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Posted On: 12/17/2020 9:08:25 AM
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MUST READ - Mind Medicine Stock Price Increases Over 1,000% Since June: Why It Happened
Everyone should read this to know what they hold... this is not a penny stock play. This is a disruption in the making.
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https://pulse2.com/mind-medicine-mindmed-stoc...ince-june/
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The stock price of Mind Medicine (MindMed) Inc (OTCQB: MMEDF) — a neuro-pharmaceutical company for psychedelic inspired medicines — increased over 1,000% since June as it went from $0.30 per share to $3.34 as of 3:55 PM ET today. There are several reasons why the stock price increased since then.
June 2020
Phase 2a Clinical Trial Of LSD For Microdosing
Back in June, MindMed had announced it was expanding its Phase 2a clinical trial of LSD microdosing for Adult ADHD. And the company announced it will add an additional clinical trial site and Principal Investigator at the University Hospital Basel in Basel, Switzerland , the birthplace of LSD for its Phase 2a clinical trial of LSD microdosing.
MindMed’s microdosing division has been pioneering the clinical development of consuming very low and sub-hallucinogenic doses of psychedelic substances. And the company intends to continue building its microdosing division into a global leader for microdosing psychedelics and expand a diverse R&D pipeline of sub-hallucinogenic doses of psychedelics to treat various mental health issues including Adult ADHD.
Specifically, MindMed is interested in the adult segment for ADHD as it comprises over 46.5% of the total ADHD medication market in the US. And the total U.S. market size for ADHD medications is currently valued at $12.9 billion annually. Of the estimated 10 million American adults that have ADHD, it is projected that only 10.9% actually seek and receive treatment for their condition.
Back then, MindMed Co-Founder & Co-CEO JR Rahn said that the genesis of MindMed came as he was hearing anecdotal evidence from friends in Silicon Valley that microdosing was helping them to get off stimulant based ADHD medications and with other medical ailments.
As part of the Phase 2a multicenter trial, MindMed revealed that the world-leading researcher in psychedelics pharmacology and clinical research Dr. Matthias Liechti would be serving as an additional Principal Investigator on the first ever Phase 2a Proof of Concept clinical trial evaluating LSD for the treatment of Adult ADHD.
MindMed had previously signed a clinical trial agreement with Maastricht University (a leader in microdosing research based in the Netherlands) as part of the same Phase 2a clinical trial. And the world’s top psychedelics microdosing clinical researcher Maastricht University Associate Professor Dr. Kim Kuypers would be serving as a Principal Investigator for the trial — which is scheduled to begin both in the Netherlands and Switzerland by the end of 2020.
Project Lucy
In June, MindMed also announced it launched Project Lucy — which is a commercial drug development program for the treatment of anxiety disorders. And the company said that it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of LSD, administered by a therapist. And this is the first experiential, psychedelic-assisted therapy to be added to the company’s drug development pipeline.
With the launch of Project Lucy, MindMed started preparing a total of three Phase 2 commercial drug trials based on psychedelic inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.
At the time, MindMed Co-Founders and Co-CEOs JR Rahn and Stephen Hurst said that this announcement demonstrated the company’s strong capabilities to efficiently execute on our vision of building a synergistic platform that can take an idea and turn it into a later stage clinical trial with the sense of urgency investors expect and patients deserve.
Previously, MindMed had acquired exclusive worldwide data rights to eight completed or ongoing clinical trials from the University Hospital Basel evaluating LSD based on over 10 years of research. And MindMed started planning to assemble and use this data as part of its briefing package to the FDA.
Phase 2 Clinical Trial Of LSD For “Suicide Headaches” Starts Treating Patients
Mind Medicine (MindMed) also announced it was supporting and collaborating on Phase 2 clinical trial evaluating LSD for the treatment of cluster headaches at University Hospital Basel’s Liechti Lab. The Phase 2 trial started recruiting patients in early January and has commenced treating patients with LSD.
Cluster headaches (also known as “suicide headaches”) due to the severity of the pain caused are often viewed as one of the most profoundly painful conditions. And the pain occurs on one side of the head or above an eye and can last for weeks or months. Studies have demonstrated increased suicidality associated with patients experiencing cluster headache attacks.
There is non-clinical and anecdotal evidence that suggests LSD can abort attacks and decrease the frequency and intensity of the attacks. And there is a need for new treatment approaches for cluster headaches as current available medications often mismanage cluster attack periods.
The Phase 2 trial is investigating the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in 30 patients who are suffering from Cluster Headaches compared with placebo. And the study is a double-blind, randomized, placebo-controlled two-phase cross-over study design.
MindMed’s collaboration will assess if there is clinical evidence for a future commercial drug trial through the FDA pathway. And treatments for cluster headaches may potentially qualify for an Orphan Drug Designation and be eligible for certain development incentives provided by the FDA for rare diseases.
Liechti Lab and MindMed are intending to learn how they can make the administration of LSD more targeted for cluster headache patients through this Phase 2 trial and future clinical trials. And as part of the collaboration with UHB Liechti Lab, MindMed gains exclusive, global use to all data and IP generated in the Phase 2 trial of LSD for cluster headaches.
Evaluation Of Ayahuasca’s Active Ingredient DMT In Phase 1 Clinical Trial Collaboration
In June, MindMed had announced a Phase 1 Trial to experiment with dosing methods to better understand how humans react to DMT, which sets the stage for future potential Phase 2a proof of concept trials. And MindMed started pursuing N,N-Dimethyltryptamine (DMT), the principally active ingredient in Ayahuasca as part of its R&D collaboration with the University Hospital Basel’s Liechti Lab.
