Michigan State University

Molecure has reduced the number of active projects from seven to five, focusing resources on the most promising assets; Key areas for further development and value building for Molecure are: OATD-01 as a potential breakthrough therapy for the treatment of sarcoidosis and MASH, and OATD-02 in trials in patients with solid tumors. Development of projects in the discovery phase powered by machine learning and generative artificial intelligence (GenAI) methods includes a small-molecule drug discovery platform that modulates mRNA translational function and the USP7 program; Molecure’s strategic goal is to conclude a partnership agreement in the OATD-01 program, enabling it to initiate a Phase II clinical trial in its next indication, MASH (ang. metabolic dysfunction-associated steatohepatitis), with its partner as soon as possible; Molecure’s OATD-02 clinical trial is nearing the determination of a maximum tolerable dose (MTD) or potentially therapeutic dose (Ph2RD), which should increase interest from potential oncology partners; In active programs at an earlier stage of development, in early 2025 Molecure plans to identify a candidate for preclinical development in the USP7 project (a deubiquitinase inhibitor in immuno-oncology), followed by intensified partnering discussions in this program, and to identify lead compounds for two mRNA targets for which the Company has previously obtained proof-of-concept in vitro and to sign a collaboration or partnership agreement in the mRNA platform; Molecure’s expenditures to complete both clinical trials and continue development of the most promising early-stage projects between Q4 2024 and the end of 2025 are estimated at about PLN 95 million; Molecure intends to use four possible sources of financing: transaction proceeds such as up-front payment(s) on one or more partnering agreements, grants and subsidies, and equity issuances with possible use of debt instruments. Warsaw, 15 October 2024 – Molecure S.A. (“Molecure”, WSE ticker: MOC), a clinical-stage biotechnology company that leverages its globally unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that directly modulate protein activity and mRNA translational function to treat incurable diseases, has updated its portfolio of research programs, focusing on its most promising clinical projects: OATD-01 and OATD-02, and the preclinical USP7 project and mRNA platform. Reducing the number of projects that are in the early stages is intended to manage resources more efficiently and focus on clinical programs that have the greatest commercial potential. At the same time, Molecure is continuing promising preclinical projects such as USP7 and early-stage projects in its mRNA platform, in which the Company uses artificial intelligence (AI) to virtually screen and optimize drugs targeting mRNA. „We have decided to update our research pipeline, focusing resources and efforts on the development and commercialization of projects that will bring the greatest increase in the Company’s value, contributing to our mission. We are getting closer to reaching a milestone in the development of OATD-01 in Phase II clinical trials, while aiming to determine the maximum tolerable drug dose (MTD) and/or recommended Phase II dose (Ph2RD) for OATD-02. Both molecules are being administered to pulmonary sarcoidosis patients and oncology patients in Phase II and Phase I clinical trials, respectively. Progress in both trials should reinforce interest from strategic partners in the coming year. We see tremendous potential for value especially in the OATD-01 project, which, thanks to its unique and pioneering mechanism of action – blocking chitinase activity – has the potential to become a therapy in the area of unmet medical needs and diseases that affect a growing proportion of the population. The huge body of compelling preclinical data we have accumulated – ours and those of our partners – as well as literature data confirm that elevated chitinase expression leads to excessive macrophage activity, which in turn is responsible for the induction of many serious diseases, including sarcoidosis and MASH. Molecure is a clear leader and pioneer in the development of chitinase inhibitors, and we are the only company in the world to bring such a compound into clinical trials, currently at the proof of concept stage in humans, being tested in patients with active pulmonary sarcoidosis. We want to see preliminary confirmation of the efficacy of our compound through data from an interim analysis, which we plan for Q3 2025. MASH disease, or steatohepatitis associated with metabolic disorders, in particular, is an extremely attractive therapeutic and commercial area. Over the past decade or so alone, the incidence rate of the disease has increased several to a dozen times, and the global market is projected to be worth more than $25 billion in 2032. Positive data confirming efficacy in part of the mechanisms responsible for the disease processes of MASH and the approval this year of the first drug in this indication, developed by Madrigal, have contributed to a more