4M Therapeutics Awarded $120,000 Grant from SynGAP Research Fund to Evaluate GSK3β Inhibition in Preclinical SYNGAP1-Related Disorders Research
Skillman, NJ – Nov. 12, 2024 – 4M Therapeutics Inc. (4MTx), an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative diseases, today announced that the Company has been awarded a $120,000 grant from SynGAP Research Fund dba Cure SYNGAP1 (SRF) to evaluate central nervous system effects of novel glycogen synthase kinase 3 beta (GSK3β) inhibitors 4MT2001 and 4MT1060. SynGAP is a protein that plays an important role in neuroplasticity and cognition. SYNGAP1 loss of function variants are associated with intellectual disability, autism spectrum disorder, and seizures, among other symptoms.
The project, entitled, “Dosing and Administration of GSK3β inhibitors in Mice to Support SynGAP1 Research” intends to expose mice to different dose levels of 4MT2001 and 4MT1060 and examine central nervous system target engagement of both single and repeat (7-day) dosing. The project will examine both blood and brain levels of 4MT2001 and 4MT1060, obtain brain homogenates, and evaluate the expression of pCRMP2 and PKC substrates.
“We are pleased that the scientific review by SRF recognized the potential of GSK3β inhibition, and in particular our lead asset, 4MT2001, as well as our 4MT1060 compound, to address a key underlying mechanism behind SynGAP1 disorder,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “It has been well characterized that GSK3β inhibition through lithium enhances synaptic plasticity and neurogenesis, and our novel GSK3β inhibitors could provide a significant therapeutic advancement in this space, with higher potency and selectivity combined with improved safety.”
“As a parent of a child with SYNGAP1-Related Disorders (SRD), I am acutely aware of the need to find a treatment for the underlying condition that causes SRD that is not only effective but safe,” said J. Michael Graglia, Co-Founder and Managing Director of SRF. “We look forward to supporting 4MTx in this project and the key insights it will provide towards our mission of finding better therapeutic options for people living with SYNGAP1-Related Disorders.”
SRF is a 501(c)(3) public charity incorporated in 2018. The mission is to improve the quality of life of SYNGAP1 patients through the research and development of treatments, therapies and support systems. Completely family led, SRF is the largest non-government funder of SynGAP research. The founders cover operational costs, allowing donations to go toward research and programs to help SYNGAP1 patients and their families. SRF’s mantra is Collaboration, Transparency & Urgency.
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative conditions. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
4M Therapeutics’ Compounds to be Utilized in Research Project Funded by National Institute on Aging
− Research project on the aging of human brain cells will use 4M Therapeutics’ small molecule compounds
− NIA grant of $3.9 million will help fund project, which will strengthen scientific understanding of 4M’s novel pipeline
Skillman, NJ – October 17, 2024 – 4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative diseases, today announced that the company will provide its novel compounds for use in a research project by Jerome Mertens, Ph.D., Associate Professor of Neurosciences at the University of California San Diego and Adjunct at the Salk Institute. Dr. Mertens was awarded $3.9 million in grant funding from the National Institute on Aging (NIA) and will be the principal investigator for the project, titled “Age-equivalent neurons from mild cognitive impairment (MCI) patients to investigate early determinants of Alzheimer’s dementia (AD).”
The project will study neurons derived from reprogrammed skin cells, a method that creates neurons that have the key effects of aging. Dr. Pablo Lapuerta, CEO and Co-Founder of 4M Therapeutics, will act as an advisor on the project and assist with the selection of compounds for further testing.
“Dr. Mertens’ research on human brain cells has potential applications across a largely underserved elderly patient population, and we are honored that his lab would choose to use 4M’s compounds as part of this study,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “This collaboration will deepen our understanding of the therapeutic potential of our pipeline. Inhibition of GSK3β promises to enhance neuroplasticity and neurogenesis, with the potential to address age-related cognitive decline. This regenerative pathway could play a key role in protecting against dementia.”
“We are grateful to the NIA for funding this research, as elderly patients with MCI have no approved treatment options,” said Dr. Mertens. “We hope to uncover new findings surrounding MCI that could impact an area of high unmet need and millions of patients.”
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative diseases. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
4M Therapeutics Presented Preclinical Data at the 26th Annual Conference of the International Society for Bipolar Disorders
Skillman, NJ – October 1, 2024 – 4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative conditions, today announced an oral presentation at the 26th Annual Conference of the International Society for Bipolar Disorders, which took place from September 29 to October 1, 2024, in Reykjavik, Iceland. The presentation, titled “Novel Small Molecule Inhibitors of GSK3β for the Treatment of Bipolar Disorder,” was presented by Dr. Pablo Lapuerta, CEO, on October 1, 2024.
The presentation examined the effects of lithium and two of 4M Therapeutics’ novel, small molecule GSK3B inhibitors on amphetamine-induced positive ultrasonic vocalizations (USVs), a validated model of positive affective state. Results showed that 4M’s novel GKS3B inhibitors had comparable efficacy to lithium, with marked increases in USVs with AMP attenuated by lithium, 4MT-A, and 4MT-B. The magnitude of reduction in flat USVs was generally 40-80%, depending on time interval, dose, and type of tone. In addition, animal safety data for 4MT-A indicates it has the potential to avoid the renal toxicity of lithium, and combined with its efficacy data, supports its advancement into clinical development for bipolar disorder.
