CARLSBAD, Calif., Nov. 13, 2020 /PRNewswire/ -- Qualigen
Therapeutics, Inc. (Nasdaq: QLGN) announces that
Michael Poirier, President, Chief
Executive Officer and Chairman, has issued a letter to Qualigen's
stockholders. The full text is as follows:
To My Fellow Stockholders,
Since our last business update in August, Qualigen Therapeutics
has made significant progress in advancing our strategic plan,
including the following highlights:
AS1411. We are excited to be moving forward with our lead
compound AS1411, a nucleolin-targeting DNA aptamer drug candidate
for the treatment of COVID-19 and other viruses. Preclinical
research conducted at the University of
Louisville (UofL) has demonstrated that AS1411 has potent
antiviral activity against SARS-CoV-2, the coronavirus responsible
for COVID-19. Importantly, we believe AS1411 holds potential
as a broad antiviral therapeutic agent, which could significantly
expand its applications and commercial potential.
In October 2020, we received a
positive response to our Pre-Investigational New Drug (Pre-IND)
application meeting request from the U.S. Food and Drug
Administration (FDA) that is in general agreement with our planned
clinical development of AS1411 for the treatment of COVID-19. We
are pleased with the FDA's response and plan to move forward with
filing the IND application in order to initiate a Phase 2a clinical
trial in the first half of calendar year 2021.
Like everyone else, we are heartened by news of recent
advancements with COVID-19 vaccines; however, we believe there will
still be a long-term and significant market opportunity for
innovative therapies such as AS1411 to treat COVID-19 and other
viral-based respiratory diseases. Furthermore, we believe
that the urgency placed on regulators to advance potential
therapies for COVID-19, in addition to vaccines, may provide us an
accelerated path to potential approval of our first drug candidate.
The data and infrastructure resulting from this may, in turn, serve
to streamline subsequent clinical trials for additional indications
for AS1411 to combat other viruses, both currently known and those
that might affect us in the future.
In this regard, we entered into manufacturing agreements with
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec, and with
IRISYS LLC in order to ensure adequate supply of AS1411 for our
anticipated clinical trials. We believe that if AS1411 is approved
by the FDA for commercial usage, these manufacturing agreements
will help assure an efficient and large-scale rollout of this
product.
Finally, to further enhance our AS1411 intellectual property
portfolio, we jointly filed a U.S. provisional patent application
entitled "Methods of inhibiting or treating coronavirus infection,
and methods for delivering an anti-nucleolin agent" with UofL.
If AS1411 can successfully serve as a protective defense (or
prophylaxis) against, as well as treat, COVID-19 or other
viral-based diseases, such as seasonal influenza, this would be a
very exciting usage for our technology. We believe that for
use as a prophylaxis, AS1411 could be administered by means of
inhalers, nose spray or eye drops to individuals who have recently
come in contact with SARS-CoV-2, or are at high risk of contracting
the virus.
ALAN, RAS-F and STARS™. The balance of our
therapeutic pipeline primarily focuses on fighting cancer, and we
continue to make progress with each of our drug and device
candidates.
- Expanded research agreement with UofL for ALAN cancer drug
candidate. In October 2020,
we announced an amended sponsored research agreement with UofL
to advance ALAN (the AS1411 aptamer attached to a gold
nanoparticle). UofL will perform preclinical studies on acute
myeloid leukemia and we aim to file an IND and initiate a Phase 1
clinical trial later in calendar year 2021. Additionally, UofL
will perform studies on other indications including glioblastoma, a
malignant brain cancer that is difficult to treat because most
drugs cannot pass the blood-brain membrane, and non-small cell lung
cancer, which comprises approximately 85% of the 1.6 million global
lung cancer cases each year.
- Signed exclusive license agreement with UofL for RAS
interaction inhibitor drug candidates. In July 2020, we signed an exclusive worldwide
license agreement with UofL for the intellectual property covering
the RAS-F family of RAS oncogene protein-protein interaction
inhibitor small molecule drug candidates. We continue to work with
UofL to evaluate these compounds and identify a lead drug candidate
to stop tumor growth, especially in pancreatic, colorectal and lung
cancers. Although drugs that target downstream signaling of
RAS are available, they have shown limited clinical activity, most
likely because RAS acts like a hub that activates multiple
effectors. As such, blocking any single pathway, or even two,
typically provides disappointing clinical effect. By contrast, the
intended mechanism of action for the RAS-F small molecules is to
inhibit or block the binding of mutated RAS to their effector
proteins, thereby leaving the proteins from mutated RAS unable to
cause further harm.
