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 financial results
for the first quarter ending March 31, 2023, and provides a
corporate update.
Highlights For First
Quarter and To Date
2023:
Therapeutics Highlights:
QN-302
-
Orphan Drug Designation granted by FDA for the intended indication
of pancreatic cancer
-
Good laboratory practice (GLP) toxicology studies initiated
-
Composition of Matter patent for QN-302 technology granted to
University College London Business, as exclusively licensed to
Qualigen
-
Scientific Posters, Abstracts, and Publications:
-
Peer Reviewed Journal Publication – Molecules, March 2023
-
“The Potent G-Quadruplex-Binding Compound QN-302 Downregulates
S100P Gene Expression in Cells and in an In Vivo Model of
Pancreatic Cancer”
-
American Association for Cancer Research (AACR) Annual Meeting,
April 2023 – four posters
Pan-RAS
-
Scientific Posters, Abstracts, and Publications:
-
American Association for Cancer Research (AACR) Special Conference:
Targeting RAS, March 2023 – two abstracts
-
American Society of Clinical Oncology (ASCO) 2023 Annual Meeting,
June 2-6, 2023: one poster, one abstract
QN-247
- Scientific Posters,
Abstracts, Publications:
- American
Association for Cancer Research (AACR) Annual Meeting, April 2023 –
one poster
Diagnostics Highlights:
FastPack
-
Reported 123% year-over-year increase in FastPack product sales
following the expiration of the Sekisui Distribution Agreement on
March 31, 2022 and the Company now recognizing 100% of the revenue
from sales of FastPack diagnostic test kits and instruments
- Promoted Benedict
Abugan to Vice President to lead the FastPack business and
corporate communications
Michael Poirier, Qualigen’s Chairman and CEO
commented, “We had a successful first quarter with a significant
revenue increase year-over-year from our FastPack business. We are
pleased to see an increase in our sales since taking back the
commercial activities associated with FastPack, as further
illustrated by a quarter-over-quarter increase of nearly 16% from
Q4 2022.
“Within our cancer therapeutics pipeline, we are
making continued progress both on the development side, and through
recognition within the scientific community. We continue to advance
the development of our lead therapeutics program, QN-302, our
G-quadruplex (G4) transcription inhibitor, for G4-targeted solid
tumors, including pancreatic cancer, for which we are diligently
working toward the submission of an Investigational New Drug (IND)
application around mid-year with the goal of commencing clinical
trials later this year. Concurrently, our discovery-stage pan-RAS
platform continues to be of high interest to the scientific
community and pharmaceutical industry, as evidenced by its
acceptance in high-profile scientific conferences, including a
poster at the upcoming ASCO meeting, and we are making continued
progress in developing our pan-RAS platform toward identification
of a lead pan-RAS candidate.
“Additionally, the austerity measures we
implemented in January 2023 to prudently manage capital appear to
be yielding the intended results, as we have managed to maximize
the efficiency of our operations without sacrificing either key
operational requirements or development priorities. In the
meantime, we continue to assess new strategic opportunities for
collaboration, monetization, and other ways to capitalize on our
current assets.
“We remain steadfast in our strategic plan to
transition Qualigen Therapeutics to a clinical stage cancer
therapeutics company, and to continue to develop our pan RAS-driven
platform,” concluded Mr. Poirier.
Financial Highlights
Revenues for the quarter ended March 31, 2023
were approximately $1.6 million compared to approximately $0.7
million for the same period of 2022, an increase of approximately
$0.8 million or 123%, which is attributed to the Company’s resuming
sales, marketing and distribution activities and, accordingly,
recognizing 100% of the revenue from sales of FastPack diagnostic
test kits and instruments as of April 1, 2022.
General and administrative expenses decreased
from $2.9 million, during the three months ended March 31,
2022, to $1.7 million during the three months ended March 31,
2023. This decrease was primarily due to a decrease in stock-based
compensation expense of $0.9 million, a decrease in insurance
expenses of $0.2 million, and a decrease in legal expenses of $0.3
million, offset by increases in consulting expenses of $0.1 million
and other payroll related expenses totaling $0.1 million.
Research and development costs increased from
$1.9 million for the three months ended March 31, 2022 to $2.1
million for the three months ended March 31, 2023. Of the $2.1
million of research and development costs for the three months
ended March 31, 2023, $1.3 million (60%) was attributable to
therapeutics and $0.8 million (40%) was attributable to
diagnostics. Of the $1.9 million of research and development costs
for the three months ended March 31, 2022, $1.6 million (84%)
was attributable to therapeutics and $0.3 million (16%) was
attributable to diagnostics.
