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 twelve
months ended December 31, 2023, and other recent developments.
“We are off to a strong start in 2024 and are pleased to have
regained compliance with Nasdaq. Additionally, we have executed a
settlement agreement with the Plaintiffs, and can now focus on
developing our non-addictive product candidates for pain
management,” commented Gerald W. Bruce, Chief Executive Officer of
Virpax.
“Recently we reported the initial results from the pilot study
of Probudur™ performed by the U.S. Army Institute of Surgical
Research (USAISR). The findings were in line with our expectations
and support our earlier studies of Probudur. We are excited for the
USAISR’s next study which as planned would be a head-to-head
comparison with free bupivacaine and EXPAREL® and expect it to
start mid-year,” continued Mr. Bruce. “As of today, we are still on
track to file the IND later in 2024.”
“We are continuing to develop Envelta™, our non-addictive pain
product candidate for acute and chronic pain, with the NIH under
our NCATS in-kind grant and are making progress towards filing the
IND,” added Mr. Bruce.
“Virpax has developed a core competency in identifying, applying
for and winning government grants. We continue to apply for funding
when we believe we have a strong chance of success. Currently,
there are a number of applications that we continue to work on
while we await decisions on those that have been previously
submitted. This strategy has proven to be an excellent source of
non-dilutive funding and we will continue to pursue it.
“We are also continuing to work with our partners identifying
and evaluating sublicensing options. Together, we are making
progress with our lead pain assets in both the global animal
healthcare market as well as assessing potential geographical
opportunities.
“We expect to achieve some significant milestones this year and
look forward to sharing them. Our team is committed to the
important and potentially game-changing product candidates that are
under development, and their efforts are greatly appreciated,”
concluded Mr. Bruce.
RECENT DEVELOPMENTS
- On March 18, 2024, Virpax filed an 8K announcing that it had
regained compliance with Nasdaq’s minimum bid price
requirement.
- The litigation settlement and mutual release agreement between
the Company and Sorrento Therapeutics, Inc. (Sorrento) and Scilex
Pharmaceuticals, Inc. was approved by the United States Bankruptcy
Court for the Southern District of Texas which is overseeing the
Sorrento Bankruptcy filing. As a result, Virpax made its initial
payment under the agreement on March 18, 2024.
- On February 7, 2024, Virpax announced the initial results from
the pilot study for Probudur™ performed by the U.S. Army Institute
of Surgical Research (USAISR) under an existing Cooperative
Research and Development Agreement (CRADA). This study was designed
to determine if Probudur reduces pain behaviors in a rat model of
incisional pain. Two concentrations of Probudur were injected into
the tissue around the incision site as well as a saline solution
for the control group. Both doses of Probudur showed reduction in
incision-induced pain behaviors. The Company expects that the next
step by the USAISR would be a full powered study comparing Probudur
with free bupivacaine and EXPAREL®.
- Virpax was highlighted in a Forbes.com article on January 14,
2024, entitled, “Virpax: A Promising Stock in A Sickly Biotech
Market.” The article discussed the Company’s lead pain products as
well as mentioning grants from both the National Institutes of
Health and the Pentagon.
- On December 29, 2023, Virpax announced that at a Special
Meeting of Shareholders on December 28th, stockholders approved an
amendment to the certificate of incorporation, at the discretion of
the Board of Directors of the Company, to undertake a reverse stock
split. Subsequently, On February 27, 2024, the Company announced
that it would execute a 1-for-10 reverse stock split of its common
stock effective March 1, 2024, to regain compliance with Nasdaq’s
minimum bid price.
- On November 17, 2023, Virpax announced the resignation of
Anthony P. Mack as CEO and Chairman effective immediately. The
Board appointed Gerald W. Bruce as CEO and Dr. Eric Floyd as
Chairman.
- 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 USAISR is the U.S. Department of
Defense’s primary laboratory for developing solutions for trauma
and critical care challenges in combat casualties.
FINANCIAL RESULTS FOR THE YEARS ENDED DECEMBER 31, 2023, AND
2022
Twelve Months Ended December 31, 2023
Operating Expenses
General and administrative expenses were $10.6 million for the
year ended December 31, 2023, compared to $11.1 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,
severance, and professional fees.
