Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company
focused on developing novel therapeutics for the treatment of
cancer and viral diseases, today announced its financial results
for the quarter ended March 31, 2021, and provided an update on its
therapeutics pipeline and other corporate developments.
The Company will present its first quarter 2021
financial results and operational highlights in a conference call
on May 18, 2021 at 4:10 p.m. EDT.
Highlights from the Quarter Ended March
31, 2021:
“We were very pleased to see the improvement in
our revenue growth during the first quarter from our FastPack®
System. Despite the challenges of operating during the pandemic, we
managed to safely stay open to manufacture and ship our FastPack
immunoassay products to meet the needs of our valued Diagnostics
customers," stated Michael Poirier, Chief Executive Officer at
Qualigen Therapeutics, Inc. He added: “While we are maintaining our
diagnostics business, we are also working diligently to develop our
therapeutics pipeline, which includes QN-165, QN-247, RAS-F, and
STARS™.”
“We continue to strengthen our team with proven
pharmaceutical professionals who leverage their knowledge and
experience in order for us to achieve important milestones with
each of our pipeline programs,” stated Amy Broidrick, EVP, Chief
Strategy Officer.
Pipeline and Corporate
Highlights
- Made significant progress with the
IND-enabling studies for Qualigen’s lead candidate, QN-165, which
is a broad-spectrum antiviral drug candidate for treating COVID-19
and other viral-based infectious diseases.
- Completed the R&D evaluation
and qualification for QN-247, a DNA coated gold nanoparticle cancer
drug candidate that has the potential to target various types of
cancer with minimal side effects. The nanoparticle coating
technology is similar to the core nanoparticle coating technology
used in Qualigen's blood-testing diagnostic products.
- Continued our license and sponsored
research agreements with the University of Louisville to evaluate
the use of QN-247 with G-quadruplex binders. Qualigen plans to seek
to obtain Orphan Drug status for QN-247 for one or more
indications, such as pancreatic cancer, acute myeloid leukemia and
pediatric neuroblastoma. Orphan Drug status, if obtained, would be
expected to confer several advantages including faster review and
increased market protection.
- Entered into a Material Evaluation
and Option Agreement with the University College London (UCL) which
will allow Qualigen to study a significant potential indication for
QN-247 with improved selectivity for pancreatic cancer cells. In
addition to the pancreatic cancer treatment indication, Qualigen
will also continue to evaluate QN-247 to treat leukemia and
glioblastoma, and as an adjuvant therapy to stop the recurrence of
cancer after initial treatment.
- Qualigen’s patent portfolio for
therapeutics now has 37 owned or in-licensed patents and patent
applications covering the QN-247 and/or QN-165 programs, 26 of
which are issued.
First Quarter 2021 Financial
Highlights
- Revenues in the three months ended
March 31, 2021 were $1.9 million compared to $1.5 million during
the three months ended March 31, 2020, an increase of $0.4 million.
Our operating revenues are primarily generated from sales of
diagnostic tests. This increase was primarily due to recognition of
license revenue from Yi Xin Duan Jishu (Suzhou) Ltd. under our
agreement with them for FastPack in China.
Net product sales remained level at
approximately $1.4 million during the three months ended March 31,
2021 and 2020, but improved compared to the later 2020 quarters
which were negatively impacted by the COVID-19 pandemic.
- License revenue during the three
months ended March 31, 2021 was approximately $479,000, due to the
recognition of revenue from the Yi Xin transaction.
- General and administrative expenses
increased to $2.9 million during the three months ended March 31,
2021 from $0.9 million during the three months ended March 31,
2020. This increase was primarily due to overhead expenses related
to our public-company status in the three months ended March 31,
2021 in contrast to our private-company status in the three months
ended March 31, 2020.
- As of March 31, 2021, Qualigen
Therapeutics had $21.9 million of cash and cash equivalents.
Conference Call Information
Qualigen will host a conference call for
analysts and investors to present its first quarter 2021 financial
results and operational highlights on May 18, 2021 at 4:10 p.m.
EDT. Management will answer questions at the end of the call.
Please submit questions for management no later than 10:00 a.m. EDT
on Monday, May 17, 2021 to ir@qualigeninc.com.
Speakers on the call from Qualigen will be
Michael Poirier, Chairman, Chief Executive Officer and Christopher
Lotz, Vice President and Chief Financial Officer.
We encourage participants to pre-register for
the conference call using the following link:
https://dpregister.com/sreg/10154044/e5f384fc7c
Callers who pre-register will be given a
conference passcode and unique PIN to gain immediate access to the
call and bypass the live operator. Participants may register at any
time, including up to and after the call start time.
A live webcast of the call will be available at
the following
link:https://services.choruscall.com/mediaframe/webcast.html?webcastid=sljQb3Cl
Those without internet access or unable to register may dial in
by calling: Participant Dial In (Toll Free):
1-866-777-2509Participant International Dial In: 1-412-317-5413
A recording and a transcript of the call will be
available on the Investors page of the Company’s website at
https://www.qualigeninc.com.
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. Our cancer
therapeutics pipeline includes QN-247 (formerly referred to as ALAN
or AS1411-GNP), RAS-F and STARS™. QN-247 is a DNA coated gold
nanoparticle cancer drug candidate that has the potential to target
various types of cancer with minimal side effects; the nanoparticle
coating technology is similar to the core nanoparticle coating
technology used in our blood-testing diagnostic products. The
foundational aptamer of QN-247, QN-165 (formerly referred to as
AS1411), is also a drug candidate for treating COVID-19 and other
viral-based infectious diseases; we currently plan that our first
clinical trial would be a trial of QN-165 against COVID-19. 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, and vitamin D status. 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 prospects
and strategy for the development of therapeutic drug candidates.