The increase in diagnostic research and
development costs was primarily due to $0.6 million in research and
development expenses assumed in connection with the acquisition of
NanoSynex, offset by a reduction of $0.1 million in FastPack
research and development expenses. The decrease in therapeutics
research and development costs was primarily due to a decrease of
pre-clinical research and development costs of $0.6 million in
QN-247 expenses, a decrease of $0.2 million in stock-based
compensation expenses, a decrease in pan-RAS expenses of $0.1
million, offset by an increase in QN-302 pre-clinical research and
development costs of $0.5 million.
For the quarter ended March 31, 2023, the
Company reported a net loss attributable to Qualigen Therapeutics,
Inc. of approximately $3.8 million, or $0.78 per common share basic
and diluted, compared to a net loss of approximately $4.3 million,
or $1.22 per common share basic and diluted, for the corresponding
period in 2022.
Net cash used in operating activities was $2.6
million for the quarter ended March 31, 2023, as compared to $3.9
million for the corresponding period in 2022. As of March 31, 2023,
the Company had approximately $4.4 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. The investigational compounds
within our RAS 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. 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). In addition to our
oncology drug pipeline, we have 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 prospects
and strategy for its diagnostics business and development of its
therapeutic drug candidates. Actual events or results may differ
from the Company's expectations. For example, there can be no
assurance that the Company will be able to continue to maintain its
diagnostic sales and marketing engine without interruption after
resuming worldwide sales, marketing and distribution
responsibilities associated with FastPack from Sekisui Diagnostics,
compete with others in this industry or expand market demand and/or
market share for its diagnostics products, nor can there be any
assurance that the Company will be able to bring the NanoSynex
diagnostics technology to market or successfully develop any drugs
(including QN-302, pan-RAS and QN-247); that preclinical
development of the Company's drugs (including QN-302, pan-RAS and
QN-247, 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,
RAS and QN-247, and QN-165). The Company's stock price could be
harmed if any of the events or trends contemplated by the
forward-looking statements fail 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 AND COMPREHENSIVE LOSS
(Unaudited)
|
For the Three Months Ended March
31, |
|
|
2023 |
|
2022 |
|
REVENUES |
|
|
|
|
Net product sales |
$ |
1,607,170 |
|
$ |
722,029 |
|
Total revenues |
|
1,607,170 |
|
|
722,029 |
|
|
|
|
|
|
EXPENSES |
|
|
|
|
Cost of product sales |
|
1,264,828 |
|
|
828,848 |
|
General and
administrative |
|
1,714,434 |
|
|
2,898,751 |
|
Research and development |
|
2,121,551 |
|
|
1,864,745 |
|
Sales and marketing |
|
199,114 |
|
|
138,323 |
|
Total expenses |
|
5,299,927 |
|
|
5,730,667 |
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
(3,692,757 |
) |
|
(5,008,638 |
) |
|
|
|
|
|
OTHER EXPENSE
(INCOME), NET |
|
|
|
|
Gain on change in fair value
of warrant liabilities |
|
(1,038,673 |
) |
|
(683,242 |
) |
Interest expense (income),
net |
|
544,236 |
|
|
(6,309 |
) |
Loss on voluntary conversion
of convertible debt |
|
1,077,287 |
|
|
— |
|
Other income, net |
|
(4,881 |
) |
|
(36 |
) |
Loss on fixed asset
disposal |
|
300 |
|
|
— |
|
Total other expense (income),
net |
|
578,269 |
|
|
(689,587 |
) |
|
|
|
|
|
LOSS BEFORE (BENEFIT)
