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Numinus announces shareholder approval of resolution in connection with the proposed acquisition of Novamind

Numinus announces shareholder approval of resolution in connection with the proposed acquisition of Novamind

  • Novamind shareholders, at a separate meeting held today, have also approved the transaction
  • Transaction expected to be completed on or about June 10, 2022

VANCOUVER, BC, June 8, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus”, the “Company”) (TSX: NUMI) (OTCQX: NUMIF) is pleased to announce shareholders have approved the Company’s resolution to issue common shares in the capital of Numinus (the “Common Shares”) in connection with the proposed acquisition (the “Transaction) of Novamind Inc. (“Novamind”).  Novamind shareholders have also voted to approve the acquisition of Novamind by Numinus, pursuant to a plan of arrangement, at a separate meeting of Novamind shareholders held today.

“We are pleased with the overwhelming support of both Numinus and Novamind shareholders for this significant and transformational transaction. This acquisition will position our business as one of the leading integrated mental wellness companies in North America offering Ketamine- and psychedelic-assisted therapies, with 13 wellness clinics, four clinical research sites and a dedicated psychedelics research laboratory,” said Payton Nyquvest, Founder & CEO, Numinus.  “We look forward to completing the acquisition soon and working closely with the Novamind team to share best practices and grow our collective mental health and wellness service offering.”

Details of the Transaction and share issuance are set out in Numinus’ management information circular (“Circular”), dated May 4, 2022, which is available under the Company’s profile on SEDAR at www.sedar.com.

At the special meeting of shareholders of the Company (the “Meeting”), an ordinary resolution authorizing and approving the issuance of up to 63,010,034 Common Shares of the Company to the securityholders of Novamind was approved by 98.71% of the votes cast by shareholders. The Common Shares of the Company issued pursuant to the Transaction will be distributed to individual Novamind securityholders following the completion of the transaction.

A total of 32,679,640 Common Shares of the Company were voted at the Meeting online or by proxy, representing approximately 15.68% of the issued and outstanding Common Shares of the Company as of the meeting record date. The Company has filed a report of voting results on the resolution voted upon at the Meeting under its profile on SEDAR at www.sedar.com.

Completion of the Transaction remains conditional upon approval of the Supreme Court of British Columbia (the “Court”) and certain other customary closing conditions. The application for the final order from the Court is scheduled to be heard on June 10, 2022. Assuming that all conditions to closing of the Transaction are satisfied or waived, the Transaction is expected to be completed on or about June 10, 2022. For a more detailed description of the Transaction, please refer to the Circular.

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 news release includes certain “forward‐looking information” and “forward‐looking statements” (collectively “forward‐looking statements”) within the meaning of applicable Canadian securities legislation, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to future business activities and operating performance. All statements in this news release that address events or developments that the Company expects to occur in the future are forward‐looking statements. Forward‐looking statements are statements that are not historical facts and are often identified by words such as “expect”, “plan”, “anticipate”, “project”, “target”, “potential”, “schedule”, “forecast”, “budget”, “estimate”, “intend” or “believe” and similar expressions or their negative connotations, or that events or conditions “will”, “would”, “may”, “could”, “should” or “might” occur, and include information regarding: (i) expectations regarding whether the proposed Transaction will be consummated, including whether conditions to the consummation of the Transaction will be satisfied, or the timing for completing the Transaction and receiving the required regulatory and court approvals, (ii) expectations regarding the potential benefits of the Transaction and the ability of the combined company to successfully achieve business objectives; and (iii) expectations for other economic, business, and/or competitive factors.

Forward‐looking statements necessarily involve assumptions, risks and uncertainties, certain of which are beyond the Company’s control. These forward‐looking statements are qualified in their entirety by cautionary statements and risk factor disclosure contained in filings made by the Company with the Canadian securities regulators, including the Company’s financial statements and related MD&A for the financial year ended August 31, 2021 and its interim financial statements and related MD&A for the three and six months ended February 28, 2022, all filed with the securities regulatory authorities in all provinces and territories of Canada, except Québec, and available under the Company’s profile at www.sedar.com. The risk factors are not exhaustive of the factors that may affect the Company’s forward‐looking statements. The Company’s forward‐looking statements are based on the applicable assumptions and factors management considers reasonable as of the date hereof, based on the information available to management of the Company at such time.  The Company does not assume any obligation to update forward‐looking statements if circumstances or management’s beliefs, expectations or opinions should change other than as required by applicable securities laws. There can be no assurance that forward‐looking statements will prove to be accurate, and actual results, performance or achievements could differ materially from those expressed in, or implied by, these forward‐looking statements. Accordingly, undue reliance should not be placed on forward‐looking statements.

