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Tetra Bio-Pharma Provides Management Update

02/28/2022
  • Significant reduction in cash burn rate
  • Preliminary data on QIXLEEF™ safety and efficacy
  • Update on REDUVO™ New Drug Submission
  • Update on ARDS-003 preclinical SARS-CoV-2 studies
  • Disclosure of revised intangible assets

/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATION IN THE UNITED STATES/

OTTAWA, ON, Feb. 28, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) a leader in cannabinoid-derived drug discovery and development is providing its shareholders with a management update explaining the Management Discussion and Analysis (MD&A) fiscal year end report. 

Following the 2021 Annual General Meeting, the new Board of Directors (BOD) recommended that the Company focus its operations on two key value creating drug assets. In parallel, the BOD and executive team worked to reduce monthly expenses. Both decisions were key to minimize the yearly financing needs as the Company drives two of its drugs towards marketing approval and commercialization. The two assets that the Company focused on were QIXLEEF™ and REDUVO™.  In the case of QIXLEEF™, the primary focus has been targeting a drug approval indication related to reduction of opioids. Plenitude© clinical operations were maintained as long term safety and efficacy data will be required for drug approval by regulators. The focused operations led to an average monthly cash burn of $3.1 million CAD during the months of January to August 2021 down to an average of $1.2 million CAD from September to November.  The prudent management of costs and prioritization of projects allowed the Company to end its fiscal year with $4.8 million CAD.

The Company has several other drug assets that could enter clinical trials subsequent to government funding and/or co-development partnerships. In addition, any of these assets could be licensed to a biotechnology or pharmaceutical company. The CAUMZ™ drug asset benefits from a bridge to QIXLEEF™ whereby all clinical achievements of QIXLEEF™ will benefit CAUMZ™, thus reducing clinical requirements for drug approval and lowering the risk of unsuccessful clinical outcomes in pivotal trials.

The REDUVO™ AdVersa® asset was delayed pending successful new drug approval in Canada. ARDS-003 trials were not launched pending government funding or a partnership. The vision for the PPP-003 remains licensing or co-development with a partner.

QIXLEEF™
The observed outcomes indicate that the REBORN©1 and PLENITUDE© clinical trials should continue, and enrolment accelerated. The clinical data also demonstrates the importance of accelerating testing in non-cancer patient populations because of the larger potential market size and the critical need for therapies to reduce opioid use. More data are necessary to confirm the role of QIXLEEF™ in pain management and opioid reduction.

REBORN©  - Preliminary Safety & Efficacy Outcomes
The REBORN©1 Phase II trial is expected to be completed in 2022. Despite the additional site in the USA and protocol amendments aimed at accelerating enrolment, the impact of COVID-19 on clinical sites remained an issue affecting speed of recruitment and enrolment in 2021 and early Q1 2022. The Company is actively working on opening clinical sites outside of the USA to further accelerate enrolment. The REBORN©2 Phase II/III trial is expected to be initiated in 2022 in the United States, Australia, Canada, and Europe. 

The open-label design of the study allowed the Company to verify the performance of the investigational new drug QIXLEEF™ with respect to both efficacy and safety. To date the observed adverse effect profile of QIXLEEF™ is similar to that observed in previous clinical trials. This includes no serious adverse events and no unexpected adverse events. 

Preliminary data from over 40 episodes of breakthrough pain in each of the experimental and active treatment groups, suggests that QIXLEEF™ could be an effective analgesic for pain management and allow reduction of the use of opioids, thereby confirming that the clinical trial should continue, and enrolment be accelerated. More data are necessary to confirm the role of QIXLEEF™ in pain management and opioid reduction.  

PLENITUDE© - Preliminary Safety & Efficacy Outcomes
As an addition to standard end-of-life care, QIXLEEF™ aims to improve quality of life and help reduce the pain of adults with terminal cancer. PLENITUDE©, a Phase II clinical trial cleared by the FDA, is a 4-week trial to evaluate the safety and efficacy of inhaled QIXLEEF™ on uncontrolled cancer pain in 78 adult patients with symptoms related to advanced, incurable cancer, and uncontrolled cancer-related pain. Despite the number of activated sites, the impact of COVID-19 on clinical sites remains an issue affecting speed of recruitment and enrolment. Therefore, the Company is working on plans to open additional sites, in and out of the USA.

The Plenitude© trial is double-blind thereby limiting the Company's ability to assess the current clinical outcomes with certainty. To date the observed adverse drug event profile in the study patients includes a blend of mild to moderate effects in terms of severity, with the majority being mild. The adverse drug events are similar to that observed in previous clinical trials. This includes no serious adverse events and no unexpected adverse events. 

With regards to efficacy, the blinded format of the study prevents the Company from confirming any QIXLEEF™ related outcomes. However, the study results demonstrate that the data from many patients shows clinically significant improvement in pain which is maintained over time. The observed outcomes signal that the clinical trial should continue, and enrolment be accelerated. 

