MindMed March 8, 2023 1:30 p.m. ET TD Cowen Health Care Conference https://wsw.com/webcast/cowen132/mnmd/2007768
(Video) Oppenheimer 33rd Annual Healthcare Conference March 13, 2023 2:00 p.m. ET https://wsw.com/webcast/oppenheimer27/mnmd/2776508 All you have to do is register and it will bring you to the video.
(Video) MindMed - 35th Annual Roth Conference March 13, 2023 2:30 p.m. PT Moderator: Jonathan Aschoff, Ph,D, ROTH MKM https://wsw.com/webcast/roth46/mnmd/1828180
MindMed – executive interview with Dan Karlin, CMO https://www.edisongroup.com/edison-tv/mindmed-executive-interview-with-dan-karlin-cmo/32146/ MindMed is a clinical-stage US biopharmaceutical company aiming to leverage psychedelic medicines to target life-debilitating mental health conditions such as anxiety, ADHD and autism. Its most advanced clinical programmes are investigating the use of LSD D-tartrate (MM-120) for treating generalised anxiety disorder (GAD) and attention-deficit hyperactivity disorder (ADHD). The Phase IIb GAD trial is a randomised dose-finding study that will recruit up to 200 patients and is expected to deliver top-line results in H223. The Phase IIa proof-of-concept study in ADHD will assess the safety and efficacy of low-dose MM-120 as treatment for ADHD in adults, with readouts anticipated in H223. Additionally, the company will initiate a Phase I study in 2023 investigating R-MDMA for treating autism spectrum disorder. MindMed is also looking to use digital platforms to provide scalable, accessible and safe psychedelic treatment solutions to patients, overcoming the resourcing constraints faced by healthcare providers and promoting adoption. In this video, Daniel Karlin, MindMed’s Chief Medical Officer, provides background on the clinical investigation of psychedelics in psychiatric disorders and the company’s developmental pipeline.
MindMed Appoints Mark R. Sullivan as Chief Legal Officer and Corporate Secretary April 13, 2023 07:00 AM Eastern Daylight Time https://www.businesswire.com/news/h...s-Chief-Legal-Officer-and-Corporate-Secretary NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the appointment of Mark R. Sullivan, effective today, as Chief Legal Officer and Corporate Secretary. “This is an exciting time to be joining the Company at this pivotal juncture as it advances towards several key inflection points for its pipeline” Tweet this “We are very excited to welcome Mark to our management team. Mark brings tremendous legal and public company life sciences expertise and will be a strong addition to our executive team. We believe Mark’s experience, insights and guidance will prove invaluable as MindMed progresses to the next stage of its evolution. I look forward to working closely with Mark during this transformative time for the company,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “This is an exciting time to be joining the Company at this pivotal juncture as it advances towards several key inflection points for its pipeline,” said Mr. Sullivan. “I look forward to working with the MindMed management team as the Company continues advancing its clinical programs and pursues commercial capabilities to fulfill its mission of improving the lives of the millions of individuals suffering from brain health disorders.” Mr. Sullivan is an experienced public company General Counsel and Corporate Secretary, with extensive expertise and demonstrated success in the areas of SEC reporting, financing, corporate governance and compliance, mergers and acquisitions, intellectual property, litigation management and business development. Prior to joining the Company, Mr. Sullivan was the General Counsel and Corporate Secretary of Sesen Bio, a biopharmaceutical company (prior to its merger with Carisma Therapeutics) (NASDAQ: CARM), from August 2019 to April 2023. Before that, he served as a private consultant to numerous life sciences companies. Previously, he served as the General Counsel, Chief Compliance Officer and Secretary of MModal Inc. (Nasdaq: MODL), formerly MedQuist, Inc., a leading healthcare IT company, until it was taken private by One Equity Partners, the private investment arm of JP Morgan Chase & Co. Prior to joining MModal, Mr. Sullivan was in private practice with Pepper Hamilton LLP and Drinker Biddle & Reath LLP. Mr. Sullivan received a B.A. from the University of Pennsylvania and a J.D. from the Rutgers University School of Law. About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. 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 includes, but is not limited to, statements regarding anticipated upcoming milestones, trials and studies, results and timing of clinical trials. 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 in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. Contacts For Media & Investor Inquiries, please contact: Maxim Jacobs, CFA Vice President, Investor Relations and Corporate Communications Mind Medicine (MindMed) Inc. [email protected] [email protected]
New study: My Experiences: Leveraging Digital Technologies to Better Understand Mental Health MindMed listed as collaborator. Sponsored by 4YouandMe https://clinicaltrials.gov/ct2/show/NCT05753605 Brief Summary: Mental health disorders are one of the most challenging chronic conditions to identify, treat and manage. This is largely due to the fact that diagnoses are almost entirely based on the patient's recall of current and past subjective experiences of symptoms; and then further interpreted by a healthcare professional introducing multiple layers of information biases in the formulation of a diagnosis. Accordingly, mental health conditions remain prevalent with high rates of misdiagnosis, inappropriate treatment and delayed intervention. In light of the heterogeneity across and within mental health conditions, a personalized interventional approach holds merit, yet the tools to effectively track an individual's day to day objective and subjective experience needed to achieve an individualized care approach have not until recently existed. Digital technologies such as passive and active sensing from smartphones and from wearable devices are shedding light on the capabilities of tracking new objective measures of health that could translate to key symptoms of mental health conditions. 'Multimodal data' approaches are those that attempt to translate a variety of electrical signals from digital devices to relevant health outcomes. The combination of digital devices to detect multimodal measures of mental health symptoms offers a unique opportunity to take a ground up approach in understanding the fluidity of mental health symptoms occurring at the individual level that might lend insight into new phenotypes of mental health illnesses that could have a physiological underpinning. The Study Investigators aim to characterize the multiplexing and fluid nature of mental health symptoms across individuals experiencing mental health symptoms and conditions using digital tools (i.e., wearables and mobile apps) and additional context information collected from virtual study support calls. The Investigators hope to know how objective measures from sensor data translate to core symptoms, episodes and flares across mental health disorders, and develop new (or new applications of) machine learning anomaly detection approaches and determine whether anomalies in expected symptom portraits can be reliably detected and enhanced by the addition of objectively measured data.