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative conditions. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
4M Therapeutics Announces Positive Preclinical Data for Lead Asset 4MT2001 Demonstrating Central Nervous System Target Engagement
Statistically significant target engagement data parallel positive effects seen on animal behavior
Data to be presented at the 26th Annual Conference of the International Society for Bipolar Disorders
SKILLMAN, N.J.--(BUSINESS WIRE)--4M Therapeutics Inc. (4MTx), an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative diseases, today announced new preclinical data for its lead program, 4MT2001, a novel small molecule glycogen synthase kinase 3 beta (GSK3β) inhibitor, that demonstrated clear central nervous system (CNS) target engagement paralleling its positive effects on animal behavior.
“The preclinical target engagement data further validate our accelerated development of 4MT2001,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We expect to begin dosing in our GLP toxicology (animal safety) studies over the next few weeks, and we remain on track to initiate a Phase 1 trial for 4MT2001 in 2025.”
In preclinical studies, low doses of 4MT2001 produced statistically significant reductions in brain pCRMP2 levels and brain PKC substrates (p<0.05) versus dextroamphetamine (D-AMPH). The biomarker pCRMP2 is a highly specific indicator of GSK3β activity, and previous studies have shown lithium also reduces brain levels of both pCRMP2 and PKC substrates. The effects of 4MT2001 on these two key CNS biomarkers and the positive results previously shown on two measures of animal behavior (motion and vocalizations) support the profile of 4MT2001 as a potent, targeted, and safer mood stabilizer for people with bipolar disorder and other CNS conditions.
Dr. Lapuerta will present these target engagement data, along with preclinical data examining the efficacy of 4MT2001 on amphetamine-induced positive appetitive ultrasonic vocalizations (USVs), at the upcoming 26th Annual Conference of the International Society for Bipolar Disorders, taking place from September 29 to October 1, 2024, in Reykjavik, Iceland. Details of the presentation are below.
Session Title: New & Trending Oral Session IX
Presentation Title: Novel Small Molecule Inhibitor of GSK3β for the Treatment of Bipolar Disorder
Presentation Date and Time: October 1, 2024, from 9:50 AM to 10:00 AM GMT (5:50 AM to 6:00 AM EDT)
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative diseases. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
Contacts
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
ir@4mtx.net
4M Therapeutics Presented Novel Preclinical Data at SOBP Annual Meeting 2024 Demonstrating Potent Effects of Inhibitors of GSK3β for the Treatment of Bipolar Disorder
GSK3β inhibitors showed successful CNS target engagement and efficacy comparable to lithium at significantly lower doses in models of bipolar disorder
Skillman, NJ – May 13, 2024 – 4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative conditions, today announced the presentation of a poster at the Society of Biological Psychiatry (SOBP) Annual Meeting, that occurred from May 9-11, 2024, in Austin, Texas. The poster, titled “The Effects of Novel Small Molecules in a Preclinical Model of Positive Affective State,” was presented on May 11, 2024.
“Our presentation underscored the capability of our novel small molecules to selectively target GSK3β and demonstrate efficacy for the treatment of bipolar disorder and acute mania,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We continue to accelerate the development of much-needed therapeutic options that have the potential to significantly improve upon the safety and efficacy of the standard of care for patients with neuropsychiatric conditions. We remain on track to initiate a Phase 1 clinical trial for our lead investigational compound in 2025.”
The poster examined the effects of 4M Therapeutics’ glycogen synthase kinase 3 beta (GSK3β) inhibitors, 4MT-A and 4MT-B, on amphetamine (AMP)-induced positive appetitive ultrasonic vocalizations (USVs), a validated model of positive affective state. Marked increases in USVs when treated with AMP were attenuated by lithium, and equal or greater reduction in USVs was observed when treated with 4MT-A and 4MT-B at 1/500th to 1/1000th the concentration of lithium. Similar patterns were observed across USV categories and treatment groups in both the first and second hour after AMP dosing. In addition, supporting data showed target engagement for 4MT-A through the reduction of pCRMP2 in vitro in excitatory cortical neurons and in vivo in rat brain. These statistically significant reductions in pCRMP2 demonstrated GSK3β inhibition affecting a key biomarker.
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative conditions. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
ir@4mtx.net
4M Therapeutics Announces Formation of Clinical Advisory Board with Experts in Neuropsychiatry and Neurodegeneration
Appointees Andrew J. Cutler, M.D., Paul E. Keck, M.D., Jonathan Meyer, M.D., Andrew Nierenberg, M.D., and Gary Sachs, M.D. join clinical consultant, Maurizio Fava, M.D.
SKILLMAN, N.J.--May 2, 2024--4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative conditions, today announced the formation of its Clinical Advisory Board comprised of five physician scientists and leaders in the treatment and research of a variety of neuropsychiatric and neurodegenerative conditions. This group of experts join Dr. Maurizio Fava, the company’s clinical consultant, in providing invaluable guidance and insights to the 4M Therapeutics management team.
