Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTCQB: KALTF)
(the "
Company" or "
Kalytera") has
engaged Echelon Wealth Partners to determine the value, on a
risk-adjusted basis, of its cannabidiol ("
CBD")
therapeutic products for the prevention and treatment of graft
versus host disease ("
GVHD"), and to assist with
the review of potential out-licensing opportunities for the
commercial rights to these products.
Kalytera has recently received unsolicited
inquiries from companies interested in the rights to Kalytera’s
GVHD products, and, in response to these inquiries, Kalytera’s
board of directors approved the engagement of Echelon."As
previously discussed, the business strategy we are pursuing for our
GVHD products is to out-license the commercial rights for these
products after we have completed the ongoing Phase 2 study in
prevention of GVHD," stated Robert Farrell,
President and CEO of Kalytera. "Consistent with this strategy, and
based on the fact that we have already received unsolicited
inquiries regarding the rights to these products, we have chosen to
engage Echelon to determine the current risk adjusted value of
these products, and to assist us in managing the process for
identifying the optimum corporate partner or partners who may
assist with some or all further costs for development of these
products, such as the costs for Phase 3 clinical testing. Echelon
will also assist Kalytera in evaluating any consideration that may
be received by Kalytera for the commercial rights to its GVHD
products, such as up-front license fees, and/or milestone payments
and royalties.”There can be no assurance that the review of
potential out-licensing or other opportunities with respect to the
Company’s GVHD products will result in a transaction or any
proceeds or other consideration. Any potential transaction or
other opportunity will be evaluated by Kalytera’s Board of
Directors. The Company does not intend to discuss developments with
respect to the review process unless a transaction is approved, or
further disclosure becomes appropriate.Kalytera intends to allocate
any up-front consideration received in connection with any
successful out-license or other transaction in respect of its GVHD
program to research and development work required to expedite the
development of its proprietary cannabinoid compound for treatment
of pain, as well as other preclinical cannabinoid development
programs.Status of GVHD ProgramKalytera’s product
development program evaluating CBD in the prevention of acute GVHD
consists of three separate clinical studies: (1) Study KAL-05; (2)
Study KAL-07; and (3) Study KAL-08.
Study KAL-05Study KAL-05 is the
Company’s ongoing open label, multicenter, Phase 2 clinical study
to evaluate multiple doses of CBD for the prevention of acute GVHD
following allogeneic hematopoietic cell transplantation, commonly
referred to as bone marrow transplantation. The study is evaluating
the PK profile, safety, and efficacy of CBD at doses of 75, 150,
and 300 mg twice daily (“BID”). The first
12-patient cohort was administered the low dose of 75 mg BID, and
this cohort has completed the study with very encouraging results,
as previously reported. The second 12-patient cohort, is being
administered the medium dose of 150 mg BID, and this cohort is
currently being enrolled. It is anticipated that Study KAL-05 will
be complete later this year, and will provide support for the
planned Phase 3 registration study required for regulatory approval
by the FDA.
Study KAL-07Study KAL-07, the
“food effect study”, is a double blind, randomized, two period, two
treatment, fixed sequence, crossover (fed versus fasted) study to
evaluate the effect of food on the pharmacokinetics of CBD, along
with robust ECG monitoring in 32 healthy volunteers. This study is
being conducted at a single site in Melbourne, Australia.
FDA guidelines also require that a proposed new drug be
evaluated for its effects on cardiac rhythm. This evaluation is
typically done in a separate study known as a QT or QTc study. To
save time and expense, Kalytera is including a robust ECG
evaluation of each subject enrolled in Study KAL-07. By including
this evaluation in the design of Study KAL-07, the Company will be
able to complete another critical study evaluation on the pathway
to registration, without having to initiate a separate QT or QTc
study for this purpose.
Study KAL-08Study KAL-08, the
“drug-drug interaction study”, is a second healthy volunteer study
that has been requested by the FDA. This drug-drug interaction
study will measure the effect of certain anti-fungal drugs upon
metabolism of CBD, and the Company anticipates that it will
complete Study KAL-08 during the third quarter this year. This
study will also be conducted at a single site in Melbourne,
Australia.
About Echelon Wealth PartnersEchelon is a
leading independent, Canadian-owned and operated wealth management
and capital markets firm, with more than $5 billion in assets under
administration and management. Echelon provides full service
investment banking services and equity research across a range of
industries. Their team of investment bankers provides access to
strategic advisory, M&A, analysis and valuation services, as
well as creative equity and debt solutions.
About Kalytera
TherapeuticsKalytera Therapeutics, Inc.
("Kalytera") is pioneering the development of a
next generation of cannabinoid therapeutics. Through its proven
leadership, drug development expertise, and intellectual property
portfolio, Kalytera seeks to establish a leading position in the
development of novel cannabinoid medicines for a range of important
unmet medical needs, with an initial focus on graft versus host
disease and the treatment of acute and chronic pain.
- Website Home: https://kalytera.co/
- News and Insights: https://kalytera.co/news/
- Investors: https://kalytera.co/investors/
Cautionary StatementsNeither
TSX Venture Exchange nor its Regulation Services Provider (as that
term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this
release.
This press release may contain certain
forward-looking information and statements ("forward-looking
information") within the meaning of applicable Canadian securities
legislation, that are not based on historical fact, including
without limitation in respect of its product candidate pipeline,
planned clinical trials, regulatory approval prospects,
intellectual property objectives, review of out-licensing and other
opportunities with respect to its GVHD products and any potential
transaction relating thereto or proceeds thereof and other
statements containing the words "believes", "anticipates", "plans",
"intends", "will", "should", "expects", "continue", "estimate",
"forecasts" and other similar expressions. Readers are cautioned to
not place undue reliance on forward-looking information. Actual
results and developments may differ materially from those
contemplated by these statements depending on, among other things,
the risk that future clinical studies may not proceed as expected
or may produce unfavourable results, the uncertainty associated
with being able to identify, evaluate and complete any
out-licensing transaction or other opportunity, and the impact on
the Company’s business of the announcement of the review of
out-licensing or other opportunities and any opportunity or
transaction that may actually be pursued. Kalytera undertakes no
obligation to comment on analyses, expectations or statements made
by third parties, its securities, or financial or operating results
(as applicable). Although Kalytera believes that the expectations
reflected in forward-looking information in this press release are
reasonable, such forward-looking information has been based on
expectations, factors and assumptions concerning future events
which may prove to be inaccurate and are subject to numerous risks
and uncertainties, certain of which are beyond Kalytera's control.
The forward-looking information contained in this press release is
expressly qualified by this cautionary statement and is made as of
the date hereof. Kalytera disclaims any intention and has no
obligation or responsibility, except as required by law, to update
or revise any forward-looking information, whether as a result of
new information, future events or otherwise.
Contact Information
- Robert Farrell President, CEO (888) 861-2008
info@kalytera.co
Kalytera Therapeutics (TSXV:KALY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Kalytera Therapeutics (TSXV:KALY)
Historical Stock Chart
From Apr 2023 to Apr 2024