MindMed Collaborators Announce Positive Topline Data from Phase 2 Trial of Lysergide (LSD) in Major Depressive Disorder (MDD) https://www.businesswire.com/news/h...ysergide-LSD-in-Major-Depressive-Disorder-MDD – Primary endpoint achieved statistically significant improvement in MDD symptoms – – Confirmation of activity of lysergide in brain health disorders with direct relevance to MindMed’s MM-120 program in Generalized Anxiety Disorder (GAD) – – Data presented on April 14, 2023 in Basel, Switzerland – NEW YORK, April 14, 2023 — 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, announced today that Prof. Matthias Liechti and Dr. Felix Mueller, MindMed collaborators at University Hospital Basel (UHB) and the University Hospital of Psychiatry, have released positive topline data from a double-blind, investigator-initiated trial evaluating lysergide in the treatment of MDD. These findings were presented on April 14, 2023 in Basel, Switzerland. The topline data demonstrated significant, rapid, durable and beneficial effects of lysergide and its potential to mitigate symptoms of MDD. The high dose lysergide regimen in which patients received 100 µg at their first dosing day and 200 µg at their second dosing day (separated by four weeks) resulted in statistically and clinically significant improvements on the primary endpoint, which was the change in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores 6 weeks after the first administration as compared to control (whether or not the patient received a second administration). The control group in this study received a lower dose regimen of 25 µg on both treatment days. Patients in the high dose arm (n=28) demonstrated a least square mean change from baseline in IDS-C scores of -12.9 points compared to -3.6 points in the lower dose arm (n=27, p=0.02). The statistically significant benefit as measured by IDS-C was maintained up to 16 weeks after the first administration compared to placebo (p=0.008). Data from the secondary endpoints were also encouraging. The investigational drug was generally well-tolerated, as indicated by reported adverse events, changes in vital signs and laboratory values. “We continue to be encouraged by the positive results being generated on the clinical activity of lysergide by our collaborators at UHB,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “The statistically and clinically significant improvements observed in this study reinforce preliminary findings that have shown the clinical potential of lysergide in anxiety, depression and other brain health disorders. These positive findings are particularly relevant to our MM-120 program in generalized anxiety disorder, given the high degree of comorbidity of GAD and MDD. I would like to congratulate and thank our collaborators at UHB for once again generating high quality clinical data that continue to support the progression of our pipeline.” Prof. Matthias Liechti, co-primary investigator of the trial, commented, “Historical studies of lysergide in MDD demonstrated rapid, robust and sustained improvement in depressive symptoms. We also observed improvement in depressive symptoms in patients with anxiety disorders in another of our recently published trials. We believed it was necessary to confirm the historical studies with ones using modern methods. Hence, we designed this randomized-controlled trial to assess the benefits of lysergide treatment in MDD. Importantly, an active small dose of lysergide was used as the control. We are extremely encouraged by the results we presented today, which demonstrate the strong, rapid and enduring improvements of this compound in patients suffering from MDD. We look forward to publishing the completed results in a peer-reviewed journal along with additional analyses. Our lab will continue investigating the therapeutic potential of lysergide and other psychedelics.” About the Phase 2 Investigator-Initiated Clinical Trial The investigator-initiated clinical trial was a double-blind, active-controlled, Phase 2 trial that investigated the safety and efficacy of lysergide for treating 61 patients with MDD. Patients allocated to the treatment intervention received 100 μg of lysergide on the first dosing day and 200 μg on the second dosing day, with dosing days separated by approximately 4 weeks. Patients allocated to the active control intervention received 25 μg of lysergide on the first dosing day and 25 μg of lysergide on the second dosing day. The primary efficacy endpoint was improvement in MDD symptoms six weeks after the first administration (2 weeks after the second administration), as measured by the clinician-rated Inventory of Depressive Symptomatology (IDS-C). Secondary outcome measures included improvements in the self-rated version of the Inventory of Depressive Symptomatology (IDS-SR), Beck Depression Index (BDI), State-trait anxiety inventory (STAI-G)) along with other psychiatric symptom assessments. Patients were followed for up to 16 weeks following the first dosing session. For additional information on this trial, see clinicaltrials.gov [NCT03866252]. MindMed supports the UHB Liechti Lab in conducting investigator-initiated trials for lysergide and other novel therapies and has exclusive access and rights to the data generated by these studies.
