Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life
sciences company focused on developing treatments for adult and
pediatric cancers with potential for Orphan Drug Designation, while
also commercializing diagnostics, today announces its financial
results for the first quarter ended March 31, 2022, and provides an
update on its diagnostics business, therapeutics pipeline, and
other corporate developments.
Corporate Highlights During Q1 and to
Date:
|
● |
Resumed worldwide sales, marketing, and distribution rights for
FastPack® from former partner, Sekisui Diagnostics; expected to
lead to meaningful sales growth |
|
|
|
|
● |
Entered into definitive agreements to acquire majority stake in
Israeli diagnostics technology company NanoSynex, with closing
expected in Q2 2022 |
|
|
|
|
● |
Shishir Sinha appointed as Sr. Vice President, Chief Operating
Officer, to lead Qualigen’s growing diagnostics business |
|
|
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|
● |
Secured worldwide rights to G-Quadruplex-selective transcription
inhibitors from University College London to develop as cancer
therapeutics – QN302 — and engaged world renowned scientist Prof.
Stephen Neidle as a consultant |
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|
|
|
● |
QN-302’s scientific importance recognized as three posters were
accepted for presentation at the prestigious American Association
for Cancer Research (AACR) conference |
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|
● |
Engaged TD2, a leading oncology focused contract research
organization, for the development of QN-302 for solid tumors, in
particular pancreatic cancer |
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|
|
● |
Extended its research collaboration with University of Louisville
Research Foundation for its RAS Program |
Michael Poirier, Qualigen’s Chairman and CEO
commented, “We are pleased with all that we accomplished in the
first quarter of 2022 as we executed on our mission of putting
patients first while maximizing stakeholder value as a diversified
life sciences company. With respect to our therapeutics pipeline,
we implemented an exclusive worldwide license agreement with UCL
Business Ltd, the commercialization company for University College
London, to develop QN-302, which now represents our lead
therapeutics program. QN-302 is a G-Quadruplex (G4) selective
transcription inhibitor which we are developing to treat pancreatic
cancer, prostate cancer as well as other rare solid tumors. We also
presented in vivo research that demonstrate the potential of the
compound to treat multiple cancer types during the AACR conference;
and at the end of the quarter, we announced TD2 as our CRO. We are
on track with IND-enabling studies this year, and we are looking
forward to discussing further progress in this development.”
“In March, we extended and expanded our research
agreement with the University of Louisville Research Foundation to
develop our RAS-F platform. This facilitates our efforts to
generate and select additional compounds, fully explore mechanisms
within the RAS pathway, and drive the program towards a lead
clinical candidate.”
“The end of the quarter also marked our return
to fully managing the sales, marketing, and distribution of
FastPack®, which is our revenue producing diagnostic business. As
of April 1, 2022, we will be entitled to 100% of the revenue from
FastPack® sales that was previously shared with Sekisui. The
decrease in first quarter revenue represented a one-time event due
to the expiration of our distribution agreement with Sekisui, which
resulted in Sekisui reducing its purchases from us during the
quarter as it sold off its remaining inventory prior to termination
of the agreement. In April we assumed experienced sales
professionals from Sekisui and our outlook for future quarters
continues to show sales growth. We expect to demonstrate increased
revenues in upcoming quarters.”
“The successful development and
commercialization of diagnostics is part of our corporate DNA, and
in furtherance of this we recently announced the signing of
definitive agreements to acquire a majority stake in NanoSynex in a
mostly-stock deal. NanoSynex’s potentially game-changing technology
is an Antimicrobial Susceptibility Testing (AST) platform that aims
to provide clinical laboratories worldwide with a rapid, accurate
and personalized test for bacterial infections, with the goal of
quickly matching the correct antibiotics to treat a patient’s
particular infection. With NanoSynex’s technology, we aim to make a
meaningful impact in the global fight against antibiotic resistant
‘superbugs’.”
“We believe there is significant potential in
this platform, and that it provides us with the opportunity to
leverage our long-standing diagnostics development, regulatory and
commercial expertise to help bring this platform to market, which
we believe will enable better targeting of antibiotics for their
most suitable uses to ultimately result in faster and more
efficacious treatment, thereby potentially reducing hospitals
mortality and morbidity rates. We have also assigned Shishir Sinha,
who has expertly managed our FastPack® operations, to oversee our
entire diagnostics business. We believe Shishir’s expertise will be
valuable to help that business continue to grow both organically
through our newly re-acquired distribution rights to FastPack® and
through the NanoSynex partnership,” concluded Mr. Poirier.
First Quarter Financial
Highlights
Revenues for the three months ended March 31,
2022, were $0.7 million compared to approximately $1.9 million in
the same quarter of the previous year. All revenues generated
during the quarter were from product sales of diagnostic tests.
