CARLSBAD, Calif., Jan. 26, 2021 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company
focused on developing novel therapeutics for the treatment of
cancer and viral diseases, announces achievement of a milestone
event which triggered a payment obligation from Yi Xin Zhen Duan Jishu (Suzhou) Ltd. of Suzhou,
China (Yi Xin) to Qualigen.
The milestone event pertained to the initiation of technology
transfer of Qualigen's core FastPack® System, a rapid and highly
accurate immunoassay testing system consisting of the FastPack
Analyzer and the FastPack single-use, disposable test pouch.
Under the terms of an agreement announced in October 2020, Yi Xin will develop, manufacture
and sell new generations of diagnostic test systems based on
Qualigen's core FastPack® "laboratory in a pouch" technology, which
includes high throughput diagnostic systems. In addition, Yi
Xin will have the rights to manufacture and sell Qualigen's current
generations of rapid point-of-care FastPack diagnostic products in
China. The agreement called for net cash payments to Qualigen
in the fourth quarter of calendar 2020 and the first quarter of
calendar 2021 totaling in the mid- to high-hundreds of thousands of
dollars, and Qualigen is also eligible to receive low- to
mid-single-digit royalties on net sales.
"Yi Xin provides entrée to the China market for our patented FastPack
diagnostics product line and we are encouraged by the strong start
to this alliance," stated Michael
Poirier, Chairman, Chief Executive Officer and President of
Qualigen. "This collaboration represents an expansion opportunity
with additional resources to grow the FastPack line in an efficient
manner while we advance our therapeutics pipeline focused on the
treatment of cancer and viral-based diseases toward clinical trials
this year."
"Accurate testing at the point of patient care is becoming
increasingly important across China to achieve better patient outcomes and
utilize healthcare resources more efficiently. We are looking
forward to launch the current FastPack product and developing new
generations of the FastPack system that include a high-volume
system analyzer for use in large hospitals and reference
laboratories," said Peng Zhou,
President and Chief Executive Officer of Yi Xin.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused
on developing novel therapeutics for the treatment of cancer and
viral diseases, as well as maintaining and expanding its core
FDA-approved FastPack System, which has been used successfully in
diagnostics for 20 years. The Company's cancer therapeutics
pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN
(AS1411-GNP) is a DNA coated gold nanoparticle cancer drug
candidate that has the potential to target various types of cancer
with minimal side effects. The foundational nucleolin-targeting DNA
aptamer of ALAN, AS1411, is also a drug candidate for use in
treating COVID-19 and other viral-based infectious
diseases. RAS-F is a family of RAS oncogene
protein-protein interaction inhibitor small molecules for
preventing mutated RAS genes' proteins from binding to their
effector proteins; preventing this binding could stop tumor growth,
especially in pancreatic, colorectal and lung cancers. STARS is a
DNA/RNA-based treatment device candidate for removal from
circulating blood of precisely targeted tumor-produced and viral
compounds. Because Qualigen's therapeutic candidates are still in
the development stage, Qualigen's only products that are currently
commercially available are FastPack System diagnostic instruments
and test kits, used in physician offices, clinics and small
hospitals around the world. The FastPack System menu includes rapid
point-of-care diagnostic tests for cancer, men's health, hormone
function, vitamin D status and antibodies against SARS-CoV-2.
Qualigen's facility in Carlsbad,
California is FDA and ISO Certified and its FastPack product
line is sold worldwide by its commercial partner Sekisui
Diagnostics, LLC. For more information on Qualigen Therapeutics,
Inc., please visit https://www.qualigeninc.com/.
Forward-Looking Statements
This news release contains forward-looking statements by the
Company that involve risks and uncertainties and reflect the
Company's judgment as of the date of this release. These statements
include those related to expected payments to the Company under the
Yi Xin agreement and Yi Xin's future development, manufacturing and
sales activities. Actual events or results may differ from the
Company's expectations. For example, there can be no assurance that
Yi Xin's future development, manufacturing and sales activities
will proceed as anticipated or that Yi Xin (which is a newly-formed
company) will be able to honor its contractual obligations to the
Company; that clinical trials will be applied for by or approved to
begin by any projected timeline or will proceed as contemplated by
any projected timeline; that the Company will successfully develop
any drugs or therapeutic devices; that preclinical or clinical
development of the Company's drugs or therapeutic devices will be
successful; that future clinical trial data will be favorable or
that such trials will confirm any improvements over other products
or lack negative impacts; that any drugs or therapeutic devices
will receive required regulatory approvals or that they will be
commercially successful; that patents will issue on the Company's
owned and in-licensed patent applications; that such patents, if
any, and the Company's current owned and in-licensed patents would
prevent competition; that the Company will be able to procure or
earn sufficient working capital to complete the development,
testing and launch of the Company's prospective therapeutic
products; that the Company will be able to maintain or expand
market demand and/or market share for the Company's diagnostic
products generally, particularly in view of COVID-19-related
deferral of patients' physician-office visits and FastPack
reimbursement pricing challenges; that adoption and placement of
FastPack PRO System instruments (which are the only
FastPack instruments on which the Company's SARS-CoV-2
IgG test kits can be run) will be widespread; that the Company
will be able to manufacture the FastPack PRO System instruments and
SARS-CoV-2 IgG test kits successfully; that any
commercialization of the FastPack PRO System instruments and
SARS-CoV-2 IgG test kits will be profitable; or that the FDA
will ultimately approve an Emergency Use Authorization for the
Company's SARS-CoV-2 IgG test. The Company's stock price
could be harmed if any of the events or trends contemplated by the
forward-looking statements fails to occur or is delayed or if any
actual future event otherwise differs from expectations. Additional
information concerning these and other risk factors affecting the
Company's business (including events beyond the Company's control,
such as epidemics and resulting changes) can be found in the
Company's prior filings with the Securities and Exchange
Commission, available at www.sec.gov. The Company
disclaims any intent or obligation to update these forward-looking
statements beyond the date of this news release, except as required
by law. This caution is made under the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995.
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SOURCE Qualigen, Inc.