LSD to treat severe anxiety? Cleveland Clinic at forefront of psychedelic research https://www.cleveland.com/metro/202...nic-at-forefront-of-psychedelic-research.html Published: Apr. 15, 2023, 5:30 a.m. LSD study Cleveland Clinic Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic – Lutheran Hospital, adjusts a monitor in the room where participants in an LSD study will receive doses of the drug, or a placebo. LSD may be able to help the large numbers of American adults diagnosed with a mental health disorder. Julie E Washington, cleveland.com Julie Washington, cleveland.com CLEVELAND, Ohio — The Cleveland Clinic is in the vanguard of a new era of research into psychedelic medicine. The Clinic is the only Ohio site participating in a national study looking at whether LSD, administered in a controlled setting, can help people with severe anxiety. The disorder is a risk factor for suicide. If the results of the Clinic’s trial and others like it across the country are positive, LSD could be approved as a psychiatric treatment within the next five years, said Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic – Lutheran Hospital. He is running the Clinic’s LSD study, and is co-director of the hospital’s Treatment-Resistant Depression Clinic. “Psychedelics are the most powerful psychoactive drugs that we have,” Barnett said. “We believe that if LSD is used appropriately by trained personnel in a therapeutic setting, it can be extremely beneficial.” Starting this month, study participants will go to Lutheran to receive a single dose of LSD or a placebo, as part of the randomized, placebo-controlled trial, while under observation, Barnett said. They may notice that colors look more intense or that they are able to hear music in more detail than normal. Small doses of LSD loosen up the patient’s consciousness and make them more readily able to discuss unconscious thoughts. Larger doses induce what’s called a mystical experience, during which people feel connected with the universe and as if they have experienced the divine. LSD may be able to help the large numbers of American adults diagnosed with a mental health disorder, said MindMed CEO Robert Barrow. MindMed, which is sponsoring the study at the Clinic and 19 other sites, investigates the therapeutic potential of psychedelic drugs for psychiatry, addiction, pain and neurology. Psychedelic drugs have the unique ability to show clinical benefits quickly while also maintaining those benefits for up to a year after only a few doses, Barrow said. “In a field that has seen little meaningful innovation in decades, this represents a potential revolution in the treatment landscape for the many patients suffering from conditions like generalized anxiety disorder,” Barrow said. Those interested in joining the study can follow this link. Discovered in 1943, LSD — or lysergic acid diethylamide — was the subject of numerous scientific studies into its psychiatric use during the 1950s and 1960s. But its association with drug culture, and eventual criminalization, slowed its use in research. “That history included over 20 studies in hundreds of patients with anxiety, depression and other neurotic illness, with consistent remarkable treatment responses,” MindMed’s Barrow said. “Fortunately, we have seen a resurgence of research with LSD and the psychedelic drug class over the past several years, and this modern research has confirmed those earlier findings,” Barrow said. The Cleveland study is among one of the first industry-sponsored trials involving LSD in about 50 years, the Clinic’s Barnett said. “There’s really just so much that we don’t know,” Barnett said. “Research has been shut down for so long that we’ve had to start at the beginning. But there are a lot of very positive signs from research decades ago.” Comfortable room guides LSD experience A cozy room — decorated with cushioned chairs, a rug and pillows in soothing blues and taupes — has been set up at Lutheran especially for people taking LSD as part of the trial. Study participants lie on a couch, don eyeshades and listen to a curated music playlist after ingesting LSD or a placebo. It is a double-blinded trial, which means that neither the caregivers nor the patient know who is receiving a drug or a placebo. Participants can get 20 micrograms, 50 micrograms, 100 micrograms, 200 micrograms or a placebo. Some people experience anxiety in the first hour after taking LSD. Facilitators use breathing exercises and guided imagery to help bring them back to a therapeutic response, Barnett said. Study participants currently taking medications such as antidepressants must be willing to taper off those medications over a few weeks as part of the trial, he said. This allows researchers to evaluate the effectiveness of LSD without the assistance of other psychiatric medications. Study participants also need healthy hearts, because psychedelics raise blood pressure and heart rates. Very rarely, psychedelic drugs can unmask bipolar or schizophrenia in patients who have a family history of those disorders, but who have not yet had symptoms. People with family histories of bipolar disorder or schizophrenia are excluded from the study, Barnett said. After receiving LSD or a placebo, study participants stay at Lutheran for at least 12 hours under observation, he said. Patients have nine visits to Lutheran total for the study, including the one-time LSD dosing session. There are six follow-up visits after the dosing session to evaluate the patients’ anxiety. These occur weekly to every four weeks, with the last one occurring 12 to 17 weeks after the dosing session. “We think that LSD will be shown to be able to be safely administered in a supportive setting in a hospital environment,” Barnett said. Clinic LSD study “I think that we're going to see a fundamental shift in the way that psychiatry is practiced over the next five to 10 years, with psychedelics becoming a mainstay of treatment for many patients,” said Dr. Brian Barnett of the Cleveland Clinic. He is running the Clinic’s LSD study investigating the drug as a treatment for severe anxiety.Julie E Washington, cleveland.com LSD: ‘three scary letters’ or beneficial drug? There was a time when LSD was part of normal psychiatric treatment, especially on the East and West coasts, Barnett said. Some LSD studies suggested that it helped patients with alcohol use disorder by helping them achieve a new self-image and willpower, according to a 2015 article published in the Canadian Medical Association Journal. Another study published during this era, suggested that anxiety related to a recent cancer diagnosis decreased in patients who were treated with LSD. But as LSD became linked with 1960s counterculture and drug abuse — although most experts say it is not addictive — the drug was made illegal. “When I was growing up, LSD were probably the three scariest letters in the English language,” the Clinic’s Barnett said. Currently, LSD is classified as a Schedule 1 substance, MindMed’s Barrow said. This means it is considered to have a high potential for abuse and no currently accepted medical use. But attitudes toward LSD are changing. Oregon became the first U.S. state to decriminalize the possession of small amounts of LSD in 2020. MindMed is conducting other trials to test LSD’s safety and effectiveness in treating attention deficit hyperactivity disorder. Other investigators are looking into the use of psilocybin, or magic mushrooms, to treat patients who are in hospice. “The best way to get a drug rescheduled from Schedule 1 is to provide evidence of an accepted medical use,” MindMed’s Barrow said. If LSD is approved for patient use, it would probably be delivered in a clinical setting under supervision, Barrow said. Because LSD is illegal, the Clinic had to meet Drug Enforcement Agency regulations before it could join the study. The drug is stored in a locked refrigerator that’s bolted to the floor, in a room monitored by surveillance cameras. Staff underwent background checks. “It took us more than a year working behind the scenes with the company, the FDA and the Drug Enforcement Agency to get this off the ground,” the Clinic’s Barnett said. These regulations are well intentioned, but they also make psychedelic research hard to do, Barnett said. Advocacy groups are working with Congress to reduce these bureaucratic barriers to further research. “Having to go through months — even years — of paperwork is really what slows down the efforts by companies to bring these drugs to market as medications,” Barnett said. The Clinic began recruiting for the MindMed study in February, with plans to treat its first study participants this month. The hospital system hopes to enroll at least 10 participants in the phase 2 study. The Clinic’s Barnett hopes this study leads to the creation of a larger psychedelic therapy research community in Cleveland. “I think this is a valuable opportunity for the scientific community (in Cleveland) to really catch up and participate in the psychedelic renaissance,” he said. “I think there’s going to be some significant opportunities to develop new treatments that could be potentially life-changing for patients.”
