--Company Highlights Development Timelines
for Product Candidates--
Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company")
(NASDAQ:VRPX) a company specializing in developing non-addictive
product candidates for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and viral barrier
indications, today announced its financial results for the quarter
ended September 30, 2022, and other recent developments.
“I believe that Virpax has made good progress this past year
toward our stated goals,” commented Anthony P. Mack, Chairman and
CEO of Virpax. “Our accomplishments include ongoing development of
our existing product candidates, broadening our product pipeline,
utilizing grants where appropriate, and assessing the potential of
our product candidates for partnering with pharmaceutical companies
in the animal health market. We recently separated our pipeline
into Rx products that we intend to develop and commercialize in the
U.S., and over-the-counter (OTC) products that we expect to license
out or partner with a company that specializes in the OTC
marketplace.
“From a financial perspective, we are judiciously managing our
cash and expect to have sufficient funds to advance our programs
for at least 12 months from the filing of our Form 10-Q for the
period ended September 30, 2022, exclusive of any potential future
grants, Cooperative Research and Development Agreements (CRADAs) or
licensing fees we may pursue, if appropriate. We have global rights
for all of our product candidates and therefore we believe there
are opportunities to pursue ex-U.S. companies for potential
licensing deals.
“While we recently filed an S-3 shelf registration statement
with the SEC, this filing was done to ensure financial flexibility.
Our focus remains on our strategy of raising non-dilutive financing
to progress our clinical pipeline,” continued Mr. Mack.
“We have an enthusiastic and committed team, numerous ongoing
preclinical trials, and are actively moving our product candidates
forward with the possibility of starting human clinical trials
sometime in 2023,” concluded Mr. Mack.
Rx Pipeline
Probudur™
Probudur is an injectable bupivacaine liposomal hydrogel for
postoperative pain management which Virpax believes has improved
onset and extended duration of action compared to existing
treatment options. The Company engaged Charles River Laboratories
to perform preclinical animal studies as part of required FDA
investigational new drug (IND) enabling trials. Virpax
strategically delayed the start of these trials in order to improve
the formulation to potentially enhance manufacturing efficiencies,
prolong duration and extend patent protection. The Company
anticipates the relevant patent to be filed during the first half
of 2023. Additionally, Lipocure, from whom the Company licenses the
unique bupivacaine liposome hydrogel, is in the process of scaling
up production of the enhanced formulation in anticipation of
starting IND-enabling studies in the third quarter of 2023.
In addition, Virpax entered into a CRADA with the U.S. Army
Institute of Surgery (USAISR) in April of 2022. The research
project will evaluate the analgesic and physiological effects of
Probudur for battlefield injury induced pain as a long-lasting
local anesthetic for use in battlefield trauma and critical
care.
Envelta™
Envelta is an endogenous enkephalin intranasal spray for acute
and chronic pain, including pain associated with cancer. This
product leverages Nanomerics’ Molecular Envelope Technology (MET)
platform, which Virpax licensed, to deliver the endogenous
enkephalin formulation through an intranasal delivery device
enabling the enkephalin to cross the blood-brain barrier via the
olfactory route while bypassing the liver. This product candidate
is being funded through an in-kind CRADA with the National
Institutes of Health's (NIH) National Center for Advancing
Translational Sciences (NCATS) entered into by Virpax and the NIH
in August of 2020.
To date, four in vitro studies have been completed along with an
in vivo acute efficacy study. Two dose range finding studies in
rats and dogs have also been successfully completed with no adverse
toxicologic findings. In vivo chronic efficacy studies are being
planned and it is expected that they will be completed in the first
quarter of 2023.
In addition to the ongoing studies, NCATS in collaboration with
Virpax is working on the necessary preclinical manufacturing work
and NCATS is working with its manufacturer on scaling up production
of Envelta with expected completion in the second half of 2023. An
IND filing of Envelta is currently anticipated for the first
quarter of 2024.
