Believes Socially Responsible Investment Principles Support FCM’s Plan to Bring MM-120 To the Market in 2026 to Benefit Millions with Mental Health Disorders
FCM Directors Will Put in Place Strict Corporate Governance to Assure the Safety of All Subjects On MindMed’s Clinical Trials
Dr. Freeman and Other FCM Directors Pledge to Extend Lockup Period for Selling Shares Until June 15, 2026
Time is Running Out to Save MindMed
Vote on FCM’s BLUE Proxy to Restore Shareholder Value at MindMed
SHERIDAN, Wyo., June 09, 2023 (GLOBE NEWSWIRE) -- FCM MM Holdings, LLC ("FCM"), representing approximately 3.5% of the outstanding common shares of Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (“MindMed” or the “Company”), calls for socially responsible investors to vote for change at MindMed.
Although investing in companies like MindMed is ultimately about generating a positive return, FCM and many other influential investors believe there should be a social conscience element involved in investing too. As has been revealed in this proxy campaign, MindMed dosed healthy volunteers in Australia with MM-110 at doses that were 35 times higher than what the FDA deemed safe without further animal safety studies. Previously, MindMed’s then CMO, Dr. Scott Freeman, stopped the Phase I trial on June 15, 2020, at a dosage of 8 mg for safety reasons. However, Dr. Freeman was immediately suspended from his position as CMO by the MindMed board and management three hours after stopping the study.
Current MindMed executives and directors then amended MindMed’s protocols to dose patients at 660 mg a day (about 35 times the FDA safety limit). These high doses, which were administered in Fall/December 2021, exceeded FDA guidelines, occurred while Robert Barrow was CEO and Mr. Krebs, and Ms. Vallone were members of the board. In August of 2022, the MM-110 studies were shuttered after the FDA reiterated the regulatory requirement of additional animal safety studies prior to proceeding with human studies in the United States. If elected, the FCM nominees will implement strict corporate governance policies to assure the safety of all patients on clinical trials conducted by MindMed.
MindMed is now pursuing its next regulatory debacle with an unnecessarily slow and expensive clinical path by pursuing a Phase IIb dose finding trial that will delay the approval and commercialization of MM-120. FCM believes socially responsible investors interested in bringing MM-120 to market for the benefit of millions of potential patients can be achieved under the oversight of the FCM director candidates who have decades of drug development experience.
Under FCM’s plan, MindMed would file a New Drug Application for MM-120 (LSD) with the FDA in 2026 by starting a Phase III trial by the end of 2023. MM-120 can benefit millions of people with mental health disorders but the current entrenched management is ensconced in a Phase IIb dose finding study and has spent a substantial sum on consultants, namely Greenleaf Health, Inc., to justify this unnecessary trial, rather than engaging with FCM to come up with the best clinical strategy.
FCM has demonstrated that no other clinical development team in the last decade followed MindMed’s clinical strategy. Of the 62 CNS drugs approved in last decade, by well-established and experienced pharmaceutical companies, all drugs with successful Phase II studies like MM-120 have completed a Phase III dose finding study (or pivotal Phase IIb), as the FCM plan proposes, rather than an unnecessary Phase IIb. FCM’s plan would bring MM-120 to patients in need years ahead of MindMed’s plan, which does not even have a start date for its Phase III trial. As sell-side analysts estimate MindMed will run out of money in mid-2024, it is essential to cut costs to preserve and use the $130 million currently on the balance sheet to complete the Phase III trial.
“I founded MindMed to better society and improve the lives of people struggling with mental illness. I am appalled by MindMed’s apparent disregard for patient safety, and their pursuit of a clinical path that will delay life changing medicine for millions of potential patients. We stand behind our plan and have pledged to lockup our shares until 2026 to coincide with the planned completion of the Phase III study, if the FCM director slate is elected. FCM’s director candidates meet both financial and socially responsible investing standards and we need your support to make urgent changes at MindMed,” said FCM Nominee Dr. Freeman.
Vote the BLUE Proxy to Support FCM’s Plan to Restore Value for All Shareholders
FCM urges MindMed shareholders to join the fight against the current Board and management team and vote FOR all four of its highly qualified nominees at the 2023 annual general meeting of shareholders on the BLUE proxy card.
Shareholders who have questions or require any assistance with their vote, please contact Okapi Partners LLC, at (855) 305-0856 or info@okapipartners.com.
About FCM
FCM MM Holdings, LLC is a special purpose vehicle set-up to represent nine early investors in MindMed, including Dr. Scott Freeman and Mr. Chad Boulanger. FCM holds a 3.5% beneficial ownership of MindMed's outstanding shares and represents additional interests in MindMed shares through holdings in Savant Addiction Medicine LLC, Savant HWP, Inc., and Savant HWP Holdings, LLC. FCM is managed by Mr. Jake Freeman and each of FCM’s stakeholders are deeply invested in MindMed's long-term success.
