On November 14, 2025 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2025.

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"In the third quarter, Verrica achieved multiple commercial, corporate, scientific and regulatory milestones providing a strong foundation for future growth in YCANTH as well as significant upside potential from our late-stage clinical pipeline," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. "Throughout the past year, while growing adoption of YCANTH for molluscum, we have also significantly advanced our late-stage clinical programs in two of the highest unmet needs in dermatology."

Dr. Rieger continued, "For the nine months ending September 30, 2025, we dispensed 37,642 applicator units compared to 17,119 units in the prior year, representing a 120% increase. I commend our team for more than doubling dispensed units of YCANTH over this period while reducing operating expenses by nearly half. We also made three significant advances in our development pipeline over this same period. First, we have begun our global Phase 3 clinical program of YCANTH (VP-102) in common warts with our Japanese development partner, Torii Pharmaceutical, with targeted first patient enrolled in the United States this year. Verrica also

helped support Torii in obtaining the approval of YCANTH for molluscum in Japan in September. Second, we recently received European regulatory feedback providing a pathway to registration for YCANTH for molluscum in Europe without the need for additional Phase 3 studies. Finally, we received clear and positive feedback from the FDA about the study design for a Phase 3 development program for our oncology asset, VP-315, for basal cell carcinoma, the most common form of skin cancer. Each of these development opportunities represent meaningful future growth potential for Verrica, and together we believe they compose one of the most advanced portfolios of late-stage product candidates in dermatology."

"Recent interest in Verrica’s pipeline candidates at multiple scientific and business conferences has demonstrated the potential of our portfolio, enabling potential partnering and other non-dilutive financing discussions to help support further development and commercialization efforts for these late-stage programs. I couldn’t be more proud of our simultaneous achievement of these goals, and we are excited to see what’s ahead for Verrica into the end of 2025 and beyond," concluded Dr. Rieger.

Conference Call and Webcast Information

The Company will host a conference call on Monday, November 17, 2025, at 8:30 am, to discuss its third quarter 2025 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-800-245-3047

International Dial-In Number: 1-203-518-9765

Conference ID: VERRICA

Participants can use Guest dial-in #s above and be answered by an operator.

Webcast:

View Source;tp_key=4cd2293ef2

The call will be broadcast live over the Web and can also be accessed on Verrica Pharmaceuticals’ website: www.verrica.com.

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

•
During the third quarter, YCANTH dispensed applicator units totaled 14,093, representing a sequential increase of 4.9% over the 13,434 dispensed applicator units of YCANTH for the second quarter of 2025.

•
During the third quarter, in partnership with the Company’s Japanese development partner, Torii Pharmaceutical Co. Ltd. ("Torii"), the Company initiated clinical startup activities for the global Phase 3 program in common warts and expects first patient enrollment in the United States by the end of 2025.

•
The Company expects to launch YCANTH Rx, a new non-dispensing pharmacy option, in the fourth quarter of 2025. YCANTH Rx is designed to give prescribers a single place to write all YCANTH prescriptions and assist with benefits investigation, processing any prior authorizations and enrollment in the Company’s copay assistance program. Prescriptions written to YCANTH Rx will then be routed to a dispensing pharmacy in the Company’s pharmacy network that is contracted with the patient’s insurance plan.

•
In addition, the Company’s total sales force rose to 45 sales representatives in October, and it plans to increase the size of the sales force to 50 in 2026.

•
On October 20, 2025, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive feedback that supports the filing of a Marketing Authorization Application for Verrica’s product, YCANTH, as a treatment for molluscum contagiosum ("molluscum") in Europe. The Company sought and received positive written feedback from the CHMP to gain scientific advice on the development of YCANTH for the treatment of molluscum in adult and pediatric patients 2 years of age and older. Several key issues discussed in the feedback included alignment on:

•
The acceptability of the design of the previously-completed Phase 3 studies, including study duration, choice of primary and secondary endpoints and the choice of patient population;

•
The clinical safety data package to support MAA filing; and

•
The adequacy of nonclinical studies and published literature to support the MAA filing.

