NEW YORK–(BUSINESS WIRE<\/a>)– Greenleaf<\/a> is a leading FDA regulatory consulting firm run by former senior FDA officials, including Dr. John Jenkins and Dr. Sandy Kweder, former Director and Deputy Director of the Office of New Drugs at the FDA, respectively, the highest office within the Center for Drug Evaluation and Research (\u201cCDER\u201d) that oversees new drug approvals at FDA.<\/p>\n \nIn its report, Greenleaf notes the vital importance of the ongoing Phase 2b trial:1<\/sup><\/p>\n \nGreenleaf also highlights the risks of proceeding without a Phase 2 trial:<\/p>\n \nIn direct contradiction of FCM\u2019s proposed ideas for the Company, Greenleaf notes that prior academic studies of LSD should be considered \u201chypothesis generating\u201d and cannot be solely relied upon for regulatory decision making, stating:<\/p>\n \nFCM MM Holdings, LLC (\u201cFCM\u201d), an entity affiliated with Jake Freeman, Scott Freeman and Chad Boulanger, is waging a distracting and costly campaign to take control of MindMed\u2019s Board at the 2023 Annual General Meeting of Shareholders (the \u201cAnnual Meeting\u201d), scheduled for June 15, 2023. Based on its publicly released materials, a core tenet of FCM\u2019s ideas for the Company is to \u201cskip\u201d Phase 2 for MM-120 in GAD and move directly into Phase 3, in large part by relying on prior academic studies of LSD.<\/p>\n \nMindMed is already making significant progress on its Phase 2b trial evaluating MM-120 for GAD, as demonstrated by the Company\u2019s recent announcement that the trial is over 50% enrolled and dosed. The trial plans to enroll up to 200 participants who will receive a single administration of 25 \u00b5g, 50 \u00b5g, 100 \u00b5g or 200 \u00b5g of MM-120 or placebo. Topline results are expected to be announced in late 2023.<\/p>\n \n\u201cAs we have consistently said, our regulatory strategy for MM-120 is the right one and was formulated over several interactions with FDA. Our ongoing Phase 2b study answers critical clinical and regulatory questions that will enable us to maximize the speed, efficiency and likelihood of success of our Phase 3 program,\u201d said Robert Barrow, Chief Executive Officer and Director of MindMed. \u201cDr. Jenkins\u2019 and Dr. Kweder\u2019s extensive experience as senior officials inside FDA, and their objective analysis validating our approach, reinforces that there is no credible basis for FCM\u2019s misplaced claim that MindMed could skip its Phase 2 study of MM-120 in GAD and go directly into Phase 3. Further, it underscores that by supporting this strategy of FCM\u2019s, our shareholders would be putting not just the future of MM-120, but also their investments, at significant risk.\u201d<\/p>\n VISIT <\/b>WWW.PROTECTMINDMED.COM<\/b><\/a> FOR MORE INFORMATION<\/b><\/p>\n Due to new U.S. federal rules requiring us to list FCM\u2019s nominees in addition to the Board\u2019s nominees, your WHITE<\/span> proxy card this year has more names on it than the six directors to be elected. The inclusion of FCM\u2019s nominees on our WHITE proxy card does NOT mean the Board endorses them.<\/b><\/p>\n Vote TODAY on the WHITE<\/span> proxy card FOR all six of the Board\u2019s nominees, WITHHOLD on FCM\u2019s nominees and FOR the other proposals recommended by your Board.<\/b><\/p>\n You can help reject FCM\u2019s efforts to take control of the Board by discarding any blue proxy cards and materials you may receive from FCM.<\/b><\/p>\n Shareholders will receive proxy materials directly via the preferred method, hard copy or email, specific to each shareholder\u2019s account. If you have any questions, or need assistance voting your shares, please contact the firm assisting us in the solicitation of proxies:<\/b><\/p>\n \nMorrow Sodali LLC About MindMed<\/b><\/p>\n \nMindMed 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 disorders.<\/p>\n \nMindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.<\/p>\n Cautionary Notes and Forward-Looking Statements<\/b><\/p>\n \nCertain statements in this press release related to the Company constitute \u201cforward-looking information\u201d 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 \u201cwill\u201d, \u201cmay\u201d, \u201cshould\u201d, \u201ccould\u201d, \u201cintend\u201d, \u201cestimate\u201d, \u201cplan\u201d, \u201canticipate\u201d, \u201cexpect\u201d, \u201cbelieve\u201d, \u201cpotential\u201d or \u201ccontinue\u201d, or the negative thereof or similar variations. Undue reliance should not be placed on forward-looking information, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. There can be no assurance that the plans, intentions or expectations upon which forward-looking statements are based will in fact be realized. Forward-looking information in this press release includes, but is not limited to, statements regarding the potential benefits and development of the Company\u2019s product candidates, trials, studies and programs; the strengths and benefits of the Company\u2019s strategic plan; the Company\u2019s business plans and objectives; the ability of MindMed to achieve success consistent with management\u2019s expectations; and the expected impact and results of the Company\u2019s corporate governance practices, including of the Company Board\u2019s director nominees.<\/p>\n \nForward-looking information is based on the opinions and estimates of management of the Company at the date the statements are made, as well as a number of assumptions made by, and information currently available to, the Company concerning, among other things, anticipated performance of its product candidates and programs, business prospects, strategies, regulatory developments, the development of its product candidates into effective products, the ability to produce products if approved, the approval by regulators of any products that are developed, and the non-occurrence of the risks and uncertainties outlined below or other significant events occurring outside of MindMed\u2019s normal course of business. Although management of the Company considers these assumptions to be reasonable based on information currently available to it, they may prove to be incorrect.