Virpax® Pharmaceuticals, Inc. (“Virpax” or the
“Company”) (NASDAQ: VRPX), a company specializing in developing
non-addictive products for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and viral barrier
indications, today announced its financial results for the three
months ended June 30, 2023, and other recent developments.
“In the second quarter, we continued to make progress with our
Rx product candidates,” commented Anthony P. Mack, Chairman and
Chief Executive Officer of Virpax. “As well, we strengthened the
organization with the appointment of a new Chief Financial Officer
(CFO), who aside from his experience with public biotech companies
has a broad financial background encompassing licensing, M&A
and fund raising. Additionally, we added a leading expert in
liposomal drug delivery and nanotechnology to support the
advancement of our leading product candidate, Probudur™. I am proud
of the high caliber talent that we have attracted to Virpax,
joining us as we develop our pipeline of innovative drug
candidates.”
“We successfully won another competitive cooperative research
and development agreement (CRADA). This one is for our NobrXiol™
product candidate which is being designed to identify novel agents
to meet unmet medical needs in epilepsy. We now have CRADA’s for
all three of our Rx product candidates, two with the National
Institutes of Health (NIH) and one with the Department of Defense
(DOD). These successes reinforce our non-dilutive grant funding
strategy and demonstrate how Virpax has been able to develop a team
to support this effort.”
“In May, our grants core team participated in the virtual CB
Tech Watch Seminar showcasing our Molecular Envelope Technology
(MET) and our over-the-counter (OTC) AnQlar™ product candidate for
viral inhibition. Participating in this event were representatives
of a number of Federal agencies including Defense Advanced Research
Products Agency (DARPA), Defense Threat Reduction Agency (DTRA),
and the U.S. Army and Navy among others. This was an excellent
opportunity for us to introduce Virpax to these groups, and we
expect it to be beneficial as we continue to apply for grant
funding from the DOD.”
“Finally, as we enter the second half of 2023, we anticipate
reporting results from additional pre-IND studies in advance of
entering the clinic in 2024, initiating studies for our Probudur
and NobrXiol CRADAs by year end, submitting additional grant
applications and potentially monetizing our OTC product
candidates,” concluded Mr. Mack.
RECENT DEVELOPMENTS
- On August 10, 2023, Virpax announced that it filed a new
provisional patent application with the United States Patent and
Trademark Office (USPTO) entitled “NSAID Formulation and Method”
related to its Epoladerm™ product candidate. Epoladerm is an
over-the-counter diclofenac topical spray film that the Company is
developing for pain associated with Osteoarthritis.
- On July 24, 2023, Virpax rang the Nasdaq closing bell.
- On July 13, 2023, Virpax announced that it had filed a new
provisional patent application with the USPTO entitled “Intranasal
Delivery” related to its Envelta™ product candidate. Envelta
utilizes MET for the delivery of Enkephalin intranasally for severe
cancer pain and non-cancer pain. The enkephalin/MET formulation is
delivered using a delivery device which propels the formulation
into nose such that the enkephalin is delivered to the brain.
- On June 21, 2023, Virpax announced that it has entered into a
CRADA with the National Institute of Neurological Disorders and
Stroke (NINDS), part of the U.S. NIH Division of Translational
Research which conducts and funds research on brain and nervous
system disorders. Virpax will be partnering with the Epilepsy
Therapy Screening Program (ETSP) whose mission is to identify novel
agents to address unmet medical needs in epilepsy, including the
identification of next generation products focused on addressing
drug resistant epilepsy, disease prevention and modification. Under
the CRADA, NINDS ETSP will evaluate Virpax’s NobrXiol™ product
candidate that is being developed for the management of rare
pediatric epilepsy.
- On June 20, 2023, Virpax announced the appointment of Vinay
Shah as Chief Financial Officer. Mr. Shah joins Virpax from
Aravive, Inc., a clinical stage biotech company, where he served
for five years as the CFO. Prior to Aravive, he was with Pacira
Pharmaceuticals, Inc. for nine years in financial positions of
increasing responsibilities. Mr. Shah has over 30 years of
financial experience, successfully establishing financial
functions, participating in licensing and M&A transactions, and
engaging in fund raising activities.
