Virpax Pharmaceuticals Reports 2022 First Quarter Results and Recent Developments
Virpax Pharmaceuticals (NASDAQ:VRPX) reported a Q1 2022 operating loss of approximately $5.1 million, up from $2.3 million in Q1 2021, driven by increased research and development expenses. Key developments include securing global rights for AnQlar and completing initial preclinical studies for VRP324, aimed at managing epilepsy-related seizures. The Company announced a cooperation agreement with the U.S. Army for Probudur, which could reduce postoperative opioid use. Cash position stands at approximately $30.8 million, with a focus on non-dilutive funding strategies.
- Secured global rights for AnQlar, expanding market potential.
- Completed initial preclinical studies for VRP324, showing potential for higher efficiency in seizure management.
- Entered a CRADA with the U.S. Army for Probudur, which may reduce opioid dependency after surgery.
- Identified distinct regulatory pathways for product candidates based on FDA guidance.
- Maintained a cash position of approximately $30.8 million, supporting ongoing development.
- Operating loss increased to approximately $5.1 million from $2.3 million year-over-year.
- Research and development expenses rose to approximately $3.3 million, indicating higher costs in product development.
-- Company Continues to Successfully Advance Product Candidates --
“We continue to make excellent progress with all of our drug product candidates,” stated
“For substantially all of our product candidates, we have identified a distinct regulatory pathway (NCE, 505(b)(2), or OTC) based on FDA pre-IND guidance. Our robust pipeline provides
“We believe that our cash position, as well as our development and regulatory strategies, may allow Virpax to advance each product candidate efficiently and cost-effectively towards an anticipated clinical trial. As an example, we expect that data from our Molecular Envelope Technology (MET) preclinical studies may be able to be used to support the development of two drug candidates. Since Envelta and VRP324 both use our MET powder formulation, we may be able to reference the same MET preclinical data for both submissions, saving us time and money.
“As mentioned in a previous announcement, assuming the Envelta IND enabling studies and Phase 1 ‘first-in-human’ studies are accepted by the FDA for an acute/chronic pain indication, the parent IND and Phase 1 data is expected to be used to cross reference to the proposed PTSD indication, eliminating the need to repeat both the preclinical and Phase I work for a second indication,” continued
“While we have now secured global rights to all of our product candidates, our intention is to commercialize any products that we are able to get approved by the FDA in the
RECENT DEVELOPMENTS
-
On
May 5, 2022 , Virpax announced a CRADA with theU.S. Army Institute of Surgical Research (USAISR), theU.S. Department of Defense’s (DOD) primary laboratory for developing solutions for trauma and critical care challenges in combat casualties, to evaluate Probudur. Probudur is being developed by Virpax to significantly reduce or eliminate the need for opioids after surgery in approved indications. In preclinical trials, Probudur has shown long duration pain control for at least 96 hours. -
On
April 26, 2022 , Virpax reported the successful completion of initial preclinical studies for VRP324, its nasal product candidate to manage seizures associated with epilepsy in children and adults. In this preclinical PK study using nasal administration in a rodent model, VRP324 was able to deliver high concentrations of cannabidiol (CBD) to the brain and confirmed that there were higher levels of CBD in the brain versus the plasma. Virpax believes that VRP324 may achieve higher efficiency via the nasal route compared to the oral CBD product currently on the market and may have negligible liver first-pass metabolism, thereby avoiding drug to drug interactions and potentially producing fewer side effects. -
On
March 22, 2022 , Virpax reported that all FDA required preclinical studies for EpoladermTM have been completed. Virpax is drafting FDA IND submission documents for Epoladerm that will include these preclinical studies. -
On
March 15, 2022 , Virpax announced that it expanded its exclusive agreement withNanomerics Ltd. for AnQlar, its anti-viral product candidate, to include worldwide rights (an expansion from North American rights only).