- Issuance of STARS technology U.S. patent. In
August 2020, the United States Patent
and Trademark Office issued patent No. 10,744,258 entitled "Devices
and Methods for On-Line Whole Blood Treatment" regarding our
Selective Target Antigen Removal System (STARS) technology.
STARS is a DNA/RNA-based treatment for the removal of viral
and tumor-produced compounds from a patient's blood. While still
early in development, this technology is based on the core,
commercialized science behind our FastPack® products, and
could have widespread application.
FastPack® diagnostic products. As of the date of this
letter, communications with the FDA concerning the requested
Emergency Use Authorization for our FastPack COVID-19 antibody test
indicate that our regulatory review is still in queue. We are
confident that the data we have provided to the FDA show that our
test meets or exceeds the efficacy guidelines for approval of an
EUA, and we are frustrated by the unusually long delay. We
still believe that a rapid, accurate, point-of-care testing system
like FastPack would be beneficial as vaccines for COVID-19 – which
generate antibodies for limited periods of time – begin release in
2021.
Furthermore, we have made important strategic moves recently to
advance distribution and next-generation versions of our core
FastPack "laboratory in a pouch" technology. In October 2020, we entered into a commercialization
agreement with China's
Yi Xin Zhen Duan Jishu (Suzhou) Ltd.
for them to develop, manufacture and sell new generations of
diagnostic test systems based on FastPack. In addition,
Yi Xin Zhen Duan Jishu will have
rights to manufacture and sell our current generations of FastPack
products in China. We were pleased to enter this agreement as
it provides non-dilutive upfront funding plus potential future
royalties, and China is a region
we would not otherwise have entered with FastPack.
Corporate updates. In August 2020, we welcomed
Amy Broidrick to our Board of
Directors. Ms. Broidrick's background includes key
roles in the successful worldwide launches and marketing of such
notable drugs as VYTORIN®, Zetia® and
Celebrex®. It is already evident she will be a valuable
asset to Qualigen given her expertise in corporate
development, marketing and business innovation with global
organizations, as well as with small-cap companies.
Lastly, to fund the continued development of our pipeline, we
raised $18 million in two
registered-direct offerings under separate purchase agreements in
July and August 2020. With a cash balance of $14.5 million as of September 30, 2020, we believe Qualigen has the
necessary capital to fund our clinical trial for AS1411 and to
advance our pipeline through calendar year 2021.
Additionally, we continue to be opportunistic and evaluate
strategic relationships that provide potential to enhance our
pipeline in oncology and build long-term shareholder
value.
As I mentioned, we are delighted with our progress to date and
are very excited about our momentum and Qualigen's future
prospects. I would like to thank our employees for their
outstanding efforts and commitment, and our investors for their
continued support.
Sincerely,
Michael Poirier
President, Chief Executive Officer and Chairman
Financial Results for the Fiscal Second Quarter Ended
September 30, 2020
Total revenues for the three months ended September 30, 2020 were $0.8 million compared with $1.2 million for the same period in 2019, with
all revenues in both periods derived from the sale of diagnostic
products. The decrease was primarily due to fewer tests performed
as the COVID-19 pandemic resulted in a decrease in patient
non-emergency visits to physician offices, clinics and small
hospitals.
General and administrative expense was $2.7 million for the three months ended
September 30, 2020 compared with
$0.2 million for the prior-year
period. The difference is largely attributable to the addition of
expenses associated with operating as a publicly traded company in
the current period.
Research and development expense was $0.9
million for the three months ended September 30, 2020 compared with $0.2 million for the prior-year period. The
increase is related to advancing Qualigen's therapeutic pipeline
and work on its COVID-19 antibody diagnostic test and FastPack PRO
instrument.
Loss from operations for the three months ended September 30, 2020 increased to $3.7 million from $0.3
million for the prior-year period. Net loss for the
three months ended September 30, 2020
was $8.1 million, or $0.41 per share, compared with a net loss of
$0.4 million, or $0.06 per share, for the same period of
2019. Net loss for the 2020 period included non-cash charges
of $4.4 million related to the change
in fair value of warrant liabilities, as well as additional
non-cash charges totaling $1.2
million for stock-based compensation expense.
