NeoLIPA: a Single Center Phase II Open Label Study of Neoadjuvant LTX-315 in Combination with Pembrolizumab in Patients with Clinically Detectable and Resectable Stage III-IV Melanoma

This clinical trial aims to evaluate the effectiveness of a new treatment approach for patients with stage III or IV melanoma that has spread to other parts of the body but can still be surgically removed. The study combines two treatments: LTX-315 and pembrolizumab.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment&amp;#39;s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.

Start Date01 Nov 2024

Sponsor / Collaborator

Oslo universitetssykehus HF

[+1]

NCT05188729

/ CompletedPhase 2

A Phase 2, Multicenter, Open-label, Proof-of-concept Study with Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects with Basal Cell Carcinoma

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).
The study is expected to enroll approximately 80 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

Start Date01 Feb 2022

Sponsor / Collaborator

Verrica Pharmaceuticals, Inc.

[+3]

NCT04796194

/ Active, not recruitingPhase 2

A Phase II Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to Pembrolizumab

ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

Start Date01 Jun 2021

Sponsor / Collaborator

Lytix Biopharma AS

[+2]

100 Clinical Results associated with Ruxotemitide

100 Translational Medicine associated with Ruxotemitide

100 Patents (Medical) associated with Ruxotemitide

Literatures (Medical) associated with Ruxotemitide

03 Mar 2025·Molecular Pharmaceutics

Efficient Delivery of Oncolytic Peptide LTX-315 by ZIF-8: pH-Responsive Release, Improved Stability, and Reduced Hemolysis

Article

Author: Chen, Xin-Qi ; Wang, Cai-Yun ; Chen, Yu-Zhen ; Du, Shan-Shan ; Cui, Su-Su ; Liu, Qing ; Qi, Yun-Kun

The first-in-class oncolytic peptide LTX-315 has exhibited positive anticancer responses in multiple phase I/II clinical trials. Nevertheless, the linear peptide LTX-315 suffers from poor proteolytic stability and undesired toxicity, especially hemolysis, which may limit its widespread applications. Except for the direct structural modifications, drug delivery systems (DDSs) are expected to protect LTX-315 from degradation and shield its hemolytic properties. Therefore, the LTX-315 and zeolitic imidazolate framework (ZIF-8)-based nanoparticles (NPs) were constructed with a high LTX-315 encapsulation rate of 59.9%, utilizing the biomineralized "one-pot method" in an aqueous system. The release of LTX-315, in vitro anticancer potency, serum stability, anticancer durability, antimigration activity, hemolysis effect, subcellular localization, and the membrane disruption/permeation effects of LTX-315@ZIF-8 NPs were investigated. LTX-315@ZIF-8 NPs exhibited potent cytotoxicity against cancer cells. The serum stability experiment and time-inhibition curve assay indicated that ZIF-8 NPs could effectively improve the stability of LTX-315, prolong the duration of anticancer action, and enhance the cytostatic potency. Especially, the LTX-315@ZIF-8 NPs not only effectively attenuated the hemolytic toxicity of LTX-315 but also achieved the pH-responsive release of LTX-315. The mechanism investigation indicated that LTX-315@ZIF-8 NPs possessed potent membranolytic activity and reduced the mitochondrial membrane potential to trigger cell death. Collectively, this paper not only established a robust strategy to improve the stability and reduce the hemolytic properties of LTX-315 but also provided a reliable reference for the future delivery of oncolytic peptides.