VP-315

•
On November 4, 2025, the Company presented new data on VP-315 from its Phase 2 trial in basal cell carcinoma (BCC) at the 40th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The presentation revealed supportive immunologic mechanistic data that helps explain why VP-315 shrinks treated basal cell carcinomas in many patients (as evidenced by a 97% objective response rate and a 86% reduction in overall tumor size), but also a potential abscopal-like effect in non-treated lesions, which strongly suggests immune system engagement.

•
The FDA confirmed alignment with the Company’s plan for the Phase 3 program to encompass two placebo-controlled Phase 3 studies with approximately 100 subjects each and a primary endpoint of complete clearance as assessed at week 14. Based on the discussion with the FDA, the Company expects these studies will be adequate to support a New Drug Application (NDA) filing, with long-term follow-up studies to be conducted as post-approval commitments.

CORPORATE

•
On September 19, 2025, Verrica announced that its development partner, Torii, received approval from the Japanese Ministry of Health, Labour and Welfare for YCANTH (TO-208) for the treatment of molluscum. The approval triggered a $10 million cash milestone payment, which Verrica received in September 2025.

•
On July 1, 2025, the Company announced a second amendment to its Collaboration and Licensing Agreement with Torii to initiate the global Phase 3 program of YCANTH (TO-208) for the treatment of common warts.

•
Torii agreed to accelerate an $8 million milestone payment to Verrica for initiating the global Phase 3 program, which the Company received in July 2025.

•
Torii agreed to pay Verrica a $10 million milestone payment in cash for the Japanese approval of YCANTH (TO-208 in Japan) for molluscum. As noted above, Torii received approval for YCANTH in Japan in September 2025.

•
Torii will continue to split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of the trial costs, representing approximately 90% of the current trial budget. To repay its half of the trial costs, Verrica will offset amounts otherwise owed by Torii for future royalties, certain transfer price payments and remaining development milestones (not including the $8 million and $10 million milestone payments noted above).

•
Verrica will initiate a manufacturing transfer to Torii for YCANTH (TO-208) applicators to be sold in Japan, which is expected to take place in stages over the next several years. In the interim, Verrica will continue to receive from Torii a transfer price for applicators manufactured by Verrica’s manufacturing partners. After the transfer of at least one component of the manufacturing process, Verrica will begin receiving royalties related to net sales in Japan of applicators manufactured by Torii and/or its manufacturing partners in lieu of the transfer price for completed applicators.

Financial Results

Third Quarter 2025 Financial Results

•
Product revenue, net was $3.6 million for the three months ended September 30, 2025, compared to negative net product revenue of $1.9 million for the three months ended September 30, 2024, which included a provision for product returns of $1.7 million and no revenues from ex-factory sales. Product revenue, net, relates to the delivery of YCANTH to Verrica’s distribution partners.

•
License and collaboration revenue was $10.7 million for the three months ended September 30, 2025, compared to $0.1 million for the three months ended September 30, 2024. License and collaboration revenue for the three months ended September 30, 2025, consisted of $10 million of Torii milestone revenue as well as $0.7 million of collaboration revenue for supplies and development activity with Torii. Collaboration revenue for the three months ended September 30, 2024, consisted of supplies and development activity with Torii.

•
Costs of product revenue were $0.8 million for the quarter ended September 30, 2025, compared to $0.4 million for the quarter ended September 30, 2024.

•
Selling, general and administrative expenses were $9.4 million for the quarter ended September 30, 2025, compared to $16.1 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $5.6 million was primarily due to lower expenses related to commercial activities for YCANTH (VP-102), including decreases in compensation, benefits and travel due to reduced sales force of $3.5 million, decreased commercial costs of $1.2 million, and decreased marketing and sponsorship costs of $0.8 million.