Financial Results for the Six Months Ended September 30, 2020
Total revenues for the six months ended September 30, 2020 were $1.7 million compared with $2.7 million for the same period in 2019, with
all revenues in both periods derived from the sale of diagnostic
products. The decrease was primarily due to fewer tests performed
as the COVID-19 pandemic resulted in a decrease in patient
non-emergency visits to physician offices, clinics and small
hospitals.
General and administrative expense was $4.6 million for the six months ended
September 30, 2020 compared with
$0.5 million for the prior-year
period. The increase is largely attributable to the addition of
expenses associated with operating as a publicly traded company in
the current period.
Research and development expense was $1.5
million for the six months ended September 30, 2020 compared with $0.9 million for the prior-year period. The
difference is primarily related to increased spending for the
therapeutic pipeline.
Loss from operations for the six months ended September 30, 2020 increased to $6.3 million from $0.8
million for the prior-year period. Net loss for the
six months ended September 30, 2020
was $26.7 million, or $1.87 per share, compared with a net loss of
$1.0 million, or $0.17 per share, for the same period of
2019. Net loss for the 2020 period included non-cash charges
of $20.6 million related to the
change in fair value of warrant liabilities, as well as additional
non-cash charges totaling $1.6
million for stock-based compensation expense.
Qualigen had cash and cash equivalents of $14.5 million as of September 30, 2020, as a result of the
$18 million in gross proceeds raised
during the second quarter of fiscal year 2021. The Company believes
its cash and cash equivalents are sufficient to fund its
anticipated operations through calendar year 2021.
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 almost 20 years. The Company's cancer therapeutics
pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN
(AS1411-GNP) is a DNA coated gold nanoparticle cancer drug
candidate that has the potential to target various types of cancer
with minimal side effects. The foundational nucleolin-targeting DNA
aptamer of ALAN, AS1411, is also being studied as a drug
candidate for use in treating COVID-19 and other viral-based
infectious diseases. 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, vitamin D status and antibodies against SARS-CoV-2.
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 potential future development, testing,
efficacy, approval, manufacturing and commercialization of product
candidates, including the possible effectiveness of AS1411 against
COVID-19 or other viral infections. 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; 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; that adoption
and placement of FastPack PRO System instruments (which are the
only FastPack instruments on which the Company's SARS-CoV-2
IgG test kits can be run) will be widespread; that the Company
will be able to manufacture the FastPack PRO System instruments and
SARS-CoV-2 IgG test kits successfully; that any
commercialization of the FastPack PRO System instruments and
SARS-CoV-2 IgG test kits will be profitable; or that the FDA
will ultimately approve an Emergency Use Authorization for the
Company's SARS-CoV-2 IgG test. 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.
—Tables to Follow—
QUALIGEN
THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
|
|
|
|
For the Three
Months Ended
September
30,
|
|
|
For the Six Months
Ended
September
30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
REVENUES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
|
$
|
361,218
|
|
|
$
|
526,865
|
|
|
$
|
845,641
|
|
|
$
|
1,087,516
|
|
Net product
sales—related party
|
|
|
476,496
|
|
|
|
634,262
|
|
|
|
896,140
|
|
|
|
1,584,446
|
|
Collaborative
research revenue
|
|
|
—
|
|
|
|
40,000
|
|
|
|
—
|
|
|
|
40,000
|
|
Total
revenues
|
|
|
837,714
|
|
|
|
1,201,127
|
|
|
|
1,741,781
|
|
|
|
