On February 26, 2026 Prokarium’s CEO, Ibs Mahmood, reported that it will be presenting at the 41st Annual EAU Congress, London, UK, 13-16th March 2026.

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!

Presentation information:

Presentation Title: PARADIGM 1 – A multi-center Phase 1 study evaluating the safety and clinical effect of a novel microbial immunotherapeutic (ZH9) in patients with relapsed NMIBC – A first interim review (Abstract ID: A0089)
Session Title: High-risk NMIBC: Evolving BCG–immunotherapy strategies and technical advances in TURB (Abstract Session 05)
Session Date and Time: Friday 13th March, 16:20 – 16:56

(Press release, Prokarium, FEB 26, 2026, View Source [SID1234663087])

On February 26, 2026 Boehringer Ingelheim reported that the U.S. Food and Drug Administration (FDA) approved HERNEXEOS (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1

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!

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Boehringer is currently enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. (NCT06151574).

Accelerated approval is based on data from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion LUNG-1 trial which demonstrated an objective response rate of 76%, including 11% of patients with a complete response and 65% of patients with a partial response.1 Zongertinib demonstrated a duration of response of ≥6 months in 64% of patients.1 This data builds upon the FDA accelerated approval of HERNEXEOS for previously treated patients in August 2025.

"Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy, a manageable safety profile, and once daily oral administration," said coordinating investigator for the Beamion LUNG-1 trial, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "Now these patients finally have a targeted treatment option that they can receive immediately following identification of a HER2 mutation."

"With HERNEXEOS now approved for patients with HER2-mutant advanced NSCLC as an initial treatment option, we are delivering on our promise to transform care for people with this rare and aggressive cancer," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "This approval marks a shift towards personalized care with a targeted treatment option for patients with HER2 mutated lung cancer. It underscores our relentless focus on accelerating innovation to address a significant unmet need."

HER2 (ERBB2) mutations occur in approximately 2-4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.2,3,4 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.2,4

"We first learned about the HER2 genetic mutation as a lung cancer driver in a small subset of patients more than 20 years ago," said Danielle Hicks, Chief Patient Officer of GO2 for Lung Cancer. "Half of these people do not respond to the current standard of care, which is why it is vital to provide them with a treatment option that has been designed specifically for their disease. Understanding your biomarkers is so important because it can unlock more personalized and effective treatment options."

Zongertinib demonstrated a manageable safety profile as an initial treatment that was consistent with that observed and reported in previously treated patients. Adverse events led to dose discontinuations in 6% of patients.1 In a pooled safety population, which included 292 patients with HER2 (ERBB2)-mutant NSCLC, both treatment-naïve and previously treated, the most common (>20%) adverse reactions were diarrhea (54%), rash (28%), hepatotoxicity (27%), fatigue (25%), nausea (23%), musculoskeletal pain (21%), and upper respiratory tract infection (20%).1

The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner’s National Priority Voucher for zongertinib, underscoring its potential to meet critical patient needs for this rare and aggressive cancer.

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.2 The condition is often diagnosed at a late stage, and fewer than 1 in 10 patients are alive five years after diagnosis.6,7 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,9,10 There remains a high unmet need for additional treatment options for people living with advanced NSCLC.

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.2

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).1,11 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.

Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,4

The treatment is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, FEB 26, 2026, View Source [SID1234663103])

On February 26, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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!

"I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics," said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. "I’m also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the Phase 1 basket study of FT819 across the U.S., U.K. and E.U., with the ultimate goal to advance FT819 to commercialization in various autoimmune diseases. Last year’s accomplishments are further highlighted by strong fourth-quarter clinical site activation, accelerated patient enrollment, expansion of FT819 into additional autoimmune diseases, the advancement of our next generation CAR T-cell programs, and continuation of our scientific leadership through quality conference presentations and manuscript publications. Importantly, additional clinical signals across autoimmune disease and in oncology without the use of conditioning chemotherapy are further validating the breadth of our platform. We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation."

