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, 2024, and other recent developments.
“After successful meetings at BIO in San Diego, we remain
encouraged by the progress we have made in advancing our product
candidates, identifying and applying for additional grants, and
engaging in discussions for licensing and other opportunities with
a steady stream of potential new partners,” stated Gerald W. Bruce,
CEO of Virpax Pharmaceuticals.
“Last month we reported positive results from a pharmacokinetics
and safety study in a Swine Model pilot study for our lead asset,
Probudur™, our long-acting liposomal bupivacaine formulation for
immediate and extended pain relief. This followed encouraging
results from our Maximum Tolerated Dose study in Sprague-Dawley
Rats that we announced at the end of April,” continued Mr. Bruce.
“We expect to announce additional results from our remaining
studies in anticipation of our first-in-human trials.”
“Additionally, we were able to secure financing and pay off the
remaining balance of our litigation settlement, removing the
overhang on our stock and finally putting this issue firmly behind
us. We also regained compliance with the minimum bid price
requirement for continued listing on Nasdaq,” concluded Mr.
Bruce.
RECENT DEVELOPMENTS
- During July 2024, Virpax received proceeds of approximately
$2.8 million from the issuance of approximately two million shares
of common stock received from investors who exercised warrants
received in the May 15th public offering.
- On July 24, Virpax announced that it had received formal notice
from the Listing Qualifications staff of The Nasdaq Stock Market
indicating that Virpax had regained compliance with the minimum bid
price requirement, one of the two Nasdaq citations received, for
continued listing on the exchange.
- On July 10, Virpax announced results for a pharmacokinetics
(PK) and safety study in a Swine Model pilot study for Probudur,
Virpax’s long-acting liposomal bupivacaine formulation injected at
a wound site to provide both immediate and extended pain relief.
Probudur was subcutaneously injected into 4 juvenile domestic pigs
at a dose of 30 mg/kg and was well-tolerated by all of the pigs and
demonstrated a long-term, slow-release profile. Histopathology was
also conducted at the injection site and Probudur was
well-tolerated by all pigs in this study.
- On July 8, Virpax announced that it closed a $2.5 million
secured loan financing from an institutional investor which enabled
the final payment of its litigation settlement. As a condition of
the financing, the Company’s Board of Directors has been
reorganized, and has been reduced to seven members from eight. Four
new board members were selected by the institutional investor and
appointed to the Board, and five former Board members resigned. The
loan was subsequently repaid in full on July 25th from proceeds of
warrants exercised by investors who participated in the Company’s
May 15th public offering.
- On June 3, 2024, Gerald W. Bruce, CEO of Virpax, delivered the
corporate presentation at the Bio International Convention in San
Diego and hosted numerous meetings with interested parties.
- On May 15, 2024, Virpax announced a public offering of
1,666,667 shares of common stock (or common stock equivalents in
lieu thereof), Series A-1 common warrants to purchase up to
1,666,667 shares of common stock, and Series A-2 common warrants to
purchase up to 1,666,667 shares of common stock, at a combined
public offering price of $1.35 per share and associated Series A-1
common warrant to purchase one share of common stock and Series A-2
common warrant to purchase one share of common stock, for aggregate
gross proceeds of approximately $2.25 million, before deducting
placement agent fees and other offering expenses. The Series A-1
and A-2 warrants have an exercise price of $1.35 per share, will be
exercisable immediately, and will expire five years and eighteen
months from the initial issuance date, respectively.
- 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.
FINANCIAL RESULTS FOR THE THREE MONTHS ENDED JUNE 30,
2024
General and administrative expenses were $1.5 million for the
three months ended June 30, 2024, compared to $1.9 million for the
same period in 2023. The primary reason for the decrease in general
and administrative costs was due to severance expense recorded for
the three months ended June 30, 2023, related to our former CFO,
which was not incurred in 2024, along with reduced stock option and
Directors and Officers insurance expense.
Research and development expenses were $2.0 million for the
three months ended June 30, 2024, compared to $1.3 million for the
same period in 2023. The increase was primarily attributable to
$1.1 million related to preclinical activities for Probudur, the
Company’s lead asset. This was partially offset by a decrease in
AnQlar and Epoladerm preclinical activities, including credit for
cancellation of a prior AnQlar contract.
The operating loss for the three months ended June 30, 2024, was
$3.5 million, compared to $3.1 million for the same period in
2023.
