PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher (PHRM) applied for an orphan drug designation for a ketamine treatment for a rare seizure condition called Status Epilepticus. If approved, the designation would give the company potential tax credits, grant eligibility, and exclusive marketing rights.

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Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

Focus on the discovery and development of novel therapeutic strategies to treat obesity and its related metabolic disorders

TORONTO, Nov. 24, 2021 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0, OTC Pink: CMNDF), (“Clearmind” or the “Company”), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, is pleased to announce it has signed an agreement to fund a new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory, to evaluate the Company’s proprietary compound, MEAI’s direct effect on binge eating including food and water intakes as well as activity and metabolic parameters.

The study, which will be overseen by Prof. Joseph (Yossi) Tam, D.M.D., Ph.D., head of the Obesity and Metabolism Laboratory and Associate Professor of Pharmacology at the Hebrew University’s Institute for Drug Research, will focus on testing the potential of MEAI to treat binge eating and related behaviors, and will support the discovery and development of novel therapeutic strategies to safely treat obesity and its associated metabolic disorders.

Increasingly prevalent in developed nations, the conditions of being overweight and obese are a serious health concern as they contribute to so many other conditions, including heart disease, stroke, type 2 diabetes, fatty liver disease, and certain types of cancers, some of the leading causes of preventable, premature death in the US. The Center for Disease Control and Prevention estimates that about 74% of adults in the US are overweight1 and over 40% are considered obese2. According to a recent study published in 2020, this phenomenon is also accompanied with the high and rising costs of obesity to the US Health Care system at an estimated annual medical cost for the full non-institutionalized population of adults, in 2013, equaling $342.2 billion.

Adi Zuloff-Shani, Ph.D., CEO of Clearmind, commented on the announcement, “The medical community has yet to establish an effective therapeutic or preventative treatment for obesity, despite its increasing prevalence and severe negative impacts on the medical and economic health of people around the world. Clearmind has been able to demonstrate the positive influence MEAI has on binge behavior with regard to alcohol use, and our preliminary research indicates it may have a similar effect on metabolic disorders.”

Prof. Tam added, “I have spent my career exploring the biological mechanisms underlying obesity and the metabolic syndrome, intending to develop an effective drug therapy. After viewing the early data on MEAI, I am optimistic that this compound has the potential to be a building block for a real solution and look forward to working with the Clearmind team to advance our shared objective.”

The first phase of the three-stage study will focus on assessing the direct effect of MEAI on food and water intakes as well as its ability to modulate activity and metabolic parameters.

Following the initial screening, the study will evaluate MEAI’s efficacy as a therapeutic metabolic agent on a high-fat diet-induced obese mouse model, by measuring MEAI’s potential to treat obesity, hepatic injury, glycemic and hormonal imbalance. Lastly MEAI’s binge eating and drinking mitigating properties will be determined by comparison of cumulative food and sucrose preference, respectively.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of four patent families. The first, “Binge Behavior Regulators”, has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute”, has been approved for a European patent, with pending applications in the U.S., China and India. 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.

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

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (778) 400-5347
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 discussion of the new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory and the benefits of product candidate. 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.

Better Plant Adds Nationwide Natural Foods To Its Distribution Network

Better Plant Adds Nationwide Natural Foods To Its Distribution Network

Vancouver, B.C. – November 24, 2021: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FRA: YG3) (“Better Plant”), a wellness company that develops and sells sustainable, plant-based products that are better for health and better for the earth, announces that it has added Nationwide Natural Foods Inc. (“Nationwide”) as a distributor for Jusu Bar juices in Canada.

Nationwide brings with them a seasoned salesforce of 7 account managers with accounts across Canada for major and independent grocery stores focused on delivering clean, natural products that cater to a certain lifestyle. Accounts included in Nationwide’s distribution network include Sobeys, The Jim Pattison Group of Stores, Country Grocer, Whole Foods Market, Nutters, and Sunterra Markets.

“On behalf of my father’s company we are quite excited to be working alongside Jusu Juice to offer retailers some great cold pressed juices that are full of wellness and nutrition to offer their shoppers,” says Randy Sihota, Operations and Business Development for Nationwide. “We’re looking forward to seeing more innovative nutritious creations come out of the Jusu Bar, it all starts from the ground up”.

“Working with Nationwide allows us to capitalize on the wide network of grocery chains they service across Canada”, says Amber Allen, Director of Sales for Better Plant. “Having dedicated representatives in each region ensures our brand presence across Canada. This fits well with our growth strategy to increase distribution for Jusu Bar throughout Eastern Canada.”

