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Marvel Biosciences Initiates Its Final FDA-Required Experiment Prior to Initiating Human Trials for Its Lead Drug Candidate MB-204

Calgary, Alberta--(Newsfile Corp. - December 12, 2022) - Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), announces it has initiated its 10-day, dose-ranging toxicology study, using dogs, for its lead drug candidate MB-204.

To date, the Company's MB-204 has shown positive and promising data addressing depression, anxiety as well as its potential benefit in protecting patient's vital organs while going through chemotherapy treatments. As the maximum tolerated single-dose studies have been completed, FDA guidelines for drug development next prescribe an approximately one-week multiple dosing study required to run the industry standard 4-week good lab practise (GLP) toxicology studies. The studies are all required by the FDA prior to entering FDA Phase I human trials.

"We continue to achieve our milestones in a timely fashion and have made great progress in getting our key asset, MB-204 ready to enter human trials in early 2023," said Rod Matheson, CEO of Marvel Biosciences. "MB-204 has the potential to target a very significant market and we will continue to closely monitor the effects of this lead asset drug and will seek all opportunities to maximize shareholder value from our key asset."

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"This is the final milestone we need to run to identify the best doses in our upcoming 4-week GLP dog study, which in combination with our rat studies, will enable us to commence human clinical testing of MB-204," said Dr. Mark Williams, Chief Science Officer. "We are close to completing the 7-day dose-ranging study using rats as well and will update our stakeholders on our progress shortly."

MB-204 is a fluorinated derivative of the U.S. FDA approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving concentration.

About Marvel Biosciences Corp.

Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company that utilizes a "drug redevelopment" approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought, as the new potential asset is developed by the Company. The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.

Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer's, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring additional undisclosed targets to expand its asset pipeline.

Contact Information
Investor Relations:
Virtus Advisory Group
Tel: 416-644-5081
Email: info@virtusadvisory.com
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469

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

All information contained in this news release with respect to the Company and its subsidiary, (collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party.

This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company 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 expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. 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 Canadian securities law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/147530