Qualigen Therapeutics, Inc. (Nasdaq: QLGN) today announces its
intention to prioritize its focus to its oncology pipeline that
includes QN-247 and RAS-F. These plans follow feedback the Company
received from the United States Food and Drug Administration
regarding Qualigen’s investigational new drug (IND) application for
one of its other compounds, QN-165, for the treatment of COVID-19
in hospitalized patients.
“Although the FDA requested that we perform
additional pre-clinical toxicity and safety pharmacology studies
before proceeding with clinical trials in COVID-19 patients, we
believe that, given the time horizon which these suggested studies
would require, coupled with the already very crowded COVID-19
vaccine and therapeutic landscape, the best and most prudent
strategy for us at this time is to pivot to focusing primarily on
our oncology pipeline that includes QN-247 and RAS-F assets for
which we have already seen encouraging preclinical data,” commented
Michael Poirier, Qualigen’s Chairman and Chief Executive Officer.
“We appreciate the FDA’s guidance regarding our approach to QN-165,
which helps us to solidify our priority to address unmet medical
needs in treating cancer patients. We look forward to sharing
ongoing progress with our shareholders.”
Qualigen also today announces its second quarter
and six-months 2021 financial results and provides a recap of the
highlights of the 2021 second quarter.
Highlights from the Quarter Ended June 30, 2021:
- Q2 revenues
increased 24 percent to $1.1 million, compared to $0.9 million in
the same quarter of the previous year
- First-half
revenues increased 28 percent to $3.0 million, compared to $2.4
million in the same six month period of the previous year
- Cash
equivalents of approximately $15.2 million at June 30, 2021
- 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 (with or without such binders) 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.
- In May 2021,
Qualigen announced that it had named Tariq Arshad, MD, MBA, to the
newly-created position of Senior Vice President, Chief Medical
Officer. Dr. Arshad brings more than 20 years of biotech and
pharmaceutical experience to Qualigen.
- In June 2021,
Qualigen announced that it was added to the Russell Microcap®
Index. Membership in the Russell Microcap Index means automatic
inclusion in certain growth and value indexes. FTSE Russell
determines membership for its indexes primarily by objective,
market-capitalization rankings as well as style attributes.
Second Quarter and Six Month
Financial Highlights and
Analysis
Revenues for the three months ended June 30,
2021 were $1.1 million compared to approximately $0.9 million in
the same quarter of the previous year. Our 2021 second quarter
revenues were all generated from sales of diagnostic tests. This
product sales improvement was due to a recovery from the effects of
the COVID-19 pandemic.
Revenues for the six month period ended June 30,
2021 were $3.0 million compared to $2.4 million in the same six
month period of the previous year. This increase primarily resulted
from the recognition during the first quarter of license revenue
from Yi Xin Zhen Duan Jishu (Suzhou) Ltd. under a Technology
Transfer Agreement, an item which had no counterpart during the
prior year, as well as an increase in diagnostic product sales
reflecting recovery from the effects of the COVID-19 pandemic.
For the three months ended June 30, 2021, we
reported a net loss of $5.3 million, or $0.18 per share, compared
to a net loss of $18.6 million, or $2.12 per share, for the
corresponding period in 2020. Net loss for the three month 2020
period included non-cash charges of $16.2 million related to a
change in fair value of warrant liabilities, compared to a non-cash
gain of $2.1 million from change in fair value of warrant
liabilities in the current three month period.
For the six months ended June 30, 2021, the
Company reported a net loss of $9.0 million, or $0.31 per share,
compared to a net loss of $19.5 million, or $2.71 per share, in the
corresponding six month period in 2020. Net loss for the six month
2020 period included non-cash charges of $16.2 million related to a
change in fair value of warrant liabilities, compared to a non-cash
gain of $4.2 million from change in fair value of warrant
liabilities in the current six month period.
License revenue during the six months ended June
30, 2021 was approximately $0.5 million, because of the recognition
of license revenue from the Yi Xin transaction.