 

About Nationwide Natural Foods Inc.

Nationwide is a Canadian owned and operated family business since 2000. Nationwide specializes in the distribution of various domestic and imported products to retailers across Canada. It offers a wide selection of natural, organic, gluten free, vegan and vegetarian products, with products including dry, refrigerated and frozen.

Nationwide is dedicated to providing its customers with the highest level of quality products and customer service in addition to affordable pricing. Purchasing, logistics and distribution are closely monitored to ensure maximum efficiency.

Nationwide has seen a steady growth since 2000 and its goal is for continuous improvement of the services offered to its retailers. Its customer base includes major and independent grocery stores, specialty stores, coffee shops, and bistros.

 

About Better Plant Sciences Inc.

Better Plant harnesses plant intelligence and leverages modern science to offer sustainable, plant-based products that are better for health and better for the earth. It makes and sells over 75 proprietary products, all made with 100% natural ingredients, under the brands Jusu, Urban Juve and Wright & Well.  Better Plant operates Jusu Bar, a quick serve restaurant alternative in Victoria, BC, which serves up fresh, healthy, and nutritious options with a focus on Jusu cold-pressed juices. Jusubar.com offers home delivery of refrigerated plant-based beverages consisting of cold-pressed juices and packaged juice cleanses. Through its Shopify enabled eCommerce sites getjusu.com and urbanjuve.com, Better Plant sells plant-based personal care products and cleaning products. Better Plant products are sold through a network of online and brick and mortar retail locations including Whole Foods Market, Pharmasave, Healthy Planet and Vitasave. Better Plant also offers operational, financial, and other services to companies with businesses that align with Better Plant’s mission to help create a better world.

 

For more information or to purchase Jusu Wellness products, visit getjusu.com or follow Jusu Wellness on Instagram or Facebook.

 

For more information or to purchase Jusu Bar products, visit jusubar.com or follow on Instagram.

 

For more information on Better Plant, visit betterplantsciences.com or follow on InstagramTwitter or LinkedIn.

 

Penny White, President & CEO

penny@betterplantsciences.com

1-833-515-2677

 

Investor Relations:

Alexandra Dumanski

invest@betterplantsciences.com

1-833-515-2677

 

Sales Inquiries:

Amber Allen, Head of Sales

amber@betterplantsciences.com

604-808-8118

 

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of COVID-19, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Better Plant cautions readers not to place undue reliance on forward-looking statements provided by Better Plant, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better Plant expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Seelos Therapeutics Raises $20 Million in Private Placement of Senior Secured Convertible Note

Seelos Therapeutics Raises $20 Million in Private Placement of Senior Secured Convertible Note

NEW YORK, Nov. 24, 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, today announced the placement of a $22.0 million senior secured convertible note (the “Note”) and shares of Seelos common stock (the “Closing Shares”) to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds.

Seelos intends to use the proceeds for general corporate purposes and to advance the development of its product candidates.

“2021 has been a volatile year for the biotech sector and this financial commitment from the team at Lind further strengthens our balance sheet and provides for additional future funding,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The team at Lind has been a terrific partner for us and their creative and innovative funding solutions are thoughtfully and strategically designed to fit the needs of their partners. We are proud to once again work together, and we look forward to the continued execution of our ongoing and future studies.”  

The following are some of the key features of the Note:

  • 36-month maturity with a 0% coupon for the first year
  • After the first anniversary, the Note shall bear interest at an annual rate of 5% per annum and interest payments will be required monthly thereafter
  • Repayment of principal in 24 monthly payments beginning in November 2022 equal to the then-outstanding principal amount of the Note, divided by the number of months remaining until the Note’s maturity date
  • Any principal and interest repayments may be made, at the Company’s sole discretion, in cash, common stock, or a combination of both
  • Starting 9 months after the date of issuance of the Note, convertible at Lind’s option into shares of Seelos common stock at a fixed conversion price of $6.00 per share
  • Seelos has the right to prepay (i) up to 66 2/3% of the outstanding principal amount of the Note prior to the nine-month anniversary of the issuance date of the Note, and (ii) up to the entire outstanding principal amount of the Note on or after the nine-month anniversary (or, if Seelos prepays any amount of the Note during the first nine months, the 12 month anniversary) of the issuance date of the Note, subject to Lind’s right to convert a portion of the Note at $6.00 per share in certain circumstances
  • The agreement includes up to an additional $30.0 million of funding in senior secured convertible notes based on achievement of certain future milestones, which may be either at the option of Seelos or with the mutual agreement of Seelos and Lind depending on the milestone

“Lind is once again pleased to increase our investment in Seelos to help fund multiple registrational studies,” said Phillip Valliere, Managing Director at The Lind Partners. “Raj and the Seelos team have continued to execute at a very high level since our initial funding last December and we are glad to re-invest to fund further development of their pipeline.” 