Clinical Development & Program Updates

FT819 Off-the-Shelf CAR T-cell Program in Autoimmune Disease for Broad Patient Accessibility

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population.

•
FT819-102 Phase 1 clinical trial now enrolling in 16 clinical sites across the U.S., U.K. and E.U. The Company’s ongoing multi-center, Phase 1 clinical trial of FT819 (NCT06308978) is designed to evaluate the safety, pharmacokinetics, and efficacy of a single dose of FT819 following either i) Regimen A, a fludarabine (flu)-free less-intensive conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, or ii) Regimen B, added to maintenance therapy without the use of conditioning chemotherapy. The disease indications in the basket study include systemic lupus erythematosus (SLE), anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
•
Fifteen SLE patients across the two regimens have been treated, as of February 25th;
•
Four SSc patients have also been treated in the two regimens as of February 25th, with the first SSc patient treated with FT819 and less-intensive conditioning chemotherapy (Regimen A) exhibiting improvements in health assessment questionnaire (HAQ), clinician global assessment (CGA), patient global assessment (PtGA) and modified Rodnan skin score (mRSS) at the 3-month follow-up, as of February 9th data cut off; and
•
One IIM patient has also been treated, as of February 25th.
Clinical site expansion and enrollment across the study indications continue to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers. The Company expects to provide clinical, regulatory, and operational updates in the second half of 2026.

•
Successfully treated patients in FT819-102 clinical trial as outpatient treatment. This achievement represents a major clinical milestone: the successful dosing of autoimmune patients with FT819 off-the-shelf CAR T-cell therapy in an outpatient setting, without the need for extended hospitalization and observation. By eliminating the need for extended hospitalization and reducing or eliminating the use of conditioning chemotherapy, FT819 removes key logistical and clinical barriers that have limited autoimmune patient access to CAR T-cell therapies, facilitating broad patient access to such potentially transformative medicine.
This unique ability for outpatient treatment of CAR T cells in autoimmune disease reflects meaningful clinical progress. Enabling a feasible treatment option in community hospital-based settings and plans for treatment in infusion centers has the potential to expand access to FT819 off-the-shelf CAR T cells to a broader patient population, facilitate service to underserved regions, reduce burden on healthcare infrastructure, and improve the scalability and practical delivery of CAR T-cell therapy.

•
Data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrate meaningful and durable clinical responses, broad accessibility, and favorable safety profile of FT819 in SLE. At the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company reported that 12 patients had been treated in the FT819-101 Phase 1 study, and provided clinical data for 10 patients with greater than 1 month follow-up as of a data cut off date of October 22, 2025, showing progressive and durable reductions in disease activity, including mean SLEDAI-2K score reductions of up to 78% by six months from the dose level 2 (DL2) cohort, complete renal responses in lupus nephritis, and sustained B-cell depletion with immune cell remodeling. FT819 was well tolerated with no dose limiting toxicities, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and only low-grade incidences of cytokine release syndrome (CRS), supporting outpatient, on-demand treatment.

Next-generation off-the-Shelf CAR T-cell Program with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy

•
Preclinical data demonstrates potent activity and functional persistence of FT836 across a broad array of cancers. FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.

•
FT836 demonstrates clinical activity in CRC without the use of conditioning chemotherapy. In July, the FDA allowed the Company’s investigational new drug (IND) application to initiate Phase 1 clinical testing of FT836 off-the-shelf CAR T cells. The Phase 1 study is designed to assess the safety and activity of FT836 as monotherapy and in combination with standard of care therapies without administration of conditioning chemotherapy for the treatment of advanced solid tumors. The Company has now treated three colorectal cancer (CRC) patients with FT836 at DL1 of 300 million cells, given on Days 1 and 15, with the first dose requiring 24-hour hospitalization and the second dose being given as outpatient. FT836 was well-tolerated with no ICANS, GvHD, CRS or dose-limiting toxicities reported at DL1, supporting its potential as a broadly accessible treatment with a favorable safety profile. As of the January 23rd 2026 data cut off, one of the three CRC patients treated in combination with cetuximab at DL1, a heavily pretreated 45 year old male who was refractory to cetuximab and had received 7 prior lines of therapy, demonstrated early evidence of anti-tumor activity, including a greater than 50% reduction in carcinoembryonic antigen (CEA) levels and significant reduction in lactate dehydrogenase (LDH) levels at Day 29 post treatment, with tumor reduction seen across all target lesions of approximately 20% decrease in the sum of diameters at the 46-day evaluation scan. Notably, these observations were achieved without conditioning chemotherapy, a capability of FT836 attributed to its Sword and ShieldTM Technology. The clinical response is assessed on Day 56 and the patient is under consideration for a second treatment cycle. The ongoing clinical protocol trial is open to enrollment for treatment of patients with breast, colorectal, ovarian, head and neck, endometrial, gastric/gastroesophageal junction, and non-small cell lung cancers. The Company expects to provide additional clinical data updates in the second half of 2026.