Research and development expenses increased to
$4.5 million for the three months ended June 30, 2021, from $0.6
million for the three months ended June 30, 2020. This increase was
primarily attributable to $3.4 million in expenses related to the
potential application of QN-165 to treatment of COVID-19 during the
quarter. Research and development expenses increased to $8.0
million for the six months ended June 30, 2021 from $0.8 million
for the six months ended June 30, 2020. This increase was primarily
due to $5.9 million in expenses related to the potential
application of QN-165 to treatment of COVID-19, in addition to
increased pre-clinical research and development costs for QN-247
and RAS as well as wind-down costs related to the withdrawn
COVID-19 antibody diagnostic test and stock-based compensation
expense related to our public-company status.
General and administrative expenses increased to
$3.0 million during the three months ended June 30, 2021, from $2.0
million during the three months ended June 30, 2020. General and
administrative expenses increased to $5.8 million for the six
months ended June 30, 2021, compared to $2.9 million during the six
months ended June 30, 2020. The increases for both periods were
primarily a result of overhead expenses related to our
public-company status in contrast to our private-company status
during most of the 2020 periods.
As of June 30, 2021, we had $15.2 million of
cash and cash equivalents.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc.’s cancer
therapeutics pipeline includes QN-247, RAS-F, and STARS. QN-247
(formerly referred to as ALAN) 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, is also a drug candidate for viral-based
infectious diseases. (QN-165 was formerly referred to as AS1411.)
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.
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
preclinical or clinical development of the Company's drugs
(including QN-247 and RAS-F, and deprioritized infectious-disease
programs such as QN-165) or therapeutic devices will be completed
on any projected timeline or will be successful; that the FDA will
approve any of the Company’s IND applications; that any 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 (including QN-247 and RAS-F) or therapeutic
devices; 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 (including 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 current
owned and inlicensed 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 (including QN-247 and RAS-F, and
any repositioning of QN-165); or that the Company will be able to
maintain or expand market demand and/or market share for the
Company's diagnostic products. 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
Form 10-K, all of which 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
KugelmanAtlanta Capital Partners, LLC(404) 856-9157 or (866)
692-6847 Toll Free - U.S. & Canadadk@atlcp.com
Tony SchorInvestor Awareness, Inc.(847)
971-0922tony@investorawareness.com
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited)
|
|
For the Three MonthsEnded June
30, |
|
|
For the Six MonthsEnded June
30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
1,117,935 |
|
|
$ |
904,067 |
|
|
$ |
2,538,776 |
|
|
$ |
2,315,823 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
478,654 |
|
|
|
— |
|
Collaborative research revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
45,000 |
|
Total revenues |
|
|
1,117,935 |
|
|
|
904,067 |
|
|
|
3,017,430 |
|
|
|
2,360,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
916,624 |
|
|
|
807,922 |
|
|
|
2,119,103 |
|
|
|
1,799,574 |
|
General and administrative |
|
|
2,952,100 |
|
|
|
1,979,614 |
|
|
|
5,826,038 |
|
|
|
2,897,993 |
|
Research and development |
|
|
4,508,466 |