On June 30, 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
as that term is defined in the Private Securities Litigation Reform
Act of 1995, as amended, including those described below. 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 statement regarding announcing
additional results from our remaining studies in anticipation of
our first-in-human trials . These statements relate to future
events and involve known and unknown risks, uncertainties, and
other factors, including the Company’s ability to successfully
complete research and further development and commercialization of
Company drug candidates in current or future indications; the
Company’s ability to obtain additional grants to help fund upcoming
clinical trials; 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 Company’s ability to
maintain its Nasdaq listing and cure the stockholder’s equity
deficiency; the Company’s ability to obtain capital to meet its
current and long-term liquidity needs on acceptable terms, or at
all, including the additional capital which will be necessary to
complete studies and clinical trials that the Company plans to
initiate and other factors listed under “Risk Factors” in the
Company’s Annual Report on Form 10-K and Quarterly Reports on Form
10-Q that the Company has filed 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)
June 30, 2024
December 31, 2023
ASSETS
Current assets
Cash
$
1,870,729
$
9,141,512
Prepaid expenses and other current
assets
719,880
486,833
Total current assets
2,590,609
9,628,345
Total assets
$
2,590,609
$
9,628,345
LIABILITIES AND STOCKHOLDERS’ (DEFICIT)
EQUITY
Current liabilities
Accounts payable and accrued expenses
$
2,885,107
$
1,694,024
Litigation liability
2,500,000
6,000,000
Total current liabilities
5,385,107
7,694,024
Total liabilities
5,385,107
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 June 30, 2024, and December 31, 2023
—
—
Common stock, $0.00001 par value;
100,000,000 shares authorized, 2,837,898 shares issued and
outstanding as of June 30, 2024; and 1,171,233 shares issued and
outstanding as of December 31, 2023
28
12
Additional paid-in capital
63,420,289
61,478,444
Accumulated deficit
(66,214,815
)
(59,544,135
)
Total stockholders’ (deficit) equity
(2,794,498
)
1,934,321
Total liabilities and stockholders’
(deficit) equity
$
2,590,609
$
9,628,345
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
June 30,
For the Six Months Ended June
30,
2024
2023
2024
2023
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)
$
1,502,288
$
1,948,700
$
3,191,470
$
2,364,151
Research and development
1,956,094
1,290,787
3,569,369
2,526,401
Total operating expenses
3,458,382
3,239,487
6,760,839
4,890,552
Loss from operations
(3,458,382
)
(3,239,487
)
(6,760,839
)
(4,890,552
)
OTHER INCOME (EXPENSE)
Interest expense
(11,002
)
—
(11,002
)
—
Other income
19,128
126,720
101,161
257,251
Total other income
8,126
126,720
90,159
257,251
Net loss
$
(3,450,256
)
$
(3,112,767
)
$
(6,670,680
)
$
(4,633,301
)
Basic and diluted net loss per share
$
(1.75
)
$
(2.66
)
$
(4.24
)
$
(3.96
)
Basic and diluted weighted average common
stock outstanding
1,977,093
1,171,233
1,574,163
1,171,233
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Six Months Ended June
30,
2024
2023
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(6,670,680
)
$
(4,633,301
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation
145,229
358,840
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
(233,047
)
(469,003
)
Accounts payable and accrued expenses
885,559
552,180
Litigation liability
(3,500,000
)
—
Net cash used in operating activities
(9,372,939
)
(4,191,284
)
CASH FLOWS FROM FINANCING
ACTIVITIES
Proceeds from public offering
2,249,993
—
Payments for issuance costs
(453,368
)
—
Issuance of common stock upon exercise of
pre-funded warrants
7
—
Proceeds from insurance financing
agreement
502,798
—
Payments to insurance financing
agreement
(197,274
)
—
Net cash provided by financing
activities
2,102,156
—
Net change in cash
(7,270,783
)
(4,191,284
)
Cash, beginning of period
9,141,512
18,995,284
Cash, end of period
$
1,870,729
$
14,804,000
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version on businesswire.com: https://www.businesswire.com/news/home/20240813061007/en/
Investors Relations Contact: Betsy Brod Affinity Growth
Advisors betsy.brod@affinitygrowth.com (212) 661-2231
Media Contact: Robert Cavosi RooneyPartners
rcavosi@rooneypartners.com (646) 638-9891
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