than 4-fold increase in the market value of this company and resulted in a significant increase in interest in MASH among big pharma and large biotech companies. We are determined to capitalize on the potential of our molecule and our strong data for development in precisely this indication, so we want to attract a partner who will support our research from the financial side, as well as further strengthen our expertise in the area of metabolic diseases. We are confident that success in Phase II clinical trials in one, and even more so in both indications (MASH and sarcoidosis) will lead to a multiplication of the value of our flagship molecule, and thus the Molecure” – says Marcin Szumowski, CEO, co-founder and shareholder of Molecure S.A. Molecure is also advancing its most promising preclinical programs. In the USP7 project, among other collaborations with Avicenna Biosciences, the Company has overcome challenges in optimizing drug-like parameters for lead compounds (drug-like properties), and is developing a revised formulation of the drug. As a result of this work, a candidate is planned for official preclinical development in early 2025, followed by intensified partnering talks. It is worth recalling that in 2023, Exelixis acquired an exclusive global license from Insilico Medicine for the development and commercialization of the USP1 inhibitor (identified through its AI platform), a molecular target in the mechanisms of synthetic lethality. The up-front payment in this transaction was $80 million. In the mRNA program, on the other hand, the Company is well on its way to selecting lead compounds for two mRNA targets for which it has reached proof-of-concept stage in vitro over the past 12 months, confirming the ability of small molecules to bind to mRNA fragments and efficacy in inhibiting translation of pathogenic proteins. The Company’s priorities in this area, having already achieved initial validation of the methodology’s efficacy and generation of functional in vitro molecules, are to identify lead compounds and enter into commercial service or partnering agreements. Molecure’s ability to commercialize early-stage projects has been demonstrated through a deal with U.S. biotechnology company Ocean Biomedical, Inc. (NASDAQ: OCEA) in the YKL-40 program. On October 15, 2024, the Company entered into an exclusive license agreement with its U.S. partner covering the sale of rights to molecules from the YKL-40 program, including the lead compound OAT-3912, previously developed by Molecure at the early discovery stage, and a second patent for a molecular screening assay, allowing Molecure to continue its research program. The revenue potential for Molecure assuming the achievement of milestones in program development by Ocean Biomedical and the launch of the drug, according to the “bio-dollar value” formula, was set at approximately $32 million. Recognizing the greatest commercial potential in clinical programs, Molecure has reduced the number of active programs in the discovery phase, closing the least promising program conducted under a know-how licensing agreement with the University of Michigan and Michigan State University (the Company plans to terminate this agreement, which will be done at no cost to the Company). In addition, development activities in the USP21 project have been temporarily suspended. Molecure’s outlays for completing both clinical trials and continuing the development of the most promising early-stage projects in the period from Q4 2024 to the end of 2025 will amount to about PLN 95 million, including: Clinical phase programs – approx. PLN 40 million Discovery and preclinical development programs (including AI tools) – approx. PLN 16 million mRNA platform (including AI tools) – approx. PLN 23 million General and administrative expenses, including business development and IR – approx. PLN 16 million. In parallel with the reduction of the Molecure pipeline, there was also a reduction in the workforce in the area of the three early programs, which translated into savings of more than PLN 3 million by the end of September this year, while by the end of 2025 the total planned savings from this will amount to about PLN 13 million. Taking into account Molecure’s cash holdings (PLN 28.6 million as of the end of September this year) in order to complete the two clinical trials and continue the development of the most promising early-stage projects, the Company estimates a funding requirement of about PLN 70 million. To raise funds, Molecure intends to use four possible sources of financing: transaction proceeds such as up-front payment(s) from one or more partnering agreements, grants and subsidies, and issuance of equity and/or debt instruments. Summary of financial data in 1-3Q 2024.