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Numinus Wellness Inc. Reports Q3 2022 Results

Numinus Wellness Inc. Reports Q3 2022 Results

  • Revenues grew 32% year-over-year to $0.74 million for the quarter
  • Clinic network revenues grew 59.5% from the same quarter last year and 7.5% compared to prior quarter
  • Achieved 24.4% gross margin and $180,845 gross profit of during Q3 2022
  • Ended quarter with strong cash position of $41.8 million
  • Completed acquisition of Novamind, positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies
All financial results are reported in Canadian dollars unless otherwise stated.

VANCOUVER, BC, July 14, 2022 /CNW/ –  Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal quarter results for the three and nine months ended May 31, 2022 (“Q3 2022”).  Q3 2022 results do not reflect contributions from the acquisition of Novamind, which completed subsequent to quarter end, on June 10, 2022. 

“Our fiscal third quarter was highlighted by the announcement of our acquisition of Novamind, and the activities leading up to the completion of that strategic transaction on June 10, 2022. Now, with 13 wellness clinics across North America, four clinical research sites and a dedicated psychedelics research facility, Numinus is firmly positioned as a leading mental health care company providing psychedelic-assisted therapies. We’re very pleased with how our operations are integrating and with the collaborative efforts we are already seeing across our new expanded team,” said Payton Nyquvest, Founder and CEO. “We look forward to sharing our combined performance with you when we announce our fiscal fourth quarter results – which will be the first quarter demonstrating the power of our larger, cross-border platform.”

“Today, including the contributions of Novamind, Numinus is one of the highest revenue-producing mental health care companies providing psychedelic and ketamine-assisted therapies, with more than $12 million of combined proforma annual revenues (based on trailing four quarters). We continue to be excited about the momentum building across our business and our outlook ahead. With significantly strengthened revenue streams, a growing number of client services, and positive regulatory reforms underway, our focus is squarely on reaching profitability as quickly as possible. Our strategy to accelerate Numinus’ path to profitability also includes expanding higher-margin services, increasing business development activities, and proactively managing our operating costs. Our goal is to achieve operational profitability within two years and corporate positive cashflow within three years,” concluded Mr. Nyquvest.

Third Quarter Financial Highlights

  • Revenues grew 31.8% year-over-year to $741,064 million in Q3 2022, due primarily to the acquisitions of Mindspace and the Neurology Centre of Toronto. Sequentially, revenues declined by 5.7% from the prior quarter, due entirely to shifting strategic priorities at Numinus Bioscience – where analytical testing services for third-party corporate clients has ceased due to changing sector dynamics. The elimination of this revenue stream was partially offset by 7.5% revenue growth achieved through Numinus’ clinic network operations.
  • Gross margin grew to 24.4% during Q3 2022, compared to -2.8% in Q3 2021. The improvement in gross margin is due mostly to the completion of acquisitions between periods, and the offering of higher-margin services.
  • Gross profit of $180,845 in Q3 2022, a significant improvement compared to the gross loss of $15,497 in Q3 2021.
  • Loss was $7.0 million for Q3 2022, compared to a loss of $4.8 million in Q3 2021, due in part to corporate development and legal expenses related to the acquisition of Novamind Inc.
  • Cash balance of $41.8 million as of May 31, 2022.

First Nine Months Financial Highlights

  • Revenues during the first nine months of fiscal 2022 grew 126.5% year-over-year to $2.3 million due primarily to the continued post-acquisition growth of Mindspace and the acquisition of NCT.
  • Gross margin during the first nine months of 2022 was 19.9%, compared to -11.1% in the same period last year.
  • Gross profit during the first nine months of 2022 was $460,569, a significant improvement compared to the gross loss of $113,356 in the same period of 2021.
  • Loss was $20.2 million for the first nine months of 2022, compared to a loss of $11.0 million in the first nine months of 2021.

Operational Highlights During and Subsequent to Q3 2022
As a reminder, operational performance for the third quarter and first nine months of fiscal 2022 does not include contributions from the acquisition of Novamind, which completed subsequent to quarter-end, on June 10, 2022.

Numinus Wellness Clinic Network

  • Q3 2022 revenue of $731,064, a 7.5% sequential increase from Q2 2022, and a 59.5% increase compared to $458,316 during the same period last year.
  • During Q3 2022, clients received a total of 5,634 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments, paid group programs and Ketamine-assisted psychotherapy), representing a 5.9% increase in clinic appointments compared to Q2 2022.
  • As of May 31, 2022, Numinus had five wellness clinics and two clinical research sites. As of July 14, 2022, following the acquisition of Novamind, Numinus has 13 wellness clinics offering services to clients (one in Vancouver, one in Toronto, three in Montreal, eight in Utah and two in Arizona). In addition, the Company has four dedicated research clinics where psychedelic studies are being conducted (two in Salt Lake City, one in Vancouver and one in Montreal).
  • Following a review of its growth initiatives and opportunities, Numinus has decided to cancel its previously announced second wellness clinic location in Vancouver, Canada. The acquisition of Novamind has provided additional growth opportunities that the Company expects could provide higher return-on-investment.
  • Subsequent to the quarter, on June 23, 2022, Numinus launched a pilot mental health program for corporate clients: Corporate Ketamine-Assisted Psychotherapy (“Corporate KAP”). This Utah-based program is aimed at helping businesses improve employee mental health by offering ketamine-assisted psychotherapy as a health benefit for eligible employees.

Clinical Trials

  • On March 30, 2022, Numinus announced it began administering MDMA-assisted psychotherapy to clinical trial volunteers for the “multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)” trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC).
  • On May 16, 2022, Numinus announced it received Health Canada Special Access Programme (“SAP”) approval to provide psilocybin-assisted therapy to a patient with treatment-resistant depression. This was Numinus’ first psilocybin-assisted therapy treatment outside of clinical trials; amongst the first to use this regulatory mechanism through Health Canada’s SAP.
  • As part of the Company’s focus on accelerating its timeline to profitability, Numinus has decided to postpone its clinical trials of NBIO-01 and NBIO-03, given the high cost of clinical trials. Once the company can see a clear pathway to regulatory approvals or has achieved profitability, the clinical trials for these drug candidates will commence.

