The companies expect a third-quarter close.
The companies expect a third-quarter close.
The Daily Hit is a recap of the top financial news stories for March 14, 2023.
Ascend Increases Revenue in Q4, but Still Not Profitable
New York-based Ascend Wellness Holdings Inc. (CSE: AAWH.U) (OTCQX: AAWH) got leaner and meaner while also expanding its footprint significantly in 2022, but that wasn’t enough to make the company profitable yet. Read more here.
Arkansas Medical Marijuana Sales Surge in First Two Months of 2023
Arkansas medical marijuana patients spent a total of $45.5 million on products in January and February, up 9.6% from the first two months of 2022. The total amount purchased by registered patients in that period was 8,832 pounds. Read more here.
Psychedelic Patent Battle Heats up Between Reunion Neuroscience and Mindset Pharma
Psychedelic clinical research firm Reunion Neuroscience Inc. (NASDAQ: REUN) is taking Mindset Pharma Inc. (OTCQB: MSSTF) to federal court over claims that the company copied its main psychedelic formula and presented it as its own invention while applying for a patent. Read more here.
Politicians at SXSW Suggest Narrow Window for Cannabis Rescheduling
There’s a narrow window for federal cannabis legalization, according to politicians speaking at this year’s SXSW conference in Austin, Texas. During the cannabis track, consultant Andrew DeAngelo challenged his panelists for answers on why federal legalization had not seen any progress. Read more here.
Altopa Inc., a company that markets a blender designed to blend cannabis oils into drinks, can’t escape a securities suit alleging it deceived investors. A North Carolina federal judge on Monday found that the bulk of the claims that Altopa misled investors were pled well enough to survive a challenge. Read more here.
Combined sales of recreational and medical cannabis in Connecticut totaled more than $18 million in February, the first full calendar month since the Jan. 10 launch of the legalized sale of recreational marijuana in the state. Read more here.
Psychedelic clinical research firm Reunion Neuroscience Inc. (NASDAQ: REUN) is taking Mindset Pharma Inc. (OTCQB: MSSTF) to federal court over claims that the company copied its main psychedelic formula and presented it as its own invention while applying for a patent.
Reunion filed a lawsuit against Mindset in the U.S. District Court for the District of New Jersey and is seeking to have its Chief Scientific Officer, Nathan Bryson, added as an inventor of the RE104 compound patent.
The company is also making claims for co-ownership of the patent, unfair conduct in the patent application process, and breach of contract.
“Reunion is proud of its inventions to further its mission to improve the lives of patients and families who suffer from depression and other mental health disorders and intends to vigorously protect its intellectual property position to the fullest extent,” it said in a Tuesday morning statement.
Reunion said it had been developing RE104 to treat postpartum depression and other mental health conditions and was given a patent by the U.S. Patent and Trademark Office (PTO) in April 2022, allowing the company the exclusive right to make and sell the composition until 2041. The patent made public the composition of Reunion’s psychedelic compound.
According to court documents, Reunion alleges that Mindset, another clinical psychedelics firm, copied RE-104 after it saw it in the patent approval and presented it as its own invention to the PTO in June, a few months after the Reunion’s chemical composition was made public.
It claims Mindset named two of its employees as co-inventors of RE-104, even though Bryson was the sole inventor, the company said. Reunion accused Mindset of misrepresentation and fraudulently omitted Bryson’s involvement.
Reunion alleges that Mindset “brazenly” told Reunion that it needed a license from Mindset to use the compound. Wanting to avoid litigation, the two sides agreed to meet to resolve the conflict. Reunion also noted in the court documents that the issue was affecting its third-party funding and wanted to resolve the issue so that its funding could move forward.
The filing stated, “The parties orally agreed on the timing, form, and amount of upfront payments, milestone payments, and royalties.”
After the meeting between the two companies, the CEOs shook hands on an agreement, but the case accuses Mindset of later walking back on the deal.
Reunion said it is suing Mindset to protect its intellectual property and hold it liable for purposely hurting the company.
In a statement released shortly after Reunion made the case public on Tuesday, Mindset said that it “disagrees with and denies the allegations set forth by Reunion.”
“The company plans to vigorously defend itself against this lawsuit,” it said.
Reunion requested a variety of remedies from the court. The company wants the inventorship of the Mindset’s patent to be corrected, meaning that the actual inventors of the patent are recognized, and for the director of the PTO to issue a certificate of correction reflecting this change.
Reunion also wants a declaration that states that it co-owns Mindset’s patent and the inventions claimed within it, and a separate declaration that Mindset engaged in conduct that makes the patent legally unenforceable.
The company is also seeking financial compensation such as its lawyers to be paid, damages resulting from Mindset flipping its position after an oral deal was made, and damages for its interference with Reunion’s ability to profit.
In January, Reunion completed an interim analysis of its phase 1 clinical trial of RE104. The trial involved 32 healthy volunteers who were given ascending doses of RE104, with two of eight subjects receiving a placebo in each cohort.
The drug was found to be safe and well tolerated with no severe adverse events, and showed robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience compared to psilocybin.
The company said that it identified a dose level at which most participants achieved a “complete mystical experience,” which has been shown to correlate with psychedelic treatment responses in clinical trials of patients with depression, anxiety, and substance use disorder.
Reunion said it had moved to submit the data to the FDA as part of a pre-Investigational New Drug meeting in preparation for phase 2 trial development.
Reunion Neuroscience Inc. (NASDAQ: REUN) reported financial results for the third quarter ending December 31, 2022 with no revenue for the biotech company. Reunion did report a net loss from continuing operations of $12.5 million or $1.07 per share for the three versus a loss of $5.9 million or $0.51 per share for the same time period in 2021. As of December 31, 2022, the company held cash, cash equivalents, and investments of $32.4 million.