“Our newly formed Clinical Advisory Board brings together pioneers from top institutions across the country dedicated to treating central nervous system disorders,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-Founder of 4M Therapeutics. “We continue to build a robust team that we believe will enable us to capitalize on the potential of our novel drugs to better address a growing need for safer and more effective therapies for the brain. I would like to welcome each new member to 4M Therapeutics, and we look forward to leveraging their expertise and decades of experience to advance our promising pipeline of compounds into the clinic.”
Andrew J. Cutler, M.D.
Dr. Cutler is a Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. He holds a BS in Biology from Haverford College, and obtained his medical degree from the University of Virginia School of Medicine, where he was elected into the Alpha Omega Alpha (AOA) honor medical society. Dr Cutler completed his medical internship and residencies in both Internal Medicine and Psychiatry at the University of Virginia Health Sciences Center, where he also did research training in dopamine receptor pharmacology. He is board certified in Internal Medicine by the American Board of Internal Medicine and in Psychiatry by the American Board of Psychiatry and Neurology. He is also a Certified Physician Investigator (CPI) from the Association of Clinical Research Professionals (ACRP).
Dr. Cutler has been conducting clinical research since 1993 and has been a Principal Investigator on over 400 clinical trials in a variety of CNS and medical indications, focusing on ADHD, bipolar disorder, depression and schizophrenia in children, adolescents and adults. He was an Assistant Professor of Psychiatry at the University of Chicago before moving to Florida and founding Florida Clinical Research Center (FCRC) in 1998. He sold FCRC to Meridien Research in 2016. He retired from Meridien as Executive Vice President and Chief Medical Officer in 2019. He has authored more than 150 peer-reviewed scientific articles and has presented more than 300 abstracts and posters at scientific meetings around the world. He is a peer reviewer for several prominent medical journals and has served on several editorial boards. He has chaired or attended over 250 medical and scientific advisory boards, delivered more than 3,000 national and international pharmaceutical promotional talks, and over 300 continuing medical education (CME) and Grand rounds presentations. He has participated in more than 50 national satellite TV medical education broadcasts and led 200-plus national medical web conferences. Dr. Cutler consults with pharmaceutical and biotechnology companies and serves on the board of the Neuroscience Education Institute.
Dr. Cutler is a member of the American Psychiatric Association (APA), the Florida Psychiatric Society (FPS) and the American Medical Association (AMA). He is honored to be a Fellow of both the APA and the Academy of Psychosomatic Medicine. He has received numerous professional honors and awards, including the Merck Award for outstanding medical scholarship, the University of Virginia Pride Award for outstanding patient care, the William Sorum Award from the APA, the Outstanding Congressional Fellow Award from the 103rd US Congress, a citation from Florida Hospital for outstanding patient care, and the Distinguished Clinical Professional Award from the Central Florida Mental Health Association.
Maurizio Fava, M.D.
Dr. Fava is Chair of the Department of Psychiatry/Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network and Institute at MGH, and serves as the associate dean for clinical and translational research and the Slater Family Professor of Psychiatry at Harvard Medical School. Dr. Fava is a world leader in the field of depression and clinical psychopharmacology. He has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international circulation which have been cited more than 100,000 times and with an h index greater than 150 on Google Scholar.
Dr. Fava obtained his medical degree from the University of Padova School of Medicine and completed residency training in endocrinology at the same university. He then moved to the United States and completed residency training in psychiatry at MGH. He founded and was director of the hospital’s Depression Clinical and Research Program from 1990 until 2014. Under Dr. Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.
Dr. Fava has been successful in obtaining funding as principal or co-principal investigator from both the National Institutes of Health and other sources for a total of more than $150 million. Dr. Fava’s prominence in the field is reflected in his role as the co-principal investigator of STAR*D, the largest research study ever conducted in the area of depression, of the RAPID Network, the NIMH-funded series of studies of novel, rapidly-acting antidepressant therapies, and of the Clinical Coordinating Center of EPPIC-Net, the NINDS-funded network conducting proof-of-concept trials in pain. Dr. Fava is a well-known national and international lecturer, having given more than 300 presentations at national and international meetings. He is the former President of the American Society of Clinical Psychopharmacology and, in 2023, Dr. Fava was elected to the National Academy of Medicine.
Paul E. Keck, M.D.
Dr. Keck is Craig and Frances Lindner Professor of Psychiatry and Neuroscience at the University of Cincinnati (UC) College of Medicine. He is also President-CEO of the Lindner Center of HOPE, a state-of-the-science, UC-affiliated comprehensive mental health center in Mason, Ohio. He has been in the top 20 of the most cited scientists in the world, publishing in the fields of psychology and psychiatry, since 1996.
He is the author of over 375 scientific papers in leading medical journals. He has also contributed over 175 reviews and chapters to major psychiatric textbooks. Dr. Keck is the editor or author of 6 scientific books.
Dr. Keck is the recipient of numerous honors, including the Gerald Klerman Young Investigator Award from the National Depressive and Manic-Depressive Association (NDMDA); the Gerald Klerman Senior Investigator Award from the Depression & Bipolar Support Alliance (DBSA); the Exemplary Psychiatrist Award from the National Alliance of the Mentally Ill (NAMI); the Philip Isenberg Teaching Award from Harvard Medical School; two Communicator Awards for Continuing Medical Education; and two Golden Apple Teaching Awards from the University of Cincinnati College of Medicine. He is listed as one of the Best Doctors in Cincinnati by Cincinnati Magazine, The Best Doctors in America, & Top Psychiatrists In America, & The World's Most Influential Scientific Minds by ScienceWatch.