MindMed was providing startup funding for a Phase 1 clinical trial testing various intravenous dosing regimens of DMT, expected to begin in Q4 of 2020. And DMT is a naturally-occurring psychedelic substance and is the active ingredient used in Ayahuasca ceremonies by indigenous Amazonian shamanic practitioners.
DMT causes a rapid onset and offset of action compared to similar psychedelic substances such as psilocybin or LSD. And when administered as an Ayahuasca brew, natural substances are mixed with DMT to prolong its experiential effects and slow the metabolism in the human body.
July 2020
Dosing 18-MC Phase 1 Study Completed
Towards the end of July, MindMed said it has concluded dosing in a Phase 1 Single Ascending Dose (SAD) study of 18-MC. And the dosing of 18-MC was well tolerated in humans and will help advance planning for a Phase 2a clinical trial in opioid addiction. This study has not incurred any delays due to the COVID-19 pandemic and the Multiple Ascending Dose (MAD) study is on track according to the original development timeline.
18-MC is known as a non-hallucinogenic molecule based on the psychedelic substance ibogaine. And the study tested doses ranging from 4mg to 16mg twice a day and all participants were evaluated for pharmacokinetics and safety.
MindMed’s addiction treatment unit is currently focused on developing novel medicines that are inspired by psychedelics for addiction to address the growing opioid crisis in both Canada and the US. And the US opioid crisis is estimated to cost the US economy over $500 billion annually.
And MindMed said it was planning to begin the Phase 2a study of 18-MC in opioid addiction by the end of this year.
August 2020
Dr. Peter Gasser Joins As Clinical Advisor For Project Lucy
Mind Medicine (MindMed) announced in August that it has engaged renowned psychedelic assisted therapy expert Dr. Peter Gasser as an advisor to its LSD experiential therapy program Project Lucy. Dr. Gasser is known for pioneering the legal and medical use of psychedelics through clinical research and compassionate access in Switzerland.
Dr. Gasser has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. And through compassionate access in Switzerland, Dr. Gasser holds several individual treatment permissions to treat patients with MDMA and LSD.
Dr. Gasser and University Hospital Basel’s Dr. Matthias Liechti are conducting a Phase 2 trial of LSD-assisted therapy for anxiety disorders. And MindMed previously acquired the exclusive license to this ongoing Phase 2 trial through its collaboration agreement with the University Hospital Basel.
“Dr. Gasser is one of the leading global experts on psychedelic-assisted therapy and it’s an honor for us to work together as we build Project Lucy into a world-class commercial drug development program,” said Rahn. “Dr Gasser’s vast experience and history treating patients as a therapist through compassionate access in Switzerland also interests the company and will have tremendous benefits to our patients.”
Dr. Gasser had helped pioneer compassionate access for end of life psychedelic assisted therapy in Switzerland. And around that time, the Canadian health minister approved compassionate access of psilocybin assisted therapy for terminally ill patients.
R&D Expansion In Europe; Dr. Miri Halperin Wernli Appointed As As President
Mind Medicine said in August is expanding its presence in Europe. And the leading neuro-pharmaceutical company for psychedelic inspired medicines will open an operating subsidiary in Switzerland that will oversee clinical development, scientific collaborations, and the expansion of MindMed’s business in Europe.
And as part of the ramp-up and planning process for its growing global pipeline of clinical programs of psychedelic inspired medicines, MindMed’s board of directors had appointed Dr. Miri Halperin Wernli as President to help guide MindMed’s clinical development strategy and provide further leadership to its R&D pipeline.
Dr. Wernli was tasked with expanding the clinical and scientific team in Europe. And her immediate primary leadership responsibilities center around the company’s LSD microdosing program and Project Lucy, which is the LSD experiential therapy program for anxiety disorders. Dr. Halperin Wernli will also help implement R&D collaborations in Europe which include the company’s partnership with the University Hospital Basel’s Liechti Lab.
Dr. Wernli is a senior pharmaceutical and biomedical executive with over 30 years of strategic and operational leadership in the biopharmaceutical industry and a deep understanding of drug and product development in heavily regulated environments. And Dr. Wernli has held worldwide senior leadership positions in product development, R&D and Strategic Marketing throughout Switzerland and in the United States at leading pharmaceutical companies including Merck, Sharp & Dohme, Roche, and Actelion Pharmaceuticals. And Dr. Wernli had previously co-founded and led Creso Pharma, an Australian listed medical cannabis company with operations in Europe and Canada.
Q2 2020 Financial Results
On August 20, 2020, Mind Medicine had reported its Q2 2020 financial results. The company announced total assets on June 30, 2020, were $29.8 million including $24 million in cash — which will be used primarily for executing the company’s multiple clinical trials. And the company reported that the net and comprehensive loss of $5.8 million for the three months ended June 30, 2020.
First-Ever Clinical Trial Combining MDMA And LSD
At the end of August, Mind Medicine said that it was collaborating with the University Hospital Basel’s Liechti Lab to combine MDMA and LSD in a groundbreaking Phase 1 clinical trial. And the Phase 1 MDMA-LSD trial was scheduled to start in Q4 of this year in Basel, Switzerland.
