MindMed Reviews First Quarter 2022 Monetary Outcomes and Enterprise Highlights

– Superior scientific applications for 3 lead drug candidates –

– Strengthened management workforce with the appointment of Francois Lilienthal, MD as Chief Industrial Officer –

– Money runway by key scientific readouts in 2023 and into 2024 –

– Firm to host convention name at this time at 8:30 AM ET –

NEW YORK, Could 16, 2022 /PRNewswire/ — Thoughts Medication (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Firm”), a scientific stage biopharmaceutical firm growing novel merchandise to deal with mind well being issues, at this time reported its monetary outcomes for the quarter ended March 31, 2022.

“The outset of 2022 was marked by vital progress throughout all facets of the corporate that propelled our enterprise ahead, as we continued to advance and de-risk our three lead product candidates: MM-120 for the therapy of generalized anxiousness dysfunction, MM-402 for the therapy of core signs of autism spectrum dysfunction, and MM-110 for the administration of opioid use dysfunction,” stated Robert Barrow, Chief Govt Officer and Director of MindMed. “We anticipate a number of upcoming catalysts and additional progress throughout our drug growth pipeline in addition to our enabling applied sciences. We stay up for constructing on this momentum and imagine we’re nicely positioned to ship on the therapeutic potential of psychedelics and different novel targets to remodel the therapy of mind well being issues.”

Current Highlights and Anticipated Upcoming Milestones

MM-120 (LSD D-tartrate): a proprietary, pharmaceutically optimized type of lysergic acid diethylamide (LSD) that’s being developed for the therapy of generalized anxiousness dysfunction (GAD). MM-120 can also be being studied underneath numerous dosing regimens for the therapy of grownup consideration deficit hyperactivity dysfunction (ADHD) and for the therapy of power ache.

• Examine MMED008, a Part 2b dose-optimization trial of MM-120 for the therapy of GAD, was initiated.
• In December 2021, Examine MMED007, a Part 2a proof-of-concept trial, was initiated for the therapy of ADHD. The research is designed to evaluate the protection and efficacy of repeated low-dose MM-120 administration.
• A Part 2a trial of MM-120 in a power ache situation is predicted to provoke in This autumn 2022.

MM-110 (zolunicant HCl or 18-MC): a congener of ibogaine that the Firm is growing for the therapy of opioid withdrawal. MM-110 is an α3β4 nicotinic cholinergic receptor antagonist that has been examined in preclinical fashions of withdrawal and substance use issues.

• In December 2021, the Firm accomplished MMED003, a Part 1 trial of MM-110. On this research, 77 contributors obtained as much as 325 mg of MM-110 twice (on a single day) or have been administered as much as 90mg of MM-110 twice day by day for seven days, and 31 contributors obtained a placebo.
• The outcomes of this profitable Part 1 research have knowledgeable the Part 2a trial design that’s anticipated to be initiated in Q2 2022.
• In Could 2022, the Firm introduced an upcoming webinar on substance use issues and withdrawal administration that includes displays from famous consultants within the discipline, Kelly E. Dunn, PhD, MBA, Professor, Johns Hopkins College of Medication and Stuart Gitlow, MD, MPH, MBA, Previous President of the American Society of Dependancy Medication. Following displays by Drs. Dunn and Gitlow, the MindMed management workforce will present an outline of MM-110 and its potential to handle a essential hole in present therapy of opioid use dysfunction.

MM-402 or R(-)-MDMA: an artificial R-enantiomer of MDMA that reveals emotions of connectedness and compassion that the Firm is growing for the therapy of core signs of autism spectrum dysfunction. Preclinical research of R(-)-MDMA show its acute prosocial results, whereas its diminished dopaminergic exercise means that it could exhibit much less stimulant exercise, neurotoxicity, hyperthermia and abuse legal responsibility profile when in comparison with racemic MDMA or the S(+)-enantiomer of MDMA. 

• IND-enabling research are at the moment ongoing and, by the Firm’s collaboration with College Hospital Basel, a comparative Part 1 pharmacokinetic/pharmacodynamic trial of R(-)-MDMA, S(+)-MDMA and (+)- MDMA in wholesome volunteers is predicted to start in Q3 2022.

Digital Medication Initiatives 

MindMed Session Monitoring System (MSMS): technological platform and product that gives the muse for the event and implementation of a set of regulated and unregulated merchandise to be used by clinicians and sufferers throughout therapy classes which will additionally embody the usage of consciousness altering drugs. 

• Session Monitoring System (SMS-01): The research is designed to guage the passive assortment of sensory knowledge throughout a consciousness-altering therapeutic session utilizing the MSMS.
• Nervousness Digital Diagnoses for Precision Psychiatry (ADDAPT, MMED-D001): The newly developed cell software to help the research is at the moment in personal beta, enrolling by invitation.
• Quantifying the Processes and Occasions of Psychotherapy at Scale (MM061302): The research stays on observe and is continuous to enroll and acquire knowledge.

Collaborations and Partnerships 

• In Could 2022, Dr. Frederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at College Hospital Basel (UHB), introduced outcomes from the LSD-Help Examine, a Part 2 placebo-controlled investigator-initiated scientific trial of LSD within the therapy of tension issues, at London’s PSYCH Symposium.
• Preliminary topline security and efficacy outcomes for LSD in 46 sufferers with clinically vital anxiousness demonstrated the numerous, speedy, sturdy, and useful results of LSD and potential to soundly mitigate signs of tension and despair.