A magna cum laude and Phi Beta Kappa graduate of Dartmouth College, Dr. Keck received his MD with honors from the Mount Sinai School of Medicine, New York, NY. He served his internship in Internal Medicine at the Beth Israel Medical Center in New York and completed his residency training in Psychiatry at Harvard Medical School and McLean Hospital, Belmont, MA. Dr. Keck remained on faculty at McLean and Harvard before joining the Department of Psychiatry at the University of Cincinnati in 1991.
Jonathan Meyer, M.D.
Dr. Meyer is a Voluntary Clinical Professor of Psychiatry at University of California, San Diego, and a Distinguished Life Fellow of the American Psychiatric Association. He is a graduate of Stanford University and Harvard Medical School, finished his adult psychiatry residency at LA County-USC Medical Center and completed fellowships there in Consultation/Liaison Psychiatry and Psychopharmacology Research. Dr. Meyer has teaching duties at UC San Diego and the Balboa Naval Medical Center in San Diego, and is a psychopharmacology consultant to the first episode psychosis program at Balboa Naval Medical Center in San Diego. Dr. Meyer has lectured and published extensively on psychopharmacology, and is the sole author of the chapter on the Pharmacotherapy of Psychosis and Mania for the last 3 editions of Goodman & Gilman's The Pharmacological Basis of Therapeutics. Along with Dr. Stephen Stahl, he is co-author of the Clozapine Handbook published in 2019, The Clinical Use of Antipsychotic Plasma Levels released in 2021, and The Lithium Handbook published in 2023, all three by Cambridge University Press.
Andrew Nierenberg, M.D.
Dr. Nierenberg is the Director of the Dauten Family Center for Bipolar Treatment Innovation Massachusetts General Hospital and Professor of Psychiatry, Harvard Medical School. In addition to directing the Dauten Center, Dr. Nierenberg is the co-director of Mass General’s Center for Clinical Research Education and associate director of the Depression Clinical and Research Program. He also holds the Thomas P. Hackett, MD, Endowed Chair in Psychiatry at Mass General.
After completing his residency in psychiatry at New York University/Bellevue Hospital, he studied clinical epidemiology at Yale University as a Robert Wood Johnson Clinical Scholar. Dr. Nierenberg then joined the faculty at Harvard Medical School, first at McLean Hospital in Belmont, MA and then at Massachusetts General Hospital. He is also an Honorary Professor in the School of Medicine, Faculty of Health at Deakin University, Geelong, Australia, and an Honorary Skou Professor at Aarhus University in Denmark.
Dr. Nierenberg focuses on clinical trials for bipolar disorder and depression, with over 590 published papers and a Google Scholar h-index of 125. He has been listed among The Best Doctors or Top Doctors in America for the treatment of mood and anxiety disorders yearly since 1994. He has been honored with the International Society for Bipolar Disorders Mogens Schou Award for Research and the Brain and Behavior Research Foundation’s Colvin Prize. Dr. Nierenberg is currently the PI of the Sequential Multiple Assignment of Treatment study for bipolar depression (SMART-BD) and the Bipolar Disorder Learning Health Network.
Dr. Nierenberg graduated from the Albert Einstein College of Medicine of Yeshiva University, Bronx, NY.
Gary Sachs, M.D.
Dr. Sachs is an internationally recognized expert clinician and clinical trialist with extensive experience in rater training and clinical trial methodologies for mood and anxiety disorder research. As Principal Investigator of the National Institute of Mental Health (NIHM) Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), Dr. Sachs led the largest treatment study ever conducted for bipolar disorder. He has been instrumental in developing practice guidelines and technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials.
Dr. Sachs is Clinical Vice President of Signant Health. He founded Concordant Rater Systems which was acquired by Signant Health in 2010. Dr. Sachs was also the founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is Associate Clinical Professor of Psychiatry at the Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include clinical trial methodology, placebo response mitigation, psychopharmacology, patient centric outcome measures, bipolar mood disorder, and development of measure-based practice guidelines. Dr. Sachs served on the board of directors for the Depression and Bipolar Support Alliance. Dr Sachs was president of the International Society for CNS Clinical Trial Methodology (ISCTM) 2022-2024. He has authored over 200 peer reviewed articles.
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative diseases. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaboration between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
ir@4mtx.net
4M Therapeutics Strengthens Executive Leadership Team with Appointment of Kimberly Lee, D.O. as Chief Business Officer
Dr. Lee brings over 20 years of biotechnology industry and Wall Street experience
Skillman, NJ – March 4, 2024 – 4M Therapeutics Inc., an early-stage biotechnology company developing treatments for neuropsychiatric and neurodegenerative conditions, today announced the appointment of Kimberly Lee, D.O. as Chief Business Officer and member of the executive management team. Dr. Lee has over 20 years of biotechnology industry and Wall Street experience with expertise in financial and corporate strategy across a broad range of therapeutic areas including CNS, oncology, nephrology, pain and metabolic and rare diseases.
“We are excited to welcome Kim to the team to maximize the potential of our pipeline and to drive strategic growth,” said Dr. Pablo Lapuerta, Chief Executive Officer and Co-founder of 4M Therapeutics. “Her experience will be instrumental as we enter the next phase of the company's life cycle.”
