Tetra Bio-Pharma and Cannvalate Enter Into Partnership

Rhea-AI Summary

Tetra Bio-Pharma has partnered with Cannvalate, agreeing to invest CAD$7.5M for clinical trials of its drug candidates in Australia. This partnership allows Tetra to benefit from a 43.5% tax credit on clinical trial expenses. Cannvalate will manage trials for the REBORN®, PLENITUDE®, and CAUMZ® drugs. Additionally, Dr. Sud Agarwal has been appointed as a Special Advisor to the CEO. Proceeds from a private placement of common shares will fund R&D activities and are expected to be received in tranches based on operational milestones.

Positive

• Partnership with Cannvalate enhances potential for drug development in Australia.
• Significant tax credit of 43.5% on clinical trial expenses improves financial outlook.
• Appointment of Dr. Sud Agarwal strengthens the leadership team and clinical expertise.

Negative

• None.

• Cannvalate to invest CAD$7.5M in Tetra.
• Cannvalate to launch and manage QIXLEEF™ and CAUMZ™ clinical trials in Australia.
• The Company to benefit from a 43.5% tax credit on all money spent on clinical trials in Australia.

OTTAWA, ON, May 5, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) a leader in cannabinoid-derived drug discovery and development, today announced it has entered into a research and development agreement with Cannvalate Pty Ltd ("Cannvalate") for the initiation of the REBORN®, PLENITUDE® and CAUMZ® clinical trials in Australia, and a subscription agreement contemplating a private placement (the "Private Placement") of common shares in the capital of the Company (the "Common Shares") with Cannvalate for aggregate proceeds to the Company of up to CAD$7,500,000. 

The Company has also appointed Dr. Sud Agarwal as a Special Advisor to the CEO and the board of directors with a mandate to advise on strategic aspects of the Company's activities and to aid in the advancement of our key programs: QIXLEEF™ and CAUMZ™.

Partnership with Cannvalate

Tetra has entered into a research agreement with Cannvalate for the performance of clinical trials of Tetra's drug candidates in Australia. Cannvalate is a medical cannabis company bringing in safe and effective cannabinoid-based products to the Australian market. Cannvalate's wholly owned entity, iNGENū, is one of the largest global CROs specializing in cannabinoid clinical trials. By conducting Tetra's clinical trial activities in Australia with iNGENū, it will allow the Company to benefit from a 43.5% tax credit on all money spent on clinical trials in Australia, and an increased access to patients seeking participation in trials where the pharmaceutical cannabis drug is provided at no cost. Through the Cannvalate partnership, Tetra aims to efficiently assess the clinical viability of its drug products, as well as any new products developed.

Dr. Guy Chamberland, CEO and CRO of Tetra stated, "We have been developing inhaled cannabinoid drugs since 2016 and have a wealth of data to support the potential development of a new generation of drugs to help patients suffering from chronic diseases.  It takes years of research and development to have a drug in two Phase 2 trials designed to support drug approval in the USA and Europe. Finding ways to accelerate timelines while reducing the monthly burn is a continuous battle for all biotechnology companies.  This partnership is intended to allow Tetra to achieve both goals."

Private Placement

Cannvalate also agreed to acquire Common Shares of Tetra on a private placement basis, through seven (7) distinct tranches, for aggregate proceeds of CAD$7,500,000. The first tranche providing for the issuance of Common Shares having an aggregate subscription price of CAD$500,000 was triggered by the signing of the subscription agreement, whereas the subsequent tranches of the Private Placement will be triggered by the completion of various operational events in connection with the REBORN®, PLENITUDE® and CAUMZ® clinical trials, such as the achievement of first patient enrolments in each such trial. The Company intends to use the proceeds of the Private Placement to fund its clinical trials and R&D activities in collaboration with Cannvalate and iNGENū.

