Psilera, Inc.

TAMPA, Fla., March 26, 2024 /PRNewswire/ -- Psilera, a leading biotechnology company developing groundbreaking therapies for hard-to-treat neurological disorders, is pleased to announce the appointment of Magali Haas, M.D., Ph.D., to its esteemed Board of Directors. Dr. Haas brings a wealth of experience from multiple leadership roles at Janssen and Johnson & Johnson, as well as biotechnology, and mission-driven nonprofits. Continue Reading Psilera adds key player to Board to further advance their next-generation neurological drug development. Post this Magali Haas, M.D., Ph.D. "We are thrilled to welcome Magali as an independent member of our Board of Directors," said Dr. Chris Witowski, CEO of Psilera. "Her extensive background in neuroscience and experience translating early-stage research and clinical development align perfectly with our mission at Psilera." Dr. Haas currently serves as Founder and Chair of Cohen Veterans Bioscience, a non-profit organization dedicated to improving the detection and treatment of post-traumatic stress (PTS) and traumatic brain injuries (TBI) through cutting-edge research, where she served as CEO & President for ten years. Her dedication to optimizing brain health across a patient's lifespan led her to establish the Brain Health Nexus, a global initiative focused on operationalizing brain health through the development, validation and adoption of a global brain health index. "Joining the board of Psilera provides a thrilling opportunity to be at the forefront of brain health research," said Dr. Haas. "I'm deeply impressed by their unique capabilities melding artificial intelligence and machine learning, a proprietary compound library, and a patient-centric ethos. I look forward to working with the leadership team and my board colleagues on transformative advancements for patients." Dr. Haas's appointment to Psilera's Board of Directors further solidifies the company's commitment to advancing brain health and underscores its dedication to attracting top talent in the field. With her invaluable contributions, Psilera is poised to make significant strides in its pursuit of improving the lives of individuals affected by brain-related conditions. About Psilera Psilera is a biopharmaceutical company focused on developing innovative patient-centric therapies for neurological disorders. They are the first company to target neurodegenerative diseases with their first-in-class, next-generation psychedelic derivative, PSIL-006, delivering results without hallucinogenic effects. With a deep commitment to scientific excellence and patient centricity, Psilera aims to transform the lives of individuals affected by devastating neurodegenerative diseases. For more information visit . Media Contact: Katie DeMarsh [email protected] SOURCE Psilera

TAMPA, Fla., Jan. 23, 2024 /PRNewswire/ -- Psilera, a leading biopharmaceutical company focused on developing novel treatments for neurological disorders, is pleased to announce the selection of behavioral variant frontotemporal dementia (bvFTD) as the lead indication for its groundbreaking drug candidate, PSIL-006. This devastating form of early-onset dementia currently lacks approved treatments to manage symptoms or slow disease progression. BvFTD is a debilitating disorder that leads to progressive cognitive decline, personality changes, and impaired social behavior. It typically affects individuals as young as 40 years old, causing significant distress to patients and their families. Psilera's decision to pursue this indication for PSIL-006 underscores the company's commitment to advancing innovative therapies for underserved patient populations. "Selecting bvFTD as the lead indication for PSIL-006 is a significant milestone for Psilera and a major step forward in our mission to address unmet medical needs in mental health," said Dr. Jackie von Salm, Co-Founder and CSO of Psilera. "After having personal experience with this rare and devastating form of dementia, we aim to make a meaningful impact on the lives of patients and their families who are left without any treatment options." "PSIL-006 has shown significant promise in preclinical studies and addresses treatment-limiting side effects for neurodegenerative conditions such as bvFTD," said Dr. Chris Witowski, Co-Founder and CEO of Psilera. "Our differentiated approach in an area of high unmet need enables us to investigate PSIL-006 as a potential first-in-class drug for bvFTD." Psilera remains dedicated to advancing the development of PSIL-006 and is actively engaged in preclinical studies to further evaluate its safety and efficacy. The company is committed to collaborating with regulatory authorities, healthcare professionals, and patient advocacy groups to ensure the successful development of PSIL-006. About Psilera Psilera is a biopharmaceutical company focused on developing innovative patient-centric therapies for neurological disorders. They are the first company to target neurodegenerative diseases with their novel next-generation psychedelic derivative, PSIL-006, delivering results without hallucinogenic effects. With a deep commitment to scientific excellence and patient-centricity, Psilera aims to transform the lives of individuals affected by devastating neurodegenerative diseases. For more information, please visit . Media Contact: Katie DeMarsh Katie@Psilera.com

PSIL-006 is the first drug candidate from Psilera's extensive pipeline to progress into advanced safety studies prior to first-in-human clinical trials TAMPA, Fla., May 25, 2023 /PRNewswire/ -- Psilera, a biopharmaceutical company developing next-generation mental health treatments for take home use, announces the selection of their lead clinical candidate, PSIL-006. This novel drug with similar characteristics to psilocybin while lacking hallucinogenic effects was derived from Psilera's in-house discovery pipeline. When compared directly in preclinical in vivo studies, PSIL-006 was able to induce rapid and positive behavioral changes representative of alcohol use disorder (AUD), anxiety, depression, and cognitive disorders similar to the psilocybin mimic, psilacetin. In multiple proof-of-concept clinical trials, psilocybin has shown positive efficacy for addiction (AUD and nicotine dependence), depression, and end-of-life anxiety. PSIL-006 represents a non-hallucinogenic alternative to psilocybin. With fewer side effects, PSIL-006 could enable take-home dosing to greatly enhance treatment scale over psilocybin and other psychedelics. PSIL-006 is a non-hallucinogenic serotonin receptor 6 (5-HT6) and 2A (5-HT2A) dual agonist that selectively reduces hallucinogenic effects while retaining rapid therapeutic benefits. The unique activity seen in preclinical models represents a novel mechanism of action for addiction and psychiatric disorders. "PSIL-006 epitomizes our patient-centric values at Psilera. Our focus is to provide new treatment options to a larger patient population for difficult to treat mental illnesses," said Dr. Chris Witowski, Co-Founder and CEO at Psilera. "We are enthusiastic by the data with PSIL-006 and look forward to providing further updates as we progress towards the clinic." About Psilera - Psilera leverages a world-class scientific and executive team to reimagine psychoactive natural products into effective and insurance-backed take home therapies. Their drug discovery engine combines novel syntheses of new compounds with a technology-enabled platform to design next-generation neurological drugs at the atomic level. Psilera has developed new compound classes which are non-hallucinogenic with rapid therapeutic benefits. Psilera's mission is to enhance the lives of patients by delivering new treatment options with fewer side effects in psychiatric, addiction, and neurodegenerative disorders. Psilera is defining the new era in mindful medicine. Investor Contact: Chris Witowski, CEO Chris@psilera.com Media Contact: Katie DeMarsh, Operations Manager Katie@psilera.com