Over the past year, Dr. Lee collaborated with 4M Therapeutics as a strategic advisor, providing tactical input and support to the Company’s management team. Prior to that, she held the role of Chief Corporate Affairs Officer at Taysha Gene Therapies. Prior to joining Taysha, she served as Head of Corporate Strategy and Investor Relations at Lexicon Pharmaceuticals, Inc., and Vice President of Corporate Strategy, Corporate Communications, and Investor Relations at Raptor Pharmaceuticals through its acquisition by Horizon Pharma. Preceding her corporate roles, Kim served as a Managing Director and Senior Equity Research Analyst covering the biotechnology sector at Janney Montgomery Scott and ThinkEquity. She also held equity research roles at Wedbush Securities and Jefferies after beginning her career on Wall Street at Stephens. Dr. Lee received her B.S. in Biological Sciences from Stanford University and her medical degree from Kirksville College of Osteopathic Medicine. She is a licensed physician in California and has published in several peer-reviewed journals.
“During my time as an advisor, I was incredibly impressed by the progress made at 4M Therapeutics in the development of more targeted and safer alternatives to lithium and atypical antipsychotics, and the potential for differentiated value creation and am thrilled to now be joining the company in this new role,” said Dr. Lee. “I look forward to working more closely with the team and its world-leading group of scientific innovators to position the company for long-term success and to ultimately bring transformative treatment options to the significant patient population suffering from mental health disorders that are underserved by the current standard of care, beginning with bipolar mania.”
About 4M Therapeutics Inc.
4M Therapeutics Inc. (4MTx) is advancing treatments for neuropsychiatric and neurodegenerative conditions. The Company focuses on targets for a wide array of disorders and indications. 4MTx applies unique insights from its living human brain cell platform, which was developed through a collaborative effort between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. The Company’s pipeline includes potential breakthrough treatments for bipolar mania, agitation in Alzheimer’s disease, neurodegeneration, and other CNS disorders. For more information, visit www.4mtx.net.
For investor and media inquiries, please contact:
Kimberly Lee, DO
Chief Business Officer
4M Therapeutics CEO Pablo Lapuerta to Speak on "Opportunities for Biomarker Development in Neuroscience" at the 9th Annual Biomarker and Companion Diagnostics Conference
FOR IMMEDIATE RELEASE
4M Therapeutics CEO Pablo Lapuerta to Speak on "Opportunities for Biomarker Development in Neuroscience" at the 9th Annual Biomarker and Companion Diagnostics Conference in San Diego, California
Skillman, NJ – February 1st, 2024 – 4M Therapeutics Inc., an early stage biotechnology company developing therapies for central nervous system (CNS) disorders, is proud to announce that its CEO, Dr. Pablo Lapuerta, will be a featured speaker at the 9th Annual Biomarker and Companion Diagnostics Conference in San Diego, California. Dr. Lapuerta's presentation, titled "Opportunities for Biomarker Development in Neuroscience," will delve into the cutting-edge advancements and the future of personalized medicine in neurology.
As a respected leader in the biotech industry, Dr. Lapuerta brings nearly three decades of experience in clinical development and a deep commitment to enhancing patient care through scientific innovation. His talk will highlight the pivotal role of biomarkers in diagnosing, monitoring, and managing neurological diseases, with a particular focus on how these indicators are transforming the landscape of treatment options and patient outcomes.
"Biomarkers represent a critical frontier in neuroscience, offering the promise of more precise and effective interventions for complex conditions," said Dr. Lapuerta. "Our work at 4M Therapeutics is at the forefront of this exciting field, and I look forward to sharing our insights and discoveries with my colleagues at the conference."
The 9th Annual Biomarker and Companion Diagnostics Conference is renowned for gathering the world's leading experts in biomedical research, offering a platform for sharing the latest innovations and strategies in biomarker development. Dr. Lapuerta's presentation is scheduled for 11am PT on February 9th, 2024.
About 4M Therapeutics Inc.:
4M Therapeutics Inc. (4MTx) develops therapies for central nervous system (CNS) disorders. We focus on targets for a wide array of disorders and indications. We apply unique insights from our living human brain cell platform, which was developed through a collaborative effort between Harvard, MIT, and the University of Washington to identify and design more effective and safer therapeutics. For more information, visit www.4mtx.net.
For media inquiries, please contact:
Ben Williams, Chief Business Officer, 4M Therapeutics Inc.
ben@4mtx.net
WEBINAR: Developing Innovative Compounds for Psychiatric& Neurological Conditions
4MTx is currently raising a final angel round and will be providing updates on the recent progress towards clinical trial initiation in Q1 2025. Join us on October 26th from 11am PDT (2 pm EST) to learn more about our lead program, pipeline, and platform from Founder/CEO/Director Pablo Lapuerta, MD, and Director Lawrence Goldstein, PhD.
4M Therapeutics Inc. (4MTx) is developing targeted therapies for the treatment of brain disorders by modulating key pathways associated with neuronal health. Their lead asset, 4MT2001, aims to replace lithium therapy by providing equal or better efficacy with a superior safety profile for bipolar disorder. Their pipeline has the potential to address Alzheimer’s disease, frontal temporal dementia, and other brain diseases with broad clinical, commercial, and partnering potential. 4MTx is currently raising a final angel round and will be providing updates on the recent progress towards clinical trial initiation in Q1 2025.