Management Additions

• In April 2022, Francois Lilienthal, MD was appointed as Chief Industrial Officer. With greater than twenty years of worldwide biopharmaceutical expertise, Dr. Lilienthal will step into this position to help the development of the Firm’s scientific and business targets.

First Quarter 2022 Monetary and Different Current Highlights

Money Steadiness. As of March 31, 2022, MindMed had money totaling $120.5 million in comparison with $133.5 million as of December 31, 2021. MindMed believes its accessible money can be enough to satisfy its working necessities past its key growth milestones in 2023 and into 2024.

Web Money in Working Actions. The online money utilized in working actions was $12.9 million for the three months ended March 31, 2022, in comparison with $10.0 million for a similar interval in 2021.

Analysis and Improvement (R&D). R&D bills have been $10.2 million for the three months ended March 31, 2022, in comparison with $6.8 million for a similar interval in 2021. The rise of $3.4 million was primarily as a consequence of $4.4 million of inside bills associated to compensation prices for extra headcount of $2.0 million and a rise in non-cash bills of $1.7 million of stock-based compensation bills. This improve was offset by a lower in exterior spending of $0.8 million associated to our preclinical and different applications.

Normal and Administrative (G&A). G&A bills have been $8.3 million for the three months ended March 31, 2022, in comparison with $7.0 million for a similar interval in 2021. The rise of $1.2 million was primarily as a consequence of a rise of $0.9 million in non-cash stock-based compensation bills. Different contributors to the rise included greater skilled service bills together with accounting, audit, authorized, compliance, director and officer insurance coverage, and investor and public relations and personnel prices to help the expansion of the corporate.

Web Loss. The online and complete loss for the three months ended March 31, 2022, was $18.5 million, in comparison with $13.8 million for a similar interval in 2021.

Convention Name and Webcast Reminder

MindMed administration will host a convention name at 8:30 AM EDT at this time to offer a company replace and evaluate the Firm’s first quarter 2022 monetary outcomes. People might take part within the name by way of phone by dialing (877) 407-0789 (home) or (201) 689-8562 (worldwide) and utilizing convention ID 13728028. The webcast may be accessed reside right here or on MindMed’s Investor Sources webpage. The webcast can be archived on the Firm’s web site for a minimum of 30 days after the convention name.

About MindMed

MindMed is a clinical-stage biopharmaceutical firm growing novel merchandise to deal with mind well being issues, with a selected deal with psychiatry, dependancy, ache and neurology. Our mission is to be the worldwide chief within the growth and supply of therapies that unlock new alternatives to enhance affected person outcomes. We’re growing a pipeline of progressive drug candidates, with and with out acute perceptual results, concentrating on the serotonin, dopamine and acetylcholine techniques.

MindMed trades on NASDAQ underneath the image MNMD and on the Canadian NEO Alternate underneath the image MMED.

Ahead-Trying Statements

Sure statements on this information launch associated to the Firm represent “forward-looking info” throughout the which means of relevant securities legal guidelines and are potential in nature. Ahead-looking info just isn’t primarily based on historic information, however relatively on present expectations and projections about future occasions and are due to this fact topic to dangers and uncertainties which might trigger precise outcomes to vary materially from the longer term outcomes expressed or implied by the forward-looking statements. These statements usually may be recognized by means of forward-looking phrases resembling “will”, “might”, “ought to”, “might”, “intend”, “estimate”, “plan”, “anticipate”, “count on”, “imagine”, “potential” or “proceed”, or the unfavourable thereof or comparable variations. Ahead-looking info on this information launch embody, however usually are not restricted to, statements concerning anticipated upcoming milestones and research, outcomes and timing of scientific research, anticipated progress and developments of medication and applied sciences, persevering with collaborations and partnerships, and the provision of money and money equivalents. There are quite a few dangers and uncertainties that might trigger precise outcomes and the Firm’s plans and targets to vary materially from these expressed within the forward-looking info, together with historical past of unfavourable money flows; restricted working historical past; incurrence of future losses; availability of further capital; lack of product income; compliance with legal guidelines and rules; problem related to analysis and growth; dangers related to scientific trials or research; heightened regulatory scrutiny; early stage product growth; scientific trial dangers; regulatory approval processes; novelty of the psychedelic impressed medicines business; in addition to these danger elements mentioned or referred to herein and the dangers described within the Firm’s Annual Report on Kind 10-Ok for the yr ended December 31, 2021 and its Quarterly Report on Kind 10-Q for the interval ended March 31, 2022 underneath headings resembling “Particular Word Concerning Ahead-Trying Statements,” and “Danger Elements” and “Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations” and different filings and furnishings made by the Firm with the securities regulatory authorities in all provinces and territories of Canada which can be found underneath the Firm’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Alternate Fee on EDGAR at www.sec.gov. Besides as required by legislation, the Firm undertakes no responsibility or obligation to replace any forward-looking statements contained on this launch because of new info, future occasions, modifications in expectations or in any other case.

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SOURCE Thoughts Medication (MindMed) Inc.