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 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.

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!

"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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended September 30, 2025 and highlighted recent developments.

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"During our third quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "We expect to initiate our Phase 2b clinical study of IKT-001, our prodrug of imatinib mesylate, in PAH during the fourth quarter of 2025."

Recent Developments:

Advancement of IKT-001 as a therapy in PAH:
The proposed Phase 2b IMPROVE-PAH trial is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. The Company’s bioequivalence studies previously confirmed that 500 mg of IKT-001 has comparable exposure in humans to 383 mg of imatinib. The primary efficacy endpoint is change in pulmonary vascular resistance at Week 26. Secondary endpoints include 6-minute walk distance, World Health Organization functional class, and pharmacokinetics. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least 50 patients at 12-weeks of follow-up.
The Company has been actively working with potential sites and presently expects to initiate IMPROVE-PAH in the fourth quarter of 2025.
Appointed veteran biopharma executive Timothy Pigot as the Company’s Chief Commercial and Strategy Officer.
The Company also expects to present at the Jefferies Global Healthcare Conference in London on Monday, November 17th, 2025.
Financial Results

Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $77.3 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the quarter ended September 30, 2025, was $11.9 million, or $0.13 per share, compared to a net loss of $5.8 million, or $0.65 per share in the quarter ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was $35.5 million, or $0.40 per share, compared to a net loss of $15.4 million, or $2.03 per share, for the nine months ended September 30, 2024.

R&D Expenses: Research and development expenses were $7.6 million for the quarter ended September 30, 2025, compared to $4.2 million for the quarter ended September 30, 2024. Research and development expenses were $23.4 million for the nine months ended September 30, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $1.8 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $10.0 million for the nine months ended September 30, 2024.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2025 were $5.6 million, compared to $1.6 million for the quarter ended September 30, 2024. Selling, general and administrative expenses for the nine months ended September 30, 2025 were $16.8 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $5.6 million for the nine months ended September 30, 2024.

(Press release, Inhibikase Therapeutics, NOV 14, 2025, View Source [SID1234659991])

On November 14, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s third quarter ended September 30, 2025, and provided a corporate update.

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"TuHURA remains highly focused on the execution of its clinical development programs, including enrollment in our Phase 3 pivotal trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in the first line treatment of patients with advanced or metastatic MCC. This accelerated, registration-directed trial, conducted under an SPA Agreement with the FDA, has the potential, if successful, to satisfy the requirements for both accelerated and regular approval without the need to conduct a post-approval confirmatory trial," stated Dr. James Bianco, President and Chief Executive Officer of TuHURA. "In parallel to advancing our late-stage development candidate IFx-2.0, we are working with experts in the treatment of AML to complete the protocol design for our Phase 2 study of TBS-2025, our VISTA inhibiting antibody, in patients with NPM1 mutated AML. We are on track to submit our proposed Phase 2 plan to FDA next month and initiate the Phase 2 randomized study in the first quarter of next year."

Dr. Bianco continued, "In addition to our clinical programs, we were excited to see validation of the scientific merit related to our discovery of the potential role of the DOR expression on Myeloid Derived Suppressor Cells (MDSCs) by being selected by the Joint Program Committees of the ASH (Free ASH Whitepaper) 2025 Annual Meeting for an oral presentation. We look forward to presenting our data demonstrating that the DOR is a potential novel target to reprogram the immune suppressing capabilities of MDSCs and tumor-associated macrophages (TAMs). Together with regulatory T cells (Tregs), these immunosuppressive cells are collectively responsible for acquired resistance to cancer immunotherapies. The DOR technology is the backbone of our program to develop first-in-class bi-specific, bi-functional immune modulating antibody drug conjugates (ADCs). TuHURA’s oral presentation at the ASH (Free ASH Whitepaper) 2025 Annual Meeting is on December 7th at 5:15pm ET."

Corporate Highlights

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Acceptance of Oral and Poster Presentations at ASH (Free ASH Whitepaper) 2025 Annual Meeting and Exposition. TuHURA announced that ASH (Free ASH Whitepaper) has accepted the following abstracts for presentation:

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Oral Presentation: Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs)

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Poster Presentation: Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype to Overcome Acquired Resistance and Enhance the Effectiveness of Cancer Immunotherapies

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Moffitt Cancer Center Poster Presentation: Delta opioid receptor signaling modulates myeloid suppression in Myelodysplastic Syndromes

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Strengthening of TuHURA Team Through the Appointment of Dr. Michael Turner. In November 2025, Michael Turner, Ph.D. was appointed as Vice President of Immunology. Dr. Turner has over 20 years of experience in immunology and oncology, with experience at leading industry companies such as Sanofi Genzyme, Alkermes, Ventus Therapeutics and Third Harmonic Bio.

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$50 Million At-The-Market (ATM) Facility Filed. In November 2025, TuHURA became eligible to file a "shelf" registration statement on Form S-3 and entered into agreement providing for an ATM facility of up to $50 Million. TuHURA will become able to sell shares under the ATM facility when the S-3 registration statement filed on November 3, 2025 becomes effective under the rules and regulations of the SEC.

Upcoming Targeted Milestones by Program

IFx-2.0 (Innate immune agonist)

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Q2 2026: Anticipate preliminary results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP).

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Q4 2026: Anticipate completion of enrollment in the randomized, placebo-controlled Phase 3 accelerated approval trial in first line treatment as adjunctive therapy to Keytruda in advanced or metastatic MCC.

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Q1 2027: Anticipate topline results from the Phase 3 accelerated approval trial.

TBS-2025 (VISTA inhibiting antibody)

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Q4 2025: Submission of the Phase 2 protocol and plan to the FDA for TBS-2025 in hematologic malignancies.

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Q1 2026: Initiation of a Phase 2 trial of VISTA inhibiting mAb in relapsed or refractory NPM1-mutated AML in combination with a menin inhibitor.

Lead ADC Selection

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Q1 2026: TuHURA has developed a library of potent, highly selective DOR inhibitors to be evaluated in its MDSC assays. TuHURA expects to select a lead DOR inhibitor to conjugate to TBS-2025 for testing in preclinical models.

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Q3 2026: Anticipates first proof of concept in-vivo results from its lead immune modulating ADC.

Financial Results for the Three Months and Nine Months Ended September 30, 2025

Research and development expenses were $4.9 million and $2.9 million for the three months ended September 30, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($22.1) million and ($12.1) million for the nine months ended September 30, 2025, and 2024, respectively.

As of September 30, 2025, TuHURA’s total shares outstanding was approximately 51.2 million.

(Press release, TuHURA Biosciences, NOV 14, 2025, View Source [SID1234659979])