2,711,962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
|
318,460
|
|
|
|
408,203
|
|
|
|
673,887
|
|
|
|
724,716
|
|
Cost of product
sales—related party
|
|
|
603,015
|
|
|
|
603,890
|
|
|
|
1,055,510
|
|
|
|
1,265,157
|
|
General and
administrative
|
|
|
2,664,658
|
|
|
|
202,679
|
|
|
|
4,644,272
|
|
|
|
471,696
|
|
Research and
development
|
|
|
870,876
|
|
|
|
200,217
|
|
|
|
1,468,221
|
|
|
|
347,858
|
|
Research and
development—related party
|
|
|
—
|
|
|
|
1,193
|
|
|
|
—
|
|
|
|
540,618
|
|
Sales and
marketing
|
|
|
98,045
|
|
|
|
74,518
|
|
|
|
186,889
|
|
|
|
176,912
|
|
Total
expenses
|
|
|
4,555,054
|
|
|
|
1,490,700
|
|
|
|
8,028,779
|
|
|
|
3,526,957
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS
|
|
|
(3,717,340)
|
|
|
|
(289,573)
|
|
|
|
(6,286,998)
|
|
|
|
(814,995)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE
(INCOME), NET
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
|
|
4,395,300
|
|
|
|
—
|
|
|
|
20,596,700
|
|
|
|
—
|
|
Interest expense,
net
|
|
|
715
|
|
|
|
65,480
|
|
|
|
58,079
|
|
|
|
135,465
|
|
Other income,
net
|
|
|
(2,447)
|
|
|
|
(248)
|
|
|
|
(252,561)
|
|
|
|
(1,240)
|
|
Total other expense
(income), net
|
|
|
4,393,568
|
|
|
|
65,232
|
|
|
|
20,402,218
|
|
|
|
134,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE
PROVISION FOR INCOME TAXES
|
|
|
(8,110,908)
|
|
|
|
(354,805)
|
|
|
|
(26,689,216)
|
|
|
|
(949,220)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROVISION FOR
INCOME TAXES
|
|
|
2,305
|
|
|
|
1,420
|
|
|
|
2,902
|
|
|
|
1,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
|
(8,113,213)
|
|
|
|
(356,225)
|
|
|
|
(26,692,118)
|
|
|
|
(950,790)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.41)
|
|
|
$
|
(0.06)
|
|
|
$
|
(1.87)
|
|
|
$
|
(0.17)
|
|
Weighted—average
number of shares outstanding, basic and diluted
|
|
|
19,799,468
|
|
|
|
5,602,214
|
|
|
|
14,303,058
|
|
|
|
5,602,214
|
|
QUALIGEN
THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (Unaudited)
|
|
|
|
September 30,
2020
|
|
|
March 31,
2020
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
14,465,541
|
|
|
$
|
153,121
|
|
Accounts receivable,
net
|
|
|
179,870
|
|
|
|
417,122
|
|
Accounts receivable —
related party, net
|
|
|
189,474
|
|
|
|
290,180
|
|
Inventory,
net
|
|
|
805,383
|
|
|
|
660,138
|
|
Prepaid expenses and
other current assets
|
|
|
1,925,446
|
|
|
|
98,385
|
|
Total current
assets
|
|
|
17,565,714
|
|
|
|
1,618,946
|
|
Right-of-use
asset
|
|
|
483,643
|
|
|
|
—
|
|
Property and
equipment, net
|
|
|
1,565,275
|
|
|
|
1,447,514
|
|
Equipment held for
lease, net
|
|
|
32,726
|
|
|
|
64,005
|
|
Intangible assets,
net
|
|
|
1,009,453
|
|
|
|
571,270
|
|
Other
assets
|
|
|
18,334
|
|
|
|
18,279
|
|
Total
Assets
|
|
$
|
20,675,145
|
|
|
$
|
3,720,014
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
408,254
|
|
|
$
|
879,264
|
|
Accrued expenses and
other current liabilities
|
|
|
726,542
|
|
|
|
1,243,764
|
|
Notes payable,
current portion
|
|
|
787,478
|
|
|
|
1,913,255
|
|
Deferred revenue,
current portion
|
|
|
58,773
|
|
|
|
105,416
|
|
Deferred revenue —
related party
|
|
|
95,160
|
|
|
|
271,206
|
|
Due to related
party
|
|
|
176,046
|
|
|
|
926,385
|
|
Lease
liability
|
|
|
247,050
|
|
|
|
—
|
|
Warrant
liabilities
|
|
|
20,596,700
|
|
|
|
—
|
|
Total current
liabilities
|
|
|
23,096,003
|
|
|
|
5,339,290
|
|
Notes payable, net of
current portion
|
|
|
159,670
|
|
|
|
305,805
|
|
Lease liability, net
of current portion
|
|
|
303,894
|
|
|
|
—
|
|
Deferred revenue, net
of current portion
|
|
|
4,219
|
|
|
|
2,689
|
|
Total
liabilities
|
|
|
23,563,786
|
|
|
|
5,647,784
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
deficit
|
|
|
(2,888,641)
|
|
|
|
(1,927,770)
|
|
Total Liabilities
and Stockholders' Deficit
|
|
$
|
20,675,145
|
|
|
$
|
3,720,014
|
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content:http://www.prnewswire.com/news-releases/qualigen-therapeutics-issues-ceo-letter-to-stockholders-reports-on-significant-progress-and-fiscal-second-quarter-financial-results-301172676.html
SOURCE Qualigen, Inc.