Numinus Research – Laboratory Operations

  • Given sector consolidation, the decreasing corporate client base for psychedelic substance analytical services and limited revenue generating opportunities, Numinus Bioscience intends to focus purely on proprietary research activities for the foreseeable future. The divisions’ analytical testing capabilities remain available for proprietary and on-request projects; however, the company has eliminated its business development activities for these services to reduce expenses in this period of sector dislocation. As this business decision was implemented partway through the quarter, Numinus Bioscience generated revenue of $10,000 during Q3 2022 and is not expected to generate any further revenue from analytical testing services until and unless sector dynamics improve to sustain those business operations.
  • In March 2022, Numinus Bioscience expanded its research capabilities as a result of the addition of a Public Health Agency of Canada for a Containment Level 2 (CL2) pathogens and toxins license, and the approval from Health Canada to add Ayahuasca & San Pedro to its federal license for psychedelic research.
  • On June 22, 2022, Numinus Bioscience filed a patent application to the World Intellectual Property Organization (WIPO), an agency of the United Nations, for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds. A provisional patent application for the process was submitted to the United States Patent & Trademark Office (USPTO) on June 24, 2021. With this additional filing, international patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands, and the United Kingdom, where psychedelic research is currently active.

Corporate Updates

  • On June 27, 2022, Numinus introduced its new logo and brand identity, which will unify Numinus’ presence across North America. The rebranding activities will be accomplished in phases and completed by the end of 2022.
  • On April 12, 2022, Numinus announced it made an offer to acquire Novamind – positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies. The transaction was overwhelmingly approved by Numinus and Novamind shareholders at separate shareholder meetings on June 8, 2022. On June 10, 2022, the acquisition of Novamind was completed with Novamind shareholders receiving 0.84 Numinus shares per Novamind share. As a result of the acquisition, Novamind was delisted from the CSE and OTC exchanges.
  • On June 10, 2022, Numinus announced several executive appointments. Michael Tan was promoted to President and Chief Operating Officer, Reid Robison was appointed Chief Clinical Officer, and Paul Thielking has been appointed Chief Science Officer.

Q3 2022 Key Performance Metrics

For the quarter ended May 31:
20222021% change 
     Numinus Bioscience¹ revenue10,000103,760-90.4 %
     Numinus Clinic Network2 revenue731,064458,31659.5 %
Total Revenue$741,064$562,07631.8 %
Cost of revenue(560,219)(577,573)-3.0 %
Gross Profit (Loss)$180,845$(15,497)n.m.
   Gross profit margin24.4 %-2.8 %n.m.
General and administrative expenses(5,269,941)(2,485,805)112.0 %
Share-based compensation(212,321)(610,386)-65.2 %
Sales and marketing expenses(441,723)(967,670)-54.4 %
Depreciation & Amortization(173,219)(76,226)127.2 %
Research and development expenses(506,665)(631,124)-19.7 %
Transaction costs(456,747)(8,369)5,357.6 %
Loss before other items$(7,008,112)$(4,824,424)43.5 %
Other items(142,209)(29,347)384.6 %
Revaluation of contingent liability13,8680100.0 %
Loss and comprehensive loss$(7,008,112)$(4,824,424)45.3 %
Loss per share, basic and diluted$(0.03)$(0.02)34.1 %
Average number of shares outstanding,basic and diluted210,247,839149,026,9718.4 %
1 Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations, which ceased analytical testing services to third-party corporate clients during Q3 2022.
2 Numinus Clinic Network revenues generated through NCT, Mindspace and Numinus Health.


Numinus’ condensed consolidated financial statements for the three and nine months ended May 31, 2022 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.

Conference Call and Webcast Details

Interested parties are invited to participate in the Company’s Q3 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.

Date:Thursday, July 14, 2022
Time:5:30 p.m. (EST)
Dial-In:1 (888) 330-3632 (Toll-free North America), 1 (646) 960-0837 (International)
Code:3547386
Webcast:https://event.on24.com/wcc/r/3825889/3D9B9AD399CFA2D70257C91AC4C8F78A


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.

Disclaimer

Neither Numinus Wellness Inc., nor any of its subsidiaries is a professional corporation licensed to practice health services. In jurisdictions where health services may only be provided by a corporation if that corporation holds a valid permit to do so, Numinus and its subsidiaries operate in a management services function to affiliated professional corporations, who provide health services to patients. Numinus and its subsidiaries do provide health services directly to patients in those jurisdictions where authorized to do so.

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 impact of the Russia-Ukraine conflict on the global economy; 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.

SOURCE Numinus Wellness Inc.

For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations & Communications, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, Hilary Strath, Director, Communications, hilary.strath@numinus.com

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Pasithea Therapeutics Awarded a Drug Development Research Grant

Pasithea Therapeutics Awarded a Drug Development Research Grant

— AUD $1 million (U.S $694,000) grant transferred as part of Alpha-5 Integrin, LLC transaction —
— Provides approximately U.S. $694,000 of non-dilutive funding —

MIAMI BEACH, Fla., July 14, 2022 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced the availability of an AUD $1 million (U.S. $694,000) drug development research award following the Company’s acquisition of Alpha-5 integrin, LLC (“Alpha-5”). The grant was awarded by FightMND, the largest independent funder of amyotrophic lateral sclerosis (“ALS”)/motor neuron disease (“MND”) research in Australia.