The combined MDMA-LSD treatments have the potential to create next-generation psychedelic assisted therapy paradigms. And when added to a psychedelic assisted therapy session, MDMA has the potential to reduce some known rare negative side effects that may occur while using LSD or other classic psychedelics on their own. Plus it has been shown that classic psychedelics such as psilocybin and LSD can sometimes induce short-term unpleasant effects for patients during a psychedelic assisted therapy session. These symptoms often include negative thoughts, rumination, panic and paranoia.
MDMA (an empathogen) is known to acutely induce feelings of increased well-being and trust. And by combining LSD and MDMA within the same session, the Liechti Lab and MindMed are evaluating if the combination produces greater overall positive acute effects when compared to LSD or MDMA on their own. MDMA may reduce some of the negative mood effects of LSD and make the patient more comfortable during psychedelic-assisted therapy.
“The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD. Inducing an overall primarily positive acute response during psychedelic assisted therapy is critical because several studies showed that a more positive acute experience is linked to a greater therapeutic long-term effect in patients,” explained Dr. Liechti.
The Phase 1 Clinical Trial is expected to take around one year to complete. And if MindMed finds the results promising, the company may decide to undertake further studies with treatments combining MDMA and LSD, and prepare patient trials for various indications.
September 2020
NASDAQ Up-Listing Application
At the end of September, MindMed said it submitted an application for a NASDAQ up-listing and it appointed Canaccord Genuity as a financial advisor. The listing of MindMed’s shares on NASDAQ would be subject to a number of regulatory requirements, including review of the company and acceptance for listing by NASDAQ. But there are no assurances that NASDAQ acceptance will be granted.
“The psychedelic medicine industry is maturing and expanding rapidly, and we want to grow with it. We look forward to working with Canaccord Genuity to evaluate the opportunity for an up-listing on NASDAQ and help us navigate M&A opportunities now available to the company,” stated Rahn.
Shortly after making this announcement, the hype around Mind Medicine’s stock started to surge. The volume of trades went from hundreds of thousands per day to millions per day in September, which helped drive the price up. Many people started talking about the stock in investor chatrooms on Discord, Facebook Groups, StockTwits, and Twitter.
Mind Medicine had issued a press release at the time about how management was unaware of any material change in MindMed’s operations that would account for the recent increase in market activity. This announcement was issued at the rest of IIROC on behalf of the NEO Exchange.
Comparing Effects Induced By LSD And Psilocybin
In September, Mind Medicine announced that the company has been conducting R&D work on psilocybin in collaboration with the University Hospital Basel’s Liechti Lab in a study to better understand and compare the altered states of consciousness induced by psilocybin and LSD. And MindMed is interested in understanding how psilocybin or LSD affects humans differently so that it can design better later stage trials or potentially even combine substances in future next-generation psychedelic assisted therapies for patients.
As part of MindMed’s exclusive license agreement with the University Hospital Basel, MindMed said it is going to retain an exclusive license to all IP and any patents generated from data or findings in the study and related work on psilocybin like pharmacokinetic data and information on the metabolism. The study is anticipated to finish in Q2 2021.
October 2020
MindMed Partners With NYU Langone Medical Center To Launch A Training Program For Psychedelic Therapies And Medicines
MindMed had announced a funding commitment to found and launch a clinical training program focused on psychedelic assisted therapies and psychedelic inspired medicines at NYU Langone Health. The NYU Langone Health Psychedelic Medicine Research Training Program is considered the first step in a larger initiative to establish a Center for Psychedelic Medicine at NYU Langone Health.
NYU Langone Health and NYU Grossman School of Medicine were early pioneers of clinical research with psychedelic assisted therapies and psychedelic inspired medicines for substance use disorders and other mental illnesses. And through this funding initiative, MindMed aims to catalyze efforts to recruit and train more psychiatrists and clinical investigators to undertake necessary research to develop training tools capable of scaling and optimizing the delivery of psychedelic assisted therapies and psychedelic inspired medicines to millions of patients across the United States.
“MindMed’s funding meets an important need for recruiting more clinical investigators and psychiatrists to the expanding and promising areas of psychedelic assisted therapies and psychedelic inspired medicines, which can help so many people suffering from addiction and other mental illnesses,” noted Charles R. Marmar, M.D., Chair, Department of Psychiatry, NYU Grossman School of Medicine. “NYU Langone Health’s training of the next generation of researchers and psychiatrists will help to advance and hopefully soon deploy this emerging category of medicines including psilocybin-assisted therapy for Alcohol Use Disorder and MindMed’s ibogaine-derived molecule 18-MC for Opioid Use Disorder patients.”
This new endeavor is building upon a longstanding partnership between MindMed’s drug development team and the Department of Psychiatry at NYU Grossman School of Medicine — which have collaborated since 2009 on an ibogaine derived molecule known as 18-MC. And MindMed plans to soon enter a Phase 2 trial with 18-MC for opioid use disorder patients. The NYU Langone Health Psychedelic Medicine Research Training Program will have an initial focus on substance use disorders including opioid addiction and alcoholism.
MindMed is committing $5 million over a 5-year period to the NYU Langone Health Psychedelic Medicine Research Training Program and the future corresponding Center for Psychedelic Medicine at NYU Langone Health. And NYU Langone Health will have full and free discretion in using these funds for the development and conduct of the training program and operations of the Center for Psychedelic Medicine. The launch of the Center for Psychedelic Medicine at NYU Langone Health is still subject to additional funding from other undisclosed partners and parties.
Upsized Financing Closed
In late October, MindMed had announced it closed upsized financing of CAD $28.75 million with strong institutional demand for psychedelic medicines. Post-financing, MindMed now has cash reserves of CAD $50.1m (USD $37.8m) to enable continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.
