The Canadian psychedelics company reported a loss of C$7.6 million for the first quarter.
The Canadian psychedelics company reported a loss of C$7.6 million for the first quarter.
Some consultants are getting paid in stock instead of cash.
Mydecine sells Mindleap and gets a much-needed cash infusion.
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) has burned through its cash and is closing its research operations in Denver Colorado. The psilocybin company reported financial results for the six months ending June 30, 2022, with a net loss of $8.09 million or a basic and diluted loss per share of $(1.31).
Mydecine said it had $324,146 in cash and cash equivalents as of June 30, 2022. The company had $1.4 million at the end of December. As of June 30, 2022, Mydecine said it had an accumulated deficit of $133,166,197 (December 31, 2021 – $124,915,140), On March 8, 2022, the company entered into an unsecured note payable with an institution for $153,840 which bears a 5% interest rate annually and matures on March 7, 2023. The balance of the note payable on June 30, 2022, was $87,916 including accrued interest of $2,777.
At the end of June, Mydecine management decided to stop the research that was being conducted in the research facility located in Denver, CO. According to the company’s filing, during the quarter, the employees at this facility were released or transferred to other functions of the company. Management began preparations to liquidate the laboratory equipment and furniture in this location and, subsequent to the end of the quarter, negotiated an amendment that changed the termination date of the lease.
On July 26, 2022, the company said it agreed to the Second Amendment of its Business Lease and First Amendment related to the research and development facility located in Denver, CO. The landlord waived monthly lease payments for the month of June 2022 and the partial month of July 2022 in exchange for the laboratory equipment, leasehold improvements, and furniture (the Lab Assets) within the research and development facility. The company said it also agreed to allow the landlord to keep the security deposit of $9,149.13 that the company paid at the beginning of the lease. Mydecine then transferred ownership of the Lab Assets, in “as is” condition, to the landlord and was released from any further obligations for lease payments, cleaning costs, and the obligation to restore the space to its original condition.
CEO Josh Bartch said, “The company stated in our financials that we had decided to close down the DENVER lab, and only the DENVER lab. This lab was focused on Mycology research and was a very small, non-material subset of the overall company’s focus, which is as a pure biotech, drug development company. The decision to close down the Colorado lab was for multiple reasons, first is that the Mycology research no longer fit into the company’s plan moving forward as a singularly focused biotech company, focused on developing improved second and third-generation psychedelic molecules, something the company does very well and efficiently. Second, the company, like many companies in a variety of sectors, has scaled down operations in order to cut burn rate to adapt to times, we have also done a very good job at accomplishing this as well. The closure of the Colorado lab has no material effect on the company’s overall business strategy, in fact we view it as a positive evolution.”
In addition to shutting down the lab, Mydecine decided to reduce the scope of daily operation within the Mindleap Health subsidiary. “The platform remained, and remains, available to subscribers and continued to generate operating revenues and expenses through June 30, 2022. However, software development activities were paused and the Company released Mindleap’s consultants. Management will continue to assess plans for the Mindleap platform that include, but are not limited to, strategic opportunities.”
Bartch added, “The decision to lay off the Mindleap staff is a decision the company made in regards to the future of the application under the Mydecine roof. Management made the decision that Mindleap as an application would be better suited with a company that had either an immediate use for the application, such as a clinic organization and or was solely focused on technology or app development. To that end we made the decision to sell the application, which we will be updating the market on in the near term. This will result in two direct benefits to the company, one it saves a significant amount of money in monthly and annual burn, as well as strengthens the balance sheet with non-dilutive capital.”
Just last month Mydecine announced it has successfully synthesized multiple short-acting MDMA analogs. This family of analogs had been specifically designed by experts at Mydecine to have a shorter half-life than traditional MDMA. The company has named this family of novel molecules MYCO-006 and applied for patent coverage with the World Intellectual Property Organization.
During the Second Quarter, Gordon Neal who served as the Chairman of the Company’s board of directors and the chair of the Audit Committee resigned, effective May 31, 2022, in order to attend to his other business interests. Mr. Todd Heinzl, who is the owner of The Governance Box consultancy and who has been working as a corporate governance consultant for the company, was nominated to succeed Mr. Neal the chairman of the board of directors.
On August 12, 2022, the company announced that Damon Michaels, Josephine Wu, Dr. Saeid Babaei and Dr. Victoria Hale had resigned as directors of the Company. As a result of the resignations, the company is currently working to identify suitable candidates to replace Mr. Michaels, Ms. Wu, Dr. Babaei and Dr. Hale on the board, and to recruit and appoint three new independent directors to the company’s board of directors and audit committee.
