Verrica Pharmaceuticals Reports Third Quarter 2025 Financial Results

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])

Inhibikase Therapeutics Announces Third Quarter 2025 Financial Results and Highlights Recent Activity

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])

TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate Update

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


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:


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)


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


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


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.


$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)


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).


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.


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

TBS-2025 (VISTA inhibiting antibody)


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


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


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.


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])

Sensei Biotherapeutics Reports Third Quarter 2025 Financial Results

On November 14, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the third quarter 2025.

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On October 30, 2025, the Company announced that its Board of Directors determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations.

In connection with this strategic review, the Company has implemented a workforce reduction to preserve cash, reducing its workforce by approximately 65 percent. The Company is retaining a small team of employees to assist in exploring strategic alternatives, maintaining compliance with regulatory and financial reporting requirements, and managing the orderly cessation of development activities.

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $25.0 million as of September 30, 2025, as compared to $41.3 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the quarter ended September 30, 2025, compared to $4.6 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily attributable to lower personnel and facilities costs, and reduced lab supply costs.

General and Administrative (G&A) Expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2025, compared to $3.2 million for the quarter ended September 30, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs.

Net Loss: Net loss was $4.6 million for the quarter ended September 30, 2025, compared to $7.3 million for the quarter ended September 30, 2024.

(Press release, Sensei Biotherapeutics, NOV 14, 2025, View Source [SID1234659978])

Purple Biotech Reports Third Quarter 2025 Financial Results and Provides Business Update

On November 14, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported financial results for the three months ended September 30, 2025, and provided a business update.

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"During the quarter, we secured the necessary funds to support the development of our CAPTN-3 technology platform through significant milestones. We plan to conduct non-GLP and GLP toxicology studies, submit an Investigational New Drug application (IND) and initiate a Phase 1 study for IM1240 in 2026. CAPTN-3 continues to produce tri-specific NK and T cell engagers with a novel, differentiated tumor-associated antigen arm. IM1240, the first tri-specific antibody from the platform, targets 5T4, and IM1305, with a TROP2 antigen-targeting arm, has recently entered the development pipeline," said Purple Biotech CEO Gil Efron. "While the versatility and applicability of the CAPTN-3 tri-specific construct are only beginning to garner attention, we believe in its synergistic, yet safe activation of both the innate and adaptive immune systems to help overcome tumor immune evasion."

Recent Clinical and Corporate Highlights:

CAPTN-3 Tri-Specific Antibody Platform

● Nominated IM1305 as the second tri-specific antibody development candidate from the CAPTN-3 platform, targeting TROP2 in addition to masked CD3 and NKG2A arms (capped-CD3xTROP2xNKG2A)

● IM1240, the first CAPTN-3 tri-specific antibody development candidate targeting 5T4 (capped-CD3x5T4xNKG2A), achieved a manufacturing and scalability milestone with a commercially viable yield.

● In collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, demonstrated IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies

● IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation planned for 2026

CM24 (α-CEACAM1 monoclonal antibody)

● The biomarkers identified in the CM24 Phase 2 study will be used for patient selection in the Phase 2b study, which is subject to partnering.

● Detailed design for the next study focuses on two main objectives:

○ A separate arm testing CM24 alone in combination with standard of care to assess the contribution of each component. The second arm will test CM24 plus anti-PD1 plus standard of care. The third arm will test standard of care alone.

○ Selection of patients based on the identified biomarkers, which are expected to result in better outcomes for patients in the treatment arms.

NT219 (IRS1/2 degrader and STAT3 blocker)

● Received an intention to grant a European patent covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance

● Ongoing NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux)

● The Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus

Financial Results for the Three Months Ended September 30, 2025

Research and Development Expenses were $0.6 million for the three months ended September 30, 2025, representing a decrease of $0.8 million, or 56.4%, from $1.3 million in the same period of 2024. The decrease was primarily attributable to reduced costs associated with the CM24 Phase 2 study.

General and Administrative Expenses were $0.8 million for the three months ended September 30, 2025, consistent with the $0.8 million reported in the same period of 2024, reflecting continued cost management discipline.

Operating Loss was $1.4 million for the three months ended September 30, 2025, a decrease of $0.8 million, or 35.8 %, compared to $2.1 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses.

Adjusted Operating Loss (as reconciled below) was $1.3 million for the three months ended September 30, 2025, a decrease of $0.7 million compared to $2.0 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses.

Finance Income, net, was $0.1 million for the three months ended September 30, 2025, compared to $1.5 million in the same period of 2024, representing a decrease of $1.4 million, primarily attributable to a lower non-cash gain from the revaluation of outstanding warrants and issuance-related expenses.

Net Loss was $1.3 million, or $0.29 per basic and diluted ADS, for the three months ended September 30, 2025, compared to a net loss of $0.7 million, or $0.39 per basic and diluted ADS, in the same period of 2024. The year-over-year change was primarily attributable to a $0.8 million reduction in operating expenses and a $1.4 million decrease in finance income, net.

As of September 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $10.5 million. The Company’s cash runway is expected into the first half of 2027.

(Press release, Purple Biotech, NOV 14, 2025, View Source [SID1234659976])