GB-7008-01-vcMMAE

Co-founded by acclaimed oncologist Dennis Slamon, M.D., Ph.D., of University of California at Los Angeles (UCLA) and entrepreneur and CEO David Licata, as well as leadership from a distinguished set of industry veterans, including Executive Chairman Mark Alles, former Chairman and CEO of Celgene Corporation. Funding to advance TORL-1-23, a first-in-class, clinical-stage ADC targeting Claudin 6, TORL-2-307, a clinical-stage ADC targeting Claudin 18.2 and other novel clinical and preclinical stage programs. $158M Series B Financing led by Goldman Sachs Asset Management, with participation from UC, Office of the Chief Investment Officer, Bristol Myers Squibb, Deep Track Capital, Vertex Ventures HC, Moore Strategic Ventures, Cowen Healthcare Investments, Perceptive Xontogeny Venture Fund, and existing investors including Alexandria Venture Investments and OCV Partners. Amit Sinha, Head of Life Sciences Investing within Goldman Sachs Asset Management and Lynn Seely, M.D., President and CEO of Lyell Immunopharma to join TORL Board of Managers as part of Series B financing. LOS ANGELES, April 13, 2023 /PRNewswire/ -- TORL BioTherapeutics LLC (TORL), a biopharmaceutical company focused on developing new biologics for cancer treatment, announced today its public launch and the closing of a $158 million Series B financing. TORL's pipeline of antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs) were discovered in the laboratory of 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 (DGSOM). He is an accomplished physician and scientist whose research was pivotal in identifying HER2 as a target in breast cancer and the development and initial approval of trastuzumab (Herceptin). Dr. Slamon's lab went on to discover CDK4/6 as an important target in hormone receptor (HR+) positive breast cancer. Subsequently, his group led the clinical development of CDK4/6 inhibitors, resulting in breakthrough status therapies palbociclib (Ibrance) and ribociclib (Kisqali), in HR+ breast cancer. TORL is built on a strategic partnership with the Slamon Research Lab at UCLA, whereby the Company has exclusive development and commercial rights to biologics-based drug candidates focused on promising cancer targets. TORL's lead drug programs target Claudin 6 (CLDN 6) and Claudin 18.2 (CLDN 18.2), both of which are currently in clinical trials. The Company also expects to put 2-3 additional compounds into clinical trials over the next 12 months, with plans to advance 1-2 new compounds each year. "It has been very rewarding to use 30 years of experience, lessons learned, and preclinical models developed in our lab for this new company for," said Dennis Slamon, M.D., Ph.D., Co-Founder of TORL. "This unique academic/corporate partnership allows us to quickly identify novel targets, validate them preclinically, then proceed to bring these new biologic treatments into clinical testing and development in an exceptionally rapid and efficient manner. Our goal is to develop compounds that address critical or as yet unmet medical needs while simultaneously providing new and effective treatment options for cancer patients that can be life and practice changing. There are more of these to come, and we are thrilled we have this partnership to expand cancer therapy." Leveraging the Slamon research lab's unique discovery engine and validation platforms, TORL was founded to promote its novel oncology biologics with industry leading speed and capital efficiency. Since its inception in 2018, TORL has moved forward three, internally developed drug programs into the clinic and advanced two more through IND-enabling studies with less than $50 million. "It has been tremendously gratifying to pioneer TORL's innovative approach to drug discovery and development, culminating in the launch of multiple clinical trials with our drugs over the past year", said David Licata, TORL's CEO. "We created and demonstrated an original, capital efficient structure which, despite the challenging market conditions, attracted a distinguished group of biotech investors with a shared vision for rapid cancer drug development. With the close of this Series B financing, we can advance our new programs into the clinic and existing clinical-stage programs into the next phase." "Despite meaningful advances in the diagnosis and treatment of cancer, most patients worldwide continue to face serious morbidity and significant mortality," said Mark Alles, TORL's Executive Chairman. "With strong support from our highly accomplished investors, we are building a preeminent biopharmaceutical company dedicated to the discovery, development and commercialization of first and best-in-class antibody-based immunotherapies to improve and extend the lives of people living with this terrible disease." "TORL represents a unique model for company formation. Through their holistic relationship with the Slamon research lab and UCLA, the Company can leverage decades of scientific expertise and deep research capabilities while avoiding the significant costs and risks associated with early-stage discovery," said Amit Sinha, Head of Life Sciences Investing within Goldman Sachs Asset Management. "We believe TORL-1-23 and TORL-2-307 represent promising potential therapies for ovarian and gastric cancers, two indications with significant unmet patient need. We look forward to partnering with the TORL team to rapidly advance the lead programs toward late-stage clinical trials while progressing the broader portfolio of novel programs." TORL builds on a 30-year history of scientific collaboration amongst a team of clinical pioneers and laboratory researchers. In addition to Dr. Dennis Slamon, the scientific founding team includes: John Glaspy, M.D., MPH, Professor of Medicine, DGSOM, UCLA Neil O'Brien, Ph.D., Associate Professor of Medicine, DGSOM, UCLA Martina McDermott, Ph.D., Adjunct Assistant Professor of Medicine, DGSOM, UCLA Ben Hoffstrom, Ph.D., Adjunct Assistant Professor, Medicine, DGSOM, UCLA Sarah Larson, M.D., Assistant Professor, Medicine DGSOM, UCLA Mike Press, M.D., Ph.D, Professor of Pathology, Keck School of Medicine of