Bartch concluded by saying, “Mydecine remains alive and well, and has made the necessary changes and pivots in business strategy to position it for success in the future. The company’s primary operations have been and remain in exclusive partnership with Applied Pharmaceutical Innovations out of the University Of Alberta, where Mydecine has been developing several families of first, second and third generation novel, improved psychedelic molecules for going on 3 years now. In addition to that, the company continues to work alongside Johns Hopkins to both support the NIDA Grant funded study for smoking cessation, in which is using Medicines MYCO-001 drug, as well as to continue to develop Mydecines clinical trial for smoking cessation/substance use disorder for MYCO-004.”
While the numbers on the spreadsheets of psychedelics companies are still to be taken with a grain of salt, given that this is an emerging biotechnology industry still in the drug development stage, there are encouraging signs that perhaps 2022 could be the beginning of a rebound.
Some of the financial downbeat news from 2021 is more than offset by acquisitions and partnerships news that have or will soon give the psychedelics industry the sort of financial firepower that has been predicted for years. For example, the January acquisition of Eleusis, a clinical-stage life science company, by Silver Spike Acquisition Corporation, created a combined company enterprise value of approximately $446 million.
Here are the results of financial reports from the fiscal year 2021 for three selected psychedelics companies, each with a note about what the company has done or is doing to advance its standing and give it some real financial muscle going forward.
– Enveric Biosciences Inc. (NASDAQ: ENVB), is a neuroscience company developing next-generation psychedelic-inspired mental health medicines, based in Naples, Florida.
Enveric made a couple of strategic moves in 2021 to build on its foundational aspirations, including being added to the new AdvisorShare Psychedelics ETF trading on the NYSE Arca exchange; and filing and publishing four patent applications for psychedelic-inspired drug candidates with the World Intellectual Property Organization (WIPO). The four patent applications are focused on the tryptamine family of novel molecules. The company’s net loss for the year was $48.8 million, $40 million more than in 2020, but it reported it still had $17.4 million in cash with working capital of $15.3 million and had raised $10 million during the year that it expects to use to advance its new drug delivery platform and assist with managing its growing IP portfolio.
Good news for 2022: The company also announced a collaboration with the University of Calgary on a clinical trial for cancer-related distress, expected to launch in 2023. And in September, Enveric completed the acquisition of MagicMed Industries Inc., a privately-held biotechnology company focused on creating a library of novel derivative psychedelic molecules such as psilocybin, N, N-dimethyltryptamine (DMT), and other molecular derivatives with applications across multiple indications, in an all-stock transaction. With this acquisition, Enveric intends to expand into a next-generation neuroscience drug discovery platform of novel psychedelics that addresses the large unmet mental health challenges related to the central nervous system.
– Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS), is a clinical-stage natural psychedelic drug development company based in Vancouver, BC, Canada.
Filament Health is riding high with cash and cash equivalents of $4.6 million and working capital of $5 million as of the end of 2021. The Canadian company spent just $5.4 million on operating expenses last year.
Good news for 2022: Filament’s superpower was in leveraging its stock in 2021: issued 99,844 common shares to a service provider in exchange for the reduction of $39,938 in debts owing; issued 1,650,000 options to purchase common shares to six parties; and issued 226,000 restricted share unit awards, under which the holders have the right to receive an aggregate of 226,000 common shares.
– Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA), is a biotechnology company developing innovative first- and second-generation novel therapeutics for the treatment of mental health and addiction based in Vancouver, BC, Canada.
Mydecine appears to be regrouping after a discontinued operation cost them $5.3 million in 2021, which contributed to a net loss of $28.9 million for the year. For the two years ending December 2021, the company has experienced a combined net loss of just over $55.8 million. The Canadian company reports that it had $1.5 million in cash and cash equivalents as of the end of 2021, has secured additional funding and is moving forward with clinical trials and projects to expand its IP portfolio.
Good news for 2022: Mydecine progressed to a Phase 2b smoking cessation study following a positive meeting with the Food and Drug Administration (FDA) to review the company’s Investigational New Drug (IND) application. In Q2 2022, the company plans to file an IND and breakthrough status application and will begin patient recruitment upon receipt of FDA approval. The multi-site study’s lead investigator will be Johns Hopkins University. The company also signed a five-year Master Collaboration Research Agreement with Johns Hopkins University School of Medicine, demonstrating the company’s commitment to advancing psychedelic medicine by exploring multiple molecules and drugs for various indications.
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) reports that its R&D team has discovered over 40 compounds with pharmacological potential in mushrooms. Mydecine said that it has screened over 25 mushroom species, including various varieties of p. cubensis, and has selected and analyzed over 40 unique compounds found throughout the various species. Of these compounds, a large majority appear to have never been reported before and could be vital to the critical effects of naturally-sourced mushrooms on human health and wellbeing as well as synergistic effects with pure psilocybin.
