MNMD - MindMed Inc.

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  1. Twiggs462

    Twiggs462 Member

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    Novamind to Host MindMed Phase IIb Trial for LSD and Anxiety
    Published: Mar 16, 2022

    TORONTO, ON / ACCESSWIRE / March 16, 2022 /Novamind Inc. (CSE:NM)(OTCQB:NVMDF)(FSE:HN2) ("Novamind" or the "Company"), a leading mental health company specialized in psychedelic medicine, is pleased to announce it has been selected by Mind Medicine, Inc. (NASDAQ:MNMD), (NEO:MMED) ("MindMed") to host a phase IIb randomized clinical trial investigating lysergic acid diethylamide (LSD) for generalized anxiety disorder (GAD) in adults ("LSD Clinical Trial"). MindMed is a clinical-stage biotech company developing the next generation of psychedelic-inspired medicines and therapies.

    The LSD Clinical Trial is the most advanced program in MindMed's clinical drug development pipeline and is the first commercial study of LSD in over 40 years. The primary objective of the study is to determine the reduction in anxiety symptoms for up to twelve weeks after a single administration of MindMed's proprietary drug candidate, MM-120, a pharmacologically optimized form of LSD being developed for GAD and other brain-based disorders. The multi-site LSD Clinical Trial plans to enroll 200 participants with dosing expected later this year.

    Novamind will host the LSD Clinical Trial at its Draper, Utah research site, further strengthening its track record of hosting neuropsychiatry and psychedelic clinical trials. In October 2021, Novamind was awarded two DEA Schedule 1 licenses for psilocybin research, qualifying it to conduct a recently announced phase II trial for major depressive disorder sponsored by the Usona Institute, as well as future psilocybin trials. Novamind expects to add LSD under the licenses in relation to the LSD Clinical Trial.

    "With anxiety disorders being among the most common mental health conditions, there's a pressing need for new treatment options and, in particular, medications with novel mechanisms of action like LSD," said Dr. Reid Robison, Chief Medical Officer, Novamind. "We're honored to participate in this research study involving such a long-awaited therapy with potential to transform the treatment paradigm in anxiety."

    Jamie Freedman, Director of Clinical Operations, MindMed, said: "We're pleased to have finalized our site selection process. Working with companies like Novamind who have experience running clinical research sites for Schedule I substances will be critical to the quality and success of this trial."

    Yaron Conforti, CEO and Director, Novamind, commented, "We're excited to host MindMed's historic clinical trial, and to contribute to advancing LSD towards FDA approval. Our team continues to build on Novamind's reputation as an industry leader in clinical research for psychedelic medicine, and we are proud to be a trusted partner for this important work."

    The LSD Clinical Trial is expected to move through a series of key milestones over the coming months to prepare for enrollment and patient dosing.

    To learn more about Novamind's clinical research division, visit this link.

    About Novamind
    Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visitnovamind.ca.

    About MindMed
    MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. 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. Visit www.mindmed.co for more information.

    Contact Information
    Yaron Conforti, CEO and Director
    Telephone: +1 (647) 953 9512

    Samantha DeLenardo, VP, Communications
    Email: [email protected]

    Investor Relations
    Email: [email protected]

    Forward-Looking Statements
    This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations including the risks detailed from time to time in the Company's public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

    SOURCE: Novamind Inc.




    View source version on accesswire.com:
    https://www.accesswire.com/693268/Novamind-to-Host-MindMed-Phase-IIb-Trial-for-LSD-and-Anxiety



    https://www.biospace.com/article/re...-mindmed-phase-iib-trial-for-lsd-and-anxiety/
     
  2. Twiggs462

    Twiggs462 Member

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    MindMed to Host Earnings Call to Discuss Full-Year 2021 Financial Results and Provide Business Update
    [​IMG]


    NEWS PROVIDED BY

    Mind Medicine (MindMed) Inc.
    Mar 21, 2022, 07:30 ET


    • MNMD), (NEO: MMED), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that it will host its earnings call on Monday, March 28, 2022, at 8:30 a.m. EDT to discuss its financial results for the full year ended December 31, 2021 and provide a business update.