Pasithea is developing a monoclonal antibody (mAbs) for the treatment of ALS and other neuroinflammatory disorders. Currently, there is no cure for ALS, and there are no effective treatments to halt or slow the progression of the disease. Alpha-5/beta-1 integrin expression is significantly increased in ALS animal models and post-mortem human ALS and significantly upregulated with disease progression. Pasithea has multiple monoclonal antibody candidates against alpha-5/beta-1 integrin. Treatment with these antibodies extends survival and improves motor function in the SOD1 mice model of ALS.

“With the transfer of this grant, we will have a source of non-dilutive funds to test our monoclonal antibodies in the TDP-43 mouse model and progress the candidate toward the clinic. Ultimately, we aim to help ALS/MND patients who are in dire need of effective therapy,” stated Dr. Tiago Reis Marques, CEO of Pasithea.

About Amyotrophic Lateral Sclerosis

ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. It most commonly affects people between the ages of 40 and 70, with an average age of 55 at the time of diagnosis. It affects as many as 30,000 patients in the United States, with 5,000 new cases diagnosed each year. The average life expectancy after diagnosis is two to five years, but some patients may live for years or even decades. While 5-10% of cases are hereditary (familial ALS), the large majority of cases (90-95%) are not hereditary (Sporadic ALS). The cause of ALS is not completely understood and multiple complex factors may contribute to the death of motor neurons. Currently there is no known cure or treatment that halts or reverses the progression of ALS, and FDA only approved 2 medications so far for the treatment of this disorder, both shown to modestly slow the progression of ALS.

About FightMND

Founded in 2014, FightMND was established in Australia with the purpose of finding effective treatments and ultimately a cure for Motor Neuron Disease (MND), also referred to as ALS or Lou Gehrig’s Disease. FightMND, with its vision of a world without MND, is the largest independent funder of MND research in Australia. What FightMND has done since 2014, is be the voice and the guiding star for Australians who want to fight “The Beast”. Integral to this vision is the determination to help facilitate the translation of the growing body of new knowledge about the disease into a cure for MND patients in Australia and abroad. For more information about FightMND, visit the website at https://fightmnd.org.au.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact

Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations

Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released July 14, 2022

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Enveric Biosciences Advances Drug Development for Mental Health Indications and Intellectual Property Portfolio

Enveric Biosciences Advances Drug Development for Mental Health Indications and Intellectual Property Portfolio

July 13, 2022

— Advancing to IND-enabling studies with multiple drug candidates —

— Enveric’s Growing Patent Portfolio Validated —

CAMBRIDGE, Mass. – Enveric Biosciences, Inc.(NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, today revealed drug discovery and development progress targeting mental health indications and intellectual property (IP) advances achieved during the first half of 2022.

“The first half of 2022 was foundationally successful for Enveric. We validated and executed on the corporate premise that we can deploy PsyAITM, our proprietary artificial intelligence tool, and PsybraryTM, our expanding proprietary portfolio of new chemical entities and drug candidates, to design and improve upon new drug molecules inspired by legacy psychedelic drugs,” said Dr. Joseph Tucker, PhD, Enveric’s Chief Executive Officer.

“Enveric is pleased to advise that our predictions have materialized, and our platforms have successfully generated a large number of promising new molecules that have successfully passed primary screening and moved on to lead optimization, providing us with a strong slate of drug candidates. Our leading program, EVM-201, includes a number of new molecules currently in lead optimization that are geared towards providing improved characteristics and drug-like properties compared with psilocybin. The successful outcomes from our testing efforts completed in the first half of 2022 have positioned the company very well to advance our drug candidates towards the clinic,” continued Dr. Tucker.

Clinical-Need Driven

Based on extensive direct clinical understanding of the current unmet needs in anxiety, depression, PTSD, and other mental health indications, coupled with in-depth knowledge of the current treatment landscape, Enveric’s Clinical Team is well positioned to tackle the challenges ahead, while aiming to shepherd novel new treatments for a host of mental health indications.

Enveric’s Clinical Team is led by a past Board-certified psychiatrist and clinical trialist Chief Medical Officer, Dr. Bob Dagher, MD. Dr. Dagher joined Enveric in December 2021, bringing a wealth of clinical trial management and new CNS-drug development experience from his past roles, including at WCG, Cadent, Covance, Sanofi and GSK, in addition to his first-hand experience in treating patients from his previous clinical practice in psychiatric medicine.

Next-Generation Drug Discovery

Enveric’s Discovery Team, spearheaded by Chief Innovation Officer Dr. Peter Facchini, PhD, an international leader in natural product biochemistry and biotechnology, completed the rational design of more than 300 Generation-2 (“Gen-2”) psilocin prodrug candidates using well-established design strategies, but adapted to the unique structure of psilocin.

The 300 Gen-2 original concept designs, now housed within the PsybraryTM, were screened using PsyAITM. The assessment helped predict chemical structures with appropriate receptor binding, toxicology, and pharmacokinetic profiles that would trigger the desired mechanisms of action while reducing undesirable side effects, and the initial candidate evaluation included, among other metrics, prodrug-likeness, toxicity, ease of chemical synthesis and degree of IP-white space surrounding the molecule.

Ranked scoring of these and other AI assessments, as well as commercial considerations (e.g., ease of procuring synthetic starting materials), prioritized 31 novel Gen-2 molecules that have been synthesized in sufficient quantities (~10 mg, 95% purity) for preliminary pharmacological screening. Enveric’s Chemistry Group, led by Dr. Kaveh Matinkhoo, PhD, completed these syntheses, 29 of which were deemed stable enough to advance.

Deep-dive chemical structure searches, patentability, and freedom-to-operate reviews were performed on all 29 candidates, under the leadership of Lead Internal Counsel C. Michael Gegenheimer. All the patentability analyses indicated potential patentability results, and 25 of the 29 molecules presented minimal concern with freedom to operate.