- On May 10, 2023, Virpax announced that it had been invited to
present its MET, as well as its AnQlar™ product candidate for viral
inhibition that utilizes MET, at the June 8, 2023, virtual CB Tech
Watch Seminar. CB Tech Watch Seminar is a forum for companies to
highlight their science and technology to agencies within the DOD
as well as other Federal agencies and military branches.
- On April 27, 2023, Virpax announced that it has engaged Dr.
Pardeep Gupta, a leading expert in liposomal drug delivery and
nanotechnology, to support the development of Probudur, Virpax’s
proprietary patented long-acting injectable liposomal bupivacaine
for postoperative pain management. Dr. Gupta’s involvement is
expected to include advising on chemistry, manufacturing and
controls (CMC), technology transfer and buildout required for the
commercialization of Probudur.
- On April 5, 2023, Virpax announced the successful completion of
dose ranging studies for rats and dogs in its Envelta™ development
program. Envelta is the Company’s non-opioid pain product candidate
for acute and chronic pain that is being funded under an in-kind
grant from the National Center for Advancing Translational Sciences
(NCATS), part of the NIH.
SECOND QUARTER 2023 FINANCIAL RESULTS
General and administrative expenses were $1.9 million for the
three months ended June 30, 2023, compared to $2.6 million for the
same period in 2022. The decrease was primarily due to lower legal
defense costs related to litigation and was partially offset by an
increase in salaries and wages, severance, and fees related to
market assessment efforts.
Research and development expenses were $1.3 million for the
three months ended June 30, 2023, compared to $3.3 million for the
same period in 2022. The decrease was primarily attributable to
decreases in preclinical activities for AnQlar, NobrXiol, and
Epoladerm. This was slightly offset by an increase in preclinical
activity related to Probudur.
The operating loss for the three months ended June 30, 2023 was
$3.2 million, compared to an operating loss of $5.9 million for the
same period in 2022.
As of June 30, 2023, cash and cash equivalents were $14.8
million, compared to $19.0 million as of December 31, 2022.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
product candidates using its proprietary technologies to optimize
and target drug delivery. Virpax is initially seeking FDA approval
for two prescription drug candidates that employ two different
patented drug delivery platforms. Probudur™ is a single injection
liposomal bupivacaine formulation being developed to manage
post-operative pain and Envelta™ is an intranasal molecular
envelope enkephalin formulation being developed to manage acute and
chronic pain, including pain associated with cancer. Virpax is also
using its intranasal Molecular Envelope Technology (MET) to develop
two other product candidates. PES200 is a product candidate being
developed to manage post-traumatic stress disorder (PTSD) and
NobrXiol™ is a product candidate being developed for the nasal
delivery of a pharmaceutical-grade cannabidiol (CBD) for the
management of rare pediatric epilepsy. Virpax recently acquired
global rights to NobrXiol. Virpax is also seeking approval of two
nonprescription product candidates: AnQlarTM, which is being
developed to inhibit viral replication caused by influenza or
SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray
film formulation being developed to manage pain associated with
osteoarthritis. For more information, please visit virpaxpharma.com
and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking Statement
This press release contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private
Securities Litigation Reform Act, as amended, including those
relating to the Company's planned clinical trials, product
development, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of
operations, business strategies, potential growth opportunities and
other statements that are predictive in nature. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets
in which we operate and management's current beliefs and
assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the
negatives of those terms and include statements such as the Company
continuing to make progress with its Rx product candidates, the
virtual CB Tech Watch Seminar being beneficial as the Company
continues to apply for grant funding from the DOD, reporting
results from additional pre-IND studies in advance of entering the
clinic in 2024, initiating studies for Probudur and NobrXiol
CRADAs, submitting additional grant applications and potentially
monetizing the Company’s OTC product candidates and the benefits
anticipated from the appointment of Dr. Gupta and Mr. Shah . These
statements relate to future events or the Company’s financial
performance and involve known and unknown risks, uncertainties, and
other factors, including the Company’s ability to successfully
complete research and further development, including reporting
results from additional pre-IND studies in advance of entering the
clinic in 2024, and commercialization of Company drug candidates in
current or future indications; the Company’s ability to obtain
additional grant funding, the uncertainties inherent in clinical
testing; the Company’s ability to manage and successfully complete
clinical trials and the research and development efforts for
multiple product candidates at varying stages of development; t;
the timing, cost and uncertainty of obtaining regulatory approvals
for the Company’s product candidates; the Company’s ability to
protect its intellectual property; the loss of any executive
officers or key personnel or consultants and the ability of such
executives to make valuable contributions to the Company;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company’s product candidates; the
Company’s ability to continue to obtain capital to meet its
long-term liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete clinical
trials that the Company plans to initiate; and other factors listed
under “Risk Factors” in our annual report on Form 10-K and
quarterly reports on Form 10-Q that the Company files with the U.S.
Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
CONDENSED BALANCE
SHEETS
June 30, 2023
December 31, 2022*
(Unaudited)
ASSETS
Current assets
Cash
$
14,804,000
$
18,995,284
Prepaid expenses and other current
assets
1,147,368
678,365
Total current assets
15,951,368
19,673,649
Total assets
$
15,951,368
$
19,673,649
LIABILITIES AND STOCKHOLDERS'
DEFICIT
Current liabilities
Accounts payable and accrued expenses
$
1,646,770
$
1,094,590
Estimated litigation liability
2,000,000
2,000,000
Total current liabilities
3,646,770
3,094,590
Total liabilities
3,646,770
3,094,590
Commitments and contingencies
Stockholders' equity
Preferred stock, par value $0.00001,
10,000,000 shares authorized; no shares issued and outstanding as
of both June 30, 2023 and December 31, 2022
—
—
Common stock, $0.00001 par value;
100,000,000 shares authorized, 11,714,284 shares issued and
outstanding as of June 30, 2023 and December 31, 2022
117
117
Additional paid-in capital
61,292,409
60,933,569
Accumulated deficit
(48,987,928
)
(44,354,627
)
Total stockholders' equity
12,304,598
16,579,059
Total liabilities and stockholders'
equity
$
15,951,368
$
19,673,649
*
Derived from audited financial
statements
CONDENSED STATEMENTS OF
OPERATIONS
(UNAUDITED)
For the Three Months Ended
June 30,
For the Six Months Ended June
30,
2023
2022
2023
2022
OPERATING EXPENSES
General and administrative (net of
insurance reimbursement of $0 and $1,250,000 during the three and
six months ended June 30, 2023 - See Note 5)
$
1,948,700
$
2,645,618
$
2,364,151
$
4,428,031
Research and development
1,290,787
3,258,471
2,526,401
6,599,877
Total operating expenses
3,239,487
5,904,089
4,890,552
11,027,908
Loss from operations
(3,239,487
)
(5,904,089
)
(4,890,552
)
(11,027,908
)
OTHER INCOME
Other income
126,720
19,374
257,251
6,191
Loss before tax provision
(3,112,767
)
(5,884,715
)
(4,633,301
)
(11,021,717
)
Income taxes
—
—
—
—
Net loss
$
(3,112,767
)
$
(5,884,715
)
$
(4,633,301
)
$
(11,021,717
)
Basic and diluted net loss per share
$
(0.27
)
$
(0.50
)
$
(0.40
)
$
(0.94
)
Basic and diluted weighted average common
stock outstanding
11,714,284
11,712,753
11,714,284
11,710,733
CONDENSED STATEMENTS OF CASH
FLOWS
(UNAUDITED)
For the Six Months Ended June
30,
2023
2022
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(4,633,301
)
$
(11,021,717
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
358,840
456,041
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
(469,003
)
(610,863
)
Accounts payable and accrued expenses
552,180
395,682
Net cash used in operating activities
(4,191,284
)
(10,780,857
)
Net change in cash
(4,191,284
)
(10,780,857
)
Cash, beginning of year
18,995,284
36,841,992
Cash, end of year
$
14,804,000
$
26,061,135
Supplemental disclosure of cash and
non-cash transactions
Cash paid for interest
$
—
$
—
Cash paid for taxes
$
—
$
—
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814071888/en/
Vinay Shah Chief Financial Officer vshah@virpaxpharma.com
610-727-4597 Or Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
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