“Most mushrooms, especially the noxious species, have not been investigated for their chemical components,” says Senior Scientist, Duff Sloley. “Most of these compounds are evolved to protect the mushroom’s fruiting body from predation by insects, nematodes, and bacteria and are complex and metabolically expensive to produce. Since these compounds are evolved to affect biological systems and aspects of metabolic pathways, they stand a higher chance of proving to be useful pharmaceuticals,” he continued. “As a consequence, studies of the structural, chemical, and possibly fortuitous pharmacological properties of these unknown compounds may lead to the development of beneficial pharmacological treatments for a number of disease states.”
“We have seen accelerated progress through Mydecine’s fully integrated research and cultivation facilities,” stated Josh Bartch, CEO of Mydecine. “These tremendous advances in our treatment development could not have been possible without our state-of-the-art R&D center and world-class research team. We not only have the ability to discover new compounds, but test them for efficacy, manufacture them for clinical research through a scientific rigor. This end-to-end capability is a critical to successful drug development and sets Mydecine apart.”
The focus on mushrooms is part of the company’s overall strategy to separate itself from its cannabis assets. By doing so, Mydecine can then list its shares on the NASDAQ exchange in the U.S. The company said it had expected to receive the interim order from the Supreme Court of British Columbia on or about June 7, 2021. If shareholders approve, the Spin-Out is anticipated to close on or about the week of July 12, 2021.
Mydecine Innovations Group (OTC: MYCOF) has announced its four lead novel drug candidates as it prepares for its Pre-Investigational New Drug (IND) meetings with the FDA and Health Canada. Mydecine said it believes that these drug candidates are unique and patentable in the United States and Canada and has received advice from counsel confirming such belief.
“Our first four novel drug candidates deliver on our long-term strategic road map for drug development with regular milestones that iteratively add value over time. By increasing the complexity of these compounds, we are increasing layers of patents applied, which in turn, also adds pharmaceutical value to the drug candidates,” said Joshua Bartch, Co-Founder, and CEO, Mydecine Innovations Group. “The promise of these molecules is undeniable. By providing scalable, more stable compounds and delivery mechanisms for research and development, it means that new treatments for previously untreatable mental illnesses are close at hand.”
The four initial drug candidates include:
“In addition to Mydecine’s natural product portfolio, we believe these natural compounds also provide excellent starting points for new compounds which further meet the demands of the clinic and have improved safety, efficacy, and formulation properties. Our research focus on molecular design achieves these goals,” said Dr. Hoyer who is a drug-discovery expert and Mydecine Scientific Advisory Board Member.
“These candidates add layers of safety and dose-ability for the use of psychedelic compounds in medical research and eventually medical practice,” said Chief Science Officer and Co-Founder of Mydecine Rob Roscow. “We are essentially taking the value that is currently present in natural molecules, such as the psilocybin molecule in MYCO-001, and adding in patentable safety features. We want to create attractive features for the research community by providing compounds that can enhance therapy, reduce anxiety, and maximize delivery mechanisms.”
Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) has submitted a formal application to list its common shares on the NASDAQ Stock Exchange. NASDAQ is the second-largest exchange by market capitalization worldwide and is home to many of the world’s best technology companies. “We believe the Company is entering an accelerated growth phase and the timing could not be better for listing our Shares to NASDAQ,” said Josh Bartch, CEO & Chair of Mydecine. “This listing is intended to open the investment opportunity to a larger and more diverse pool of investors and help create greater shareholder value. A listing on the NASDAQ Capital Market is a natural progression for the Company and our shareholders.”
Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) announced that it has completed its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The company said it is now preparing to export the harvest to its Canadian cGMP Facility which has a Health Canada schedule 1 Dealer’s License attached to it, allowing for legal import.
“We are pleased to announce the completion of our first commercial harvest of natural psilocybin mushrooms,” said Joshua Bartch, CEO and Chairman of Mydecine. “There is more research needed on these compounds in order to better understand the entourage effect experienced by patients which has shown dramatically effective results compared to single-molecule synthetic psilocybin in preliminary studies. As the industry grows, the need for naturally occurring psilocybin and access to large quantities of these molecules will be paramount and we are excited to be the first to advance this movement at scale.”
Mydecine said that its final product will be made available for purchase by other licensed institutions and companies conducting clinical research into the efficacy of these compounds to treat various health conditions including anxiety, addiction, depression and PTSD. Portions of the harvest will also be used for Mydecine’s proprietary genetic, pharmacology, and clinical research. The clinical use will be for the studies and developing protocols of psilocybin-assisted psychotherapy to treat PTSD in veterans and other frontline workers.