•
Research and development expenses were $2.2 million for the quarter ended September 30, 2025, compared to $2.4 million for the same period in 2024. Excluding the impact of stock-based compensation, the increase of $0.1 million was in line with the prior year.

•
Interest income was $0.2 million for the quarters ended September 30, 2025 and 2024.

•
Interest expense was $2.1 million for the quarter ended September 30, 2025, and $2.4 million for the same period in 2024. Interest expense is related to borrowings under the Company’s credit agreement with OrbiMed. The decrease of $0.3 million was related to a lower principal balance.

•
For the quarter ended September 30, 2025, net loss was $0.3 million, or $0.03 per basic and diluted share, compared to a net loss of $22.9 million, or $4.88 per share, for the same period in 2024.

•
For the quarter ended September 30, 2025, non-GAAP net income was $1.2 million, or $0.13 per basic and diluted share, compared to a non-GAAP net loss of $20.2 million, or $4.31 per share, for the same period in 2024.

•
As of September 30, 2025, Verrica had $21.1 million in cash and cash equivalents.

Year-to-Date September 2025 Financial Results

•
Product revenue, net was $11.6 million for the nine months ended September 30, 2025, compared to $6.3 million for the nine months ended September 30, 2024. For the nine months ended September 30, 2025, product revenue, net was primarily related to an increase in deliveries of YCANTH to Verrica’s distribution partners.

•
License and collaboration revenue was $18.9 million for the nine months ended September 30, 2025, compared to $1.0 million for the nine months ended September 30, 2024. License and collaboration revenue for the nine months ended September 30, 2025, consisted of $18.0 million in milestone revenue from Torii as well as supplies and development activity. License and collaboration revenue for the nine months ended September 30, 2024, consisted of supplies and development activity with Torii.

•
Costs of product revenue were $1.5 million for the nine months ended September 30, 2025, compared to $1.3 million for the nine months ended September 30, 2024.

•
Selling, general and administrative expenses were $27.1 million in the nine months ended September 30, 2025, compared to $48.9 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $18.8 million was primarily due to lower expenses related to commercial activities for YCANTH (VP-102), including decreases in compensation, benefits and travel due to reduced sales force of $11.6 million, decreased marketing and sponsorship costs of $4.6 million, decreased commercial costs of $1.3 million, and decreased legal costs of $1.3 million.

•
Research and development expenses were $6.3 million in the nine months ended September 30, 2025, compared to $10.7 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $3.6 million was primarily related to decreased clinical trial costs for VP-315 of $2.7 million and decreased chemistry, manufacturing and controls costs of $0.8 million.

•
Interest income was $0.7 million for the nine months ended September 30, 2025, compared to $1.2 million for the same period in 2024. The decrease of $0.5 million was primarily due to a lower cash balance.

•
Interest expense was $6.4 million for the nine months ended September 30, 2025, and $7.1 million for the same period in 2024. Interest expense is related to borrowings under the OrbiMed Credit Agreement. The decrease of $0.6 million was related to a lower principal balance.

•
For the nine months ended September 30, 2025, net loss was $9.8 million, or $1.03 per share, compared to a net loss of $60.4 million, or $12.96 per share, for the same period in 2024.

•
For the nine months ended September 30, 2025, non-GAAP net loss was $4.2 million, or $0.44 per share, compared to a non-GAAP net loss of $52.4 million, or $11.24 per share, for the same period in 2024.

(Press release, Verrica Pharmaceuticals, NOV 14, 2025, View Source [SID1234659992])

On November 14, 2025 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2025.

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"In the third quarter, Verrica achieved multiple commercial, corporate, scientific and regulatory milestones providing a strong foundation for future growth in YCANTH as well as significant upside potential from our late-stage clinical pipeline," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. "Throughout the past year, while growing adoption of YCANTH for molluscum, we have also significantly advanced our late-stage clinical programs in two of the highest unmet needs in dermatology."

