Mydecine Innovations Group Engages ethica CRO as Contract Research Organization Partner for Phase 2A PTSD Clinical Trials

Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) ("Mydecine" or the "Company"), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO ("ethica CRO"), a full-service Contract Research Organization ("CRO") that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization ("CRO") for its upcoming Phase 2A PTSD clinical trials.

ethica CRO is a full-service, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. ethica CRO provides a complete range of clinical study management and biometrics services for clinical research phases I through IV. Since its inception in 2002, ethica CRO has dedicated its efforts to bring a new dimension to the clinical research industry, the ethical dimension, focused on integrating research participants as partners in research rather than simply subjects of research. ethica CRO was the first CRO in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies

"We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine's upcoming Phase 2A PTSD clinical trials," commented Josh Bartch, CEO of Mydecine Innovations Group. "Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine's clinical development. We believe that with ethica CRO's deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States."

ethica CRO's dedication to research participant protection made it a partner of choice for the Canadian Department of National Defence. ethica CRO has participated in a series of clinical development programs with the Canadian DND and various NATO allies, most notably synthetic cannabinoids in the treatment of PTSD, injectable antidotes to chemical weapons, and skin decontamination kits for neutralizing chemical warfare agents.

"Psychedelics and psychedelic-assisted therapies are rapidly proving to be some of the most exciting developments in mental health treatment in decades," said Murray Jensen, Managing Director of ethica CRO. "Mydecine's ambitious approach to researching and tackling the mental health challenges facing veterans and other frontline workers aligns with our values and mission at ethica and we are excited to hit the ground running with the Mydecine team as they push forward in their pursuit to transform mental health."

Mydecine's international Phase 2A clinical trials will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia. Through these trials, Mydecine hopes to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting, utilizing strict protocols approved by research ethics boards and build upon the body of work that has led to psilocybin-assisted psychotherapy to receive "breakthrough" status by the FDA.

About Mydecine Innovations Group
Mydecine Innovations Group™ is an emerging biopharma and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health challenges and enhancing wellbeing. The company's world-renowned medical and scientific advisory board is advancing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine's portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.

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

About ethica CRO Inc.
Founded in 2002, ethica CRO is a full-service contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology, medical device and natural health product industries. ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies. Human research protection program (HRPP) accreditation by an independent, industry-recognized organization confirms that an organization's processes ensure the respect and protection of research participants, and that its services meet or exceed industry standards.

Learn more at: www.ethicaCRO.com and follow us on Twitter and LinkedIn .

Mydecine Innovations Group Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
adonohoe@kcsa.com / nopich@kcsa.com
212-896-1265 / 212-896-1206

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

Corp Communication:
Charles Lee, Investor Relations
corp@mydecineinc.com
+1 720-277-9879

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 .

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management's current expectations and assumptions. 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, 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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

The Conversation (0)

Seelos Therapeutics Announces 1-for-8 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-8 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday May 16, 2024.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Company's common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on Thursday, May 16, 2024 . Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F307. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.

At the effective time of the reverse split, every 8 issued and outstanding shares of the Company's common stock will be converted automatically into one share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 400,000,000 shares to 50,000,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 17.4 million to approximately 2.2 million.

About Seelos Therapeutics:

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

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 reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our 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. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent 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 Avenue, 2 nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-8-reverse-stock-split-302144966.html

SOURCE Seelos Therapeutics, Inc.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Melodiol Global Health Limited

Mernova’s Strong Progress Continues

Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to advise that its wholly owned Canadian subsidiary, Mernova, continues to make strong operational progress.

Keep reading...Show less

Compass Pathways Announces First Quarter 2024 Financial Results and Business Highlights

  • COMP360 phase 3 pivotal program in treatment-resistant depression (TRD) on track for top-line COMP005 trial data in fourth quarter 2024, COMP006 trial top-line data expected mid-2025
  • Compass announces positive phase 2 COMP360 data in post-traumatic stress disorder (PTSD)
  • Michael Gold to join Compass as Head of R&D
  • Compass enters into additional commercial collaborations, including with Reliant Medical Group, part of Optum Care
  • Cash position of $262.9 million at March 31, 2024
  • Conference call May 8 at 8:00 am ET (1:00 pm UK)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2024 and provided an update on recent business progress.

Kabir Nath, Chief Executive Officer, said, "We were pleased to see the positive results from the phase 2 PTSD study, a condition with significant unmet need and limited therapeutic options for the people who live with it. PTSD is a logical extension for COMP360 psilocybin treatment as there is significant overlap in patients living with treatment-resistant depression and PTSD. These strong data enable us to explore the optimal path forward to advance clinical development in PTSD alongside our phase 3 pivotal program in TRD, which is on track for initial data this year. We also continue to prepare for commercialization of COMP360 in TRD if approved by the FDA and have established collaborations with important mental health providers in the US to investigate models for the delivery of COMP360 psilocybin treatment at scale in diverse care settings."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

  • Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed
  • Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12)
  • 81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3% response and 54.5% remission at week 12
  • Measures of symptom scores relative to baseline improved following a single 25mg dose administered with psychological support (n=22)

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today announced top-line results from an open-label phase 2 study evaluating the safety and tolerability of investigational COMP360 psilocybin treatment in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints. Study observations included meaningful and sustained symptom improvement from baseline in mean CAPS-5 total score, a measure of disease severity, and in Sheehan Disability Scale (SDS) score, a measure of functional impairment in daily life. Administration of COMP360 was well-tolerated, with a safety profile consistent with previous studies.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Melodiol Global Health Limited

Notice of Annual General Meeting/Proxy Form

Notice is hereby given that the Annual General Meeting (‘Meeting’) of Shareholders of Melodiol Global Health Limited (‘Company’) will be held by virtual meeting facility at 9.30am (WST) on Friday, 31 May 2024.

Keep reading...Show less

Compass Pathways establishes research collaboration with Mindful Health Solutions to inform the development of a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment

Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, and Mindful Health Solutions (MHS), one of the US's leading providers of innovative behavioral health care, today announced that they have entered into a research collaboration agreement to inform the development of a scalable and cost-effective delivery model for COMP360 psilocybin treatment, if approved for treatment-resistant depression (TRD). This is the latest of several collaborations for Compass, intended to better understand a range of potential approaches to deliver COMP360 to patients in different care settings.

MHS offers comprehensive mental health care services for patients living with TRD and other mental health conditions. They focus on early adoption of advanced, interventional treatment options, as part of a long-term, holistic care model that includes medication management and psychotherapy. MHS operates over 20 outpatient clinics located across California, Washington, Texas, and Georgia.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×