Shareholder Contact:
Okapi Partners LLC
info@okapipartners.com
(855) 305-0856
Media:
Riyaz Lalani & Dan Gagnier
Gagnier Communications
fcmmm@gagnierfc.com
Additional Information
FCM's and its nominees (Dr. Scott Freeman, Dr. Farzin Farzaneh, Mr. Vivek Jain, and Mr. Alexander Wodka) beneficially own, own, control or exercise direction over an aggregate of 1,009,181 common shares of MindMed (the “Shares”). FCM may be deemed to control an additional 359,357 Shares pursuant to a proxy coordination agreement.
Information in Support of Public Broadcast Solicitation
Shareholders are being asked at this time to execute a proxy in favour of FCM's nominees for election to the Board at the AGM or any other resolutions at the AGM, which has been formally scheduled for June 15, 2023. In connection with the AGM, FCM has filed definitive proxy materials with the Securities and Exchange Commission (the "Final FCM Circular") containing further disclosure concerning FCM's nominees for election to the Board at the AGM, together with additional details concerning the completion and return of forms of proxy and voting information forms ("VIFs") for use at the AGM. Shareholders of MindMed are urged to read the Materials filed today as well as the Final FCM Circular, when issued, because they will contain important information.
The below disclosure is provided pursuant to section 9.2(4) of National Instrument 51-102 – Continuous Disclosure Obligations in accordance with securities laws applicable to public broadcast solicitations.
This press release and any solicitation made by FCM in advance of the AGM is, or will be, as applicable, made by FCM and not by or on behalf of the management of MindMed.
Shareholders of MindMed are being asked at this time to execute proxies in favour of FCM's nominees for election to the Board at the AGM or any other matters to be considered at the AGM. FCM has issued the Final FCM Circular and FCM intends to make its solicitation primarily by mail, but proxies may also be solicited personally by telephone, email or other electronic means, as well as by newspaper or other media advertising or in person, by FCM, certain of its members, partners, directors, officers and employees, FCM's nominees or FCM's agents, including Okapi Partners LLC (“Okapi”), which has been retained by FCM as its strategic shareholder advisor and proxy solicitation agent. Pursuant to the agreement between Okapi and FCM, Okapi will receive a fee of up to $75,000, plus customary fees for each call to or from shareholders of MindMed, and will be reimbursed for certain out-of-pocket expenses, with all such costs to be borne by FCM. In addition, FCM may solicit proxies in reliance upon the public broadcast exemption to the solicitation requirements under applicable Canadian corporate and securities laws, by way of public broadcast, including press release, speech or publication, and in any other manner permitted under applicable Canadian laws. Any members, partners, directors, officers or employees of FCM and their affiliates or other persons who solicit proxies on behalf of FCM will do so for no additional compensation. The anticipated cost of FCM’s solicitation is estimated to be $400,000 plus disbursements. The costs incurred in the preparation and mailing of the Materials and the Final FCM Circular, and the solicitation of proxies by FCM will be borne by FCM, provided that, subject to applicable law, FCM may seek reimbursement from MindMed of FCM's out-of-pocket expenses, including proxy solicitation expenses and legal fees, incurred in connection with a successful reconstitution of the Board.
A registered shareholder of MindMed who has given a proxy may revoke the proxy at any time prior to use by:
(a) depositing an instrument in writing revoking the proxy, if the shareholder is an individual signed by the shareholder or his or her legal personal representative or trustee in bankruptcy, and if the shareholder is a corporation signed by the corporation or by a representative appointed for the corporation, either: (i) at the registered office of MindMed at any time up to and including the last business day preceding the day of the AGM or any adjournment(s) thereof, at One World Trade Center, Suite 8500, New York, New York 10007; or (ii) with the chairman of the AGM on the day of the AGM or any adjournment(s) thereof before any vote in respect of which the proxy has been given has been taken; or
(b) revoking the proxy in any other manner permitted by law.
A non-registered shareholder may revoke a form of proxy or VIF given to an intermediary or Broadridge Investor Communications (or any such other service company) at any time by submitting another properly completed form of proxy or VIF, as the latest form of proxy or VIF will automatically revoke any previous one already submitted, or by written notice to the intermediary in accordance with the instructions given to the non-registered shareholder by its intermediary.
Neither FCM, nor any of its directors or officers, or any associates or affiliates of the foregoing, nor any of FCM's nominees for election to the Board at the AGM, or their respective associates or affiliates, has: (i) any material interest, direct or indirect, in any transaction since the beginning of MindMed's most recently completed financial year or in any proposed transaction that has materially affected or would materially affect MindMed or any of its subsidiaries; or (ii) any material interest, direct or indirect, by way of beneficial ownership of securities or otherwise, in any matter currently known to be acted on at the upcoming meeting of MindMed shareholders, other than the election of directors; except that on August 31, 2020, Dr. Scott Freeman entered into a consulting agreement with MindMed, which, among other things, granted Dr. Scott Freeman 26,389 vested options with a strike price of CAD$4.95 per share and 16,667 unvested options with a strike price of CAD$4.95 per share.
The registered address of MindMed is located at One World Trade Center, Suite 8500, New York, New York, 10007. A copy of this press release may be obtained on MindMed’s SEDAR profile at www.sedar.com.
