Industry: Psychedelic Medicine / Digital Therapeutics / Biotechnology
Location: New York, NY / Toronto, Ontario
Flagship Products: 18-MC, Project Lucy, Albert Digital Medicine
Treatment Focus: Addiction, ADHD, Anxiety, Depression, Headaches
Ticker: $MNMD (NASDAQ), $MMED (NEO), $MMQ (DAX),
Investor Presentation: Link
Financial Reports: Link
SEC Filings: Link
SEDAR Filings: Link
Hallucinogen Research History: Link
1. MindMed develops psychedelic based medications and treatment protocols for the treatment of mental health and neurological disorders.
2. Psychedelic based medicine is an emerging industry, with decades of anecdotal success.
3. A 2017 Global Drug Survey, cites psilocybin as the safest recreational drug.
4. Mental health awareness is increasing, while social stigmas are decreasing.
5. The World Health Organization estimates that mental health accounts for 10% of the global disease burden.
6. In 2014, it was reported that mental health and substance abuse services account for approximately $50 billion in annual revenue, and $300 billion when ancillary services are considered.
7. The global mental health market is expected to grow at a CAGR of 5.02%.
8. Venture capital funding for mental health startups is at an all time high indicating a significant shift in the industry.
9. MindMed maintains approximately $144.7M in cash on hand.
10. MindMed has at least five known catalysts expected to occur this year, including a Nasdaq listing that is imminent.
11. MindMed has six medications and treatment protocols currently in clinical trials, including treatments for opioid addiction, depression, anxiety, and headaches.
12. MindMed is backed by notable investors, including Shark Tank’s Kevin O’Leary and Canopy Growth Corp founder, Bruce Linton, who serves as a Board Director.
13. MindMed is the second largest holding in Horizons’ PSYK ETF, the world’s first psychedelic ETF.
MindMed is an early stage biotechnology company founded in 2019, and headquartered in New York City. They are focused on discovering, developing and deploying psychedelic based medications and treatment protocols, primarily derived from Psilocybin, LSD, MDMA, DMT and Ibogaine. The company is led by Chief Executive Officer and Co-Founder, JR Rahn, a former Silicon Valley tech executive, and President and Board Director, Dr. Miri Halperin Wernli, a thirty year pharmaceutical and biomedical executive who previously served at several major pharmaceutical companies, such as Merck, Roche, and Actelion. Their pipeline is focused on treating a range of common mental health and neurological disorders, such as addiction, anxiety, depression, and headaches.
PRODUCTS AND SERVICES
MindMed engages in the research and development of medications and treatments derived from LSD, Psilocybin, MDMA, DMT, and Ibogaine.
18-MC: 18-Methoxycoronaridine is a novel derivative of Ibogaine, a naturally occurring psychoactive substance found in plants, which has demonstrated promising results in treating drug, alcohol, and nicotine addiction. 18-MC has a significantly improved safety profile, and is shown to be neither psychoactive nor psychedelic. At MindMed, 18-MC is currently entering Phase 2A trials for the treatment of opioid addiction.
Project Lucy: This program intends to develop and commercialize psychedelic assisted therapies for the treatment of anxiety disorder. Experimental doses of LSD will be evaluated under supervision, and in coordination with ongoing patient therapies. In December of 2020, MindMed announced the successful completion of a Pre-IND meeting with the FDA for Project Lucy, as well as preparations to open an Investigational New Drug (IND) in August of 2021, with a Phase 2B clinical trial for LSD assisted therapy.
Albert Digital Medicine: Digital therapeutics are evidence based interventions guided by software for the treatment and prevention of diseases and disorders. These digital tools include wearable devices, machine learning, and AI systems. Albert is an early stage platform intended to develop a comprehensive toolset focused on delivering psychedelic based treatments and therapies in combination with digital therapeutics. Dr. Miri Halperin Wenli, MindMed’s President and Head of Chair of Technology Evaluation, is currently designing an experimental clinical trial that pairs psychedelic inspired medicines, such as LSD, with digital therapeutics to track, engage, and influence patient behavior.
