KA-2507

Proceeds will advance lead candidate AGT100216, a peripherally restricted and selective HDAC6 inhibitor, into a first-in-human clinical Phase 1/2 study Gerhard Koenig appointed as executive chairman of Augustine's Board of Directors LEUVEN, Belgium--(BUSINESS WIRE)-- Augustine Therapeutics, a pioneering biotech company focused on novel treatments for neurodegenerative and cardiometabolic diseases, today announced that it has raised EUR 17 million (USD 18.5 million) in the first closing of its Series A round. The financing was led by Asabys Partners, with participation from Eli Lilly and Company, and the US-based Charcot-Marie-Tooth Research Foundation. Current investors AdBio partners, V-Bio Ventures, PMV, VIB and Gemma Frisius Fund also joined the round. Augustine Therapeutics is developing best-in-class, novel, potent and subtype-selective small-molecule inhibitors of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, a class II histone deacetylase. HDAC6 is a well-known molecular target with strong biological rationale for neurological disorders and high therapeutic potential in cardiometabolic disease. Inhibition of HDAC6 plays a leading role in axonal protection and regeneration by controlling the efficiency of internal axonal transport. Augustine’s novel generation of HDAC6 inhibitors (HDAC6i) are chemically distinct and superior to the first generation hydroxamate-based inhibitors developed so far, allowing them to safely and selectively reverse and inhibit the pathophysiological changes associated with neuromuscular diseases such as Charcot-Marie-Tooth (CMT), peripheral neuropathies induced by chemotherapies (CIPN), as well as neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS). The proceeds from this first close will be used to advance Augustine’s lead candidate, AGT100216, into a Phase 1/2 first-in-human clinical trial in 2025. AGT100216 is a peripherally restricted and selective small molecule HDAC6i with a unique mechanism-of-action that has strong potential in CMT and CIPN. The financing will further support the development of the company’s pipeline, including the advancement of its next-generation drug candidates with additional peripheral-restricted or brain penetrant properties for cardiometabolic and neurodegenerative diseases, as well as fund the expansion of the Augustine executive and R&D team. “The support from both new and existing investors in this first closing is a reflection of the tremendous efforts and scientific excellence of our team in advancing a unique pipeline of potential breakthrough therapeutics for patients,” said Sylvain Celanire, CEO of Augustine Therapeutics. “Our HDAC6 inhibitors have unique properties designed to achieve meaningful benefits for patients with neurodegenerative and cardiometabolic diseases. Our first clinical candidate, AGT100216, has demonstrated impressive preclinical efficacy in CMT studies highlighting its ability to halt disease progression, significantly reverse the disease phenotype and rescue axonal integrity in a dose-dependent manner. We are looking forward to capitalizing on our unique pipeline with the strategic insights we are gaining from our Board and Executive Chairman Gerhard Koenig.” Clara Campàs, Founding and Managing Partner at Asabys Partners, said: “Augustine’s molecules are unique, selective and potent, providing a competitive advantage in modulating a validated target with potential impact in a large variety of indications. Augustine’s novel generation of chemically distinct HDAC6 inhibitors are unprecedented and have the potential to overcome some of the typical limitations of other HDAC6 inhibitors currently being tested in early clinical development. We are thrilled to have joined a strong consortium of investors alongside Eli Lilly and Company, the current investors and Augustine’s exceptional team to further develop these molecules to clinical proof of concept.” In conjunction with the financing, Clara Campàs, Founding and Managing Partner at Asabys Partners, has joined Augustine Therapeutics’ Board of Directors. Isabel Jiménez, Associate at Asabys, and a representative from Eli Lilly and Company, will join as Board Observers. In addition, Augustine Therapeutics announced today the appointment of Gerhard Koenig as Executive Chairman of its Board of Directors. Gerhard Koenig has been a Non-Executive Director on Augustine’s Board since May 2022, and currently serves as CEO and Founder of Arkuda Therapeutics, a Boston-based biotech company, focused on the development of lysosomal function enhancers in neurodegenerative diseases. Gerhard is also a Board Member of Vigil Therapeutics (NASDAQ: VIGL) focused on rectifying Microglial dysfunction in neurodegenerative diseases. Full bios of the complete Board of Directors can be found on the company’s website via this link. About Augustine Therapeutics Augustine Therapeutics is a Belgian biotech company, founded in 2019 and a spin-off company of VIB-KU Leuven. The company is building a portfolio of best-in-class small molecules HDAC6 inhibitors for the treatment of severe peripheral and CNS diseases. Its scientific foundation originates from the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven Center for Brain and Disease Research, tackling the underlying mechanism of axonal degeneration of peripheral nerves through