•
FT839 preclinical data presented at 2025 ASH (Free ASH Whitepaper) Annual Meeting demonstrates broad targeting capacity across autoimmune diseases and hematologic malignancies withoutthe need for conditioning chemotherapy. FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second program to contain the Company’s Sword and ShieldTM technology. At the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026.

Fourth Quarter 2025 Financial Results

•
Cash & Investment Position: Cash, cash equivalents, and investments as of December 31, 2025 were $205.1 million.
•
Total Revenue: Revenue was $1.4 million for the fourth quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
•
Total Operating Expenses: Total operating expenses were $36.1 million for the fourth quarter of 2025, including research and development expenses of $25.4 million and general and administrative expenses of $10.7 million. Such amount included $5.5 million of non-cash stock-based compensation expense.
•
Shares Outstanding: As of December 31, 2025, common shares outstanding were 115.4 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.

(Press release, Fate Therapeutics, FEB 26, 2026, View Source [SID1234663069])

On February 26, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2025. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2025 compared to the fourth quarter and full year 2024.

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!

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the fourth quarter of 2025 was $59.9 million, compared to $54.4 million in the fourth quarter of 2024. Product revenue, net for the full year 2025 was $204.1 million, compared to $195.2 million in 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $13.4 million, or $0.27 per basic share and $0.26 per diluted share, for the fourth quarter of 2025, compared to net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024. The fourth quarter of 2025 included a net change in a valuation allowance that unfavorably impacted net income by $3.2 million, or $0.06 per basic and diluted share, compared to the fourth quarter of 2024, which included a partial release of a valuation allowance that favorably impacted net income by $7.1 million, or $0.15 per basic and diluted share. Net income for full year 2025 was $31.1 million, or $0.62 per basic share and $0.61 per diluted share, compared to net income of $30.3 million, or $0.62 per basic and diluted share, for full year 2024.

Non-GAAP adjusted net income was $15.1 million, or $0.30 per basic share and $0.29 per diluted share, for the fourth quarter of 2025, compared to non-GAAP adjusted net income of $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024. Non-GAAP adjusted net income for full year 2025 was $38.1 million, or $0.76 per basic share and $0.75 per diluted share, compared to non-GAAP adjusted net income of $38.5 million, or $0.79 per basic share and $0.78 per diluted share, for full year 2024. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2025 was $14.4 million, compared to $15.6 million in the fourth quarter of 2024. Net cash provided by operating activities for full year 2025 was $41.8 million, compared to net cash provided by operating activities of $38.9 million for full year 2024. At December 31, 2025, Puma had cash, cash equivalents, and marketable securities of $97.5 million, compared to cash, cash equivalents, and marketable securities of $101.0 million at December 31, 2024. Total debt at December 31, 2025 was $22.5 million, compared to total debt at December 21, 2024 of $67.0 million.

