Tetra and Prepaire Jointly Apply to BARDA for Funding

• Companies jointly submitted a $750,000 USD application to BARDA to use Prepaire™ Shield discovery platform to assess repurposed drugs combined with onternabez as Chemical Threat Medical Countermeasures.
  
  
• Partnership leverages respective expertise, technology, and capabilities to identify new combination therapies and improve clinical trajectories of patients exposed to pulmonary and nerve chemical agents.

OTTAWA, ON, Oct. 11, 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 announced today it has successfully submitted, in collaboration with Prepaire, a grant application to the Office of Biomedical Advanced Research and Development Authority (BARDA), Division of Research, Innovation and Ventures (DRIVe).

The project aims at improving the management of patients exposed to pulmonary (i.e., chlorine, phosphogene) or nerve chemical agents (i.e., Sarin, Soman, or Tabun) and optimize their clinical trajectories to minimize the outcome following mass casualty events.

Tetra and Prepaire will combine their respective expertise and capabilities to reinvent the drug development process through a fast, innovative, and cost-effective approach using the Prepaire™ Shield discovery platform and Tetra's proprietary compound, onternabez. Prepaire™ Shield is an integrated multi-modal/level data solution encompassing state-of-the-art Artificial Intelligence (AI) to generate new potential combination treatments with in vitro validation testing using induced pluripotent stem cells (IPSC) and a retrosynthesis tool to help develop a comprehensive Clinical Decision Support system. Newly identified therapies will include repurposed drugs combined with Tetra's investigational compound, onternabez, to treat acute and long-term effects of pulmonary and nerve Chemical War Agents (CWAs). Onternabez is a selective activator of the cannabinoid type 2 receptor (CB2R), which is part of the body's endocannabinoid system and an important target for homeostatic regulation of the Central Nervous System and the Immune System. Pre-clinical efficacy studies have shown that onternabez has anti-inflammatory and anti-fibrotic properties, decreasing pulmonary and systemic inflammation and ARDS-related drug damage. Additionally, onternabez exhibits neuro-anti-inflammatory and neuroprotectant activities in response to pathophysiological brain insults. Therefore, the management of patients who have been exposed to a pulmonary CWA can significantly benefit from combination treatments that address the acute hyperinflammation/CRS and potential downstream pulmonary fibrosis. Additionally, patients exposed to nerve chemical agents could benefit from the new drug synthesis models for developing AChE (acetylcholine esterase) reactivators to be administered together with an anti-inflammatory and neuroprotectant agent to prevent long-term neuro-deficiency.

Carl Freer, Founder and Chief Innovation Officer at Prepaire, stated "We are excited by the opportunity for Prepaire and Tetra to be considered to partner with BARDA to identify medical countermeasures to managing patients who have been exposed to a pulmonary CWA and can significantly benefit from combination treatments that address this acute hyperinflammation/CRS and potential downstream pulmonary fibrosis. Patients could benefit from the new drug synthesis models for developing AChE reactivators to be administered with an anti-inflammatory and neuroprotectant agent to prevent long-term neuro-deficiency. Prepaire Shield is designed to accelerate the pace of discovery and innovation, including its vast data sets and advanced analytics, enabling faster evidence-based decision-making. These efforts will unlock hidden insights and provide new and unique perspectives using intelligence in previously unavailable ways to analyze relevant therapeutics."

Guy Chamberland, CEO, and CRO at Tetra commented "CWA attacks substantially increased over the last decade in certain regions of the globe, but the treatment of civilian populations stayed the same over the last 50 years and is mainly about advanced life support. Prepaire's disruptive technology, Prepaire Shield, together with our onternabez compound, has the potential to unveil new combination treatments to improve the management of choking and nerve agent victims. I'm excited by this innovative drug discovery approach and the opportunity in front of us."

Onternabez, the active substance of ARDS-003, a novel First in Human (FIH) drug product, is a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an important immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent Sepsis, acute respiratory distress syndrome (ARDS) and organ damage - ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult (McIntosh, 2020).  While the clinical profile of ARDS arising from viral (COVID) or bacterial sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra's pre-clinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression. Additionally, pre-clinical efficacy studies have shown that onternabez-induced CB2R activation dampens the pro-inflammatory behavior of microglia, decreasing the expression of neuronal pro-inflammatory cytokines and the release of nitric oxide, ultimately reducing secondary damage to the neurons in the central nervous system.

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.

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Some statements in this 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 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.

SOURCE Tetra Bio-Pharma Inc.