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Virpax Pharmaceuticals, Inc. (VRPX) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

SEC Filings

VRPX Quarterly Reports

    10-Q Quarterly Report August 2022
  • 10-Q Quarterly Report May 2022
  • 10-Q Quarterly Report November 2021
    10-Q Quarterly Report August 2021
    10-Q Quarterly Report May 2021

VRPX Registration of Securities

Virpax Pharmaceuticals, Inc.

CIK: 1708331 Ticker: VRPX

Exhibit 99.1

 

VIRPAX PHARMACEUTICALS REPORTS 2022 FIRST QUARTER RESULTS AND RECENT DEVELOPMENTS

 

--Company Continues to Successfully Advance Product Candidates --

 

BERWYN, PA, May 16, 2022 — Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ:VRPX), today announced its financial results for the quarter ended March 31, 2022, and other recent developments.

 

“We continue to make excellent progress with all of our drug product candidates,” stated Anthony P. Mack, Chairman and Chief Executive Officer of Virpax. “In the first quarter of 2022, we secured global rights for AnQlar™, completed initial preclinical studies for VRP324, which is being developed to manage seizures associated with epilepsy in children, and announced the entry into a new CRADA with the U.S. Army for Probudor™.

 

“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 U.S. commercial opportunities as well as ex-U.S. business opportunities. We intend to pursue global sublicensing and co-development opportunities with strategic biopharmaceutical partners as part of our non-dilutive funding strategy. Additionally, we will continue to pursue non-dilutive government and military grant agreements similar to our recently announced CRADA with the U.S. Army and our ongoing CRADA for the development of Envelta with the National Institutes of Health’s National Center for Advancing Translational Sciences, which was awarded in 2020.

 

“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 Mr. Mack.

 

“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 U.S. and secure licensees for the rest of the world. Additionally, for our anti-viral product candidate, AnQlar, we intend to license or partner with another company that has OTC experience as we focus strictly on branded products. This licensing strategy along with our continued active pursuit of grants is non-dilutive and may extend our cash runway,” concluded Mr. Mack.

 

 

 

 

RECENT DEVELOPMENTS

 

On May 5, 2022, Virpax announced a CRADA with the U.S. Army Institute of Surgical Research (USAISR), the U.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 with Nanomerics 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 MARCH 31, 2022, AND 2021

 

Operating Expenses

 

General and administrative expenses were approximately $1.8 million for the first quarter of 2022, an increase of about $0.5 million from the first quarter of 2021. The increase was due to legal expenses, compensation related to new hires, insurance costs and non-executive board compensation. These expenses were partially offset by a decrease in stock-based compensation.

 

Research and development expenses were approximately $3.3 million for the first quarter of 2022 compared to approximately $1.1 million for the first quarter of 2021. The increase in research and development expenses was primarily attributable to milestone payments related to AnQlar, an increase in preclinical activities for AnQlar, Epoladerm and Probudur, and to a lesser degree, an increase in regulatory activities for Envelta and preclinical activities related to VRP324.

 

The operating loss for the first quarter of 2022 was approximately $5.1 million, as compared to $2.3 million for the first quarter of 2021.

 

Cash Flows

 

Operating Activities

 

Cash used in operations was approximately $6.0 million for the three months ended March 31, 2022, compared to $3.1 million for the three months ended March 31, 2021. The increase in cash used in operations was primarily the result of the increase in net loss and an increase in prepaid insurance and prepaid research and development costs.

 

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Financing Activities

 

Cash provided by financing activities was approximately $15.3 million during the three months ended March 31, 2021, attributable primarily to net proceeds received from our initial public offering in February 2021 of $15.8 million, after deducting underwriting discounts and offering expenses. This was slightly offset by repayment in full of certain promissory notes in the amount of approximately $0.5 million in February 2021. No financing activities took place during the three months ended March 31, 2022.

 

At March 31, 2022, the Company had cash and cash equivalents of approximately $30.8 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 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 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.

 

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VIRPAX Pharmaceuticals, Inc.