The subscription price per Common Share issuable under the first tranche will be at a discount of 7% to the 5-day VWAP of the Common Shares on the Toronto Stock Exchange ("TSX") on the day of execution of the subscription agreement with respect to the Private Placement. Subject to compliance with the rules and regulations of the TSX, the subscription price per Common Share issuable under the second and third tranches will be at a discount of 7%, whereas the subscription price per Common Share issuable under the fourth to seventh tranches will be at a discount of 20%, in each case based on to the 5-day VWAP of the Common Shares on the TSX prior to the date of the issuance of the respective tranche. In accordance with the terms of the Private Placement, the subscription price per Common Share shall be adjusted upwards to ensure that Cannvalate and its affiliates shall not beneficially own, or have control or direction over, Common Shares in excess of 19.99% of the number of Common Shares issued and outstanding immediately after giving effect to the issuance of Common Shares issuable under the applicable tranche.

Upon completion of the fifth tranche of the Private Placement which will result in the Company having received aggregate proceeds of CAD$4,500,000, the Company will enter into a nomination right agreement with Cannvalate providing for the grant of a seat on Tetra's board of directors to Dr. Sud Agarwal for so long as Cannvalate owns or exercises control or direction, directly or indirectly, over 10% or more of the issued and outstanding Common Shares.  Guy Chamberland, CEO and CRO of Tetra stated, "Dr. Agarwal will bring both inhalation clinical expertise and cannabinoid drug development experience to Tetra's board.  His addition will further strengthen our board as we continue to evolve into a cannabinoid pharmaceutical company." 

The securities issued pursuant to the Private Placement will be subject to a four-month hold period from the date of their respective issuance. Completion of the Private Placement remains subject to the receipt of all necessary regulatory approvals, including the approval of the TSX.

This news release does not constitute an offer to sell or a solicitation of an offer to sell any securities of the Company in the United States. The securities described in this news release have not been and will not be registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

About Dr. Sud Agarwal BSc, MB ChB, FANZCA

Dr. Sud Agarwal is the Co-Founder and CEO of Cannvalate and iNGENū, a globally renowned contract research organisation in the cannabinoid space. Dr. Agarwal is an internationally recognised key opinion leader in the clinical use of medicinal cannabis and is regularly invited as a keynote to key industry and pharmaceutical events. His research interests include synthetic cannabinoid drug development, novel inhalational cannabinoids drug-device combinations and cannabinomimetic analogues.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.

For more information visit: www.tetrabiopharma.com

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

Forward-looking statements

Some statements in this news release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements in the news release include, without limitation, statements with respect to clinical trials for the Company's drug candidates and expected timing thereof, the benefits expected to be derived by the Company from the partnership with Cannvalate, the expected closing of the tranches under the Private Placement and timing thereof, the expected aggregate proceeds to be received by the Company under the Private Placement, the receipt of regulatory approval with respect to the Private Placement, including the receipt of TSX approval, the expected use of the proceeds under the Private Placement and the appointment of Dr. Sud Agarwal to the board of directors of the Company. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

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SOURCE Tetra Bio-Pharma Inc.

FAQ

What is the partnership between Tetra Bio-Pharma and Cannvalate about?

Tetra Bio-Pharma has entered into a partnership with Cannvalate to conduct clinical trials for its drug candidates in Australia, with a total investment of CAD$7.5M.

How much tax credit will Tetra receive for its clinical trials in Australia?

Tetra Bio-Pharma will benefit from a 43.5% tax credit on all money spent on clinical trials in Australia.

What are the clinical trials Tetra is initiating with Cannvalate?

Tetra is launching the REBORN®, PLENITUDE®, and CAUMZ® clinical trials in collaboration with Cannvalate.

How will Tetra fund its clinical trials and research activities?

Tetra will fund its clinical trials and research through proceeds from a private placement of common shares amounting to CAD$7.5M.

Who is Dr. Sud Agarwal and what is his role at Tetra?

Dr. Sud Agarwal has been appointed as a Special Advisor to the CEO, focusing on strategic aspects and advancing key programs at Tetra.