Thetis Pharmaceuticals LLC

ESSEX, Conn.--( BUSINESS WIRE )--Thetis Pharmaceuticals, LLC (“Thetis”), a pharmaceutical company developing an oral, small molecule Resolvin E1 (RvE1) drug targeting the BLT1 receptor to treat inflammatory bowel disease (IBD) and cancer, today announced the appointment of Fabio Cataldi, MD, to its Board of Managers and Scientific Advisory Board. “We are excited to have Fabio join our Board,” said Gary Mathias, co-founder and CEO of Thetis. “His expertise in gastroenterology and clinical development will help guide Thetis as we advance oral TP-317 into a Phase 1b clinical trial in patients with moderate-to-severe ulcerative colitis.” Dr. Cataldi has more than 20 years of experience in drug development. He currently serves as chief medical officer (CMO) of Abivax SA and previously was CMO at Landos Biopharma, Inc. through its sale to AbbVie in 2024. Dr. Cataldi also held senior R&D roles at Arena Pharmaceuticals, AbbVie, Shire, Pfizer, Biogen, and Novartis. He received his medical degree from the Second University V Division of General Surgery in Italy and completed post-doctoral research at Beth Israel Deaconess Medical Center in Boston. “I am honored to join the Thetis Board and collaborate with such a forward-thinking team,” said Cataldi. “Their novel approach to the BLT1 pathway holds great promise for addressing unmet needs in IBD and cancer. I am excited to contribute my expertise to advance the TP-317 clinical program and improve the lives of patients suffering from these difficult diseases.” About Thetis Pharmaceuticals Thetis is a clinical-stage pharmaceutical company focused on developing innovative treatments for chronic inflammatory diseases and cancer. Thetis’ lead candidate, TP-317, is a first-in-class, oral Resolvin E1 (RvE1) drug candidate that targets the LTB4-BLT1 pathway to activate the body’s natural healing mechanisms. In a Phase 1a study, TP-317 was safe, well tolerated, and effectively delivered RvE1 to systemic circulation. Thetis plans to initiate a Phase 1b trial in ulcerative colitis patients in 2025. Thetis is supported by private investors, the National Institutes of Health (NIH), and prominent philanthropies, including the Helmsley Charitable Trust, Crohn's & Colitis Foundation, and the Kenneth Rainin Foundation.

Dr. Sznol to guide clinical investigation of Resolvin-based therapies in metastatic melanoma ESSEX, CT., November 7, 2023. Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing a first-in-class small molecule ChemR23 agonist to treat cancer and autoimmune diseases small molecule (TP-317) to treat cancer and autoimmune diseases, announced today that Dr. Mario Sznol has joined its Scientific Advisory Board (SAB). Dr. Sznol is Professor of Medicine, Clinical Research Team Leader (Melanoma-Renal Cancer Program), and Co-Leader of Cancer Immunology Program at the Yale Cancer Center. Gary Mathias, Chief Executive Officer of Thetis, commented, “Dr. Sznol has an international reputation with unique expertise and experience in cancer immunotherapy, drug development for cancer, and treatment of patients with melanoma and renal cell carcinoma, which makes him a perfect choice to help Thetis in the development of TP-317 to treat metastatic melanoma. Dr. Sznol is an expert in clinical application of immune checkpoint inhibitors and brings an important perspective to our clinical strategy for TP-317, which in preclinical studies has shown single agent efficacy comparable to standard-of-care immunotherapy and chemotherapy and enhanced efficacy when combined with these other agents.” Dr. Sznol noted that “TP-317 offers a highly differentiated strategy to address resistance to immunotherapy in the tumor microenvironment (TME), which is an important target in cancer drug development. I am delighted to join the Thetis SAB to help develop this promising small molecule drug for metastatic melanoma.” Dr. Sznol joins the Thetis SAB with 35 years of experience in cancer research and development. He graduated from Baylor College of Medicine where he subsequently trained in internal medicine, and then completed a medical oncology fellowship in the Department of Neoplastic Diseases at Mount Sinai Hospital. He spent the next twelve years in the Cancer Therapy Evaluation Program of the National Cancer Institute. From 1999-2004, he served as Vice President of Clinical Development and Executive Officer of Vion Pharmaceuticals in New Haven, Connecticut. In 2004, he joined the medical oncology faculty of the Yale University School of Medicine as co-leader of the Melanoma Program and is currently Professor of Internal Medicine, Leader of the Melanoma-Renal Cancer Clinical Research Team, and Co-Director of Cancer Immunology Program. About TP-317 and Disease Programs TP-317 is a patent-protected small molecule drug that delivers Resolvin E1 (RvE1), an endogenous lipid mediator that restores immune homeostasis. Unlike anti-inflammatory drugs and anti-cancer agents that are immuno-suppressive, TP-317 activates innate and adaptive immune pathways to treat disease without compromising host-protective immunity. Cancer Program: In cancer, TP-317 is being developed as an adjunct to immune checkpoint inhibitors in refractory metastatic melanoma and advanced non-small cell lung cancer (NSCLC), and as adjunct to chemotherapy in pancreatic cancer. TP-317 has demonstrated potent single agent activity in melanoma, lung cancer and pancreatic cancer tumor models, and enhanced efficacy when combined with immune checkpoint inhibitors or chemotherapy in “immune cold” and immune-responsive tumors. In the same studies, TP-317 has been shown to promote myeloid directed antigen presentation and increased IFN-y response in the tumor microenvironment, which may contribute to TP-317’s robust anti-tumoral effects. IBD Program: In inflammatory bowel disease, TP-317 is being developed as a first-line oral therapy for mild-to-moderate Crohn’s disease and as second-line oral therapy for mild-to-moderate ulcerative colitis patients who are not well controlled on 5-ASA or corticosteroids. In colitis models, oral TP-317 dosed once daily has shown efficacy in DSS, TNBS, TNFΔARE and T-cell transfer colitis models. In DSS-induced colitis, TP-317 has shown comparable efficacy to 5-ASA and the JAK inhibitor filgotinib and enhanced efficacy when combined with 5-ASA. Mechanistically, RvE1 has demonstrated a unique ability to shift the inflamed mucosa towards immune homeostasis and promote intestinal barrier repair, a key driver and measure of efficacy in human IBD. About Thetis Pharmaceuticals Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and inflammatory bowel disease. Thetis’ proprietary HEALER™ technology enables the pharmaceutical development of Resolvins, overcoming the stability, manufacturing, and formulation hurdles that have limited their commercial development. Thetis is supported by venture capital investors, NIH, and leading private philanthropies, including the Helmsley Charitable Trust, the Crohn’s & Colitis Foundation, and the Kenneth Rainin Foundation. Disclaimer TP-317 is an investigational drug product that has not been approved by the U.S. Food and Drug Administration. For more information, please visit Thetis Pharmaceuticals’ website ( ). Contact Information Gary Mathias, CEO gmathias@thetispharma.com

