease globally with a projected global market size of USD 11.5 bn in 2028 and
3.6 million new cases in the US annually.
Presentations of study abstracts and posters are important milestones as it’s a
significant opportunity to showcase the strength and efficacy of the drug
candidate in front of industry experts and big pharma.

Dr. Øystein Rekdal, Chief Executive Officer of Lytix Biopharma, commented, “We
are excited about the strong clinical results demonstrating the potent
anticancer effects of LTX-315 in basal cell carcinoma. These results highlight
the potential of LTX-315 to serve as a non-surgical treatment for millions of
patients, offering a valuable alternative in early lines of therapy. With such
promising efficacy and safety data, we see significant commercial potential in
addressing one of the largest and fastest-growing cancer markets globally.”

The data will be presented by Verrica Pharmaceutical at the Fall Clinical
Dermatology Conference in Las Vegas from October 24-27, 2024. Verrica expects to
finalize the phase II study in H1 2025 and plans to request an End-of-phase II
meeting with the Food and Drug Administration (FDA) to determine next steps for
the development of LTX-315 for the treatment of BCC in the first half of 2025.

Multi-billion-dollar market potential
The abstracts detail clinical findings from Part 2 of the Phase II study, which
is designed to evaluate the safety, tolerability, and antitumor efficacy of
LTX-315 in patients with BCC. The study demonstrated that in approximately 51%
of treated tumors complete elimination of tumor cells were achieved, with no
treatment-related serious adverse events reported. Furthermore, the study showed
an 86 percent overall reduction of tumor size. In addition, physicians
highlighted the potential of LTX-315 to be used as a first-line therapy.

LTX-315 has the potential to offer a non-surgical alternative for the three to
four million cases of BCC diagnosed in the U.S. each year, representing a
multi-billion-dollar commercial opportunity, according to Verrica
Pharmaceuticals.

Lytix Biopharma continues to explore opportunities to bring LTX-315 to a broader
patient population, including metastatic cancer leveraging its unique mechanism
to activate systemic immune responses in cancer patients.

Licensing partners for skin cancer diseases
In 2020 Lytix entered a worldwide license agreement with Verrica Pharmaceuticals
to develop and commercialize LTX-315 for dermatologic oncology conditions (skin
cancer) except metastatic melanoma and Merkel cell carcinoma. Verrica
Pharmaceuticals is a US-based dermatology therapeutics company developing
medications for skin diseases requiring medical interventions.

Basal cell carcinomas are typically found in areas of the body more exposed to
the sun, with ~80% of BCCs located on the face and head, and the disease has a
high unmet need for new treatment options.

Financial implications and next steps
Under the license agreement with Verrica Pharmaceuticals, Lytix may receive
aggregate payments of up to USD 110 million upon achieving certain clinical,
regulatory, and sales milestones and tiered royalties based on worldwide annual
net sales ranging in the low double digits to the mid-teens.

For more information, please contact:

Dr. Øystein Rekdal, CEO
oystein.rekdal@lytixbiopharma.com
+47 975 73 358

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 novel technology based on world leading research in host-defense
peptide-derived molecules. Lytix Biopharma’s lead product, LTX-315, is a
first-in-class oncolytic molecule representing a new principle to boost
anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that can work
in many different cancer indications and treatment settings, both as mono- and
combination therapy.

About Verrica
Verrica is a dermatology therapeutics company developing medications for skin
diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102)
(cantharidin), is the first and only commercially available treatment approved
by the FDA to treat adult and pediatric patients two years of age and older with
molluscum contagiosum, a highly contagious viral skin infection affecting
approximately 6 million people in the United States, primarily children. YCANTH®
(VP-102) is also in development to treat common warts and external genital
warts, two of the largest remaining unmet needs in medical dermatology. Verrica
is developing VP-103, its second cantharidin-based product candidate, for the
treatment of plantar warts. Verrica has also entered a worldwide license
agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly
LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell
carcinoma and squamous cell carcinoma. For more information, visit
www.verrica.com.

More information:
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