Video - MindMed update on major depressive disorder data: Rob Barrow, CEO https://www.edisongroup.com/edison-...epressive-disorder-data-rob-barrow-ceo/32225/ MindMed is a clinical-stage US biopharmaceutical company aiming to leverage psychedelic medicines to target life-debilitating mental health conditions such as anxiety, ADHD and autism. Its most advanced clinical programmes are investigating the use of LSD D-tartrate (MM-120) for treating generalised anxiety disorder (GAD) and attention-deficit hyperactivity disorder (ADHD). The Phase IIb GAD trial is a randomised dose-finding study that will recruit up to 200 patients and is expected to deliver top-line results in H223. The Phase IIa proof-of-concept study in ADHD will assess the safety and efficacy of low-dose MM-120 as treatment for ADHD in adults, with readouts anticipated in H223. Additionally, the company will initiate a Phase I study in 2023 investigating R-MDMA for treating autism spectrum disorder. MindMed is also looking to use digital platforms to provide scalable, accessible and safe psychedelic treatment solutions to patients, overcoming resourcing constraints faced by healthcare providers and promoting adoption.
MindMed CEO Explains New Vision For Company - TDR Exclusive Is MindMed, the pioneer in psychedelic medicine, still the leading company in the space? In our latest TDR Psychedelic Exclusive we sit down with MindMed (NEO: MMED) CEO Robert Barrow to discuss the changes within the company since the stock split and if the company should still be considered one of the industry leaders. With over $160M in cash right now, Barrow explains the latest results of their Phase 2 trial and when investors can anticipate the readouts from it. He also provides a comparison of their IP versus traditional LSD, and what exactly they're looking to accomplish with their latest trial involving MM-120. MindMed trades publicly on the NEO exchange under the ticker symbol NEO: MMED. They went public back in 2020 and featured notable names within the company that included former CEO JR Rahn, along with ABC Shark Tank Host Kevin O’Leary, and founder and former CEO at Canopy Growth Bruce Linton. Timestamps: 0:00 - 1:36 How CEO Got Started In Industry 1:37 - 3:55 What’s Changed About Mindmed? 3:56 - 5:20 Feedback Since Changes Have Been Made 5:21 - 8:48 Latest Phase 2 Results 8:49 - 10:05 AA Founder Tried LSD 10:06 - 12:25 MindMed IP Versus LSD 12:26 - 13:58 Timeline On Readouts 13:59 - 15:33 Forward Thinking Statement For Investors 15:34 - 17:21 How Commercialization Will Work 17:22 - 18:07 Will Insurance Eventually Cover 18:08 - 20:24 How Mental Health Landscape Will Change 20:25 - 22:50 Co-Founder & Former CMO A Distraction 22:51 - 23:41 BioTech Industry Has Been Hit Hard
MindMed Sends Letter to Shareholders Highlighting Company’s Positive Momentum and Value-Enhancing Strategy https://www.businesswire.com/news/h...ositive-Momentum-and-Value-Enhancing-Strategy Files Definitive Proxy Materials in Connection with June 15, 2023 Annual Meeting Board’s Nominees Possess Essential Pharmaceutical Industry, Capital Allocation and Corporate Governance Experience Needed to Drive Company’s Success at Pivotal Moment – With Two Key Clinical Readouts Expected Later This Year Believes FCM’s Nominees Lack Relevant Experience and are Unqualified to Serve as MindMed Directors – Let Alone Take Control of the Company Urges Shareholders to Protect Their Investment and Vote on the WHITE Proxy Card for ALL Six of the Board’s Nominees May 02, 2023 08:00 AM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--The Board of Directors (the “Board”) of Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today sent a letter to shareholders highlighting the importance of voting at its upcoming 2023 Annual Meeting of Shareholders (the “Annual Meeting”). By voting for the Board’s nominees, shareholders can support the significant progress that has been made under the current Board to achieve MindMed’s mission to deliver on the therapeutic potential of psychedelics and other novel candidates to address the significant unmet need in brain health disorders. The Company also announced that it has filed its definitive proxy statement and WHITE proxy card with the U.S. Securities and Exchange Commission (“SEC”) in connection with its upcoming Annual Meeting to be held on June 15, 2023. The Company has launched www.ProtectMindMed.com to keep shareholders up to date on key developments leading up to the Annual Meeting. The full text of the Board’s letter to shareholders, which can be viewed and downloaded here, follows: May 2, 2023 Dear Fellow Shareholders, Thank you for your investment in MindMed. Your vote at the Company’s 2023 Annual General Meeting of Shareholders, scheduled for June 15, 2023, is critically important this year. Voting is now open, and we are asking you to elect the directors you believe are best qualified to lead the Company through a pivotal period in our lifecycle, as we progress key Phase 2 trials in MM-120 and initiate our first sponsored clinical trial of MM-402. Our mission is to deliver on the therapeutic potential of psychedelics and other novel candidates to address the significant unmet need in brain health disorders. We have overseen tremendous progress toward this goal, and your current Board and management team are creating a foundation for the Company that will generate sustainable value for all shareholders. Your support of the Company’s highly qualified director candidates is essential to ensure this progress continues. FCM MM Holdings, LLC (“FCM”), an entity affiliated with Jake Freeman, Scott Freeman and Chad Boulanger, has nominated four director candidates who we believe are unqualified to serve on your Board. FCM is waging a proxy contest to take control of the Company despite only owning a small percentage of our outstanding shares and failing to provide any realistic strategic plan for MindMed. We believe that allowing FCM to harm the Company’s current strategy and management team – who have been successfully executing our plan under your Board’s oversight – would put your investment at risk. We strongly urge you to protect your investment by voting today on the WHITE proxy card FOR the election of the Board’s highly qualified nominees – Chief Executive Officer Robert Barrow, Dr. Suzanne Bruhn, Dr. Roger Crystal, Andreas Krebs, Chair Carol A. Vallone, and new candidate David W. Gryska, a 35-year industry veteran who has served as Chief Financial Officer of two S&P 500 pharmaceutical companies – and WITHHOLD on FCM’s inferior nominees. YOUR BOARD IS OVERSEEING A WELL-DEFINED PLAN TO CREATE VALUE BY BRINGING IMPORTANT NEW TREATMENTS TO PATIENTS – WE URGE YOU TO STAY THE COURSE AT THIS CRITICAL MOMENT Since Robert Barrow took on the role of CEO in mid-2021, we have made decisive and comprehensive changes that are essential to the long-term success of our organization. We have recruited an efficient and execution-oriented team with deep experience in the successful research, development and commercialization of brain health treatments. We have also built an internal organizational infrastructure – which incorporates high standards of compliance and financial controls – to support our operations as a publicly traded pharmaceutical