IDEAYA Biosciences Announces First-Patient-In for Phase 1 Trial of IDE034, a Potential First-In-Class B7H3/PTK7 Bispecific TOP1 ADC

On February 25, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that the first patient has been enrolled in its Phase 1 dose escalation/expansion trial evaluating IDE034, an investigational PTK7/B7H3 bispecific TOP1 ADC. The company is planning to evaluate safety, tolerability and PK of IDE034 as a monotherapy in the Phase 1 trial, and also plans to test combinations with agents that target the DNA damage response (DDR) pathway, such as their proprietary PARG inhibitor, IDE161. Dosing of the first patient with IDE034 triggers a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.

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"This is an important milestone for IDE034 as well as our broader ADC/DDR portfolio focused on exploring combinations of highly selective TOP1 ADCs with agents targeting the DDR pathway. We are excited to begin dosing patients with IDE034, a B7H3/PTK7 bispecific ADC that has demonstrated promising signs of efficacy as a monotherapy and synergy in combination with IDE161 across several preclinical tumor cell models. IDE034 is our second proprietary TOP1 ADC, building on the progress we have made with IDE849, our DLL3 TOP1 ADC currently in Phase 1 for SCLC and NEC, and represents another potentially first-in-class therapy for cancer patients in need of new and improved treatment options," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP 1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats. IDEAYA estimates that B7H3/PTK7 are co-expressed in approximately 30-40% of certain large solid tumor types, including lung, breast, ovarian and colorectal cancers, while exhibiting minimal dual antigen expression in normal tissue. In preclinical tumor models, IDE034 has also demonstrated compelling combination potential with IDE161, the company’s oral PARG inhibitor, that suggests these mechanisms may synergize to enhance the efficacy and durability of TOP1 ADCs.

(Press release, Ideaya Biosciences, FEB 25, 2026, View Source [SID1234663012])

Nuvation Bio to Participate in Upcoming Investor Conferences

On February 25, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in four upcoming investor conferences, including fireside chats at two conferences.

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The management team will participate in fireside chats and one-on-one meetings at the following conferences:

TD Cowen 46th Annual Health Care Conference – fireside chat on Wednesday, March 4, 2026, at 10:30 a.m. ET in Boston, MA

The Citizens Life Sciences Conference – fireside chat on Wednesday, March 11, 2026, at 8:25 a.m. ET in Miami, FL
The management team will participate in one-on-one meetings only at the following conferences:

UBS Biotech Summit Miami: Catalyst for Change on Monday, March 9, 2026, in Miami, FL

Jefferies Biotech on the Beach Summit on Tuesday, March 10, 2026, in Miami, FL
Live webcasts of each fireside chat will be available on the Investor Relations section of the Nuvation Bio website. An archived recording will be available for 90 days following each event.

(Press release, Nuvation Bio, FEB 25, 2026, View Source [SID1234663011])

Kura Oncology to Participate in Three Upcoming Investor Conferences

On February 25, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the following investor conferences:

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TD Cowen Health Care Conference
March 4, 2026
11:50 a.m. ET / 8:50 a.m. PT

Leerink Partners Global Biopharma Conference
March 10, 2026
10:40 a.m. ET / 7:40 a.m. PT

Barclays Global Healthcare Conference
March 12, 2026
9:00 a.m. ET / 6:00 a.m. PT

Live audio webcasts will be available in the Investors section of Kura’s website at View Source, with archived replays available following all three events.

(Press release, Kura Oncology, FEB 25, 2026, View Source [SID1234663004])

Xencor Reports Fourth Quarter and Full Year 2025 Financial Results

On February 25, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the fourth quarter and full year ended December 31, 2025.

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"Xencor’s lead oncology drug candidate is XmAb819, a novel first-in-class T-cell engager that could offer a much-needed new therapeutic modality for patients with advanced clear cell renal cell carcinoma (ccRCC). Excitement from the clinical community on our initial data from the dose-escalation study presented during ENA 2025 supports achieving our goal of presenting dose-expansion data during a medical meeting in the second half of 2026 and our plans to initiate a pivotal study during 2027," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Building on the early success in ccRCC, we recently opened additional dose expansion cohorts in other tumor types that have high ENPP3 expression: colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma."