Mind Medicine Inc. (NEO: MMED) (OTCQB: MMEDF) has filed a final short form prospectus with the securities commissions or similar authorities in each province of Canada, other than Québec with regards to a previously announced bought deal. The company’s underwriters have agreed to purchase 15,800,000 units of MindMed, on a “bought deal” basis, at a price per Unit of $1.90 for gross proceeds of $30,020,000.
The company said it has also granted the Underwriters an over-allotment option to purchase up to an additional 15% of the Units at the Issue Price, exercisable in whole or in part, at any time on or prior to the date that is 30 days following the closing of the Offering. If this option is exercised in full, an additional $4,503,000 will be raised pursuant to the Offering and the aggregate proceeds of the Offering will be $34,523,000.The Offering is scheduled to close on or about December 11, 2020.
Havn Life Sciences Inc. (CSE:HAVN) has signed a Memorandum of Agreement with the international veteran’s organization, Heroic Hearts Project. Heroic Hearts is a registered 501(c)(3) nonprofit organization founded in the United States that connects military veterans struggling with mental trauma, to psychedelic therapy options including ayahuasca, psilocybin, and ketamine. Heroic Hearts also provides support and professional counseling to these veterans throughout the process. These veterans typically have tried all the available resources offered by the Department of Veteran Affairs with limited success leaving them with very few options. Heroic Hearts currently has branches across the United States, Canada, and the United Kingdom.
“This collaboration between Havn Life and Heroic Hearts has the potential to make an extraordinary impact on the mental health and wellness of military veterans,” said Susan Chapelle, EVP of Research and Development at Havn Life. “Under the agreement, Havn Life will supply products and compounds to be used in Heroic Hearts’ future clinical studies that will investigate the effects of low-dosage psychedelic compounds on veterans suffering from emotional trauma and PTSD. This progressive research will help develop clinical trial formulations to aid in the recovery of PTSD and other trauma-related disorders. We look forward to working closely with veterans and others with military backgrounds.”
Mindleap Health, a subsidiary of Mydecine Innovations Group Inc. (OTC:MYCOF) has launched a digital health platform that combines telehealth with mood, emotion, and habit tracking. Starting with psychedelic integration, the Mindleap platform will bring mental health specialists online, enabling a new era of digital mental health and wellness. The company said that later this year it will add other types of mental health specialists such as addiction and holistic wellness specialists.
Simon Abou-Antoun Mindleap Chief Technology officer said, “Mindleap was designed with trust as our number one priority. Our platform is fully secure and all data is encrypted in-transit and at-rest and we are committed to each individual’s right to full privacy and confidentiality when they use our platform.”
The Mindleap platform is available for download for free on both the IOS and Google Play stores. Potential patients can browse vetted and experienced specialists and easily schedule appointments and purchase mental health services. Specialists on Mindleap benefit from the platform’s full freedom to manage their virtual practice on their terms setting their own prices, choosing the hours they work each week (with no minimums or maximums). Mindleap says its specialists are able to offer more personalized support all while providing end-users with the tools needed to track their progress and take control of their mental health.
The Mindleap platform said it will provide a comprehensive space for users to actively engage with specialists starting with aftercare for therapeutic psychedelic use.
The company has noted that over the past decade, a growing body of research published by leading academic institutions such as Imperial College of London, Yale University, and Johns Hopkins University has demonstrated that psychedelic medicines like MDMA, psilocybin (the active compound ingredient found in magic mushrooms), MDMA, and ketamine can be used as effective and safe treatments to treat a variety of mental health conditions, much better than current pharmacological treatments and therapies. In tandem with this breakthrough knowledge, a series of educational programs have emerged to educate mental health and wellness specialists on how to administer psychedelic medicines in guided therapeutic sessions, as well as to provide care after a psychedelic experience.
Integration specialists help clients through a systematic process that can turn their psychedelic experience into something practical – this can include making sense of unique images or ideas that came to mind during a psychedelic experience, as well as setting new goals, habits and behaviors that can help to improve a person’s life. This process is called integration or aftercare and is an important part of using psychedelics for therapeutic purposes and personal growth.
Mindleap says it does not encourage people to spend time on their phones while taking psychedelic substances, and does not facilitate psychedelic use via the platform, but acknowledges a need for people to connect with trained professionals who can help them discuss and understand their individual psychedelic experiences.
Mindleap’s software development team has built the platform to meet all HIPAA guidelines by implementing secure electronic access to health data and remains in compliance with privacy regulations and best practices. Mindleap said it has strict policies around how data is handled and stored; all data is encrypted in-transit and at-rest, and specialists are not permitted to save their clients’ data – they can only view it temporarily while the user chooses to share it during a video call.
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