Dr. Huang to guide preclinical and clinical investigation of resolvin-based therapies in solid tumor cancers Ridgefield, CT – (October 14, 2021) – Thetis Pharmaceuticals LLC (“Thetis”), a biopharmaceutical company developing Resolvin-based therapies to treat cancer and autoimmune diseases, announced today that Dr. Sui Huang has joined its Scientific Advisory Board. Dr. Huang is a molecular and cellular biologist with expertise in systems biology of cancer progression and inflammation. Gary Mathias, Chief Executive Officer of Thetis, commented, “As a result of Dr. Huang’s seminal discoveries in gene regulatory networks and non-genetic dynamics of tumor progression, we have a deeper appreciation of protumor inflammation as a key driver of tumor progression, metastasis, and therapy-induced resistance. These insights underlie the focus of our lead cancer drug, TP-317, a unique resolvin-based therapy that activates the body’s natural inflammation resolution pathways to treat solid tumor cancers.” Dr. Huang added, "Existing cancer therapies designed to kill tumor cells are inherently a double-edged sword. By triggering cell death, these therapies lead to an inflammatory response that paradoxically promotes tumor growth and consequently limits their efficacy. Mechanistically, Resolvins reprogram the tumor microenvironment to counteract the protumor effects that inevitably accompany cell killing caused by the cancer treatment itself, by clearing cell debris, downregulating inflammatory cytokines, and promoting anti-tumor immunity.” Dr. Huang is a professor at the Institute for Systems Biology (ISB), a Seattle-based biomedical research organization. The Huang Laboratory at ISB is focused on investigating the interface between normal cell development and tumor cell development, and the integral role played by chronic inflammation in triggering this transformation. Dr. Huang obtained his doctorates in medicine and molecular biology at the University of Zurich in 1995. After completing postdoctoral training in cancer biology, he joined the faculty at Harvard Medical School in Boston and subsequently moved to the University of Calgary to work alongside Stuart Kauffman on gene regulatory networks and cancer differentiation therapy. In 2019, Dr. Huang was announced as a member of a global research team funded with a $25 million grant from Cancer Research UK to find novel ways of treating cancers directed at inflammation as a root cause of tumor initiation and progression. About TP-317 TP-317 is a patent-protected new molecular entity that delivers Resolvin E1 (RvE1), a naturally-occurring lipid mediator discovered by biomedical researchers at Harvard Medical School. TP-317 offers a novel approach to reprogram the tumor microenvironment and activate anti-tumor immunity. Recent preclinical studies demonstrate that TP-317 has potent single agent activity in multiple tumor models, and additive effects with chemotherapy and anti-PD1 in cold tumors. Based on this data and a comprehensive safety package, TP-317 is being developed as a once per week subcutaneous injection for gastrointestinal cancers, including pancreatic and metastatic colorectal cancer. About Thetis Pharmaceuticals Thetis is a biopharmaceutical company dedicated to improving the lives of patients suffering from cancer and autoimmune diseases. Thetis’ proprietary HEALER™ technology platform enables the pharmaceutical development of Resolvins, a class of endogenous lipid mediators that regulate immune homeostasis by resolving inflammation and clearing cell debris. Thetis’ HEALER™ technology overcomes the stability, manufacturing, and formulation hurdles that have limited the development of Resolvins as pharmaceutical agents, unlocking their robust pharmacology to be developed as first-in-class small molecule drugs. Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding Thetis’ expectations regarding the development and the continued progress of Thetis’ programs, including the intended incentives conferred by orphan-drug designation, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, the anticipated benefits of our HEALER platform, the expected safety pro our product candidates, timing and likelihood of success of our current or future product candidates, and the market opportunity for our product candidates. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Actual results could differ from those projected in any forward-looking statements due to numerous factors, including, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, including our ability to recruit and enroll patients in our studies; our ability to address the requests of the U.S. Food and Drug Administration; competition in the industry in which we operate; and market conditions. These forward-looking statements are made as of the date of this press release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Disclaimer TP-317 is an investigational drug product that has not been approved by the U.S. Food and Drug Administration. For more information, please visit Thetis Pharmaceuticals’ website ( ) and follow Thetis on Twitter (@thetispharma). Contact Information Aaron Mathias Senior Director of Business Development amathias@thetispharma.com