Research and development expenses were $5.1 million for the year
ended December 31, 2023, compared to $10.8 million for the same
period in 2022. The decrease was primarily attributable to a
milestone payment in 2022 related to AnQlar and decreases in
preclinical activities for AnQlar, NobrXiol, and Epoladerm. This
was partially offset by an increase in preclinical activity for
Probudur.
The operating loss for the year ended December 31, 2023, was
$15.2 million, compared to an operating loss of $21.7 million for
the same period in 2022.
As of December 31, 2023, Virpax had cash of approximately $9.1
million, compared to $19.0 million as of December 31, 2022.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
products 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
one other prescription product candidate, NobrXiol™, which is being
developed for the nasal delivery of a pharmaceutical-grade
cannabidiol (CBD) for the management of rare pediatric epilepsy.
Virpax has competitive cooperative research and development
agreements (CRADAs) for two of its prescription drug candidates,
one with the National Institutes of Health (NIH) and one with the
Department of Defense (DOD). 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,” “continue,” “would” and similar expressions
and the negatives of those terms and include statements such as the
planned head-to-head comparison with free bupivacaine and EXPAREL®,
USAISR’s next study expected to start mid-year, the Company being
on track to file an Investigational New Drug (IND) Application in
2024, continuing to develop Envelta, continuing to apply for
funding, continuing to work with the Company’s partners identifying
and evaluating sublicensing options, 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
and achieving significant milestones this year. 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 starting the USAISR’s study mid year, 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 short and long-term liquidity needs
on acceptable terms, or at all, including the additional capital
which will be necessary to fulfill contractual obligations of its
settlement, continue operations and commence and 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.
CONSOLIDATED BALANCE
SHEETS
December 31, 2023
December 31, 2022
ASSETS
Current assets
Cash
$
9,141,512
$
18,995,284
Prepaid expenses and other current
assets
486,833
678,365
Total current assets
9,628,345
19,673,649
Total assets
$
9,628,345
$
19,673,649
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable and accrued expenses
$
1,694,024
$
1,094,590
Litigation liability
6,000,000
2,000,000
Total current liabilities
7,694,024
3,094,590
Total liabilities
7,694,024
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 the years ended December 31, 2023 and 2022
—
—
Common stock, $0.00001 par value;
100,000,000 shares authorized, 1,171,233 shares issued and
outstanding as of the years ended December 31, 2023 and 2022
12
12
Additional paid-in capital
61,478,444
60,933,674
Accumulated deficit
(59,544,135
)
(44,354,627
)
Total stockholders’ equity
1,934,321
16,579,059
Total liabilities and stockholders’
equity
$
9,628,345
$
19,673,649
CONSOLIDATED STATEMENTS OF
OPERATIONS
For the Year Ended December
31,
2023
2022
OPERATING EXPENSES
General and administrative (net of
insurance reimbursement of $1,250,000 during the year ended
December 31, 2023 – See Note 5)
$
10,572,181
$
11,082,463
Research and development
5,117,608
10,762,670
Total operating expenses
15,689,789
21,845,133
Loss from operations
(15,689,789
)
(21,845,133
)
OTHER INCOME
Other income
500,281
194,413
Loss before income taxes
(15,189,508
)
(21,650,720
)
Income taxes
—
—
Net loss
$
(15,189,508
)
$
(21,650,720
)
Basic and diluted net loss per share
$
(12.97
)
$
(18.49
)
Basic and diluted weighted average common
stock outstanding
1,171,233
1,171,020
CONSOLIDATED STATEMENTS OF
CASH FLOWS
For the Year Ended December
31,
2023
2022
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(15,189,508
)
$
(21,650,720
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
544,770
745,034
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
191,532
2,052,079
Accounts payable and accrued expenses
599,434
(993,101
)
Litigation liability
4,000,000
2,000,000
Net cash used in operating activities
(9,853,772
)
(17,846,708
)
Net change in cash
(9,853,772
)
(17,846,708
)
Cash, beginning of year
18,995,284
36,841,992
Cash, end of year
$
9,141,512
$
18,995,284
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version on businesswire.com: https://www.businesswire.com/news/home/20240326207993/en/
Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
Virpax Pharmaceuticals (NASDAQ:VRPX)
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