Dr. Rieger continued, "For the nine months ending September 30, 2025, we dispensed 37,642 applicator units compared to 17,119 units in the prior year, representing a 120% increase. I commend our team for more than doubling dispensed units of YCANTH over this period while reducing operating expenses by nearly half. We also made three significant advances in our development pipeline over this same period. First, we have begun our global Phase 3 clinical program of YCANTH (VP-102) in common warts with our Japanese development partner, Torii Pharmaceutical, with targeted first patient enrolled in the United States this year. Verrica also

helped support Torii in obtaining the approval of YCANTH for molluscum in Japan in September. Second, we recently received European regulatory feedback providing a pathway to registration for YCANTH for molluscum in Europe without the need for additional Phase 3 studies. Finally, we received clear and positive feedback from the FDA about the study design for a Phase 3 development program for our oncology asset, VP-315, for basal cell carcinoma, the most common form of skin cancer. Each of these development opportunities represent meaningful future growth potential for Verrica, and together we believe they compose one of the most advanced portfolios of late-stage product candidates in dermatology."

"Recent interest in Verrica’s pipeline candidates at multiple scientific and business conferences has demonstrated the potential of our portfolio, enabling potential partnering and other non-dilutive financing discussions to help support further development and commercialization efforts for these late-stage programs. I couldn’t be more proud of our simultaneous achievement of these goals, and we are excited to see what’s ahead for Verrica into the end of 2025 and beyond," concluded Dr. Rieger.

Conference Call and Webcast Information

The Company will host a conference call on Monday, November 17, 2025, at 8:30 am, to discuss its third quarter 2025 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-800-245-3047

International Dial-In Number: 1-203-518-9765

Conference ID: VERRICA

Participants can use Guest dial-in #s above and be answered by an operator.

Webcast:

View Source;tp_key=4cd2293ef2

The call will be broadcast live over the Web and can also be accessed on Verrica Pharmaceuticals’ website: www.verrica.com.

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

•
During the third quarter, YCANTH dispensed applicator units totaled 14,093, representing a sequential increase of 4.9% over the 13,434 dispensed applicator units of YCANTH for the second quarter of 2025.

•
During the third quarter, in partnership with the Company’s Japanese development partner, Torii Pharmaceutical Co. Ltd. ("Torii"), the Company initiated clinical startup activities for the global Phase 3 program in common warts and expects first patient enrollment in the United States by the end of 2025.

•
The Company expects to launch YCANTH Rx, a new non-dispensing pharmacy option, in the fourth quarter of 2025. YCANTH Rx is designed to give prescribers a single place to write all YCANTH prescriptions and assist with benefits investigation, processing any prior authorizations and enrollment in the Company’s copay assistance program. Prescriptions written to YCANTH Rx will then be routed to a dispensing pharmacy in the Company’s pharmacy network that is contracted with the patient’s insurance plan.

•
In addition, the Company’s total sales force rose to 45 sales representatives in October, and it plans to increase the size of the sales force to 50 in 2026.

•
On October 20, 2025, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive feedback that supports the filing of a Marketing Authorization Application for Verrica’s product, YCANTH, as a treatment for molluscum contagiosum ("molluscum") in Europe. The Company sought and received positive written feedback from the CHMP to gain scientific advice on the development of YCANTH for the treatment of molluscum in adult and pediatric patients 2 years of age and older. Several key issues discussed in the feedback included alignment on:

•
The acceptability of the design of the previously-completed Phase 3 studies, including study duration, choice of primary and secondary endpoints and the choice of patient population;

•
The clinical safety data package to support MAA filing; and

•
The adequacy of nonclinical studies and published literature to support the MAA filing.

VP-315

•
On November 4, 2025, the Company presented new data on VP-315 from its Phase 2 trial in basal cell carcinoma (BCC) at the 40th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The presentation revealed supportive immunologic mechanistic data that helps explain why VP-315 shrinks treated basal cell carcinomas in many patients (as evidenced by a 97% objective response rate and a 86% reduction in overall tumor size), but also a potential abscopal-like effect in non-treated lesions, which strongly suggests immune system engagement.