SOURCE Numinus Wellness Inc.

For further information: 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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Novamind Shareholders Approve Proposed Acquisition by Numinus

Novamind Shareholders Approve Proposed Acquisition by Numinus

Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.

  • Numinus shareholders, at a separate meeting held today, have also approved the resolutions related to the Transaction
  • Transaction expected to be completed on or about June 10, 2022

TORONTO, ON / June 8, 2022 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2)(“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, is pleased to announce that at its special meeting (the “Meeting”) of its holders (the “Shareholders”) of common shares (the “Novamind Shares”) held today, Shareholders voted to approve the previously announced proposed acquisition of Novamind by Numinus Wellness Inc. (“Numinus”) in an all-share transaction (the “Transaction”). Numinus shareholders have also voted to approve the acquisition of Novamind in a separate meeting of Numinus shareholders held today.

The Transaction required approval by not less than two-thirds (66⅔%) of the votes cast by Shareholders present in person or represented by proxy and entitled to vote at the Meeting, and by a simple majority of the votes cast by Shareholders present in person or represented by proxy and entitled to vote at the Meeting, other than the persons required to be excluded for the purpose of such vote pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”).

A total of 28,403,240 Novamind Shares were voted at the Meeting in-person or by proxy, representing approximately 57.0% of the issued and outstanding Novamind Shares as at May 2, 2022, with 98.5% voting in favor of the Transaction (96.5% after excluding the votes required to be excluded in determining minority approval pursuant to MI 61-101).

The completion of the Transaction is also conditional upon the approval of the Supreme Court of British Columbia (the “Court”) and satisfaction of other customary approvals including regulatory and third-party approvals. The application for the final order from the Court is scheduled to be heard on June 10, 2022. Assuming all conditions to closing of the Transaction are satisfied or waived, the Transaction is expected to be completed on or about June 10, 2022. Following completion of the Transaction it is anticipated that Novamind Shares will be delisted from the Canadian Securities Exchange and the Company will cease to be a reporting issuer under applicable Canadian securities law. The Shares will also no longer be posted for trading on the OTCQB.

Full details of the Transaction are described in the Company’s management information circular dated May 6, 2022, which is available on the Company’s SEDAR profile at www.sedar.com.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Investor Relations
Email: IR@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to the Transaction. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including expectations regarding whether the Transaction will be consummated, including whether conditions to the consummation of the Transaction will be satisfied, or the timing for completing the Transaction and receiving the required regulatory and court approvals, including the final order, and the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The Company does not assume any obligation to update forward‐looking statements if circumstances or management’s beliefs, expectations or opinions should change other than as required by applicable securities laws.

Cautionary Statements
The securities of the Company referred to in this press release have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws. Accordingly, the securities of the Company may not be offered or sold within the United States unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from the registration requirements of the U.S. Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of any offer to buy any securities of the Company in any jurisdiction in which such offer, solicitation or sale would be unlawful. Neither the Canadian Securities Exchange nor its regulation services provider accepts responsibility for the adequacy or accuracy of this news release.

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LOVE Pharma Inc. Announces First Closing of Financing

LOVE Pharma Inc. Announces First Closing of Financing

VANCOUVER, BC, CANADA (June 8, 2022) – LOVE Pharma Inc. (“LOVE” and or “the Company”) (CSE:LUV) (FSE: G1Q0), announces it has completed a first closing of a non-brokered private placement. The Company accepted subscriptions for 72,971,998 units at a price of $0.011 per unit, for gross proceeds of $802,691.99.  Each unit consists of one common share and one common share purchase warrant.  Each warrant entitles the holder to purchase one additional common share at $0.05 for a period of two years from the date of closing, subject to the option of the Company to accelerate the expiry date in the event that its shares trade at $0.15 or more for 10 consecutive days.

The Company paid $25,415.36  in cash and issued 2,310,487  broker warrants on the same terms as noted above, to qualified finders. Securities issued pursuant to this tranche are subject to trading restrictions until October 9, 2022.

Proceeds will be used for working capital and to review possible acquisitions.