November 2020
Completion Of Phase 1 Study Measuring Dosing Effects of LSD
MindMed in partnership with University Hospital Basel’s Liechti Lab announced the completion and publication of a Phase 1 study on the acute dose dependent effects of LSD. And the completed Phase 1 study will help MindMed in dose-finding and the planning of future Phase 2 clinical trials of LSD in patients with anxiety disorders and other medical conditions.
Specifically, the Phase 1 study measured LSD dose-dependently induced subjective responses starting at microdoses (25 ug) up to experiential doses (200 ug). And maximal good drug effects were reached at a 100 ug dose. But an experiential dose of 200 ug LSD was shown to induce greater ego dissolution than a lesser 100 ug dose. Ego-dissolution is thought to be one of the key therapeutic potentials of the psychedelic experience and psychedelic assisted therapy process.
MindMed’s team is actively preparing Project Lucy — which intends to evaluate the efficacy of LSD assisted therapy for anxiety disorders in a Phase 2b clinical trial.
And MindMed and University Hospital Basel are filing patent applications on clinical trial data generated through the collaboration’s numerous clinical trials and R&D. MindMed maintains an exclusive license to the data and IP generated through its continued research collaboration and licensing agreement with the Liechti Lab at University Hospital Basel.
The Phase 1 study used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy participants (eight women, eight men) — who underwent six 25 h trial sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of ketanserin (40 mg). LSD showed dose-proportional pharmacokinetics and first-order elimination. And in addition, effects of the high 200 µg dose of LSD were effectively prevented by a pretreatment with the 5-HT2A receptor antagonist ketanserin indicating that psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.
The study was published in Neuropsychopharmacology, which is an international scientific journal and the official publication of the American College of Neuropsychopharmacology (ACNP).
Q3 2020 Financial Results
On November 13, MindMed had announced its third-quarter financial results. The total assets as of September 30, 2020 were $23.7 million, including $18.2 million in cash. And the company reported a net and comprehensive loss of $8.6 million for the three months ended September 30, 2020 and $21.4 million for the 9 months ended September 30, 2020.
On October 30, 2020, Mind Medicine announced the closing of financing for gross proceeds of USD $21.6 million ($28.8 million CAD). And post October financing, the company had cash reserves of USD $37.8 million ($50.1 million CAD) to enable continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.
Approval Of Protocol Design To Evaluate Microdoses
In November, MindMed had received approval of protocol design to evaluate microdoses of LSD for adult ADHD in Phase 2a clinical trial. MindMed has received a positive response on its protocol design for a Phase 2a clinical trial evaluating microdoses of LSD in the treatment of adult ADHD from the Swiss and Dutch health authorities. And MindMed has also successfully submitted a pre-IND briefing package to the FDA for its Project Lucy, a potential Phase 2b Efficacy Trial evaluating LSD Assisted Therapy in anxiety disorders.
The company also reached an agreement with University Hospital Basel Liechti Lab to conduct an interim analysis anticipated in Q1 2021 for its Phase 2a clinical trial of LSD assisted therapy for anxiety disorders currently ongoing in Switzerland. MindMed’s Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities. And MindMed is working with our site coordinators in Switzerland and the Netherlands on our patient recruitment strategy and will provide updates on recruitment progress in due course.
Launch Of Albert, A Digital Medicine Division For Psychedelic Medicines
MindMed had announced it is establishing a digital medicine division known as Albert. And Albert is in the process of assembling and recruiting a leading team of technologists, therapists, and clinical drug development experts to help the company research, develop and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and experiential therapies combined with digital therapeutics.
Digital therapeutics are known as being evidence-based therapeutic interventions for patients to prevent, manage, or treat a mental disorder or disease. And pairing digital tools like wearables and the latest in machine learning with psychedelic assisted therapies can give healthcare providers the ability to optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.
December 2020
Successful Completion Of Pre-IND Meeting With The FDA For Project Lucy
In the middle of December, MindMed announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for an anxiety disorder. And the successful completion of this engagement with the FDA is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. MindMed intends to open the IND with the FDA in August 2021 with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.
“The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021,” Rahn acknowledged.
Preliminary data has been analyzed for MindMed’s addiction treatment program evaluating the ibogaine derivative 18-MC — which the company has named Project Layla. And the preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well tolerated at the doses tested to date, and no Serious Adverse Events (SAEs) have been reported.
Based on the safety profile observed to date, MindMed’s clinical team and 18-MC’s Medical Director Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. And once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.
Upsizing Of Previously Announced Bought Deal Public Offering
On December 15, MindMed had announced it saw an upsizing of its previously announced bought deal public offering. Initially, Mind Medicine announced that a syndicate of underwriters were purchasing on a bought deal basis pursuant to the filing of a short form prospectus an aggregate of 11,364,000 units of the company at a price of C$4.40 per unit for aggregate gross proceeds to the company of C$50,001,600. But then MindMed said it was pleased to announce that it has agreed to increase the size of its previously announced bought deal financing led by Canaccord Genuity (the lead underwriter). Canaccord had agreed to purchase, on a bought deal basis pursuant to the filing of a short form prospectus an aggregate of 18,200,000 units of the company at a price of C$4.40 per unit for aggregate gross proceeds to the company of C$80,080,000.
The net proceeds of the offering will be used for investment in Project Lucy, Albert (the company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.
Everyone should read this to know what they hold... this is not a penny stock play. This is a disruption in the making.
