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Enveric Biosciences Appoints Dr. Bob Dagher as Chief Medical Officer

Enveric Biosciences Appoints Dr. Bob Dagher as Chief Medical Officer

NAPLES, Fla., Dec. 6, 2021 — Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, today announced the appointment of Bob Dagher, MD, as Chief Medical Officer, effective immediately.

Dr. Dagher brings over 20 years of experience working in clinical development in the pharmaceutical industry for both small and large pharmaceutical companies and as a board-certified physician from the American Board of neurology and psychiatry. He has an extensive therapeutic background concentrated in the neuroscience space which includes a focus on psychotic, affective and anxiety disorders, as well as neuroimmunology, neurodegeneration and movement disorders. Furthermore, Dr. Dagher has supported and driven successful drug development programs from preclinical stages through Phase 4 clinical trials.

“Dr. Dagher joins our team at a crucial time where we are continuing to build momentum and drive development of our key psychedelic molecules for the mind and cannabinoids for the body,” said Dr. Joseph Tucker, Chief Executive Officer, Enveric Biosciences. “Dr. Dagher brings extensive experience working in the pharmaceutical industry with a focus and passion for drug development for neurological and mental health indications. His experience is expected to be very valuable as he will lead Enveric alongside our clinical team in continuing to advance our pipeline. Dr. Dagher’s addition to Enveric is key addition as we continue our focus on building a world-class management team.”

“As a trailblazing Company working to discover and develop the next-generation treatments through the use of both psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, Enveric has major potential to make a real difference for mental health and cancer patients in need,” said Dr. Dagher. “As Chief Medical Officer, I look forward to working with the leadership and clinical teams to harness the power of these groundbreaking technologies to truly help bring solutions to various indications ranging from cancer-related distress to a whole host of other mental health disorders.”

Prior to joining Enveric, Dr. Dagher served as the Chief Medical Officer at WCG MedAvante-ProPhase where he led the clinical science organization to help forge and develop compelling scientific solutions to match industry challenges. Before joining WCG, Dr. Dagher served as the Chief Medical Officer at Cadent Therapeutics, where he led and advanced the company’s pipeline of small molecules, coupled with the implementation of precision biomarkers, for the development of innovative programs in rare diseases and common indications targeting movement and cognitive disorders. Following his early experience treating patients in academic and private practice settings, Dr. Dagher started his career in the pharmaceutical industry at GlaxoSmithKline, followed by Sanofi/Genzyme working on neurology, psychiatry, and urology indications.

Robert Wilkins, MD, stepped down from his role of Chief Medical Officer on November 29th, 2021. David Johnson, Executive Chairman, stated, “I want to thank Robert for his commitment to Enveric over the past two years. His contributions to our team have been significant and meaningful. His leadership has helped guide our transformation into the biotechnology company we are today. We relied on Robert’s expertise having worked with several biomedical startups in the past and have valued his deep knowledge in the pharmaceutical space. His guidance and insights have helped shape Enveric’s leadership team. We are grateful for the significant contributions he has made to Enveric and wish him the best of luck on his future endeavors.”

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is an innovative biotechnology company developing next-generation mental health and oncology treatments and clinical discovery platform, leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body. Enveric’s robust pipeline supports drug discovery efforts and clinical development programs to enable potential commercialization of effective treatments for millions of patients in need around the world. For more information, please visit www.enveric.com.

Cautionary Statement Regarding 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 statements that are not purely historical, 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 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
valter@kcsa.com / asoss@kcsa.com

Media Contacts

Raquel Cona
KCSA Strategic Communications
212.896.1204
rcona@kcsa.com

Cision View original content:https://www.prnewswire.com/news-releases/enveric-biosciences-appoints-dr-bob-dagher-as-chief-medical-officer-301437503.html

SOURCE Enveric Biosciences

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Mydecine Files Full Patent Application Covering Multiple Families of Psilocin Analogs

Mydecine Files Full Patent Application Covering Multiple Families of Psilocin Analogs

Dr. Saeid Babaei Appointed Independent Board Member as Mydecine Moves Closer to NASDAQ Listing in Q1 2022

DENVER, Dec. 06, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has filed a full patent application covering multiple families of psilocin analogs. The application includes solutions to directly address further precision in delivery control and shelf stabilization of psilocin, psilocybin’s active metabolite, both of which are critical for use in the medical setting.

