Human Papillomavirus Infection

- Posters to 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., Oct. 24, 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 the acceptance of two abstracts that will be presented as posters at the Fall Clinical Dermatology Conference, which is being held from October 24-27, 2024, in Las Vegas, Nevada. The posters will feature clinical data from Part 2 of the Company’s Phase 2 study of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”). The presentations are 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”. The posters will include safety and histologic clearance data from 82 patients with up to 2 target BCC tumors (total 92 tumors) in Part 2 of the Phase 2 study evaluating VP-315 for the treatment of BCC, including patients with tumors on the head and neck. Part 2 of the Phase 2 trial was designed to further explore dosing regimens to help identify the recommended regimen for a Phase 3 study program. Approximately 51% of tumors treated in Part 2 achieved complete histological clearance and patients with residual tumor on average achieved approximately 71% reduction in tumor size. There were no Treatment Related Serious Adverse Events, and most Treatment Related Adverse Events were mild to moderate. The Company 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 to determine the next steps for the development of VP-315 for the treatment of BCC in the first half of 2025. “We believe the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315 are a meaningful step forward in potentially providing BCC patients with additional treatment options,” said Ted White, President and Chief Executive Officer of Verrica. “We are encouraged by our preliminary results, which we believe support the use of VP-315 as a first line therapy for use in both primary, and neoadjuvant settings. As a novel oncolytic peptide administered directly into the tumor, VP-315 has the potential to offer a non-surgical alternative for the three to four million cases of BCC diagnosed in the U.S. each year, representing a multi-billion-dollar commercial opportunity for Verrica.” About the Phase 2 Trial of VP-315The Phase 2 trial 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 lesion. 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 has an exclusive worldwide license to develop and commercialize VP-315 for 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 U.S., and incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinomas 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 June 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

DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management. Essentially all cervical cancer cases worldwide are caused by HPV infection. SAN DIEGO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health to address critical unmet challenges in women’s health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. Daré will receive $10 million in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions. DARE-HPV is an innovative investigational treatment for HPV-related cervical disease. Essentially all cervical cancers worldwide are caused by HPV infection, and despite the advancements in HPV screening and vaccination, an estimated 100,000 women are still treated for cervical precancer and an estimated 4,000 women still die from cervical cancer in the U.S. every year. Today, cervical precancers are monitored until they reach a late stage, since the most common treatment is a surgery which removes part of the cervix; however, the surgery is associated with an increased risk of preterm birth and sexual dysfunction and therefore is not recommended for patients with fertility concerns. “DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well as earlier stage HPV-related cervical infections, which could change the paradigm around how HPV-related cervical diseases are clinically managed today,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We are thrilled that ARPA-H shares our vision for this product candidate's potential to transform the management of HPV-related cervical diseases with this at-home strategy to control the virus that causes cervical cancer.” ARPA-H sought solutions within six topics of interest in women’s health, and received an unprecedented response of submissions. ARPA-H launched the Sprint for Women’s Health in February, with First Lady Jill Biden announcing the funding as the first major deliverable from the White House Initiative on Women’s Health Research. The ARPA-H Sprint for Women’s Health is conducted in collaboration with the Investor Catalyst Hub of ARPANET-H, the agency’s nationwide health innovation network that connects people, innovators, and institutions to accelerate better health outcomes for everyone. Daré will work with an ARPA-H Program Manager and the Investor Catalyst Hub over two years to develop DARE-HPV, receiving milestone-based payments aligned to research activities and performance objectives. The ARPA-H launchpad program accelerates transformative health solutions’ path to impact by providing funding and market transition support. As a launchpad performer, Daré will also work with an Entrepreneur-in-Residence and participate in Launchpad Accelerator, which includes customized curriculum, virtual events, and in-person workshops to support performer market transition. About HPV-Related Cervical Diseases and DARE-HPV Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Essentially all cervical cancers worldwide are caused by infection with one of 14 carcinogenic, or “high-risk” HPV types (hrHPV). While some HPV infections are transient, persistent hrHPV infection can progress to cervical cancer through the persistence and progression of cervical lesions. DARE-HPV is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential to be a first-in-category treatment for HPV-related cervical diseases. There currently are no U.S. Food and Drug Administration (FDA)-approved, non-surgical pharmaceutical interventions to treat high-grade cervical lesions (also called high-grade squamous intraepithelial lesions (HSIL) or high-grade cervical intraepithelial neoplasia (CIN 2/3)) and no FDA-approved treatments for HPV infection. DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention for the treatment of CIN and other HPV-related cervical pathologies. In the U.S., about 10% of women with HPV infection on their cervix will develop long-lasting HPV infections that put them at risk for cervical cancer. The American Cancer Society estimates that approximately 13,820 new cases of invasive cervical cancer will be diagnosed and more than 4,000 women will die from the disease in the U.S. in 2024. Additionally, each year in the U.S., an estimated 100,000 people are treated for cervical precancer, of which approximately 74% are between the ages of 18–39 years, during prime childbearing and childrearing years. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking StatementsDaré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s expectation that it will receive $10 million in funding from ARPA-H, DARE-HPV’s potential as a safe and effective treatment for HPV-related cervical diseases, the potential for DARE-HPV to be the first FDA-approved pharmaceutical intervention for treatment of late-stage cervical lesions and other HPV-related cervical pathologies, and the potential market opportunity for DARE-HPV, if approved. As used in this press release, the description of a product candidate as “first-in-category” is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Daré is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to achieve the product development and other milestones required for it to receive payments under its ARPA-H funding award; Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relationsinnovations@darebioscience.com Source: Daré Bioscience, Inc.