01 Jan 2025·Journal of Advanced Research

LTX-315 is a novel broad-spectrum antimicrobial peptide against clinical multidrug-resistant bacteria

Article

Author: Tang, Yang ; Peng, Mingxiu ; Chen, Sheng ; Heng, Heng ; Sun, Liang ; Yang, Chen ; Zhao, Jiamin ; Dai, Liang ; Chan, Edward Wai-Chi

INTRODUCTIONInfections stemming from multidrug-resistant bacteria present a substantial threat to public health today. Discovering or synthesizing novel compounds is crucial to alleviate this pressing situation.OBJECTIVEThe main purpose of this study is to verify the antibacterial activity of LTX-315 and explore its primary action mode.METHODSThrough antibacterial phenotype assay screening, we obtained a potent compound named LTX-315 from diverse drug libraries, 10,926 compounds in total. Then, the bactericidal effect and its action mode were explored through biochemical and chemistry methods such as atime-killing curve, scanning electronic microscopy, isothermal titration calorimetry analysis, and nuclear magnetic resonance. Finally, the efficacy in vivo of LTX-315 against drug-resistant bacteria was proved through amice infection model.RESULTSIn this study, LTX-315, an oncolytic peptide, was discovered to effectively eliminate gram-positive and gram-negative pathogens, even for those multidrug-resistant strains. Through strong electrostatic interactions, LTX-315 can bind to the membrane component phosphatidylglycerol (PG) with extremely high affinity (nanomolar level). Strikingly, in contrast to the typical electrostatic interactions of antibacterial peptides, the indole group of LTX-315, situated near the alkyl chain, exhibits significantly enhanced recognition and interaction with PG due to the hydrophobic effect of the alkyl chain. Furthermore, it exerts various impacts on cell membranes, including damaging integrity, increasing permeability, and decreasing membrane fluidity. Additionally, microscopy revealed significant cell disintegration. The influence, in turn, disrupts several physiological activities inside cells, such as increasing the reactive oxygen species level, ultimately leading to cell death. Finally, the efficacy of LTX-315 in vivo against multidrug-resistant and hypervirulent Klebsiella pneumoniae was demonstrated.CONCLUSIONThe unique mechanism of LTX-315 involves high-affinity binding to PG and subsequent membrane disruption, providing a novel approach against multidrug-resistant bacteria compared to conventional antibiotics. As a potential candidate, it shows promise in effectively treating bacterial infections, particularly those caused by drug-resistant bacteria, thereby addressing the escalating challenge of antibiotic resistance worldwide.

31 Dec 2024·OncoImmunology

LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate tumor specific T cells in patients with metastatic soft tissue sarcoma

Article

Author: Stratford, Richard ; Monberg, Tine ; Petersen, Michael Mørk ; Svane, Inge Marie ; Sundvold, Vibeke ; Albieri, Benedetta ; Junker, Niels ; Sveinbjornsson, Baldur ; Nielsen, Morten ; Met, Özcan ; Krarup-Hansen, Anders ; Rekdal, Øystein ; Camilio, Ketil ; Hovgaard, Dorrit ; Clancy, Trevor

LTX-315 is an oncolytic peptide that elicits both local and systemic immune responses upon intratumoral injection. In the present pilot trial, we treated patients with metastatic soft tissue sarcoma with the combination of LTX-315 and adoptive T-cell therapy using in vitro expanded tumor-infiltrating lymphocytes. Six heavily pretreated patients were included in the trial and treated with LTX-315 of which four patients proceeded to adoptive T-cell therapy. Overall, the treatment was considered safe with only expected and manageable toxicity. The best overall clinical response was stable disease for 208 days, and in this patient, we detected tumor-reactive T cells in the blood that lasted until disease progression. In three patients T-cell reactivity against in silico predicted neoantigens was demonstrated. Additionally, de novo T-cell clones were generated and expanded in the blood following LTX-315 injections. In conclusion, this pilot study provides proof that it is feasible to combine LTX-315 and adoptive T-cell therapy, and that this treatment can induce systemic immune responses that resulted in stabilization of the disease in sarcoma patients with otherwise progressive disease. Further optimization of the treatment protocol is warranted to increase clinical activity. ClinicalTrials.gov Identifier: NCT03725605.