To strengthen the IP protection for the overall Gen-2 prodrug program, three provisional patent applications, covering 7 structurally diverse clinical classes and thousands of additional potential new drug candidates, have been filed so far in 2022, and additional provisional and PCT filings are expected to continue throughout the year.

In other IP developments, an additional three of Enveric’s international patent applications protecting tryptamine derivatives have been published by the World Intellectual Property Organization, bringing the total published so far to seven.

EVM-201 Drug Candidate Testing

Following the initial Gen-2 ideation, patent filing, synthesis, and screening efforts, more extensive assays were performed on the advancing drug candidates. Numerous internal assays were performed under the leadership of Dr. Jill Hagel, PhD, Vice-President of Innovation and Dr. Sheetal Raithatha, PhD, Director of Research and Development. The internal results were then confirmed and validated using leading independent, third-party Contract Research Organizations (CROs), covering 122 Toxicology tests, 72 receptor-binding and potency tests, 31 pharmacokinetic tests and 24 animal-model tests to provide ample information to support candidate nomination.

The synthesis and analysis of these comprehensive pharmacology and toxicology datasets, both internal and external, was led by Dr. Kevin Leach, PhD DABT, Vice President of Preclinical and Translational Research. Enveric is now moving towards lead-candidate nomination and, in preparation for IND filing, has initiated numerous IND-enabling studies on several of the leading candidates at third-party CROs.

Recognizing the need for stable drugs with robust, reproducible, and cost-effective manufacturing, several Contract Development & Manufacturing Organizations (CDMOs) are currently engaged with Enveric’s Chemistry Team to determine how best to manufacture our molecules. Enveric has plans in place to produce material at commercial facilities and the CDMO personnel have worked with our chemists to validate that our processes will work at their facilities. This is another necessary step prior to filing the IND. Finally, preliminary formulation work is underway, with a particular focus on enabling improved routes of administration.

“The first half of the year has indeed been busy and productive for the dedicated team here at Enveric. We are all very excited at how those efforts have begun to bear fruit. We look forward to advising our shareholders of further key developments, which we anticipate will continue to unfold during the remainder of 2022,” concluded Dr. Tucker.

About Enveric Biosciences

Enveric Biosciences, Inc. (NASDAQ: ENVB) is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For additional information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of the company to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contacts

Valter Pinto / Allison Soss

KCSA Strategic Communications

212.896.1254 / 212.896.1267

EnvericBio@kcsa.com

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FSD Pharma Subsidiary Lucid Psycheceuticals Files for Patent on Novel Formulations of Palmitoylethanolamide, Presents Preclinical Toxicology Results at an International Symposium

FSD Pharma Subsidiary Lucid Psycheceuticals Files for Patent on Novel Formulations of Palmitoylethanolamide, Presents Preclinical Toxicology Results at an International Symposium

Toronto, July 13, 2022 – FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today that is wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), filed a provisional patent application on novel formulations of palmitoylethanolamide (PEA). The new patent application is based on the results of completed preclinical animal toxicology studies and phase 1 clinical trial using FSD201 (ultramicronized PEA), sponsored by FSD Pharma. Patent applications are important tools to protect intellectual property of the company for commercialization and value proposition for the shareholders.

FSD Pharma is diligently pursuing the clinical development of FSD201 for various indications. On May 31, 2022, the Company announced the submission of an Investigational New Drug application with the U.S. Food and Drug Administration (“FDA”) and Health Canada detailing a planned Phase 2 clinical trial of FSD201 for the treatment of a yet-to-be-disclosed inflammatory disorder. FSD Pharma is fortifying its intellectual property position through additional novel formulations using PEA with superior biopharmaceutical profiles to serve patients in need.

FSD Pharma presented their preclinical toxicology results on FSD201 at the 32nd Annual Symposium of the International Cannabinoid Research Society held in Galway, Ireland on June 25-30, 2022, in a scientific peer setting. FSD Pharma and Lucid were represented at the conference by Dr. Lakshmi P. Kotra (CEO, Lucid Psycheceuticals), Dr. Andrzej Chruscinski (Vice-President, Clinical and Scientific Affairs, Lucid Psycheceuticals), and Dr. Mohammad Ebrahimzadeh (Scientist, Lucid Psycheceuticals). The poster presentation titled, “Preclinical Safety Pharmacology and Toxicology of FSD201, A Palmitoylethanolamide Composition” discussed the safety pharmacology and toxicokinetics of FSD201, which were completed by FSD Pharma for regulatory filings with the U.S. FDA. The poster presentation provided support for the clinical development of FSD201, revealing well-tolerated doses of FSD201 in two different animal species.

“New patent applications are a critical step for protecting our assets in the development of effective therapeutics targeting brain and inflammatory disorders,” said Dr. Kotra. “Novel, high-quality treatments and intellectual property are important to us as an innovation-driven company, and I am very pleased with our team’s performance to stay on target towards the key milestones in 2022, including the planned Phase 2 trial of FSD201.”

About FSD Pharma

FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc., a wholly owned subsidiary of FSD Pharma, is focused on pharmaceutical research and development of its lead compound, FSD201, an ultra-micronized PEA, for the treatment of inflammatory diseases. Lucid Psycheceuticals Inc., a wholly owned subsidiary of FSD Pharma, is focused on the research and development of its lead compounds, Lucid-Psych and Lucid-MS. Lucid-Psych is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

Contacts

Zeeshan Saeed, Founder, President and Executive Co-Chairman of the Board, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8884

For information: info@fsdpharma.com
Investor Relations: ir@fsdpharma.com
Website: www.fsdpharma.com