The Note and the Closing Shares were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the Note, have not been registered under the Act or applicable state securities laws. Accordingly, the Note, the Closing Shares and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About The Lind Partners

The Lind Partners manages institutional funds that are leaders in providing growth capital to small- and mid-cap companies publicly traded in the US, Canada, Australia and the UK. Lind’s funds make direct investments ranging from US$1 to US$30 million, invest in syndicated equity offerings and selectively buy on market. Having completed more than 100 direct investments totaling over US$1 Billion in transaction value, Lind’s funds have been flexible and supportive capital partners to investee companies since 2011.

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 disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York. For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

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 related to Seelos’ expectations on the anticipated use of proceeds from the financing and the additional potential $30.0 million of funding and achievement of milestones thereunder. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risks associated with the implementation of Seelos’ business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price and general market conditions, 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 most recent 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 Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Cybin Awards Grant for Psychedelic Treatment Clinic at Lenox Hill Hospital to Benefit Underserved Communities

Cybin Awards Grant for Psychedelic Treatment Clinic at Lenox Hill Hospital to Benefit Underserved Communities

Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced it has awarded a grant for the first psychedelic treatment clinic at Lenox Hill Hospital, part of Northwell Health, to serve marginalized and underserved communities on the Upper East Side of Manhattan, New York. The program aims to become one of the first hospital-based clinical sites to offer psychedelic medicine in the United States.

Lenox Hill Hospital is a 450-bed, acute care facility on Manhattan’s Upper East Side and the flagship Manhattan hospital of Northwell Health – the largest healthcare system in New York State. Highlights of the program include:

  • Founded by Kimia Pourrezaei, DO, and Gregory Mendoza, LCSW-R, of the Lenox Hill Hospital Outpatient Center for Mental Health, the clinical program is dedicated to addressing health inequities by prioritizing care for marginalized and underserved populations;
  • The program will increase accessibility by offering treatment with no out of pocket cost for individuals who would otherwise be unable to afford this service;
  • The clinic plans to also provide psychedelic treatments to frontline healthcare workers affected by COVID-19;
  • Clinicians will receive training in MDMA-, ketamine-, and tryptamine-assisted psychotherapy.

Clinicians will also receive training in EMBARK, a transdiagnostic psychedelic psychotherapy model that can be adapted to address a range of clinical indications and populations. EMBARK is Cybin’s psychotherapy model created by Dr. Alex Belser, Cybin’s Chief Clinical Officer and Bill Brennan, Ph.D. (cand.).

“Lenox Hill Hospital is excited by the potential of these modalities for the treatment of previously intractable conditions such as severe depression, chronic PTSD, and OCD,” said David Roane, MD, Chairman of Psychiatry at Lenox Hill Hospital. “With this grant from Cybin, Lenox Hill Hospital aims to become one of the first hospital-based clinical sites offering psychedelic medicine in the country and is dedicated to addressing health inequities by prioritizing care for marginalized and underserved populations. In particular, people of color are greatly underrepresented in psychedelic research studies and our team is committed to inclusive recruitment of patients.”

“It’s time for psychedelic medicine to climb down from the ivory tower and into the community. We are honored to support this program at Lenox Hill Hospital to start a low-cost/no-cost psychedelic-clinic for marginalized and underserved communities in New York,” said Dr. Alex Belser, Chief Clinical Officer of Cybin.

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 USA, UK 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.

About Lenox Hill Hospital
Lenox Hill Hospital, a member of Northwell Health, is a 450-bed, fully accredited, acute care hospital located on Manhattan’s Upper East Side with a national reputation for outstanding patient care and innovative medical and surgical treatments. U.S. News & World Report has ranked Lenox Hill among the nation’s best for cardiology and heart surgery; diabetes and endocrinology; ear, nose and throat; geriatrics; gynecology; neurology and neurosurgery; and orthopedics. In addition, the hospital received “high performing” designations from U.S. News for its performance in cancer, gastroenterology and GI surgery, pulmonology and lung surgery, and urology. For more information, go to www.lenoxhill.northwell.edu.