      Individuals may participate via telephone by dialing (877) 407-0789 (domestic) or (201) 689-8562 (international) and using conference ID 13728028. The webcast can be accessed live here or on MindMed's Investor Resources webpage. The webcast will be archived on the company's website for at least 30 days after the conference call.

      About MindMed

      MindMed is a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. 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 drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

      MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

      For Investors: [email protected]

      For Media: [email protected]

      SOURCE Mind Medicine (MindMed) Inc.

    https://www.prnewswire.com/news-rel...ts-and-provide-business-update-301506279.html
     
  3. Twiggs462

    Twiggs462 Member

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    MindMed Announces Transition of CFO
    [​IMG]


    NEWS PROVIDED BY

    Mind Medicine (MindMed) Inc.
    Mar 25, 2022, 17:30 ET

    SHARE THIS ARTICLE

    • MNMD), (NEO: MMED) (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that its Chief Financial Officer, David Guebert, will be retiring from his position on March 31, 2022.

      "On behalf of the Board of Directors and Executive team, I would like to thank Dave, who was essential to the founding and early growth of our organization," said Robert Barrow, Chief Executive Officer and Director of MindMed. "As we advance our robust drug development and digital medicine programs, we continue to identify leaders who will guide MindMed through this critical stage in our growth. Dave leaves us well positioned financially and strategically to create long-term value for shareholders and to deliver on our commitment to patients in need of novel treatment options."

      MindMed has retained an executive search firm to assist the Company's Board of Directors in identifying a new Chief Financial Officer with expertise and experience in the US biotech market.
     
  4. Twiggs462

    Twiggs462 Member

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    MindMed CEO Rob Barrow at Web Summit 2021: Therapy 2.0 - The next step in brain health

     
  6. Twiggs462

    Twiggs462 Member

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    MindMed to Host Earnings Call to Discuss Full-Year 2021 Financial Results and Provide Business Update


    NEW YORK, March 21, 2022 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that it will host its earnings call on Monday, March 28, 2022, at 8:30 a.m. EDT to discuss its financial results for the full year ended December 31, 2021 and provide a business update.

    Individuals may participate via telephone by dialing (877) 407-0789 (domestic) or (201) 689-8562 (international) and using conference ID 13728028. The webcast can be accessed live here or on MindMed’s Investor Resources webpage. The webcast will be archived on the company’s website for at least 30 days after the conference call.
     
  7. Twiggs462

    Twiggs462 Member

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    #47 Twiggs462, Mar 27, 2022
    Last edited: Mar 27, 2022
  8. emmett kelly

    emmett kelly Well-Known Member

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    only one way for it to go and that is up. really short candles. would be nice to see some long green ones.

    [​IMG]
     
  9. Twiggs462

    Twiggs462 Member

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    MindMed Reports Full Year 2021 Financial Results and Business Highlights
    • FDA cleared MindMed's Investigational New Drug (IND) application for Phase 2b dose optimization trial of MM-120
    • Progressed development programs for all three lead product candidates
    • Cash balance of $133.5 million at year end 2021

    NEW YORK, March 28, 2022 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today reported its financial results for the full-year ended December 31, 2021.

    "2021 was a year of major advancements across all aspects of MindMed, with significant growth in our organization, development programs and research collaborations. We established a regulatory pathway for MM-120 in the treatment of GAD and, with MM-402, launched a program to develop a novel treatment for core symptoms of autism spectrum disorder – both of which represent meaningful leaps forward in the field of psychiatry," said Robert Barrow, Chief Executive Officer and Director of MindMed. "We expect 2022 to be a transformational year in which we continue to drive substantial growth across our pharmaceutical and digital medicine pipelines. I am incredibly proud of our team's achievements and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, leading to meaningful improvements in patient outcomes in these major areas of unmet medical need."

