Author: Newsdesk

Positioned as Leader in Emerging Psychedelic Therapeutics Market through Robust IP Portfolio, Novel Clinical Trials and Evolving Proprietary Technology

Strengthened Balance Sheet with Approximately $30 Million in Capital Raised Subsequent to the Year-End

Announced Appointment of Experienced Software and Engineering Leader, William Cook as Interim CEO of Mindleap

DENVER, May 03, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“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, today reported its financial results for the full year ended December 31, 2020 and provided a business update.

“In 2020, our team worked diligently and effectively to establish the foundation of Mydecine. We focused on closing strategic acquisitions and partnerships, advancing our clinical trials and building our intellectual property portfolio to position Mydecine as a key player in the advancement of psychedelic-assisted psychotherapy,” stated Josh Bartch, CEO of Mydecine. “Now, as we move ahead in 2021 with a vertically-integrated business model in place supported by a strengthened balance sheet and expanded team of world-class executives, we are strongly positioned to enter the next chapter of Mydecine’s journey to lead the future of the psychedelic therapeutics industry.”

“In addition, we are extremely excited to announce the appointment of William Cook as the Interim CEO & Technical Director of Mindleap, at this important juncture of our Company’s development.  Mr. Cook’s extensive technical and leadership experience combined with his passion for individuals’ mental health brings an exceptional combination to the leadership of Mindleap.

As a West Point grad, Mr. Cook designed the Patriot missile system software parameters for the Army and then at Raytheon, led the development of Patriot software including that used in Desert Storm.  Mr. Cook architected and led a team of over 200 engineers developing the THAAD missile defense ‘brain’ software at Litton Industries, receiving Litton’s highest honors for technical achievement and leadership.

Thereafter, Mr. Cook founded an engineering firm, demonstrating his critical role in leadership and driving growth for several major companies and projects.  Mr. Cook also received his master’s degree in Marriage, Family and Child Therapy and has performed thousands of hours of deep trauma-healing work in group and private psychotherapy, placing mental healthcare at the center of his passions. Mr. Cook a trusted leader of our Mindleap team as we launch Mindleap 2.0 in the spring of 2021,,” commented Mr. Bartch.

Business Highlights During and Subsequent to the Fourth Quarter 2020

Novel Clinical Studies

• Launched clinical trials in three continents for the Phase 2a study of psychedelic treatments for PTSD in veterans, EMS, and first responders with aims to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting.
   
• Completed the world’s first international legal export of dried psilocybin mushrooms providing access to a quality source of much needed product for both research purposes, as well as to sell and transfer CGMP naturally-derived psilocybin to other licensed research facilities around the globe.
• Sponsored several studies with academia, including the first lab-based study of established microdosing at Macquarie University in Australia and neuron level response to psilocybin at University of Maryland.
   
• Entered into an exclusive partnership with Applied Pharmaceutical Innovation (API) at the University of Alberta, as well as, expanded capabilities that enables support of multiple drug development and clinical trial programs simultaneously.
   
• Identified four lead novel drug candidates that are unique and patentable:
  • MYCO – 001 is pure psilocybin from natural fungal sources.
  • MYCO – 002 is an entactogenic compound that has been created with the goal of reducing harm and improving the safety profile vs. traditional MDMA.
  • MYCO – 003 is a psilocybin-based formula with reduced anxiety potential, with the aim of removing the possibility of “bad trips,” even with severely ill patients.
  • MYCO – 004 is a patch delivered tryptamine compound. Properties include short duration (~2hours), transdermal, precision dosing and long-term compound stability.

Robust IP Portfolio

• In October 2020, Mydecine filed its provisional patent for the treatment of post-traumatic stress disorder (PTSD) with psilocybin.
   
• In January 2021, Mydecine filed seven provisional patent applications with the United States Patent and Trademark Office (USPTO) in its efforts to discover valuable novel compounds in fungi for medicinal and pharmaceutical use.
   
• In February 2021, Mydecine filed a provisional patent for Mindleap’s mental health technology with the USPTO and the Canadian Intellectual Property Office.