Forward Looking Information

Certain statements contained herein are “forward-looking statements.” Often, but not always, forward-looking statement can be identified by the use of words such as “plans”, “expects”, “expected”, “scheduled”, “estimates”, “intends”, “anticipates”, “hopes”, “planned” or “believes”, or variations of such words and phrases, or states that certain actions, events or results “may”, “could”, “would”, “might”, “potentially” or “will” be taken, occur or be achieved. Forward-looking statements contained in this press release include statements related to the Company’s subsidiary Lucid Psycheceuticals filing for a patent on novel formulations of PEA and presenting preclinical toxicology findings at a global symposium. FSD cannot give any assurance that such forward-looking statements will prove to have been correct. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Factors that may cause such material differences include without limitation: the fact that the drug development efforts of both Lucid and FSD BioSciences are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of Lucid and FSD BioSciences may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of Lucid and FSD BioSciences; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of Lucid and FSD BioSciences; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of Lucid and FSD BioSciences; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected, or impacted by COVID-19 related issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of Lucid and FSD BioSciences; and other risks. Further information regarding factors that may cause actual results to differ materially are included in the Company’s annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR (www.sedar.com) and with the U.S. Securities and Exchange Commission on EDGAR (www.sec.gov) under the heading “Risk Factors.” Any forward-looking statement contained in this release speaks only as of its date. The Company does not undertake to update any forward-looking statements, except to the extent required by applicable securities laws.

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Optimi Health Finalizes Psilocybin Supply Agreement With Bloom Psychedelic Therapy and Research Centre

Optimi Health Finalizes Psilocybin Supply Agreement With Bloom Psychedelic Therapy and Research Centre

JULY 13, 2022

Partnership a unique opportunity to showcase Canada as a clinical and cultivation mecca

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company cultivating and synthesizing high quality psychedelics and natural functional and psilocybin mushroom strains for transformational human experiences, is pleased to announce that it has finalized a supply agreement with Bloom Psychedelic Therapy And Research Centre (“Bloom”), a Calgary-based provider of mental health services, including psychedelic-assisted therapies employing ketamine treatments.

“Our Supply Agreement with Bloom solidifies another key relationship for Optimi,” said CEO Bill Ciprick. “Their position as therapeutic practitioners, as well as their work in conducting the kind of clinical trials necessary to advance regulatory outcomes for psychedelic medicines, make them ideal partners in alignment with Optimi’s strategic goals.”

Optimi will supply Bloom with sufficient biomass of natural psilocybin to begin conducting its previously announced clinical trial in partnership with the IMPACT Clinical Trial Accelerator Program housed within Alberta’s Life Sciences Innovation Hub at the University of Calgary.

The proposed phase I dosing study will aim to find the optimal microdose or low dose of psilocybin that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic effects.

Bloom Founder and CEO, Jim Parker, says the partnership between Bloom and Optimi provides an incredible opportunity to measure true GMP-produced, Canadian-sourced natural psilocybin.

“Regulatory bodies in Canada and across the world are watching Canada’s fledgling psychedelics industry and how it performs in quality, safety, and efficacy,” said Parker. “So, I see this as an early watershed moment where good therapeutic practices, combined with Optimi’s Canadian-GMP-grade natural psilocybin, could establish Canada as a real leader amongst those wanting to learn from us.”

Since the completion of its combined 20,000 square feet of psilocybin cultivation and production facilities in Princeton, British Columbia, Optimi has pursued a revenue-focused strategy of clinical therapeutic and research partnerships with the intention of developing logistical channels that will underpin the future of the psychedelics industry.

“To echo Jim’s perspective on Canada defining itself as a leader in psychedelics, I believe the more Optimi produces, tests, and supplies trials and patients across the country, the more we’ll be able to establish the benchmarks needed to develop a true cultivation mecca in Canada and eventually the world,” added Ciprick.

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story aiming to be the number one trusted, compassionate supplier of safe, natural, EU-GMP psilocybin and functional mushrooms across the world. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s 20,000 sq ft of state-of-the-art, technologically advanced in-house production and research facilities cultivate, test, and synthesize high quality mushroom strains and psychedelic substances such as MDMA.

Based in Princeton, British Columbia, Optimi is developing a robust and innovative IP portfolio through its Health Canada psilocybin Dealer’s License.

Optimi’s vision is to unlock the regenerative power of mushrooms, promote psychedelic science, and set the highest standard of trusted, GMP operational excellence in the world.

Optimi’s promise is to make possible a future whereby natural psychedelic alternatives aid a wide variety of mental health conditions.

ABOUT BLOOM PSYCHEDELIC THERAPY AND RESEARCH CENTRE

The Bloom Psychedelic Therapy and Research Centre is a world-class research centre committed to furthering the science supporting the use of psychedelics for depression, suicidal ideation, anxiety, PTSD, and chronic pain. We are pleased to house the University of Calgary’s first research chair committed to this endeavor. The Parker Psychedelic Research Chair led out of the Mathison Centre for Mental Health Research & Education at the Hotchkiss Brain Institute in the Cumming School of Medicine, is furthering important research into alternative therapies for mental health.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Michael Kydd
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
www.optimihealth.ca

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

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Psyched Wellness Announces July 19th, 2022 as the Official Date To Commence Pre-Orders for Calm

Psyched Wellness Announces July 19th, 2022 as the Official Date To Commence Pre-Orders for Calm

The announcement comes on the company’s second anniversary, marking its growth and success

Toronto, Ontario–(Newsfile Corp. – July 13 2022, 2022) – Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) (the “Company” or “Psyched“), a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, is celebrating its second anniversary and is thrilled to share that the previously announced pilot run of its Amanita Muscaria derived product, Calm is nearly complete and the company is ready to move forward with pre-orders. Starting July 19th, 2022, the company will begin accepting pre-orders, with products anticipated to reach consumers in the United States in the Fall of 2022.

Calm is the company’s flagship product, and is the first legal Amanita Muscaria mushroom extract approved for sale in the USA. It does not require a prescription, leaving the retail landscape open to many possibilities for distribution and listing potential.