    Recent Highlights and Anticipated Upcoming Milestones
    MM-120 (LSD D-tartrate): a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD) that is being developed for the treatment of generalized anxiety disorder (GAD). MM-120 is also being studied under various dosing regimens for the treatment of adult attention deficit hyperactivity disorder (ADHD) and for the treatment of chronic pain.

    • In January 2022, the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application for the Phase 2b dose-optimization trial of MM-120 for the treatment of GAD.
      • Study MMED008, a Phase 2b dose-optimization study of MM-120 for the treatment of GAD, is expected to begin in Q2 2022.
    • In December 2021, Study MMED007, a Phase 2a proof-of-concept study, was initiated for the treatment of ADHD. The study is designed to assess the safety and efficacy of repeated low-dose MM-120 administration.
    • A clinical study of MM-120 in a chronic pain condition is expected to be initiated in Q4 2022.
    MM-110 (zolunicant HCl or 18-MC): a derivative of ibogaine that the Company is developing for the treatment of opioid withdrawal. MM-110 is an α3β4 nicotinic cholinergic receptor antagonist that has been extensively tested in preclinical models of substance use disorders.

    • In January 2022, the USAN Council assigned the non-proprietary name "zolunicant" (pronounced: zoe lun' i kant), to MM-110 or 18-MC.
    • In December 2021, the Company completed a Phase 1 study of MM-110 with topline data expected in Q2 2022. These results will inform the design of the planned Phase 2a study in individuals undergoing standardized supervised opioid withdrawal, which is expected to commence in Q2 2022. The Phase 2a study will evaluate the safety, tolerability and efficacy of MM-110 in mitigating symptoms of opioid withdrawal and facilitating completion of detoxification.
    MM-402 (R(-)-MDMA): a synthetic enantiomer of MDMA that exhibits prosocial and empathogenic activity that the Company is developing for the treatment of core symptoms of autism spectrum disorder. Preclinical studies of R(-)-MDMA demonstrate its acute prosocial effects, while its diminished dopaminergic activity suggests that it may exhibit a favorable safety, tolerability and abuse liability profile when compared to racemic MDMA or the S(+)-enantiomer of MDMA.