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; or 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. 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.
Investor Relations:
For further information: David Kugelman(404)
856-9157 Office(866) 692-6847 Toll Free - U.S. &
Canadadk@atlcp.com
Tony Schor(847)
971-0922tony@investorawareness.com
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
|
|
For the Three Months Ended March
31, |
|
|
|
2021 |
|
|
2020 |
|
REVENUES |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,420,842 |
|
|
$ |
1,411,755 |
|
License revenue |
|
|
478,654 |
|
|
|
— |
|
Collaborative research revenue |
|
|
— |
|
|
|
45,000 |
|
Total revenues |
|
|
1,899,496 |
|
|
|
1,456,755 |
|
|
|
|
|
|
|
|
|
|
EXPENSES |
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
1,202,479 |
|
|
|
991,651 |
|
General and administrative |
|
|
2,873,939 |
|
|
|
918,379 |
|
Research and development |
|
|
3,499,373 |
|
|
|
238,059 |
|
Sales and marketing |
|
|
136,587 |
|
|
|
92,262 |
|
Total expenses |
|
|
7,712,378 |
|
|
|
2,240,351 |
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(5,812,882 |
) |
|
|
(783,596 |
) |
|
|
|
|
|
|
|
|
|
OTHER (INCOME)
EXPENSE, NET |
|
|
|
|
|
|
|
|
Gain on change in fair value of warrant liabilities |
|
|
(2,122,900 |
) |
|
|
— |
|
Interest (income) expense, net |
|
|
(17,343 |
) |
|
|
90,757 |
|
Other income, net |
|
|
(542 |
) |
|
|
(1,158 |
) |
Total other (income) expense, net |
|
|
(2,140,785 |
) |
|
|
89,599 |
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE PROVISION
FOR INCOME TAXES |
|
|
(3,672,097 |
) |
|
|
(873,195 |
) |
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME
TAXES |
|
|
530 |
|
|
|
(619 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(3,672,627 |
) |
|
|
(872,576 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.16 |
) |
Weighted—average number of
shares outstanding, basic and diluted |
|
|
28,165,796 |
|
|
|
5,602,214 |
|
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited)
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,947,912 |
|
|
$ |
23,976,570 |
|
Accounts receivable, net |
|
|
862,235 |
|
|
|
615,757 |
|
Inventory, net |
|
|
885,855 |
|
|
|
953,458 |
|
Prepaid expenses and other current assets |
|
|
1,219,759 |
|
|
|
2,678,894 |
|
Total current assets |
|
|
24,915,761 |
|
|
|
28,224,679 |
|
Right-of-use assets |
|
|
376,616 |
|
|
|
430,795 |
|
Property and equipment,
net |
|
|
224,932 |
|
|
|
247,323 |
|
Equipment held for lease,
net |
|
|
10,687 |
|
|
|
17,947 |
|
Intangible assets, net |
|
|
189,294 |
|
|
|
187,694 |
|
Other assets |
|
|
18,334 |
|
|
|
18,334 |
|
Total
Assets |
|
$ |
25,735,624 |
|
|
$ |
29,126,772 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
485,551 |
|
|
$ |
500,768 |
|
Accrued expenses and other current liabilities |
|
|
1,869,424 |
|
|
|
746,738 |
|
Notes payable, current portion |
|
|
10,683 |
|
|
|
131,766 |
|
Deferred revenue, current portion |
|
|
381,366 |
|
|
|
486,031 |
|
Lease liability, current portion |
|
|
262,601 |
|
|
|
254,739 |
|
Warrant liabilities |
|
|
6,187,200 |
|
|
|
8,310,100 |
|
Total current liabilities |
|
|
9,196,825 |
|
|
|
10,430,142 |
|
Notes payable, net of current
portion |
|
|
4,923 |
|
|
|
6,973 |
|
Lease liability, net of
current portion |
|
|
168,254 |
|
|
|
236,826 |
|
Deferred revenue, net of
current portion |
|
|
135,235 |
|
|
|
158,271 |
|
Total liabilities |
|
|
9,505,237 |
|
|
|
10,832,212 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Series Alpha convertible
preferred stock, $0.001 par value; 7,000 shares authorized; 180
shares issued and outstanding as of March 31, 2021 and December 31,
2020 |
|
|
1 |
|
|
|
1 |
|
Common stock, $0.001 par
value; 225,000,000 shares authorized; 28,833,059 shares and
27,296,061 shares issued and outstanding as of March 31, 2021 and
December 31, 2020 |
|
|
28,833 |
|
|
|
27,296 |
|
Additional paid-in
capital |
|
|
86,721,672 |
|
|
|
85,114,755 |
|
Accumulated deficit |
|
|
(70,520,119 |
) |
|
|
(66,847,492 |
) |
Total stockholders’
equity |
|
|
16,230,387 |
|
|
|
18,294,560 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
25,735,624 |
|
|
$ |
29,126,772 |
|
Qualigen Therapeutics (NASDAQ:QLGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Qualigen Therapeutics (NASDAQ:QLGN)
Historical Stock Chart
From Apr 2023 to Apr 2024