Enveric Biosciences (NASDAQ: ENVB) announced that the United States Patent and Trademark Office issued U.S. Patent No. 11,752,130, titled “Carboxylated Psilocybin Derivatives and Methods of Using,” pertaining to the Company’s EVM301 Series of molecules being developed as potential treatments for mental health disorders.
“Our EVM301 Series consists of small molecule therapies designed with the intent to enhance neuroplasticity while reducing or eliminating hallucinations associated with other psychedelic or psychedelic-inspired agents,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “This unique design could be potentially game-changing in the treatment of depression and anxiety as it offers the opportunity to administer psilocybin-derived medications without the requirement for a healthcare professional to observe during dosing. We believe this could greatly enhance the commercial opportunity of EVM301 Series-based therapies, benefiting patients and healthcare systems broadly by reducing the need for costly and time-intensive requirements for supervision throughout the treatment. For these reasons, Enveric is seeking to build a robust intellectual property portfolio for our EVM301 Series with this U.S. patent providing a critical IP cornerstone.”
This new patent, issued September 12, 2023, provides Enveric with intellectual property rights with claims to novel compositions and pharmaceutical drug formulations for a family of carboxylated derivatives of tryptamine-based drug candidates. The company said it expects the patent to further strengthen and add value to Enveric’s EVM301 Series of compounds, which are undergoing lead optimization and preclinical candidate characterization procedures.
Last month Diamond Equity Research issued a report covering the company although it should be noted that Diamond was paid by Enveric to perform the analysis which noted the company’s market cap was lower than its cash position.
The report stated, “We assume a discount rate of 12.50% and a probability of success for EB-373 at 10%, resulting in a valuation of $21.02 million based on our risk-adjusted DCF approach. Notably, the company’s current market capitalization of $4.86 million is lower than its net cash position of $7.07 million. It’s important to consider that this situation, commonly found in non-revenue-generating biotech companies, often arises due to elevated risks and the potential for higher cash burn rates. Additionally, we undertook a comparable company-based valuation analysis, assigning a weightage of 10% to this relative valuation approach. The blended approach resulted in a valuation of $21.47 million, or $10.00 per share, contingent on successful execution by the company.”
Seelos Therapeutics, Inc. (Nasdaq: SEEL) announced top-line data demonstrating clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile from the double-blind, placebo-controlled cohort (Part 2) of its Phase II study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD).
However, while Montgomery-Åsberg Depression Rating Scale (MADRS) results at 24 hours after dosing utilizing 2-way ANCOVA with baseline MADRS as a covariate (the pre-defined primary endpoint/analysis) demonstrated clinically meaningful results, it did not achieve statistical significance under the methodology used (p=0.069, 3.3 point LS mean treatment difference).
“The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care,” said Tim Whitaker, M.D., Chief Medical Officer of Seelos. “We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps. In addition, we want to thank the study participants, as well as the clinical trial sites and staff, for their expert and careful care of these high-risk study patients.”
Seelos said in a statement that the SLS-002 drug demonstrated early and persistent reductions in symptoms of depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). The graph presents results from the mixed model for repeated measures (MMRM) analysis of change from baseline in MADRS total score.
Smaller Study Size
The company had planned on enrolling 220 patients, however, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. Seelos did note that due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post-dosing). “However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint, had the study reached full enrollment (220 patients).”
“The analyses of the 147 enrolled subjects in this multicenter, double-blind placebo-controlled trial of SLS-002 demonstrated both meaningful early and persistent improvement in depressive symptoms, as well as clinically meaningful reduction in acute suicidality symptoms relative to standard of care,” said Tim Whitaker, M.D., Chief Medical Officer of Seelos. “We believe these results demonstrate the therapeutic potential of SLS-002 to address this huge unmet need and those at risk. We look forward to our discussions with the FDA to align on next steps.”
“We believe these data are remarkable. We expect to move forward with our development of SLS-002 after the end of Phase II meeting with the FDA,” said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. “The improvements with SLS-002 were robust and continued to improve across efficacy scales with 5 doses over the two-week treatment period. In addition to the data on efficacy, the differentiated and well-tolerated safety profile of SLS-002 highly underscores this product candidate’s uniqueness and potential for the treatment of ASIB in MDD. We look forward to advancing this therapy toward a potential first approval for an important unmet need for this patient population, especially considering that 2022 experienced the highest number of suicides in U.S. history.”
Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), closed its United States-only public offering raising approximately $2.25 million. The offering consisted of 7,500,000 common shares and pre-funded warrants and 7,500,000 common warrants. Clearmind said it plans to use the money for general corporate purposes, which may include operating expenses, research, and development, including clinical and pre-clinical testing of its product candidates, working capital, future acquisitions, and general capital expenditures.
The company noted in its offering that it had received a notification from NASDAQ that the shares had traded under a dollar and it had 180 days to get the share price back up. That deadline is November 13, 2023, however, the company could potentially ask for another 180-day extension. This offering though will further dilute shares and could potentially lower the price even further.
The company reported that at the end of 2022, it had $3.8 million in cash, but also warned investors that it was burning through cash and the company had a $14 million deficit. For the year ending in 2022, the company reported a net loss of $6.8 million.
Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.
Additional details stated that the common warrants are immediately exercisable, will expire five years from the date of issuance, and will have an exercise price of $0.30 (C$0.40) per common share. Each common share (or pre-funded warrant in lieu thereof) was sold together with one common warrant at a combined purchase price of $0.30 (C$0.40) per share (or $0.299 (C$0.399) per pre-funded warrant after reducing $0.001 (C$0.001) attributable to the exercise price of the pre-funded warrants) but were issued separately. The common warrants and pre-funded warrants are not listed on any exchange.
Psychedelics firm Mydecine Innovations Group Inc. (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA), which is still in the pre-revenue stage, announced a plan to offer 18.75 million additional shares for distribution at 20 cents apiece, in an attempt to raise $3.75 million.
The offering, outlined in a prospectus filed with Canadian securities regulators late last week, the offering was expected to close over the weekend, according to a press release from Mydecine.
If successful, the money will be used first and foremost “to assist in the transition to the (Canadian Securities Exchange,” according to the prospectus, which could be considered an uplisting from the NEO exchange on which Mydecine now trades in Canada.
In addition, the money raised would also be used to “settle outstanding fees owed to the NEO (exchange), to fund and develop the company’s research and development initiatives, intellectual property portfolio, its clinical trials and research partnerships, its continued development and drug pipeline and for general working capital purposes,” according to the prospectus.
The new 18.75 million shares would join the existing 26.4 million shares of Mydecine already being traded.
The move is the latest in a lengthy string of capital raise moves made by Mydecine executives, and the company has also had something of a revolving door of c-suite leaders.
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