Psyched: Cybin Gets $9 Price Target, FSD Pharma Acquires Lucid, New Trials From Psilera, Awakn, PharmaDrug And Braxia, California Bill Put On Hold

Contents

1. California Psychedelics Bill Put On Hold Until 2022 
2. FSD Pharma To Purchase Lucid Psycheceuticals For $9 Million
3. Psycheceutical Licenses New Delivery Technologies For Psychedelics
4. Braxia Scientific Launches Broad Criteria Trial On Psilocybin For Depression
5. Awakn To Launch Ketamine Study For Gambling Addiction
6. PharmaDrug Strikes Deal With Johns Hopkins University For A Clinical Trial Into Psychedelic DMT
7. Cantor Gives Cybin An Overweight Rating And x4 Price Target
8. National Institute On Drug Abuse To Research DMT In Partnership With Psilera
9. The Milestone Round

California Psychedelics Bill Put On Hold Until 2022 

A California bill meant to decriminalize the use and possession of a wide range of psychedelic substances was put on hold by its sponsor, state Senator Scott Wiener.

The bill had made significant progress in the state legislature by passing a full senate vote as well as two Assembly committees.

If approved, the legislation would remove criminal penalties for the possession, personal use and social sharing of some natural and synthetic drugs in the psychedelic spectrum, including psilocybin, DMT, ibogaine, LSD, mescaline and MDMA for those 21 and older. 

Wiener chose to re-introduce it again next year in an effort to further educate skeptical legislators and build more public support.

“SB519 advanced deep into the legislative process — honestly, way further than I anticipated since it’s a new idea in the Legislature,” Sen. Wiener said in a tweet. “But we need more time to build support in the Assembly to achieve final passage.”

FSD Pharma To Purchase Lucid Psycheceuticals For $9 Million

FSD Pharma Inc. HUGE HUGE announced it is entering a definitive agreement to acquire Lucid Psycheceuticals Inc. 

Lucid has exclusive worldwide licensing rights from the University Health Network in Canada, to a patent-protected family of new chemical entities. From this IP, the company derived its lead therapeutic candidate for neurodegenerative disorders, called Lucid-21-302, currently undergoing scale-up processing and IND-enabling studies.

The company’s pipeline also includes Lucid-201, a psychedelic drug candidate targeting mental health disorders.

The all-stock transaction will include 4.5 million Class B subordinate voting shares of FSD Pharma, valued at approximately $9 million.

As part of the deal, Lucid’s co-founder and CEO, Dr. Lakshmi Kotra will lead FSD Pharma’s drug development pipeline in psychedelics and medical cannabis.

Psycheceutical Licenses New Delivery Technologies For Psychedelics

Psycheceutical Inc. was issued a license for two technologies that, combined, could allow for new ways of administering psychedelics to patients.

“The technology has been used for years for traditional pharmaceutical drugs; we are the first to license it exclusively for use with psychedelics,” a Psycheceutical spokesperson told Benzinga.

One of these patented technologies is the “Janus delivery system.” It allows psychedelics to be administered without unwanted side effects and toxicity by bypassing the stomach and the liver, using technology comprised of layered nanoparticles to target specific cells.

The second technology, called the “NeuroDirect delivery system,” administers neuroactive compounds directly to nerve connections to the brain, bypassing the blood-brain barrier, allowing for smaller doses, improved efficacy and immediate response.

“Combining the patented technologies of the Janus particle solution with the NeuroDirect delivery system solves the problem most psychedelic drug development companies are targeting: a safe, effective, take-at-home drug. The stronger the medicine, the more likely the need for on-site medical oversight; this layers in massive costs,” said Chad Harman, CEO of Psycheceutical. 

Braxia Scientific Launches Broad Criteria Trial On Psilocybin For Depression

Braxia Scientific Corp. BRAX BRAXF is launching a randomized clinical trial using psilocybin for adults with treatment-resistant depression.

According to Braxia, this trial will have wider inclusion criteria than other similar studies.

"This will be the broadest study of its kind," said Dr. Joshua Rosenblat, medical director of the Canadian Rapid Treatment Centre of Excellence Inc., a wholly-owned subsidiary of Braxia Scientific where the study will be held.

"Whereas most other treatment-resistant depression studies limit participation to patients that have not found relief from a maximum of five other potential remedies, our research will not have an upper limit, and will even include patients that have endured dozens of unsuccessful medical trials, including ketamine and electroconvulsive therapy,” Rosenblat said.

The trial will also include patients with more than two failed medical trials, as well as patients with bipolar depression.

