NNI-362

Dr Emer Leahy, a leader with over 30 years of CNS drug discovery and business development experience joins the Board ROCKVILLE, Md., April 12, 2023 (GLOBE NEWSWIRE) -- Neuronascent Inc., a clinical-stage, neuron generating, biopharmaceutical company, is pleased to announce the addition of industry leader Emer Leahy, Ph.D., MBA, to its Board of Directors. This is a key time for Neuronascent, following the successful completion of its Phase 1a randomized clinical trial of NNI-362 in healthy aged subjects for Alzheimer’s disease, and potentially other age-related disorders, and with NNI-351’s recent designation by the U.S. Food and Drug Administration (FDA) for both orphan and rare pediatric drug development for Fragile X syndrome. The guidance of Dr. Leahy at the board level will be invaluable as Neuronascent aims to advance its novel neuron generating therapies further into clinical trials. “The appointment of Dr. Emer Leahy to our board of directors adds tremendous expertise in the development of central nervous system therapies toward commercialization, as well as guiding Neuronascent in developing pharmaceutical industry partnerships,” said founder and CEO Judith Kelleher-Andersson, PhD. Dr. Leahy holds a PhD in neuropharmacology from University College Dublin, Ireland, and an MBA from Columbia University. She is the long-standing President and CEO of PsychoGenics, Inc., as well as an adjunct associate professor of Neuroscience at Mount Sinai School of Medicine in New York City. Dr. Leahy has more than 30 years of experience in drug discovery, clinical development and business development for pharmaceutical and biotechnology companies, including extensive knowledge of technology assessment, licensing, mergers and acquisitions, and strategic planning. “I am honored to join the Neuronascent Board. I have long been impressed with the company’s novel platform that has identified multiple development candidates including NNI-362 with phase 1 clinical data and the potential to transform the way we think about, and treat, neurodegenerative conditions,” said Dr Leahy. “I have been inspired by what has been accomplished to date, and I look forward to working alongside Judy and the rest of the board to bring these innovative treatment options to those living with severely disabling neurodegenerative conditions.” About Neuronascent, Inc. Neuronascent, Inc., [ ] a privately-held, clinical-stage pharmaceutical company, was founded to discover and develop novel therapies that treat central nervous system disorders with high-unmet need by replacing and enhancing neuron numbers, not just neural connections. Through its proprietary phenotypic screening platform, Neuronascent has discovered a pipeline of small molecule regenerative candidates with patents issued, including NNI-351 for Fragile X syndrome, a rare pediatric disorder. NNI-362, Neuronascent’s lead, patented, new chemical entity, was developed to reverse age-related disorders by producing new neurons to replace those lost due to chronic neurodegeneration. Safe Harbor Statement This release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are commonly identified by words such as “would,” “may,” “will,” “expects,” and other terms with similar meaning. Forward-looking statements are based on current beliefs, assumptions and expectations and speak only as of the date of this release and involve risks and uncertainties that could cause actual results to differ materially from current expectations. Corporate Contact: Judith Kelleher-Andersson, PhD. Founder and CEO jkelleher@neuronascent.com Media Contact: Nick Veronico Nickver@sbcglobal.net

ROCKVILLE, Md., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Neuronascent Inc., today announced its abstract entitled “Reduction of plasma p-Tau181 from a Phase 1a Randomized Trial of NNI-362 in a healthy aged population consistent with amelioration of tau hyperphosphorylation in human differentiated neuron cultures” has been accepted for a poster presentation at 15th Clinical Trials on Alzheimer’s Disease (CTAD 2022) to be held in San Francisco, Calif., on Nov. 29 through Dec. 2, 2022. The primary goal of this trial was to assess the safety and tolerability of oral NNI-362 in healthy aged subjects. “These findings are very encouraging since the pre-clinical results are indeed being mimicked in the clinic, including both safety and potential efficacy markers, as we move toward a Phase 2 proof-of-concept trial,” said founder and CEO Judith Kelleher-Andersson, PhD. Dr. R. Scott Turner, MD, PhD, director of the Memory Disorders Program, Georgetown University, will be presenting this data at CTAD 2022 as one of the accepted late-breaking posters. The Phase 1a single ascending and multiple ascending dose (SAD + MAD) trial of NNI-362 demonstrated a significant reduction from pretreatment-baseline of an Alzheimer’s disease progression biomarker, with no change observed with placebo in healthy aged subjects. This placebo-controlled, randomized trial was fully supported by a grant from the National Institute on Aging (NIA, part of the National Institutes of Health). In topline results, NNI-362, administered from 10 to 240 milligrams orally, once daily, showed no serious adverse events and no dose-dependent adverse events. Alzheimer’s is a disease of aging, the greatest risk-factor, but there is not a single therapy available to halt or reverse this chronic neurodegenerative disorder. Results in aged subjects demonstrated that on Day 16, with SAD/MAD daily oral dosing of placebo and NNI-362 at 120 mg and 240 mg, NNI-362 significantly reduced phosphoTau181 levels compared to baseline, while no reduction with placebo. PhosphoTau181 is a plasma measure of potential Alzheimer’s progression in brain. NNI-362 targets adult-born neuron regeneration and neuroprotection through a unique mechanism to promote translation and neuron survival (Sumien et al., 2021: https://doi.org/10.1186/s13287-020-02126-3) in models of age-related disorders. This disease-agnostic neuron replacement / enhancement therapy aims to be a first-in-class oral therapy to halt and reverse Alzheimer’s and other age-related neurodegenerative disorders. The research reported in this press release was supported by NIA under award number R01AG056561. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About NNI-362 In aging patients, endogenous neuron regeneration is diminished. This diminution is exacerbated in patients suffering from neurodegeneration (for example, Alzheimer’s patients). NNI-362, Neuronascent’s lead, patented, new chemical entity, was developed to reverse age-related disorders by producing new neurons to replace those lost due to chronic neurodegeneration. This ability supports the drug’s use to halt and reverse Alzheimer’s disease and other age-related neurodegenerative disorders. About Neuronascent, Inc. Neuronascent, Inc., [www.neuronascent.com] a privately-held, clinical-stage pharmaceutical company, was founded to discover and develop novel therapies that treat CNS disorders with high-unmet need by replacing and enhancing neuron numbers, not just neural connections. Through its proprietary phenotypic screening platform, Neuronascent has discovered a pipeline of small molecule regenerative candidates with patents issued, including NNI-351 for Fragile X syndrome, a rare pediatric disorder. Safe Harbor StatementThis release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are commonly identified by words such as “would,” “may,” “will,” “expects,” and other terms with similar meaning. Forward-looking statements are based on current beliefs, assumptions and expectations and speak only as of the date of this release and involve risks and uncertainties that could cause actual results to differ materially from current expectations. Corporate Contact:Judith Kelleher-Andersson, PhD.Founder and CEOjkelleher@neuronascent.com Media Contact:Nick Veronico Nickver@sbcglobal.net