    • IND-enabling studies are currently ongoing and, through the Company's collaboration with University Hospital Basel, a comparative Phase 1 pharmacokinetic/pharmacodynamic study of R(-), S(+) and + MDMA is expected to commence in mid 2022.
    Digital Medicine Initiatives
    • In February 2021, the Company completed the acquisition of HealthMode and fully integrated its team to enable rapid progression of digital medicine and business operations functions.
    • Having engaged in a productive Pre-Submission meeting with FDA in late 2021, in January 2022, the first subjects were enrolled into the Session Monitoring System (SMS-01) study evaluating the passive collection of sensory data during a consciousness-altering therapeutic session using the MindMed Session Monitoring System (MSMS).
    • Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT, MMED-D001): A Natural History Study and our newly developed mobile application to support the study is expected to launch in private beta in Q2 2022.
    • In September 2021, the first participants were enrolled by invitation in the Quantifying the Processes and Events of Psychotherapy at Scale (MM061302) study.
    Collaborations and Partnerships
    • University Hospital Basel (UHB): The Company continued to support the ongoing collaboration with the Liechti Lab at UHB in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with the Liechti laboratory's research with LSD and other psychedelic compounds, including data from preclinical studies and over 15 completed and 9 ongoing clinical trials.
      • In March 2022, the peer-reviewed publication of a double-blind placebo-controlled comparative study of LSD and psilocybin was published in Neuropsychopharmacology. The study demonstrated that the key differences between LSD and psilocybin are dose-dependent rather than substance-dependent. These findings have the potential to assist with dose-finding, trial design and inform future studies evaluating the therapeutic utility of psychedelics.
      • In November 2021, the peer-reviewed publication of a randomized, double-blind, placebo-controlled study evaluating the interacting effects of an SSRI and psilocybin in healthy volunteers was published in Clinical Pharmacology and Therapeutics. The study suggests psilocybin is safe to take in combination with an SSRI.
    • Nextage Therapeutics Ltd: The Company entered into a collaboration with Nextage Therapeutics in April 2021 to explore the therapeutic potential of noribogine in a proprietary brain targeted liposome drug delivery technology system to mitigate risks of peripheral adverse effects.
    • MindShift Compounds AG: The Company continued to progress its collaborative research and development activities with MindShift Compounds AG in Basel, Switzerland, focusing on the discovery and optimization of next generation compounds, including those with and without acute perceptual effects.
    • The Chopra Foundation: The company ultimately did not reach a definitive agreement for a potential collaboration and discontinued the engagement.
    Director & Officer Appointments
    • In December 2021, Robert Barrow was appointed as Chief Executive Officer and as a member of the Board of Directors. Mr. Barrow previously served as interim Chief Executive Officer and Chief Development Officer of MindMed and brings strategic expertise and deep industry insight to his role.
    • In December 2021, Cynthia Hu, JD was appointed as Chief Legal Officer and Corporate Secretary.
    • In November 2021, Carrie Liao, CPA was appointed as VP, Corporate Controller and Principal Accounting Officer.
    • In September 2021, Carol Vallone and Andreas Krebs were appointed to the Board of Directors and were subsequently appointed as chair and vice chair, respectively.
    • In May 2021, Sarah Vinson, MD was appointed to the Board of Directors.
    • In February 2021, Daniel Karlin, MD, MA was appointed as Chief Medical Officer.
    Scientific Advisory Board Appointments
    • Over the course of 2021, we made significant additions to our Scientific Advisory Board (SAB), including:
      • Robert C. Malenka, MD, PhD (Professor, Stanford University) – SAB chair
      • Maurizio Fava, MD (Psychiatrist-In-Chief, Mass General Hospital; Associate Dean and Professor of Psychiatry, Harvard Medical School)
      • Peter Bergethon, MD (President, Symmetry Research; formerly Vice President, Biogen)
      • Robert Dworkin, PhD (Professor, Rochester University; Director, ACTTION public-private partnership)
      • Bryan Roth, MD, PhD (Professor, University of North Carolina; Director, NIMH Psychoactive Drug Screening Program)
      • Maria Oquendo, MD, PhD (Chair and Professor of Psychiatry, University of Pennsylvania; Past President, American Psychiatric Association)
    2021 Financial Results
    Cash Balance. As of December 31, 2021, MindMed had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. MindMed believes its available cash and cash equivalents will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.

    Net Cash in Operating Activities. The net cash used in operating activities was $45.8 million for the year ended December 31, 2021, compared to $23.6 million for the same period in 2020.

    Research and Development (R&D). R&D expenses were $34.8 million for the year ended December 31, 2021, compared to $18.6 million for the year ended 2020. The increase was primarily due to an increase of $2.7 million in expenses related to our MM-120 clinical research, $2.3 million in expenses related to our MM-110 clinical research, $3.5 million in expenses related to preclinical and other research programs, offset by a $3.5 million decrease of expense in connection with various external R&D collaborations. Internal costs increased $11.1 million primarily related to an increase in non-cash expenses of $6.6 million of stock-based compensation expenses and $2.6 million of amortization of our developed technology.

    General and Administrative (G&A). G&A expenses were $59.1 million for the year ended December 31, 2021, compared to $14.4 million for the year ended 2020. The increase was primarily due to an increase of $28.9 million in non-cash stock-based compensation expenses of which $21.9 million related to the modification of stock options and RSUs. Other contributors to the increase included higher professional services including accounting, audit, legal, compliance, director and officer insurance, and investor and public relations and personnel costs to support the growth of the company.