About Love Pharma Inc.

With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. (CSE: LUV) (FSE: G1Q0) was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.

For further information, please contact:

Investor Relations

Telephone: 1 (604) 343-2977

E-mail: investors@love-pharma.com

www.love-pharma.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management’s current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “predicts”, “intends”, “targets”, “aims”, “anticipates”, “may” or “believes” or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved.  A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID–19, including the impact of COVID–19 on the Company’s business, financial condition and results of operations, lack of investor demand for Bitcoin and/or Bitcoin futures exchange traded funds, and dependence upon regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.

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Nova Mentis Receives Controlled Substances Export Approval From The U.S DEA For The Company’s Proprietary Psilocybin Drug NM 1001

Nova Mentis Receives Controlled Substances Export Approval From The U.S DEA For The Company’s Proprietary Psilocybin Drug NM 1001

Vancouver, British Columbia – June 7, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce it received the required controlled substances export approval from the U.S. Drug Enforcement Administration (DEA). The Company’s proprietary psilocybin drug (NM-1001), has been received at the Toronto Institute of Pharmaceutical Technology (TIPT®) labs in Toronto, Canada to be used to formulate and manufacture psilocybin microdose capsules for a planned Phase 2A fragile X syndrome clinical study.

“NOVA is excited to have completed the successful import of our proprietary psilocybin drug (NM-1001) into Canada. This allows us to move forward with the formulation and final production of microdose capsules in preparation for our clinical trial application submission to Health Canada. Our science team has delivered promising preclinical results and we look forward to continuing to advance our research program to demonstrate the important role that microdose therapy may play in the treatment of autism spectrum disorder and FXS,” stated Will Rascan, President & CEO of Nova Mentis Life Science Corp.

Earlier this year, NOVA announced that a very low microdose formulation of the Company’s proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS.

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc

Instagram: @novamentislsc

Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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PharmaTher Announces Positive Results from Study of KETABET™ for Depression

PharmaTher Announces Positive Results from Study of KETABET™ for Depression

KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale

Study results are adequate to give an effect size in powering a placebo-controlled clinical study

PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depressionTORONTO, June 7, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.

The investigator-led observational study is a randomized crossover study with subjects suffering from unmanageable depression and currently receiving ketamine treatment but experiencing unwanted side effects of ketamine. The study enrolled 10 subjects and aimed to determine if the administered oral betaine anhydrous before ketamine treatment can reduce some or all of the unwanted side effects observed in the first few hours of ketamine therapy as determined by the Clinician Administered Dissociative States Scale (“CADDS”). Alleviation or reduction of side effects support further progression of this product strategy. The CADDS is currently the standard scale used for studies assessing acute psychoactive effects of ketamine. It is used to measure present-state dissociative symptoms and assess treatment-emergent dissociative symptoms. The CADDS is comprised of 23 questions each evaluated on a 5-point scaling system (0 = “not at all”, 1 = “mild”, 2 = “moderate”, 3 = “severe”, and 4 = “extreme”). Assessment is based on three components, including depersonalization, derealization and amnesia, and an overall total score representing the severity of the condition. Depersonalization is a state in which one loses a sense of identity relative to thoughts and feelings. Derealization is a state where one feels detached from their surroundings.

The Study’s data support the benefit of pre-treatment with oral anhydrous betaine prior to ketamine administration for certain side effects measured by CADDS, including depersonalization and derealization. A reduction in mean of 66% at 40 minutes following ketamine infusion initiation was seen for each of these measures in the Study. Ketamine and betaine were well tolerated with no serious adverse events reported. Although the Study was not meant for statistical significance, it supports the Company’s planned placebo-controlled phase 2 clinical study incorporating KETABET™ in the Company’s proprietary microneedle patch and will further evaluate betaine anhydrous dose, timing of pre-treatment, and duration of effect on depersonalization and derealization effects of low-dose ketamine. Reduction in the depersonalization and derealization side effects associated with low-dose ketamine infusion will potentially improve treatment compliance, treatment dose range, and treatment duration associated with ketamine therapy. Additional influence of pre-treatment with betaine prior to low-dose ketamine administration will further define the Company’s KETABET™ product scope for this and potentially other indications. Complete results of the Study are expected to be submitted for presentation at a medical congress by 2H-2022.