REDUVO™
On December 30, 2020, the Company submitted its first new drug submission (NDS) for the REDUVO™ soft gel capsules to Health Canada to obtain approval and a drug identification number (DIN) for the prescription drug. The submission is currently in the final stage of review by the regulator.

During the period ended November 30, 2021, the Company began pre-launch activities such as, but not limited to, different validation reports, tech transfer, manufacturing setup and Medical Science Liaison (MSL) touchpoints with healthcare professionals for its REDUVO™ drug candidate. The Company is currently awaiting official communication from Health Canada to expand manufacturing and launch activities. It is important to keep in mind Health Canada has prioritized vaccines and COVID-19 related treatments, diverting the department's key personnel to review and expedite these files. This explains the delays in communication and feedback from Health Canada.

ARDS-003 (Onternabez)
ARDS-003 is a new patent protected therapeutic developed to treat hyperinflammatory conditions, such as those seen in patients suffering from viral infections, such as SARS-CoV-2. The investigational drug is designed to dampen the cytokine release syndrome and could be administered in combination with dexamethasone and/or antivirals. The following summary results, previously undisclosed, are from studies initiated early 2021, before halting clinical and manufacturing activities on ARDS-003. A study in the LPS Septic Lung model demonstrated statistically significant reduction of serum cytokines and chemokines. After demonstrating a statistically better health score status following infection of mice with SARS-CoV-2, a new study was initiated to assess the impact of ARDS-003 on serum cytokines. This latter study demonstrated statistically significant reduction in serum cytokines on Day 6 post-infection. This study also compared ARDS-003 to Remdesivir. The results of these studies were used to demonstrate to governmental funding agencies the potential role of ARDS-003 in the management of patients infected with viruses, such as SARS-CoV-2.

Intangible assets
The Company's intangible assets represent Tetra's drug development program in its various early to advanced-stage clinical phases.

The MD&A provides a detailed description of the impact of the COVID-19 pandemic on its operations. As at November 30, 2021, the Company has recognized the following impact of the COVID-19 pandemic on its operations:

    1. On May 1, 2019, as part of the acquisition of Panag, the Company acquired various intangible assets with a purchase price allocation of $14,519,183.
    2. As at November 30, 2021, the Company has not completed the enrolment for the trial which has resulted in management uncertainty in regards to the timing of completion and the ultimate commercialization of QIXLEEF™. As at November 30, 2021, the Company had capitalized approximately $8,437,090 in acquisition and other costs related to the development of QIXLEEF™ as well as CAUMZ™ (the synthetic second generation of QIXLEEF™).
    3. During the period from May 1, 2019 to November 30, 2021, the Company capitalized certain licensing agreements to support its clinical activities. As at November 30, 2021, the Company had capitalized $3,198,414 of licensing agreement costs.

The above assets are not yet available for use as management has determined that it will require a significant investment and more time to complete in an expedited and timely manner the required clinical trials, studies, and other efforts needed to commercialize these assets under the FDA and Health Canada approvals in their respective markets.

During the year ended November 30, 2021, in accordance with IAS 36, Impairment of Assets, the Company determined that the recoverable amount of the clinical trials asset did not support its continued value and revalued the asset in Q4 of fiscal 2020, which is presented as a revaluation of intangible assets of $23,978,449 in the consolidated statement of income (loss) and comprehensive income (loss).

The Company has disclosed in various news releases in 2020 and 2021 that it is still in the process of actively looking for ways to speed up enrolment to complete its Reborn© and Plenitude© clinical trials. That said, the impairment to the above noted intangible assets is a function of IFRS' requirement for a Company to assess its long-life assets for potential indicators of impairment and not an assessment of management's beliefs in the current status and overall potential of the clinical trials. The core principle of IAS 36 indicates intangible assets should be subject to impairment and re-evaluation based on the expected future cash flows the asset, in current form, will produce. During the last quarter for the period ended November 30, 2021, upon the required impairment analysis, it was determined that future cash flows of the assets had changed significantly because the conditions mentioned above. The asset valuation model is also sensitive to discount rates and long-term growth rates. Accordingly, it is reasonably possible that future changes in assumptions may negatively impact future assessments of the recoverable amount of the Company's assets.

According to the accounting standard, impairment of assets can be reversed if the circumstances that cause the impairment loss are favorably resolved. The Company will continue to evaluate the recoverability of its assets on a yearly basis, as work progresses on its portfolio.

Business Strategy
The Company's goals over the next fiscal year are:

  • Rapidly advance QIXLEEF™ through clinical development and continue to advance towards regulatory approval in the United States, Europe, and Canada.
  • Get the REDUVO™ soft gel market approval in Canada then accelerate REDUVO™ AdVersa® development in the Rest of the World.
  • Initiate clinical development phase of ARDS-003 (Onternabez) and seek a Global out licensing deal with a pharmaceutical company.

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 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; the inability of the Company to find licensing or co-development partners for its drug candidates;  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.

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