VRP324
Virpax has acquired the exclusive worldwide rights from
Nanomerics to use Nanomerics’ MET platform for the nasal delivery
of cannabidiol (CBD) for the management of epilepsy in children (a
rare pediatric disease) and adults. As part of this agreement,
Nanomerics is developing an investigational formulation delivered
via the nasal route to enhance CBD transport to the brain which
could potentially eliminate any drug interaction issues and bypass
the digestive system, possibly eliminating many of the side effects
associated with the product currently in use on the market.
Nanomerics demonstrated the ability of its platform technology to
deliver CBD directly to the brain in an animal model.
Virpax prepared and submitted the pre-IND briefing documents to
the FDA in October 2022 and expects to receive a response in
December 2022.
OTC Pipeline
Epoladerm™
Epoladerm is a diclofenac topical spray film that is being
developed as an OTC product candidate for pain associated with
osteoarthritis of the knee. In December of 2021, the Company
executed a clinical trial agreement with Altasciences Company, Inc.
to conduct a study in Canada. We have experienced delays in
initiating enrollment for this clinical study that were initially
due to a delay in procuring the active pharmaceutical ingredient
necessary for the drug product candidate and delays related to
supply chain disruptions. Additionally, we recently discovered a
degradant issue after an extensive review of the formulation.
MedPharm, from whom the Company licenses the product, is working
on a revised formulation. This work is expected to be completed in
the first quarter of 2023. Assuming a successful reformulation,
MedPharm will begin manufacturing batches of the product candidate
that Virpax expects to use in their First-in-Human study now
anticipated to begin towards the end of 2023.
AnQlar™
AnQlar (formerly MMS019) is a high-density intranasal molecular
masking spray in development as an OTC Intranasal Medical Device
product for protection against respiratory infections, such as
SARS-CoV-2 and influenza. Virpax anticipates that AnQlar will be
used as an adjuvant to barrier-based personal protective equipment.
While Virpax has successfully completed a number of required
pre-clinical studies for its OTC medical device application, the
Company anticipates that it will have to complete stability
testing, human factor testing for medical devices, safety studies
and supplementary in-vitro studies.
We may seek to out-license or partner both Epoladerm and AnQlar
as we continue to focus our efforts on our prescription drug
pipeline.
FINANCIAL RESULTS
Three Months Ended September 30, 2022
Operating Expenses
General and administrative expenses were approximately $4.9
million for the third quarter of 2022, an increase of about $3.4
million from the prior year’s third quarter. The increase was due
to legal expenses and an accrual of an estimated litigation
liability, compensation expense, insurance costs and board of
director fees.
Research and development expenses were approximately $2.8
million in the quarter compared to approximately $1.7 million from
the prior year’s third quarter. The increase in research and
development expenses was primarily attributable to an increase in
preclinical activities for AnQlar, offset by a decrease in
preclinical work related to Probudur, a decrease in preclinical and
regulatory activities related to Epoladerm, a decrease in VRP324
mainly due to a milestone payment paid to Nanomerics in the prior
period and a slight decrease in regulatory activities related to
Envelta.
The operating loss for the third quarter of 2022 was
approximately $7.7 million, as compared to $3.2 million for the
same period a year ago.
Nine Months Ended September 30, 2022
Operating Expenses
General and administrative expenses were approximately $9.3
million for the nine months ended September 30, 2022, an increase
of about $4.5 million as compared to the nine months ended
September 30, 2021. The increase in general and administrative
costs was the result of an increase in litigation defense efforts
due to legal fees and the accrual of an estimated litigation
liability, an increase in salaries and wages and employee benefits,
an increase in insurance costs for directors’ and officers’
insurance, an increase in non-executive board compensation, and an
increase in grant writing and grant consulting fees. This was
slightly offset by a decrease in stock-based compensation.
