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MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and psilocybin

MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and psilocybin

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD, NEO: MMED, DE: MMQ; the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce the publication of the first data on the interaction of the selective serotonin uptake inhibitor (SSRI) escitalopram with the acute response to psilocybin in humans. The publication resulted from a randomized, double-blind, placebo-controlled, crossover pharmacology study in healthy volunteers conducted by the University Hospital Basel Liechti Lab and sponsored by MindMed.

The study found that escitalopram pre-treatment had no relevant impact on positive mood effects of psilocybin but significantly reduced negative effects like anxiety and adverse cardiovascular reactions, compared with placebo pre-treatment in the study’s healthy volunteers. Escitalopram did not alter the pharmacokinetics of psilocin. Escitalopram did not alter QTc intervals or circulating BDNF levels before or after psilocybin administration. The study was published in Clinical Pharmacology and Therapeutics. The full-text can be accessed here: https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2487

“Two key questions arise around the use of psilocybin in patients undergoing antidepressant treatment,” said Prof. Matthias Liechti, the principal investigator of the study. “First, for safety reasons, should a patient stop using antidepressants before receiving psilocybin? Second, if there is no safety risk, will the antidepressant reduce the patient’s response to psilocybin? These results indicate that psilocybin may be dosed during escitalopram treatment without apparent impact on the effect of psilocybin. Thus, the study answers the first question and provides a positive indication for the second.”

The study results highlight important areas for future research. Dr. Miri Halperin Wernli, Executive President of MindMed, added: “If the results are confirmed in subsequent studies, with other substances and in patients rather than healthy individuals, antidepressants may no longer need to be stopped for psilocybin treatment. Further studies are needed with a longer antidepressant pre-treatment time and patients with psychiatric disorders to further define interactions between antidepressants and psilocybin or other psychedelics.”

 

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 safety, effects and benefits of escitalopram pre-treatment and the acute response to psilocybin in humans, the results for future studies and the need for antidepressants to be stopped for psilocybin treatment. 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

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MindMed Announces Participation at Upcoming Investor Conferences

MindMed Announces Participation at Upcoming Investor Conferences

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announces that Robert Barrow, Chief Executive Officer of MindMed, will participate in the following investor conferences:

 Advances in Mental Health Virtual Conference, presented by Maxim Group LLC and hosted by M-Vest

Live Sessions Date:  Wednesday, Sept. 22, 2021
Session Times:         12:00-1:00 p.m. ET and 1:00-2:00 p.m. ET

 

CIBC’s 20th Annual Eastern Institutional Conference

Presentation Date:  Thursday, Sept. 23, 2021

Presentation Time:  3:35-4:05 p.m. ET

 

2021 Cantor Virtual Global Healthcare Conference

Presentation Date:    Wednesday, Sept. 29, 2021

Presentation Time:   2:00-2:30 p.m. ET

A replay of the webcasts will be available in the “Investors” section of MindMed’s website for 30 days following each of the presentations.

 

About MindMed

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 to 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 MindMed’s participation in upcoming investor conferences. 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.

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MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed Announces Financial Results for the Third Quarter 2021 and Business Highlights; Cash Balance of $145.9 USD ($185.4 CAD) to Execute on Diverse Clinical Pipeline

MindMed (Nasdaq: MNMD, NEO: MMED, DE: MMQ), a leading biotech company developing psychedelic-inspired therapies, has announced its quarterly financial results for the quarter ended September 30, 2021.

Third Quarter 2021 Financial Highlights (in USD)

  • Cash Balance. Total assets as of September 30, 2021 were $178.6 million, including $145.9 million in cash, as compared to $85.6 million, including $80.1 million in cash, as of December 31, 2020
  • Net Cash Used in Operating Activities. Net Cash Used in Operating Activities of $10.8 million and $31.9 million for the three and nine months ended September 30, 2021, as compared to $5.8 million and $16.5 million for the three and nine months ended September 30, 2020, respectively
  • Net Loss. Net and comprehensive loss of $24.3 million and $74.6 million for the three and nine months ended September 30, 2021, as compared to $8.6 million and $21.4 million for the three and nine months ended September 30, 2020

