Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage
therapeutics company focused on developing treatments for adult and
pediatric cancers with potential for Orphan Drug
Designation,
today announces financial
results for the second quarter ending June 30, 2023, and provides a
corporate update:
Highlights For Second
Quarter and To Date 2023:
Therapeutics Highlights:
QN-302
- Received US FDA clearance to
initiate Phase 1 clinical trial of QN-302 for treatment of advanced
or metastatic solid tumors
- Presented four posters at the
American Association for Cancer Research (AACR) Annual Meeting, in
April 2023:
- “A comparison of the activity of
the quadruplex-targeting experimental drugs QN-302 and CX-5461
(Pidnarulex) in wild-type and gemcitabine-resistant pancreatic
cancer cell lines” Ahmed Ahmed, Tariq Arshad, and Stephen Neidle
(Poster)
- “The potent quadruplex-binding
compound QN-302 down-regulates the S100P gene in vitro and in vivo
models of pancreatic cancer: a potential therapeutic target and
biomarker for PDAC” Nicole Williams, Jenny Worthington, Ahmed
Ahmed, Tariq Arshad, and Stephen Neidle (Poster)
- “The potent quadruplex-binding
compound QN-302 shows anti-tumor activity as a monotherapy in an
orthotopic in vivo model of pancreatic cancer” Nicole Williams,
Danielle Santos, Jenny Worthington, Ahmed Ahmed, Tariq Arshad and
Stephen Neidle (Poster)
- “Structure-based design rules for
potent quadruplex-binding compounds based on the naphthalene
diimide core” Stephen Neidle (Poster)
Pan-RAS
- Presented data at the American
Society of Clinical Oncology (ASCO) Annual Meeting, in June 2023:
- “Impact of novel pan-RAS inhibitors
on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic
cancer cell lines.” Howard Donninger, Rachel Ferrill, Becca Von
Baby, Joe Burlison, John O. Trent, Michael Sabo, Tariq Arshad,
Geoffrey J. Clark (Poster)
- “A novel pan-RAS inhibitor for
luminal B breast cancer.” Tariq Arshad, Howard Donninger, Mike
Sabo, John Trent, Geoffrey J. Clark, Joe Burlison. This abstract
can be found in the ASCO 2023 Annual Meeting Abstract Book
(Abstract)
QN-247
- Presented one poster at the
American Association for Cancer Research (AACR) Annual Meeting, in
April 2023:
- “Nano-immunotherapy: Efficacy of
nanoconjugate QN-247 in a Triple Negative Breast Cancer (TNBC)
mouse model” Tariq Arshad, Stephen Fait, Guy Gammon, Andrew Hertig,
Mark J. Sarno (Poster)
Diagnostics Highlights:
- Sold FastPack® diagnostics business to Chembio
Diagnostics, Inc., an American subsidiary of French diagnostics
provider BIOSYNEX Group, a leader in the design and
distribution of rapid tests
- Amended our Master Funding Agreement with NanoSynex to
substantially reduce or eliminate Qualigen’s future cash funding
obligations
Michael Poirier, Qualigen’s Chairman and CEO
commented, “2023 has been a transformative year for Qualigen
Therapeutics. Despite continued industry headwinds, we
significantly advanced our oncology-focused pipeline within budget
and timelines. To build on our momentum, the company recently
achieved two major milestones: We received US FDA Investigational
New Drug (IND) clearance to initiate a Phase 1 clinical trial for
QN-302, a small molecule G-Quadruplex (G4)-selective transcription
inhibitor for treatment of advanced or metastatic solid tumors, and
we divested our FastPack® diagnostics business.”
“On August 1st we received news that the FDA
cleared the Company’s IND application for QN-302. Based on this
clearance, the Company plans to initiate the Phase 1 clinical trial
in the second half of 2023 and will enroll patients with advanced
or metastatic solid tumors. This clearance is the culmination of
dedicated efforts by the Qualigen team and our extensive network of
collaborators, subject matter experts, and service providers and
exemplifies our steadfast commitment to patients.
The proposed Phase 1 trial is a multicenter,
open-label, dose escalation, safety, pharmacokinetic, and
pharmacodynamic study with dose expansion to evaluate safety,
tolerability, and antitumor activity of QN-302 in patients with
advanced solid tumors that have not responded to or have recurred
following treatment with available therapies. The Company
anticipates dosing of at least 24 patients in the Phase 1 trial can
be completed in 2024.”
