TNXP - Growing Medical Support Helps Buoy Psychedelic Research
FinancialBuzz.com News Commentary
New York, NY (12/14/2020) – There is a plethora of innovations that scientists and researchers have accomplished in biotechnology in recent years. Among the popular fields of study for biotech companies are gene editing, tissue engineering and regeneration, nanobiotechnology and others. In addition, new segments under the biotech umbrella are constantly being developed. For example, the medical cannabis segment has rapidly emerged in recent years, and the continuously growing acceptance of psychedelic drugs is further evidence. According to recent studies by a number of universities and research institutions, data indicates the usefulness of potential applications of psilocybin. It is a naturally occurring substance that is being examined for the potential use in the treatment of psychiatric conditions. Currently, psychedelics have been used as potential treatments for various health conditions including depression, panic disorders, post-traumatic stress disorder (PTSD), and opiate addiction. Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED), COMPASS Pathways plc (NASDAQ: CMPS), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), Numinus Wellness Inc. (TSX-V: NUMI) (OTC: LKYSF), Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) are all working on psychedelic treatments.
The perceptions about psychedelics and their possible uses have started to shift from a potentially dangerous party drug to an approachable medicinal product. For example, earlier in 2019, the U.S. Food and Drug Administration (FDA) approved Spravato (esketamine) a nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). According to The Verge, Steve Levine, the founder of Actify Neurotherapies, which runs 10 ketamine clinics around the country explained that “we deliver an off-label treatment that has the baggage of being known as a club drug… Now we’ve moved from ‘we deliver horse tranquilizer off-label’ to ‘we deliver FDA-approved Spravato’ and it’s just easier to talk to people about that.”
Mind Medicine (MindMed) Inc. (OTCQB: MMEDF) (NEO: MMED) announced last week that “it has closed its previously announced bought deal short form prospectus offering, including the exercise in full of the underwriter’s over-allotment option (the “Offering”). In connection with the Offering, the Company issued 18,170,000 units of the Company (the “Units”) at a price per Unit of CAD $1.90 (the “Issue Price”) for gross proceeds of CAD $34,523,000. The Offering was conducted by Canaccord Genuity Corp., as lead underwriter, and Eight Capital.
Each Unit comprises one subordinate voting share of the Company (a “Subordinate Voting Share”) and one-half of one Subordinate Voting Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one Subordinate Voting Share at an exercise price of CAD $2.45 until December 11, 2023. If, at any time following the closing of the Offering, the daily volume weighted average trading price of the Subordinate Voting Shares on the NEO Exchange Inc. is greater than CAD $4.00 per Subordinate Voting Share for the preceding 10 consecutive trading days, the Company may, upon providing written notice to the holders of Warrants, accelerate the expiry date of the Warrants to the date that is at least 30 days following the date of such written notice. The Warrants will be listed for trading on the facilities of the NEO Exchange Inc. (the “NEO”) under the symbol “MMED.WA”, subject to the final approval of the NEO.
Since the founding of Mind Medicine Inc. in May 2019, MindMed has now raised a total of CA$121.4M (US$94.8M) in investment capital before fundraising and deal expenses.
MindMed Co-Founder & Co-CEO, J.R. Rahn said, ‘The COVID-19 pandemic has made it clearer than ever that the current global mental healthcare system demands more comprehensive solutions to address multiple mental health and addiction crises around the world. This successful upsized financing from investors offers further validation that psychedelic medicines are being viewed as a promising new frontier in mental health treatments. As we advance and design this new treatment paradigm in mental health and addiction, we believe that interlacing digital therapeutics alongside regulated psychedelic drug development through rigorous science at the FDA and other regulatory bodies will be integral to advancing the potential healing of millions of patients globally.’
The Company intends to use the net proceeds of the Offering for investment in its digital medicine division, additional microdosing research and development, as well as general working capital and corporate purposes, including to further fund its ongoing programs.
Post-financing, the Company now has cash reserves of CA$85M (US$66.4M) to enable development of its digital medical division Albert and continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.
With Albert, the Company aims to build an integrated digital platform to improve patient safety, outcomes, and clinical trial design. By pairing digital tools, such as wearables and the latest in machine learning, with psychedelic assisted therapies, MindMed can optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.”
COMPASS Pathways plc (NASDAQ: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company focuses on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. COMPASS is pioneering the development of a new model of psilocybin therapy, in which the Company’s proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. Earlier last month, the Company announced that it has joined the Psychiatry Consortium, an international collaboration to accelerate drug discovery and development in areas of urgent, unmet medical need.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. Last month, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), for the treatment of military-related PTSD. “The paradox that confounds modern PTSD studies is that the placebo response has increased over time, even as we and others have striven to improve study methods and data quality,” said Dr. Lederman.
Numinus Wellness Inc. (TSX-V: NUMI) (OTC: LKYSF) reported back in September that it has begun cultivating Psilocybe mushrooms, for the purpose of psilocybin production, at its 7000 square-foot Health Canada licensed facility. Psilocybin-assisted psychotherapy is currently being studied as a treatment for a range of mental health conditions including depression, anxiety, and substance use disorders. “We are thrilled to start growing mushrooms at our laboratory under our Health Canada licence,” says Michael Tan, Chief Operating Officer. “We envision a day when the option of natural, plant-based psilocybin is available for use in therapies at Numinus Clinics and by others, and this is a tangible step towards that goal.” Numinus’s vertically integrated ecosystem positions the Company to be a first-in-market, trusted leader in the delivery of psychedelic-assisted psychotherapies when regulated. From product development and supply, to analytics and testing, to clinical protocol development and implementation science in partnership with leading research organizations, the ecosystem approach allows Numinus to ensure quality control and best-in-class delivery with steady revenue streams to support its developments.
Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) announced last month an update on its oral thin-film delivery system with psilocybin being developed under a research partnership agreement with Reed Research Group out of the University of Wisconsin-Madison. Following several months of prototyping on a wide range of dosage forms, the Company has completed an oral thin-film strip product with psilocybin with dosage forms ranging between 1 mg and 20 mg and demonstrating its versatility through physio-chemical characterization (e.g. tensile strength of films) of bio comparable tannin-chitosan composite materials, dissolution and disintegration testing, and rate of psilocybin release from composites. Currently, technical and scientific data is being processed and finalized. “We are very pleased to have achieved this development milestone of our orally dissolvable thin film strip for psilocybin, which can be used in FDA human clinical studies and as a unique product for medical use in states where psilocybin therapy use is permitted, such as Oregon following the passage of Measure 109,” said Michael Frank, CEO of Revive.
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