|
|
|
597,345 |
|
|
|
8,007,840 |
|
|
|
835,403 |
|
Sales and marketing |
|
|
135,543 |
|
|
|
88,844 |
|
|
|
272,129 |
|
|
|
181,106 |
|
Total expenses |
|
|
8,512,733 |
|
|
|
3,473,725 |
|
|
|
16,225,110 |
|
|
|
5,714,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
|
(7,394,798 |
) |
|
|
(2,569,658 |
) |
|
|
(13,207,680 |
) |
|
|
(3,353,253 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER (INCOME)
EXPENSE, NET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (gain) on change in fair value of warrant liabilities |
|
|
(2,075,100 |
) |
|
|
16,201,400 |
|
|
|
(4,198,000 |
) |
|
|
16,201,400 |
|
Interest (income) expense, net |
|
|
(12,718 |
) |
|
|
57,364 |
|
|
|
(30,061 |
) |
|
|
148,121 |
|
Other (income), net |
|
|
(2,352 |
) |
|
|
(250,114 |
) |
|
|
(2,894 |
) |
|
|
(251,272 |
) |
Total other (income) expense, net |
|
|
(2,090,170 |
) |
|
|
16,008,650 |
|
|
|
(4,230,955 |
) |
|
|
16,098,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE PROVISION
FOR INCOME TAXES |
|
|
(5,304,628 |
) |
|
|
(18,578,308 |
) |
|
|
(8,976,725 |
) |
|
|
(19,451,502 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROVISION (BENEFIT)
FOR INCOME TAXES |
|
|
605 |
|
|
|
597 |
|
|
|
1,135 |
|
|
|
(22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
$ |
(5,305,233 |
) |
|
$ |
(18,578,905 |
) |
|
$ |
(8,977,860 |
) |
|
$ |
(19,451,480 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.18 |
) |
|
$ |
(2.12 |
) |
|
$ |
(0.31 |
) |
|
$ |
(2.71 |
) |
Weighted—average number of
shares outstanding, basic and diluted |
|
|
28,850,451 |
|
|
|
8,746,250 |
|
|
|
28,510,014 |
|
|
|
7,174,233 |
|
|
QUALIGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(Unaudited)
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
15,232,402 |
|
|
$ |
23,976,570 |
|
Accounts receivable, net |
|
|
766,911 |
|
|
|
615,757 |
|
Inventory, net |
|
|
1,073,335 |
|
|
|
953,458 |
|
Prepaid expenses and other current assets |
|
|
2,033,857 |
|
|
|
2,678,894 |
|
Total current assets |
|
|
19,106,505 |
|
|
|
28,224,679 |
|
Right-of-use assets |
|
|
321,076 |
|
|
|
430,795 |
|
Property and equipment,
net |
|
|
253,261 |
|
|
|
247,323 |
|
Equipment held for lease,
net |
|
|
5,821 |
|
|
|
17,947 |
|
Intangible assets, net |
|
|
183,933 |
|
|
|
187,694 |
|
Other assets |
|
|
18,334 |
|
|
|
18,334 |
|
Total
Assets |
|
$ |
19,888,930 |
|
|
$ |
29,126,772 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
784,474 |
|
|
$ |
500,768 |
|
Accrued expenses and other current liabilities |
|
|
1,923,708 |
|
|
|
746,738 |
|
Notes payable, current portion |
|
|
— |
|
|
|
131,766 |
|
Deferred revenue, current portion |
|
|
325,988 |
|
|
|
486,031 |
|
Operating lease liability, current portion |
|
|
270,640 |
|
|
|
254,739 |
|
Warrant liabilities |
|
|
4,112,100 |
|
|
|
8,310,100 |
|
Total current liabilities |
|
|
7,416,910 |
|
|
|
10,430,142 |
|
Notes payable, net of current
portion |
|
|
— |
|
|
|
6,973 |
|
Operating lease liability, net
of current portion |
|
|
98,145 |
|
|
|
236,826 |
|
Deferred revenue, net of
current portion |
|
|
112,057 |
|
|
|
158,271 |
|
Total liabilities |
|
|
7,627,112 |
|
|
|
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 June 30, 2021 and December 31,
2020 |
|
|
1 |
|
|
|
1 |
|
Common stock, $0.001 par
value; 225,000,000 shares authorized; 28,902,188 and 27,296,061
shares issued and outstanding as of June 30, 2021 and December 31,
2020, respectively |
|
|
28,902 |
|
|
|
27,296 |
|
Additional paid-in
capital |
|
|
88,058,267 |
|
|
|
85,114,755 |
|
Accumulated deficit |
|
|
(75,825,352 |
) |
|
|
(66,847,492 |
) |
Total stockholders’
equity |
|
|
12,261,818 |
|
|
|
18,294,560 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
19,888,930 |
|
|
$ |
29,126,772 |
|
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