USC With scientific advisors including Tom Boone, Ph.D., Brian Lawliss, Ph.D., and Leonard Presta, Ph.D. TORL Board of Directors Mark Alles – Executive Chairman Mark Attanasio – Co-Founder and Managing Partner, Crescent Capital Group LP David Licata – Co-Founder and CEO Neil O'Brien, Ph.D. – Co-Founder Amit Sinha – Partner, Goldman Sachs Lynn Seely, M.D. – President and CEO of Lyell Immunopharma Dennis Slamon, M.D., Ph.D. – Co-Founder TD Cowen acted as exclusive placement agent for the Series B financing. Crandon Law LLC served as counsel to TORL BioTherapeutics LLC. Latham & Watkins LLP. served as counsel to Goldman, Sachs & Co. LLC. About TORL BioTherapeutics TORL BioTherapeutics LLC is a clinical-stage biopharmaceutical company with the objective of developing novel, antibody-based therapeutics to transform the lives of cancer patients. Its lead candidate, TORL-1-23, is a CLDN6-directed ADC developed for patients across multiple cancer types. The Company also has two other clinical-stage programs; an ADC and mAb targeting CLDN 18.2. Additionally, TORL is developing a broad pipeline of novel preclinical ADCs and mAb in oncologic indications with a high unmet medical need. TORL is headquartered in Los Angeles. SOURCE TORL Biotherapeutics LLC

Lonza to support the development and manufacturing of CTIM-76, Context’s CLDN6 x CD3 bispecific antibody clinical candidate The bispecific antibody-based therapy is being developed to redirect T-cell mediated lysis toward malignant cells expressing CLDN6 PHILADELPHIA and BASEL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing medicines for solid tumors, and Lonza, a global development and manufacturing partner to the pharma, biotech, and nutrition industries, today announced that the companies are collaborating to manufacture CTIM-76, Context’s clinical development candidate. CTIM-76 is a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody targeting CLDN6 positive tumors. Under the terms of the agreement, Lonza will provide manufacturability assessment, gene and cell line construction, and process development. The drug substance will be manufactured at Lonza’s Slough (UK) site, and the drug product will be manufactured at the Stein and Visp (CH) sites. Context will leverage Lonza’s expertise in developing and manufacturing complex proteins, as well as the extensive regulatory competence and manufacturing network. Martin Lehr, CEO, Context, commented: “Bispecific antibody drug candidates targeting cancer signaling pathways pose unique challenges related to their development and manufacturing. We are delighted to entrust Lonza with manufacturing Context’s clinical development candidate, CTIM-76, to target CLDN6-positive tumors. We believe this collaboration will provide us with high-quality drug substance and drug product for clinical development and beyond.” Jennifer Cannon, Executive Vice President, Global Head of Mammalian Biologics, Lonza, added: “With the biopharmaceutical sector shifting towards more complex protein formats, it is crucial to ensure manufacturability and scalability of these novel therapies. Context has an exciting portfolio, including its CTIM-76 bispecific antibody product, that can benefit from our expertise and experience in supporting the manufacturing of complex therapeutics.” About Claudin 6 and CTIM-76 Claudin 6 (CLDN6) is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others. With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an important drug target. CTIM-76 is a CLDN6 and CD3 bispecific antibody currently in preclinical development that is capable of binding to tumor cells expressing CLDN6 and stimulating intra-tumoral T cells by the CD3 arm that is designed to be activated only upon tumor engagement while silent elsewhere. CLDN6 is expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer, and gastric cancer. Preclinical studies of CTIM-76 show it effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN6 antibody and CD3 antibody while avoiding systemic immunotoxicity commonly seen with CD3 antibodies as a drug class. CTIM-76 has the potential for convenient dosing and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. About Context Therapeutics® Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company committed to advancing medicines for solid tumors, with a primary focus on female cancers. The Company’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. Context is developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6 positive tumors, currently in preclinical development. Additionally, the company is advancing onapristone extended release (ONA-XR), a novel, first-in-class, potent, and selective progesterone receptor antagonist, currently in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancers. Context is headquartered in Philadelphia. For more information, please visit or follow the Company on Twitter and LinkedIn. About Lonza Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry. Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With more than 17,000 full-time employees, we comprise high-performing teams and individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 3 billion with a CORE EBITDA of CHF 987 million in H1 2022. Find out more at . Follow @Lonza on LinkedIn Follow @LonzaGroup on Twitter Context Therapeutics Contact Details Media Contact: Gina Cestari 6 Degrees 917-797-7904 gcestari@6degreespr.com Investor Relations Contact: Laine Yonker Edison Group lyonker@edisongroup.com Lonza Contact Details media@lonza.com Forward-looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as "may," "will," "expect," "anticipate," "plan," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the selectivity, dosing convenience, potency, binding, scalable manufacturing, and safety pro CTIM-76, (ii) the potential benefits of the agreement, including the ability of Lonza to perform as expected and to provide Context with the necessary drug substance and drug product, (iii) the potential benefits of our product candidates, and (iv) the likelihood data will support future development. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.