– Preclinical data demonstrate that inhibiting the p300 KAT domain reactivates p53 in HPV-driven tumors resulting in anti-tumor activity –SAN MATEO, Calif., and CAMBRIDGE, Mass., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, today announced preclinical data from its p300 KAT inhibitor program for human papillomavirus (HPV)-driven tumors at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Kronos Bio is exploring the utility of its p300 KAT inhibitor, KB-9558, for HPV-driven tumors. In the presentation, the authors show that the HPV genome preferentially integrates into transcriptionally active regions in the human genome where it becomes dependent on p300 to drive expression of its E6 and E7 oncogenes. It is widely recognized that elevated transcription of HPV E6 and E7 genes promotes degradation of tumor suppressors p53 and Rb. Importantly, inhibition of p300 KAT activity was highly selective in repressing the transcription of E6 and E7, which in turn led to restoration of the p53 and Rb pathways and drove anti-tumor effects through apoptosis and inhibition of uncontrolled tumor cell growth. "Continued expression of certain viral genes, especially E6 and E7, plays a critical role in tumor growth and progression of HPV-driven tumors, including head & neck, cervical, and other anogenital cancers. Importantly, there are no approved targeted therapies that inhibit E6 and E7,” said Charles Lin, Ph.D., chief scientific officer of Kronos Bio. "While this is early-stage research, given the ability of p300 KAT inhibition to target E6 and E7 and restore tumor suppressor pathways, we believe this p300 KAT inhibitor has the potential to be a remarkable and unique approach toward ensuring that fewer people suffer from HPV-driven cancer." In the presentation titled, "Oncogenic human papillomavirus hijacks p300 to drive viral transcription, creating a therapeutic vulnerability that can be exploited with selective p300/CBP catalytic inhibitors", the authors describe the experiments that led to the following key findings: HPV integrates into the human genome at specific locations where p300 regulates transcriptionp300 inhibition demonstrated specific and potent reduction of expression of HPV oncogenes E6 and E7, both at the RNA and protein levelLoss of E6 and E7 led to restoration of p53 and Rb tumor suppressor pathways which led to the upregulation of p53 activated genes (e.g., CDKN1A) and downregulation of Rb repressed genes (e.g., CDK1)Re-expression of E6 and E7 from an exogenous lentiviral vector where viral oncogene transcription is not mediated by p300 KAT activity reversed the effects of p300 KAT inhibition on p53 restoration and anti-tumor effectsThese findings support the potential of KB-9558, a p300 KAT inhibitor, to treat HPV-driven tumors given its potential to suppress E6 and E7 expression and restore the p53 pathway The poster presentation will take place on October 24, 2024, and is currently available under the Publications section of the Kronos Bio website. About Kronos BioKronos Bio is a clinical-stage biopharmaceutical company dedicated to developing small molecule therapeutics that address deregulated transcription, a hallmark of cancer and autoimmune disease. Our proprietary discovery engine decodes complex transcription factor regulatory networks to identify druggable cofactors. We screen for and optimize small molecules that target these cofactors in a disease-specific context. Kronos Bio has a pipeline of three drug candidates. Istisociclib (KB-0742) is currently enrolling ovarian cancer patients in a Phase 1/2 clinical trial. Preclinical candidate KB-9558 is being developed for multiple myeloma and HPV-driven tumors. KB-7898 is Kronos Bio’s first autoimmune development candidate and has a target indication of Sjögren’s disease. Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit https://www.kronosbio.com or follow the Company on LinkedIn. Forward-Looking StatementsStatements in this press release that are not statements of historical fact are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release, in some cases, uses terms such as “anticipate,” “believe,” “could,” “expect,” “plan,” “will,” “may,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding Kronos Bio’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, KB-9558’s ability to potentially treat HPV-driven tumors; the potential of Kronos Bio’s product candidates, pipeline and its proprietary discovery engine; and other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: changes in the macroeconomic environment or competitive landscape that impact Kronos Bio’s business; whether Kronos Bio will be able to progress its preclinical pipeline on the timelines anticipated, including due to risks inherent in the development of novel therapeutics; the risk that results of preclinical studies, early clinical trials (including preliminary results) and pharmacokinetic modeling are not necessarily predictive of future results; and risks associated with the sufficiency of Kronos Bio’s cash resources and need for additional capital. These and other risks are described in greater detail in Kronos Bio’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 8, 2024. Any forward-looking statements that are made in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Except as required by law, Kronos Bio assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.