•
The FDA confirmed alignment with the Company’s plan for the Phase 3 program to encompass two placebo-controlled Phase 3 studies with approximately 100 subjects each and a primary endpoint of complete clearance as assessed at week 14. Based on the discussion with the FDA, the Company expects these studies will be adequate to support a New Drug Application (NDA) filing, with long-term follow-up studies to be conducted as post-approval commitments.

CORPORATE

•
On September 19, 2025, Verrica announced that its development partner, Torii, received approval from the Japanese Ministry of Health, Labour and Welfare for YCANTH (TO-208) for the treatment of molluscum. The approval triggered a $10 million cash milestone payment, which Verrica received in September 2025.

•
On July 1, 2025, the Company announced a second amendment to its Collaboration and Licensing Agreement with Torii to initiate the global Phase 3 program of YCANTH (TO-208) for the treatment of common warts.

•
Torii agreed to accelerate an $8 million milestone payment to Verrica for initiating the global Phase 3 program, which the Company received in July 2025.

•
Torii agreed to pay Verrica a $10 million milestone payment in cash for the Japanese approval of YCANTH (TO-208 in Japan) for molluscum. As noted above, Torii received approval for YCANTH in Japan in September 2025.

•
Torii will continue to split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of the trial costs, representing approximately 90% of the current trial budget. To repay its half of the trial costs, Verrica will offset amounts otherwise owed by Torii for future royalties, certain transfer price payments and remaining development milestones (not including the $8 million and $10 million milestone payments noted above).

•
Verrica will initiate a manufacturing transfer to Torii for YCANTH (TO-208) applicators to be sold in Japan, which is expected to take place in stages over the next several years. In the interim, Verrica will continue to receive from Torii a transfer price for applicators manufactured by Verrica’s manufacturing partners. After the transfer of at least one component of the manufacturing process, Verrica will begin receiving royalties related to net sales in Japan of applicators manufactured by Torii and/or its manufacturing partners in lieu of the transfer price for completed applicators.

Financial Results

Third Quarter 2025 Financial Results

•
Product revenue, net was $3.6 million for the three months ended September 30, 2025, compared to negative net product revenue of $1.9 million for the three months ended September 30, 2024, which included a provision for product returns of $1.7 million and no revenues from ex-factory sales. Product revenue, net, relates to the delivery of YCANTH to Verrica’s distribution partners.

•
License and collaboration revenue was $10.7 million for the three months ended September 30, 2025, compared to $0.1 million for the three months ended September 30, 2024. License and collaboration revenue for the three months ended September 30, 2025, consisted of $10 million of Torii milestone revenue as well as $0.7 million of collaboration revenue for supplies and development activity with Torii. Collaboration revenue for the three months ended September 30, 2024, consisted of supplies and development activity with Torii.

•
Costs of product revenue were $0.8 million for the quarter ended September 30, 2025, compared to $0.4 million for the quarter ended September 30, 2024.

•
Selling, general and administrative expenses were $9.4 million for the quarter ended September 30, 2025, compared to $16.1 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $5.6 million was primarily due to lower expenses related to commercial activities for YCANTH (VP-102), including decreases in compensation, benefits and travel due to reduced sales force of $3.5 million, decreased commercial costs of $1.2 million, and decreased marketing and sponsorship costs of $0.8 million.

•
Research and development expenses were $2.2 million for the quarter ended September 30, 2025, compared to $2.4 million for the same period in 2024. Excluding the impact of stock-based compensation, the increase of $0.1 million was in line with the prior year.

•
Interest income was $0.2 million for the quarters ended September 30, 2025 and 2024.

•
Interest expense was $2.1 million for the quarter ended September 30, 2025, and $2.4 million for the same period in 2024. Interest expense is related to borrowings under the Company’s credit agreement with OrbiMed. The decrease of $0.3 million was related to a lower principal balance.

•
For the quarter ended September 30, 2025, net loss was $0.3 million, or $0.03 per basic and diluted share, compared to a net loss of $22.9 million, or $4.88 per share, for the same period in 2024.