"In 2026, we plan to present additional key clinical data and progress updates as we also advance XmAb541 and our ongoing B-cell depleting autoimmune programs, respectively. Our TL1A pipeline in inflammatory bowel disease continues to advance, as well. We are making great progress with enrollment in our Phase 2b XENITH-UC study of XmAb942 and are excited to begin the first-in-human study of XmAb412, our novel TL1A x IL23p19 bispecific antibody in the second half of 2026. We are proud of our execution across an evolved clinical pipeline and of the Xencor team’s focus on designing proteins to deliver novel medicines for patients."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-optimization continues. Tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are now open to enrollment. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and initiate a pivotal study of XmAb819 in ccRCC during 2027.

XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in Phase 1 clinical development for patients with advanced gynecologic and germ cell tumors. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and evaluate plans for a pivotal study of XmAb541 during 2027.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Xencor is on-track to present final results from the Phase 1 study of XmAb942 in healthy volunteers in a poster titled "XmAb942, a Potential Best-in-class, Long-acting Anti-TL1A Antibody for the Treatment of Inflammatory Bowel Disease: Phase 1 Final Results" at Digestive Disease Week (DDW), being held May 2-5, 2026 in Chicago and online, and to provide an update on progress achieved in the XENITH-UC study around year-end 2026.

XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. Xencor is on track to present the preclinical characterization of XmAb412 in a poster titled "Discovery and Characterization of XmAb412: A Novel, High-Affinity, Anti-TL1A x Anti-IL23 Native-like Bispecific Antibody With Extended Half-life for the Treatment of Inflammatory Bowel Disease" at DDW in May 2026 and to initiate a first-in-human study of XmAb412 in 2H26.
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment. Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26.
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 development for patients with idiopathic inflammatory myopathies (IIM). Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.

XmAb808 (B7-H3 x CD28), a bispecific antibody designed to provide conditional co-stimulation of T cells when also bound to tumor cells. Xencor plans to present a poster characterizing preclinical combinations of XmAb808 with multiple CD3 T cell engaging bispecific antibodies at a medical meeting in 1H26.
Xtend U.S. Patent Term Extension: In December 2025, Xencor announced the issuance of U.S. Patent 12,492,253, which covers Xencor’s Xtend Fc domain for extending the half-life of antibodies targeting C5, with a term that extends into December 2028. Xencor anticipates receiving low-single digit royalties on net sales of Ultomiris (ravulizumab-cwvz), an anti-C5 antibody engineered with a licensed Xtend Fc domain, into December 2028 in the United States. Ultomiris is a drug being developed and commercialized by Alexion Pharmaceuticals, Inc., and is a registered trademark of Alexion. Xencor previously secured regulatory extensions of exclusivity in several EU countries, Japan and Australia. Based upon consensus sales forecasts, Xencor estimates recognizing potential royalty revenue in excess of the caps under its royalty agreement with OMERS in the range of $100 million to $120 million in aggregate for the extended patent term through 2028.

Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $400 million and $430 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2025

Cash, cash equivalents, and marketable debt securities totaled $610.8 million as of December 31, 2025 compared to $706.7 million as of December 31, 2024.

Total revenue for the fourth quarter ended December 31, 2025 was $28.2 million compared to $52.8 million for the same period in 2024. Revenue for the full year ended December 31, 2025 was $125.6 million compared to $110.5 million for the same period in 2024. The increase in revenue in 2025 compared to 2024 was primarily driven by revenue recognition associated with Alexion and Incyte license agreements.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2025 were $64.8 million compared to $51.1 million for the same period in 2024. R&D expenses for the full year ended December 31, 2025 were $239.4 million compared to $227.7 million for the same period in 2024. Increased R&D expenses in 2025 compared to 2024 were primarily driven by higher external and internal costs associated with pipeline programs, partially offset by lower stock-based compensation expense.

General and administrative (G&A) expenses for the fourth quarter ended December 31, 2025 were $17.0 million compared to $14.9 million for the same period in 2024. G&A expenses for the full year ended December 31, 2025 were $63.6 million compared to $61.2 million for the same period in 2024. G&A expenses in 2025 compared to 2024 remained relatively consistent.

