- 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:
- 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.
- 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™).
- 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.