•
For the quarter ended September 30, 2025, non-GAAP net income was $1.2 million, or $0.13 per basic and diluted share, compared to a non-GAAP net loss of $20.2 million, or $4.31 per share, for the same period in 2024.

•
As of September 30, 2025, Verrica had $21.1 million in cash and cash equivalents.

Year-to-Date September 2025 Financial Results

•
Product revenue, net was $11.6 million for the nine months ended September 30, 2025, compared to $6.3 million for the nine months ended September 30, 2024. For the nine months ended September 30, 2025, product revenue, net was primarily related to an increase in deliveries of YCANTH to Verrica’s distribution partners.

•
License and collaboration revenue was $18.9 million for the nine months ended September 30, 2025, compared to $1.0 million for the nine months ended September 30, 2024. License and collaboration revenue for the nine months ended September 30, 2025, consisted of $18.0 million in milestone revenue from Torii as well as supplies and development activity. License and collaboration revenue for the nine months ended September 30, 2024, consisted of supplies and development activity with Torii.

•
Costs of product revenue were $1.5 million for the nine months ended September 30, 2025, compared to $1.3 million for the nine months ended September 30, 2024.

•
Selling, general and administrative expenses were $27.1 million in the nine months ended September 30, 2025, compared to $48.9 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $18.8 million was primarily due to lower expenses related to commercial activities for YCANTH (VP-102), including decreases in compensation, benefits and travel due to reduced sales force of $11.6 million, decreased marketing and sponsorship costs of $4.6 million, decreased commercial costs of $1.3 million, and decreased legal costs of $1.3 million.

•
Research and development expenses were $6.3 million in the nine months ended September 30, 2025, compared to $10.7 million for the same period in 2024. Excluding the impact of stock-based compensation, the decrease of $3.6 million was primarily related to decreased clinical trial costs for VP-315 of $2.7 million and decreased chemistry, manufacturing and controls costs of $0.8 million.

•
Interest income was $0.7 million for the nine months ended September 30, 2025, compared to $1.2 million for the same period in 2024. The decrease of $0.5 million was primarily due to a lower cash balance.

•
Interest expense was $6.4 million for the nine months ended September 30, 2025, and $7.1 million for the same period in 2024. Interest expense is related to borrowings under the OrbiMed Credit Agreement. The decrease of $0.6 million was related to a lower principal balance.

•
For the nine months ended September 30, 2025, net loss was $9.8 million, or $1.03 per share, compared to a net loss of $60.4 million, or $12.96 per share, for the same period in 2024.

•
For the nine months ended September 30, 2025, non-GAAP net loss was $4.2 million, or $0.44 per share, compared to a non-GAAP net loss of $52.4 million, or $11.24 per share, for the same period in 2024.

(Press release, Verrica Pharmaceuticals, NOV 14, 2025, View Source [SID1234659992])

On November 14, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Cidara Therapeutics, Inc. (Nasdaq: CDTX) ("Cidara"), a biotechnology company developing drug-Fc conjugate (DFC) therapeutics, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Cidara for $221.50 per share in cash, for a total transaction value of approximately $9.2 billion.

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                  Schedule Your 30 min Free Demo!

"We continue to execute our science-led business development strategy, augmenting our pipeline with CD388, a potentially first-in-class, long-acting antiviral designed to prevent influenza in individuals at higher risk of complications," said Robert M. Davis, chairman and chief executive officer, Merck. "We intend to build on the Cidara team’s remarkable progress, and are confident that CD388 has the potential to be another important driver of growth through the next decade, creating real value for shareholders."

Cidara’s lead candidate, CD388, consists of a small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody designed to prevent influenza A and B. CD388 is currently being evaluated in the Phase 3 ANCHOR study (NCT07159763) among adult and adolescent participants who are at higher risk of developing complications from influenza. Supported by results from the Phase 2b NAVIGATE study (NCT06609460), the U.S. Food and Drug Administration (FDA) granted CD388 Breakthrough Therapy Designation. The NAVIGATE study met all primary and secondary endpoints associated with preventing symptomatic laboratory-confirmed influenza in healthy unvaccinated adults ages 18 to 64. CD388 was previously granted Fast Track Designation by the FDA.