    Net Loss. The net and comprehensive loss for the year ended December 31, 2021 was $92.3 million, compared to $33.7 million for the year ended 2020.

    About MindMed

    MindMed is a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. 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 drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

    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.

    MindMed 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. 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.

    For Media: [email protected]

    For Investors: [email protected]
     
  10. Twiggs462

    Twiggs462 Member

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    I agree, but I think it will come in due time this is a great accumulation period right now for this sector. They have a great staff and team to make this a success and well positioned.

     
  11. Twiggs462

    Twiggs462 Member

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  12. Twiggs462

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    MindMed Appoints Francois Lilienthal, MD as Chief Commercial Officer

    NEWS PROVIDED BY
    Mind Medicine (MindMed) Inc.
    Apr 05, 2022, 07:30 ET

    - Dr. Lilienthal brings over 20 years of global biopharmaceutical experience, leading the development and commercialization of innovative medicines across multiple therapeutic areas including psychiatry and neurology -

    NEW YORK, April 5, 2022 /PRNewswire/ -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced the appointment of Francois Lilienthal, MD as Chief Commercial Officer. With more than two decades of global biopharmaceutical experience and after serving as a consultant for MindMed over the past six months, Dr. Lilienthal will step into this role to support the advancement of the Company's clinical development programs.

    "I am incredibly excited to welcome Dr. Lilienthal to our senior management team. His addition demonstrates the scale and immediacy of the opportunity MindMed sees in the brain health disorders market," said Robert Barrow, Chief Executive Officer at MindMed. "Dr. Lilienthal's expertise in growing businesses through successful global product launches across a range of therapeutic indications will be critical as we advance our pipeline and seek to address the massive need for novel therapies. We look forward to his guidance as we bring an entirely new class of drugs to market to transform the landscape of treatments for brain health disorders."

    Dr. Lilienthal commented, "This is a pivotal time for the industry and I am honored to be joining MindMed, a company that is on the cutting edge of neuropsychiatry. I believe there is potential for psychedelic-derived medicine to address brain health disorders and look forward to working closely with the executive team as we continue conversations with the FDA and advance MindMed through its next phase of growth."

    Dr. Lilienthal is an accomplished global biopharmaceutical leader and trained physician with over 20 years of experience leading the commercialization of novel medicines and driving multi-billion-dollar growth across diversified portfolios and businesses. Dr. Lilienthal held several global leadership roles at Merck, leading successful global brand launches for HIV and Hepatitis C. He oversaw the creation of commercial processes integrating new capabilities such as digital technologies, advanced data analytics and global partnerships into clinical development. Dr. Lilienthal served as Executive Director and U.S. Brand Leader at Tibotec, where he launched three innovative HIV brands and drove the launch of Prezista, which achieved $800M in annual revenues at its peak. Dr. Lilienthal has also served as Executive Director and Global Marketing Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson and Director and Global Marketing Leader at Bristol Myers Squibb. Dr. Lilienthal earned his MD and MA from the University of Paris and holds an MBA in Marketing and Management from the University of Pennsylvania.

    About MindMed

    MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. 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 drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

    MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

    For Investors: [email protected]

    For Media: [email protected]
     
  13. Twiggs462

    Twiggs462 Member

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    Resume of Francois Lilienthal

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  14. Twiggs462

    Twiggs462 Member

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    Twiggs462 Member

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  16. Twiggs462

    Twiggs462 Member

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    Look at the employee growth on LinkedIn - the company is going to grow and become profitable. The folks joining these type of companies are passionate and want to press forward hard... harder than most workers. I really believe that.