* Operating income of PLN 1.1 million (including a grant from the NIH and income from the Innovative Workers Credit), compared to PLN 3.3 million for 1-3Q 2023. Operating expenses amounted to PLN 22.8 million, compared to PLN 25.2 million for 1-3Q 2023. Operating expenses for 9Q 2024 were lower y-o-y by PLN 2.4 million, driven by lower expenses for programs in early stages of development (by PLN 1.3 million), as well as lower expenses for consulting services, including legal services (by PLN 1.0 million). Net loss amounted to PLN 20.8 million, compared to PLN 18.4 million for the same period in 2023. As of September 30, 2024, Molecure had cash and cash equivalents of PLN 28.6 million. In addition, contracted grant funding for future years is more than PLN 32 million. The company plans to attract further grants for projects within its developing pipeline of clinical and preclinical programs. * Comparative figures for Q1-Q3 2023 have been restated for comparability due to a change in accounting policy. *** About Molecure S.A. Molecure S.A. is a biotechnology company that discovers and develops drugs to the clinical stage, leveraging its own unique expertise in medicinal chemistry and biology to explore and develop first-in-class small-molecule drugs that, through direct modulation of previously unexplored protein and RNA targets, could provide therapies for many incurable diseases. Molecure has generated a diverse portfolio of seven distinct programs with the support of leading academic research institutions around the world, including Yale University, Rutgers University, the Flemish Institute for Biotechnology (VIB) in Ghent, the University of Michigan, Trinity College Dublin (TCD) and the International Institute of Molecular and Cell Biology in Warsaw (MIBMiK). The most advanced drug candidate developed by Molecure is OATD-01, a first-in-class CHIT1 inhibitor for the treatment of interstitial lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, and MASH, which is in phase II clinical trials. The second drug candidate is OATD-02, an oral, selective, first-in-class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer, whose Phase I clinical trial has begun with first patient administration in Q1 2023. Molecure’s headquarters and laboratories are located in Warsaw and Lodz. The company is listed on the Warsaw Stock Exchange (ticker: MOC). Detailed information can be found on: https://molecure.com/pl/ LinkedIn: Molecure | Twitter: @molecure_sa | YouTube: Molecure SA

The head and neck surgeon specialist is now seeing new patients DETROIT, Sept. 23, 2024 /PRNewswire/ -- The Barbara Ann Karmanos Cancer Institute welcomes Nithin Peddireddy, M.D., a head and neck surgical oncologist specializing in benign and malignant head and neck neoplasms. These include mouth, jaw, and throat cancers, salivary gland masses, melanoma, and skin cancers of the face, neck and scalp. Dr. Peddireddy joins Karmanos's Head and Neck Oncology Multidisciplinary Team (MDT). He is accepting new patients at Karmanos Cancer Center in Detroit and Karmanos Cancer Institute at McLaren Flint. He joined Karmanos and McLaren Health Care on Aug. 19, 2024. Continue Reading Nithin Peddireddy, M.D., joins the Barbara Ann Karmanos Cancer Institute in Detroit and the Karmanos Cancer Institute at McLaren Flint. "It's such an honor to join an organization at the forefront of cancer treatment and development," said Dr. Peddireddy. "Being from the Greater Flint area, I am excited to be able to provide care for patients from my hometown and in Detroit. I'm ready to work with my patients and colleagues to provide the best care and options for removing head and neck masses and the reconstruction necessary afterward." Dr. Peddireddy is an ear, nose and throat (ENT) physician with a subspecialty in advanced head and neck surgery, including thyroid and parathyroid surgery, and comprehensive reconstruction utilizing rotational flaps and microvascular surgery with free flaps. He'll work alongside medical and radiation oncologists, dental oncologists, endocrinologists, pathologists, radiologists, speech-swallow therapists, and other surgical oncologists to create individualized and thorough treatment plans for each of his patient cases. "We continue to grow our expertise to offer patients across the state the best oncologic care," said George Yoo, M.D., FACS, chief medical officer at the Karmanos Cancer Hospital. "Dr. Peddireddy will work side by side with experienced oncologists and collaborate on complicated cases, where we work to give the patient the best outcome. Offering his services not only in Detroit but further into the Karmanos Cancer Network also gives more patients access to surgical treatment that may not be offered elsewhere." "We are continuing our commitment to bring highly-trained oncology specialists to the Karmanos Cancer Institute at McLaren Flint so patients do not have to travel far to get the care they need," said Chris Candela, McLaren Flint President and CEO. "It has added significance to see someone like Dr. Peddireddy return to his hometown to be a valuable resource for the communities we serve." Dr. Peddireddy finished his fellowship in head and neck surgical oncology and microvascular reconstruction at Case Western Reserve University in Cleveland, Ohio. He completed his residency in otolaryngology at the University of Michigan, received his doctorate of medicine at the University of Cincinnati, and completed his