MindMed Appoints Javier Muniz, M.D., as Vice President of Research and Development Strategy

Rhea-AI Summary

MindMed (NASDAQ: MNMD) has appointed Dr. Javier A. Muniz as Vice President of Research and Development Strategy. Dr. Muniz brings over 20 years of experience in uniformed services, including 11 years at the FDA where he provided regulatory oversight for psychiatric drug development programs. He will strengthen R&D operations as the company prepares to initiate three Phase 3 studies of MM120 orally disintegrating tablet for generalized anxiety disorder and major depressive disorder. Dr. Muniz's expertise in psychiatry, regulatory science, and drug development, along with his experience in psychedelic and entactogen-based therapies, positions him to advance MindMed's pipeline toward potential approvals.

Positive

• Strategic hire with extensive FDA regulatory experience
• Preparation for three Phase 3 clinical trials underway
• Pipeline advancement towards multiple potential drug approvals

Negative

• None.

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 the appointment of Javier A. Muniz, M.D., as Vice President of Research and Development (R&D) Strategy. In his new role, Dr. Muniz will drive innovation and growth of MindMed’s R&D operations as the Company prepares to initiate three Phase 3 studies of MM120 orally disintegrating tablet (ODT) in generalized anxiety disorder and major depressive disorder.

Javier Muniz, M.D. - Vice President of Research and Development Strategy, MindMed (Photo: Business Wire)

“Javier’s extensive expertise leading interdisciplinary scientific teams at the U.S. Food and Drug Administration (FDA), combined with his deep experience within the uniformed services in the fields of neuroscience and psychiatry makes him a welcome addition to the MindMed team,” said Dan Karlin, M.D., M.A., Chief Medical Officer of MindMed. “His leadership will play an important role in strengthening our R&D operations as we advance the therapeutic potential of our pipeline, prepare for two potential approvals and aim to reshape the treatment landscape for people living with brain health disorders.”

Dr. Muniz will report to Dr. Karlin.

“I am thrilled to join MindMed at such a pivotal moment in the Company’s history, with potential approvals of MM120 ODT for multiple indications on the horizon,” said Dr. Muniz. “The groundbreaking science and purpose-driven culture made this a unique and compelling opportunity. I look forward to advancing our pipeline and ushering in psychedelics as a potential transformational treatment paradigm in psychiatry.”

Javier A. Muniz, M.D.

Dr. Muniz is an expert in psychiatry, regulatory science, and drug development, with more than 20 years of experience in the uniformed services. He served 11 years at the FDA as a member of the U.S. Public Health Service, where he held roles including clinical team leader, associate director, acting deputy director, and supervisory health scientist. He provided regulatory oversight for innovative psychiatric drug development programs, including first-in-class treatments, the first “digital” pill, and breakthrough therapy-designated programs. He also co-authored several guidance for industry documents.

Dr. Muniz is a recognized thought leader in psychedelic and entactogen-based therapies, having presented at numerous national and international conferences on scientific and regulatory challenges. Before the FDA, he served in the U.S. Air Force, directing psychiatric programs at Andrews Air Force Base, and Fort Meade, MD, where he supported national security missions, led rapid-response teams for the U.S. Department of Health and Human Services, and provided care to Wounded Warriors.

Dr. Muniz completed his undergraduate and medical degrees in Puerto Rico and his psychiatry residency at Mount Sinai Medical Center in New York City. He is board-certified in psychiatry and has received numerous awards, including two Presidential Unit Citations, the Meritorious Service Medal, and the Afghanistan Campaign Medal.

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 Company’s anticipated upcoming milestones, trials and studies; and the potential benefits of the Company’s product candidates. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241203094211/en/

For Media: media@mindmed.co

For Investors: ir@mindmed.co

Source: Mind Medicine Inc.

FAQ

What is MindMed's (MNMD) new appointment for VP of R&D Strategy?

MindMed has appointed Dr. Javier A. Muniz as Vice President of Research and Development Strategy to drive innovation and growth of R&D operations.

What clinical trials is MindMed (MNMD) preparing to initiate?

MindMed is preparing to initiate three Phase 3 studies of MM120 orally disintegrating tablet (ODT) in generalized anxiety disorder and major depressive disorder.

What is Dr. Muniz's background before joining MindMed (MNMD)?

Dr. Muniz served 11 years at the FDA as part of the U.S. Public Health Service and previously served in the U.S. Air Force, with over 20 years of experience in uniformed services.

What therapeutic areas is MindMed (MNMD) targeting with MM120 ODT?

MindMed is targeting generalized anxiety disorder and major depressive disorder with its MM120 orally disintegrating tablet (ODT).