company. These changes have transformed MindMed from a nascent public company with a single product candidate to a high-functioning organization in a position of strength as we enter a critical period for our R&D pipeline. By progressing this strategy to develop our diversified pipeline of clinical programs, we are on track to build a world-class fully integrated pharmaceutical organization to create long-term value for our shareholders. We are also well capitalized, with cash on hand of $142.1 million as of the end of 2022 – sufficient to fund the Company’s operations beyond our key development milestones in 2023 and into the first half of 2025. MindMed is at a pivotal inflection point – with clinical readouts on our two lead product candidates expected this year: Our Phase 2b study of MM-120 for the treatment of Generalized Anxiety Disorder (“GAD”), and Our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in ADHD. We also plan to share preclinical results demonstrating the potential of MM-402 in autism spectrum disorder and to initiate our first sponsored clinical trial of MM-402. Our research with patients and healthcare practitioners in the U.S. and Europe indicates that there is significant demand for a new class of drugs that can offer faster, more effective and longer lasting benefits for patients with GAD. This represents a tremendous potential addressable market for our therapies. We have also pursued a robust strategy to maximize and protect the value of our intellectual property: our patent portfolio includes 26 pending U.S. applications and 12 pending Patent Cooperation Treaty applications. These include applications covering compositions, dosing, dosage formulations and methods of treatment, among others, with projected expiration dates beginning in 2041. Our current management team and R&D leaders – all of whom have been hired since Scott Freeman left the Company – are the inventors of a majority of our pending patents, in particular those that we believe are most significant for market protection of our lead product candidates. MindMed currently owns and retains all clinical data and manufacturing rights for MM-120, and we are aggressively protecting and expanding our intellectual property portfolio. Don’t simply take our word for it – third-party analysts agree that our strategy is working: “We continue to see shares undervaluing the opportunity for a novel mechanism to treat GAD even with conservative assumptions around patent life and market uptake, and look to additional derisking events this year.” – RBC Capital Markets, March 9, 2023 “Despite competition from several emerging psychedelic biotechs, we believe MNMD is a well-capitalized leader poised to disrupt the large, growing mental health market.” – Oppenheimer, August 25, 2022 “We are reiterating our Buy rating and $21 price target on MindMed following the release of clinical data with LSD in major depressive disorder.” – EF Hutton, April 14, 2023 WE HAVE A WORLD CLASS BOARD – WITH EXACTLY THE RIGHT EXPERIENCE – THAT IS PURSUING SHAREHOLDERS’ BEST INTERESTS Our Board’s diverse set of nominees are six highly qualified individuals, five of whom are independent. They collectively possess significant senior executive and public company director experience and have relevant backgrounds and expertise in the areas critical to MindMed’s success: drug development and commercialization; financial management and capital allocation; and corporate governance and compliance. Since June 2021, we have completed a comprehensive and proactive effort to refresh our Board to ensure it has the right mix of experience and expertise to execute on our strategic objectives. In 2021, the Company recruited Carol Vallone (Chair of the Board of Trustees of the #1 hospital for psychiatry among all hospitals nationwide) and Andreas Krebs (former Executive at Wyeth) to join our Board – both of whom are experienced executives with track records for success in business launches to exits, capital raises, extensive leadership and governance experience in pharmaceuticals and healthcare, and strong histories of supporting value-creating organizational growth. In 2022, we added Drs. Roger Crystal and Suzanne Bruhn, who are both accomplished executives and directors of successful pharmaceutical and biotechnology companies, and bring decades of experience in leading clinical research, regulatory strategy, commercialization and partnerships. Our additional nominee for election at this year’s Annual Meeting, David Gryska, will further strengthen our Board. Mr. Gryska is a respected life sciences professional with over 35 years of experience as a senior financial executive, including as Chief Financial Officer of two S&P 500 companies – Incyte (NASDAQ: INCY) and Celgene Corp. He currently serves as a board member at Seagen Inc. (NASDAQ: SGEN), which has agreed to be acquired by Pfizer Inc. (NYSE: PFE) for $43.0 billion, and Forte Biosciences, Inc. (NASDAQ: FBRX). He previously served as a board member of GW Pharmaceuticals plc prior to its acquisition by Jazz Pharmaceuticals (NASDAQ: JAZZ) for $7.2 billion in 2021 and of Aerie Pharmaceuticals prior to its acquisition by Alcon (NYSE: ALC) for $750.0 million in 2022. The Company’s slate of directors represents a 100% refreshment of the Board since Mr. Barrow took on the role of CEO in mid-2021. DO NOT SUPPORT ANY OF FCM’S CANDIDATES – THIS WOULD RISK YOUR INVESTMENT BY POTENTIALLY UNDOING OUR SIGNIFICANT PROGRESS SINCE 2021 FCM has not made a convincing case that any change is needed – let alone the replacement of a majority of the Board. Further, FCM has not put forth a coherent plan for how its nominees would enhance value for MindMed’s shareholders. Consistent with the Board’s commitment to constructive shareholder engagement, members of the Board and management have met with Jake Freeman, Scott Freeman and Chad Boulanger numerous times since August 2022 to evaluate FCM’s perspectives on the Company and its strategic direction. In these discussions it became abundantly clear that FCM does not understand MindMed’s business – which has significantly evolved since Scott Freeman left the Company in 2020 – or the associated regulatory processes. The ideas FCM floated in its August 2022 “Value Enhancement Plan” – which it still embraces – as well as thoughts it has put forth haphazardly on social media, would destroy shareholder value. These proposals reflect a pronounced misunderstanding of FDA drug approval processes, an ignorance of the capital allocation and financing needs of a company at MindMed’s growth stage, and a disregard for what is in the best interests of all shareholders. To highlight two examples: There is no credible basis for FCM’s misplaced claim that MindMed could skip its Phase 2 study for MM-120 and go directly to Phase 3. When pressed by us in meetings, Scott Freeman and FCM’s other representatives could not provide any substantive responses to our questions about their plan to skip Phase 2. FCM appears to lack familiarity with both the complex regulatory regime governing our clinical programs and the basics of the drug development process. Their claims may be relevant to oncology products (the only therapeutic area in which FCM candidates have worked) but are