undergraduate education at the U-M. He has participated in grant-funded research, has clinical teaching experience, and has contributed to numerous published studies, articles, chapters, and abstracts. Dr. Peddireddy is also a member of the American Academy of Otolaryngology – Head and Neck Surgery. View Dr. Peddireddy's physician profile here. To request an appointment, visit karmanos.org or call 1-800-KARMANOS. About the Barbara Ann Karmanos Cancer Institute Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment and compassion. The Karmanos vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in Michigan. For more than 75 years, the administrative and research headquarters, along with the premier specialty cancer hospital, have been located in downtown Detroit. With 16 network sites, Karmanos delivers world-renowned care and access to clinical trials throughout Michigan and northern Ohio. The National Cancer Institute recognizes Karmanos as one of the best cancer centers in the nation with a comprehensive cancer center designation. Its academic partnership with the Wayne State University School of Medicine provides the framework for cancer research and education – defining new standards of care and improving survivorship. For more information, call 1-800-KARMANOS (800-527-6266) or visit . Follow Karmanos on Facebook, Twitter, LinkedIn and YouTube. About McLaren Flint McLaren Flint is a 378-bed tertiary teaching hospital in Flint, Michigan, offering a full range of comprehensive and advanced services for residents in greater Genesee County. McLaren Flint is affiliated with Michigan State University (MSU) College of Human Medicine in its medical residency programs, including family practice, internal medicine, general surgery, and orthopedic surgery. McLaren Flint also maintains Fellowship programs in vascular surgery, health psychology, cardiology, and pulmonary and critical care in partnership with MSU. McLaren Flint is certified as a BCBSM Blue Distinction Center+ for Bariatric Surgery and Spine Surgery and has earned the Advanced Comprehensive Stroke Center Designation by the Joint Commission and 2024 Get with the Guidelines Gold Plus Award for Stroke Care from the American Heart Association. McLaren Flint is further designated a Breast Imaging Center of Excellence by the American College of Radiology and holds Laboratory Accreditation from the American College of Pathologists. The Karmanos Cancer Institute at McLaren Flint is accredited by the American College of Radiology Radiation Oncology Practice and Michigan Radiation Oncology Quality Consortium (MROQC) 2021 Gold. Learn more at mclaren.org/flint. About McLaren Health Care McLaren Health Care, headquartered in Grand Blanc, Michigan, is a $6.6 billion, fully integrated health care delivery system committed to quality, evidence-based patient care and cost efficiency. The McLaren system includes 13 hospitals in Michigan, ambulatory surgery centers, imaging centers, a 640-member employed primary and specialty care physician network, commercial and Medicaid HMOs covering more than 732,838 lives in Michigan and Indiana, home health, infusion and hospice providers, pharmacy services, a clinical laboratory network and a wholly owned medical malpractice insurance company. McLaren operates Michigan's largest network of cancer centers and providers, anchored by the Karmanos Cancer Institute, a National Cancer Institute-designated comprehensive cancer centers. McLaren has 28,000 full-, part-time and contracted employees and more than 113,000 network providers throughout Michigan, Indiana and Ohio. Learn more at mclaren.org. SOURCE Karmanos Cancer Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Dr. Harkema will spearhead the expansion of transcutaneous and epidural implant spinal stimulation techniques at top centers across the U.S. EAST HANOVER, N.J., Sept. 12, 2024 /PRNewswire/ -- Prominent Neuroscientist Susan Harkema, PhD, will join Kessler Foundation as director of Consortium Growth for Spinal Stimulation in the Tim and Caroline Reynolds Center for Spinal Stimulation on October 1, 2024. She comes to the Foundation after a long, accomplished career at the University of Louisville, KY. Continue Reading Neuroscientist Susan Harkema, PhD, joins Kessler Foundation's Tim and Caroline Reynolds Center for Spinal Stimulation Post this Prominent neuroscientist Susan Harkema, PhD, will join Kessler Foundation in October 2024 as director of Consortium Growth for Spinal Stimulation in the Tim and Caroline Reynolds Center for Spinal Stimulation. In her newly created position, Dr. Harkema will concentrate on developing and expanding the research implementation of both transcutaneous and epidural implant stimulation at centers in the U.S. and internationally. She will report directly to the Foundation's Chief Medical Officer Steven Kirshblum, MD, and indirectly to Gail Forrest, PhD, director of the Reynolds Center for Spinal Stimulation and associate director of the Center for Mobility and Rehabilitation Engineering Research . Dr. Harkema is nationally recognized for her research in the field of spinal cord