<\/p>\n \nThere are numerous risks and uncertainties that could cause actual results and the Company\u2019s 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; changes in market conditions; lack of product revenue; compliance with laws and regulations; changes in government policy; 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\u2019s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and the Company\u2019s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 under headings such as \u201cSpecial Note Regarding Forward-Looking Statements,\u201d and \u201cRisk Factors\u201d and \u201cManagement\u2019s Discussion and Analysis of Financial Condition and Results of Operations\u201d 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\u2019s profile on SEDAR at www.sedar.com<\/a> and with the U.S. Securities and Exchange Commission (\u201cSEC\u201d) on EDGAR at www.sec.gov<\/a>. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise.<\/p>\n Additional Information and Where to Find It<\/b><\/p>\n \nMindMed has filed with the SEC and Canadian securities regulatory authorities on May 1, 2023 a definitive proxy statement on Schedule 14A (the \u201cproxy statement\u201d), containing a form of WHITE universal proxy card, with respect to its solicitation of proxies for the annual general meeting of shareholders of MindMed on June 15, 2023 (the \u201cAnnual Meeting\u201d). Details concerning the nominees of MindMed\u2019s Board for election at MindMed\u2019s Annual Meeting are included in the proxy statement. This press release is not a substitute for the proxy statement or other document that MindMed has filed or may file with the SEC and Canadian securities regulatory authorities in connection with any solicitation by MindMed.<\/p>\n \nINVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO AND THE ACCOMPANYING WHITE UNIVERSAL PROXY CARD) FILED BY MINDMED AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC AND CANADIAN SECURITIES REGULATORS WHEN THEY BECOME AVAILABLE CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT MINDMED AND ANY SOLICITATION. Investors and security holders may obtain copies of these documents and other documents filed with the SEC and Canadian securities regulatory authorities by MindMed free of charge through the website maintained by the SEC at www.sec.gov<\/a> or through the Company\u2019s profile on SEDAR at www.sedar.com<\/a>. Copies of the documents filed by MindMed are also available free of charge by accessing MindMed\u2019s website at www.mindmed.co<\/a>.<\/p>\n Participants in the Solicitation<\/b><\/p>\n \nThis press release is neither a solicitation of a proxy or consent nor a substitute for any proxy statement or other filings that may be made with the SEC and Canadian securities regulatory authorities. Nonetheless, MindMed, its directors and executive officers and other members of management and employees may be deemed under U.S. securities laws and Canadian securities laws to be participants in the solicitation of proxies with respect to a solicitation by MindMed. Information about MindMed\u2019s executive officers and directors and other participants in the solicitation, including their respective interests, by security holders or otherwise, is available in the proxy statement. To the extent holdings of MindMed securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC and if applicable, on the System for Electronic Disclosure by Insiders (SEDI) in accordance with insider reporting requirements of Canadian securities laws. These documents are or will be available free of charge at the SEC\u2019s website at www.sec.gov<\/a> and either through the Company\u2019s profile on SEDAR at www.sedar.com<\/a> or updated filings on SEDI at www.sedi.ca<\/a>.<\/p>\n 1<\/sup> Emphasis added.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230525005317\/en\/<\/a><\/span><\/p>\n \nFor Media: OR<\/p>\n Longacre Square Partners For Investors: OR<\/p>\n Morrow Sodali KEYWORDS:<\/b> New York North America United States United Kingdom Europe Canada<\/p>\n INDUSTRY KEYWORDS:<\/b> Other Health Research General Health Professional Services Pharmaceutical Mental Health Science Biotechnology FDA Consulting Other Science Health<\/p>\n
\nMind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the \u201cCompany\u201d or \u201cMindMed\u201d), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that the Company has published a report by Greenleaf Health, Inc. (\u201cGreenleaf\u201d) setting forth an independent expert regulatory assessment of MindMed\u2019s MM-120 (lysergide D-tartrate) development strategy. The analysis \u2013 led by the former Director and Deputy Director of the Office of New Drugs at the U.S. Food and Drug Administration (\u201cFDA\u201d) \u2013 focuses on MindMed\u2019s clinical and regulatory development strategy for MM-120 and its ongoing Phase 2b trial in patients with generalized anxiety disorder (\u201cGAD\u201d). The findings support MindMed\u2019s view that this trial is essential to the development of MM-120 in GAD and answers critical questions to inform a responsible development program. To read the full report, please visit: protectmindmed.com<\/a><\/p>\n\n
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509 Madison Avenue, Suite 1206
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New York, NY 10022
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Banks and Brokers Call: (203) 658-9400
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Shareholders Call Toll Free: (800) 662-5200
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Email: MNMD@investor.morrowsodali.com<\/a><\/p>\n<\/p>\n
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media@mindmed.co
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Joe Germani \/ Dan Zacchei
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mindmed@longacresquare.com
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ir@mindmed.co
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Michael Verrechia \/ Eric Kamback
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MNMD@investor.morrowsodali.com<\/a><\/p>\n
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