not relevant in the development of treatments for major market psychiatric disorders. FCM’s approach to cost cutting and program investments is misguided and would be highly destructive to the business. FCM’s proposed “slash and burn” approach ignores the key drivers of value for a clinical stage biotech company. The path for MindMed to create shareholder value and benefit patients is to ensure that we have the resources needed to retain top talent and successfully execute on our clinical development plan and go-to-market strategy. Over the past two years, we have attracted one of the top rosters of talent in our sector, and we continue to operate as an efficient and high-functioning team. We take a highly disciplined approach to expenditures: relative to our two largest and closest peers, we spend materially less in absolute terms, with less of that money allocated to SG&A. In an effort to avoid a costly and distracting proxy contest, we have presented FCM with multiple constructive proposals, including offering to place a mutually-agreed upon independent director on the Board. Unfortunately, FCM has rejected all of our attempts to find common ground. FCM’s unprofessional public communications are not indicative of a mature or experienced approach to business. This is not a group that shareholders should want to have any representation on the MindMed Board. FCM’S NOMINEES ARE UNQUALIFIED TO SERVE ON THE BOARD After careful consideration of FCM’s intended nominees, the Board has concluded that they do not – individually or collectively – possess relevant industry background or experience that would be additive, especially in comparison to the Board’s proposed slate of directors. As a result, the Board strongly believes that it is in the best interests of all shareholders to NOT VOTE FOR ANY OF FCM’s CANDIDATES to be elected. None of the FCM nominees has ever served on the board of a public healthcare company or as an executive of a public healthcare company (other than Scott Freeman, who held an executive role for less than a year at MindMed when it was a nascent organization). In fact, the only public company director experience of any of the nominees was at a ~$21 million market cap e-paper display company listed in Canada only. Despite FCM’s overinflated touting of their qualifications, these nominees lack essential experience or expertise in key areas of focus for the Company’s success (see Table 1). Table 1 MINDMED CANDIDATES Significant experience overseeing research, development and commercialization of pharmaceutical products Extensive public company and corporate governance experience in the pharmaceutical / healthcare industry Successfully overseeing the execution of the Company’s strategy to bring brain health treatments to market and build a foundation to deliver shareholder value Deserving of your vote on the WHITE proxy card ✔ ✔ ✔ ✔ FCM CANDIDATES No credible strategic plan for the Company No significant public healthcare company board experience or gender diversity No meaningful experience overseeing the commercialization of pharmaceutical products or successful clinical trials NOT deserving of your vote ✖ ✖ ✖ ✖ *** MindMed’s Board is committed to delivering sustainable long-term value creation for all shareholders. This is a critical period of execution for the Company, and allowing FCM’s inexperienced and unqualified nominees to be elected to the Board – let alone take control of it – would risk substantial and permanent value destruction. We ask that you act to protect your investment by voting FOR ALL of the Board’s recommended nominees, voting WITHHOLD on FCM’s nominees and discarding any proxy materials you receive from FCM. Sincerely, The MindMed Board of Directors VISIT WWW.PROTECTMINDMED.COM FOR MORE INFORMATION Due to new U.S. federal rules requiring us to list FCM’s nominees in addition to the Board’s nominees, your WHITE proxy card this year has more names on it than the six directors to be elected. The inclusion of FCM’s nominees on our WHITE proxy card does NOT mean the Board endorses them Vote TODAY on the WHITE proxy card FOR all six of the Board’s nominees, WITHHOLD on FCM’s nominees, and FOR the other proposals recommended by your Board You can help reject FCM’s efforts to take control of the Board by voting WITHHOLD on FCM’s nominees and discarding any blue proxy cards and materials you may receive from FCM Proxy materials will be distributed by banks, brokers and other nominees in the coming days. Shareholders will receive proxy materials directly via the preferred method, hard copy or email, specific to each shareholder’s account. Shareholders that do not receive proxy materials over the next week, please contact your broker and request the WHITE voting control number or contact Morrow Sodali with questions. If you have any questions, or need assistance voting your shares, please contact the firm assisting us in the solicitation of proxies: Morrow Sodali LLC 509 Madison Avenue, Suite 1206 New York, NY 10022 Banks and Brokers Call: (203) 658-9400 Shareholders Call Toll Free: (800) 662-5200 Email: [email protected] About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
MindMed Announces Enrollment Milestone in Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD) – Over 50% of patients dosed across 20 active clinical sites – – On Track for Topline Results in late 2023 – May 17, 2023 04:01 PM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that the company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for GAD is over 50% enrolled and dosed. The trial plans to enroll up to 200 participants who will receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are expected to be announced in late 2023. "This progress is a testament to the tireless work and dedication of all the individuals executing this study and stands out as one of the fastest recruiting efforts for this class of therapies in development” Tweet this “We are thrilled by the quality and efficiency with which study enrollment has progressed as we approach our expected topline data release later this year. This progress is a testament to the tireless work and dedication of all the individuals executing this study and stands out as one of the fastest recruiting efforts for this class of therapies in development,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We have seen a meaningful acceleration in enrollment over the last few months since our full set of study sites were activated early this year with 25 patients enrolled just in the last 30 days. I would like to thank our team, the study investigators and their staff and the many patients who have helped us achieve this important milestone.” The Phase 2b trial in patients diagnosed with GAD is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial plans to enroll up to 200 participants who will be randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064). https://www.businesswire.com/news/h...of-MM-120-in-Generalized-Anxiety-Disorder-GAD