injury, neural plasticity, and neuromodulation. She held the position of professor in the Departments of Neurology and Neurosurgery at the University of Louisville for more than 20 years. She also held the Owsley B. Frazier Rehabilitation Chair in Neurological Rehabilitation and associate director of the Kentucky Spinal Cord Injury Research Center where she led the Pediatric NeuroRecovery, Adult NeuroRecovery, and Epidural Stimulation programs. Under her leadership over the past decade, these programs have collectively been awarded over $70 million in grants for spinal cord injury research. During that same timeframe, she also led six rehabilitation centers and nine community fitness and wellness centers in the translation of scientific knowledge into clinical practice as the director of the Christopher and Dana Reeve Foundation NeuroRecovery Network. "I'm looking forward to joining forces with Kessler Foundation because it offers an unparalleled opportunity to collaborate with some of the brightest minds and push the boundaries of innovation in spinal cord injury research," said Dr. Harkema. "Joining this esteemed organization allows me to contribute my knowledge while being part of a team that is at the forefront of groundbreaking developments. The Foundation represents a unique chance to continue growing professionally and make a significant impact in an environment that values excellence and forward-thinking," she explained. Dr. Harkema's studies concentrate on understanding how the spinal cord can adapt and reorganize itself in response to injury and interventions, which has significant implications for developing novel therapies to promote recovery led by advancements in epidural stimulation. "Dr. Harkema's research focuses on neural plasticity of spinal networks and recovery of function after spinal cord injury, which complements the work conducted by Foundation scientists on control and modulation of motor and sensory functions. With her knowledge, experience, and drive, our team is poised for unrivaled success," asserted Dr. Kirshblum. He also serves as co-director of the Reynolds Center and the Center for Spinal Cord Injury Research at the Foundation. Among her notable achievements is the discovery of the role neuromodulation and rehabilitation strategies play in restoring motor and autonomic functions in individuals living with spinal cord injury. Her recent studies have demonstrated that adults and children living with chronic paralysis can recover voluntary leg movement, stand independently, and improve cardiovascular and bladder function through epidural stimulation. These findings have expanded translational research, driving efforts to enhance the design and functionality of implantable epidural stimulators. Dr. Harkema has published more than 110 scholarly manuscripts and book chapters; delivered over 100 worldwide lectures and keynotes; and sat on numerous advisory boards and review panels. She earned her Bachelor of Science and PhD degrees in physiology at Michigan State University and conducted her postdoctoral fellowship in neurology at the University of California, Los Angeles (UCLA). After joining the faculty at UCLA in 1995 as an assistant researcher, Dr. Harkema became an assistant professor in the Department of Neurology and the Brain Research Institute. "We welcome the renowned Dr. Susan Harkema, whose expertise will undoubtedly strengthen our research efforts and help us push the boundaries of what's possible in the field of spinal cord research," affirmed Rodger DeRose, president and CEO of the Foundation. "Having Susie join our team is a significant boost to our research initiatives, and will allow us to explore new avenues and accelerate the progress of our work," he added. "I've had the privilege of working with Dr. Harkema over the last 15 years on numerous interventions, clinical trials, and collaborative research initiatives. I'm thrilled that she will be joining our team to help fulfill the goal of the Reynolds Center to extend both transcutaneous and epidural implant stimulation to other prominent centers throughout the U.S.," said Dr. Forrest, adding, "We are confident that Dr. Harkema will provide invaluable insights, accelerating our research and development efforts to deliver cutting-edge solutions." About Kessler Foundation Kessler Foundation, a major nonprofit organization in the field of disability, is a global leader in rehabilitation research. Our scientists seek to improve cognition, mobility, and long-term outcomes, including employment, for adults and children with neurological and developmental disabilities of the brain and spinal cord including traumatic brain injury, spinal cord injury, stroke, multiple sclerosis, and autism. Kessler Foundation also leads the nation in funding innovative programs that expand opportunities for employment for people with disabilities. For more information, visit KesslerFoundation.org. Stay Connected with Kessler Foundation X (formerly known as Twitter) | Facebook | YouTube | Instagram | SoundCloud SOURCE Kessler Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED