Kalytera Therapeutics, Inc. (TSX VENTURE: KLY and OTC: KALTF) (the
"
Company" or "
Kalytera") today
announced that it has entered into a License Agreement (the
“License Agreement”) with Salzman Group, Inc.
(
“Salzman Group”), under which Salzman Group has
granted to Kalytera an exclusive, worldwide license to develop and
commercialize Salzman Group’s proprietary drug, R-107, for the
treatment of coronavirus and COVID-19 infection.
The License Agreement is the first step in a
larger transaction in which Kalytera will acquire Salzman Group
(the “Acquisition”). The Acquisition is expected
to close later this year, subject to customary conditions including
TSX Venture Exchange (the “TSXV”) and shareholder
approvals.
Salzman Group is the owner of R-107, a
proprietary drug with issued and pending composition of matter and
method of use patents in approximately 40 countries, including the
U.S., Australia, Brazil, China, Europe, India, Japan, Russia and
South Korea. In addition to coronavirus and COVID-19 infection,
Salzman Group is also developing R-107 for treatment of chlorine
inhalation lung injury, and pulmonary arterial hypertension.
Highlights
- R-107 is a liquid prodrug
of nitric oxide. Based on the clinical evidence of nitric oxide’s
antiviral activity against strains of coronavirus, Kalytera will
develop R-107 for treatment of coronavirus and COVID-19
infection.
- Following completion of a
Phase 1 clinical safety and
pharmacokinetic study, Kalytera intends to apply
for funding from the U.S. Department of Health and Human Services
for the costs of Phase 2 and Phase 3 clinical studies of R-107
in coronavirus and COVID-19
infection.
- Kalytera expects the Phase
1 clinical safety and pharmacokinetic
study to be completed this year.
- Under the terms of the
License Agreement, Kalytera will pay a license fee to Salzman Group
of 130 million Kalytera common shares.
- On June 22, 2020, the
British Columbia Securities Commission (the “BCSC”) issued a
Failure-to-File Cease Trade Order against the Company (the "FFCTO")
due to the Company's failure to file by the prescribed filing
deadlines its annual financial statements for the
year ending December 31, 2019, and the accompanying
Management’s Discussion and Analysis and
certifications, (the “Filings”). Except for the
partial revocation order granted for the Company’s ongoing private
placement (as disclosed in the Company's
press release of July 15, 2020), the FFCTO prohibits share
issuances by the Company (including any issuance to Salzman Group)
unless a full revocation is granted by the BCSC (and any other
commission in a jurisdiction where the securities of the Company
may be issued). The Company is working with its auditors, Ernst
& Young, to complete the Filings, and anticipates that final
approval and posting of the Filings on www.sedar.com will be
completed soon. Upon filing of the Filings, the Company will apply
to have the FFCTO fully revoked, at which time after the FFCTO has
been lifted the Company will issue the license fee of 130 million
Kalytera common shares to Salzman Group.
R-107 is a liquid prodrug of nitric oxide, and,
within the past two months, there has been an increased focus on
the potential of nitric oxide for treatment of coronavirus and
COVID-19 infection, with several clinical trials being initiated to
evaluate inhalable nitric oxide in this disease. R-107 is
potentially more effective, efficient and less expensive than
inhalable nitric oxide.
R-107 is a proprietary and novel molecule that
acts as a nitric oxide donor. Nitric oxide normally exists in a
gaseous state, and is approved by the FDA for administration to
patients via inhalation therapy requiring a special type of
delivery device, and complex administration by trained respiratory
therapists. R-107, in contrast, is a liquid that is readily
administered by a single intramuscular injection. In addition to
its clear advantages in simplicity of administration, R-107 does
not lose its potency after prolonged periods of administration. In
contrast, other nitric oxide donors in liquid form, such as
nitroglycerin, rapidly induce tolerance and lose biological
activity after more than a single dose. Accordingly, R-107 is
poised to be the first liquid nitric oxide donor that is easy and
inexpensive to administer and provides sustained and biologically
effective delivery.
Gaseous nitric oxide has shown clinical evidence
of antiviral activity against strains of coronavirus. For
example, inhaled nitric oxide has demonstrated an inhibitory effect
on the replication of the SARS virus (“SARS-CoV”).1 The SARS virus
is a coronavirus. Inhalable nitric oxide is being evaluated
in a Phase 2 clinical study sponsored by Massachusetts General
Hospital in severe acute respiratory syndrome in COVID-19.2
There is currently a critical global shortage of
devices for delivery of inhalable nitric oxide, and, even if such
devices were to become available, administration of gaseous nitric
oxide would be complex and labor-intensive, substantially limiting
the number of patients that could be treated at any one time.
The Company believes that its R-107 drug will
allow for multiple patients to be treated simultaneously, in a
potentially safe and less labor-intensive manner, without the need
for special delivery equipment.
The Company is not making any express or implied
claims that its product has the ability to eliminate, cure, or
contain the Covid-19 (or SARS-2 Coronavirus) at this time.