Research and development expenses increased by approximately
$6.3 million to $9.4 million for the nine months ended September
30, 2022, from $3.1 million for the nine months ended September 30,
2021. The increase was primarily attributable to an increase in
milestone payments related to AnQlar, an increase in preclinical
activity related to AnQlar’s ongoing IND enabling studies and
regulatory consulting, increases in preclinical and regulatory
activity related to Epoladerm, an increase in preclinical work for
Probudur related to ongoing formula optimization, an increase in
VRP324 due to a milestone payment, and a slight increase in
regulatory activities related to Envelta.
Cash Flows
Operating Activities
Cash used in operations was approximately $16.3 million for the
nine months ended September 30, 2022, compared to approximately
$9.6 million for the nine months ended September 30, 2021. The
increase in cash used in operations was primarily the result of the
increase in net loss, prepaid expenses and current assets offset by
an increase in accounts payable and accrued expenses.
Financing Activities
Cash provided by financing activities was approximately $51.3
million during the nine months ended September 30, 2021,
attributable primarily due to net proceeds received from our
initial public offering in February 2021 and an underwritten public
offering in September 2021, after deducting all underwriting
discounts and offering expenses. This was slightly offset by
repayment in full of an outstanding promissory note of
approximately $0.5 million in February 2021. No financing
activities took place during the nine months ended September 30,
2022.
At September 30, 2022, the Company had cash of approximately
$20.6 million.
About Virpax Pharmaceuticals
Virpax is developing branded product candidates for
non-addictive pain management and neurological disorders using its
proprietary technologies that optimize and target drug delivery.
Virpax is initially seeking FDA approval of its three different
patented drug delivery platforms. Epoladerm™ is a topical
diclofenac spray film formulation being developed to manage pain
associated with osteoarthritis of the knee. Probudur™ is a single
injection long-acting liposomal bupivacaine formulation being
developed to manage post-operative pain. Envelta™ is an intranasal
Molecular Envelope Technology (MET) enkephalin formulation being
developed for the management of acute and chronic pain, including
pain associated with cancer, as well as post-traumatic stress
disorder (PTSD) under the name PES200. MET technology is also used
in AnQlar™, a candidate to inhibit viral replication caused by
influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a
product candidate for the nasal delivery of a pharmaceutical-grade
cannabidiol (CBD) for the management of epilepsy in children (a
rare pediatric disease) and adults. For more information, please
visit www.virpaxpharma.com.
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. These forward-looking statements reflect
management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct or that those goals will be
achieved, and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
successfully complete research and further development and
commercialization of Company drug candidates in current or future
indications; our ability to find, and enter into transaction(s)
with, suitable counterparties with whom to partner or license our
product candidates, if we choose to do so; the uncertainties
inherent in clinical testing and accruing patients for clinical
trials; our ability to manage and successfully complete multiple
clinical trials and the research and development efforts for our
multiple product candidates at varying stages of development; the
effects of the outbreak of COVID-19 on our business and results of
operations; the availability, cost, delivery and quality of
clinical materials supplied by contract manufacturers, who may be
our sole source of supply; the timing, cost and uncertainty of
obtaining regulatory approvals; the failure of the market for the
Company's programs to continue to develop; our ability to protect
the Company's intellectual property; the loss of any executive
officers or key personnel or consultants; competition; changes in
the regulatory landscape or the imposition of regulations that may
affect the Company's product candidates; our ability to continue to
obtain capital to meet our long-term liquidity needs on acceptable
terms, or at all, including the additional capital which will be
necessary to complete the clinical trials that we have initiated or
plan 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 we file with the 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.
VIRPAX PHARMACEUTICALS,
INC.