4M Therapeutics Inc. Announces Oversubscribed $2.575 Million Financing Round
FOR IMMEDIATE RELEASE
4M Therapeutics Inc. Announces Oversubscribed $2.575 Million Financing Round
July 20, 2023
Contact:
Ben Williams, Chief Business Officer
Email: info@4mtx.net
Skillman, NJ — 4M Therapeutics Inc. (4MTx), a biotechnology innovator in the field of Central Nervous System (CNS) disorder treatments, has completed a $2.575 million financing round, surpassing the original goal of $1.5 million. The total investment in 4MTx is $4 million to date.
This investment round included the participation of company founders, all members of the Board of Directors, five consultants, and three advisors to the company. Investors in the financing include professionals with vast pharmaceutical experience, including three current biotech CEOs, as well as high net-worth individuals committed to the advancement of treatments for Bipolar and Alzheimer's Disease.
Mark Pavao, Managing Partner of Biotech Value Advisors, explained why he invested in 4MTx: “In my over 30 years of experience in global biopharma commercialization I have helped bring many neuroscience drugs to market, including blockbusters Abilify and Nurtec-ODT. 4MTx’s lead program targets meaningful improvement to the current standard of care in a large psychiatric indication that has significant unmet need. Once approved, I am confident that 4MTx can successfully scale and execute its commercial launch plan.”
Pablo Lapuerta, MD, Chief Executive Officer of 4MTx, stated, "We are grateful to all the investors who have placed their trust in 4MTx. Together we are committed to developing new treatments that improve the lives of those battling Bipolar Disorder, Alzheimer's Disease, and the other CNS disorders where we can have a positive impact."
About 4MTx:
4M Therapeutics Inc. (4MTx) is a biotechnology startup dedicated to the development of new treatments for CNS disorders, utilizing living human brain cells to transform drug discovery. Concentrating on conditions like bipolar disorder, Parkinson's, and Alzheimer's, where neural plasticity is impaired, the 4MTx pipeline includes two GSK3B inhibitors, a glutamate antagonist, and a CDK5 inhibitory peptide. With a lead program slated for human clinical trials in 2025, and world-renowned scientific founders in neurobiology, chemistry, and regenerative medicine, 4MTx is positioned at the forefront of neuroscience. To learn more or to engage with us, visit www.4mtx.net or follow us on LinkedIn.
Andrew A. Nierenberg Joins the 4M Therapeutics Scientific Advisory Board
[Skillman, NJ & Boston, MA]: 4M Therapeutics Inc. (4MTx) today announced that Andrew A. Nierenberg has joined its Scientific Advisory Board
Dr. Nierenberg holds the Thomas P. Hackett, MD, Endowed Chair in Psychiatry at Massachusetts General Hospital, is Director of the Dauten Family Center for Bipolar Treatment Innovation, and is a Professor at Harvard Medical School. Dr. Nierenberg’s primary interests are treatment-resistant depression, bipolar depression, and innovative treatments for mood disorders.
"I am excited to join the team at 4M Therapeutics", says Dr. Nierenberg. "Together we have world-class scientists, strong executive leadership, and a wonderful opportunity to develop new therapies for patients."
"It is a pleasure to have Dr. Nierenberg join us”, says Pablo Lapuerta, Founder & CEO at 4MTx. "This year 4MTx made a lot of progress in advancing towards clinical development, and Dr. Nierenberg’s contribution as a world expert in bipolar disorder prepares us well for the future."
About 4MTx: 4M Therapeutics Inc. is a startup biotech company based on the principle that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from human induced pluripotent stem cells. The initial focus is bipolar disorder and Alzheimer's disease, conditions where targeted drug discovery can support and improve neuroplasticity and neurogenesis. The scientific founders are world-leaders in neurobiology, chemistry, and the pharmacology of neuroplasticity. For more information, please visit www.4mtx.net and engage with us on LinkedIn.
4M Therapeutics, Inc., Enters Into Strategic Partnership with Vala Sciences, Inc., to Advance the 4MTx Pipeline
Alexandra-Sophia C. Piliotis
4M Therapeutics, Inc.
4M Therapeutics, Inc., Enters Into Strategic Partnership with Vala Sciences, Inc., to Advance the 4MTx Pipeline
[Skillman, NJ & San Diego, CA]: 4M Therapeutics, Inc., (4MTx) today announced a new partnership with Vala Sciences Inc. (Vala). This partnership will leverage Vala’s expert services via their breakthrough kinetic high-content screening technology and toolset to advance 4MTx’s innovative pipeline.
“I am excited to partner with Vala and work with Jeff Price again,” says Stephen J. Haggarty, Ph.D., Scientific Founder at 4MTx. “Jeff and I worked together previously conducting NIH funded research to advance the understanding of pathways to target for treating of bipolar disorder. It is amazing to have this innovative team that has worked with me coming back to advance the 4M Therapeutics pipeline.”
“I have known Stephen Haggarty for many years, and we have published together in the Proceedings of the National Academy of Sciences,” says Jeffrey H. Price, M.D., Ph.D., CEO, Founder, and President at Vala. “Stephen’s expertise in neuroscience and drug discovery is a formidable combination. We are honored to help advance an innovative pipeline derived from Stephen’s and his colleague’s human stem cell-based screens and discovery of neuroplasticity mechanisms that have the potential for treating multiple neuropsychiatric disorders.”