“Given the data demonstrating the antiviral
activity of nitric oxide against coronaviruses3, as well as the
even greater body of data demonstrating the potential activity of
nitric oxide in treatment of viral-associated lung disease4,
Kalytera and Salzman Group are working together to advance R-107
into Phase 1 clinical testing,” stated Robert Farrell, President
and CEO of Kalytera. “We plan to submit an Investigational New Drug
Application (IND) to the Australian Therapeutic Goods
Administration (TGA) and the U.S Food and Drug Authority (FDA) in
support of a first-in-human Phase 1 clinical trial. We are planning
to carry out this Phase 1 safety and pharmacokinetic study of
intramuscular R-107 using a single dose escalation design in 32
healthy middle-aged volunteers at CMAX, a clinical contract
research organization located at Royal Adelaide Hospital in
Australia. The study will be initiated during the third quarter,
and we expect it to be completed during fourth quarter this
year.”
Professor Salvatore Cuzzocrea, President of the
University of Messina and former President of the European Shock
Society is working with Salzman Group and Kalytera, and has
read and approved of the scientific disclosure in this news
release. Professor Cuzzocrea has deep expertise regarding the
medical use of nitric oxide and nitric oxide donors, and has
published more than 600 papers on nitric oxide. He has conducted
research and experiments with nitric oxide and nitric oxide donors
since 1994, and worked closely as an advisor with the Salzman Group
team that designed and invented R-107.
The Acquisition of Salzman
Group
Kalytera announced, on May 19, 2020, that it had
signed a Letter of Intent dated May 12, 2020 (the “LOI”) to
acquire Salzman Group.
The TSX Venture Exchange (the
“TSXV”) reviewed Kalytera’s submission relating to
the acquisition of Salzman Group (the “Acquisition
Transaction”), and informed the Company that the TSXV’s
approval of the Acquisition Transaction is subject to routine
conditions, as well as the following specific conditions:
- The Acquisition Transaction will be
completed in two parts:
° The first part
of the Acquisition Transaction will consist of the grant by Salzman
Group to Kalytera of an exclusive, worldwide license to develop and
commercialize R-107 for treatment of coronavirus and COVID-19
infection. As consideration for the license, Kalytera will issue to
the shareholders of Salzman Group 130 million shares of Kalytera’s
common stock. Upon issuance of these shares to the
shareholders of Salzman Group, such shareholders will own, in the
aggregate, approximately 19% of Kalytera’s common shares. The
issuance of these shares is subject to the FFCTO being fully
revoked to allow Kalytera to issue these shares to the Salzman
Group. As mentioned, Kalytera will apply to have the FFCTO removed
as soon as it makes the Filings.° The second part of the
Acquisition Transaction will close following the issuance of
additional common shares to the shareholders of Salzman Group,
which will bring their aggregate ownership of Kalytera’s common
shares to approximately 49.9%, as of the date of such issuance (the
“Additional Shares”). In consideration for the
issuance of the Additional Shares, the Salzman Group shareholders
will transfer all shares of Salzman Group to Kalytera. The second
part of the Acquisition Transaction is subject to routine
conditions, as well as the following specific conditions:
• The Company
must obtain the approval of disinterested shareholders for the
issuance of the Additional Shares to the shareholders of Salzman
Group;• Upon closing of the second part of the Acquisition
Transaction, the Company must have sufficient working capital and
financial resources for a six month period; and• Salzman Group
and the Company must provide to the TSXV Salzman Group’s audited
financial statements for 2018 and 2019.
“We are delighted to have completed the first
part of the Acquisition Transaction, by obtaining from Salzman
Group the exclusive, worldwide license to develop R-107 for
treatment of coronavirus and COVID-19 infection. We will need
approximately 10 weeks to complete the second part of the
transaction, which will give Salzman Group time to complete the
audits of their financial statements for 2018 and 2019, and will
give Kalytera time to prepare for and schedule a special meeting of
shareholders,” stated Robert Farrell, President and CEO of
Kalytera. ”We expect the shareholder meeting to occur in September,
and, assuming that the disinterested shareholders approve the
Acquisition Transaction, we will close the Acquisition at that
time.
Kalytera and Salzman Group to
Collaborate on Development of R-107 for Coronavirus and COVID-19
Infection Prior to Completion of the Acquisition
Kalytera and Salzman Group have also entered
into a Sponsored Research and Development Agreement (the
“R&D Agreement”), under which the parties will
collaborate on the clinical development, regulatory approval,
manufacturing and commercialization of R-107 for treatment of
coronavirus and COVID-19 infection. Under the R&D Agreement,
Salzman Group will fund all costs for the Phase 1 clinical
safety and pharmacokinetic study, which will evaluate the safety of
R-107 in 32 subjects.
About Kalytera Therapeutics
Kalytera Therapeutics, Inc.
("Kalytera") is committed to developing new
treatments for a variety of diseases and disorders, by discovering,
developing, manufacturing and delivering innovative human
therapeutics. Kalytera focuses on areas of unmet medical need, and
leverages its expertise to find solutions that will improve health
outcomes and dramatically improve people's lives.
- Website
Home: https://kalytera.co/
- News and
Insights: https://kalytera.co/news/
-
Investors: https://kalytera.co/investors/
Cautionary Statements
Neither 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 (including
with respect of the FFCTO and the granting of any partial or full
revocation orders for it), intellectual property objectives 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 unfavorable results. 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
1 Akerstrom S et. Al. Nitric oxide inhibits the
Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus.
J Virol 2005; 79(3):1966-9.2 ClinicalTrials.gov Identifier:
NCT043063933 Akerstrom S et. Al. Nitric oxide inhibits the
Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus.
J Virol 2005; 79(3):1966-9.4 Nitric Oxide Investigated
as COVID-19
Treatmentwww.webmd.com/lung/news/20200409/nitric-oxide-investigated-as-covid19-treatment
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