Third Quarter 2021 Business Highlights

  • Announced the Appointment of Andreas Krebs and Carol Vallone as Board Directors and the Transition of Bruce Linton
  • Appointed three new members to its Scientific Advisory Board: Dr. Maria Oquendo, Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania; Dr. Bob Dworkin, Professor of Anesthesiology and Perioperative Medicine, Neurology, and Psychiatry, and Professor in the Center for Health + Technology, at the University of Rochester School of Medicine and Dentistry; and Dr. Bryan Roth, University of North Carolina Psychiatrist and Pharmacologist
  • MindMed and Liechti Lab Provided Results from the Psilocybin Research and Development (R&D) Collaboration
  • Joined the Clinical Trials Transformation Initiative and Critical Path Institute’s Patient-Reported Outcome Consortium
  • Announced a Strategic Research Collaboration with Sphere Health
  • MindMed and BioXcel Therapeutics Published an International Patent Application Describing a System for Identifying Agitation Episodes
  • Announced Collaboration with Forian to Advance Development of Personalized Psychiatry for Anxiety Disorders

Management Update & Earnings Call

Management will host an earnings call to review the third quarter financials and business developments on Wednesday, November 17th, 2021, at 8:00 am EST. Details are below:

https://mindmed-co.zoom.us/webinar/register/WN_Tp–QUSPS9u17HCQwxlc4Q

Complete financial statements along with related management’s discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada at www.SEDAR.com and on the Electronic Data Gathering, Analysis, and Retrieval system (EDGAR), the electronic filing system for the disclosure of documents of issuers in the United States at www.sec.gov.

About MindMed

MindMed is a clinical-stage biotech company that discovers, develops, and deploys 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 to 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. For more information: www.mindmed.co

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 start of MindMed’s Phase 1 clinical trial of dimethyltryptamine (DMT), the business and the therapeutic potential of MindMed’s product candidates, the ability to successfully execute and delivery on the R(-)-MDMA Program, the ability to achieve success with our collaborations with Sphere Health and Forian, the successful outcome of the Phase 1 clinical trial of DMT, the ability to initiate a Phase 2 clinical trial of DMT, regulatory approvals, the effects of DMT, subject enrollment and the administration method of DMT. 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

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MindMed to Present at the Jefferies London Healthcare Conference

MindMed to Present at the Jefferies London Healthcare Conference

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce that its CEO, Robert Barrow, will be speaking at Jefferies 2021 London Healthcare Conference, taking place on November 16-19. Management will be available during the conference for in-person and virtual one-on-one meetings.

A video webcast of the presentation will be available for viewing on-demand beginning on Wednesday, November 17 at 9:20 AM GMT for those registered for the event. The webcast will also be accessible in the “Investors” section of MindMed’s website. MindMed will maintain an archived replay of the webcast on its website for 30 days after the conference.

 

About MindMed

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 to 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.

Media Contact: mindmed@150bond.com

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Congrats to the top psychedelics companies of 2021!

The 1st Annual Microdose Awards

These leading companies were recognized for their accomplishments at Microdose Psychedelic Insights’ Wonderland: Miami – the world’s largest psychedelic business event ever.

Company of the Year: Cybin Inc. (CYBN)

Psilocybin Company of the Year: MycroDose Therapeutics (private)

Ketamine Company of the Year: Field Trip Health (FTRP)

Ibogaine Company of the Year: MindMed (MNMD)

DMT Company of the Year: Psilera Bioscience (private)

LSD Company of the Year: MindMed (MNMD)

MDMA Company of the Year: MAPS (non-profit)

Platform Company of the Year: MindMed (MNMD)

Drug Development Company of the Year: Awakn Life Sciences (AWKN)

Retreat of the Year: Synthesis

Clinic of the Year: Awakn Life Sciences (AWKN)

B2C Tech Company of the Year: Fireside Project (non-profit)

B2B Tech Company of the Year: MycroDose Therapeutics (private)

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MindMed Appoints Dr. Maria Oquendo to its Scientific Advisory Board

MindMed Appoints Dr. Maria Oquendo to its Scientific Advisory Board

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce the appointment of Maria A. Oquendo, M.D., Ph.D. to its Scientific Advisory Board.