MindMed Completes Enrollment of Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD) https://www.businesswire.com/news/h...of-MM-120-in-Generalized-Anxiety-Disorder-GAD – 198 participants dosed across 20 clinical sites – – On track for topline results in Q4 2023 – September 12, 2023 07:30 AM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment and dosing in Study MMED008, the Company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for the treatment of GAD. “Completion of enrollment of this study is a significant milestone for MindMed and moves us one step closer to our goal of transforming the treatment of GAD for the millions suffering from the disorder,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Thanks in large part to the enthusiasm we have seen regarding MM-120 among investigators and patients, as well as the strong execution of our team, we were able to enroll almost 200 participants in this trial in just over a year. We anticipate sharing topline results during the fourth quarter of this year.” Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial has enrolled 198 participants who were randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120, or placebo. The primary objective of the study is to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 4. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064). About MindMed MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. 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 includes, but is not limited to, statements regarding anticipated timing and results from the Phase 2b clinical trial of MM-120] and the potential benefits of the Company’s product candidates. 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 in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023 under headings such as “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. Contacts For Media & Investor Inquiries, please contact: Maxim Jacobs, CFA Vice President, Investor Relations and Corporate Communications Mind Medicine (MindMed) Inc. [email protected] [email protected]
Slide Deck Comparisons Presentation URLs Sept 2023 - https://mindmed.co/wp-content/uploads/2023/09/MindMed-Investor-Presentation-September-2023.pdf March 2023 - https://mindmed.co/wp-content/uploads/2023/03/MindMed-Investor-Presentation-March-2023.pdf Differences Page 1 - No Change - except dates Page 2 - No Change Page 3 - March 2023 had a business highlights page, in September 2023 we have now flag-shipped the MM-120 and MM-402 programs Page 4 - We have moved the "There is an Urgent Need for Better Treatments" slide from what was on Page 6 prior up to page 4. ANXIETY figure was removed in favor of the term GAD and the percentage was adjusted from 21% to 10%. Previous figures were pulled from NIMH 2020; Mental Illness where as the new figures are pulled from Mental and Substance Use Disorders Prevalence Study (MDPSU): Findings Report 2023 - Keeping in mind that ANXIETY is different from the term GAD and while the percentage is lower it is now targeted to GAD. Page 5 - Pipeline remains unchanged. Page 6 - "Advancing the Field with Strong IP & Strategic Competitive Moats" slide has remain unchanged Page 7 - "MM-120 - LSD D-tartrate" Title Slide has now changed the "Key Milestones Anticipated" from "GAD Readout - Late 2023 | Phase 2b" and "ADHD Readout - Late 2023 | Phase 2a" to now read "Phase 2b in GAD Topline Data | Q4 2023" and "Phase 2a in ADHD Topline Data | Q4 2023 / Q1 2024" respectively. Page 8 - "Lead Candidate with Evidence Across Multiple Therapeutic Areas" remains unchanged. Page 9 - "Emerging Treatment Paradigm for Brain Health Disorders" remains unchanged. Page 10 - New Slide - "Mechanism of Action Driving Potential Durable Clinical Response" in regards to LSD Page 11 - New Slide - "An Urgent Need for Better Anxiety Treatments" presents general data points on current SSRI issues and why new treatments are needed. Page 12 - "Legacy of LSD Clinical Research in Psychiatric Disorders" - has now updated and split the entry on the the table from "UHB’s LSD-Assist" entry to now include both "HOLZE 2022" which correlated with the UHB entry and also includes "HOLZE 2023" outlining an additional 61 patient study. Page 13 - "Modern Evidence in Anxiety Disorders" title has been updated with the term Modern which was not present in the last version of this slide. Remaining data is unchanged. Page 14 - "Phase 2b Generalized Anxiety Disorder (GAD)" title has been reduced from "MM-120 | Phase 2b Generalized Anxiety Disorder (GAD)" Removing MM-120 from the headline, still present in slide. Page 15 - "Potential MM-120 Clinical Care Model" remains unchanged Page 16 - "Digital Unlocks Potential Opportunities Throughout the Product Lifecycle" has moved up from page 31 on March slide deck. No changes. Could suggest push for digital in these trials. Page 17 - "Potential Pathway to Commercial Success for MM-120" remains unchanged Page 18 - "Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" title has been reduced from "MM-120 | Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" Removing MM-120 from the headline, still present in slide. As the main slide for this area we do have new topics and points related to this study. Page 19 - "Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" timeline slide for study remains unchanged. Page 20 - "MM-402 R(-)-MDMA" Title Slide has now changed the "Key Milestones Anticipated" from "Phase 1 Study Initiation 2023 | Phase 1" to now read "Phase 1 Study Initiation | Q4 202" and "Phase 1 IIT (UHB-Sponsored) Topline Data | H1 2024". Page 21 - New Slide - "Differentiated Mechanism of Action Targets Key Pathways" in regards to R-MDMA Page 22 - "No Approved Drugs for Core Symptoms of Autism Spectrum Disorder (ASD)" remains unchaged Page 23 - "Preclinical Data Indicate Potential Enhanced Benefit/Risk Profile" remains unchanged Page 24 - "Clinical Data Support Opportunity for MDMA in ASD" remains unchanged. Page 25 - Collaborations & Early R&D" Title Slide - remains unchanged. Page 26 - "External Collaborations Aim to Accelerate Discovery & Development" remains unchanged Page 27 - "Exclusive Collaboration with Leading Researchers" remains unchanged. Page 28 - "Our Leadership Team" - Moved to this page from being on page 4 previsouly and has now added Mark Sullivan, JD CLO. All team members have new photos. Page 29 - "Our R&D Leadership Team" no changes other than new photos for all team members. Page 30 - New Slide - "Our Team Has Significant Drug Development Experience" sub tag reads "Our Management and R&D team’s relevant experience overseeing the approval of drug candidates positions MindMed for success" with both CNS and Other drug products listed. Quite attractive to say the least Page 31 - "Business Highlights" changes to the last 3 points. Expected cash runway into 2026 ($116.9 million and committed credit facility are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital.) LSD and MDMA study timeline terminology updated. Page 32 - Last Slide - Logo - Remains unchanged Slides Removed: Slides related to Digital "Digital to Complement Drug Delivery Through the Patient Journey", "Digital Enables Alignment of Incentives for Broad Market Access", "Digital Pipeline Progression Aligns with Drug Development" and Slides related to MM-110 have been removed. I don't believe this is for any other reason that to concentrate fully on the studies, digital was mentioned in Page 16. That is all that is needed. MM-110 is mentioned on pipeline page with same sub note as previous.