PROVISION FOR INCOME TAXES |
|
(4,271,026 |
) |
|
(4,319,051 |
) |
|
|
|
|
|
(BENEFIT) PROVISION
FOR INCOME TAXES |
|
(163,777 |
) |
|
736 |
|
|
|
|
|
|
NET LOSS |
|
(4,107,249 |
) |
|
(4,319,787 |
) |
|
|
|
|
|
Net loss attributable to
noncontrolling interest |
|
(261,028 |
) |
|
— |
|
|
|
|
|
|
Net loss attributable
to Qualigen Therapeutics, Inc. |
$ |
(3,846,221 |
) |
$ |
(4,319,787 |
) |
|
|
|
|
|
Net loss per common share,
basic and diluted |
$ |
(0.78 |
) |
$ |
(1.22 |
) |
Weighted—average number of
shares outstanding, basic and diluted |
|
4,959,122 |
|
|
3,529,405 |
|
|
|
|
|
|
Other comprehensive
loss, net of tax |
|
|
|
|
Net loss |
$ |
(4,107,249 |
) |
$ |
(4,319,787 |
) |
Foreign currency translation
adjustment |
|
119,723 |
|
|
— |
|
Other comprehensive loss |
|
(3,987,526 |
) |
|
(4,319,787 |
) |
Comprehensive loss
attributable to noncontrolling interest |
|
(261,028 |
) |
|
— |
|
Comprehensive loss
attributable to Qualigen Therapeutics, Inc. |
$ |
(3,726,498 |
) |
$ |
(4,319,787 |
) |
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, |
|
|
2023 |
|
2022 |
|
ASSETS |
|
|
|
|
Current
assets |
|
|
|
|
Cash |
$ |
4,362,757 |
|
$ |
7,034,434 |
|
Accounts receivable, net |
|
411,104 |
|
|
538,587 |
|
Inventory, net |
|
1,480,755 |
|
|
1,586,297 |
|
Prepaid expenses and other
current assets |
|
1,283,358 |
|
|
1,661,220 |
|
Total current assets |
|
7,537,974 |
|
|
10,820,538 |
|
Restricted cash |
|
5,586 |
|
|
5,690 |
|
Right-of-use assets |
|
1,364,901 |
|
|
1,422,538 |
|
Property and equipment,
net |
|
522,408 |
|
|
345,087 |
|
Intangible assets, net |
|
5,839,330 |
|
|
5,845,702 |
|
Goodwill |
|
625,602 |
|
|
625,602 |
|
Other assets |
|
18,334 |
|
|
18,334 |
|
Total
Assets |
$ |
15,914,135 |
|
$ |
19,083,491 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable |
$ |
899,948 |
|
$ |
857,311 |
|
Accrued vacation |
|
353,557 |
|
|
467,948 |
|
Accrued expenses and other
current liabilities |
|
1,893,733 |
|
|
1,511,856 |
|
R&D grant liability |
|
634,330 |
|
|
780,682 |
|
Deferred revenue, current
portion |
|
112,902 |
|
|
116,161 |
|
Operating lease liability,
current portion |
|
248,809 |
|
|
240,645 |
|
Short term debt-related
party |
|
958,952 |
|
|
950,722 |
|
Warrant liabilities |
|
400,800 |
|
|
788,100 |
|
Warrant liabilities - related
party |
|
2,183,174 |
|
|
2,834,547 |
|
Convertible debt - related
party |
|
558,238 |
|
|
60,197 |
|
Total current liabilities |
|
8,244,442 |
|
|
8,608,170 |
|
Operating lease liability, net
of current portion |
|
1,236,024 |
|
|
1,301,919 |
|
Deferred revenue, net of
current portion |
|
40,712 |
|
|
49,056 |
|
Deferred tax liability |
|
192,587 |
|
|
357,757 |
|
Total liabilities |
|
9,713,766 |
|
|
10,316,902 |
|
Commitments and Contingencies
(Note 13) |
|
|
|
|
Stockholders’
equity |
|
|
|
|
Qualigen Therapeutics, Inc.
stockholders' equity: |
|
|
|
|
Common stock, $0.001 par
value; 225,000,000 shares authorized; 5,052,463 and 4,210,737
shares issued and outstanding as of March 31, 2023 and December 31,
2022, respectively |
|
42,952 |
|
|
42,110 |
|
Additional paid-in
capital |
|
111,887,447 |
|
|
110,528,050 |
|
Accumulated other
comprehensive income |
|
170,444 |
|
|
50,721 |
|
Accumulated deficit |
|
(107,231,393 |
) |
|
(103,385,172 |
) |
Total Qualigen Therapeutics,
Inc. stockholders' equity |
|
4,869,450 |
|
|
7,235,709 |
|
Noncontrolling interest |
|
1,330,919 |
|
|
1,530,881 |
|
Total Stockholders'
Equity |
|
6,200,369 |
|
|
8,766,590 |
|
Total Liabilities
& Stockholders' Equity |
$ |
15,914,135 |
|
$ |
19,083,491 |
|
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
Qualigen Therapeutics (NASDAQ:QLGN)
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