Enhanced Leadership

• Appointed Dr. Rakesh Jetly as Chief Medical Officer in November 2020. Dr. Jetly brought a wealth of experience not only as a medical advocate for the use of psychedelic-assisted psychotherapy, but also as a prominent voice in the fight against PTSD and other mental health issues facing vulnerable populations like veterans and first responders.
   
• In January 2021, Dean Ditto joined the Company as Chief Financial Officer. Mr. Ditto has over 20 years of financial leadership experience, as well as, tenure with a Big 4 public accountant firm.
   
• In March 2021, Michel Rudolphie, former Novartis Norway CEO and former CEO and President of Make-A-Wish International, joined the Company as President of European Operations.
   
• Strengthened the Board of Directors with the appointments of veteran corporate finance and capital markets professional, Gordon Neal and Josephine Wu, both experienced at bringing numerous successful drugs to market.
   
• In April 2020, William Cook, an experienced software and engineering leader, was appointed interim CEO of Mindleap. Mr. Cook will be focused on the successful launch of Mindleap V2.

Capital Markets

• Raised approximately $30 million in capital subsequent to the year-end 2020.
   
• Successfully completed its migration to NEO Exchange and commenced trading on March 23, 2021.
   
• Submitted formal application to list on the NASDAQ Stock Exchange and took the necessary steps to qualify.

Financial Results for the Full Year 2020

Net Loss: Net loss attributable to common stockholders was $26.9 million for the year ended December 31, 2020, or a basic and diluted loss per share attributable to common stockholders of $0.24, as compared to a net loss attributable to common stockholders of $21.5 million for the year ended December 31, 2019, or a basic and diluted loss per share attributable to common stockholders of $0.96.

Cash Position: As of December 31, 2020, the Company had cash and cash equivalents of $2.2 million. Subsequent to the year-end 2020, the Company raised approximately $30 million and is well-funded to advance its IP portfolio, expand clinical trial calendar, expand European operations; and build out its technology division.

Conference Call and Webcast Information

The Company will host a conference call and audio webcast on Monday, May 3^rd at 10:30 a.m. ET. The dial-in numbers for the conference call are 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International). Please dial in 10 to 15 minutes prior to the start time of the conference call and an operator will register your name and organization.

The conference call will also be available via webcast, which can be accessed through the Investor Relations section of Mydecine’s website, https://www.mydecine.com/#investors or here.

For interested individuals unable to join the conference call, a replay of the call will be available through May 17, 2021, at +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 13718466. The online archive of the webcast will be available on https://www.mydecine.com/#investors after the conclusion of the call.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

For more information, please contact:

Media Contacts

Anne Donohoe / Nick Opich
KCSA Strategic Communications
[email protected]
1-212-896-1265 / 1-212-896-1206

Investor Contacts

Charles Lee, Investor Relations
[email protected]
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
[email protected]
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer [email protected]

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.

TORONTO, May 03, 2021 (GLOBE NEWSWIRE) — VitalHub Corp. (the “Company” or “VitalHub”) (TSXV: VHI) is pleased to announce the sale of recently acquired Transforming Systems’ proprietary SHREWD Region Platform to the National Health Service (NHS) East of England Regional Team (the “Regional Team”).

The NHS East of England regional provides care for a population group of over 6 million people and includes six Integrated Care Systems (ICS), covering Cambridge & Peterborough, Norfolk & Waveney, Bedfordshire, Luton & Milton Keynes, Mid & South Essex, and Suffolk & North East Essex localities in addition the original Herts & West Essex pilot area. 

The neighboring ICS to the East of England Region, Hertfordshire and West Essex, has been a user of the SHREWD Region Module for two years. The successful implementation and use of the SHREWD platform has resulted in this expansion of use, with the Regional Team adopting use of the solution across the region, including amongst 17 hospital sites.

The initial use of the product, with an opportunity to expand to include additional modules, involves the creation of an intelligent conveyancing system, intended to support the East of England Ambulance Service (EEAST). The solution will enable data to be gathered across the region’s emergency departments to enable improved tactical decision-making is respect to patient transport, toward optimizing resource allocation and care delivery.

SHREWD Region provides a simple, single view of real-time pressure in urgent and emergency care across a large geographical area, spanning multiple systems, trusts and providers. The data is displayed via a heatmap, reflecting live acute and system Operational Pressures Escalation Levels (OPEL) statuses, revealing emerging pressure at a glance.