The partnership of 4MTx and Vala Sciences builds upon on this previously successful collaboration to produce cutting-edge work.
About 4MTx: 4M Therapeutics Inc. is a startup biotech company based on the principle that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from human induced pluripotent stem cells. The initial focus is bipolar disorder and Alzheimer's disease, conditions where targeted drug discovery can support and improve neuroplasticity and neurogenesis. The scientific founders are world-leaders in neurobiology, chemistry, and the pharmacology of neuroplasticity. For more information, please visit www.4mtx.net and engage with us on LinkedIn.
About Vala: Vala Sciences, Inc., is a biotechnology company that performs proprietary phenotypic Kinetic Image Cytometry® (KIC®, a superset of high content screening) to achieve unrivaled in vitro prediction of human clinical responses to drug compounds. Vala leverages its expertise in cardiac and neural biology, cell imaging, data analysis, and assay development to reduce clinical failures of drug candidates. Vala’s toolset, which includes the most advanced high throughput functional disease models of human iPSC-derived heart, brain, and muscle tissues, delivers the highest predictivity of human responses. For more information on Vala Sciences Inc., please visit valasciences.com and engage with us on LinkedIn.
4M Therapeutics Inc. Announces New Patent License Agreement
FOR IMMEDIATE RELEASE: Thursday, June 30, 2022
Alexandra-Sophia C. Piliotis
4M Therapeutics Inc.
brenda@4mtx.net
4M Therapeutics Inc. Announces New Patent License Agreement
[Skillman, NJ]: 4M Therapeutics Inc. (4MTx) today announced that it has signed an exclusive patent license agreement with Massachusetts Institute of Technology (MIT) for technology relating to treatment of bipolar disorder and other brain disorders.
“We are very excited to sign this license with MIT, which enable us to advance 4MT-02, an important part of the 4MTx pipeline,” says Pablo Lapuerta, Founder and Chief Executive Officer at 4MTx. “This agreement brings forth a great opportunity for 4MT-02, an advanced compound that could be ready for clinical trials in 2024.”
“I am very happy to see 4MT-02 move forward in pre-clinical development,” said Dr. Lawrence Goldstein, Director at 4MTx. “4MT-02 was developed as a potential therapeutic agent owing to great scientific progress in understanding how 4MT-02 targets key pathways in the brain.”
This patent license agreement is one of several steps that 4MTx has taken to build and strengthen its intellectual property. The terms of this agreement remain confidential as agreed between the parties.
About 4MTx:
4M Therapeutics Inc. is a startup biotech company based on the principle that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from human induced pluripotent stem cells. The initial focus is bipolar disorder and Alzheimer's disease, conditions where targeted drug discovery can support and improve neuroplasticity and neurogenesis. The scientific founders are world-leaders in neurobiology, chemistry, and the pharmacology of neuroplasticity. For more information, please visit www.4mtx.net and engage with us on LinkedIn.
Don Hayden and Lawrence Goldstein join 4M Therapeutics Inc. Board of Directors
FOR IMMEDIATE RELEASE: Wednesday, May 11, 2022
Benjamin C. Williams
4M Therapeutics Inc.
ben@4mtx.net
Don Hayden and Lawrence Goldstein join 4M Therapeutics Inc. Board of Directors
Skillman, NJ: 4M Therapeutics Inc. (4MTx) today announced that Don Hayden and Lawrence Goldstein have joined its Board of Directors.
Don Hayden is an accomplished biopharmaceutical executive and board member, having served earlier in his career at the highest levels in big pharma and thereafter as Chairman or Director of numerous biotechnology companies. During his 25-year career at Bristol-Myers Squibb, Don held a series of key leadership roles including President of Global Pharmaceuticals. Don has served as Board Chairman at a wide range of companies, including REGENXBIO, Amicus Therapeutics, Insmed, Vitae Pharmaceuticals, Gloucester Pharmaceuticals, and WindMIL Therapeutics. He continues to serve as Chairman of Otsuka America Pharmaceuticals Incorporated and Avanir Pharmaceuticals. Don received an M.B.A. from Indiana University and his undergraduate degree from Harvard University.
“I've known Pablo Lapuerta for over 20 years," says Don. "Significant unmet medical need remains in the treatment of neuropsychiatric disorders and neurodegenerative diseases. 4M Therapeutics' unique science offers the opportunity to improve treatment across a range of these disorders and diseases."
“We are honored to have Don join our Board as our Chairman," said Pablo Lapuerta, Founder & CEO at 4MTx. "He brings a wealth of experience and leadership to 4MTx.”
Lawrence SB Goldstein is a Cell Biologist, Geneticist and Neuroscientist recognized for his work on intracellular movements and neurodegenerative disease. Larry was a Full Professor with tenure at Harvard University and then became a Professor (now Emeritus) of Cellular and Molecular Medicine and Neuroscience at UC San Diego. He is also the Scientific Director of the Sanford Consortium for Regenerative Medicine and a co-founder of a public biotechnology, Cytokinetics. Larry has received the Public Service Award from the American Society for Cell Biology and has had a Public Policy Fellowship named for him by the International Society for Stem Cell Research. He is a member of the American Academy of Arts and Sciences and the National Academy of Sciences. Larry holds a PhD in Genetics from the University of Washington.
