Tetra Bio-Pharma Announces Closing of First Tranche with Cannvalate

Rhea-AI Summary

Tetra Bio-Pharma has closed the first tranche of a private placement with Cannvalate, issuing 8,236,681 common shares at $0.06 per share, raising $0.5 million. This tranche represents 1.95% of the company's outstanding shares. The overall placement aims for $7.5 million and will facilitate the initiation of the REBORN©1 clinical trial in Australia. The partnership with Cannvalate enables access to a 43.5% tax credit on clinical trial expenses and enhances patient recruitment for Tetra's cannabinoid therapies.

Positive

• Raised $0.5 million through the issuance of 8,236,681 shares.
• Partnership with Cannvalate enables significant tax benefits for clinical trials.
• Initiation of REBORN©1 clinical trial could advance the QIXLEEF™ drug program.

Negative

• None.

OTTAWA, ON, May 17, 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, is pleased to announce the closing of the first tranche of the previously announced private placement with Cannvalate Pty Ltd ("Cannvalate"), resulting in the issuance of 8,236,681 common shares in the capital of the Company (the "Common Shares"), representing 1.95% of the issued and outstanding Common Shares, at a price of $0.06 per Common Share for proceeds to the Company of $0.5 million.

The subscription price per Common Share issuable under the first tranche was at a discount of 7% to the 5-day VWAP of the Common Shares on the Toronto Stock Exchange ("TSX") on May 4, 2022, the day of execution of the subscription agreement. This first tranche of seven (7) distinct tranches, which will result in aggregate proceeds of $7,500,000 to the Company, triggers the collaboration with iNGENū that will lead to the initiation of the REBORN©1 clinical trial in Australia. 

Dr. Guy Chamberland, CEO and CRO of Tetra stated, "We are encouraged by the partnership with Cannvalate and iNGENū as it will allow the Company to further advance our QIXLEEF™ drug program, a promising alternative to opioids. Many investigational new drugs fail trying to carve a use in the management of severe pain. Our interim clinical data demonstrates that QIXLEEF™ has the potential to make a significant difference in patients. Our new partners join us in the race to bring alternatives to pain management."

Partnership with Cannvalate

As previously announced, 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. Conducting Tetra's clinical trial activities in Australia with iNGENū 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.

About QIXLEEF™ 

QIXLEEF™ is the Company's proprietary investigational new drug currently being studied in two U.S Food and Drug Administration (FDA) authorized clinical trials. QIXLEEF™ is a botanical therapy with a fixed dosage of tetrahydrocannabinol (THC) and cannabidiol (CBD). The drug is inhaled using a medical vaporizer and manufactured in Canada in a licensed current good manufacturing practice (cGMP) facility authorized by Health Canada.

About REBORN©1 - Clinical Trial

REBORN©1 is a Phase 2 study authorized by the U.S. FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain (BTcP). The study consists of a 10-week proof-of concept, open-label randomized study to evaluate the effect of inhaled QIXLEEF™ as compared to morphine sulfate or hydromorphone or oxycodone for the treatment of BTcP in 20 patients.

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: 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. 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. Without limiting the generality of the foregoing, statements in this news release regarding the completion of other tranches under the private placement with Cannvalate and statements regarding the clinical trials and drug candidates of the Company, including their expected benefits, are forward-looking statements. 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 did Tetra Bio-Pharma announce on May 17, 2022?

On May 17, 2022, Tetra Bio-Pharma announced the closing of the first tranche of a private placement with Cannvalate, raising $0.5 million.

What is the purpose of Tetra's partnership with Cannvalate?

The partnership aims to conduct clinical trials for Tetra's drug candidates in Australia and take advantage of tax credits on clinical trial expenses.

How much is the total expected from Tetra's private placement?

The total expected from Tetra's private placement is $7.5 million.

What is the REBORN©1 clinical trial?

The REBORN©1 clinical trial is a Phase 2 study authorized by the U.S. FDA that evaluates inhaled cannabinoids against oral opioids for managing breakthrough cancer pain.

What benefits does Tetra Bio-Pharma expect from the Cannvalate partnership?

Tetra Bio-Pharma expects to benefit from a 43.5% tax credit on clinical trials and increased access to patients for their studies.