CARLSBAD, Calif., Dec. 22, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company
focused on developing novel therapeutics for the treatment of
cancer and infectious diseases, announces that Michael Poirier, Chairman, Chief Executive
Officer and President, has issued a letter to Qualigen's
stockholders. The full text is as follows:
To My Fellow Stockholders,
This year has been very exciting and eventful for Qualigen
Therapeutics as we became a publicly traded company in May, and
subsequently delivered against our business plan with various
licensing agreements signed, patents filed and issued, and
substantial capital raised, among other key accomplishments.
Last week we announced the closing of a $12 million registered direct offering, which
brings us to a total of approximately $24
million in cash going into calendar 2021. We expect
this capital will extend our operational runway well into calendar
2022. Even more importantly, it will allow us to expedite the
development of multiple pipeline efforts in parallel, providing
Qualigen with several opportunities to reach major value inflection
points in the coming year, including the following:
- AS1411: Conduct Phase 2a clinical trial with AS1411 for the
treatment of COVID-19. Preclinical research has demonstrated
that AS1411 has potent antiviral activity against SARS-CoV-2, the
coronavirus responsible for COVID-19. Having received a positive
response to our Pre-Investigational New Drug application (Pre-IND)
meeting request from the U.S. Food and Drug Administration (FDA),
we plan to file an IND and subsequently initiate a Phase 2a
clinical trial in the first half of calendar 2021. If there are
positive Phase 2a results, we could potentially enter pivotal
trials by the end of 2021. Furthermore, with our current capital we
could commence broader development of AS1411 against other viral
diseases and explore expanded methods of delivery such as through
eye drops, nasal spray or inhalers, as described in our patent
application filed in September.
- ALAN: Initiate Phase 1 clinical trial with ALAN for the
treatment of acute myeloid leukemia (AML). Our research
partner, the University of Louisville
(UofL), continues to advance preclinical AML studies with ALAN (the
AS1411 aptamer attached to a gold nanoparticle) under the amended
sponsored research agreement we announced in October. Qualigen
plans to file an IND for ALAN and subsequently initiate a Phase 1
clinical trial for the treatment of AML in the second half of
calendar 2021. Moreover, with our current cash position we can also
now advance studies in other indications for ALAN such as
glioblastoma and non-small cell lung cancer. In addition, earlier
this month a U.S. patent was issued that protects the ALAN
technology for use with radiation therapy, MRI and other types of
tumor imaging, further expanding the potential uses and
opportunities.
- RAS: Identify lead RAS interaction inhibitor drug
candidate. Pursuant to an exclusive worldwide license agreement
signed in July, we continue to collaborate with UofL to evaluate
the RAS-F family of RAS oncogene protein-protein interaction
inhibitor small molecule drug candidates. In 2021, we plan to
identify a lead drug candidate as a therapeutic for pancreatic,
colorectal and/or lung cancers. RAS oncogenes are the most
frequently mutated class of genes in human cancers, and KRAS, HRAS
or NRAS mutations are present in approximately one-third of all
cancer patients. The additional capital will enable us to
accelerate development of our lead compound through the preclinical
stage, with the goal of filing an IND for an initial cancer
indication in the first half of calendar 2022.
- Diagnostics: Leverage our diagnostics platform. In
October 2020, we signed an important
agreement with Yi Xin Zhen Duan
Jishu (Suzhou) Ltd. for it to develop, manufacture and
market next-generation FastPack® products in China, including a high-throughput analyzer
that utilizes our patented pouch system. We have also recently been
in communication with the FDA on our Emergency Use Authorization
(EUA) submission for our FastPack® SARS-CoV-2 IgG test for COVID-19
antibodies. We remain confident that the data meet or exceed the
FDA guidelines for an EUA. As vaccines are deployed, we believe the
FastPack COVID-19 antibody test has the ability to provide an
accurate rapid solution in the marketplace.
- Pursue other strategic opportunities. In addition, we
will act strategically to identify and evaluate other opportunities
that can broaden our therapeutics pipeline.
To strengthen our senior management team, earlier this month we
announced that Amy Broidrick joined
Qualigen as Executive Vice President, Chief Strategy Officer,
having served as a Director on our Board since August. With
more than 25 years of experience across numerous business and
commercial functions in the biopharmaceutical industry, Ms.
Broidrick brings a wealth of experience to leverage as we advance
Qualigen's therapeutic programs. Moreover, she will be instrumental
in our continued evaluation of opportunities that may hold
substantial potential to enhance our pipeline.
In addition, the Board of Directors appointed Sidney Emery, Jr. as an independent Director.
Mr. Emery is a successful entrepreneur and executive with more than
50 years of leadership experience. Mr. Emery served 10 years
as Chairman and CEO of MTS Systems (Nasdaq: MTSC), the world's
leading manufacturer of mechanical testing solutions and
high-performance industrial sensors. We are confident that
Mr. Emery will provide valuable insight to Qualigen given his
significant background leading both public and private
companies.
We are pleased with the progress at Qualigen Therapeutics this
past year and are looking forward to an eventful and dynamic 2021.
We also look forward to keeping you informed of our progress. On
behalf of my colleagues at Qualigen and our Board of Directors, I
would like to thank our employees for their tremendous efforts, and
thank our investors for their continued support.
Sincerely,
Michael Poirier
Chairman, Chief Executive Officer and President
About Qualigen Therapeutics, Inc.
Qualigen
Therapeutics, Inc. is a biotechnology company focused on developing
novel therapeutics for the treatment of cancer and infectious
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 the
Company's operational cash runway, the likelihood and timing of
future approvals for and initiation of clinical trials, the
Company's development plans, activity under the Company's
China agreement, identification of
and desirability of other outside opportunities, and contributions
expected from Ms. Broidrick and Mr. Emery. Actual events or results
may differ from the Company's expectations. For example, there can
be no assurance that clinical trials will be approved to begin by
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 FastPack 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.