“In July we divested our FastPack® diagnostics
business to Chembio Diagnostics, Inc., an American subsidiary of
French diagnostics provider BIOSYNEX Group for [give price,
including amount received at closing, escrow amount and timing of
escrow release]. We are proud of the legacy our
FastPack® rapid immunodiagnostics system has established by
providing patients and doctors with high quality laboratory
solutions for over two decades. This all-cash sale enhances
our business focus while providing additional capital for our
therapeutics pipeline, in particular our clinical-stage QN-302
program and our preclinical Pan-RAS inhibitor platform. Going
forward, we will maintain streamlined operations that will reduce
overhead expenses as an out-sourced virtual model.”
“In parallel with QN-302 clinical development,
we continue to advance compounds within our Pan-RAS therapeutic
platform. We are on track to identify a late in vivo stage
candidate by the end of the year, which we will advance into
IND-enabling studies by 2024. We are very encouraged by the
interest we received at the ASCO Annual Meeting this June regarding
our poster presentation on the impact of novel pan-RAS inhibitors
on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic
cancer cell lines. We believe a pan-RAS approach may overcome KRAS
G12C resistance that effects depth and duration of responses in
current offerings, and we will continue to build our data
package with our collaborators in the second half of this
year.”
“We are looking forward to initiating our Phase
1 clinical trial of QN-302 in the second half of this year and
potentially providing a treatment option in the future to patients
who have not responded to or have relapsed following treatment with
available therapies. Along with the encouraging data presented on
our Pan-RAS platform, our therapeutics direction is taking shape,
and is an exciting time for Qualigen and our stakeholders,”
concluded Mr. Poirier.
Financial Highlights
Revenues from product sales for the quarter
ended June 30, 2023 were approximately $1.6 million compared to
approximately $1.4 million for the same period of 2022, an increase
of $0.2 million or 14%, due to growth in sales volumes and higher
average unit selling prices. Cost of product sales were $1.0
million, or 62% of product sales, compared to $1.1 million, or 77%
of product sales for the same period of 2022. The improvement was
primarily due to a reduction in force implemented in January
2023.
General and administrative expenses remained at
$2.7 million for the quarter, compared to the same period of
2022.
Research and development costs decreased from
$1.5 million for the three months ended June 30, 2022 to $1.3
million for the three months ended June 30, 2023. Of the $1.3
million of research and development costs for the three months
ended June 30, 2023, approximately $1.2 million (89%) was
attributable to therapeutics and $0.2 million (11%) was
attributable to diagnostics. Of the $1.5 million of research and
development costs for the three months ended June 30, 2022, $1.1
million (73%) was attributable to therapeutics and $0.4 million
(27%) was attributable to diagnostics.
The $0.1 million increase in therapeutics
research and development costs was primarily due to a $0.5 million
increase in QN-302 pre-clinical research and development costs,
offset by a decrease of pre-clinical research and development costs
of $0.4 million for QN-247. The $0.2 million decrease in
diagnostics research and development costs was primarily due to a
$0.2 million decrease in stock-based compensation expense and a
$0.1 million decrease in payroll expenses related to FastPack due
to the January 2023 reduction in force, offset by an increase of
$0.1 million in research and development expenses for
NanoSynex.
Sales and marketing expenses were approximately
$0.2 million for the quarter ended June 30, 2023, a decrease of
$0.1 million or 45%, compared to the quarter ended June 30, 2022,
primarily due to the January 2023 reduction in force.
For the quarter ended June 30, 2023, the Company
reported a net loss attributable to Qualigen Therapeutics, Inc. of
approximately $3.5 million, or $0.69 per common share basic and
diluted, compared to a net loss of approximately $4.1 million, or
$1.12 per common share basic and diluted, for the corresponding
period in 2022.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a clinical-stage
therapeutics company focused on developing treatments for adult and
pediatric cancer. 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 Qualigen’s
family of Pan-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.
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 development of its therapeutic drug candidates,
including the anticipated timeline for initiating the Company’s
Phase 1 clinical trial and enrolling and dosing of patients and the
identification of a late in vivo candidate. Actual events or
results may differ from the Company's expectations. There can be no
assurance that the Company will be able to successfully develop any
drugs (including QN-302, Pan-RAS and QN-247); that preclinical
development of the Company's drugs (including Pan-RAS and QN-247)
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, Pan-RAS and QN-247). 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.
