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MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA

Key Takeaway: FOR IMMEDIATE RELEASE: October 26, 2021 CONTACT: mindmed@150bond.com MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA Mind Medicine (MindMed) Inc. (NASDAQ: MNMD, NEO: MMED, DE: MMQ; the "Company"), a leading biotech company developing psychedelic-inspire

Full Press Release Details

FOR IMMEDIATE RELEASE: October 26, 2021
MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD, NEO:
MMED, DE: MMQ; the "Company"), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce an
expansion of its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses
that include Autism Spectrum Disorder (ASD). This program represents a significant expansion and diversification of MindMed's pipeline
and furthers the Company's mission to bring innovative products to benefit patients and address unmet medical needs.
Social anxiety and impairments in social functioning
are hallmarks of ASD, which occurs in approximately 2% of individuals in the US. At present, there are no approved therapies for the core
symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD. The economic cost of ASD in
the US is predicted to reach $461 billion by 2025, highlighting the need and opportunity for novel interventions. Beyond ASD, approximately
12% of the US general population experience Social Anxiety Disorder at some point in their lives, according to the National Institute
MDMA, which is a racemic mixture of two structurally
unique stereoisomers, R(-) and S(+), is currently in development for the treatment of Post-traumatic Stress Disorder (PTSD), and has demonstrated
statistically significant positive results in a pivotal Phase 3 trial. Additionally, in a pilot clinical trial, participants with ASD
showed strong and statistically significant improvements in social anxiety and functioning from short-term treatment with MDMA.
The two enantiomers of MDMA each have unique pharmacological
activity and preclinical data suggests that the R(-) enantiomer maintains the acute pro-social and empathogenic benefits of racemic MDMA,
while demonstrating fewer signs of stimulant activity, neurotoxicity, hyperthermia and abuse liability. This favorable profile suggests
that R(-)-MDMA could have applications beyond those of racemic MDMA, including the potential for novel more accessible delivery models
and repeat dosing. From a safety perspective, the company has great confidence in the R(-) enantiomer based on its favorable preclinical
pharmacology and the extent of prior human dosing of the racemic mixture, which provides valuable insight into the expected safety and
tolerability of R(-)-MDMA.
MindMed plans to advance its R(-)-MDMA development
program targeting US and EU registration and expects to initiate its first clinical trials in 2022. As a key initial study, MindMed and
the Liechti Lab at University Hospital Basel (UHB) plan to initiate a comparative pharmacokinetics and pharmacodynamic clinical trial
of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in 2022. This double blind, placebo-controlled, crossover study will assess
differences in acute and lasting effects between MDMA and its two enantiomers in healthy subjects and will provide important data
on the optimal treatment model for R(-)-MDMA.
MindMed CEO Robert Barrow said, "The launch
of our R(-)-MDMA program represents an important milestone in the continued progress of MindMed and builds on our commitment to developing
psychedelics and psychedelic-inspired therapies to treat significant unmet medical needs. The compelling clinical efficacy of MDMA coupled
with the unique pharmacological benefits of its R(-) enantiomer suggest that there is an enormous opportunity to bring this second generation
psychedelic program to market with the potential for new clinical applications, novel treatment paradigms and enhanced accessibility."
MindMed Chief Medical Officer, Daniel R Karlin,
MD, MA, said, "Our ability to enjoy life has a general dependency on feeling connected to other people, sharing experiences, and
conveying shared emotions. There are a number of disorders and conditions, and even varieties of non-pathological states, in which individuals
find it difficult to convey their own internal experience and emotions. They also may struggle to recognize the routine cues and signals
that those around them use to convey emotions. These difficulties themselves can cause cycles of distressing anxiety, and in turn worsen
both the sense, and the reality, of interpersonal disconnect. It is our intention with this new program to offer patients new hope for
meaningful connection to the millions of people for whom social anxiety and functioning create day-to-day difficulties."
MindMed is a clinical-stage psychedelic medicine
biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental
illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including
psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience
to MindMed's approach of developing the next generation of psychedelic-inspired medicines and therapies.
MindMed trades on the NASDAQ under the symbol
MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.
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 include, but are not limited to, statements
regarding the potential of R(-)-MDMA to treat social anxiety and functioning in diagnoses that include ASD and the benefits, safety, applications
and plans for advancement and studies with respect to R(-)-MDMA . Although the Company believes that the expectations reflected in such
forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed
on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements
of the Company. 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; lack of product revenue; 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 under the headings "Risk Factors" in
the Company's filings 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 on EDGAR at www.sec.gov.
Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove
incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has
attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others
that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information
are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice.
Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.
Media Contact: mindmed@150bond.com
Last updated: Oct 26, 2021