FINANCIAL RESULTS FOR THE THREE MONTHS ENDED
Operating Expenses
General and administrative expenses were approximately
Research and development expenses were approximately
The operating loss for the first quarter of 2022 was approximately
Cash Flows
Operating Activities
Cash used in operations was approximately
Financing Activities
Cash provided by financing activities was approximately
At
About
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 three drugs that employ three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. 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 products, its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its AnQlar product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. 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 statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the
CONDENSED BALANCE SHEETS |
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(Unaudited) |
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ASSETS |
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Current assets |
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|
|
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Cash |
|
$ |
30,797,135 |
|
|
$ |
36,841,992 |
|
Prepaid expenses and other current assets |
|
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3,948,839 |
|
|
|
2,730,444 |
|
Total current assets |
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34,745,974 |
|
|
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39,572,436 |
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Total assets |
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$ |
34,745,974 |
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|
$ |
39,572,436 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Accounts payable and accrued expenses |
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$ |
2,186,891 |
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$ |
2,087,691 |
|
Total current liabilities |
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2,186,891 |
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|
|
2,087,691 |
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Total liabilities |
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2,186,891 |
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2,087,691 |
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Commitments and contingencies |
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Stockholders’ equity |
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Preferred stock, par value |
|
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— |
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— |
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Common stock, |
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|
117 |
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|
117 |
|
Additional paid-in capital |
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60,399,875 |
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60,188,535 |
|
Accumulated deficit |
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|
(27,840,909 |
) |
|
|
(22,703,907 |
) |
Total stockholders’ equity |
|
|
32,559,083 |
|
|
|
37,484,745 |
|
Total liabilities and stockholders’ equity |
|
$ |
34,745,974 |
|
|
$ |
39,572,436 |
|
* | Derived from audited financial statements |
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) |
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For the
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For the
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OPERATING EXPENSES |
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General and administrative |
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$ |
1,782,413 |
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$ |
1,273,572 |
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Research and development |
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3,341,406 |
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1,075,000 |
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Total operating expenses |
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5,123,819 |
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|
|
2,348,572 |
|
Loss from operations |
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(5,123,819 |
) |
|
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(2,348,572 |
) |
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|
|
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OTHER EXPENSE |
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Other expense |
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(13,183 |
) |
|
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— |
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Interest expense |
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— |
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(30,699 |
) |
Loss before tax provision |
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(5,137,002 |
) |
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(2,379,271 |
) |
Benefit from income taxes |
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— |
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— |
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Net loss |
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$ |
(5,137,002 |
) |
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$ |
(2,379,271 |
) |
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Basic and diluted net loss per share |
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$ |
(0.44 |
) |
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$ |
(0.60 |
) |
Basic and diluted weighted average common stock outstanding |
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11,708,690 |
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3,945,153 |
|
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) |
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For the
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For the
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
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$ |
(5,137,002 |
) |
|
$ |
(2,379,271 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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|
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Non-cash interest expense |
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|
— |
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|
30,699 |
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Stock-based compensation |
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|
211,340 |
|
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|
369,884 |
|
Change in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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(1,218,395 |
) |
|
|
(936,784 |
) |
Accounts payable and accrued expenses |
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|
99,200 |
|
|
|
(164,766 |
) |
Net cash used in operating activities |
|
|
(6,044,857 |
) |
|
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(3,080,238 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Repayment of notes payable |
|
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— |
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|
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(493,480 |
) |
Proceeds from related party notes payable |
|
|
— |
|
|
|
100,000 |
|
Repayment of related party notes payable |
|
|
— |
|
|
|
(100,000 |
) |
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 |
|
|
— |
|
|
|
15,289,727 |
|
|
|
|
|
|
|
|
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Net change in cash |
|
|
(6,044,857 |
) |
|
|
12,209,489 |
|
Cash, beginning of period |
|
|
36,841,992 |
|
|
|
54,796 |
|
Cash, end of period |
|
$ |
30,797,135 |
|
|
$ |
12,264,285 |
|
|
|
|
|
|
|
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Supplemental disclosure of cash and non-cash financing activities |
|
|
|
|
|
|
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Cash paid for interest |
|
$ |
— |
|
|
$ |
34,707 |
|
Cash paid for taxes |
|
$ |
— |
|
|
$ |
— |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220516005060/en/
Chief Financial Officer
cchipman@virpaxpharma.com
610-727-4597
Or
betsy.brod@affinitygrowth.com
212-661-2231
Source: Virpax®
FAQ
What are the financial results for Virpax Pharmaceuticals for Q1 2022?
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