CONDENSED BALANCE SHEETS

 

   March 31,
2022
   December 31,
2021*
 
   (Unaudited)     
ASSETS        
Current assets        
Cash  $30,797,135   $36,841,992 
Prepaid expenses and other current assets   3,948,839    2,730,444 
Total current assets   34,745,974    39,572,436 
           
Total assets  $34,745,974   $39,572,436 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Accounts payable and accrued expenses  $2,186,891   $2,087,691 
Total current liabilities   2,186,891    2,087,691 
Total liabilities   2,186,891    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, 11,714,725 shares issued and outstanding as of March 31, 2022; 11,714,885 shares issued and outstanding as of December 31, 2021   117    117 
Additional paid-in capital   60,399,875    60,188,535 
Accumulated deficit   (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

 

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VIRPAX Pharmaceuticals, Inc.

CONDENSED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

   For the
Three
Months
Ended
March 31,
2022
  

For the
Three
Months
Ended
March 31,
2021

 
OPERATING EXPENSES        
General and administrative  $1,782,413   $1,273,572 
Research and development   3,341,406    1,075,000 
Total operating expenses   5,123,819    2,348,572 
Loss from operations   (5,123,819)   (2,348,572)
           
OTHER EXPENSE          
Other expense   (13,183)    
Interest expense       (30,699)
Loss before tax provision   (5,137,002)   (2,379,271)
Benefit from income taxes        
Net loss  $(5,137,002)  $(2,379,271)
           
Basic and diluted net loss per share  $(0.44)  $(0.60)
Basic and diluted weighted average common stock outstanding   11,708,690    3,945,153 

 

5

 

 

VIRPAX Pharmaceuticals, Inc.

CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

  

For the
Three
Months
Ended
March 31,
2022

   For the
Three
Months
Ended
March 31,
2021
 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss  $(5,137,002)  $(2,379,271)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash interest expense       30,699 
Stock-based compensation   211,340    369,884 
Change in operating assets and liabilities:          
Prepaid expenses and other current assets   (1,218,395)   (936,784)
Accounts payable and accrued expenses   99,200    (164,766)
Net cash used in operating activities   (6,044,857)   (3,080,238)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Repayment of notes payable       (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 
           
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 
           
Supplemental disclosure of cash and non-cash financing activities          
Cash paid for interest  $   $34,707 
Cash paid for taxes  $   $ 

 

6

 

 

Contact:

 

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

610-727-4597

 

Or

 

Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

 

 

7

 


The following information was filed by Virpax Pharmaceuticals, Inc. (VRPX) on Monday, May 16, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Virpax Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Balance Sheets
Condensed Balance Sheets (Parentheticals)
Condensed Statements Of Cash Flows (Unaudited)
Condensed Statements Of Changes In Stockholders??? Equity (Unaudited)
Condensed Statements Of Changes In Stockholders??? Equity (Unaudited) (Parentheticals)
Condensed Statements Of Operations (Unaudited)
Accounting Policies, By Policy (Policies)
Accounts Payable And Accrued Liabilities
Accounts Payable And Accrued Liabilities (Details) - Schedule Of Accounts Payable And Accrued Liabilities
Accounts Payable And Accrued Liabilities (Tables)
Business And Liquidity
Business And Liquidity (Details)
Commitments And Contingencies
Prepaid Expenses And Other Current Assets
Prepaid Expenses And Other Current Assets (Details) - Schedule Of Prepaid Expenses And Other Current Assets
Prepaid Expenses And Other Current Assets (Tables)
Related-Party Transactions
Related-Party Transactions (Details)
Research And Development And License Agreements
Research And Development And License Agreements (Details)
Stock-Based Compensation
Stock-Based Compensation (Details)
Stock-Based Compensation (Details) - Schedule Of Black-Scholes Option-Pricing Model
Stock-Based Compensation (Details) - Schedule Of Stock Option Activity
Stock-Based Compensation (Tables)
Stockholders' Equity
Stockholders' Equity (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Details) - Schedule Of Antidilutive Due To The Net Loss
Summary Of Significant Accounting Policies (Tables)

Material Contracts, Statements, Certifications & more

Virpax Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: VRPX
CIK: 1708331
Form Type: 10-Q Quarterly Report
Accession Number: 0001213900-22-027105
Submitted to the SEC: Mon May 16 2022 4:10:57 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

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