- 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 /CNW/ - 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.