When psilocybin is administered orally, there is wide variability in onset time for each patient, making it more difficult to standardize protocols and scale treatments. The purpose of Mydecine’s dermal route for the administration of psilocin is to directly address such controllability concerns. The Company’s patent pending permeation enhanced prodrug provides more control over the drug while also possibly eliminating undesirable properties like nausea by bypassing the digestive system.

Another concern of naturally produced psilocybin is its poor shelf stability. Mydecine’s recent filing includes a family of stabilized psilocin analogs, moving the Company closer to a drug that will meet regulatory requirements and address concerns for medical use; specifically providing access to a reliable potency psilocin source for physicians.

“The goal of creating these improved second-generation compounds is to enable safer, more effective treatments for patients along with improved management of dosage and drug behavior for clinicians. We believe these improvements are necessary for psychedelic medicines to become an accepted and adopted form of treatment,” said Chief Science Officer, Rob Roscow.

Mydecine also announced today that it has appointed Dr. Saeid Babaei, PhD, to its Board of Directors. Dr. Babaei is an experienced leader in bringing drug products from early development to commercialization. Dr. Babaei’s track record includes over 20 years of academic and corporate experience, during which he has led a number of novel and first-in-class product opportunities to either commercialization or to late-stage development. He brings tremendous business foresight having closed over 25 licensing and strategic alliance transactions, as well as raising over $50 million in equity and debt financing.

“We are pleased to welcome Dr. Babaei to the team as he brings decades of experience in biotechnology development, award-winning discoveries in gene therapy, and licensing and strategic advancements for the companies he has founded and accelerated. As Mydecine continues to move our lead candidates down the pipeline, Dr. Babaei will play an integral role in advancing our novel psychedelic-based therapeutic candidates as well as meeting NASDAQ listing requirements,” said Josh Bartch, Chairman & CEO of Mydecine.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, Instagram and LinkedIn.

For more information, please contact:

Media Contact
Morgan Kervitsky, Director of Marketing
(720) 689-4638
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
(720) 689-4638
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Source: Mydecine Innovations Group Inc.

Released December 6, 2021

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XPhyto Completes Strategic Acquisition of 3a-diagnostics GmbH

XPhyto Completes Strategic Acquisition of 3a-diagnostics GmbH

  • The acquisition positions XPhyto to be a leading Biosensor producer integrating thin film technology with 3a-diagnostics biosensor technology
  • The acquisition of 3a, a German-based rapid point-of-care diagnostics firm adds IP and a deeply experienced scientific expertise to XPhyto
  • Gains technical and business synergies
  • Secures XPhyto a near-term infectious disease biosensor portfolio and related Intellectual Property

Vancouver, Canada, and Uttenweiler, Germany (December 6, 2021) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to announce that the acquisition of 3a-diagnostics GmbH (“3a”), first announced July 20, 2021, is now complete.

“The strategic acquisition of 3a is a transformative step in XPhyto’s commercial strategy,” said Peter Damouni, XPhyto director. “The integration of a highly innovative European biosensor development company places XPhyto at the forefront of the rapid point-of-care test industry, an explosive and technology driven sector. This transaction is the second acquisition since going public in August 2019. XPhyto completed the takeover of Vektor Pharma TF GmbH in September 2019. The corporate strategy of acquiring high-tech biotechnology and pharma companies showcases the potential growth acceleration and synergies for XPhyto’s biosensors, diagnostics and drug delivery portfolios.”

3a is a research-based biotechnology company located Southeast of Stuttgart, Germany, specializing in the development, production and marketing of point-of-care (PoC) test systems. 3a has developed and patented a pipeline of oral biosensor screening tests for bacterial and viral infectious diseases, including stomatitis, periimplantitis, periodontitis, group A strep, and influenza A. The company has developed a high-throughput biosensor screening platform for rapid identification of new biosensor targets. 3a has also received grant funding from the German Federal Ministry of Education and Research for the development of real-time, low-cost and easy-to-use oral screening tests for the rapid detection of influenza A variants that are high-risk pandemic threats such as H1N1 and H5N1.