Dr. Raul Cruz, MD, Principal Investigator of the Study, commented: “The results of this pilot observational study were very promising as the pre-treatment with betaine prior to ketamine administration demonstrated a better recovery from ketamine effects and higher dose tolerability for patients that typically experience dose limiting side effects. In general, patients that typically experienced nausea during treatment had a notable reduction and improved recovery. We are encouraged by the increase in alertness and decreased dizziness with pre-treatment of betaine and look forward to incorporating this combination into our practice for patients that require ketamine therapy for depression.”      

Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with the results from this Study as it provides support for advancing our microneedle patch program in a potential Phase 2 clinical study evaluating KETABET™ for mental health and pain disorders.”

Based on the Study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 2 clinical study to allow for KETABET™ evaluation in depression under the 505(b)(2) regulatory pathway. The Company intends to use its proprietary hydrogel-forming microneedle patch for the planned Phase 2 clinical study.

Granted patents of KETABET™ are issued in the U.S. (Patent No. 11,213,495), Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). The Company expects to convert the current patent applications in Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.

Potential of KETABET™

KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1  This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.

More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide.  Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6 Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations. There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7 Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically.  Furthermore, betaine attenuates memory deficits induced by homocysteine.11

Potential of the Hydrogel-forming Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12 The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.

The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13 Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

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

Cautionary Statement

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”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
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Relmada Therapeutics to Participate in the Goldman Sachs 43rd Annual Global Healthcare Conference

Relmada Therapeutics to Participate in the Goldman Sachs 43rd Annual Global Healthcare Conference

June 07, 2022 8:30am EDT

CORAL GABLES, Fla., June 7, 2022 /PRNewswire/ — Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022, at 10:40am PT / 1:40pm ET. Please find additional details about the event below.

Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Tuesday, June 14, 2022, 10:40-11:15am PT / 1:40-2:15pm ET
Webcast: https://kvgo.com/gs/relmada-therapeutics-inc-june-2022

The webcast can also be accessed in the Investors section of the Relmada website at https://www.relmada.com/investors/ir-calendar. An archived replay will be available for 90 days after the conclusion of the event.

About REL-1017

REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of major depressive disorder (MDD). The ongoing Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in previously completed Phase 1 studies.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with focus on major depressive disorder (MDD). Relmada’s experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada’s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive and monotherapy treatment for MDD. In addition, Relmada is advancing a clinical-stage program in neurodegenerative diseases based on psilocybin and select derivative molecules. Learn more at www.relmada.com.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “expects,” “anticipates,” “believes,” “will,” “will likely result,” “will continue,” “plans to,” “potential,” “promising,” and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.

Investor Contact:
Tim McCarthy
LifeSci Advisors
212-915-2564
tim@lifesciadvisors.com 

Media Inquiries:
FischTank PR
relmada@fischtankpr.com 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/relmada-therapeutics-to-participate-in-the-goldman-sachs-43rd-annual-global-healthcare-conference-301562802.html

SOURCE Relmada Therapeutics, Inc.

Released June 7, 2022

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Awakn Life Sciences Appoints Biotech and Investment Veteran Dennis Purcell as a Special Advisor to the CEO

Awakn Life Sciences Appoints Biotech and Investment Veteran Dennis Purcell as a Special Advisor to the CEO

Seasoned Leader Brings Deep Knowledge of US Biotech Market to Awakn

TORONTO, CANADA, June 7, 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that Dennis Purcell has joined Awakn as a Special Advisor to the CEO.

Mr. Purcell brings a wealth of life science and investment experience to Awakn.  Mr. Purcell is the Founder of Aisling Capital LLC, a major life sciences venture capital firm based in New York City and has previously served as the Fund’s Senior Managing Partner and Advisor. Prior to the formation of Aisling Capital, Mr. Purcell served on the Executive Committee and as Managing Director of the Life Sciences Investment Banking Group at Chase H&Q, formerly Hambrecht and Quist. During his time in the industry, he has invested in, raised capital for, and advised hundreds of life sciences companies.

Mr. Purcell currently serves on the Board of Directors of Real Endpoints, Ichnos Pharmaceuticals, Summus Global, Shorla Oncology, and Embera Pharma.  He is also an advisor to Better Health, Cellevolve and xCellerate. He has previously served on the Boards of many other public and private Life Sciences companies. In addition, Mr. Purcell serves as an Executive-in-Residence at Columbia University and as an Endowment Committee member at the University of Delaware, where he also serves on the Pharmaceutical Innovation Board.

