Virpax Pharmaceuticals Reports 2024 First Quarter Results and Recent Developments
Virpax Pharmaceuticals (NASDAQ: VRPX) announced its Q1 2024 results and recent developments. The company reported an increase in general and administrative expenses to $1.7M and R&D expenses to $1.6M, leading to an operating loss of $3.2M. Cash reserves stood at $1.9M as of March 31, 2024. Key highlights include the positive results of the Probudur™ Maximum Tolerated Dose Study, ongoing development of Envelta™ and NobrXiol™, and a settlement agreement with Sorrento Therapeutics and Scilex Pharmaceuticals. The company is also seeking additional grants and licensing opportunities. CEO Gerald W. Bruce expressed optimism about the future despite the financial challenges.
- Probudur™ Maximum Tolerated Dose Study results confirmed the drug is well-tolerated.
- Both doses of Probudur showed reduction in incision-induced pain behaviors in a pilot study.
- Envelta™ and NobrXiol™ are progressing using Nanomerics' MET technology.
- Nanomerics awarded the King’s Award for Enterprise 2024 in the innovation category.
- Forbes article highlighted Virpax as a promising stock in a struggling biotech market.
- Settlement agreement with Sorrento Therapeutics and Scilex Pharmaceuticals approved.
- General and administrative expenses increased to $1.7M from $0.4M YoY.
- R&D expenses rose to $1.6M from $1.2M YoY.
- Operating loss widened to $3.2M from $1.5M YoY.
- Cash reserves decreased to $1.9M as of March 31, 2024.
- Significant expenses due to legal defense costs and preclinical activities.
Insights
Virpax Pharmaceuticals has reported noteworthy financial data for the first quarter of 2024. Key points include a substantial increase in general and administrative expenses, which rose to
In the short term, these increased costs reflect higher investment in their pipeline, which could signal potential future growth but also pose risks related to liquidity and profitability. The current cash position of
The Maximum Tolerated Dose Study for Probudur™ has yielded positive results, indicating that all doses were well-tolerated. This is a significant milestone, as it underlines the safety of their proprietary formulation which combines immediate and sustained pain relief. The reduction in toxicity when bupivacaine is administered with liposomes is particularly beneficial for patient outcomes versus traditional administration methods.
The pilot study by the U.S. Army Institute of Surgical Research further supports Probudur’s potential by demonstrating pain reduction in a rat model. These studies not only reinforce the therapeutic promise of Probudur but also pave the way for full-scale studies, which could attract further interest and funding.
Virpax Pharmaceuticals’ engagement in licensing opportunities and grant applications is strategic. Despite existing financial pressures, these initiatives could serve as potential lifelines, opening avenues for non-dilutive financing and partnerships. The recent recognition of Nanomerics with the King’s Award for Enterprise further validates the technological platform Virpax utilizes, potentially enhancing investor confidence in the company's innovative edge.
However, the company's current financial strain and dependency on external funding highlight the risks associated with biopharma ventures at this stage. Investors should weigh the promising clinical progress and strategic initiatives against the immediate financial challenges.
“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
“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
Research and development expenses were
The operating loss for the three months ended March 31, 2024, was
At March 31, 2024, Virpax had cash of approximately
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
CONDENSED CONSOLIDATED BALANCE SHEETS |
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(Unaudited) |
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March 31, 2024 |
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December 31, 2023 |
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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 |
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|
|
|
||||
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 |
|
|
|
|
|
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Commitments and contingencies |
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Stockholders' (deficit) equity |
|
|
|
|
||||
Preferred stock, par value |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
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 |
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(UNAUDITED) |
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For the Three Months Ended March 31, |
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|
2024 |
|
2023 |
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OPERATING EXPENSES |
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|
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General and administrative (net of insurance reimbursement of |
|
$ |
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 |
) |
|
|
|
|
|
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OTHER INCOME |
|
|
|
|
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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 |
) |
|
|
|
|
|
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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 |
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(UNAUDITED) |
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|
|
For the Three Months Ended March 31, |
||||||
|
|
2024 |
|
2023 |
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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 |
) |
|
|
|
|
|
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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
Source: Virpax Pharmaceuticals, Inc.
FAQ
What were Virpax Pharmaceuticals' Q1 2024 financial results?
What are the latest developments for Virpax Pharmaceuticals as of Q1 2024?
What were the results of the Probudur™ Maximum Tolerated Dose Study?
What is the significance of the pilot study for Probudur™?
How did general and administrative expenses change for Virpax Pharmaceuticals in Q1 2024?
What are Virpax Pharmaceuticals' plans for Envelta™ and NobrXiol™?
What was Virpax Pharmaceuticals' operating loss for Q1 2024?
What is Virpax Pharmaceuticals' cash position as of March 31, 2024?