For more information about Qualigen Therapeutics, Inc., please
visit www.qlgntx.com.
Contact:Investor Relations760-530-6487ir@qlgntx.com.
Source: Qualigen Therapeutics, Inc.
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND OTHER COMPREHENSIVE LOSS(Unaudited)
|
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,627,031 |
|
|
$ |
1,430,534 |
|
|
$ |
3,234,201 |
|
|
$ |
2,152,563 |
|
Total revenues |
|
|
1,627,031 |
|
|
|
1,430,534 |
|
|
|
3,234,201 |
|
|
|
2,152,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
1,016,542 |
|
|
|
1,099,677 |
|
|
|
2,281,368 |
|
|
|
1,928,524 |
|
General and administrative |
|
|
2,665,849 |
|
|
|
2,660,857 |
|
|
|
4,380,283 |
|
|
|
5,559,608 |
|
Research and development |
|
|
1,326,544 |
|
|
|
1,506,227 |
|
|
|
3,448,095 |
|
|
|
3,370,972 |
|
Sales and marketing |
|
|
169,223 |
|
|
|
305,103 |
|
|
|
368,337 |
|
|
|
443,426 |
|
Total expenses |
|
|
5,178,158 |
|
|
|
5,571,864 |
|
|
|
10,478,083 |
|
|
|
11,302,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(3,551,127 |
) |
|
|
(4,141,330 |
) |
|
|
(7,243,882 |
) |
|
|
(9,149,967 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE
(INCOME), NET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on change in fair value of warrant liabilities |
|
|
(440,294 |
) |
|
|
(14,800 |
) |
|
|
(1,478,967 |
) |
|
|
(698,042 |
) |
Interest expense (income), net |
|
|
377,416 |
|
|
|
(4,824 |
) |
|
|
921,652 |
|
|
|
(11,132 |
) |
Loss on voluntary conversion of convertible debt |
|
|
— |
|
|
|
— |
|
|
|
1,077,287 |
|
|
|
— |
|
Loss on disposal of equipment held for lease |
|
|
63,302 |
|
|
|
— |
|
|
|
63,302 |
|
|
|
— |
|
Other income, net |
|
|
(5,680 |
) |
|
|
376 |
|
|
|
(10,559 |
) |
|
|
341 |
|
Loss on fixed asset disposal |
|
|
— |
|
|
|
— |
|
|
|
300 |
|
|
|
— |
|
Total other expense (income), net |
|
|
(5,256 |
) |
|
|
(19,248 |
) |
|
|
573,015 |
|
|
|
(708,833 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE (BENEFIT)
PROVISION FOR INCOME TAXES |
|
|
(3,545,871 |
) |
|
|
(4,122,082 |
) |
|
|
(7,816,897 |
) |
|
|
(8,441,134 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(BENEFIT) PROVISION
FOR INCOME TAXES |
|
|
(38,182 |
) |
|
|
5,438 |
|
|
|
(201,959 |
) |
|
|
6,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(3,507,689 |
) |
|
|
(4,127,520 |
) |
|
|
(7,614,938 |
) |
|
|
(8,447,307 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
noncontrolling interest |
|
|
(43,484 |
) |
|
|
(4,116 |
) |
|
|
(304,512 |
) |
|
|
(4,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to Qualigen Therapeutics, Inc. |
|
$ |
(3,464,205 |
) |
|
$ |
(4,123,404 |
) |
|
$ |
(7,310,426 |
) |
|
$ |
(8,443,191 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(1.12 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.35 |
) |
Net loss per common share,
basic |
|
$ |
(0.69 |
) |
|
$ |
(1.12 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.35 |
) |
Weighted—average number of
shares outstanding, basic and diluted |
|
|
5,052,463 |
|
|
|
3,668,016 |
|
|
|
5,006,050 |
|
|
|
3,599,093 |
|
Weighted—average number of
shares outstanding, basic |
|
|
5,052,463 |
|
|
|
3,668,016 |
|
|
|
5,006,050 |
|
|
|
3,599,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss, net of tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,507,689 |