CONDENSED BALANCE
SHEETS
September 30, 2022
December 31, 2021*
(Unaudited)
ASSETS
Current assets
Cash
$
20,562,611
$
36,841,992
Prepaid expenses and other current
assets
3,073,150
2,730,444
Total current assets
23,635,761
39,572,436
Total assets
$
23,635,761
$
39,572,436
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable and accrued expenses
$
4,207,865
$
2,087,691
Total current liabilities
4,207,865
2,087,691
Total liabilities
4,207,865
2,087,691
Commitments and contingencies
Stockholders’ equity
Preferred stock, par value $0.00001,
10,000,000 designated shares authorized, no shares issued and
outstanding
—
—
Common stock, $0.00001 par value;
100,000,000 shares authorized, 11,714,434 shares issued and
outstanding as of September 30, 2022; 11,714,885 shares issued and
outstanding as of December 31, 2021
117
117
Additional paid-in capital
60,795,293
60,188,535
Accumulated deficit
(41,367,514
)
(22,703,907
)
Total stockholders’ equity
19,427,896
37,484,745
Total liabilities and stockholders’
equity
$
23,635,761
$
39,572,436
*
Derived from audited financial
statements
VIRPAX PHARMACEUTICALS,
INC.
CONDENSED STATEMENTS OF
OPERATIONS
(UNAUDITED)
For the Three Months Ended
September 30, 2022
For the Three Months Ended
September 30, 2021
For the Nine Months Ended
September 30, 2022
For the Nine Months Ended
September 30, 2021
OPERATING EXPENSES
General and administrative
$
4,910,039
$
1,551,570
$
9,338,070
$
4,814,114
Research and development
2,805,103
1,698,204
9,404,980
3,089,769
Total operating expenses
7,715,142
3,249,774
18,743,050
7,903,883
Loss from operations
(7,715,142
)
(3,249,774
)
(18,743,050
)
(7,903,883
)
OTHER (EXPENSE) INCOME
Interest expense
-
(28,892
)
-
(93,640
)
Other income, net
73,252
62,922
79,443
59,089
Loss before tax provision
(7,641,890
)
(3,215,744
)
(18,663,607
)
(7,938,434
)
Benefit from income taxes
—
—
—
—
Net loss
$
(7,641,890
)
$
(3,215,744
)
$
(18,663,607
)
$
(7,938,434
)
Basic and diluted net loss per share
$
(0.65
)
$
(0.53
)
$
(1.59
)
$
(1.59
)
Basic and diluted weighted average common
stock outstanding
11,713,379
6,011,796
11,711,624
4,979,553
VIRPAX PHARMACEUTICALS,
INC.
CONDENSED STATEMENTS OF CASH
FLOWS
(UNAUDITED)
For the Nine Months Ended
September 30, 2022
For the Nine Months Ended
September 30, 2021
CASH FLOWS FROM OPERATING
ACTIVITIES
Net loss
$
(18,663,607
)
$
(7,938,434
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Forgiveness of PPP Loan
—
(61,816
)
Stock-based compensation
606,758
833,084
Change in operating assets and
liabilities:
Prepaid expenses and other current
assets
(342,706
)
(999,685
)
Accounts payable and accrued expenses
2,120,174
(1,453,418
)
Net cash used in operating activities
(16,279,381
)
(9,620,269
)
CASH FLOWS FROM FINANCING
ACTIVITIES
Repayment of notes payable
—
(503,764
)
Proceeds from related party notes
payable
—
100,000
Repayment of related party notes
payable
—
(1,100,000
)
Offering costs related to secondary
offering
—
(3,020,535
)
Proceeds from secondary offering of common
stock
—
40,020,000
Offering costs related to initial public
offering
—
(2,216,793
)
Proceeds from initial public offering of
common stock
—
18,000,000
Net cash provided by financing
activities
—
51,278,908
Net change in cash
(16,279,381
)
41,658,639
Cash, beginning of period
36,841,992
54,796
Cash, end of period
$
20,562,611
$
41,713,435
Supplemental disclosure of cash and
non-cash financing activities
Cash paid for interest
$
—
$
363,640
Cash paid for taxes
$
—
$
—
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109005109/en/
Christopher M. Chipman, CPA Chief Financial Officer
cchipman@virpaxpharma.com 610-727-4597 Or Investor
Relations: Betsy Brod Affinity Growth Advisors
betsy.brod@affnitygrowth.com 212-661-2231
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