News (Medical) associated with Ruxotemitide

21 Jan 2025

·www.globenewswire.com

Verrica Pharmaceuticals Announces Presentation of Three Posters Featuring Positive Preliminary Topline Results of VP-315 for the Treatment of Basal Cell Carcinoma at the 2025 Winter Clinical Dermatology Conference

– Presented data includes a 97% Calculated Objective Response Rate (ORR) of study subjects following treatment with VP-315 – Posters highlight the safety data, tolerability data, and antitumor efficacy data of VP-315 for the treatment of basal cell carcinoma as determined by histological clearance WEST CHESTER, Pa., Jan. 21, 2025 (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 the presentation of three posters that were presented at the 2025 Winter Clinical Dermatology Conference, which was held from January 17-19, in Miami, Florida. The posters featured clinical data from Part 2 of the Phase 2 study (the “Study”) of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”). Verrica presented a poster titled “Calculated Objective Response Rate (ORR) of 97% from Post-Hoc Analysis of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational therapy for Basal Cell Carcinoma (BCC)” while encore presentations of two additional posters (titled “Results of a Phase 2 Multicenter Study Evaluating the Safety and Tolerability of VP-315, an Investigational therapy for Basal Cell Carcinoma” and “Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational Therapy for Basal Cell Carcinoma”) were also made at the conference. The posters included safety and histologic clearance data from 82 patients with up to two target BCC tumors (a total of 91 tumors) in Part 2 of the Study evaluating VP-315 for the treatment of BCC, including patients with tumors on the head and neck. Part 2 of the Study was designed to explore dosing regimens to help Verrica identify the recommended regimen for a Phase 3 study program. Approximately 51% of tumors treated in the Study achieved complete histological clearance, while those patients with a residual tumor achieved, on average, approximately 71% reduction in tumor size. There were no Treatment Related Serious Adverse Events, and most Treatment Related Adverse Events were mild to moderate. In the newly-presented poster, Verrica conducted a post-hoc analysis of the data from the Study and announced a Calculated ORR of 97%, defined as the percentage of study subjects who do not demonstrate disease progression and who experience at least a 30% level of tumor reduction along with partial or complete response following treatment The Company still expects genomic and T-cell (immune response) data in the first quarter of 2025 and plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025 to determine the next steps for the development of VP-315 for the treatment of BCC. “We remain highly encouraged by the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315, which we believe support a potential change in the treatment paradigm for patients with basal cell carcinoma,” said Dr. Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments. We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.” About the Phase 2 Study of VP-315The Study is a 2-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 BCC. The study enrolled 92 adult subjects with a histological diagnosis of BCC in at least one eligible target tumor. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729. About VP- 315VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. About Basal Cell CarcinomaBasal cell carcinoma is the most common form of cancer in the United States, and its incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinoma in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. Forward-Looking StatementsAny 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 statements concerning the potential of VP-315, the Company’s research, development and regulatory plans for VP-315, the timing of the Company’s planned clinical trials for VP-315 and reporting data from the Company’s clinical trials, and the potential market size opportunity for the treatment of basal cell carcinoma. 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 Vernica’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 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. FOR MORE INFORMATION, PLEASE CONTACT: info@verrica.com Investors: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com