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https://pulse2.com/mind-medicine-mindmed-stoc...ince-june/
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The stock price of Mind Medicine (MindMed) Inc (OTCQB: MMEDF) — a neuro-pharmaceutical company for psychedelic inspired medicines — increased over 1,000% since June as it went from $0.30 per share to $3.34 as of 3:55 PM ET today. There are several reasons why the stock price increased since then.
June 2020
Phase 2a Clinical Trial Of LSD For Microdosing
Back in June, MindMed had announced it was expanding its Phase 2a clinical trial of LSD microdosing for Adult ADHD. And the company announced it will add an additional clinical trial site and Principal Investigator at the University Hospital Basel in Basel, Switzerland , the birthplace of LSD for its Phase 2a clinical trial of LSD microdosing.
MindMed’s microdosing division has been pioneering the clinical development of consuming very low and sub-hallucinogenic doses of psychedelic substances. And the company intends to continue building its microdosing division into a global leader for microdosing psychedelics and expand a diverse R&D pipeline of sub-hallucinogenic doses of psychedelics to treat various mental health issues including Adult ADHD.
Specifically, MindMed is interested in the adult segment for ADHD as it comprises over 46.5% of the total ADHD medication market in the US. And the total U.S. market size for ADHD medications is currently valued at $12.9 billion annually. Of the estimated 10 million American adults that have ADHD, it is projected that only 10.9% actually seek and receive treatment for their condition.
Back then, MindMed Co-Founder & Co-CEO JR Rahn said that the genesis of MindMed came as he was hearing anecdotal evidence from friends in Silicon Valley that microdosing was helping them to get off stimulant based ADHD medications and with other medical ailments.
As part of the Phase 2a multicenter trial, MindMed revealed that the world-leading researcher in psychedelics pharmacology and clinical research Dr. Matthias Liechti would be serving as an additional Principal Investigator on the first ever Phase 2a Proof of Concept clinical trial evaluating LSD for the treatment of Adult ADHD.
MindMed had previously signed a clinical trial agreement with Maastricht University (a leader in microdosing research based in the Netherlands) as part of the same Phase 2a clinical trial. And the world’s top psychedelics microdosing clinical researcher Maastricht University Associate Professor Dr. Kim Kuypers would be serving as a Principal Investigator for the trial — which is scheduled to begin both in the Netherlands and Switzerland by the end of 2020.
Project Lucy
In June, MindMed also announced it launched Project Lucy — which is a commercial drug development program for the treatment of anxiety disorders. And the company said that it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of LSD, administered by a therapist. And this is the first experiential, psychedelic-assisted therapy to be added to the company’s drug development pipeline.
With the launch of Project Lucy, MindMed started preparing a total of three Phase 2 commercial drug trials based on psychedelic inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.
At the time, MindMed Co-Founders and Co-CEOs JR Rahn and Stephen Hurst said that this announcement demonstrated the company’s strong capabilities to efficiently execute on our vision of building a synergistic platform that can take an idea and turn it into a later stage clinical trial with the sense of urgency investors expect and patients deserve.
Previously, MindMed had acquired exclusive worldwide data rights to eight completed or ongoing clinical trials from the University Hospital Basel evaluating LSD based on over 10 years of research. And MindMed started planning to assemble and use this data as part of its briefing package to the FDA.
Phase 2 Clinical Trial Of LSD For “Suicide Headaches” Starts Treating Patients
Mind Medicine (MindMed) also announced it was supporting and collaborating on Phase 2 clinical trial evaluating LSD for the treatment of cluster headaches at University Hospital Basel’s Liechti Lab. The Phase 2 trial started recruiting patients in early January and has commenced treating patients with LSD.
Cluster headaches (also known as “suicide headaches”) due to the severity of the pain caused are often viewed as one of the most profoundly painful conditions. And the pain occurs on one side of the head or above an eye and can last for weeks or months. Studies have demonstrated increased suicidality associated with patients experiencing cluster headache attacks.
There is non-clinical and anecdotal evidence that suggests LSD can abort attacks and decrease the frequency and intensity of the attacks. And there is a need for new treatment approaches for cluster headaches as current available medications often mismanage cluster attack periods.
The Phase 2 trial is investigating the effects of an oral LSD pulse regimen (3 x 100 µg LSD in three weeks) in 30 patients who are suffering from Cluster Headaches compared with placebo. And the study is a double-blind, randomized, placebo-controlled two-phase cross-over study design.
MindMed’s collaboration will assess if there is clinical evidence for a future commercial drug trial through the FDA pathway. And treatments for cluster headaches may potentially qualify for an Orphan Drug Designation and be eligible for certain development incentives provided by the FDA for rare diseases.
Liechti Lab and MindMed are intending to learn how they can make the administration of LSD more targeted for cluster headache patients through this Phase 2 trial and future clinical trials. And as part of the collaboration with UHB Liechti Lab, MindMed gains exclusive, global use to all data and IP generated in the Phase 2 trial of LSD for cluster headaches.
Evaluation Of Ayahuasca’s Active Ingredient DMT In Phase 1 Clinical Trial Collaboration
In June, MindMed had announced a Phase 1 Trial to experiment with dosing methods to better understand how humans react to DMT, which sets the stage for future potential Phase 2a proof of concept trials. And MindMed started pursuing N,N-Dimethyltryptamine (DMT), the principally active ingredient in Ayahuasca as part of its R&D collaboration with the University Hospital Basel’s Liechti Lab.