Product sales declined to $0.7 million from $1.4 million in the
same quarter of the previous year due to the termination of our
distribution agreement with Sekisui Diagnostics on March 31, 2022,
resulting in reduced sales to Sekisui during the quarter as it sold
off its remaining inventory prior to termination of the
agreement.
The Company expects increased sales in future
quarters as Qualigen will receive 100% of the revenue from
FastPack® sales that was previously shared with Sekisui.
There were no license revenues during the three
months ended March 31, 2022, compared to approximately $0.5 million
in license revenues from Yi Xin under a Technology Transfer
Agreement during the first quarter of the previous year.
For the three months ended March 31, 2022,
Qualigen reported a net loss of $4.3 million, or $0.12 per share,
compared to a net loss of $5.2 million, or $0.19 per share, for the
corresponding period in 2021.
Research and development costs decreased from
$3.5 million for the three months ended March 31, 2021 to $1.9
million for the three months ended March 31, 2022. The reduction in
expenses was primarily due to a $2.6 million decrease in
pre-clinical research costs related to the potential application of
QN-165 for the treatment of COVID-19 (which has since been
deprioritized), offset by an increase of $0.4 million in
pre-clinical research costs for QN-302, which we acquired in
January 2022, an increase of $0.4 million in pre-clinical research
costs for QN-247, an increase of $0.1 million in pre-clinical
research costs for our RAS program, and an increase of about $0.1
million in payroll related expenses.
General and administrative expenses were
approximately $2.9 million, and sales and marketing expenses were
approximately $0.1 million, for the three months ended March 31,
2022, consistent with the same period in 2021.
As of March 31, 2022, Qualigen Therapeutics had
$13.6 million in cash.
About Qualigen
Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified
life sciences company focused on developing treatments for adult
and pediatric cancer, as well as maintaining and expanding its core
FDA-cleared FastPack® System, which has been used successfully in
diagnostics for over 20 years. Our investigational QN-302 compound
is a small molecule selective transcription inhibitor with strong
binding affinity to G4s prevalent in cancer cells; such binding
could, by stabilizing the G4s against “unwinding,” help inhibit
cancer cell proliferation. Our investigational QN-247 compound
inhibits nucleolin, a key multi-functional regulatory protein that
is overexpressed in cancer cells; QN-247 may thereby be able to
inhibit the cells’ proliferation. QN-247 has shown promise in
preclinical studies for the treatment of acute myeloid leukemia
(AML). The investigational compounds within Qualigen’s RAS-F family
of RAS oncogene protein-protein interaction inhibitor small
molecules are believed to inhibit or block the binding of mutated
RAS genes’ proteins to their effector proteins, thereby leaving the
proteins from the mutated RAS unable to cause further harm. In
theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of
pancreatic, colorectal, and lung cancers. In addition to its
oncology drug pipeline, Qualigen has an established diagnostics
business which manufactures and distributes proprietary and highly
accurate rapid blood testing systems to physician offices and small
hospitals for the management of prostate cancer and other diseases
and health conditions.
For more information about Qualigen
Therapeutics, Inc., please visit www.qualigeninc.com.
Forward-Looking Statements
This news release contains forward-looking
statements by Qualigen 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 strategy,
plans and objectives, including statements related to the
anticipated timing of the closing of the NanoSynex transaction and
the Company’s ability to bring this platform to market, the
Company’s prospects and strategy for its diagnostics business, the
development of its therapeutic drug candidates, including
anticipated timing of IND-enabling studies for QN-302, and the
Company’s ability to continue to fund operations into mid-2023.
Actual events or results may differ from the Company’s
expectations. For example, there can be no assurance that the
closing conditions for the NanoSynex transaction will be satisfied
or that the Company will be able to maintain its diagnostic sales
and marketing engine without interruption following the expiration
of its distribution agreement with Sekisui Diagnostics, compete
with others in this industry or expand market demand and/or market
share for its FastPack® diagnostics product, nor can there be any
assurance that the Company will be able to successfully develop any
drugs (including QN-302, QN-247 and RAS-F); that preclinical
development of the Company’s drugs (including QN-302, QN-247 and
RAS-F, and the deprioritized infectious-disease drug candidate
QN-165) will be completed on any projected timeline or will be
successful; that any clinical trials will be approved to begin by
or will proceed as contemplated by any projected timeline, or at
all; that any 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 will receive required
regulatory approvals (or Fast Track designation or Orphan Drug
status) 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
currently owned and in-licensed patents would prevent competition;
or 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 (including QN-302,
QN-247 and RAS-F, and QN-165). 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 can be found in the Company’s prior filings with
the Securities and Exchange Commission, including its most recent
annual report on Form 10-K, all of which are 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.