“This regional sale continues to demonstrate how successful implementations lead toward expansion across neighbouring regions and sites,” said Dan Matlow, CEO of VitalHub Corp. “Now more than ever, it has become essential for regions and systems to maintain a comprehensive real-time understanding of pressures and capacity within their emergency care departments. We are delighted that regions are seeing immense value in our solutions, and we are looking forward to continuing to provide vital services to ensure that these organizations continue to run smoothly and optimally.”

ABOUT VITALHUB

Software for Health and Human Services providers designed to simplify the user experience & optimize outcomes.

VitalHub provides technology to Health and Human Services providers including; Hospitals, Regional Health Authorities, Mental Health, Long Term Care, Home Health, Community and Social Services. VitalHub solutions span the categories of Electronic Health Record (EHR), Case Management, Care Coordination, Patient Flow & Operational Visibility, and DOCit Mobile Apps.

The Company has a robust two-pronged growth strategy, targeting organic growth opportunities within its product suite, and pursuing an aggressive M&A plan. Currently, VitalHub serves 275+ clients across Canada, USA, UK, Australia, Qatar, and Latvia. VitalHub is based in Toronto, Canada, with an offshore development hub in Sri Lanka. The Company is publicly traded on the TSX Venture Exchange under the symbol “VHI”.

CAUTIONARY STATEMENT

This press release includes forward-looking statements regarding the Corporation and its business, which may include, but is not limited to, statements with respect to the appointment of a new directors. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding the technology industry, failure to obtain regulatory or shareholder approvals, market conditions, economic factors, the equity markets generally and risks associated with growth and competition. Although the Corporation has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Corporation undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT INFORMATION

Dan Matlow
Chief Executive Officer, Director
(416) 727-9061
[email protected]

YONKERS, N.Y., May 03, 2021 (GLOBE NEWSWIRE) — ContraFect Corporation (Nasdaq: CFRX), a late clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 10,988,520 (the ‘520 patent), on April 27, 2021 for CF-370, the company’s second potential therapeutic product candidate. The ‘520 patent, which is owned by ContraFect, expires in March of 2039, and is the latest U.S. patent to issue from the company’s DLA patent portfolio.

The ‘520 patent, entitled “Lysin-Antimicrobial Peptide (AMP) Polypeptide Constructs, Lysins, Isolated Polynucleotides Encoding Same and Uses Thereof” contains composition of matter claims covering the CF-370 construct, and claims for methods of treating Gram-negative bacterial infections, including those caused by Pseudomonas aeruginosa (P. aeruginosa), Klebsiella pneumoniae, Acinetobacter baumannii (A. baumannii), Enterobacter cloacae and Escherichia coli.  

This patent demonstrates the Company’s commitment to developing an investigational product targeting P. aeruginosa, a Gram-negative pathogen that causes severe infections, including hospital-acquired and ventilator-associated pneumonias and pulmonary exacerbations of cystic fibrosis infections. Gram-negative bacteria have an outer membrane that makes them more resistant to antibiotics. CF-370 has been molecularly engineered to bypass this outer membrane to enable potent antimicrobial activity in human serum in vitro, providing a novel mechanism to potentially address life-threatening P. aeruginosa infections. By killing targeted bacteria upon contact, lysins are fundamentally different than conventional antibiotics.

“With the issuance of this important patent, we continue expanding ContraFect’s strong intellectual property estate covering this new class of antibacterial drugs. We believe that our superiority-based therapeutic approach, led by the Phase 3 exebacase program being developed for Staph aureus bacteremia, has the potential to fundamentally transform the treatment of patients with life-threatening infections. The need for innovative approaches that address the growing scourge of drug-resistant bacterial infectious diseases is well recognized and we believe that our direct lytic agents could be a significant part of the global solution to this issue,” said Roger J. Pomerantz, M.D., President, Chief Executive Officer, and Chairman of ContraFect.