“With today being Psyched Wellness’ 2nd anniversary as a company, we felt it was perfect timing to set a date for consumers in the United States to be able to pre-order Calm.” says Jeffrey Stevens, CEO of the company. “It has been a long journey to get to this point, and I would like to take this opportunity to thank my co-founder, David Shisel, our team, KGK Science and Vantage Hemp for all of their hard work and commitment to get us to where we are today. The most exciting part for me is that we have just scratched the surface with respect to potential uses and delivery forms for AME-1. Stay tuned for more to come from Psyched.”

Sign up to be notified of the launch here.

-30-

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

About Psyched Wellness Ltd.:

Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company’s objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.

Cautionary Statement Regarding Forward Looking Information

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and (ii) the uses and potential benefits of Amanita Muscaria.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the Company’s ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company’s operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; and the risk that there is no potential benefit of Amanita Muscaria consumption.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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Red Light Holland to Head Sponsor Psy-Fi Festival in The Netherlands from September 14-18, 2022, One Of The Largest Psy-Trance Festivals In Europe

Red Light Holland to Head Sponsor Psy-Fi Festival in The Netherlands from September 14-18, 2022, One Of The Largest Psy-Trance Festivals In Europe

  • Red Light Holland will be the exclusive provider of natural Psilocybin products at the festival estimated to host approximately 15,000 people
  • Red Light Holland will proudly sell their iMicrodose and Maka products and feature their technology Wisdom VR and Wisdom Truffle at Psy-Fi
  • Red Light Holland will provide educational workshops to promote the responsible use of Psychedelics

Toronto, Ontario–(Newsfile Corp. – July 13, 2022) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company”), an Ontario-based corporation engaged in the production, growth, and sale of a premium brand of magic truffles, is pleased to announce its sponsorship of Psy-Fi festival, one of the largest international festivals in the Netherlands which attracts thousands of visitors each year. Psy-Fi offers a large variety of music, arts, and space for personal growth.

As a lead sponsor, Red Light Holland will be the exclusive provider of Psilocybin Truffles for the festival, including featuring the Company’s iMicrodose and Maka Brands. As part of the offerings to the festival, Red Light Holland will deploy its suite of technology products including the VR experience, Wisdom, which explains how Psychedelics influence the brain (https://store.steampowered.com/app/1561720/Wisdom/). Red Light Holland will also showcase their innovative meditation device, designed by world famous structural designer Karim Rashid, The Wisdom Truffle (www.WisdomTruffle.com). Red Light Holland will further provide preparation and integration workshops to promote the responsible use of Psychedelics. These efforts will be led by Jeff Hamburg, Red Light Holland’s therapist and expert psychedelic guide and Sarah Hashkes Red Light Holland’s Chief Innovation and Technology Officer. The Psy-Fi festival will take place in The Netherlands, September 14th-18th, 2022.

“This is a huge opportunity for us to connect to a worldwide audience that shares the same values of increasing legal access to naturally occuring Psilocybin. We are thrilled to collaborate with such a well-known and respected festival that is known for its safety-first practices as well as its care about the environment,” said Todd Shapiro, CEO, and Director of Red Light Holland. “We’re excited to show the world our Rec & Tech approach with our branded psilocybin products, technology devices and our educational and responsible use messaging aiming to bring people a lot of joy and connection.”

“Psy-Fi ‘Guardians of the Gala’ is set up to be one of the bigger Psy-Trance festivals in Europe. Our team is very pleased to be able to be such a big part of a beautiful and fun festival,” said Hans Derix, Red Light Holland’s President and Dutch Native. “We will be displaying and selling our Maka and iMicrodose products via our wholly owned company SR-Wholesale to thousands of people affordably and responsibly. And our intention is to have a big Brand presence. You should come down to our amazing country in September and check it out,” added Derix.

To learn more about the festival or purchase tickets go to: https://www.psy-fi.nl/.

Red Light Holland releases Data on Psychedelic Concert

Red Light Holland releases a report with data analysis around the success of the Company’s Psychedelic concert event on April 16th, 2022. During this event participants chose to consume between 1 to 8 grams of Red Light Holland’s premium Psilocybin truffles after an intake discussion with therapist and expert psychedelic guide Jeff Hamburg. After the event participants were sent a survey and the facilitators were interviewed for the report. A small number of participants replied, but with positive results.

  • 91.7% of the attendees in the survey reported they would be interested in attending another event, 75% reported they enjoyed the music more than usual
  • 41.7% reported they felt connected to the group in a meaningful way
  • 33.3% reported lasting benefits beyond the event itself

The long-term benefits included the release of negative emotions and a lasting “Uplifted mood”. Some participants also gained insight that helped them in their personal or professional life. No significant negative effects were reported or observed.

The report with detailed statistical analysis conducted by statistician Yoav Blonder, has been sent to Oregon Health Authority representatives and members of the Washington Psilocybin service workgroup, as well as other government officials around the world Red Light Holland is connected with, to help promote regulations and best practices for group psilocybin services.

While there is no statistical significance due to the small sample size Red Light Holland sees the potential of these events in increasing affordable and equitable accessibility, especially for newcomers to the psychedelic community, as newcomers might be more interested in trying psychedelics in a safe environment supervised by experts.

The Company can not make medical claims regarding the use of psilocybin.

To read the full report: https://redlight.co/wp-content/uploads/2022/07/Psychedelic-Concert-Report.pdf.

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.

For additional information on the Company:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlight.co
Website:www.RedLight.co

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements.

Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the details of the planned psy-fi festival September 14-18, 2022; the ability to sell Maka and iMicrodose products at the Psy-Fi Festival; comments with respect to the data discovered assisting Red Light if and when the final regulations in Oregon are approved; details with respect to Measure 109; Red Light’s plans to conduct further research in the Netherlands, statements regarding Red Light’s involvement in Psy-fi festival; the intended outcomes and effects of Measure 109; statements regarding the implementation of Measure 109 by the Oregon Health Authority; details regarding the sponsorship organzied by Red Light Holland including the ability to be the lead supplier of Red Light products at Psy-Fi Festival; Red Light’s expectations of obtaining the consent of concert-goers and participants to collect and analyze data on best practices on using psychedelics and the company’s products; Red Light’s plans to be the exclusive provider of Psilocybin Truffles for the festival and the company’s ability to deploy its suite of technology products including the VR experience, Wisdom and the company’s mediation device, The Wisdom Truffle; Red Light Holland; Red Light Holland premium psilocybin truffles being available for concert goers at the event; that sponsoring the event will enable Red Light to advocate for a program that helps a wide range of Oregonians; that the data provided from the past group microdosing event will illustrate a working model to help the Oregon Psilocybin Advisory Board and the Oregon Health Authority to refine psilocybin regulations as well as help form the Washington’s Psilocybin Wellness Workgroup; the belief that the report on microdosing services can benefit people or the inability for the report to represent medical claims; the company can not make medical claims; that the report and small sample size of the data will influence Oregon, Washington State Authorities to help with regulations; that the report is a small sample size and therefore is just a small sample of participants and not used for the purposes of medical advice.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: Red Light’s ability to carry the sponsorship and be the exclusive provider of Psilocybin Truffles for the festival; Red Light Holland setting up and deploying its suite of technology products including the VR experience, Wisdom and their innovative meditation device, The Wisdom Truffle. Red Light Holland will further provide preparation and integration workshops to promote the responsible use of Psychedelics discussed in this news release, or at all; the ability of the past group microdosing event and the subsequent report to yield the expected information to assist Red Light with legalization efforts described in this new release, or at all; the report will not affect the Measure 109 being implemented; Red Light Holland’s ability to continue as a going concern; the continued commercial viability and growth in popularity of psilocybin products; continued approval of Red Light Holland by the relevant governmental and/or regulatory authorities; the continued growth of Red Light Holland; details regarding the event organized by Psy-Fi Festival organizers, including the live performances; Red Light’s continued expectations of obtaining the consent of facilitators, concert organizers and participants including concert goers to provide psilocybin truffles; Red Light Holland premium products of psilocybin truffles being available for concert-goers at the event; that the report on the group microdosing event will illustrate a working model to help the Oregon Psilocybin Advisory Board and the Oregon Health Authority to refine psilocybin regulations as well as help form the Washington’s Psilocybin Wellness Workgroup; the inability of the report to be received, read by, or acknowledged by Oregon Authorities, Washington State Authorities and other Government agencies and officials around the world.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of Red Light to carry the sponsorship of Psy-Fi festival on the terms and timelines described in this news release; the potential inability of Red Light Holland to continue as a going concern; the risks associated with the psychedelics industry in general; increased competition in the recreational and medical psilocybin markets; the potential future unviability of the psychedelics industry; public opinion and perception of the psychedelics industry; incorrect assessment of the value and potential benefits of expansion plans and various transactions; risks associated with potential governmental and/or regulatory action with respect to the psychedelics industry; changes in general economic, business and political conditions, including changes in the financial and stock markets; and risks related to infectious diseases, including the impacts of the COVID-19 pandemic; the event not proceeding as detailed and no longer organized by Psy-Fi festival organizers, including the cancellation of all the performances at the festival and/or the planned and concurrently ability to offer of the company’s products during the event Sept 14-18 2022; the risk that Covid-19 could result in the canceling of the Psy-Fi festival, Red Light’s inability to sell products and promote best practices on usage of the company’s products; Red Light’s inability to sell products and promote best practices on usage of the company’s products at the Psy-Fi festival; Red Light Holland premium iMicrodose and Maka psilocybin truffles being unavailable for concert goers; that the report on the group microdosing event will not illustrate a working model to help the Oregon Psilocybin Advisory Board and the Oregon Health Authority to refine psilocybin regulations as well as not helping form the Washington’s Psilocybin Wellness Workgroup; the belief that the statistics provided on the microdosing event can become integrated into people’s daily life not come into fruition; the report does not represent a medical diagnosis; the report represents a very small sample size and does not represent any statistical significance.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect Red Light Holland’s expectations as of the date hereof and are subject to change thereafter. Red Light Holland undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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Telescope Inks Research Agreement With Standard Lithium

Telescope Inks Research Agreement With Standard Lithium

Vancouver, BC — July 13, 2022 — Telescope Innovations Corp. (“Telescope” or the “Company”) (CSE: TELI), a chemical technology company, announces that it has signed a Master Service Agreement (“MSA”) with Standard Lithium Ltd. (“SLI”). For the first project under this MSA, Telescope will receive funding for one year to evaluate the utilization and sequestration of CO2 within the lithium brine extraction and reinjection processes developed by SLI. This project bolsters Telescope’s “Industries” division, which leverages unique lab automation and analytical capabilities to address process and manufacturing challenges in the chemical industry. 

Jason Hein, CEO of Telescope, has previously executed successful projects with SLI and is the inventor of its SiFT lithium carbonate crystallization technology. “Telescope is ideally positioned to understand the process chemistry and technology required to integrate CO2 utilization and sequestration within Standard Lithium’s operations,” he commented. “We are working towards the decarbonization of the lithium supply chain and continuing to strategically deploy Telescope’s tools and expertise across the chemical industry.”

About Standard Lithium

SLI is an innovative technology and lithium development company. SLI’s flagship project is located in southern Arkansas, where it is engaged in testing and proving the commercial viability of lithium extraction from over 150,000 acres of permitted brine operations. The president of SLI, Dr. Andy Robinson, and the CEO, Robert Mintak, are also independent directors of Telescope. However, the MSA is not considered a related party transaction within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions, and has been reviewed and approved by Telescope’s independent directors.

