Full Press Release Details
Verrica Pharmaceuticals Reports First Quarter 2023 Financial Results
New Drug Application for YCANTH (VP-102)
PDUFA Goal Date of July 23, 2023 - Potential to Become Only FDA-approved Therapy for Treatment of Molluscum Contagiosum
Raised Gross Proceeds of $32.5 Million in February 2023 in an Underwritten Offering
VP-315 Advanced into Part 2 of Phase 2 Trial in Basal Cell Carcinoma
WEST CHESTER, PA May 9, 2023 (GLOBE NEWSWIRE) Verrica Pharmaceuticals Inc. ( Verrica or the Company ) (Nasdaq: VRCA),
a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the first quarter ended March 31, 2023.
The first quarter of 2023 saw continued execution across our pipeline and strengthening of our financial position, said Ted White, Verrica s
President and Chief Executive Officer. With the upcoming PDUFA goal date of July 23, we may be poised to reach a major inflection point with the potential approval of YCANTH for
the treatment of molluscum contagiosum. Molluscum is a dermatological condition that afflicts millions of children each year in the U.S., and with no FDA approved therapies, we believe
YCANTH has the potential to address this significant unmet medical need. We also made progress with our novel oncolytic peptide, VP-315, which
advanced into the second part of our ongoing Phase 2 study in basal cell carcinoma in April 2023 following a positive safety assessment and promising signs of activity from Part 1 of the study.
We also had the opportunity to strengthen our balance sheet during the quarter, raising an additional $32.5 million in gross proceeds in an
underwritten offering to further extend our cash runway. This additional capital will help support our pre-commercial activities for YCANTH and fund
our ongoing VP-315 Phase 2 study. Looking ahead, we are excited about the progress we expect to make throughout the remainder of the year.
Business Highlights and Recent Developments
Underwritten Offering
First Quarter 2023 Financial Results
Non-GAAP Financial Measures
In evaluating the operating performance of its business, Verrica s management considers non-GAAP loss
from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial
measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary
course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from
operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but
should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.
About YCANTH (VP-102)
YCANTH (VP-102) is a proprietary drug-device
combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical
dosing and targeted administration for the treatment of molluscum. If approved, YCANTH would be the only product approved by the FDA to treat molluscum a common, highly
contagious skin disease that affects an estimated six million people in the United States, primarily children. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of
common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.
VP-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers.
The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed
to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult
subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as believe, expect, may, plan, potential, will, and similar expressions, and
are based on Verrica s current beliefs and expectations. These forward-looking statements include expectations regarding the
approval of VP-102 for the treatment of molluscum, the timing of clinical trial completion for VP-315 and
Verrica s cash and cash equivalents being sufficient to support planned operations into the first quarter of 2024. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in
such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica s reliance on third parties over which it
may not always have full control and uncertainties that are described in Verrica s Annual Report on Form 10-K for the year ended December 31, 2022 and other filings Verrica makes with the U.S.
Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not
intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
VERRICA PHARMACEUTICALS INC.
Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Collaboration revenue | $ | 37 | $ | 431 | ||||
| Operating expenses: | ||||||||
| Research and development | 2,739 | 2,445 | ||||||
| General and administrative | 4,319 | 5,118 | ||||||
| Cost of collaboration revenue | 68 | 278 | ||||||
| Total expenses | 7,126 | 7,841 | ||||||
| Loss from operations | (7,089 | ) | (7,410 | ) | ||||
| Interest income | 500 | 22 | ||||||
| Interest and other expense | (1,082 | ) | ||||||
| Net loss | $ | (6,589 | ) | $ | (8,470 | ) | ||
| Net loss per share, basic and diluted | $ | (0.15 | ) | $ | (0.31 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 43,023,379 | 27,519,053 |
VERRICA PHARMACEUTICALS INC.
Selected Balance Sheet Data
| March 31, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents | $ | 59,952 | $ | 34,273 | ||||
| Receivables, prepaid expenses and other assets | 3,145 | 4,842 | ||||||
| Total current assets | 63,097 | 39,115 | ||||||
| PP&E, lease right of use asset, other | 5,542 | 5,606 | ||||||
| Total assets | $ | 68,639 | $ | 44,721 | ||||
| Total liabilities | 3,793 | 4,688 | ||||||
| Total stockholders equity | 64,846 | 40,033 | ||||||
| Total | $ | 68,639 | $ | 44,721 |
VERRICA PHARMACEUTICALS INC.
Reconciliation of Non-GAAP Financial Measures (unaudited)
(in thousands except per share data)
| Three Months Ended March 31, 2023 | ||||||||||||
| Loss from Operations | Net loss | Net loss per share | ||||||||||
| GAAP | $ | (7,089 | ) | $ | (6,589 | ) | $ | (0.15 | ) | |||
| Non-GAAP Adjustments: | ||||||||||||
| Stock-based compensation Selling, General & Admin (a) | 836 | 836 | ||||||||||
| Stock-based compensation Research & Development (a) | 258 | 258 | ||||||||||
| Adjusted | $ | (5,995 | ) | $ | (5,495 | ) | $ | (0.13 | ) | |||
| Three Months Ended March 31, 2022 | ||||||||||||
| Loss from Operations | Net loss | Net loss per share | ||||||||||
| GAAP | $ | (7,410 | ) | $ | (8,470 | ) | $ | (0.31 | ) | |||
| Non-GAAP Adjustments: | ||||||||||||
| Stock-based compensation Selling, General & Admin (a) | 899 | 899 | ||||||||||
| Stock-based compensation Research & Development (a) | 417 | 417 | ||||||||||
| Non-cash interest expense (b) | 354 | |||||||||||
| Adjusted | $ | (6,094 | ) | $ | (6,800 | ) | $ | (0.25 | ) |
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Financial Officer