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NEW YORK--( BUSINESS WIRE )--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD), has been granted an Innovation Passport for the potential treatment of GAD under ILAP by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K. “Receiving the Innovation Passport designation is recognition of MM120 ODT’s potential to address GAD, one of the most critical and underserved needs in mental health,” said Rob Barrow, Chief Executive Officer of MindMed. “Following the receipt of Breakthrough Therapy Designation by the U.S. Food and Drug Administration, the Innovation Passport designation underscores our commitment to bringing MM120 ODT to people living with GAD and our dedication to working closely with the MHRA to expedite patient access. We are determined to offer new hope and transformative solutions where current treatments have failed to meet the needs of those who suffer from this serious condition.” Recipients of the Innovation Passport are granted access to a range of development tools to support the design, development, and approvals process in the U.K., as well as opportunities for enhanced regulatory and other stakeholder input. Specific benefits of ILAP include the potential for a 150-day accelerated Marketing Authorization Application assessment, rolling review and a continuous benefit risk assessment. The ILAP is delivered in partnership by the MHRA, the All Wales Therapeutics and Toxicology Centre, the National Institute for Health and Care Excellence and the Scottish Medicines Consortium, part of Healthcare Improvement Scotland. About Generalized Anxiety Disorder (GAD) Anxiety disorders are the world’s most common mental disorders, affecting 301 million people in 2019. 1 In the U.K., more than eight million people live with an anxiety disorder. 2 GAD is chronic and debilitating and results in fear, continuing anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. GAD is underdiagnosed and underserved and is associated with less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in two decades. About MM120 ODT MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects. The MM120 ODT Phase 3 clinical development program includes the Voyage and Panorama studies in generalized anxiety disorder (GAD) and the Emerge study in major depressive disorder (MDD). Additional clinical indications are under consideration. MindMed’s Phase 2b study, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12, with a 65% clinical response rate and 48% clinical remission rate sustained to Week 12 in the MM120 100 µg cohort. MM120 was generally well-tolerated in this study, with most adverse events rated as mild to moderate, transient, and occurring on the dosing day and being consistent with the expected acute effects of the trial drug. Based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the Phase 2b study and other research conducted by MindMed, the U.S. Food & Drug Administration granted Breakthrough Therapy Designation for the MM120 program in GAD. About MindMed MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD. Forward-looking Statements Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the potential benefits of Innovative Licensing and Access Pathway; Company’s beliefs regarding potential benefits of its product candidates; anticipated upcoming milestones, trials and studies; and potential additional indications for MM120 ODT. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov . Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. References 1. Yang, X., Fang, Y., Chen, H., Zhang, T., Yin, X., Man, J., Yang, L., & Lu, M. (2021). Global, regional and national burden of anxiety disorders from 1990 to 2019: Results from the Global Burden of Disease Study 2019. Epidemiology and Psychiatric Sciences, 30, Article e36. https://doi-org.libproxy1.nus.edu.sg/10.1017/S2045796021000275 2. Mental Health UK, What is anxiety disorder? - Mental Health UK , accessed November 29, 2024

BEDFORD, Mass.--( BUSINESS WIRE )--Delix Therapeutics, a clinical-stage neuroscience company pioneering novel neuroplasticity-promoting treatments for psychiatric and neurological disorders, today announced that the first patient has been dosed in its Phase 1b clinical trial to evaluate the pharmacodynamics (PD), safety, tolerability, and pharmacokinetics (PK) of DLX-001, a novel non-hallucinogenic neuroplastogen, in Major Depressive Disorder (MDD). “Building on promising preclinical studies that demonstrate DLX-001’s ability to rapidly promote robust structural and functional neuroplasticity within hours, as well as sustained therapeutic effects in animal models of depression, the initiation of this trial represents a pivotal milestone in the development of novel treatments for patients suffering from MDD,” said Aaron Koenig MD, Chief Medical Officer of Delix Therapeutics. “Importantly, data from our Phase 1 first-in-human study demonstrated that DLX-001 achieves therapeutic exposures with predictable PK, a favorable safety and tolerability profile, and no evidence of psychotomimetic, dissociative, or hallucinogenic effects. We are excited to progress this novel first-in-class agent and gain insights that will strengthen the design of our upcoming Phase 2 study in MDD.” The Phase 1b study will evaluate the PD, safety, tolerability, and PK of DLX-001 in approximately 20 patients with MDD. Based on the results of the completed single and multiple ascending dose (SAD-MAD) study in healthy volunteers, patients will receive daily oral DLX-001 over seven days at doses that produced statistically significant changes in quantitative electroencephalography (qEEG) in healthy volunteers. The key objective of the Phase 1b study is to assess effects on translational biomarkers following DLX-001 administration, including qEEG, polysomnography, and other exploratory markers. Preliminary efficacy will also be assessed. Delix is rapidly advancing its library of novel, non-hallucinogenic compounds into scalable, orally bioavailable therapies. The Company’s compounds have demonstrated the ability to promote fast-acting and long-lasting repair of synapses associated with neuropsychiatric and neurodegenerative conditions, without the liabilities inherent to first- and second-generation plasticity-promoting compounds such as LSD, ketamine, psilocybin, and MDMA. About DLX-001 DLX-001 is a novel, non-hallucinogenic, non-dissociative isotryptamine neuroplastogen currently being evaluated for the treatment of Major Depressive Disorder (MDD). Preclinical data has demonstrated that DLX-001 increases dendritic spine density in PFC neurons and has rapid and enduring antidepressant-like effects in animal models after a single dose. Recent Phase 1 data has demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. About Neuroplastogens Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of neuropsychiatric and neurodegenerative disorders, in addition to other synaptopathies. Leveraging our phenotypic drug discovery engine, Delix is committed to developing a pipeline of cutting-edge neuroplastogens that will target offering faster and more effective therapies addressing the underlying pathophysiology of many neuropsychiatric and neurological diseases. About Major Depressive Disorder (MDD) Major Depressive Disorder (MDD) is a prevalent and debilitating condition affecting over 280 million people globally, 1 with 21 million people suffering in the United States alone. 2 MDD represents the primary cause of disability in the world, 3 and is typically characterized by persistent feelings of sadness and loss of interest. Even with available approaches, many patients do not experience an optimal response to treatment, resulting in a significant need for new and differentiated treatments. 4 About Delix Therapeutics Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company's compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that will serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers. References: World Health Organization. Depressive disorder (depression). World Health Organization. Published March 31, 2023. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/depression . National Institute of Mental Health. Major Depression. National Institute of Mental Health. Published July 2023. https://www-nimh-nih-gov.libproxy1.nus.edu.sg/health/statistics/major-depression . National Library of Medicine. Major Depressive Disorder. National Institute of Mental Health. Published April 10, 2023. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/books/NBK559078/ . Rush, A. J., et al. Am J Psychiatry , (2006).