Dr. Oquendo is Ruth Meltzer Professor and Chairman of Psychiatry at University of Pennsylvania and Psychiatrist-in-Chief at the Hospital of the University of Pennsylvania. A summa cum laude graduate of Tufts University, she attended Vagelos College of Physicians and Surgeons at Columbia University. She completed residency at the Payne Whitney Clinic of New York Hospital Cornell. She is a member of the National Academy of Medicine, one of the highest honors in medicine.

Dr. Oquendo has used Positron Emission Tomography and Magnetic Resonance Imaging to map brain abnormalities related to mood disorders and suicidal behavior. She has over 450 peer-reviewed publications and an h-factor of 78, with over 18,000 citations.

Dr. Oquendo is Past President of the American Psychiatric Association (APA), the International Academy of Suicide Research, and the American College of Neuropsychopharmacology (ACNP). She is Vice President of the Board of the American Foundation for Suicide Prevention, Vice President of the College of International Neuropsychopharmacology, and has served on the National Institute of Mental Health’s Advisory Council.

Dr. Oquendo is a member of Tufts University’s Board of Trustees and serves on its Executive Committee. A recipient of multiple awards in the US, Europe and South America, most recently, she was honored with the Alexandra Symonds Award (APA 2017), the APA’s Research Award (2018), the Dolores Shockley Award (ACNP 2018) and the Alexander Glassman Award (Columbia University 2021).

MindMed CEO Robert Barrow said, “We are thrilled to welcome Dr. Oquendo to our Scientific Advisory Board. Our goal is to revolutionize mental health and addiction care and we want to make effective treatments accessible to broad and diverse patient populations from across the globe. Dr. Oquendo’s extensive experience in psychiatry and pharmacology, including her work with high risk patients, will be invaluable in progressing all of our research and development efforts.”

Dr. Oquendo added, “In view of the pharmacologic actions that compounds like LSD and psilocybin share with putative anti-suicidal drugs, this exciting avenue of investigation may lead to discoveries of new approaches to this life-threatening behavior.”

MindMed’s Scientific Advisory Board is composed of a diverse group of members with expertise in psychiatry, neuroscience, and clinical development. The Scientific Advisory Board leverages decades of deep knowledge in biotech and psychiatry to guide MindMed’s development programs. Members represent institutions such as Stanford University, University of Pennsylvania, University of Rochester, Boston University, and Massachusetts General Hospital.

About MindMed

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 to 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. 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

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MindMed to Present at Web Summit on Future of Mental Health

MindMed to Present at Web Summit on Future of Mental Health

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce that CEO Robert Barrow will be speaking at Web Summit, taking place on November 1-4, 2021 in Lisbon, Portugal.

Barrow will be interviewed at 11:45am WET on November 3 on the topic, “Therapy 2.0 – The next step in mental health”. The session will touch on MDMA dosing, psychedelic precision medicine, LSD neutralising and similar themes around the future for specialised mental health treatment.

Web Summit is an annual technology conference that brings together the people and companies redefining the global tech industry. Politico calls it the “world’s premier tech conference”, while The Atlantic says that Web Summit is “where the future goes to be born”.

About MindMed

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 to 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 MindMed’s participation at Web Summit. 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.

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

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

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 of Mental Health.

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.”

About MindMed

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.

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MindMed CMO to Chair Digital Biomarkers Summit

MindMed CMO to Chair Digital Biomarkers Summit

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce that Chief Medical Officer Daniel R Karlin, MD MA, will chair The Digital Biomarkers & Digital Measurements Summit, held virtually on October 26 – 27, 2021.

“Digital biomarkers and digital measurements are an area of great interest in pharmaceutical development and the delivery of healthcare. But there remains a significant gap between the lofty promises of novel technologies and evidence of their usefulness in the real world. This summit enables the sorts of discussions and collaborations that help move digital technologies toward robust clinical meaningfulness,” said Dr. Karlin. “I’m looking forward to exploring topics like expanding adoption of digital biomarkers with more patient-centered and usable technology, whole-person summative measurement, and mapping the path forward for integrated digital therapeutics.”

Beginning with an explorative comparison of the concepts of digital biomarkers, digital measurements, and trial endpoints, and covering concepts around commercialization of these advances, the summit will provide attendees with an end-to-end learning and engagement experience.

About MindMed

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 to 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 MindMed’s attendance at The Digital Biomarkers & Digital Measurements Summit, Summit program and topics and Summit attendees. 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.