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 March 31, 2024, and other recent developments.
“We recently reported results for a Probudur™ Maximum Tolerated
Dose Study, as we continue to make steady progress in anticipation
of filing our IND. The results of this study, as expected,
confirmed our belief that a single injection of Probudur was
well-tolerated. Our studies to date continue to reaffirm our belief
that Probudur’s proprietary formulation has the potential to
provide both immediate relief as well as sustained relief at the
wound site, avoiding the need for additional free bupivacaine or an
opioid,” stated Gerald W. Bruce, CEO of Virpax Pharmaceuticals.
“Both Envelta™ which is being developed to manage acute and
chronic pain, and NobrXiol™ which is being developed for the
management of rare pediatric epilepsy, utilize our intranasal
Molecular Envelope Technology (MET) developed by Nanomerics, a
London-based private company. Nanomerics was recently awarded the
United Kingdom’s most prestigious business award, the King’s Award
for Enterprise 2024 in the innovation category. This award
recognizes Nanomerics development of MET, its active excipient
platform for Precision Medicines which has improved efficacy while
reducing side effects,” continued Mr. Bruce. “We congratulate them
for this well-deserved recognition and are pleased to be utilizing
this innovative drug delivery method for a number of our product
candidates.”
“Finally, we are advancing our product candidates while
identifying and applying for additional grants as well as pursuing
licensing opportunities and engaging in discussions with interested
parties. While there are no guarantees that we will be successful,
we are encouraged with the ongoing level of interest and activity,”
concluded Mr. Bruce.
RECENT DEVELOPMENTS
- On April 30, 2024, Virpax announced the results of Maximum
Tolerated Dose Study for Probudur. The dosing ranges were selected
based on a prior preliminary study. All doses of Probudur were
well-tolerated. There were no noteworthy effects on body weight,
clinical chemistry, hematology, or coagulation. It was also
observed that bupivacaine appears to be less toxic in the presence
of liposomes than when administrated as a free drug.
- 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.
FINANCIAL RESULTS FOR THE THREE MONTHS ENDED MARCH 31,
2024
General and administrative expenses were $1.7 million for the
three months ended March 31, 2024, compared to $0.4 million for the
same period in 2023. The primary reason for the increase in general
and administrative costs was a one-time reimbursement of legal
defense costs of $1.25 million pursuant to our directors’ and
officers’ insurance policy in the first quarter of 2023, which
offset general and administrative expenses.
Research and development expenses were $1.6 million for the
three months ended March 31, 2024, compared to $1.2 million for the
same period in 2023. The increase was primarily attributable to
$0.8 million related to preclinical activities for Probudur, our
lead asset. This was partially offset by a decrease in AnQlar
preclinical activities of $0.3 million, and a decrease in NobrXiol
preclinical activities of $0.1 million.
The operating loss for the three months ended March 31, 2024,
was $3.2 million, compared to $1.5 million for the same period in
2023.
At March 31, 2024, Virpax had cash of approximately $1.9
million.
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
continuing to make steady progress in anticipation of the Company
filing its IND for Probudur, Probudur’s proprietary formulation
having the potential to provide both immediate relief as well as
sustained relief at the wound site avoiding the need for additional
free bupivacaine or an opioid, the Company advancing its product
candidates while identifying and applying for additional grants as
well as pursuing licensing opportunities and engaging in
discussions with interested parties and the next step by the USAISR
being a full powered study comparing Probudur with free bupivacaine
and EXPAREL®. 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 file its IND Probudur as planned and successfully
complete research and further development, including
commercialization of Company drug candidates in current or future
indications; the Company’s ability to obtain additional grant
funding and pursue licensing opportunities; 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.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited)
March 31, 2024
December 31, 2023
ASSETS
Current assets
Cash
$
1,866,131
$
9,141,512
Prepaid expenses and other current
assets
1,264,276
486,833
Total current assets
3,130,407
9,628,345
Total assets
$
3,130,407
$
9,628,345
LIABILITIES AND STOCKHOLDERS' (DEFICIT)
EQUITY
Current liabilities
Accounts payable and accrued expenses
$
1,843,791
$
1,694,024
Litigation liability
2,500,000
6,000,000
Total current liabilities
4,343,791
7,694,024
Total liabilities
4,343,791
7,694,024
Commitments and contingencies
Stockholders' (deficit) equity
Preferred stock, par value $0.00001,
10,000,000 shares authorized; no shares issued and outstanding as
of March 31, 2024, and December 31, 2023
—
—
Common stock, $0.00001 par value;
100,000,000 shares authorized, 1,171,233 shares issued and
outstanding as of March 31, 2024, and December 31, 2023
12
12
Additional paid-in capital
61,551,163
61,478,444
Accumulated deficit
(62,764,559
)
(59,544,135
)
Total stockholders' (deficit) equity
(1,213,384
)
1,934,321
Total liabilities and stockholders'
(deficit) equity
$
3,130,407
$
9,628,345
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
March 31,
2024
2023
OPERATING EXPENSES
General and administrative (net of
insurance reimbursement of $1,250,000 during the three months ended
March 31, 2023)
$
1,689,182
$
415,451
Research and development
1,613,275
1,235,614
Total operating expenses
3,302,457
1,651,065
Loss from operations
(3,302,457
)
(1,651,065
)
OTHER INCOME
Other income
82,033
130,531
Loss before income taxes
(3,220,424
)
(1,520,534
)
Income taxes
—
—
Net loss
$
(3,220,424
)
$
(1,520,534
)
Basic and diluted net loss per share
$
(2.75
)
$
(1.30
)
Basic and diluted weighted average common
stock outstanding
1,171,233
1,171,233
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Three Months Ended
March 31,
2024
2023
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(3,220,424
)
$
(1,520,534
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
72,719
140,583
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
(777,443
)
(828,065
)
Accounts payable and accrued expenses
(304,184
)
199,649
Litigation liability
(3,500,000
)
—
Net cash used in operating activities
(7,729,332
)
(2,008,367
)
CASH FLOWS FROM FINANCING
ACTIVITIES
Proceeds from insurance financing
agreement
502,798
—
Payments to insurance financing
agreement
(48,847
)
—
Net cash provided by financing
activities
453,951
—
Net change in cash
(7,275,381
)
(2,008,367
)
Cash, beginning of period
9,141,512
18,995,284
Cash, end of period
$
1,866,131
$
16,986,917
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240513956936/en/
Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
Virpax Pharmaceuticals (NASDAQ:VRPX)
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