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.

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 September 30, 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. Vigorous 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
Cybin Inc.
leah@cybin.com

Source: Cybin Inc

NeonMind Announces Successful Completion Of Pre-IND Consultation With FDA On Clinical Path For Obesity Drug Candidate NEO-001

NeonMind Announces Successful Completion Of Pre-IND Consultation With FDA On Clinical Path For Obesity Drug Candidate NEO-001

  • FDA feedback provides clear clinical path for NEO-001, the first obesity drug therapy focused on neuropharmacological and behavioral changes for sustainable weight loss 
  • Company plans to file an IND application for a Phase 1/2 clinical study anticipated to start in H1’2022

Vancouver, B.C. – November 23, 2021: NeonMind Biosciences Inc. (CSE: NEON) (OTCQB: NMDBF) (FRA: 6UF) (“NeonMind” or the “Company”), an integrated drug development and wellness company focused on the potential therapeutic uses of psilocybin for treating obesity and weight management conditions, announced today it successfully completed a pre-Investigational New Drug (IND) consultation with the U.S. Food and Drug Administration (FDA), regarding proposed clinical trials for NeonMind’s lead obesity drug candidate, NEO-001. The Company expects to initiate a Phase 1/2 clinical study in the first half of 2022.

“We are extremely pleased with the FDA’s feedback and the outcome of the pre-IND consultation, which validated the scientific hypothesis and clinical approach developed by the NeonMind team. The FDA provided helpful feedback and constructive recommendations for the next steps in our development plan. We appreciate the FDA’s guidance and are on track to bring the first and only psychedelic-based treatment for obesity into clinical trials,” said Robert Tessarolo, President & CEO of NeonMind. “In parallel with an IND submission, we plan to engage with a Contract Research Organization and qualify clinical sites to move expeditiously into a Phase 1/2 Proof-of-Concept study.”

The pre-IND consultation offered feedback for NeonMind to execute on measurable clinical development milestones for its NEO-001 clinical program. The FDA acknowledged the study rationale and potential therapeutic opportunity of NEO-001 for the treatment of obesity, and the justification to advance into human clinical trials. NeonMind will incorporate the FDA’s recommendations and does not expect any impact on the timing of the proposed NEO-001 clinical program. NeonMind’s proprietary therapy will be the first psychedelic program in humans to target a large population of patients struggling with sustainable weight management.

NEO-001, the Company’ lead drug candidate targeting obesity, is a high-dose psilocybin treatment coupled with behavioral therapy and lifestyle intervention, which aims to improve the efficacy of chronic weight management in adults. The Company has identified a regulatory strategy, including a target indication and product profile, which it believes will best position NeonMind as it advances its first lead candidate through development.

 

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind, and its strategic medical services partner, SRx Health Solutions,  expect to launch NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to  www.NeonMindBiosciences.com.


Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.

rob@neonmind.com

Tel: 416-750-3101

 

Investor Relations:

KCSA Strategic Communications

Scott Eckstein/Tim Regan

neonmind@kcsa.com

Tel: 212-896-1210

 

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “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 NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

Novamind Unveils New Logo and Invests in Unified Brand

Novamind Unveils New Logo and Invests in Unified Brand

TORONTO, ON / November 24, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today launched a new logo and announced that the Company will unite its subsidiaries and brands under a single Novamind brand.

Novamind is investing in a revitalized and unified brand following a year of significant growth including expansion into new states, launching new clinics and research sites and bringing to market several innovative mental health care offerings.

Novamind Logo

Novamind’s new logo is now live on its corporate website and social media platforms. The logo integrates and flows across all digital and physical properties, and represents Novamind’s core beliefs in hope, healing and transformation. The open doorway at the centre of the logo, working in conjunction with the radiating lines, is an invitation towards an improved way of life—one where taking care of mental health is a priority.

The logo reveal kicks off the multi-phase rebrand of the Company’s network of clinics and research sites, expected to be complete in 2022. The Company is also improving its website to scale alongside its growth strategy and better serve diverse audiences with enhanced content and tools. Taking inspiration from the revitalized logo, the website will provide an accessible digital entry point to Novamind’s world-class care and clinical research offerings.

Yaron Conforti, CEO and Director, commented: “The new logo, rebrand and website reflects our rapid evolution over the last year. It’s an exciting opportunity to unify our current and future assets under one unique identity that will become a trusted and recognized name for innovative mental healthcare in communities across the U.S.”

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

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

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. 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 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 forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.