About CF-370:

CF-370 is an investigational first-in-class therapeutic candidate targeting P. aeruginosa, a Gram-negative pathogen. CF-370 has been engineered to bypass the outer membrane of the bacteria and to enable potent activity in human serum. The Company believes this is a significant milestone for direct lytic agents as native lysins are typically unable to penetrate the outer membrane of Gram-negative bacteria and consequently unable to work in vitro in human blood or in animal models. However, based on the proprietary methods the Company has identified and utilizes to engineer lysins, CF-370 has exhibited the hallmark in vitro features of the lysin class, including rapid and potent bactericidal activity, synergy with a broad range of standard of care agents and the eradication of biofilms in preclinical studies. The promising data from animal models support the potential therapeutic utility of CF-370 for the treatment of serious infections caused by P. aeruginosa, including hospital-acquired and ventilator-associated pneumonias and pulmonary exacerbations of cystic fibrosis.

About ContraFect:

ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our platform of DLAs, which include lysins and amurin peptides. Lysins are a new class of DLAs which are recombinantly produced antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics. Amurin peptides are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, A. baumannii, and Enterobacter species. We believe that the properties of our lysins and amurin peptides will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections such as bacteremia, pneumonia and osteomyelitis. We have completed a Phase 2 clinical trial for the treatment of Staph aureus bacteremia, including endocarditis, with our lead lysin candidate, exebacase, which is the first lysin to enter clinical studies in the U.S. Exebacase, currently being studied in a pivotal Phase 3 clinical study, was granted Breakthrough Therapy designation by the FDA for the treatment of MRSA bloodstream infections, including right-sided endocarditis, when used in addition to SOC anti-staphylococcal antibiotics in adult patients.

Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.

Forward-Looking Statements

This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding: the ‘520 patent, the features and properties of CF-370, the Company’s portfolio, ContraFect’s ability to discover and develop DLAs as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, whether ContraFect will address life-threatening infections using its DLA platform, whether lysins are a new class of DLAs which are recombinantly produced, antimicrobial proteins with a novel mechanism of action associated with the rapid killing of target bacteria, eradication of biofilms and synergy with conventional antibiotics, whether amurins are a novel class of DLAs which exhibit broad-spectrum activity against a wide range of antibiotic-resistant Gram-negative pathogens, and whether the properties of ContraFect’s lysins and amurins will make them suitable for targeting antibiotic-resistant organisms, such as MRSA and P. aeruginosa. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including the occurrence of any adverse events related to the discovery, development and commercialization of ContraFect’s product candidates such as unfavorable clinical trial results, insufficient supplies of drug products, the lack of regulatory approval, or the unsuccessful attainment or maintenance of patent protection and other important risks detailed under the caption “Risk Factors” in ContraFect’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contacts

Michael Messinger
ContraFect Corporation
[email protected]

Carlo Tanzi, Ph.D.
Kendall Investor Relations
[email protected]

VANCOUVER, British Columbia, May 03, 2021 (GLOBE NEWSWIRE) — Golden Predator Mining Corp.(TSX.V: GPY; OTCQX: NTGSF) (“Golden Predator“) announces that the Company and Viva Gold Corp. (“Viva Gold”) have mutually agreed to terminate the arrangement agreement dated March 2, 2021 for the proposed acquisition of all of the issued and outstanding shares of Viva Gold by Golden Predator. Golden Predator also advises, regardless of the terminated Agreement with Viva Gold, Golden Predator will proceed with its plans to distribute 8,620,000 common shares of C2C Gold Corp. to shareholders of record of Golden Predator Mining Corp. by way of a return of capital transaction. A date of record will be announced.

Golden Predator will continue to focus on advancing its Brewery Creek project in the Yukon through the permitting renewal process. The Company is working with the Yukon Department of Energy, Mines and Resources, and the Yukon Water Board to renew its mining and water use licenses, with the ongoing support of the Tr’ondek Hwech’in First Nation.

ABOUT GOLDEN PREDATOR MINING CORP.

Golden Predator is advancing the past-producing Brewery Creek Mine towards a timely resumption of mining activities in Canada’s Yukon. The project has established resources grading over 1.0 g/t Gold and both a technical report and Bankable Feasibility Study underway to define the economics of a restart of heap leach operations at the Brewery Creek Mine. The 180 km² brownfield property is located 55 km by road from Dawson City, Yukon and operates under a Socio-Economic Accord with the Tr’ondëk Hwëch’in First Nation. The Company also holds the Marg Project, with a 43-101 compliant resource, the Gold Dome Project and Grew Creek Project. For additional information on Golden Predator and the Brewery Creek Mine, please visit our website: www.goldenpredator.com.