    [​IMG]
     
  17. Twiggs462

    Twiggs462 Member

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    MNMD - LSD Topline Data Released (Positive)

    NEWS - MindMed Collaborators Prof. Liechti and Dr. Holze Announce Positive Topline Data from Phase 2 Trial Evaluating LSD in Anxiety Disorders

    https://www.prnewswire.com/news-rel...ating-lsd-in-anxiety-disorders-301544722.html

    --

    [​IMG]

    - Results from the placebo-controlled investigator-initiated trial, conducted at the University Hospital Basel (UHB), demonstrate the significant, long-lasting beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression -

    - Data further validates MindMed's therapeutic approach and supports the clinical development of MM-120 for the treatment of Generalized Anxiety Disorder -

    - Data was featured in an oral presentation on May 11, 2022 at 5:05am EDT / 10:05am BST -

    NEW YORK, May 11, 2022 /PRNewswire/ -- Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that Prof. Matthias Liechti and Dr. Friederike Holze, MindMed collaborators at University Hospital Basel (UHB), have released positive topline data from a Phase 2 placebo-controlled investigator-initiated clinical trial evaluating LSD in the treatment of anxiety disorders. These findings were presented in an oral presentation at London's PSYCH Symposium on May 11, 2022.

    The topline data demonstrate the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression. LSD (200 µg) treatment resulted in significant and strong reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean (± SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007). LSD was well-tolerated.

    "We are encouraged by the positive data showing that LSD produced rapid, strong and long-lasting reductions in anxiety and depression symptoms up to 16 weeks post treatment compared with a placebo," said Dr. Miri Halperin Wernli, Executive President of MindMed. "These results represent the highest quality research ever conducted with LSD in anxiety disorders and provide contemporary confirmation of the preliminary findings of the anxiolytic and antidepressant effects of LSD in over 500 patients to date."

    Dr. Halperin Wernli continued, "The statistically significant, strong and long-lasting reductions in STAI-G scores, combined with similarly rapid and sustained responses in all secondary endpoint measurements, are extremely encouraging. These results further support MindMed's clinical development strategy. We look forward to using these findings to advance our MM-120 program for the treatment of Generalized Anxiety Disorder."

    Prof. Matthias Liechti, co-primary investigator of the trial, commented, "While psychedelics including LSD have shown beneficial effects on reducing anxiety, there has still been a need for a deeper understanding of the mechanisms and the long-lasting effects by which psychedelics exert their therapeutic effects. Thus, we designed a robust, randomized, placebo-controlled clinical trial with a long follow-up period to extend the promising findings of previously conducted smaller, open-label trials. We are extremely encouraged by the results presented today, demonstrating the long-lasting and strong reduction in patients suffering from anxiety. We look forward to reporting additional analyses and further investigating the therapeutic potential of LSD for patients suffering from anxiety disorders."

    Details on the data presentations:

    The presentation, titled "LSD as a Treatment for Anxiety Disorders: New Evidence of Efficacy," was delivered by Dr. Friederike Holze and Prof. Dr. Matthias Liechti, co-primary investigators of the trial and MindMed collaborators at University Hospital Basel (UHB).

    Key data and conclusions from the topline efficacy analysis featured in the PSYCH Symposium presentation include:

    Primary Endpoint: LSD treatment resulted in significant and strong reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean (± SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007).
    A clinical response (reduction in STAI-G scores =30%) was observed in 65% (13/20) patients in the LSD arm and in 9% (2/22) patients in the placebo arm (p=0.003).
    Effects were maximal 2 weeks after the second LSD session and sustained up to 16 weeks.
    All secondary endpoint measurements, including the HAM-D-21, BDI, and SCL-90-R, showed similarly rapid and sustained responses consistent with a lasting treatment effect on anxiety, depression, and general psychiatric symptomatology.
    Acute positive effects or mystical experiences significantly correlated with long-term therapeutic outcomes.
    LSD was well-tolerated: only one SAE was considered related to treatment and consisted of acute transient anxiety and delusions during an LSD session. There were no recorded instances of treatment-emergent suicidal ideation with intent, suicidal behavior or intentional self-injury.
    About the Phase 2 Investigator-Initiated Clinical Trial
    The investigator-initiated, two-center, clinical trial was a double-blind, placebo-controlled, Phase 2 trial that investigated the safety and efficacy of LSD for the treatment of anxiety disorders. The trial enrolled 46 patients either suffering from anxiety symptoms in life-threatening illnesses or with an anxiety disorder without severe somatic illness. Patients were randomly assigned to two sessions with either oral LSD (200 µg) or placebo administration over a trial duration of 52 weeks per patient. The primary efficacy endpoint was reduction in anxiety symptoms 16 weeks after the last LSD or placebo administration. The primary outcome measure was the State Trait Anxiety Inventory (STAI) global score, which is used to assess the severity of anxiety symptoms. Secondary outcome measures included improvements in Hamilton Depression Scale (HAM-D), Beck Depression Index (BDI), and several other major psychiatric symptoms (Symptom-Check-List-90-R) scores. For additional information on this trial see clinicaltrials.gov [NCT03153579].

    MindMed supports the UHB Liechti Lab in conducting investigator-initiated trials for LSD and other novel therapies and has exclusive access and rights to the data generated by these studies.
     
  18. Twiggs462

    Twiggs462 Member

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    MindMed Reports First Quarter 2022 Financial Results and Business Highlights 


    – Advanced clinical programs for three lead drug candidates –
    – Strengthened leadership team with the appointment of Francois Lilienthal, MD as Chief Commercial Officer –
    – Cash runway through key clinical readouts in 2023 and into 2024 –
    – Company to host conference call today at 8:30 AM ET –

    NEW YORK, May 16, 2022 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company”), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today reported its financial results for the quarter ended March 31, 2022.

    “The outset of 2022 was marked by significant progress across all aspects of the company that propelled our business forward, as we continued to advance and de-risk our three lead product candidates: MM-120 for the treatment of generalized anxiety disorder, MM-402 for the treatment of core symptoms of autism spectrum disorder, and MM-110 for the management of opioid use disorder,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We anticipate multiple upcoming catalysts and further growth across our drug development pipeline as well as our enabling technologies. We look forward to building on this momentum and believe we are well positioned to deliver on the therapeutic potential of psychedelics and other novel targets to transform the treatment of brain health disorders.”
    Recent Highlights and Anticipated Upcoming Milestones

    MM-120 (LSD D-tartrate): a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD) that is being developed for the treatment of generalized anxiety disorder (GAD). MM-120 is also being studied under various dosing regimens for the treatment of adult attention deficit hyperactivity disorder (ADHD) and for the treatment of chronic pain.

    – Study MMED008, a Phase 2b dose-optimization trial of MM-120 for the treatment of GAD, was initiated.
    – In December 2021, Study MMED007, a Phase 2a proof-of-concept trial, was initiated for the treatment of ADHD. The study is designed to assess the safety and efficacy of repeated low-dose MM-120 administration.
    – A Phase 2a trial of MM-120 in a chronic pain condition is expected to initiate in Q4 2022.
    MM-110 (zolunicant HCl or 18-MC): a congener of ibogaine that the Company is developing for the treatment of opioid withdrawal. MM-110 is an α3β4 nicotinic cholinergic receptor antagonist that has been tested in preclinical models of withdrawal and substance use disorders.
    – In December 2021, the Company completed MMED003, a Phase 1 trial of MM-110. In this study, 77 participants received up to 325 mg of MM-110 twice (on a single day) or were administered up to 90mg of MM-110 twice daily for seven days, and 31 participants received a placebo.
    – The results of this successful Phase 1 study have informed the Phase 2a trial design that is expected to be initiated in Q2 2022.
    – In May 2022, the Company announced an upcoming webinar on substance use disorders and withdrawal management featuring presentations from noted experts in the field, Kelly E. Dunn, PhD, MBA, Professor, Johns Hopkins School of Medicine and Stuart Gitlow, MD, MPH, MBA, Past President of the American Society of Addiction Medicine. Following presentations by Drs. Dunn and Gitlow, the MindMed leadership team will provide an overview of MM-110 and its potential to address a critical gap in current treatment of opioid use disorder.
    MM-402 or R(-)-MDMA: a synthetic R-enantiomer of MDMA that exhibits feelings of connectedness and compassion that the Company is developing for the treatment of core symptoms of autism spectrum disorder. Preclinical studies of R(-)-MDMA demonstrate its acute prosocial effects, while its diminished dopaminergic activity suggests that it may exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability profile when compared to racemic MDMA or the S(+)-enantiomer of MDMA.