MindMed was providing startup funding for a Phase 1 clinical trial testing various intravenous dosing regimens of DMT, expected to begin in Q4 of 2020. And DMT is a naturally-occurring psychedelic substance and is the active ingredient used in Ayahuasca ceremonies by indigenous Amazonian shamanic practitioners.
DMT causes a rapid onset and offset of action compared to similar psychedelic substances such as psilocybin or LSD. And when administered as an Ayahuasca brew, natural substances are mixed with DMT to prolong its experiential effects and slow the metabolism in the human body.
July 2020
Dosing 18-MC Phase 1 Study Completed
Towards the end of July, MindMed said it has concluded dosing in a Phase 1 Single Ascending Dose (SAD) study of 18-MC. And the dosing of 18-MC was well tolerated in humans and will help advance planning for a Phase 2a clinical trial in opioid addiction. This study has not incurred any delays due to the COVID-19 pandemic and the Multiple Ascending Dose (MAD) study is on track according to the original development timeline.
18-MC is known as a non-hallucinogenic molecule based on the psychedelic substance ibogaine. And the study tested doses ranging from 4mg to 16mg twice a day and all participants were evaluated for pharmacokinetics and safety.
MindMed’s addiction treatment unit is currently focused on developing novel medicines that are inspired by psychedelics for addiction to address the growing opioid crisis in both Canada and the US. And the US opioid crisis is estimated to cost the US economy over $500 billion annually.
And MindMed said it was planning to begin the Phase 2a study of 18-MC in opioid addiction by the end of this year.
August 2020
Dr. Peter Gasser Joins As Clinical Advisor For Project Lucy
Mind Medicine (MindMed) announced in August that it has engaged renowned psychedelic assisted therapy expert Dr. Peter Gasser as an advisor to its LSD experiential therapy program Project Lucy. Dr. Gasser is known for pioneering the legal and medical use of psychedelics through clinical research and compassionate access in Switzerland.
Dr. Gasser has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. And through compassionate access in Switzerland, Dr. Gasser holds several individual treatment permissions to treat patients with MDMA and LSD.
Dr. Gasser and University Hospital Basel’s Dr. Matthias Liechti are conducting a Phase 2 trial of LSD-assisted therapy for anxiety disorders. And MindMed previously acquired the exclusive license to this ongoing Phase 2 trial through its collaboration agreement with the University Hospital Basel.
“Dr. Gasser is one of the leading global experts on psychedelic-assisted therapy and it’s an honor for us to work together as we build Project Lucy into a world-class commercial drug development program,” said Rahn. “Dr Gasser’s vast experience and history treating patients as a therapist through compassionate access in Switzerland also interests the company and will have tremendous benefits to our patients.”
Dr. Gasser had helped pioneer compassionate access for end of life psychedelic assisted therapy in Switzerland. And around that time, the Canadian health minister approved compassionate access of psilocybin assisted therapy for terminally ill patients.
R&D Expansion In Europe; Dr. Miri Halperin Wernli Appointed As As President
Mind Medicine said in August is expanding its presence in Europe. And the leading neuro-pharmaceutical company for psychedelic inspired medicines will open an operating subsidiary in Switzerland that will oversee clinical development, scientific collaborations, and the expansion of MindMed’s business in Europe.
And as part of the ramp-up and planning process for its growing global pipeline of clinical programs of psychedelic inspired medicines, MindMed’s board of directors had appointed Dr. Miri Halperin Wernli as President to help guide MindMed’s clinical development strategy and provide further leadership to its R&D pipeline.
Dr. Wernli was tasked with expanding the clinical and scientific team in Europe. And her immediate primary leadership responsibilities center around the company’s LSD microdosing program and Project Lucy, which is the LSD experiential therapy program for anxiety disorders. Dr. Halperin Wernli will also help implement R&D collaborations in Europe which include the company’s partnership with the University Hospital Basel’s Liechti Lab.
Dr. Wernli is a senior pharmaceutical and biomedical executive with over 30 years of strategic and operational leadership in the biopharmaceutical industry and a deep understanding of drug and product development in heavily regulated environments. And Dr. Wernli has held worldwide senior leadership positions in product development, R&D and Strategic Marketing throughout Switzerland and in the United States at leading pharmaceutical companies including Merck, Sharp & Dohme, Roche, and Actelion Pharmaceuticals. And Dr. Wernli had previously co-founded and led Creso Pharma, an Australian listed medical cannabis company with operations in Europe and Canada.
Q2 2020 Financial Results
On August 20, 2020, Mind Medicine had reported its Q2 2020 financial results. The company announced total assets on June 30, 2020, were $29.8 million including $24 million in cash — which will be used primarily for executing the company’s multiple clinical trials. And the company reported that the net and comprehensive loss of $5.8 million for the three months ended June 30, 2020.
First-Ever Clinical Trial Combining MDMA And LSD
At the end of August, Mind Medicine said that it was collaborating with the University Hospital Basel’s Liechti Lab to combine MDMA and LSD in a groundbreaking Phase 1 clinical trial. And the Phase 1 MDMA-LSD trial was scheduled to start in Q4 of this year in Basel, Switzerland.
The combined MDMA-LSD treatments have the potential to create next-generation psychedelic assisted therapy paradigms. And when added to a psychedelic assisted therapy session, MDMA has the potential to reduce some known rare negative side effects that may occur while using LSD or other classic psychedelics on their own. Plus it has been shown that classic psychedelics such as psilocybin and LSD can sometimes induce short-term unpleasant effects for patients during a psychedelic assisted therapy session. These symptoms often include negative thoughts, rumination, panic and paranoia.