FOR ADDITIONAL INFORMATION:

GOLDEN PREDATOR MINING CORP. Janet Lee-Sheriff, Chief Executive Officer (604) 260-0289 [email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

TORONTO, May 03, 2021 (GLOBE NEWSWIRE) — Today Dosecann, an in-house brand owned by Auxly Cannabis Group Inc. (TSX – XLY) (“Auxly”), announces the launch of Dosecann Daily Relief CBD Cream, a new, high-strength, differentiated cannabis topical cream for Canadian wellness consumers. With 1,200mg of cannabidiol (CBD) per 60 ml unit, Dosecann Daily Relief CBD Cream has double the potency of any CBD topical currently available in the Canadian marketplace and is competitively priced to deliver the best value for a CBD topicalⁱ. Dosecann Daily Relief CBD Cream is available to order now for wholesalers across Canada, is available to consumers now in British Columbia and Saskatchewan and will also be available in Alberta in coming weeks.

Dosecann Daily CBD Cream was developed by a team of scientists, researchers and formulation experts at Auxly’s state-of-the-art laboratory in Charlottetown, PEI, under the direction of Dr. Bob Chapman, Chief Science Officer, Dosecann.

“Topicals were among the very first products we conceived of at Dosecann and I’m extremely proud that after thorough development and testing, we’ve landed on a formula that we believe is the best in the marketplace,” said Dr. Chapman. “Consumers use topicals to provide daily relief from a wide variety of symptoms such as localized pain relief, muscle soreness, tension and inflammation. Our team was driven to ensure that Dosecann Daily Relief CBD Cream offers industry-leading potency along with a formulation designed to boost CBD penetration and provide the skin moisturizing properties of high-end skin creams.”

“We’re excited to launch Dosecann Daily Relief CBD Cream and expand our expertise in the 2.0 segment into topicals,” said Brad Canario, Brand Director, Auxly. “We know from research that topicals are a high-frequency segment, with nearly 50% of topical consumers using daily, and further, that amongst Canadian cannabis users, creams are the #1 topicals format. We believe we have a truly differentiated product for wellness consumers looking for daily relief from a variety of symptoms and, as always, we focused on our pillars of quality, safety and efficacy at every stage of product development.”

The proprietary Dosecann Daily Relief CBD Cream formula combines high-quality CBD extract with Natralipid™ Meadowfoam seed oil, a plant-based emollient found in high-end skin creams and valued for moisturization, transdermal barrier repair, skin penetration and unsurpassed stability. The result is a product that promotes the fast, effective absorption of high-quality CBD extract so that the cannabinoids can get where they’re needed quickly, all the while soothing the skin by locking-in moisture without leaving a greasy feeling behind. Dosecann Daily Relief CBD Cream has a mild, neutral bamboo scent and is packaged in a recyclable glass jar with a built-in seal to preserve freshness. 

Dosecann Daily Relief CBD Cream is the latest cannabis 2.0 release from Auxly, who achieved the #1 market-share position for Cannabis 2.0 products in 2020. With today’s launch, Dosecann expands its offering of natural, science-backed products, which includes oils and precision-dosed capsules made with omega-rich Ahiflower™ oil.

About Dosecann        
Dosecann is a world-class developer of innovative cannabis products for the wellness-focused consumer, wholly owned by Auxly Cannabis Group Inc. Proudly processed at Auxly’s 52,000 sq. ft., state-of-the-art facility in Charlottetown, Prince Edward Island, Dosecann products are developed and manufactured on-site by a world-class team of scientists and experts, ensuring high-quality, precision and consistency. Dosecann’s wellness products, available at licensed cannabis retailers across Canada, consist of non-GMO capsules and oils. Built on the pillars of quality, safety and efficacy, Dosecann is cannabis – down to a science.

Learn more at dosecann.com and stay up to date at Twitter: @Dosecann; Instagram: @dosecann; Facebook: @dosecann.