    – IND-enabling studies are currently ongoing and, through the Company’s collaboration with University Hospital Basel, a comparative Phase 1 pharmacokinetic/pharmacodynamic trial of R(-)-MDMA, S(+)-MDMA and (+)- MDMA in healthy volunteers is expected to commence in Q3 2022.
    Digital Medicine Initiatives
    MindMed Session Monitoring System (MSMS): technological platform and product that provides the foundation for the development and implementation of a suite of regulated and unregulated products for use by clinicians and patients during treatment sessions that may also include the use of consciousness altering medications.
    – Session Monitoring System (SMS-01): The study is designed to evaluate the passive collection of sensory data during a consciousness-altering therapeutic session using the MSMS.
    – Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT, MMED-D001): The newly developed mobile application to support the study is currently in private beta, enrolling by invitation.
    – Quantifying the Processes and Events of Psychotherapy at Scale (MM061302): The study remains on track and is continuing to enroll and collect data.
    Collaborations and Partnerships
    – In May 2022, Dr. Frederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at University Hospital Basel (UHB), presented results from the LSD-Assist Study, a Phase 2 placebo-controlled investigator-initiated clinical trial of LSD in the treatment of anxiety disorders, at London’s PSYCH Symposium.
    – Preliminary topline safety and efficacy results for LSD in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression.
    Leadership Additions
    – In April 2022, Francois Lilienthal, MD was appointed as Chief Commercial Officer. With more than two decades of global biopharmaceutical experience, Dr. Lilienthal will step into this role to support the advancement of the Company’s clinical and commercial objectives.

    First Quarter 2022 Financial and Other Recent Highlights

    Cash Balance. As of March 31, 2022, MindMed had cash totaling $120.5 million compared to $133.5 million as of December 31, 2021. MindMed believes its available cash will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.
    Net Cash in Operating Activities. The net cash used in operating activities was $12.9 million for the three months ended March 31, 2022, compared to $10.0 million for the same period in 2021.

    Research and Development (R&D). R&D expenses were $10.2 million for the three months ended March 31, 2022, compared to $6.8 million for the same period in 2021. The increase of $3.4 million was primarily due to $4.4 million of internal expenses related to compensation costs for additional headcount of $2.0 million and an increase in non-cash expenses of $1.7 million of stock-based compensation expenses. This increase was offset by a decrease in external spending of $0.8 million related to our preclinical and other programs.

    General and Administrative (G&A). G&A expenses were $8.3 million for the three months ended March 31, 2022, compared to $7.0 million for the same period in 2021. The increase of $1.2 million was primarily due to an increase of $0.9 million in non-cash stock-based compensation expenses. Other contributors to the increase included higher professional service expenses including accounting, audit, legal, compliance, director and officer insurance, and investor and public relations and personnel costs to support the growth of the company.
    Net Loss. The net and comprehensive loss for the three months ended March 31, 2022, was $18.5 million, compared to $13.8 million for the same period in 2021.

    https://mindmed.co/news/press-relea...22-financial-results-and-business-highlights/
     
  19. Twiggs462

    Twiggs462 Member

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    MindMed believes its available cash will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.
     
  20. Twiggs462

    Twiggs462 Member

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