PSYCHEDELIC MEDICINES MedNous September 2023 This article was written by Dr Daniel Karlin, Chief Medical Officer, and Robert Barrow, Chief Executive Officer, of Mind Medicine Inc. https://media.licdn.com/dms/documen...t=YgrXR5aCvgwIcIvK9BDa1LU0PSJT7l4m7d1dCEiE-aE Commentary: FDA guides industry on psychedelic drugs In June 2023, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published its first draft guidance on drug development for the class of drugs known as psychedelics. The agency intends for this guidance to "help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.” Naturally occurring psychedelics have a long history of use in indigenous communities. More broad interest in the class began with the discovery of synthetic psychedelic molecules in the 1930s, which were widely studied for their therapeutic potential during the mid-20th century, yielding promising preliminary results. However, due to a multitude of non- scientific factors, research into their therapeutic potential became increasingly difficult after much of the class was classified as illegal controlled substances, with no currently accepted medical use and a high potential for abuse. This nearly worldwide classification made it extremely difficult for researchers to obtain funding and conduct further studies of psychedelics. Most research was abruptly halted in the 1970s. Despite these obstacles, the past decade has seen a renaissance in research of psychedelics. Beginning in the mid-2010s, a series of groundbreaking studies that confirmed the promising findings from legacy studies led to renewed research interest in the drug class and the potential to treat a wide range of brain health disorders – including, in particular, strong and durable effects in anxiety and depression among other disorders. Public acceptance of psychedelic therapies by healthcare providers and potential patients is crucial for widespread adoption and access to these treatments. By aligning with the FDA's guidelines, researchers and companies gain credibility, increasing the chances of acceptance by the medical community and the general public. FDA has long taken a forward-thinking, leadership position in facilitating rigorous research methodologies and regulatory pathways for this promising drug class, and this guidance further clarifies the programme and study-level methodological considerations that need to be addressed in order to ultimately obtain marketing authorisation for drugs of the class. These considerations are especially relevant with the psychedelic drug class, which must contend with unique challenges and opportunities given the paradigm-shifting delivery models and implications for clinical research. The FDA plays a pivotal role in regulating drug development and facilitates the efficient advancement of novel research by proactively guiding sponsors and researchers on the key considerations that could drive regulatory action in the future. With this drug class-specific guidance, the FDA has taken a significant step forward in clarifying the regulatory and R&D expectations in our field. The new guidelines provide a framework for conducting adequate, well-controlled, scientifically rigorous trials that can assess the safety and effectiveness of the drug class. While addressing unique aspects of developing psychedelics, the guidance also reinforces fundamental principles that are key to developing any new psychiatric therapy. With regard to the guidelines themselves, biopharma veterans will find the FDA’s thinking on these issues to be in line with prevailing best practices for just about any other typical pharmaceutical product, especially in the world of central nervous system (CNS) and neuropsychiatric treatments. As stated in the document, “the substantial evidence standard for establishing effectiveness of psychedelic drugs is the same as it is for all other drugs.” While some of the topics covered in the guidance may appear to be unique to the psychedelic drug class, we note that the vast majority are common to research of all CNS-active pharmacotherapies but may be simply more pronounced for psychedelics. For instance, the guidance highlights the issue of functional unblinding, a topic that is particularly relevant given the likely obvious, profound nature of the acute perceptual disturbances resulting from the administration of psychedelics. While this topic may be particularly pronounced for psychedelics, it is not unique. Many drugs – and virtually all of the approved CNS agents that are controlled substances – suffer from potential functional unblinding due either to the directly observable pharmacodynamic effects (e.g. dissociative effects of NMDA antagonists) or indirectly due to high incidence adverse events. The guidance offers well-reasoned steps that sponsors can take to mitigate these potential biases, such as using video or central raters to make assessments as objective as possible. Most advanced sponsors including our company MindMed, have already implemented such steps to mitigate these potential biases and enhance the internal and external validity of clinical trials. The draft guidance also considers the respective roles of psychotherapy and non-therapy session monitors in clinical trials. These topics remain some of the most widely debated among practitioners and supporters, warranting careful deliberation in pursuing effective guidance for drug sponsors. While the guidance provides specific expectations of the qualifications of session monitors, it also rightly highlights the complications introduced with concurrent psychotherapy. Additionally, we note that as with most clinical research studies, the strict research protocols mandated by the FDA and sponsors are likely to be overly restrictive and are rightly intended to maximise the quality and integrity of data that is intended to support claims of safety and effectiveness. We anticipate that future real-world research – assuming these products are approved and marketed – will be critical to set the standards for the practice of medicine and to elucidate treatment protocols that maximise patient benefit. While the guidance leaves room for further clarification and an evolution of thought as additional evidence is generated, the regulatory framework enumerated in this draft guidance provides the greatest clarity of regulatory expectations and R&D considerations to date.
US Patent US-11801256-B2 Antidepressant-psilocybin co-treatment to assist psychotherapy https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11801256
Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299061/ Common antidepressant escitalopram and psilocybin can be taken together safely: study https://mugglehead.com/popular-anti...silocybin-can-be-taken-together-safely-study/