“Using stem cell technology in drug discovery and development is a tremendous advance in biopharma and is particularly critical in neuroscience where both in vitro analyses and animal models have been limited," said Larry. "I am excited to advance our pipeline of small molecules that have the potential to combat disease mechanisms by modulating validated targets.”
“We are honored to have such an accomplished scientist join our Board of Directors,” says Pablo. "His experience with stem-cell based drug discovery, small molecule development, and the mechanisms underpinning neuropsychiatric and neurological disorders are already making an impact at 4MTx.”
About 4M Therapeutics Inc.: 4M Therapeutics Inc. (4MTx) is a startup biotech company based on the principle that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from induced pluripotent stem cells. Our initial focus is bipolar disorder and Alzheimer's disease, conditions where targeted drug discovery can support and improve neuroplasticity and neurogenesis. Join us at www.4mtx.net.
4M Therapeutics Files Provisional Patents
We are thrilled to announce that 4M Therapeutics has filed provisional patents covering two of our assets — 4MT-01 and 4MT-02.
This milestone represents a major step forward for our company. We look forward to announcing more patent filings fortifying our intellectual property position further in the coming months.
4M Therapeutics Announces Successful Completion of its Seed Round Financing
March 8, 2022
Skillman, New Jersey, USA — 4M Therapeutics Inc. (4MTx) has completed seed round financing. Strong interest from investors saw 4MTx raise $1.4 million, surpassing the initial target of $1.2 million. The investment is being used to optimize 4MT-01 and secure intellectual property.
"We are honored by the interest we have received in 4MTx," said Ben Williams, Vice President of Corporate Development and Co-founder. "All of our founders have invested in 4MTx, and they are joined by others with a history of strong leadership in the biotech industry.”
“I am excited to apply recent advances in stem cell technology to discover and develop medicines that could help millions of people living with bipolar disorder, Alzheimer's disease, and other conditions,” said Li-Huei Tsai, a Scientific Founder of 4MTx and Professor and Director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology.
“We would like to thank all our investors,” said Pablo Lapuerta, MD, Chief Executive Officer and Founder. “Their investment represents a vote of confidence in the team at 4MTx, and it speaks to the excitement around our innovative approach to neuroscience drug discovery and development.”
4MTx anticipates providing further updates on its scientific progress in the second half of 2022.
About 4M Therapeutics:
4M Therapeutics Inc. (4MTx) is a startup biotech company based on the belief that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from induced pluripotent stem cells. The initial focus is on bipolar disorder and Alzheimer's disease, conditions where enhancement of WNT protein expression can support neuroplasticity and neurogenesis. More information on 4MTx is available at www.4mtx.net.
About 4MT-01:
4MT-01 is a small molecule inhibitor of GSK3β (glycogen synthase kinase 3 beta). Inhibition of GSK3β has been shown to enhance WNT protein expression, which could potentially benefit people with bipolar disorder and patients with Alzheimer’s disease. 4MT-01 is an investigational product that has not been evaluated in clinical trials.
4M Therapeutics Statement Regarding Forward-Looking Statements:
This announcement contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements
For additional inquiries, contact Ben Williams, Vice President of Corporate Development and Co-founder of 4M Therapeutics, ben@4mtx.net
4M Therapeutics joins MIT Startup Exchange
January 13, 2021
Skillman, New Jersey, USA — 4M Therapeutics Inc. (4MTx) has joined the Massachusetts Institute of Technology’s Startup Exchange. The Startup Exchange actively promotes collaboration and partnerships between MIT-connected startups and industry, exclusively members of MIT’s Industrial Liaison Program (ILP). MIT Startup Exchange and the ILP are integrated programs of MIT Corporate Relations.
“MIT-connected” startups are based on licensed MIT technology, or are founded by MIT faculty, staff, or alumni.
The industry side of the exchange is represented primarily by 240+ ILP member companies. Meetings between MIT Startup Exchange startups and industry are facilitated by program directors at MIT’s Industrial Liaison Program. Each program director manages a portfolio of ILP member companies, and their primary role is to match company research interests with relevant MIT faculty and researchers. Increasingly, on-campus agendas include MIT Startup Exchange startups, based on their potential to rapidly explore and assess new technologies.
4MTx is honored to be a member of MIT Startup Exchange. We look forward to engaging with ILP member companies and their representatives to help bring life-saving medicines to the most people as quickly as possible.
Learn more about MIT Startup Exchange
About 4M Therapeutics:
4M Therapeutics Inc. (4MTx) is a startup biotech company based on the belief that the study of human brain cells represents an important advance in neuroscience discovery. 4MTx has developed a pipeline of small molecules by studying their effects on brain cells derived from induced pluripotent stem cells. The initial focus is on bipolar disorder and Alzheimer's disease, conditions where enhancement of WNT protein expression can support neuroplasticity and neurogenesis. More information on 4MTx is available at www.4mtx.net.
4M Therapeutics Statement Regarding Forward-Looking Statements:
This announcement contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements
For additional inquiries, contact Ben Williams, Vice President of Corporate Development and Co-founder of 4M Therapeutics, ben@4mtx.net