About Telescope

Telescope is a chemical technology company developing scalable manufacturing processes and tools for the pharmaceutical and chemical industry. The Company builds and deploys new enabling technologies including flexible robotic platforms and artificial intelligence software that improves experimental throughput, efficiency, and data quality. A key area of application for these tools is the development of scalable manufacturing processes for mental health medicines in the under-utilized tryptamine class of compounds, including psychedelic therapeutics. Telescope also applies these toolsets to resolve inefficiencies in industrial process chemistry and manufacturing. Our aim is to bring modern chemical solutions to meet the most serious challenges in health and sustainability. 

On behalf of the Board,

Telescope Innovations Corp.

Jason Hein, Chief Executive Officer

E: jason@telescopeinn.com 

Forward-Looking Information

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of the prospectus filed by the Company and available at www.sedar.com. 

Forward-looking statements in this document include expectations surrounding the use and viability of the intellectual property portfolio held by the Company, the research related to the utilization and sequestration of CO2 within SLI’s operations, and all other statements that are not statements of historical fact.   

Examples of such assumptions, risks and uncertainties include, without limitation, assumptions, risks and uncertainties associated with the global COVID-19 pandemic, including the risk that the Company be deemed a non-essential business and asked to temporarily cease operations; general economic conditions; adverse industry events; the success of the first project conducted with SLI; the Company’s ability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favorable terms; the ability of the Company to implement its business strategies; competition; and other assumptions, risks and uncertainties.

These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

The CSE has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Clinilabs Drug Development Corporation Begins Enrollment for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

Clinilabs Drug Development Corporation Begins Enrollment for Phase 1/2a Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

07/12/2022

EATONTOWN, N.J.–(BUSINESS WIRE)– Clinilabs Drug Development Corporation (“Clinilabs”), a global, full-service contract research organization with deep expertise in central nervous system drug development, announced today that enrollment has begun in a Phase 1/2a clinical trial of CYB003, the first novel psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (“MDD”). CYB003 is being developed by Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin”), a leading ethical biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”.

Cybin announced that it received Investigational New Drug clearance from the U.S. Food and Drug Administration for the Phase 1/2a trial at the end of June, marking the industry’s first novel psilocybin analog to enter clinical development.

“Clinilabs is honored to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003,” said Jeanine Falinski, Vice President of Strategy and Corporate Development at Clinilabs. “We are excited by the potential of these therapeutics and hope that the future is life-changing for individuals suffering from mental illness. We are encouraged by the interest from potential research participants who have already come forward prior to today.”

“Successful patient recruitment and a proper clinical environment are integral components of this trial. As a global leader in drug development services, Clinilabs is a perfect partner and we are thankful for their support and guidance,” said Doug Drysdale, Chief Executive Officer of Cybin.

About the CYB003 Phase 1/2a Trial

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations of the study drug and a response/remission will be assessed at Week 3 (after first dose) and at Week 6 (after second dose). Importantly, participants in the trial that are currently being treated with selective serotonin reuptake inhibitors will be allowed to remain on their antidepressant medication.

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at Week 3 and will provide important PK and safety data to determine a clinical path forward. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an SSRI or SNRI that is not working to their satisfaction. Participation includes 11 outpatient visits and two 2-day inpatient stays. Compensation may be up to $4,335 including travel. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, New Jersey clinical research unit, may pre-screen for study entry at www.depressionpsychedelicstudy.com or by telephone at (212) 994-4567.

About CYB003

CYB003 is a deuterated analog of psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, CYB003 can easily activate the serotonin 5-HT2A receptor.

CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. We believe CYB003 has the potential to reduce time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility​ of treatment.

About Clinilabs Drug Development Corporation

Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep expertise in CNS, we are committed to the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver a complete, first-in-human to Phase 3 spectrum of high quality, timely, and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market. We are process-driven yet structured to be nimble, providing personalized service that meets the needs of customers and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials in our 22-year history and played a pivotal role in the approval of 19 new therapies across 10 CNS indications to help transform the lives of patients worldwide.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements related to the results of the Company’s CYB003 preclinical studies, statements regarding the Company’s CYB003 Phase 1/2a trial and anticipated results, the Company’s plans to start recruiting patients immediately for its CYB003 Phase 1/2a trial,, and the Company’s plan to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the year ended March 31, 2022 and the Company’s annual information form for the year ended March 31, 2022, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media Contacts:

Jeanine M. Falinski, MBA
Vice President, Strategy & Corporate Development
Clinilabs Drug Development Corporation
jfalinski@clinilabs.com

Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com

Source: Clinilabs Drug Development Corporation

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Filament Health Issued Third Patent by United States Patent and Trademark Office

Filament Health Issued Third Patent by United States Patent and Trademark Office

The patent describes the extraction and standardization of stable doses of psychedelic compounds

Vancouver, British Columbia, July 12, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it has been issued a third patent by the United States Patent and Trademark Office (USPTO) for the extraction and standardization of natural psilocybin and associated psychedelic compounds. The patent describes essential technology for transforming psychedelic raw materials into pharmaceutical-grade, standardized drug candidates. 

“The continued growth of Filament’s American patent portfolio is a testament to the strength of our drug development platform,” said Benjamin Lightburn, Chief Executive Officer. “This approval represents the viability of our IP strategy in the US in addition to our success in Canada.”

Filament has developed innovative technology to extract and standardize stable doses of natural compounds from magic mushrooms. The Company now holds seven patents, four in Canada and three in the United States, including the first-ever patent for the extraction and standardization of natural psilocybin which was issued on August 3, 2021.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn

FILAMENT HEALTH

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

INVESTOR RELATIONS

ir@filament.health

FORWARD LOOKING STATEMENTS

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning the impact of the patent on the Company’s business and the ability of the Company to secure future patents. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.30