NUMI Numinus Wellness Inc

• Ended quarter with strong cash position of $53.9 million
• Revenues grew 245% year-over-year to $0.8 million for the quarter
• Generated gross profit of $50,965 during the quarter, representing a 6.5% gross margin
• Well-positioned to offer psychedelic-assisted psychotherapy services through Canada's newly expanded Special Access Program
• Clinical trial application made to Health Canada to begin Phase 1 study for proprietary psilocybe extract
• MAPS-sponsored MDMA-Assisted Therapy for PTSD study to begin shortly; approvals received from Health Canada and the Institutional Review Board

All financial results are reported in Canadian dollars unless otherwise stated.

VANCOUVER, BC, Jan. 20, 2022 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal first quarter results for the three months ended November 30, 2021.

"We have made significant advancements in all areas of our business over the last several months, with many exciting opportunities on the horizon," said Payton Nyquvest, Founder and CEO. "Of note, the partnership across our lab and clinical teams has been instrumental in passing key milestones on two major clinical trials: one for a proprietary Psilocybe formulation and the other a MAPS-sponsored MDMA study. In addition, we're continuing to make discoveries in our Bioscience lab and recently begun genetic testing on several newly-acquired psychedelic mushroom species." 

Mr. Nyquvest continued, "The recent amendments by Health Canada to the Special Access Programme further underscore the importance and growth potential of Numinus' wellness clinic network. With facilities purpose-designed for a wide range of psychedelic-assisted psychotherapies, therapists already trained on providing Psilocybin-assisted and MDMA-assisted therapies, and a Health Canada distribution license that allows us to import, possess, produce, and distribute psychedelic compounds – Numinus is well positioned as a national leader to provide these important treatments to those who qualify. I'm encouraged by the recent changes by Health Canada and proud of everyone at Numinus for the ongoing leadership, drive and commitment to our mission over the past quarter."

First Quarter Financial Highlights:

• Cash balance of $53.9 million as of November 30, 2021
• Revenues grew 244.5% year-over-year to $0.8 million in Q1 2021, due primarily to the acquisition of Mindspace. Sequentially, revenues grew 60.9% compared to Q4 2021.
• Gross profit of $50,965 in Q1 2022, compared to gross loss of $38,135 in Q1 2021
• Gross margin was 6.5%, compared to -16.6% in Q1 2021
• Loss was $5.4 million for Q1 2022, compared to a loss of $1.9 million in Q1 2021

Operational Highlights During and Subsequent to Fiscal First Quarter 2022:

Numinus Bioscience – Laboratory Operations

• Q1 2022 revenue of $141,702, a 56.4% sequential increase from Q4 2021, but a 27.7% decrease from $196,090 in Q1 2021. This year-over-year decline is primarily due to the Company ceasing cannabis related activities during 2021 to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company's strategy and overall objectives.
• On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus' research and development capabilities and generate new revenue streams through third-party client product testing.

Phase 1 clinical trial on NBIO-01:

• On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract ("NBIO-01"), advancing Numinus' investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
• On January 14, 2022, the Company submitted its clinical trial application to Health Canada for its Phase 1 trial of NBIO-01. The clinical trial, named HOPE, is a two-phase study that will take place at a Vancouver based clinic. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial study ("MAPPUSX"):

• On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to evaluate the safety of MDMA in treating severe PTSD, titled "A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD."
• On January 19, 2022, Numinus announced that it had received approvals from Health Canada and the Institutional Review Board to proceed with its clinical trial study for MAPPUSX. Enrollment for the trial is expected to begin shortly and will be open to eligible participants who were previously enrolled in the placebo arm of the parent study ("MAPP1") or who were not able to receive treatment due to COVID-19 restrictions.

Subsequent to the quarter:

• Numinus Bioscience secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes.

Numinus Health – Numinus Wellness Clinic Network

• Q1 2022 revenue of $647,915, a 61.9% sequential increase from Q4 2021, and a 1,857.6% increase compared to $33,098 during the same period last year when Numinus had only one clinic, which was impacted by COVID-19 during the quarter.
• On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto ("NCT") for less than $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
• During Q1 2022, clients received a total of 6,217 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments and Ketamine-assisted psychotherapy), representing a 91.9% increase in clinic appointments compared to the prior quarter (Q4 2021), due in part to the acquisition of NCT. On a same-store basis, excluding NCT, client appointments increased 42.0% compared to the prior quarter.
• On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term.

Subsequent to the quarter:

• Numinus has finalized a formal Ketamine-Assisted Psychotherapy ("KAP") training program for therapists, with virtual training sessions occurring over the next two months. This training program will expand the number of Numinus therapists qualified to provide KAP sessions to clients.
• As of January 20, 2022, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the Company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).

Corporate Updates

• On November 22, 2021, the Company changed its OTC ticker symbol to "NUMIF" (from "LKYSF") to better align with its Canadian ticker symbol.
• Subsequent to the quarter:
• On December 16, 2021, Numinus graduated to the TSX (from the TSX-Venture), trading under the symbol "NUMI".

Industry Updates

• On January 5, 2022, Health Canada implemented amendments to the Special Access Programme ("SAP"). These amendments now enable:
• • Doctors and practitioners to apply for psychedelic medicines that have shown promise through Phase 2 or Phase 3 trials, on behalf of their patients, when other traditional medicines and therapies have not proven effective.
  • Doctors and patients to hear, within 48 hours of the application being submitted, if access to psychedelic medicines are approved for their case. If approved, doctors can refer patients to clinics – such as Numinus' wellness clinics, to receive psychedelic-assisted psychotherapy.
  • Companies holding a Health Canada dealers license, including Numinus Bioscience, to act as a licensed distributor of certain psychedelic medicines for SAP approved cases.

Q1 2022 Key Performance Metrics:

Numinus' condensed consolidated financial statements for the three months ended November 30, 2021 and related management's discussion and analysis are available on Numinus' Investor Relations website at www.investors.numinus.com and under the Company's profile on SEDAR at www.sedar.com.  These documents were prepared in accordance with IFRS and with TSX-Venture disclosure timeline requirements, as the company was listed on the TSX-Venture at quarter end.

Conference Call and Webcast Details

Interested parties are invited to participate in the Company's Q1 2022 results conference call and webcast. On the call Numinus executives will review the Company's performance and recent initiatives, and answer questions from analysts.

The webcast will also be archived on the Events and Presentations page of Numinus' Investor Relations website: https://www.investors.numinus.com/events-and-presentations

About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", "believes", "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

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SOURCE Numinus Wellness Inc.