3a’s COVID-19 portfolio includes “Covid-ID Lab” a rapid point-of-care PCR test platform with a CE mark approved for sale in Europe. Total processing time is 25 minutes with minimal equipment and training. On July 28, 2021, XPhyto and 3a announced the identification of the first saliva activated “in-mouth” biosensor candidates for the detection of a COVID-19 infection. This research is the foundation for the development of the first enzyme-activated biosensors for real-time, low-cost and easy-to-use oral screening applications for the rapid detection of COVID-19.

The Company has recently received an EU commercial registration number to sell its biosensor for mouth related infections and oral inflammation, announced August 30, 2021. This product has application for the global oral health and cosmetic dentistry market. The Global Dental Services Market is expected to be $435 billion in 2021 according to MedicalExpo e-magazine and projected to reach $698.8 billion by 2030 and is growing at a CAGR of 6.4% according to Precedence Research.

“With the integration of 3a’s biosensor technology into our next-generation ODF platform, we are excited to be positioned to transform and dominate the market for rapid screening tests for a wide range of infectious diseases, including COVID-19, with highly affordable rapid oral tests starting in the coming year,” says Prof. Dr. Thomas Beckert, Managing Director of Vektor Pharma TF GmbH, a wholly owned subsidiary of XPhyto. He adds, “we have several biosensors in the development pipeline and plan to enter the market with low-cost rapid tests for infectious diseases, for which there are currently no rapid tests available, as early as 2022. We are very confident and excited to have the opportunity to revolutionize the diagnostics and rapid test market with products based on our integrated proprietary technologies, that are unique and leading in the world.”

The acquisition of 3a is projected to produce significant synergies in research and development and manufacturing; significantly improved margins for commercial products, such as Covid-ID Lab; as well as expedite commercialization of products in 3a’s near-market development pipeline. 3a’s intellectual property, including patents, know-how, expertise and contracts are included in the acquisition.
Executive management of 3a will be led by Prof. Dr. Beckert, managing director of Vektor Pharma TF GmbH. Prof Dr. Beckert is a German-based scientist and experienced corporate executive who is leading XPhyto’s drug formulation and diagnostics operations.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.

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Seelos Therapeutics Announces Issuance of Composition of Matter Patent in Japan for SLS-007

Seelos Therapeutics Announces Issuance of Composition of Matter Patent in Japan for SLS-007

NEW YORK, Dec. 6, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today that it has received an issued patent from the Japanese Patent Office (Japanese patent number 6968839, titled: STRUCTURE-BASED PEPTIDE INHIBITORS OF ALPHA-SYNUCLEIN AGGREGATION), covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson’s disease (PD).

Seelos is currently conducting in vivo pre-clinical studies delivering SLS-007 via an adeno-associated virus (AAV) that is designed to target the non-amyloid component core (NACore) of α-synuclein to inhibit abnormal aggregation and accumulation of the α-synuclein protein in the brains of patients with Parkinson’s Disease (PD). The preclinical studies are designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement parameters of SLS-007.

As previously announced, Seelos was issued a composition of matter patent for SLS-007 in the U.S. in October 2020.

About SLS-007

SLS-007 is a family of rationally designed peptidic inhibitors that target the NACore of α-synuclein to inhibit abnormal aggregation and accumulation of this protein in the brains of patients with PD. The overexpression of α-synuclein leads to the formation of α-synuclein aggregates which comprise Lewy bodies and neurites which are the hallmarks of the pathogenesis of PD. Recent in vitro and cell culture research have shown that SLS-007 has the potential to stop the propagation and seeding of α-synuclein aggregates.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the potential for SLS-007 to be a disease-modifying gene focused on intracellular α-synuclein aggregation in PD, the initiation and completion of the preclinical study of SLS-007, the ability of SLS-007 and related peptides to slow the progression of PD by stopping the seeding and potential propagation of α-synuclein aggregates, expectations regarding the results of the study, including the establishment of the in vivo pharmacokinetic and pharmacodynamics profiles and target engagement parameters of SLS-007. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
www.seelostherapeutics.com
https://twitter.com/seelostx 
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

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Psyched Wellness Announces Completion of Its 90 Day Oral Toxicity Study

Psyched Wellness Announces Completion of Its 90 Day Oral Toxicity Study

Toronto, Ontario – December 6, 2021 – Psyched Wellness Ltd. (CSE: PSYC)(OTCQB: PSYCF)(FSE: 5U9) (the “Company” or “Psyched“) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce that further to the please release dated June 28, 2021, the 90-day oral toxicity study has been completed.

