TORL BioTherapeutics Secures $96M Series C Financing and Presents Updated Phase 1 Results of Novel Claudin 6 Targeted Antibody-Drug Conjugate TORL-1-23 at the 2025 European Society of Medical Oncology Congress

Secured $96M Series C Financing; Total Raised Since 2019 Founding Exceeds $450M

Proceeds Fund the Clinical Development of TORL-1-23, Currently in a Registrational Phase 2 Study for Claudin 6 Positive (CLDN6+) Platinum-Resistant Ovarian Cancer and in Phase 1 for other CLDN6+ Cancers including Non-Small Cell Lung Cancer

Updated Data for TORL-1-23 in Patients with CLDN6+ Advanced Solid Tumors To Be Presented in Poster Session at ESMO 2025

LOS ANGELES, Oct. 7, 2025 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, today announced closing of a $96 million Series C financing. Additionally, updated results from the ongoing Phase 1 study of the Company's Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) TORL-1-23 in patients with advanced cancer will be presented in poster sessions at the 2025 European Society of Medical Oncology Congress (ESMO 2025) in Berlin, Germany.

"This financing ensures TORL is able to further the clinical development of TORL-1-23, our first- and potentially best-in-class Claudin 6 targeted ADC for women living with platinum-resistant ovarian cancer," said Mark J. Alles, Chairman and Chief Executive Officer of TORL BioTherapeutics. "We appreciate the support from our new and existing world-class life sciences investors who share our passion to discover and develop new targeted treatment options for patients with cancer."

Proceeds from this financing will advance CATALINA-2, the ongoing pivotal Phase 2 study of TORL-1-23 for CLDN6+ patients with platinum-resistant ovarian cancer (PROC) to pivotal data readout in 2027, and CATALINA-3, the confirmatory Phase 3 study of TORL-1-23 in CLDN6+ PROC initiating in 2026. In addition, funds will support registration-enabling Phase 2 and Phase 3 studies, as well as ongoing Phase 1 studies and IND-enabling work across TORL's pipeline of novel high-value targets in solid tumors and hematologic malignancies.

Updated data from the TORL-1-23 Phase 1 study will be presented at ESMO 2025 (#1074P). In this ongoing study, patients with heavily pretreated CLDN6+ ovarian, testicular, endometrial, non-small cell lung and other cancers were enrolled across multiple dose cohorts. Emerging efficacy data from this study supported further evaluation of TORL-1-23 in larger, registrational studies.

In November 2024, TORL initiated CATALINA-2, a study designed to support accelerated registration of TORL-1-23 for CLDN6+ PROC. CATALINA-2 is a global, multi-institutional, randomized, open-label Phase 2 study of TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. A CATALINA-2 Trial-in-Progress poster will be presented at ESMO 2025 (#1225TiP).

"The maturing clinical profile of TORL-1-23 continues to demonstrate the potential to improve treatment outcomes for patients with CLDN6+ platinum-resistant ovarian cancer, a defined subset of the disease with particularly poor prognosis," said Scientific Co-founder and Board Member Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine. "TORL-1-23 is the first of multiple high potential therapeutics to emerge from this unique academic-industry collaboration to redefine drug development from bench to bedside."

"TORL's mission is to discover, develop and commercialize antibody-based therapeutics to improve and extend the lives of people with cancer worldwide," said Dave Licata,Co-founder, Board Member, President, and Chief Financial Officer. "Thanks to our dedicated employees and committed investors, we are well-positioned to advance the TORL-1-23 clinical program and our emerging pipeline across solid tumors and hematologic malignancies."

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in several cancers with limited to no detectable expression observed in normal tissues, making it an ideal target for ADC development. CLDN6 is a transmembrane protein and member of a family of proteins important for cell-to-cell connectivity in normal tissues. CLDN6 expression normally occurs during embryonic and fetal development but not in adult tissues. Overexpression of CLDN6 occurs in specific malignancies and has been implicated in the pathogenesis of certain cancers including ovarian, non-small cell lung, endometrial and testicular malignancies. High expression correlates with shortened survival outcomes for patients with ovarian cancer.

About TORL-1-23

TORL-1-23 is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC. Further details can be found at https://clinicaltrials.gov/study/NCT06690775.

About CATALINA-2

CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at https://clinicaltrials.gov/study/NCT06690775.

About TORL BioTherapeutics LLC

TORL is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal antibodies and ADCs, with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets.

SOURCE TORL Biotherapeutics LLC