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Novamind Inc. (CSE: NM)(OTCQB: NVMDF) has opened a new clinic located in downtown Salt Lake City to address addiction. The SLC Clinic specializes in integrative behavioral health and services for adults with substance use disorders led by incoming Medical Director, Dr. Amy de la Garza.

Dr. Reid Robison, Novamind‘s Chief Medical Officer, commented: “Social isolation and despair related to the COVID-19 pandemic have further fueled a significant increase in substance use disorders and related deaths. Dr. de la Garza’s expertise in addiction medicine and behavioral health is a vital addition to our team as we continue to expand Novamind’s clinic footprint to address unmet need and broaden our innovative, evidence-based treatments.”

Dr. de la Garza is a board-certified family practice physician with 10 years of experience providing specialized care for patients with behavioral health and SUD diagnoses. She completed an Addiction Medicine Fellowship at the University of Utah and is an Institute for Functional Medicine Certified Practitioner. In 2017, Dr. de la Garza opened the first community-based, co-located primary care and behavioral health practice in Salt Lake City, Utah. “I am thrilled to join Novamind and look forward to establishing an innovative outpatient substance use disorder program that brings together addiction and integrative medicine and treats the whole person,” said Dr. de la Garza, who is also trained in integrative modalities and lifestyle medicine, including nutrition, movement, sleep, stress management, and social connection.

Novamind said that the SLC Clinic’s outpatient SUD services provide an alternative to residential treatment programs and work to address the highly complex public health crisis that is worsening alongside challenges related to access. In 2020 alone, 93,000 Americans died of a drug overdose-an increase of 30% from the previous year, according to the Centers for Disease Control and Prevention.

Novamind said it will collect clinical data on the efficacy of the integrative treatment approach for SUD and host upcoming studies for conditions like opioid use disorder. Additionally, the company said that the SLC Clinic will pilot an innovative and cost-effective group medical visit model that has been shown to reduce anxiety and depression, as well as improve outcomes in chronic conditions like cardiovascular disease and diabetes.

 

Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the third quarter ended September 30, 2021, and gave updates on its business. R&D expenses were $2.6 million for the quarter ended September 30, 2021, compared to $55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to the company’s technical developments and clinical trials and increases in employee expenses to support these activities. the company has no revenue to report at this time.

G&A expenses were $2.1 million for the quarter versus $5 thousand for the same quarter in 2020. GH Research said the increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses. The company also reported a net loss of $1.8 million, or $0.035 loss per share versus $60 thousand, or $0.002 loss per share, for the same quarter in 2020. Cash was $280.7 million as of September 2021 versus $5.9 million as of December 31, 2020.

GH Research lead product is GH001, which is an inhalable 5-MeO-DMT. The company also reported the successful outcome of the Phase 2 part of its Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to the FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

GH Research said it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and, pending the outcome of these meetings, it plans to initiate a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD. The company also stated that it has recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in the first quarter of 2022.

In addition, the company also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103). This trial enrolled 46 healthy volunteers with 30-day safety follow-up. The trial investigated three different single doses of GH001 in a double-blind, placebo-controlled design (6 mg (n=8), 12 mg (n=8), 18 mg (n=8), placebo (n=2 in each dose group)) and a proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day in an open-label, non-randomized design in two groups with two different intervals between doses (1 hour (n=8), 2 hours (n=8)).

High Tide Inc.  (TSXV: HITI) (NASDAQ: HITI) announced that it was going to issue up to C$40 million (or the equivalent in U.S. dollars) of common shares at the company’s discretion and subject to regulatory requirements. High Tide said it plans to use the net proceeds of the offering to fund two specific strategic initiatives it is currently developing, to support the growth and development of the company’s existing operations, funding future acquisitions as well as working capital and general corporate purposes.

“I am pleased to announce the establishment of an ATM Program. Keeping our balance sheet healthy is paramount for us. As previously mentioned, we have cut our debt by more than half over the past 12 months. Particularly considering our size and how active High Tide is, it is critical that we always have sufficient cash on hand to take advantage of any opportunities to create shareholder value,” said Raj Grover, President and Chief Executive Officer of High Tide. “This ATM Program is a very low-cost tool for us and provides an opportunity to be flexible in our approach and potentially raise some capital if and as needed to fund two strategic initiatives we are working on in particular. I look forward to sharing more regarding these initiatives in due course,” added Mr. Grover.

In September, High Tide said it expected to be at approximately 110 stores by the end of calendar 2021, despite some delays experienced in securing building permits. The company said it had made good progress on its application to enter the British Columbia market, and now expects that to occur by end of its 2021 fiscal year. Also in September High Tide said, “We are currently in discussions with multiple parties across a variety of end markets, with a particular focus on e-commerce within the growing ancillary and hemp-derived CBD markets. With a current annual run rate of revenues in the U.S. exceeding $50 million, we believe we are excellently positioned to lever our U.S. customer base to also sell cannabis once permissible by federal regulations and/or exchange policies – and the company intends to continue growing its U.S. presence in the meantime.”

High Tide said it will pay the Agents a cash fee of up to 2% of the gross proceeds and will reimburse certain expenses incurred by the Agents. Any shares sold through the ATM Program will be sold at prevailing market prices when issued (i) in ordinary brokers’ transactions on the Nasdaq Capital Market or another U.S. marketplace on which the common shares are listed, quoted, or otherwise traded or (ii) in ordinary brokers’ transactions on the TSX Venture Exchange or another Canadian marketplace on which the common shares are listed, quoted or otherwise traded.

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