KGK, the Company’s CRO partner, is now completing the 28-day recovery period, after which a tissue histopathology examination and final report will follow.

A full toxicology report of the 90-day oral repeat-dose study with AME-1 and final histopathology report is expected by mid-January 2022.

“The completion of the 90-day oral toxicity study is a major milestone for Psyched as it provides critical scientific data for the determination of safe dosage levels of AME-1, from which all of our consumer products will be derived as we prepare to launch them to market next year,” said Jeffrey Stevens, CEO of Psyched. “Although we are waiting for the final report, we are pleased to share that there was no mortality or morbidity of any of the test rodents during the study and we look forward to providing the full toxicology and histopathology reports early next year.”

The study examined the effects of Amanita Muscaria on rodents and involved a repeated dose 90-day oral toxicity study of AME-1. The new data will provide information on the major toxic effects, indicate target organs and the possibility of accumulation of test chemical, and can provide an estimate of a no-observed-adverse-effect level (NOAEL) of exposure which can be used in selecting dose levels for chronic studies and for establishing safety criteria for human exposure.

For further information, please contact:

Jeffrey Stevens
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
e: jstevens@psyched-wellness.com
Website: http://www.psyched-wellness.com

Investor Contacts:
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (978) 505-2478
e: PsychedWellness@kcsa.com

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 and Statements

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; the uses and potential benefits of Amanita Muscaria; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the continued growth of the Company; the Company completing its studies and reports upon the terms and timelines as disclosed herein; and the Company’s studies and reports generating the intended information and benefits.

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; the risk that there is no potential benefit of Amanita Muscaria consumption; the risk the Company will be unable to develop its products; the inability of the Company to complete their studies and/or reports on the intended timelines; the inability of the Company to generate reliable or positive reports therefrom; and the risk that the Company will not benefit from the studies and/or reports.

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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GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression

  • Primary endpoint met in Phase 2 part of clinical trial for GH001 in TRD
    • 7 of 8 patients (87.5%) were in remission (MADRS ≤10) at day 7 after dosing (p<0.0001)
  • Secondary endpoints met
    • Mean change from baseline in MADRS at day 7 after dosing was -24.4 points (-76%) (p<0.0001)
    • GH001 was well tolerated and no serious adverse events were reported
  • In addition, we announce positive preliminary safety results from a Phase 1 clinical pharmacology trial of GH001 in 46 healthy volunteers with 30-day follow-up supporting the safety profile of GH001 beyond day 7.

DUBLIN, Ireland, Dec. 06, 2021 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported the successful outcome of the Phase 2 part of a Phase 1/2 clinical trial of GH001, an inhalable 5-MeO-DMT product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102).

The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001). According to FDA Guidance for Industry, a 7-day endpoint is an appropriate primary efficacy endpoint for rapid-acting antidepressants.

The Phase 2 part of the clinical trial recruited 8 patients. The median age was 34 years. The median baseline severity of depression by MADRS was 32.

Patients followed a proprietary GH001 individualized dosing regimen administered on a single day with up to three increasing doses of GH001 (6 mg, 12 mg and 18 mg). The second and third doses were only administered in the event that the patient did not achieve a peak experience1 (PE) at the previously administered dose. Based on this trial design, 6 patients received 6 mg and 12 mg doses of GH001 and 2 patients received 6 mg, 12 mg and 18 mg doses of GH001. 7 patients were able to achieve a PE at their final dose, and at this final dose the mean PE total score was 90.4.

Of the 7 patients who had a remission at day 7, all were in remission beginning on day 1, with 5 in remission as early as 2 hours after dosing. The single patient who did not achieve a remission at day 7, also improved on day 7 versus baseline. 6 of the 7 patients in remission had achieved a PE at their final dose. The mean MADRS change from baseline for all 8 patients at day 7 was -24.4 points (-76%) (p<0.0001).