Clinical ResultPhase 2License out/inImmunotherapyDrug Approval

20 Dec 2024

·www.globenewswire.com

Verrica Provides Business and Operational Update

-- Dispensed applicator units in the fourth quarter of 2024 have exceeded the complete prior quarter even with significant cost reductions in sales and operational infrastructure -- Observed significant reduction in YCANTH distributor inventory levels -- New single applicator configuration for YCANTH® expected to be available in the first quarter of 2025 to help meet growing product demand, reduce acquisition costs for physician practices and expand distribution and patient access -- Continue to advance pipeline of product candidates in common warts and basal cell carcinoma WEST CHESTER, Pa., Dec. 20, 2024 (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 a business and operational update outlining the significant progress being made with respect to the new commercial strategy for YCANTH, Verrica’s lead product for the treatment of molluscum contagiosum (“molluscum”). “Over the last several weeks since our November common stock offering, we have made significant progress across a number of key initiatives to help drive demand for YCANTH,” said Jayson Rieger, PhD MBA, President and Chief Executive Officer of Verrica. “First and foremost, we are executing effectively on our previously announced commercial strategy for YCANTH, as evidenced by achievement of fourth quarter dispensed applicator units already surpassing dispensed applicator units in the prior quarter. We are growing the YCANTH business while implementing highly targeted cost management initiatives to prioritize spend that creates value and reducing or eliminating inefficient and unnecessary expenses. We are also pleased to note a significant reduction in YCANTH inventory levels from our distribution partners.” Dr. Rieger continued, “We are responding to the growing patient demand for YCANTH by increasing our distribution capabilities, making YCANTH available to more dermatologists and pediatricians through our previous distribution channels as well as through local independent pharmacies. Furthermore, we expect to provide a single applicator packaging configuration for YCANTH in the first quarter of 2025, which we anticipate will provide an added level of convenience for our independent and specialty pharmacy network. We also expect that the single applicator packaging will facilitate initial purchases of the product by health care providers who prefer same day treatment for patients by requiring significantly less cash outlay under our buy-and-bill distribution model. Finally, we expect this new packaging may increase patient access by providing added optionality to buying groups, hospitals and government entities for including YCANTH on formulary to service their patients. “As we enter 2025, we are excited about the opportunities that lie ahead for our company. As noted, we are already seeing favorable changes in the demand dynamics for YCANTH in response to our more focused and disciplined commercial strategy. Our recent financing also helped strengthen our balance sheet, while our ongoing efforts to improve Verrica’s operational efficiencies will help preserve our capital resources.” Dr. Rieger concluded, “We also believe that our pipeline opportunities provide a tremendous source of potential upside for our company. Together with our development partner, Torii Pharmaceutical, we continue to advance YCANTH (referred to as TO-208 in Japan) for the treatment of common warts, which represents the opportunity to address the single largest unmet medical need in dermatology. Additionally, encouraging preliminary data from our Phase 2 study suggests that our oncolytic peptide, VP-315, may have the potential to become a new and differentiated treatment approach for basal cell carcinoma. In summary, we have made significant progress over a short period of time, and Verrica is becoming a more focused and efficient commercial-stage company.” About YCANTH® (VP-102)YCANTH® 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. YCANTH® is the first and only commercially available product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH® was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH® was a safe and effective therapeutic for the treatment of molluscum. Approximately 228 million lives are eligible to receive YCANTH® covered by insurance. YCANTH® is available to all patients with and without insurance coverage for $25 per treatment, and further financial assistance is available for patients in need. Please visit YCANTHPro.com for additional information. YCANTH® should only be administered by a trained healthcare professional. YCANTH® is not for home use. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. Forward-Looking StatementsAny 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 statements about the availability of Verrica’s single applicator packaging configuration and the benefits of such configuration, the commercialization of YCANTH, cost management initiatives and preservation of capital resources, and the clinical development and benefits of Verrica’s product candidates, including YCANTH (VP-102). 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 risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2023, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other filings Verrica makes with the SEC. 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. FOR MORE INFORMATION, PLEASE CONTACT: Investors: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com Chris Calabrese LifeSci Advisors ccalabrese@lifesciadvisors.com

Phase 3License out/inPhase 2Drug Approval

09 Dec 2024

·www.globenewswire.com

Verrica Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

WEST CHESTER, Pa., Dec. 09, 2024 (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 that Verrica’s Compensation Committee granted David Zawitz, Verrica’s new Chief Operating Officer, a nonqualified stock option to purchase 950,000 shares of its common stock under the Company’s Inducement Plan, effective December 9, 2024. The stock option was granted as a material inducement to Mr. Zawitz’s employment with Verrica in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Verrica (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Verrica, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The option award will have an exercise price equal to the closing price of Verrica’s common stock on December 9, 2024. The option award will vest and become exercisable as to 1/8th of the shares on the date that is six months following Mr. Zawitz’s start date, and 1/48th of the shares each month thereafter on the same day of the month as the start date, subject to Mr. Zawitz’s continuous service with Verrica on such vesting dates. The option award is subject to the terms and conditions of the Inducement Plan, and the terms and conditions of a stock option agreement covering the grant. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. FOR MORE INFORMATION, PLEASE CONTACT: Investors: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com Chris Calabrese LifeSci Advisors ccalabrese@lifesciadvisors.com