DEVELOPMENT AND COMMERCIALIZATION
MindMed’s pathway to commercialization is a standard three stage process of Discovering, Developing, and Deploying. Initially, research will focus on acquiring and discovering new chemical products and treatment protocols. These compounds and protocols will enter FDA regulated clinical trials, with an effort to secure partnerships with major pharmaceutical companies. Finally, strategic affiliations with research centers, hospitals, pharmaceutical companies, and insurers will enable the licensing of medications and protocols. It is important that we monitor how their commercialization strategy develops, because psychedelic inspired treatments are new products, and it’s unclear how well they can be monetized.
SUCCESS STORIES: WHY SPRAVATO’S FDA APPROVAL MATTERS
On August 3rd, 2020, The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA had approved SPRAVATO (eskatamine), the first prescription nasal spray, for the treatment of depressive symptoms in adults with major depressive disorder, and treatment-resistant depression.
Spravato is a potent sterioisomer of ketamine, a psychedelic substance used in anesthesia, pain management, depression, and seizures. Spravato is significant for two important reasons. It represents the first FDA approved drug for depression that does not work directly on monoamines, and it is the first psychedelic drug approved by the FDA for a psychiatric condition. This demonstrates the utility of psychedelic substances, and supports the need for further research and development.
MindMed currently maintains several clinical and research partnerships.
1. Partnership with Swiss psychedelic drug discovery startup, Mindshift Compounds AG, for the purpose of developing and patenting next-generation psychedelic compounds.
2. Partnership with New York University Langone Medical Center, for the purpose of launching a clinical training program focused on psychedelic assisted therapies and medications.
3. Partnership with Liechti Lab, a psychopharmacological research center based in Switzerland, for the purpose of research and development into the effects and state of consciousness induced by psilocybin and LSD.
4. Partnership with Maastricht University, based in the Netherlands, for the purpose of conducting clinical trials for the use of LSD in adult patients with ADHD.
IN THE MEDIA
”Could the Embrace of Psychedelics Lead to a Mental-Health Revolution?”, Vogue
”Psychedelics-Drug Startup Raises $24 Million Ahead of IPO”, Wall Street Journal
”Silicon Valley’s psychedelic wonder drug is almost here”, Fast Company
”Psychedelic drug company MindMed applies for nasdaq up-listing”, Forbes
”Psychedelic drugs may transform mental health care. And big business is ready to profit from the revolution”, Fortune
”A startup that wants to use psychedelics to treat addiction just raised $6.2 million from the host of Shark Tank and the architect behind the world’s biggest cannabis grower”, Business Insider
”New York is getting its first psychedelic-medicine center, with the help of a startup called MindMed, which develops hallucinogens to treat mental illness and addiction, and is funding an institute at N.Y.U. Langone Medical Center”, The New Yorker
”MindMed surges, putting it at the forefront of psychedelic euphoria”, Bloomberg
HISTORY AND PARALLELS
The history of psychedelic discovery, use and regulation is flush with politics, propaganda, and anecdotes. Although hallucinogens have reportedly been used for centuries, it was not until the late 1930’s and 1950’s that LSD and psilocybin were isolated in a laboratory setting. In 1968, the United States government passed legislation banning the possession of LSD and psilocybin, which restricted the use of these substances in clinical research. In most developed countries, with the exception of a few, such as Brazil, Jamaica, the Netherlands, possession remains illegal. In 2000, the Psychedelic Research Group at Johns Hopkins received U.S. regulatory approval to reinitiate psychedelic based research.
As we have seen with cannabis reform, culture and politics are shifting, and substances that were previously illegal are gaining renewed support for both medicinal and recreational use. In 2012, Colorado and Washington became the first two states to legalize the recreational use of cannabis, following the passage of Amendment 64 and Initiate 502. Since then, we have seen significant efforts from additional states to either decriminalize or legalize the use of cannabis.
For additional information on the history of psychedelic substances and the regulatory milestones they achieved, please refer to this summary, posted in r/speculator.