Awakn To Launch Ketamine Study For Gambling Addiction

Awakn Life Sciences Corp. AWKN AWKNF has received approval to launch a human study looking into the effects of ketamine in gambling addiction.

The early-stage study will analyze if ketamine administration can modify reward memories associated with gambling, and if successful, will serve as the basis for possible clinical trials using the same method in improving gambling addiction.

While Awakn has begun recruiting human participants, this study is not a clinical trial, explained Prof. Celia Morgan, Awakn’s head of ketamine-assisted psychotherapy, in an interview with Benzinga.

“It’s a mechanistic study, where we’re looking at modulating memory,” she added. “We’re not looking at clinical outcomes, so we’re not looking at changes in gambling severity as an outcome of this. We’re simply looking to see how strongly people react to gambling queues.”

Through this study, the research team is trying to understand if, by blocking the body’s NMDA receptors, ketamine can block the reconsolidation of memories associated with gambling behavior.

PharmaDrug Strikes Deal With Johns Hopkins University For A Clinical Trial Into Psychedelic DMT

On Wednesday, PharmaDrug Inc. PHRX LMLLF announced a new clinical trial agreement with Johns Hopkins University’s Center for Psychedelic and Consciousness Research at the faculty of psychiatry and behavioral sciences.

The research will encompass a clinical study comparing the psychological and neural effects of N,N-dimethyltryptamine (DMT) with an undisclosed comparator molecule–presumably psilocybin, based on the university’s research record into psychedelics.

As per the agreement, PharmaDrug will gain an exclusive option to obtain worldwide, royalty-bearing commercialization licenses to all rights derived from the study’s results.

The researchers will use psychological assessment tools as well as MRI and EEG to characterize any acute and persisting subjective, affective, cognitive and neural dose-dependent effects for both drugs in human subjects.

Cantor Gives Cybin An Overweight Rating And x4 Price Target

Cantor Fitzgerald initiated coverage of Cybin CYBN.

Analysts gave Cybin an overweight rating and a 12-month price target of $9. Cybin shares closed at $2.34 on Friday. 

This means that according to the financial firm, Cybin stock could give a margin of almost 300% in just one year.

Cybin’s formulation could “prove to be a driver of scalability for the new paradigm of psychedelic-assisted therapy of the future,” according to Cantor analysts Charles C. Duncan and Pete Stavropoulos.

While Cybin’s current cash on hand will not be disclosed until the next earnings call, the analysts estimate that adding the company’s recent CA$34 million ($26 million) raise, its current cash holdings could reach CA$87.5 million ($68 million).

In a recent interview with Benzinga, Cybin CEO Doug Drysdale said the company is very well capitalized for “many years into the future.”

National Institute On Drug Abuse To Research DMT In Partnership With Psilera

Florida-based Psilera Inc. announced a “research and development agreement” with the National Institute on Drug Abuse (NIDA) for the launch of a series of preclinical studies on Psilera’s psychedelic drug pipeline.

The pipeline includes an intranasal formulation of DMT, the active ingredient in ayahuasca.

The company recently closed $2.5 million in funding for research, scientific, clinical personnel hiring and general working purposes.

The research collaboration will focus its efforts in two programs. One will study pharmacokinetics and pharmacodynamics of an intranasal formulation of DMT developed by Psilera, in preclinical animal studies.

The second initiative will determine the molecular targets of new chemical entities developed by Psilera, which will inform the company’s future drug development pipeline.

The Milestone Round

• KetamineOne Capital MEDI KONEF announced Monday that it has established a Medical Advisory Board to help guide the development of its mental health platform.

• Mind Medicine Inc. MNMD announced Tuesday that it has teamed up with Forian Inc. FORA to develop best practices for using real-world evidence information to achieve personalized characterizations of individuals with generalized anxiety disorders and other conditions.

• Havn Life Sciences Inc. HAVN HAVLF has signed an agreement to supply naturally-derived psilocybin to Mycotopia Therapies TPIA for their psychedelic therapies.

• Filament Health Corp. (NEO Exchange: FH) has completed a shipment of Good Manufacturing Practices (GMP)-compliant natural psilocybin into the United States. This export was shipped from Filament's Vancouver facility to the University of California San Francisco's Translational Psychedelic Research Program, in connection with an anticipated phase 1 FDA trial.

• Mind Cure Health Inc. MCUR MCURF has released the minimum viable product version of iSTRYM, its digital therapeutics platform (DTx) for psychedelics, into partner clinics across North America.

• Tryp Therapeutics TRYP TRYPF has completed the training of psychotherapists for its upcoming Phase 2a clinical trial using synthetic psilocybin in combination with psychotherapy for overeating disorders, in partnership with Fluence.