selective HDAC6 inhibition. For more information visit . About Asabys Partners Asabys Partners ( ) is a venture capital firm specialized in the healthcare sector, founded in 2018 by Josep Ll. Sanfeliu and Clara Campàs, participated by Alantra and with the support of Banc Sabadell as anchor investor. Asabys invests in highly innovative and disruptive companies covering unmet medical needs in the biopharma and healthtech verticals. The firm’s investment in the company comes from its vehicles Sabadell Asabys Health Innovation Investments II, FCR and Sabadell Asabys Health Innovation Investments 2B, SCR SA. About Eli Lilly and Company Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today, our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. C-LLY About the CMT Research Foundation CMTRF ( ) is a patient-led, non-profit focused on delivering treatments and cures for CMT. The foundation identifies significant obstacles or deficiencies impeding progress towards a cure and seeks out collaborators to address these issues. It's their mission to raise funds to invest in promising science with high potential of leading to treatments and cures. Founded by two patients who are driven to expedite drug delivery to people who live with CMT, the 501(c)(3) federal tax-exempt organization is supported by personal and corporate financial gifts. View source version on businesswire.com: Contacts Sylvain Celanire Chief Executive Officer Email: info@augustinetx.com For Media: Trophic Communications Stephanie May or Eva Mulder augustine@trophic.eu +31 6 52 33 15 79 Source: Augustine Therapeutics View this news release online at:

OXFORD, England--(BUSINESS WIRE)--Karus Therapeutics (‘Karus’), a leader in the development of innovative, orally-active medicines with breakthrough potential in the treatment of cancer, today announced that the first patients have been dosed in a Phase I study for its lead candidate, KA2237. This is the Company’s first product to enter clinical trials. KA2237 is a dual-selective inhibitor of two PI3K isoforms, p110ß and p110d. Inhibiting these two isoforms combines an immunotherapeutic response and a direct effect on tumor growth, through selective, targeting of the PI3K pathway. Karus believes that KA2237 has broad therapeutic applicability in the treatment of hematological and solid tumors, as a single agent and in combination with other drugs. This study forms part of the pre-clinical and clinical collaboration between Karus and the University of Texas MD Anderson Cancer Center, the world’s leading cancer research and care center. The first part of the trial has been designed to assess the safety of KA2237 alone in relapsed, treatment-resistant B cell lymphoma patients. An expansion cohort study will follow and is scheduled to start in 2017. Karus anticipates that up to 40 patients will be treated over the entire study. Dr. Simon Kerry, CEO of Karus Therapeutics, commented: “Our first clinical trial is a major milestone for the company. Karus has made exceptional progress and our collaboration with MD Anderson will help us to accelerate this clinical program. We believe that as an orally-active dual p110ß/d inhibitor, KA2237 has significant potential in the treatment of hematological and solid tumors in areas of high, unmet medical need.” Professor Stephen Shuttleworth, CSO, added: “Our R&D programs are built on many years’ investment in research that have given us a deep understanding of PI3K medicinal chemistry and tumor biology. To take a scientific concept through rational de novo-design to create KA2237, a dual-selective, small molecule PI3K inhibitor that has been designed specifically to address areas of unmet medical need, is a very rewarding moment in our journey towards developing new cancer treatments for patients with few remaining therapeutic options.” The agreement with MD Anderson covers a number of preclinical studies of Karus’s two cancer programs, KA2237 and KA2507, with a focus on identifying optimal drug combinations and the appropriate patient populations for further clinical development. The second program, KA2507, a selective-HDAC6 inhibitor, also has both a targeted therapy and immunotherapeutic action and has potential in the treatment of multiple myeloma, B- and T-cell lymphomas and PD-L1 expressing hematological and solid tumors. -Ends- About Karus Therapeutics Karus Therapeutics is a leader in the development of innovative medicines that have breakthrough potential in the treatment of cancer. The Company’s scientific excellence is reflected in its proprietary PI3K and HDAC6 inhibitor programs, from which innovative small molecule drugs with significant clinical and commercial potential have been developed. The UK-based Company is privately-held with a strong financial track record and experienced investors, including SV Life Sciences, New Leaf Ventures, Novo A/S and IP Group. For further information please visit www.karustherapeutics.com About MD Anderson The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. MD Anderson is one of only 41 comprehensive cancer centers designated by the National Cancer Institute (NCI). For the past 25 years, MD Anderson has ranked as one of the nation's top two cancer centers in U.S. News & World Report's annual "Best Hospitals" survey. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).