) |
|
$ |
(4,127,520 |
) |
|
$ |
(7,614,938 |
) |
|
$ |
(8,447,307 |
) |
Foreign currency translation adjustment |
|
|
(56,747 |
) |
|
|
65,540 |
|
|
|
119,473 |
|
|
|
65,540 |
|
Other comprehensive loss |
|
|
(3,564,436 |
) |
|
|
(4,061,980 |
) |
|
|
(7,495,465 |
) |
|
|
(8,381,767 |
) |
Comprehensive loss
attributable to noncontrolling interest |
|
|
(43,484 |
) |
|
|
(4,116 |
) |
|
|
(304,512 |
) |
|
|
(4,116 |
) |
Comprehensive loss
attributable to Qualigen Therapeutics, Inc. |
|
$ |
(3,520,952 |
) |
|
$ |
(4,057,864 |
) |
|
$ |
(7,190,953 |
) |
|
$ |
(8,377,651 |
) |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited)
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
ASSETS |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,341,659 |
|
|
$ |
7,034,434 |
|
Accounts receivable, net |
|
|
679,380 |
|
|
|
538,587 |
|
Inventory, net |
|
|
1,563,399 |
|
|
|
1,586,297 |
|
Prepaid expenses and other current assets |
|
|
1,278,077 |
|
|
|
1,661,220 |
|
Total current assets |
|
|
4,862,515 |
|
|
|
10,820,538 |
|
Restricted cash |
|
|
5,434 |
|
|
|
5,690 |
|
Right-of-use assets |
|
|
1,305,970 |
|
|
|
1,422,538 |
|
Property and equipment,
net |
|
|
498,647 |
|
|
|
345,087 |
|
Intangible assets, net |
|
|
5,833,070 |
|
|
|
5,845,702 |
|
Goodwill |
|
|
625,602 |
|
|
|
625,602 |
|
Other assets |
|
|
18,334 |
|
|
|
18,334 |
|
Total
Assets |
|
$ |
13,149,572 |
|
|
$ |
19,083,491 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,756,183 |
|
|
$ |
857,311 |
|
Accrued vacation |
|
|
332,617 |
|
|
|
467,948 |
|
Accrued expenses and other current liabilities |
|
|
1,980,555 |
|
|
|
1,511,856 |
|
R&D grant liability |
|
|
151,620 |
|
|
|
780,682 |
|
Deferred revenue, current portion |
|
|
94,474 |
|
|
|
116,161 |
|
Operating lease liability, current portion |
|
|
257,155 |
|
|
|
240,645 |
|
Short term debt-related party |
|
|
965,155 |
|
|
|
950,722 |
|
Warrant liabilities |
|
|
133,500 |
|
|
|
788,100 |
|
Warrant liabilities - related party |
|
|
2,010,180 |
|
|
|
2,834,547 |
|
Convertible debt - related party |
|
|
812,419 |
|
|
|
60,197 |
|
Total current liabilities |
|
|
8,493,859 |
|
|
|
8,608,170 |
|
Operating lease liability, net
of current portion |
|
|
1,168,653 |
|
|
|
1,301,919 |
|
Deferred revenue, net of
current portion |
|
|
28,648 |
|
|
|
49,056 |
|
Deferred tax liability |
|
|
150,369 |
|
|
|
357,757 |
|
Total liabilities |
|
|
9,841,528 |
|
|
|
10,316,901 |
|
Commitments and Contingencies
(Note 12) |
|
|
- |
|
|
|
- |
|
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 June 30, 2023 and December 31,
2022, respectively |
|
|
42,952 |
|
|
|
42,110 |
|
Additional paid-in
capital |
|
|
112,554,830 |
|
|
|
110,528,050 |
|
Accumulated other
comprehensive income |
|
|
131,891 |
|
|
|
50,721 |
|
Accumulated deficit |
|
|
(110,695,598 |
) |
|
|
(103,385,172 |
) |
Total Qualigen Therapeutics, Inc. stockholders’ equity |
|
|
2,034,075 |
|
|
|
7,235,709 |
|
Noncontrolling interest |
|
|
1,273,969 |
|
|
|
1,530,881 |
|
Total Stockholders’ Equity |
|
|
3,308,044 |
|
|
|
8,766,590 |
|
Total Liabilities
& Stockholders’ Equity |
|
$ |
13,149,572 |
|
|
$ |
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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