Mr. Purcell is also very involved with industry organizations, serving on the Executive Committee of the Board of Directors of New York Bio as well as the Investor Advisory Board of the Biotechnology Innovation Organization (BIO), where he serves as Co-Chairman helping BIO develop policy positions that affect the industry.  Other industry affiliations include the Health Care Board for the Partnership for New York City, New York State Bio Defense Initiative, and the Alliance for Regenerative Medicine Foundation.

Awakn CEO, Anthony Tennyson commented, “To have someone of Dennis’ experience, quality and calibre is excellent for our company, but also a sign of where Awakn is heading.  He has worked with so many of the top-biotech companies globally and his input and counsel will have a very positive impact as we continue to grow our business, create value for shareholders and deliver effective treatments for clients.”

Dennis Purcell commented, “It is a great pleasure to be appointed as Special Advisor to Awakn’s CEO at this important time for the company and society.  Addiction is a disease affecting hundreds of millions of people with a poor current standard of care.  In just two years, the Awakn team has built a clinical stage company with a promising pipeline and an established presence in the UK.  I look forward to helping them establish a similar presence and profile in the US as they continue to grow and scale.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction, with a focus on Alcohol Use Disorder. Awakn’s team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is disrupting this underperforming industry by rapidly advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical stage trials.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
Anthony Tennyson, CEO Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

Media Enquiries:
America and Canada: KCSA Strategic Communications 
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

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Clearmind Medicine Announces Positive Pre-Clinical Results for Cocaine Addiction Treatment

Clearmind Medicine Announces Positive Pre-Clinical Results for Cocaine Addiction Treatment

The dedicated treatment demonstrated a significant decrease in preference for an area associated with cocaine

VANCOUVER, June 7, 2022–Clearmind Medicine Inc. (CSE: CMND), (OTC Pink: CMNDF), (FSE: CWY0) (“Clearmind” or the “company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced positive pre-clinical results for its treatment for cocaine addiction using MEAI, its novel psychedelic molecule.

“This exciting research on MEAI could go a long way in helping those who need it,” said Dr. Adi Zuloff-Shani, Clearmind’s ChiefExecutive Officer. “While effective treatments for opioid addictions have been available, this could be the first dedicated treatment for cocaine addiction, which is a global crisis.”

The pre-clinical trial, led by Professor Gal Yadid and his team, from the Gonda Multidisciplinary Brain Research Center located at Bar Ilan University (RamatGan, Israel), was designed to evaluate possible reward-like effects of MEAI, on male Sprague-Dawley rats based on the Conditioned Place Preference (CPP*)model.

Rats previously conditioned with cocaine received either cocaine (at 15mg/kg) or MEAI at doses of 2.5, 5, 10 and 20 mg/kg. Rats treated with MEAI spent less time in the compartment associated with cocaine. Results suggest a potential role for MEAI in abolishing cocaine-induced conditioned place preference and eliminating heightened craving, and that the compound was not itself addictive.The 5 mg/kg dose was found the most effective dose and selected for further study.

The results followed Clearmind’s recent news regarding filing a provisional patent application related to cocaine addiction.

“Once again, MEAI has shown the potential to become a game changer in the field of addiction treatments” Zuloff- Shani added.”We intend to further explore the potential of MEAI as an anti-cocaine addiction treatment.”


*A testing method by which the animals learned to associate between reward and an environmental cue

About Clearmind Medicine Inc.

Clearmind is a new biotech company focused on the discovery and development of safe and novel psychedelic-derived therapeutics to treat alcohol use disorder and other pressing health challenges.

The Israeli- Canadian company holds several patents for the non-hallucinogenic compound MEAI (5-methoxy-2-aminoindane, a novel psychoactive substance). The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Clearmind has established a research collaboration with the Hebrew University of Jerusalem and Bar Ilan University. The partnerships aim to expand its R&D capabilities and discover new candidate treatments for other mental health issues.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol“CWY0” and on the OTC pink under the symbol “CMNDF“.