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Melanoma	Phase 2	United States	Lytix Biopharma AS	01 Jun 2021
Locally Advanced Melanoma	Phase 2	Spain	Lytix Biopharma AS	01 Jun 2021
Locally Advanced Melanoma	Phase 2	Norway	Lytix Biopharma AS	01 Jun 2021
Locally Advanced Melanoma	Phase 2	France	Lytix Biopharma AS	01 Jun 2021
Unresectable Melanoma	Phase 2	Norway	Lytix Biopharma AS	01 Jun 2021
Unresectable Melanoma	Phase 2	Spain	Lytix Biopharma AS	01 Jun 2021
Unresectable Melanoma	Phase 2	France	Lytix Biopharma AS	01 Jun 2021
Unresectable Melanoma	Phase 2	United States	Lytix Biopharma AS	01 Jun 2021
Metastatic Soft Tissue Sarcoma	Phase 2	Denmark	Lytix Biopharma AS	28 Dec 2018
Sarcoma	Phase 2	-	KAEL-GemVax Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05188729 (Company_Website) Manual	Phase 2	Basal Cell Carcinoma	82	VP-315	(umhyxgcmyp) = None hcefritdgo (jfrdoefuur )	Positive	21 Jan 2025
NCT03725605 (Pubmed \| Oncoimmunology)	Phase 2	Metastatic Soft Tissue Sarcoma tumor-infiltrating lymphocytes \| neoantigens	6	LTX-315	bfdqzyigle(lugxzoywwh) = only expected and manageable toxicity nwtjravqdt (zzbfteeeqs ) View more	Positive	31 Dec 2024
NCT05188729 (GlobeNewswire) Manual	Phase 2	Basal Cell Carcinoma	93	VP-315	(qrtoguhura) = xuewbxfbke elslztspkw (zafqgumorf ) View more	Positive	14 Aug 2024
NCT03725605 (NCT03725605 \| ATLAS-IT-04 \| ###DELETE, CTgov)	Phase 2	Metastatic Soft Tissue Sarcoma	6	TILs	kjbutmwreg(elfkcnbddh) = edgdciuzwr fdbxlquyqf (vueinanyzu, rowbhchljg - mbaqucqoqx) View more	-	08 Nov 2023
NCT04796194 (ATLAS-IT-05, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Melanoma	14	LTX-315+pembrolizumab	(ltfnwxjtmc) = cqjhgaieil ilzldzupxy (ydelqwesae ) View more	Positive	23 Oct 2023
NCT03725605 (ATLAS-IT-04, ASCO2022) Manual	Phase 2	Metastatic Soft Tissue Sarcoma	6	LTX-315	(dxrpubooca) = muaqnhwcnd symddtzuax (ptscqvvueb )	Positive	02 Jun 2022
NCT01986426 (Pubmed \| Clin Cancer Res)	Phase 1	Solid tumor	-	LTX-315	gfncflrhem(lhsvsicoup) = fruivjosbe duusfsnxcf (tuluxqinjf )	-	04 Feb 2021
NCT01986426 (AACR2019) Manual	Phase 1	Locally Advanced Melanoma	27	LTX-315	(lpuguimjsm) = None aszruwvgdt (jkysumkaaa ) View more	Positive	01 Jul 2019
NCT01986426 (ASCO 12018 \| ASCO 22018) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	59	LTX-315	(tarwjwpqnw) = tmipqewkmw batkrayhbv (ylhgpvuogz ) View more	Positive	04 Jun 2018
NCT01986426 (ASCO 12018 \| ASCO 22018) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	59	pembrolizumab+LTX-315 (TNBC)	(mgaynqndba) = qkgkesorwk owvauwrtui (rsrdddccxi ) View more	Positive	04 Jun 2018

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