MDMA (an empathogen) is known to acutely induce feelings of increased well-being and trust. And by combining LSD and MDMA within the same session, the Liechti Lab and MindMed are evaluating if the combination produces greater overall positive acute effects when compared to LSD or MDMA on their own. MDMA may reduce some of the negative mood effects of LSD and make the patient more comfortable during psychedelic-assisted therapy.
“The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD. Inducing an overall primarily positive acute response during psychedelic assisted therapy is critical because several studies showed that a more positive acute experience is linked to a greater therapeutic long-term effect in patients,” explained Dr. Liechti.
The Phase 1 Clinical Trial is expected to take around one year to complete. And if MindMed finds the results promising, the company may decide to undertake further studies with treatments combining MDMA and LSD, and prepare patient trials for various indications.
September 2020
NASDAQ Up-Listing Application
At the end of September, MindMed said it submitted an application for a NASDAQ up-listing and it appointed Canaccord Genuity as a financial advisor. The listing of MindMed’s shares on NASDAQ would be subject to a number of regulatory requirements, including review of the company and acceptance for listing by NASDAQ. But there are no assurances that NASDAQ acceptance will be granted.
“The psychedelic medicine industry is maturing and expanding rapidly, and we want to grow with it. We look forward to working with Canaccord Genuity to evaluate the opportunity for an up-listing on NASDAQ and help us navigate M&A opportunities now available to the company,” stated Rahn.
Shortly after making this announcement, the hype around Mind Medicine’s stock started to surge. The volume of trades went from hundreds of thousands per day to millions per day in September, which helped drive the price up. Many people started talking about the stock in investor chatrooms on Discord, Facebook Groups, StockTwits, and Twitter.
Mind Medicine had issued a press release at the time about how management was unaware of any material change in MindMed’s operations that would account for the recent increase in market activity. This announcement was issued at the rest of IIROC on behalf of the NEO Exchange.
Comparing Effects Induced By LSD And Psilocybin
In September, Mind Medicine announced that the company has been conducting R&D work on psilocybin in collaboration with the University Hospital Basel’s Liechti Lab in a study to better understand and compare the altered states of consciousness induced by psilocybin and LSD. And MindMed is interested in understanding how psilocybin or LSD affects humans differently so that it can design better later stage trials or potentially even combine substances in future next-generation psychedelic assisted therapies for patients.
As part of MindMed’s exclusive license agreement with the University Hospital Basel, MindMed said it is going to retain an exclusive license to all IP and any patents generated from data or findings in the study and related work on psilocybin like pharmacokinetic data and information on the metabolism. The study is anticipated to finish in Q2 2021.
October 2020
MindMed Partners With NYU Langone Medical Center To Launch A Training Program For Psychedelic Therapies And Medicines
MindMed had announced a funding commitment to found and launch a clinical training program focused on psychedelic assisted therapies and psychedelic inspired medicines at NYU Langone Health. The NYU Langone Health Psychedelic Medicine Research Training Program is considered the first step in a larger initiative to establish a Center for Psychedelic Medicine at NYU Langone Health.
NYU Langone Health and NYU Grossman School of Medicine were early pioneers of clinical research with psychedelic assisted therapies and psychedelic inspired medicines for substance use disorders and other mental illnesses. And through this funding initiative, MindMed aims to catalyze efforts to recruit and train more psychiatrists and clinical investigators to undertake necessary research to develop training tools capable of scaling and optimizing the delivery of psychedelic assisted therapies and psychedelic inspired medicines to millions of patients across the United States.
“MindMed’s funding meets an important need for recruiting more clinical investigators and psychiatrists to the expanding and promising areas of psychedelic assisted therapies and psychedelic inspired medicines, which can help so many people suffering from addiction and other mental illnesses,” noted Charles R. Marmar, M.D., Chair, Department of Psychiatry, NYU Grossman School of Medicine. “NYU Langone Health’s training of the next generation of researchers and psychiatrists will help to advance and hopefully soon deploy this emerging category of medicines including psilocybin-assisted therapy for Alcohol Use Disorder and MindMed’s ibogaine-derived molecule 18-MC for Opioid Use Disorder patients.”
This new endeavor is building upon a longstanding partnership between MindMed’s drug development team and the Department of Psychiatry at NYU Grossman School of Medicine — which have collaborated since 2009 on an ibogaine derived molecule known as 18-MC. And MindMed plans to soon enter a Phase 2 trial with 18-MC for opioid use disorder patients. The NYU Langone Health Psychedelic Medicine Research Training Program will have an initial focus on substance use disorders including opioid addiction and alcoholism.
MindMed is committing $5 million over a 5-year period to the NYU Langone Health Psychedelic Medicine Research Training Program and the future corresponding Center for Psychedelic Medicine at NYU Langone Health. And NYU Langone Health will have full and free discretion in using these funds for the development and conduct of the training program and operations of the Center for Psychedelic Medicine. The launch of the Center for Psychedelic Medicine at NYU Langone Health is still subject to additional funding from other undisclosed partners and parties.
Upsized Financing Closed
In late October, MindMed had announced it closed upsized financing of CAD $28.75 million with strong institutional demand for psychedelic medicines. Post-financing, MindMed now has cash reserves of CAD $50.1m (USD $37.8m) to enable continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.