"This milestone represents a transformational moment for Cidara and for our mission to redefine influenza prevention," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Thanks to the extraordinary dedication of our team, the Phase 2b NAVIGATE study delivered compelling results that demonstrate CD388’s potential to provide an additional option to vaccines and antivirals to help address unmet needs in influenza prevention. Merck’s global development, regulatory, and commercial capabilities provide the expertise and resources needed to bring this important innovation to those individuals who need it most."

"This acquisition expands and complements our respiratory portfolio and pipeline. Influenza continues to pose a significant global health threat, causing widespread illness, morbidity, and death each year especially in older adults and immunocompromised individuals, such as those with cancer and chronic diseases," said Dr. Dean Y. Li, president, Merck Research Laboratories. "CD388 is a novel late-phase candidate with important strain agnostic properties being evaluated for the prevention of symptomatic influenza in high-risk individuals."

The transaction has been approved by both Merck’s and Cidara Therapeutics’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Cidara Therapeutics. The acquisition is subject to a majority of Cidara Therapeutics’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the first quarter of 2026 and is expected to be accounted for as an asset acquisition.

A copy of the merger agreement pursuant to the transaction will be filed with the Securities and Exchange Commission ("SEC") and will be publicly available. In addition, Merck and Cidara will file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Merck’s internet website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or by phone at (908) 740-4000. Copies of the documents filed with the SEC by Cidara Therapeutics may be obtained at no charge from Cidara Therapeutics’ internet website at www.cidara.com or by contacting Cidara at 6310 Nancy Ridge Dr #101, San Diego, CA 92121 or by phone at (858) 283-8821.

Investor Call

Merck will hold an investor call Monday, November 17, 2025 at 8 a.m. ET to discuss the proposed transaction. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink. Additional details to join the call via dial in will be provided at a later time.

About Influenza

Influenza is an acute respiratory infection caused predominantly by influenza viruses A and B. An estimated 1 billion people worldwide are infected by seasonal influenza each year. Of the 1 billion, 3-5 million have severe cases of flu. Complications include pneumonia, exacerbation of chronic conditions, sepsis, myocarditis, encephalitis, and death in the most severe cases. Globally, an estimated 290,000-650,000 deaths occur due to flu each year with 6,300-52,000 deaths in the US.

About CD388

CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to prevent influenza infection in individuals at higher risk of influenza complications with the potential to provide season-long protection. CD388 is not a vaccine, therefore its activity is not dependent on an immune response and is expected to be efficacious in individuals regardless of immune status.

The ANCHOR study

The ANCHOR study (NCT07159763) is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of CD388, a novel long-acting antiviral conjugate, for the prevention of influenza in adults and adolescents at higher risk of developing influenza complication. The first participants were dosed in September 2025 and enrollment is ongoing in 150 sites in the Northern Hemisphere across the U.S. and the United Kingdom. The study has a target enrollment of 6,000 participants. The study will include an interim analysis in the first quarter of 2026 to assess the trial size and powering assumptions and to determine the potential need for additional enrollment.

(Press release, Cidara Therapeutics, NOV 14, 2025, View Source [SID1234659965])

On November 14, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on operational highlights for the third quarter ended September 30, 2025.