"Our financial performance in the fourth quarter and full year 2025 demonstrates continued momentum, with net income marking our third consecutive year of profitability, a testament to our disciplined execution and careful fiscal stewardship," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our current guidance forecasts that we will continue to be profitable in 2026, which we believe is a result of this continued financial discipline. In parallel, we continue to advance alisertib clinically through ALISCA-Breast1 and ALISCA-Lung1, targeting patient populations in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and extensive-stage small cell lung cancer."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q2 2026); (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q2 2026); and (iii) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2026)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the fourth quarter of 2025, total revenue was $75.5 million, of which $59.9 million was product revenue, net and $15.6 million was royalty revenue. This compares to total revenue of $59.1 million for the fourth quarter of 2024, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. For the year ended December 31, 2025, total revenue was $228.4 million, of which $204.1 million was product revenue, net and $24.3 million was royalty revenue. This compares to total revenue in 2024 of $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $58.4 million for the fourth quarter of 2025, compared to $45.7 million for the fourth quarter of 2024. Total operating costs and expenses were $191.1 million for full year 2025, compared to $199.5 million for full year 2024.

Cost of Sales

Cost of sales was $23.2 million for the fourth quarter of 2025, compared to $13.9 million for the fourth quarter of 2024. Cost of sales was $58.2 million for full year 2025, compared to cost of sales of $64.4 million for full year 2024. The $6.2 million decrease was primarily due to a decrease of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by higher domestic sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $18.4 million for the fourth quarter of 2025, compared to $16.6 million for the fourth quarter of 2024. SG&A expenses for full year 2025 were $70.8 million, compared to $80.2 million for full year 2024. The $9.4 million year-over-year decrease in SG&A expenses resulted primarily from legal fees associated with the AstraZeneca litigation in 2024.

Research and Development Expenses

Research and development (R&D) expenses were $16.8 million for the fourth quarter of 2025, compared to $15.2 million for the fourth quarter of 2024. R&D expenses for full year 2025 were $62.1 million, compared to $54.9 million for full year 2024. The $7.2 million year-over-year increase in R&D expenses resulted primarily from increased alisertib study activity.

Total Other Income (Expenses)

Total other income was insignificant for the fourth quarter of 2025, compared to total other expenses of $1.2 million for the fourth quarter of 2024. Total other expenses were $1.5 million for full year 2025, compared to $6.9 million for full year 2024.

Deferred Income Taxes

In the fourth quarter of 2025, Puma recorded a $7.1 million income tax expense, offset by a $3.8 million partial release of a valuation allowance resulting in a non-cash, deferred tax expense of approximately $3.2 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. In the fourth quarter of 2024, Puma released a portion of its valuation allowance that resulted in a non-cash, deferred tax benefit of $7.1 million.

First Quarter 2026 and Full Year 2026 Financial Outlook

First Quarter 2026

Full Year 2026

Net Product Revenue

$36–$39 million

$194–$198 million

Royalty Revenue

$2–$3 million

$20–$23 million

License Revenue

$0

$0

Total Revenue

$38–$42 million

$214–$221 million

Net Income/(Loss)*

$(8)–$(10) million

$10–$13 million

Gross to Net Adjustment

29.5%–30.5%

27.5%–28.5%

*The outlook above does not include any potential adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 26, 2026. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

(Press release, Puma Biotechnology, FEB 26, 2026, View Source [SID1234663088])

On February 26, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes.

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 line with the predefined study oversight plan, the IDMC, composed of independent clinical and statistical experts, conducted a comprehensive assessment of patient safety, trial conduct and key efficacy indicators. Based on this review, the IDMC recommended that the study continue without modifications, confirming the robustness of the trial’s conduct to date.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, commented: "We welcome this new positive assessment from the IDMC. A total of 163 patients had been randomized at the time of the meeting, with 152 included in the analysis reviewed by the IDMC. These figures are fully consistent with our recruitment objectives."

Initiated in 2024, ARTEMIA compares Tedopi monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The trial is enrolling across sites in Europe, the UK, the US and Canada and is designed to generate confirmatory data to support potential regulatory filings.

The next IDMC review is scheduled for October 2026. Study enrollment is expected to conclude by year-end 2026. Tedopi NSCLC Pivotal Phase 3 interim futility analysis is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028.

(Press release, OSE Immunotherapeutics, FEB 26, 2026, View Source [SID1234663104])