Compared with the single dose results in the previously reported Phase 1 part of the trial (12 mg, n=4; 18 mg, n=4), the proprietary GH001 individualized dosing regimen increased the rate of MADRS remission at day 7, increased the mean MADRS absolute change from baseline at day 7, increased the rate of PE, and increased the mean PE score achieved.

In accordance with the trial protocol, a study safety group (SSG) was established, including external experts, to evaluate the safety data for the clinical trial. All patients completed all planned visits. No serious adverse events (SAE) were reported. 7 of 8 patients (87.5%) experienced at least one adverse drug reaction (ADR), all of which were mild (81%) or moderate (19%) in intensity, and all of which resolved spontaneously. The ADRs reported were: headache, sensory disturbance (each in 3 patients), anxiety, flashback, nausea (each in 2 patients), muscle discomfort, abdominal discomfort, paresthesia, depressive symptom (each in 1 patient). Based on the full safety results of the trial, the SSG concluded that no unexpected or severe adverse effects and no clinically significant changes were observed in any of the safety laboratory analyses, vital signs, psychiatric safety assessments or measures of cognitive function and that no signal for suicidal ideation or behavior was observed.

Safety Results from Phase 1 Clinical Pharmacology Trial in Healthy Volunteers

In addition, we also reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103).

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

All subjects completed all planned visits. No SAEs were reported. 11 of 24 subjects (45.8%) who received GH001 in the single-dose part and 0 of 6 subjects (0%) who received placebo in the single-dose part experienced at least one ADR. In the multiple-dose part, 7 of 16 subjects (43.8%) who received GH001 experienced at least one ADR. All ADRs were mild and all ADRs resolved spontaneously. In the single-dose part, the ADRs reported were: headache (in four participants), tachycardia, crying (each in two participants), chest discomfort, dizziness, dry mouth, dyskinesia, fatigue, hypoesthesia oral, retching, somnolence, tremor (each in one participant). In the multiple dose part, the ADRs reported were: fatigue (in three participants), headache (in two participants), abnormal dreams, paresthesia oral, crying, tension (each in one participant). No clinically relevant changes were observed for vital parameters, peak expiratory flow rate, safety laboratory analyses, ECG and psychiatric safety assessments.

The preliminary results of this 30-day trial support the safety profile of GH001 single doses and the proprietary GH001 individualized dosing regimen with intra-subject dose escalation within a single day. Final source data verification, the pharmacokinetic analyses and analyses of various secondary endpoints are still ongoing. The full results from this trial are intended to support the selection of the optimal dosing interval for the individualized dosing regimen in future studies of GH001.

1The occurrence of peak experiences (PE) is assessed using a proprietary visual analogue scale (PE scale), which averages answers scored by the patient from 0 to 100 for three parameters of the experience: intensity, feelings of loss of control and profoundness. A PE is defined as a total score of at least 75 on this scale.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations
Julie Ryan
GH Research PLC
investors@ghres.com

Posted on

GH Research Reports Third Quarter 2021 Financial Results and Provides Business Updates

GH Research Reports Third Quarter 2021 Financial Results and Provides Business Updates

DUBLIN, Ireland, Dec. 06, 2021 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the third quarter ended September 30, 2021 and gave updates on its business.

Third Quarter 2021 Financial Results

Cash position

Cash was $280.7 million as of September 30, 2021, compared to $5.9 million as of December 31, 2020.

Research and development expenses

R&D expenses were $2.6 million for the quarter ended September 30, 2021, compared to $55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to our technical developments and clinical trials and increases in employee expenses to support these activities.

General and administrative expenses

G&A expenses were $2.1 million for the quarter ended September 30, 2021, compared to $5 thousand for the same quarter in 2020. The increase was primarily due to higher professional and compliance fees associated with being a public company, as well as increased employee expenses.

Net loss

Net loss was $1.8 million, or $0.035 loss per share, for the quarter ended September 30, 2021, compared to $60 thousand, or $0.002 loss per share, for the same quarter in 2020.

Business Updates

We announced today, in a separate press release, the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001 in treatment-resistant depression (TRD), where the primary endpoint was met with 7 of 8 patients (87.5%) in remission (Montgomery–Åsberg Depression Rating Scale (MADRS) ≤10) at day 7 after dosing (p<0.0001).

We plan to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and, pending the outcome of these meetings, we plan to initiate a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD.