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"The third quarter of 2025 was another milestone period for Allarity as we achieved FDA Fast Track designation for stenoparib in advanced ovarian cancer—an important acknowledgment of the potential of our lead program. We also reported new clinical data showing median overall survival now exceeding 25 months for patients in our Phase 2 trial—a remarkable finding in this difficult-to-treat population. Alongside these achievements, we continued to advance our DRP platform commercially through a new licensing and laboratory services agreement," said Thomas Jensen, CEO of Allarity Therapeutics. "The consistency of our progress reflects our disciplined, focused strategy and execution. Stenoparib continues to show durable clinical benefit in women with advanced, platinum resistant ovarian cancer, and we continue to deepen our understanding of its unique dual mechanism of action through our collaboration with the Indiana Biosciences Research Institute. With both the ongoing ovarian cancer trial progressing under Fast Track designation and the forthcoming U.S. Veterans Administration–funded small cell lung cancer combination study advancing toward initiation, we see the potential to broaden stenoparib’s therapeutic reach—offering new hope for patients across multiple hard-to-treat cancer types."

Clinical and Drug Development Progress

FDA Fast Track designation: In August 2025, the U.S. Food and Drug Administration granted Fast Track designation to stenoparib for the treatment of advanced ovarian cancer, recognizing the significant unmet medical need in this patient population. The designation enables more frequent interactions with the FDA and potential eligibility for accelerated and priority review pathways.

Landmark survival data: In September 2025, at the AACR (Free AACR Whitepaper) 7th Biennial Special Conference on Ovarian Cancer, Allarity presented new Phase 2 data showing that median overall survival for patients receiving twice-daily stenoparib has not yet been reached and now exceeds 25 months.

Ongoing trial enrollment: Enrollment continued in the new Phase 2 trial protocol evaluating stenoparib in recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer. The study has maintained steady investigator engagement and is expected to generate critical data by end of 2026.

IBRI research collaboration: Work with the Indiana Biosciences Research Institute (IBRI) remains on track, with molecular and cellular studies underway to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s anticancer activity. This research aims to deepen the Company’s mechanistic understanding of the molecule and support future development opportunities in ovarian cancers as well as other cancers such as Small Cell Lung Cancer and potentially Colorectal Cancer.

Corporate and Strategic Developments

DRP platform expansion: Signed a new commercial agreement with an EU-based biotechnology company providing a non-exclusive global license to selected breast cancer DRP algorithms and securing laboratory service commitments through the Allarity Medical Laboratory in Denmark.

Scientific visibility and partnering: In October 2025, CEO Thomas Jensen presented at Biomarkers & Precision Medicine 2025 in London, highlighting the role of the stenoparib DRP companion diagnostic in optimizing patient selection and advancing precision oncology. Earlier in the third quarter, new survival data from the ongoing ovarian cancer trial were also presented at the AACR (Free AACR Whitepaper) 7th Biennial Special Conference on Ovarian Cancer—a premier scientific forum hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Financial position: Ended the third quarter with a solid cash position, consistent with prior guidance, maintaining a financial runway through Q4 2026.

Anticipated Clinical Milestones in 2025–2026

Ovarian cancer trial progress: Continued extension of median Overall Survival in the first Ovarian cancer trial using twice daily dosing. Fast-paced enrollment in the new protocol in platinum resistant or ineligible ovarian cancer patients.

SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer expected to be open for enrollment by year-end 2025. This represents the first combination study for stenoparib and may demonstrate that the safety profile of stenoparib makes it an ideal drug for combination therapy.

Third Quarter 2025 Financial Highlights

Cash Position: As of September 30, 2025, Allarity finished the quarter with $16.9 million in cash, a decrease of $0.9 million since June 30, 2025. The Company continues to maintain a financial runway to December 2026.

R&D Expenses: Research and development expenses for the third quarter of 2025 were $1.2 million, compared to $1.0 million for the third quarter of 2024.

G&A Expenses: General and administrative expenses for the third quarter of 2025 were $1.3 million, compared to $1.6 million for the third quarter of 2024.

Net Loss: Net loss attributable to common stockholders for the third quarter of 2025 was $2.8 million, compared to a net loss of $12.2 million for the third quarter of 2024.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, NOV 14, 2025, View Source [SID1234659995])

On November 14, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its participation in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

(Press release, Cogent Biosciences, NOV 14, 2025, View Source [SID1234659966])