TORL BioTherapeutics Announces $158 Million Oversubscribed Series B-2 Financing to Advance the Clinical Development of its Novel Antibody-Drug Conjugate (ADC) Oncology Pipeline

• $158M Series B-2 Financing led by Deep Track Capital, with new participation from leading global biotechnology investors including RA Capital Management, Perceptive Advisors, and Avidity Partners as well as all existing biotechnology investors
  
  
• Proceeds advance TORL-1-23, a first and potentially best-in-class, clinical-stage ADC for the treatment of Claudin 6 positive (CLDN 6+) solid-tumors, TORL-2-307, and a clinical-stage ADC for the treatment of Claudin 18.2 positive (CLDN 18.2+) solid tumors, as well as newly disclosed programs TORL-3-600, a first-in-class clinical-stage ADC for the treatment of Cadherin 17 positive (CDH17+) advanced colorectal cancer, and TORL-4-500, a clinical-stage ADC for the treatment of DLK1 positive solid tumors

LOS ANGELES, April 10, 2024 /PRNewswire/ -- TORL BioTherapeutics, LLC (TORL), is a clinical-stage biotechnology company involved in discovery and development of new antibody-based immunotherapies designed to improve and extend the lives of patients with cancer worldwide. Today, the Company announced its closing of an oversubscribed $158 million Series B-2 financing. The financing led by Deep Track Capital, with new participation from leading global biotechnology investors including RA Capital Management, Perceptive Advisors, and Avidity Partners as well as all existing biotechnology investors including Goldman Sachs Alternatives, UC Investments, Bristol Myers Squibb, Vertex Ventures HC, Moore Strategic Ventures, Blue Owl Healthcare Opportunities, and Perceptive Xontogeny Venture Fund, brings the total raised to date to greater than $350 million. Proceeds from this Series B-2 financing will be used to continue the clinical development of TORL-1-23, the Company's first-in-class ADC to treat CLDN 6+ tumors, through Phase 1 and a pivotal Phase 2 trial that will start in the second half of 2024. This Phase 2 trial is designed to facilitate regulatory review and potential approvals for TORL-1-23 as a new therapy for patients with CLDN 6+, platinum-resistant ovarian cancer. Proceeds will also be used to fund the on-going Phase 1 studies for the TORL-2-307 program, both a monoclonal antibody (mAb) and an ADC, for the treatment of CLDN 18.2+ solid tumors, TORL-3-600, an ADC for the treatment of CDH17+ colorectal cancer, and TORL-4-500, an ADC for the treatment of Delta like non-canonical Notch Ligand 1 (DLK1) positive solid tumors.

"We are grateful for the continued support from our existing world-class life sciences investors and are extremely pleased to add RA Capital Management, Perceptive Advisors, and Avidity Partners to the TORL team," said Mark Alles, TORL's Chairman and CEO. "This investment significantly enhances our opportunity to deliver multiple data-driven milestones from our novel antibody-based discovery platform and clinical-stage oncology drug development pipeline."

"Our leadership of the TORL Series B-2 Financing reflects our confidence in the scientific and business expertise of the TORL team, and the promise and potential of the Company's emerging ADC pipeline," said Rebecca Luse, Principal at Deep Track Capital. "The era of ADCs in oncology has arrived, and TORL is well-positioned to succeed in this rapidly growing approach to treating cancer."

TORL's pipeline of targets, ADCs and mAbs were discovered in the laboratory of Board Member and Scientific Co-founder Dennis Slamon, M.D., Ph.D., Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA's David Geffen School of Medicine. Dr. Slamon is an accomplished medical oncologist and scientist whose research was pivotal in the identification of HER2 as a therapeutic target in breast cancer and the subsequent development and regulatory approvals for trastuzumab (Herceptin^Ò). His laboratory and research team also defined CDK4/6 as a therapeutic target in hormone receptor positive (HR+) breast cancer. Subsequently, Dr. Slamon's group led the clinical development of CDK4/6 inhibitors, resulting in global regulatory approvals for Palbociclib (Ibrance^Ò) and Ribociclib (Kisqali^Ò) for the clinical management of HR+ breast cancer.

"TORL is built on more than thirty years of experience discovering molecular alterations associated with solid tumors and hematologic malignancies. This work is followed by development of new and novel targeted therapeutics and clinical strategies for their use to improve and extend the lives of patients challenged with these diseases," said Dr. Slamon. "We are pleased at the spectrum of diseases for which this approach appears to work as well as the performance of our predictive and development platforms to date. We remain committed to delivering many more breakthrough therapies for patients with serious unmet global medical needs in cancer."

The Company was co-founded in 2019 by Board Member, President, and CFO Dave Licata. Through TORL's innovative and strategic partnership with the Slamon Research Laboratory at UCLA, the Company was granted exclusive development and commercialization rights to a large portfolio of biologics-based drugs designed to target specific antigens overexpressed in cancer cells. Mr. Licata's and Dr. Slamon's common vision for a new approach to antibody-based drug development created TORL and its pipeline of promising cancer therapies.

"TORL's oversubscribed Series B-2 financing provides the capital necessary for TORL to complete our pivotal, registration-enabling Phase 2 study starting later this year for TORL-1-23, a first-in-class, and potentially best-in-class, ADC targeting CLDN 6 in platinum-resistant ovarian cancer. It also allows us to continue to advance our three other promising clinical stage programs and pipeline," said Mr. Licata. "With this continued strong support from our investors, we believe we can generate significant long-term value for them, our employees, and most importantly, the patients we seek to serve."

Vince Ruiz from Crandon Law LLC served as lead counsel to TORL BioTherapeutics, LLC.

Schulte, Roth & Zabel LLP served as counsel to Deep Track Capital.

About the TORL123-001 (TRIO-049) Clinical Study
Select centers are enrolling patients in Part 2, expansion, of TORL's phase 1 study, TORL123-001 (TRIO-049), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-1-23.  Further details including current study sites can be found at https://clinicaltrials.gov/show/NCT05103683

About TORL2307MAB-001 (TRIO-051) Clinical Study
TORL is currently enrolling patients in Part 2, the expansion portion, of their phase 1 study, TORL2307MAB-001 (TRIO-051), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307MAB at select global sites around the world.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05159440

About TORL2307ADC-001 (TRIO-052) Clinical Study
TORL's Phase 1 study, TORL2307ADC-001 (TRIO-052), is currently open to enrollment for the expansion portion, Part 2, assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307ADC. Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05156866

About TORL3600-001 (TRIO-055) Clinical Study
A limited set of sites are currently enrolling patients in the escalation portion of TORL's phase 1 study, TORL3600-001 (TRIO-055), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-3-600. Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05948826

About TORL 4-500-001 (TRIO-056) Clinical Study
This Phase 1 study, TORL4500-001 (TRIO-056), is actively enrolling patients in the escalation portion, part 1, assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-4-500.  The study is open at an exclusive group of sites. Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT06005740

About TORL BioTherapeutics, LLC
TORL BioTherapeutics, LLC (TORL or Company) is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal (mAbs) and drug conjugates (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