Given GH001’s mechanism of action, we believe that GH001 may confer beneficial effects in other psychiatric and neurological disorders with unmet medical needs. We have recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in Q1 2022.

GH002, our 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach, and GH003, our recently added 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach, are currently in preclinical development. We anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).

About GH001

Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where 87.5% of patients with TRD were brought into an ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has potential to change the way TRD is treated today. Across the GH001 program, no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen.

About GH002 and GH003

GH002 is our 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach. GH003 is our 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach. GH002 and GH003 are currently in preclinical development, and we anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.

Forward-Looking Statements

This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com

 
GH RESEARCH PLC
 
Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited)
 
(in thousands, except share and per share amounts)
 
  Three months ended
September 30,		 Nine months ended
September 30,
  2021 2020 2021 2020
  $’000 $’000 $’000 $’000
         
Operating expenses        
Research and development (2,556) (55) (5,202) (105)
General and administration (2,110) (5) (3,277) (16)
Loss from operations (4,666) (60) (8,479) (121)
         
Finance expense (3) – (9) –
Foreign currency translation differences 2,832 – 3,377 –
         
Loss for the period (1,837) (60) (5,111) (121)
         
Other comprehensive income/(expense)        
Items that may be reclassified to profit or loss        
Currency translation adjustment (2,845) 15 (3,533) 15
Total comprehensive loss for the period (4,682) (45) (8,644) (106)
         
Attributable to owners:        
Loss for the period (1,837) (60) (5,111) (121)
Comprehensive loss for the period (2,845) 15 (3,533) 15
         
         
Loss per share        
Basic and diluted loss per share (in USD) (0.035) (0.002) (0.125) (0.004)
GH RESEARCH PLC
 
Condensed Consolidated Interim Statement of Financial Position (Unaudited)
 
(in thousands)
 
     
At September 30, At December 31,
  2021 2020
  $’000 $’000
ASSETS    
Current assets    
Cash 280,745 5,895
Other current assets 4,816 17
Total current assets 285,561 5,912
Non-current assets    
Property, plant and equipment 73 –
Total non-current assets 73 –
Total assets 285,634 5,912
     
LIABILITIES AND EQUITY    
Current liabilities    
Trade payables 1,214 1
Other current liabilities 819 245
Total current liabilities 2,033 246
Total liabilities 2,033 246
     
Equity attributable to owners    
Share capital 1,301 871
Share premium 291,448 5,430
Other reserves 131 –
Foreign currency translation reserve (3,333) 200
Accumulated deficit (5,946) (835)
Total equity 283,601 5,666
Total liabilities and equity 285,634 5,912
     
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Participate in psychedelic research from your phone!

World’s Largest Mobile Microdosing Study Published in Nature Scientific Reports

Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.

The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.

It’s not too late to participate – download the app here to join the study!

PDF of Article

Posted on

Want a life-changing psychedelic trip but don’t know where to start?

Wakeful Travel: Psychedelic Integration Journals

The Wakeful Integration Journal is your guide to transformation. 

It’s the ultimate tool to help you prepare for, navigate, and deeply integrate your psychedelic experiences. The journal features:

  • Prompts to discover your intentions and reflect on your trip
  • Dose tracking
  • Tips to support you along the journey
  • Colouring pages to unlock your creativity

If you want to start with microdosing rather than a full-on trip, the Wakeful Intention Journal is for you! It guides you through a 6-week microdosing protocol and helps you set intentions, notice patterns, and integrate your insights.

Support the Kickstarter here to receive a journal and begin your transformation journey!

Posted on

Cybin to Present at the Stifel GMP 2nd Annual Future of Healthcare Conference on December 8, 2021

Cybin to Present at the Stifel GMP 2nd Annual Future of Healthcare Conference on December 8, 2021

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM” is pleased to announce that Doug Drysdale, Cybin’s Chief Executive Officer, will present at the Stifel GMP 2nd Annual Future of Healthcare Conference being held virtually on Wednesday, December 8, 2021.

Mr. Drysdale’s presentation will be webcast live on December 8, 2021 at 3:30 p.m. ET. To listen to the event, please click here to register and access the webcast. The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

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 the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to TherapeuticsTM by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Investor & Media:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.