Reunion said that it continues to advance its serotonergic psychedelic compound called RE104 through the clinic as a potential fast-acting, durable treatment for patients suffering from PPD (postpartum depression). The company said in a statement that one in eight mothers experience PPD, and there remains only one FDA-approved treatment for the condition, which is administered by continuous infusion over a 60-hour inpatient hospital stay and has a black box safety warning due to excessive sedation and potential for sudden loss of consciousness.
As a novel serotonergic psychedelic, single-dose RE104 could potentially provide mothers with fast relief and a quick return to mother-child bonding and breastfeeding (an estimated 24 to 48 hours) due to RE104’s limited-duration psychoactive experience (less than four hours), durable efficacy and rapid washout period. This compares favorably to psilocybin treatments that can last six to eight hours.
In January 2023, Reunion reported that it had completed its Phase 1 interim data analysis, which showed that RE104 was safe and well tolerated, with no serious or severe adverse events. The interim analysis included 32 healthy volunteers across four ascending dose cohorts, with two of the eight subjects in each cohort receiving a placebo. RE104 demonstrated robust and pervasive pharmacodynamic effects with a shorter duration of psychedelic experience relative to published data with psilocybin (approximately three to four hours for RE104 versus six to eight hours for psilocybin).
After completing the preplanned interim analysis, and per the recommendation of the Safety Review Committee, Reunion continued with dose escalation to seek additional safety, pharmacokinetic and pharmacodynamic data. Exploring further doses with the two additional planned cohorts will provide Reunion with valuable data to inform the selection of a recommended Phase 2 dose.
Reunion also reported that it has submitted the Phase 1 data to an upcoming 2023 medical congress and to the FDA in preparation for initiating a randomized Phase 2 study evaluating RE104 versus placebo in the treatment of women with PPD in the second half of 2023. It is expected that the multicenter trial will enroll approximately 40 patients from 20 centers across North America.
Mr. Mayes added, “We also welcomed Dr. Robert Alexander as Chief Medical Officer, an accomplished pharmaceutical executive who brings to Reunion a proven track record in psychopharmacology. We remain on track to share the results of our Phase 1 study with the FDA in preparation for Phase 2 development in postpartum depression (PPD) later this year.” Alexander was a former executive at Takeda, Pfizer, AstraZeneca, GSK, and Merck, with extensive experience in psychopharmacology, having conducted or supervised clinical studies in a broad range of neurologic and psychiatric indications.
Reunion will present findings to the FDA.
Business analysts take to their crystal balls to provide an industry outlook.
Also a peek at their plans for the year ahead.
Field Trip Health has changed its name to Reunion Neuroscience Inc. (TSX: FTRP)(Nasdaq: FTRP) and reported its fiscal first quarter 2023 results for the period ending June 30, 2022. Reunion reported expenses of $5 million and a net loss of $13 million. The increase in net loss from the prior year primarily reflected the company’s focus on investing in RE104 which recently began its Phase 1 clinical trial, as well as increased public company costs.
There are no revenues at this time. As of June 30, 2022, the company had approximately $52.3 million in unrestricted cash, cash equivalents, and short-term investments.
On August 11, 2022, The company completed its split of its Field Trip Discovery and Field Trip Health divisions into two independent companies. Field Trip Health, which is the clinic side of the company, was renamed Field Trip Health & Wellness Ltd. and has received listing approval from the Toronto Stock Exchange Venture under the new ticker symbol “FTHW”.
Field Trip Discovery, which is the drug research side of the company, was renamed Reunion Neuroscience Inc. and will remain listed on the NASDAQ Stock Market and Toronto Stock Exchange under the ticker symbol “REUN”. Immediately upon closing of the Arrangement, the Company consolidated its shares on a 5:1 basis, which is expected to cure the NASDAQ minimum bid price deficiency previously announced. The company said it also received approval from the Toronto Stock Exchange for Field Trip H&W to list on the TSX-V under the ticker symbol “FTHW”. The first day of trading for both companies under their respective new tickers is August 17, 2022.
Reunion’s lead drug is RE-104 (previously known as FT-104) and it is a proprietary, novel psychedelic drug being developed for post-partum and treatment-resistant depression as a potential fast-acting antidepressant with durable efficacy. Reunion is also developing the FT-200 series, which includes compounds with the potential for more selective serotonin receptor activity with reduced psychoactivity for potential use in more chronic treatment paradigms and indications.
On July 21, 2022, announced successful first dosings in the company’s Phase 1 Clinical Study of its first novel psychedelic molecule, RE104 (formerly FT-104), being conducted in Australia. Reunion said it expects to report results from the study in the calendar fourth quarter of 2022 and is planning to seek FDA guidance on Phase 2 studies planned for 2023. During the quarter, the company was granted a patent for claims related to RE104 entitled, “Tryptamine Prodrugs”. The patent provides exclusive rights to Reunion until 2040 for the composition of matter, formulations, methods of use and methods of manufacture for a family of hemi-ester compounds of hydroxytryptamines, including Isoprocin.
Joseph del Moral, Founder and Chief Executive Officer of Reunion, said, “We are pleased to have successfully completed the split of Field Trip into two distinct companies – Reunion and Field Trip Health & Wellness. As independent companies, each will be laser-focused on executing their own strategic vision and investment priorities, and creating long-term value for their respective shareholders. The future is bright for both businesses and each is excited to continue developing and delivering innovative psychedelic-assisted treatment options.”
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