helping people with dermatological diseases live better lives
TRANSCRIPT
For Verrica, it’s personal…
Verrica, headquartered in West Chester, PA, is led by a team rich in experience developing and commercializing dermatological treatments. We are focused on redefining dermatology by bringing innovative drugs to market, improving drug delivery methods of administration, and fostering informative engagement with healthcare providers.
The company was founded in 2013 by Matt Davidson, PhD, who suffered from common warts and struggled to find a treatment with minimal side effects. The name Verrica comes from a blend of the Latin name for warts (verruca) and the word “veracity.”
2
“Our mission is to reinvent skin science and bring new FDA-approved products to market that address unmet needs in medical dermatology and help people struggling with skin diseases.”
— Ted White President and CEO
3
We retain exclusive, royalty-free rights to our product candidates across all indications.
Plantar Warts1
IND submission in 2H 2019
External Genital WartsTopline Phase 2 results in 2H 2020
Common WartsEnd of Phase 2 meeting with the FDA
PRECLINICAL PHASE 1 PHASE 2 PHASE 3
Molluscum ContagiosumNDA submitted September 2019
VP-102
VP-103
1. Phase 2 ready assuming leverage of data from VP-102.
cGMP Quality, Consistency and Precision Application for Patient Treatment VP-102 is a proprietary drug-device combination containing cantharidin (0.7% w/v). Cantharidin that has not been approved by the FDA or previously studied in a well-controlled clinical environment.
By stabilizing and purifying the cantharidin solution in a sealed glass ampule and adding innovative features, such as a visualization agent and a bittering agent to mitigate oral ingestion by children, VP-102 has the potential to be the first FDA-approved product for molluscum contagiosum and common warts (verruca vulgaris).
Innovative Therapies for Significantly Unmet Medical Needs
4
Key Milestones
DECEMBERTed White appointed President and CEO
2017
Company founded by Dr. Davidson2013
MARCHEstablished and opened corporate headquarters in West Chester, PA
JUNESuccessful IPO, Verrica becomes a member of Nasdaq
AUGUSTCompleted enrollment for molluscum Phase 3 trials of VP-102 (ahead of schedule)
2018
JANUARYReported positive Phase 3 results of VP-102 for molluscum
JUNEReported positive Phase 2 results of VP-102 in common warts
JUNEInitiated Phase 2 clinical trial of VP-102 in external genital warts
SEPTEMBERNDA submitted for VP-102 for molluscum contagiosum
2019
5
Approximately six million people are infected with
molluscum in the U.S., the majority of whom
are children.2
Molluscum is spread through skin-to-skin contact or by sharing
contaminated objects.1,3
New Path to Potentially Clearer SkinAs molluscum contagiosum is a highly contagious viral skin infection and many patients do not receive treatment, Verrica decided to prioritize molluscum as its first skin treatment indication. Approximately 1
six million people are infected with molluscum in the U.S., the majority of whom are children.2
Molluscum, caused by a pox virus, is spread through skin-to-skin contact or by sharing contaminated objects, such as clothing, towels, sports equipment, or toys.1,3 Left untreated, molluscum takes 13 months on average to resolve on its own, with some molluscum cases remaining unresolved for several years.4 Typically, molluscum presents as 10 to 30 small, raised flesh-colored bumps, or lesions, which usually appear two weeks to six months after exposure to the virus — and on any part of the body.1,5,6 The molluscum infection can spread by scratching and touching the lesions, which transmits the virus to new areas on the body or to other people.4
6
Left untreated, molluscum takes
13 months on average to resolve
on its own.4
There are currently no FDA-approved treatments for
molluscum contagiosum
Treating molluscum early may reduce the length of time of the infection, as well as avoid spreading the infection to other areas on the body or other people. In households, almost half of children with molluscum spread the infection to their siblings.7 There are no large scale clinical trials that support the safety and efficacy of current treatments in molluscum.7
Clinical Evidence of VP-102 in MolluscumIn two phase 3 studies, topline positive results demonstrated up to 50 percent of patients treated with VP-102 achieved complete clearance of all treatable molluscum lesions in 12 weeks and up to 76 percent reduction in the number of lesions. VP-102 was well tolerated in both clinical trials with no serious adverse events related to the drug. Based on the strong body of clinical evidence, Verrica submitted an NDA for molluscum in September 2019. If successful, the company hopes to bring to market the first FDA-approved therapy for treating molluscum in 2020.