About Auxly Cannabis Group Inc. (TSX: XLY) (OTCQX: CBWTF)        
Auxly is leading Canadian cannabis company dedicated to bringing innovative, effective, and high-quality cannabis products to the wellness and adult-use markets. Auxly’s experienced team of industry first-movers and enterprising visionaries have secured a diversified supply of raw cannabis, strong clinical, scientific and operating capabilities and leading research and development infrastructure in order to create trusted products and brands in an expanding global market.

Learn more at auxly.com and stay up to date at Twitter: @AuxlyGroup; Instagram: @auxlygroup; Facebook: @auxlygroup; LinkedIn: company/auxlygroup/.

For more information please contact:
Scott Campbell, 647-402-4957, [email protected] 

Notice Regarding Forward Looking Information:

This news release contains certain “forward-looking information” within the meaning of applicable Canadian securities law. Forward-looking information is frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or information that certain events or conditions “may” or “will” occur. This information is only a prediction. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking information throughout this news release. Forward-looking information includes but is not limited to: Dosecann’s execution of its product development and commercialization strategy; consumer preferences; political change, future legislative and regulatory developments involving cannabis, cannabis products and cannabis health products; and competition and other risks affecting Auxly in particular and the cannabis industry generally.

A number of factors could cause actual results to differ materially from a conclusion, forecast or projection contained in the forward-looking information in this release including, but not limited to whether: there is acceptance and demand for current and future Dosecann products by consumers and provincial purchasers, and general economic, financial market, regulatory and political conditions in which Auxly operates will remain the same. The forward-looking information in this release is based on information currently available and what management believes are reasonable assumptions. Forward-looking information speaks only to such assumptions as of the date of this release. In addition, this release may contain forward-looking information attributed to third party sources, the accuracy of which has not been verified by Auxly. The forward-looking information contained in this release is expressly qualified by the foregoing cautionary statements and is made as of the date of this release. Except as may be required by applicable securities laws, Auxly does not undertake any obligation to publicly update or revise any forward-looking information to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or results, or otherwise.

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

ⁱ Based on price-per mg of CBD.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/15c477a3-0d65-4413-bd82-f9a849412e2a

• COVAXIN effectively neutralizes Brazil variant along with UK variant and India double mutant variant

• Potential effectiveness against multiple variants reduces the possibility of mutant virus escape

• According to World Health Organization, the double mutant variant of SARS-CoV-2 has spread to at least 17 countries
  

MALVERN, Pa., May 03, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that in a new study, scientists at Indian Council of Medical Research (ICMR)-National Institute of Virology have found that COVAXIN demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2. As previously disclosed, a study conducted by ICMR also suggested that COVAXIN was effective against the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. It is notable that the Brazilian variant, B1.128.2, contains the E484K mutation that was found in New York.

In the ICMR studies, COVAXIN-vaccinated sera effectively neutralized several SARS-CoV-2 variants (B.1.617 (India, double mutant), B.1.1.7 (United Kingdom), B.1.1.28 (Brazil P2), and heterologous strain) in an in-vitro plaque reduction neutralization assay. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Ocugen: Neutralizing antibody response of COVAXIN vaccinated sera against SARS-CoV-2 strains

“We are pleased to see the results of this study as it demonstrates the potential effectiveness of COVAXIN against multiple variants, further strengthening our belief that this vaccine can potentially eliminate the possibility of mutant virus escape,” said Dr. Satish Chandran, chair of the vaccine scientific advisory board of Ocugen.

“COVAXIN continues to show strong results in all the studies conducted to date. We continue to believe this vaccine is a critical tool to include in our national arsenal to fight this pandemic. The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

Ocugen is developing COVAXIN, Bharat Biotech’s COVID-19 vaccine candidate, for the U.S. market. In the recently shared second interim results of the Phase 3 clinical trial, COVAXIN demonstrated 78% overall efficacy and 100% in severe COVID-19 disease (including hospitalization).

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^⁰C.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:

Ocugen, Inc.

Sanjay Subramanian
CFO and Head of Corp. Dev.
[email protected]

Media Contact:

LaVoieHealthScience

Lisa DeScenza
[email protected]
+1 9783955970