November 2020
Completion Of Phase 1 Study Measuring Dosing Effects of LSD
MindMed in partnership with University Hospital Basel’s Liechti Lab announced the completion and publication of a Phase 1 study on the acute dose dependent effects of LSD. And the completed Phase 1 study will help MindMed in dose-finding and the planning of future Phase 2 clinical trials of LSD in patients with anxiety disorders and other medical conditions.
Specifically, the Phase 1 study measured LSD dose-dependently induced subjective responses starting at microdoses (25 ug) up to experiential doses (200 ug). And maximal good drug effects were reached at a 100 ug dose. But an experiential dose of 200 ug LSD was shown to induce greater ego dissolution than a lesser 100 ug dose. Ego-dissolution is thought to be one of the key therapeutic potentials of the psychedelic experience and psychedelic assisted therapy process.
MindMed’s team is actively preparing Project Lucy — which intends to evaluate the efficacy of LSD assisted therapy for anxiety disorders in a Phase 2b clinical trial.
And MindMed and University Hospital Basel are filing patent applications on clinical trial data generated through the collaboration’s numerous clinical trials and R&D. MindMed maintains an exclusive license to the data and IP generated through its continued research collaboration and licensing agreement with the Liechti Lab at University Hospital Basel.
The Phase 1 study used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy participants (eight women, eight men) — who underwent six 25 h trial sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of ketanserin (40 mg). LSD showed dose-proportional pharmacokinetics and first-order elimination. And in addition, effects of the high 200 µg dose of LSD were effectively prevented by a pretreatment with the 5-HT2A receptor antagonist ketanserin indicating that psychedelic effects of LSD are primarily mediated by serotonin 5-HT2A receptor activation.
The study was published in Neuropsychopharmacology, which is an international scientific journal and the official publication of the American College of Neuropsychopharmacology (ACNP).
Q3 2020 Financial Results
On November 13, MindMed had announced its third-quarter financial results. The total assets as of September 30, 2020 were $23.7 million, including $18.2 million in cash. And the company reported a net and comprehensive loss of $8.6 million for the three months ended September 30, 2020 and $21.4 million for the 9 months ended September 30, 2020.
On October 30, 2020, Mind Medicine announced the closing of financing for gross proceeds of USD $21.6 million ($28.8 million CAD). And post October financing, the company had cash reserves of USD $37.8 million ($50.1 million CAD) to enable continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.
Approval Of Protocol Design To Evaluate Microdoses
In November, MindMed had received approval of protocol design to evaluate microdoses of LSD for adult ADHD in Phase 2a clinical trial. MindMed has received a positive response on its protocol design for a Phase 2a clinical trial evaluating microdoses of LSD in the treatment of adult ADHD from the Swiss and Dutch health authorities. And MindMed has also successfully submitted a pre-IND briefing package to the FDA for its Project Lucy, a potential Phase 2b Efficacy Trial evaluating LSD Assisted Therapy in anxiety disorders.
The company also reached an agreement with University Hospital Basel Liechti Lab to conduct an interim analysis anticipated in Q1 2021 for its Phase 2a clinical trial of LSD assisted therapy for anxiety disorders currently ongoing in Switzerland. MindMed’s Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities. And MindMed is working with our site coordinators in Switzerland and the Netherlands on our patient recruitment strategy and will provide updates on recruitment progress in due course.
Launch Of Albert, A Digital Medicine Division For Psychedelic Medicines
MindMed had announced it is establishing a digital medicine division known as Albert. And Albert is in the process of assembling and recruiting a leading team of technologists, therapists, and clinical drug development experts to help the company research, develop and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and experiential therapies combined with digital therapeutics.
Digital therapeutics are known as being evidence-based therapeutic interventions for patients to prevent, manage, or treat a mental disorder or disease. And pairing digital tools like wearables and the latest in machine learning with psychedelic assisted therapies can give healthcare providers the ability to optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.
December 2020
Successful Completion Of Pre-IND Meeting With The FDA For Project Lucy
In the middle of December, MindMed announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for an anxiety disorder. And the successful completion of this engagement with the FDA is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. MindMed intends to open the IND with the FDA in August 2021 with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.
“The FDA is one of the most impactful organizations for regulated drug development globally. We look forward to working through the FDA pathway on psychedelic assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021,” Rahn acknowledged.
Preliminary data has been analyzed for MindMed’s addiction treatment program evaluating the ibogaine derivative 18-MC — which the company has named Project Layla. And the preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well tolerated at the doses tested to date, and no Serious Adverse Events (SAEs) have been reported.
Based on the safety profile observed to date, MindMed’s clinical team and 18-MC’s Medical Director Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. And once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study. A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.
Upsizing Of Previously Announced Bought Deal Public Offering
On December 15, MindMed had announced it saw an upsizing of its previously announced bought deal public offering. Initially, Mind Medicine announced that a syndicate of underwriters were purchasing on a bought deal basis pursuant to the filing of a short form prospectus an aggregate of 11,364,000 units of the company at a price of C$4.40 per unit for aggregate gross proceeds to the company of C$50,001,600. But then MindMed said it was pleased to announce that it has agreed to increase the size of its previously announced bought deal financing led by Canaccord Genuity (the lead underwriter). Canaccord had agreed to purchase, on a bought deal basis pursuant to the filing of a short form prospectus an aggregate of 18,200,000 units of the company at a price of C$4.40 per unit for aggregate gross proceeds to the company of C$80,080,000.
The net proceeds of the offering will be used for investment in Project Lucy, Albert (the company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.
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