7
Common warts affect
approximately 22 million people
in the United States.9
Like molluscum, there is no FDA-approved
treatment for common warts.
Combating Stigma of Common Warts
Common warts are skin growths caused by a contagious viral skin infection. The human papilloma virus (HPV), the causative agent in common warts, is transmitted by touch. The virus enters the skin and causes skin growths by inducing the skin cells to multiply rapidly. Common warts, often found on hands or fingers, are benign, but treatment is recommended to prevent the spread of infection and relieve the patient’s physical and psychological discomfort. Like molluscum, there is no FDA-approved treatment for common warts, which affects approximately 22 million people in the United States.9
In June 2019, Verrica announced positive topline results of a Phase 2 trial of VP-102 in common warts and plans to request an End of Phase 2 meeting with the FDA in the second half of 2019.
8
HPV is one of the most
common sexually transmitted infections
in the U.S.
Genital warts affect more than 600,000 people
annually.10
Addressing Pervasive Challenge of Genital Warts
External genital warts are a viral skin disease caused by the human papilloma virus (HPV) which forms lesions on the surface of the skin. In the U.S., genital warts affect more than 600,000 people annually.10
A Phase 2 clinical trial evaluating the optimal dose regimen, efficacy, safety and tolerability of VP-102 in patients with external genital warts was initiated in June 2019.
9
REFERENCES1. Silverberg NB (2003) Pediatric molluscum contagiosum: Optimal treatment strategies. Pediatric Drugs (5(8): 505-512. 2. IQVIA Market Sizing Data projected from 12 months data ending September 2017. 3. Bugert JJ (2007) Genus Molluscipoxvirus. In Poxviruses; Birhauser Advances in Infectious Diseases. Edited by Mercer AA, Schmidt A, Weber O. Birkhauser Verlag, Berlin Germany. 4. Davies HD, Jackson MA, Rice SG (2017) Infectious diseases associated with organized sports and outbreak control. Pediatrics 140(4):e20172477. 5. Sladden MJ, Johnston GA (2005) Common Skin infections in children: Molluscum Contagiosum and warts Student BMJ (13). 6. Highet AS (1992) Molluscum Contagiosum Achr Dis Child 67(10) 1248-1249. 7. Silverberg NM, Sidbury R, Mancini A (2000). Childhood molluscum contagiosum: Experience with cantharidin therapy in 300 patients. JAAD 43:503-507. 8. Del Rosso JQ, Kircik L (2019) Topical cantharidin in the management of molluscum contagiosum: Preliminary assessment of an ether-free pharmaceutical grade formulation. J Clin Aesthet Dermatol 12(2): 27-30. 9. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033. 10. Patel et al. BMC Infectious Diseases 2013, 13:39
Verrica, the Ideal PartnerIn addition to demonstrating a strong core competency in clinical development, Verrica is actively pursuing industry and academic collaborations to explore the potential of its pipeline. The Company is also seeking novel product candidates that bring innovative solutions to address underserved dermatological conditions.
With a highly experienced management team with years of proven clinical development and commercial success, including highly successful launches in medical dermatology, Verrica is the ideal partner to bring a wide array of products to market.
Executive TeamTed WhitePresident and Chief Executive Officer
Brian DavisChief Financial Officer
Patrick Burnett, MD, PhDChief Medical Officer
Joe BonaccorsoChief Commercial Officer
10
“Verrica operates with an urgency to deliver innovative therapies that provide a new path forward for patients with hard-to-treat skin diseases, creating better outcomes for healthier lives.”
— Ted White President and CEO
11
Verrica Pharmaceuticals Inc. is a medical dermatology company committed to providing meaningful solutions for underserved skin diseases. We are passionate about improving the lives of patients and easing the burden of hard-to-treat skin conditions.
For Company NewsVisit us at www.verrica.comFollow us on Twitter: www.twitter.com/VerricaPharmaTraded on NASDAQ: VRCA
Contact UsFor general inquiries: [email protected] medical information and clinical research inquiries: [email protected]
10 North High Street, Suite 200West Chester, PA 19380+1 484-453-3300