Independent Third-Party Firm, Led by Former
Senior FDA Officials, Calls Phase 2b Trial “Well-designed” and
“Essential”
Report Further Demonstrates that FCM’s Proposal
to Skip Phase 2 for MM-120 – a Cornerstone of its Plan – is
Unrealistic and Would Put MindMed Shareholders’ Investments at
Risk
Visit www.ProtectMindMed.com for More
Information
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the
“Company” or “MindMed”), 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. (“Greenleaf”) setting forth an
independent expert regulatory assessment of MindMed’s MM-120
(lysergide D-tartrate) development strategy. The analysis – led by
the former Director and Deputy Director of the Office of New Drugs
at the U.S. Food and Drug Administration (“FDA”) – focuses on
MindMed’s clinical and regulatory development strategy for MM-120
and its ongoing Phase 2b trial in patients with generalized anxiety
disorder (“GAD”). The findings support MindMed’s 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
Greenleaf 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 (“CDER”) that oversees new
drug approvals at FDA.
In its report, Greenleaf notes the vital importance of the
ongoing Phase 2b trial:1
- “After review of the MM-120 regulatory history, relevant
regulatory precedent, and applicable regulations and guidance,
Greenleaf believes the ongoing Phase 2b dose-ranging clinical trial
is an essential component to the development program for
MM-120.”
- “To support FDA approval, the MM-120 program will need at least
one, and more likely two, positive, adequate and well-controlled
trials. The decision by MindMed to first initiate a dose-ranging
Phase 2b study is appropriate and sound from a clinical and
regulatory perspective.”
- “The FDA’s feedback on the proposed developed program in no
way suggests that it would accept a development program that
skips important learnings from a well-designed and conducted Phase
2b trial in favor of moving directly to a large Phase 3 pivotal
program.”
Greenleaf also highlights the risks of proceeding without a
Phase 2 trial:
- “The ongoing MM-120 Phase 2b trial is designed to address
fundamental questions about dose-response, target population,
preliminary evidence of efficacy on accepted FDA endpoints for
anxiety, and safety that will provide clarity and confidence in
designing a Phase 3 program. . . . To initiate Phase 3 trials
before these foundational issues have been adequately addressed
would substantially increase the chances of a failed trial
and/or uninterpretable results.”
- “Therefore, the studies from the published literature are not
sufficient to support a proposal for streamlining the MM-120
program directly into Phase 3.”
- “To enter Phase 3 without a well-articulated target
population and indication could result not only in misalignment
with the FDA, but more importantly the potential for a Phase 3
program that is difficult to interpret and thus more likely to
fail.”
In direct contradiction of FCM’s proposed ideas for the Company,
Greenleaf notes that prior academic studies of LSD should be
considered “hypothesis generating” and cannot be solely relied upon
for regulatory decision making, stating:
- “As for any novel study drug, the FDA is likely to view the
prior published literature around LSD use for the treatment of
anxiety as informative and hypothesis generating but not of
sufficient detail to allow for an independent review or for
regulatory decision making. This is particularly true for
LSD given the lack of dose-finding in patients with anxiety and
given that the various dosage forms utilized in the published
studies do not match what MindMed has developed or intends to use
as its to-be-marketed formulation.”
FCM MM Holdings, LLC (“FCM”), an entity affiliated with Jake
Freeman, Scott Freeman and Chad Boulanger, is waging a distracting
and costly campaign to take control of MindMed’s Board at the 2023
Annual General Meeting of Shareholders (the “Annual Meeting”),
scheduled for June 15, 2023. Based on its publicly released
materials, a core tenet of FCM’s ideas for the Company is to “skip”
Phase 2 for MM-120 in GAD and move directly into Phase 3, in large
part by relying on prior academic studies of LSD.
MindMed is already making significant progress on its Phase 2b
trial evaluating MM-120 for GAD, as demonstrated by the Company’s
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 µg, 50 µg, 100 µg or 200 µg of MM-120
or placebo. Topline results are expected to be announced in late
2023.
“As 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,” said Robert Barrow, Chief Executive Officer and Director
of MindMed. “Dr. Jenkins’ and Dr. Kweder’s extensive experience as
senior officials inside FDA, and their objective analysis
validating our approach, reinforces that there is no credible basis
for FCM’s 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’s, our
shareholders would be putting not just the future of MM-120, but
also their investments, at significant risk.”
VISIT WWW.PROTECTMINDMED.COM
FOR MORE INFORMATION
Due to new U.S. federal rules requiring us
to list FCM’s nominees in addition to the Board’s nominees, your
WHITE proxy card this year has more
names on it than the six directors to be elected. The inclusion of
FCM’s nominees on our WHITE proxy card does NOT mean the Board
endorses them.
Vote TODAY on the WHITE proxy card FOR all six of the Board’s
nominees, WITHHOLD on FCM’s nominees and FOR the other proposals
recommended by your Board.
You can help reject FCM’s efforts to take
control of the Board by discarding any blue proxy cards and
materials you may receive from FCM.
Shareholders will receive proxy materials
directly via the preferred method, hard copy or email, specific to
each shareholder’s account. If you have any questions, or need
assistance voting your shares, please contact the firm assisting us
in the solicitation of proxies:
Morrow Sodali LLC 509 Madison Avenue, Suite
1206 New York, NY 10022 Banks and Brokers Call: (203) 658-9400
Shareholders Call Toll Free: (800) 662-5200 Email:
MNMD@investor.morrowsodali.com
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
disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the symbol MMED.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press 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. 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’s product candidates, trials, studies
and programs; the strengths and benefits of the Company’s strategic
plan; the Company’s business plans and objectives; the ability of
MindMed to achieve success consistent with management’s
expectations; and the expected impact and results of the Company’s
corporate governance practices, including of the Company Board’s
director nominees.
Forward-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’s 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.
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; 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’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022 and
the Company’s Quarterly Report on Form 10-Q for the fiscal quarter
ended March 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.sedar.com and with the U.S. Securities and
Exchange Commission (“SEC”) 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 press
release as a result of new information, future events, changes in
expectations or otherwise.
Additional Information and Where to Find It
MindMed has filed with the SEC and Canadian securities
regulatory authorities on May 1, 2023 a definitive proxy statement
on Schedule 14A (the “proxy statement”), 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 “Annual Meeting”). Details concerning the nominees of
MindMed’s Board for election at MindMed’s 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.
INVESTORS 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
or through the Company’s profile on SEDAR at www.sedar.com. Copies
of the documents filed by MindMed are also available free of charge
by accessing MindMed’s website at www.mindmed.co.
Participants in the Solicitation
This 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’s 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’s website at
www.sec.gov and either through the Company’s profile on SEDAR at
www.sedar.com or updated filings on SEDI at www.sedi.ca.
1 Emphasis added.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230525005317/en/
For Media: media@mindmed.co OR Longacre Square Partners Joe
Germani / Dan Zacchei mindmed@longacresquare.com For Investors:
ir@mindmed.co OR Morrow Sodali Michael Verrechia / Eric Kamback
MNMD@investor.morrowsodali.com
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