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 September 30, 2023, and other recent developments.
“We recently announced results from two preclinical studies for
Probudur™, our lead product candidate for post operative pain, that
demonstrated significantly longer efficacy in animal models than
the product currently on the market today. With these solid
results, we believe we are on track to file our Investigational New
Drug (IND) Application and begin our Phase 2 trials of Probudur in
2024 upon completion of a few ongoing and planned additional
studies,” commented Anthony P. Mack, Chairman and Chief Executive
Officer of Virpax.
“Additionally, following our pre-IND meeting with the FDA, we
expect to submit an IND for Envelta™, our non-addictive pain
product candidate for acute and chronic pain, in mid-2024 and
initiate first in human trials in 2024. We are grateful for the
support and collaboration from the National Institutes of Health
(NIH) in the development of Envelta as a safe and effective
alternative for opioids and are excited to continue to advance this
program with them.”
“Earlier this year, we announced that we had hired two firms to
assist us in developing licensing opportunities for both our Rx and
OTC product candidates. We have had strong interest from potential
licensing partners and are encouraged by the current level of
activity,” continued Mr. Mack. “Finally, we have grant programs for
each of our Rx product candidates as part of our non-dilutive
funding strategy. We believe this is an important validation of our
assets and continue to pursue additional grant funding where we
believe we have a strong chance of winning the grant. Virpax
continues to make progress across the board, and we look forward to
sharing our results with all of our shareholders.”
RECENT DEVELOPMENTS
- On October 31, 2023, Virpax announced that it expects to submit
an IND for Envelta in mid-2024 following review of comments made by
the US Food and Drug Administration on the Company’s Pre-IND
submission. If successful, that would allow clinical trials to
begin by the middle of 2024. Envelta is the Company’s non-addictive
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.
- On October 12, 2023, Virpax announced that the cooperative
research and development agreement (CRADA) with the U.S. Army
Institute of Surgical Research (USAISR) to evaluate Virpax’s
Probudur™, an injectable long-acting liposomal bupivacaine
formulation that is injected at the wound site, has been extended
to September of 2024. The USASIR is the U.S. Department of
Defense’s primary laboratory for developing solutions for trauma
and critical care challenges in combat casualties.
- On October 2, 2023, the Company announced Gerald W. Bruce has
been appointed as President and CEO of Novvae™ Pharmaceuticals,
Virpax’s wholly-owned subsidiary focused solely on advancing the
Company’s OTC pipeline. Mr. Bruce has over 30 years’ experience in
the pharmaceutical and medical nutrition industries primarily in
commercial strategy, sales, and marketing.
- On September 27, 2023, Virpax announced results for two
pre-clinical Probudur™ dose escalation studies. Results from the
first study utilizing a planar incision model compared Probudur to
Exparel® and demonstrated three times longer efficacy for Probudur
than Exparel. In the second study, two different formulations at
the same dose of Probudur were compared to Exparel in rat incision
models and exhibited a four to five times longer effect than the
comparable product.
- 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 Molecular Envelope Technology (MET) for the delivery of
Enkephalin intranasally with a delivery device which propels the
formulation into nose such that the enkephalin is delivered
directly to the brain.
THIRD QUARTER 2023 FINANCIAL RESULTS
General and administrative expenses were $4.6 million for the
three months ended September 30, 2023, compared to $4.9 million for
the same period in 2022. The decrease was primarily due to lower
legal defense costs related to litigation, net of litigation
accrual, and was partially offset by an increase in salaries and
wages, board of directors’ fees, travel expenses, stock-based
compensation, and professional fees.
Research and development expenses were $1.5 million for the
three months ended September 30, 2023, compared to $2.8 million for
the same period in 2022. The decrease was primarily attributable to
decreases in preclinical activities for AnQlar, NobrXiol, and
Epoladerm. This was partially offset by an increase in preclinical
activity related to Probudur.
The operating loss for the three months ended September 30,
2023, was $6.1 million, compared to an operating loss of $7.7
million for the same period in 2022.
As of September 30, 2023, cash and cash equivalents were $12.2
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: AnQlar™, 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
being on track to file an Investigational New Drug (IND)
Application and begin Phase 2 trials of Probudur in 2024 upon
completion of a few ongoing and planned additional studies,
submitting an IND for Envelta in mid-2024 and initiating first in
human trials in 2024, pursuing additional grant funding where the
Company believes it has a strong chance of winning the grant and
continuing to make progress across the board. 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; 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
September 30, 2023
December 31, 2022
(Unaudited)
(Audited)
ASSETS
Current assets
Cash
$
12,152,993
$
18,995,284
Prepaid expenses and other current
assets
885,394
678,365
Total current assets
13,038,387
19,673,649
Total assets
$
13,038,387
$
19,673,649
LIABILITIES AND STOCKHOLDERS'
DEFICIT
Current liabilities
Accounts payable and accrued expenses
$
1,532,723
$
1,094,590
Estimated litigation liability
5,000,000
2,000,000
Total current liabilities
6,532,723
3,094,590
Total liabilities
6,532,723
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 September 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 September 30, 2023 and December 31, 2022
117
117
Additional paid-in capital
61,487,973
60,933,569
Accumulated deficit
(54,982,426
)
(44,354,627
)
Total stockholders' equity
6,505,664
16,579,059
Total liabilities and stockholders'
equity
$
13,038,387
$
19,673,649
CONDENSED STATEMENTS OF
OPERATIONS (UNAUDITED)
For the Three Months
Ended
September 30,
For the Nine Months
Ended
September 30,
2023
2022
2023
2022
OPERATING EXPENSES
General and administrative (net of
insurance reimbursement of $0 and $1,250,000 during the three and
nine months ended September 30, 2023 - See Note 5)
$
4,619,519
$
4,910,039
$
6,983,670
$
9,338,070
Research and development
1,495,619
2,805,103
4,022,020
9,404,980
Total operating expenses
6,115,138
7,715,142
11,005,690
18,743,050
Loss from operations
(6,115,138
)
(7,715,142
)
(11,005,690
)
(18,743,050
)
OTHER INCOME
Other income
120,640
73,252
377,891
79,443
Loss before income taxes
(5,994,498
)
(7,641,890
)
(10,627,799
)
(18,663,607
)
Income taxes
—
—
—
—
Net loss
$
(5,994,498
)
$
(7,641,890
)
$
(10,627,799
)
$
(18,663,607
)
Basic and diluted net loss per share
$
(0.51
)
$
(0.65
)
$
(0.91
)
$
(1.59
)
Basic and diluted weighted average common
stock outstanding
11,714,284
11,713,379
11,714,284
11,711,624
CONDENSED STATEMENTS OF CASH
FLOWS
(UNAUDITED)
For the Nine Months
Ended
September 30,
2023
2022
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(10,627,799
)
$
(18,663,607
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
554,404
606,758
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
(207,029
)
(342,706
)
Accounts payable and accrued expenses
438,133
2,120,174
Estimated litigation liability
3,000,000
—
Net cash used in operating activities
(6,842,291
)
(16,279,381
)
Net change in cash
(6,842,291
)
(16,279,381
)
Cash, beginning of year
18,995,284
36,841,992
Cash, end of year
$
12,152,993
$
20,562,611
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231115457375/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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