For further information, please contact:

Investor Relations

invest@clearmindmedicine.com

Telephone: (604) 260-1566

General Inquiries

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (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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Cybin Acquires DMT Clinical Study from Entheon Biomedical

Cybin Acquires DMT Clinical Study from Entheon Biomedical

06/07/2022

— Acquisition of largest Phase 1 DMT study conducted to date is expected to accelerate CYB004 program timeline by nine months —

— Phase 1 study evaluating pharmacokinetics/pharmacodynamics of DMT currently underway and will inform clinical path forward —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that, through its wholly-owned subsidiary Cybin IRL Limited, it has entered into an agreement to acquire a Phase 1 N,N-dimethyltryptamine (“DMT”) study (the “Acquisition”) from Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon”) to accelerate the clinical development path for CYB004, Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.

The Phase 1 EBRX-101 study, now named CYB004-E, is being conducted in the Netherlands at the Centre for Human Drug Research, a leading independent foundation specializing in innovative early-stage clinical drug research, in 50 healthy volunteers who smoke tobacco – making it the largest Phase 1 DMT clinical study conducted to date. Pending the close of the Acquisition, the CYB004-E study is expected to yield essential safety and dosing optimization data and will replace Cybin’s planned pilot study for CYB004 that was expected to commence in the third quarter of 2022. Entheon will continue to support the CYB004-E study and act as external consultants to Cybin.

“The most precious commodity in drug development is time and acquiring this robust Phase 1 study already underway potentially accelerates the CYB004 development program by approximately nine months. The PK findings from the CYB004-E study should also help to inform the clinical path forward for this innovative and proprietary molecule,” said Doug Drysdale, Chief Executive Officer of Cybin. “This transaction also provides Cybin with access to a world-class research foundation and the privilege to work with the Entheon team, who offer a wealth of knowledge and expertise in this psychedelic class.”

The purchase price of the Acquisition is $1,000,000 (CAD), a portion of which will be a deposit with the balance payable on closing of the Acquisition. Up to an additional $480,000 (CAD) is payable for consulting services to be provided by Entheon for up to twelve months following the closing of the Acquisition. Pursuant to the Acquisition the Company will also enter into a data license agreement with Entheon that will permit Entheon to access certain data to support the Entheon IQ program. The Company expects the Acquisition to close within 30 days, subject to the completion of certain conditions and obtaining all necessary approvals.

“With our recent IND filing for CYB003, we are quickly becoming a multi-program clinical-stage company with four sponsored human trials underway in 2022. This is especially meaningful to our work to bring our innovative psychedelic-based therapies to people in need as quickly as possible. This is a truly exciting time for Cybin,” concluded Drysdale.

About the CYB004-E Study

The CYB004-E study is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of a target-controlled intravenous infusion of DMT in healthy smokers.

Primary Objectives:

  • Evaluate the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes;
  • Characterize the PK of a single dose DMT administered continuously over 90 minutes;
  • Characterize the PD of a single dose DMT administered continuously over 90 minutes; and
  • Establish the minimum DMT dose required to produce a psychedelic effect.

Pending results from the CYB004-E study, Cybin plans to evaluate CYB004 delivered via intravenous (“IV”) and via inhalation to determine the clinical path forward. Based on preclinical results reported by Cybin in April 2022, inhaled CYB004 demonstrated:

  • Approximately 2000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability;
  • Approximately 41% improved bioavailability compared with inhaled DMT;
  • Approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend therapeutic window; and
  • Rapid onset of effect and similar low variability equivalent to IV DMT.

CYB004 is a new chemical entity for which a patent was issued by the U.S. Patent and Trademark Office in February 2022. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT. The composition of matter patent is expected to expire in 2041 before consideration of any patent term extensions.

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 regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders, the anticipated timeline for closing the Acquisition, the Company’s expectation that the Acquisition will accelerate the CYB004 timeline, and the Company’s expectations and objectives regarding the results of the study.

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 period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, 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:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

Posted on

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

The Company submits Data Access Plan to the FDA to determine potential new clinical endpoints to support Emergency Use Authorization

TORONTO, June 06, 2022 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

Following the Company recently receiving positive comments from the FDA in regards to the Company’s request to determine and agree on the Study’s potential new primary efficacy endpoints, the Company has now submitted a Data Access Plan to the FDA with the aim to unblind the pre-dose selection data and submit the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The FDA has agreed that the Company may unblind the pre-dose-selection data for the first 210 patients of the Study to further support the new primary endpoint.

In addition, the Data Safety and Monitoring Board (“DSMB”) are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19. The DSMB supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns reported.

The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

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

Cautionary Statement

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 Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.