Contact:
Jules AbrahamJQA Partners, Inc.(917)
885-7378jabraham@jqapartners.com
Source: Qualigen Therapeutics, Inc.
QUALIGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
2022 |
|
|
2021 |
|
|
|
For the Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
REVENUES |
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
722,029 |
|
|
$ |
1,420,842 |
|
License revenue |
|
|
— |
|
|
|
478,654 |
|
Total revenues |
|
|
722,029 |
|
|
|
1,899,496 |
|
EXPENSES |
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
828,848 |
|
|
|
1,202,479 |
|
General and
administrative |
|
|
2,898,751 |
|
|
|
2,873,939 |
|
Research and development |
|
|
1,864,745 |
|
|
|
3,499,373 |
|
Sales and marketing |
|
|
138,323 |
|
|
|
136,587 |
|
Total expenses |
|
|
5,730,667 |
|
|
|
7,712,378 |
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(5,008,638 |
) |
|
|
(5,812,882 |
) |
|
|
|
|
|
|
|
|
|
OTHER (INCOME),
NET |
|
|
|
|
|
|
|
|
Gain on change in fair value
of warrant liabilities |
|
|
(683,242 |
) |
|
|
(552,808 |
) |
Interest income, net |
|
|
(6,309 |
) |
|
|
(17,343 |
) |
Other income, net |
|
|
(36 |
) |
|
|
(542 |
) |
Total other income, net |
|
|
(689,587 |
) |
|
|
(570,693 |
) |
|
|
|
|
|
|
|
|
|
LOSS BEFORE PROVISION
FOR INCOME TAXES |
|
|
(4,319,051 |
) |
|
|
(5,242,189 |
) |
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME
TAXES |
|
|
736 |
|
|
|
530 |
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(4,319,787 |
) |
|
$ |
(5,242,719 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.19 |
) |
Weighted—average number of
shares outstanding, basic and diluted |
|
|
35,294,051 |
|
|
|
28,165,796 |
|
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
QUALIGEN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
13,610,894 |
|
|
|
17,538,272 |
|
Accounts receivable, net |
|
|
594,338 |
|
|
|
822,351 |
|
Inventory, net |
|
|
1,400,712 |
|
|
|
1,055,878 |
|
Prepaid expenses and other
current assets |
|
|
1,097,822 |
|
|
|
1,379,896 |
|
Total current assets |
|
|
16,703,766 |
|
|
|
20,796,397 |
|
Right-of-use assets |
|
|
1,591,072 |
|
|
|
1,645,568 |
|
Property and equipment,
net |
|
|
230,242 |
|
|
|
203,920 |
|
Equipment held for lease,
net |
|
|
221 |
|
|
|
296 |
|
Intangible assets, net |
|
|
164,818 |
|
|
|
171,190 |
|
Other assets |
|
|
18,334 |
|
|
|
18,334 |
|
Total
Assets |
|
$ |
18,708,453 |
|
|
$ |
22,835,705 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
997,406 |
|
|
$ |
886,224 |
|
Accrued expenses and other
current liabilities |
|
|
1,343,375 |
|
|
|
1,793,901 |
|
Deferred revenue, current
portion |
|
|
127,304 |
|
|
|
135,063 |
|
Operating lease liability,
current portion |
|
|
155,525 |
|
|
|
134,091 |
|
Warrant liabilities |
|
|
1,002,100 |
|
|
|
1,686,200 |
|
Total current liabilities |
|
|
3,625,710 |
|
|
|
4,635,479 |
|
Operating lease liability, net
of current portion |
|
|
1,484,833 |
|
|
|
1,542,564 |
|
Deferred revenue, net of
current portion |
|
|
81,081 |
|
|
|
92,928 |
|
Total liabilities |
|
|
5,191,624 |
|
|
|
6,270,971 |
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Common stock, $0.001 par
value; 225,000,000 shares authorized; 35,295,541 and 35,290,178
shares issued and outstanding as of March 31, 2022 and December 31,
2021, respectively |
|
|
35,295 |
|
|
|
35,290 |
|
Additional paid-in
capital |
|
|
102,545,950 |
|
|
|
101,274,073 |
|
Accumulated deficit |
|
|
(89,064,416 |
) |
|
|
(84,744,629 |
) |
Total stockholders’
equity |
|
|
13,516,829 |
|
|
|
16,564,734 |
|
Total Liabilities
& Stockholders’ Equity |
|
$ |
18,708,453 |
|
|
$ |
22,835,705 |
|
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
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