Other income, net for the fourth quarter ended December 31, 2025 was $49.4 million compared to other expense, net of $31.4 million for the same period in 2024. Other income, net for the full year ended December 31, 2025 was $87.9 million compared to other expense, net of $56.5 million in the same period in 2024. Other income, net, in 2025 compared to other expense, net, in 2024 was primarily driven by a combination of realized and unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the fourth quarter ended December 31, 2025 was $6.7 million or $(0.09) on a fully diluted per share basis compared to net loss of $45.6 million or $(0.62) on a fully diluted per share basis, for the same period in 2024. For the full year ended December 31, 2025 net loss attributable to Xencor was $91.9 million or $(1.24) on a fully diluted per share basis compared to net loss of $232.6 million or $(3.58) on a fully diluted per share basis, for the same period in 2024.

About Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting.

Digestive Disease Week is a registered trademark of DDW, LLC.

(Press release, Xencor, FEB 25, 2026, View Source [SID1234663001])

Veracyte Announces Fourth Quarter and Full Year 2025 Financial Results

On February 25, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the fourth quarter and full year ended December 31, 2025.

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"We delivered an exceptional finish to 2025, with strong double-digit growth across both Decipher and Afirma and more than 45,000 patients served with our core testing business in the quarter," said Marc Stapley, Veracyte’s chief executive officer. "We are achieving this growth while maintaining best-in-class profitability, with more than $50 million of cash generated from operations in the quarter. Looking ahead, 2026 will be an exciting year as we launch Prosigna as an LDT and TrueMRD, expanding our reach to more patients across the continuum of care while also continuing to invest in clinical evidence that reinforces the value and utility of our portfolio."

Key Fourth Quarter 2025 Financial Highlights

For the three-month period ended December 31, 2025, as compared to the same period in 2024:

Increased total revenue by 19% to $140.6 million and testing revenue by 21% to $135.8 million.
Increased total volume by 16% to 48,019 tests and testing volume by 16% to 45,516 tests.
Grew Decipher revenue by 27% to $85.6 million and Afirma revenue by 16% to $47.9 million.
Grew Decipher volume by 21% to approximately 27,200 tests and Afirma volume by 12% to approximately 18,250 tests.
Recorded GAAP net income of $41.1 million, or 29.3% of revenue, and delivered adjusted EBITDA of $42.3 million, or 30.1% of revenue.
Generated $52.6 million of cash from operations.
Key Full Year 2025 Financial Highlights

For the twelve-month period ended December 31, 2025, as compared to the same period in 2024:

Increased total revenue by 16% to $517.1 million and testing revenue by 18% to $493.2 million.
Increased total volume by 18% to 179,528 tests and testing volume by 19% to 169,714 tests.
Grew Decipher revenue by 27% to $310.7 million and Afirma revenue by 9% to $172.9 million.
Grew Decipher volume by 27% to approximately 102,000 tests and Afirma volume by 11% to approximately 67,700 tests.
Recorded GAAP net income of $66.4 million, or 12.8% of revenue, and delivered adjusted EBITDA of $142.5 million, or 27.6% of revenue.
Generated $136.3 million of cash from operations to end the year with $412.9 million of cash, cash equivalents, and short-term investments as of December 31, 2025.
Key Business Highlights

Announced over 15 abstracts featuring Decipher Prostate and Decipher Bladder that will be presented at the ASCO (Free ASCO Whitepaper) GU meeting this week, including results for Decipher Bladder from the SURE-02, NURE-combo, and BLASST-01 trials.
Highlighted the upcoming TrueMRD Muscle-Invasive Bladder Cancer (MIBC) test’s inclusion in the HCRN GU 20-444 response guided bladder-sparing trial, with data planned to be presented at ASCO (Free ASCO Whitepaper) GU.
Completed the transition of all Afirma samples to the v2 transcriptome to improve the efficiency of the Afirma testing business and enable more patients to receive a result, while providing a platform for future product launches, such as Prosigna LDT.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Fourth Quarter 2025 Financial Results

Total revenue for the fourth quarter of 2025 was $140.6 million, an increase of 19% compared to $118.6 million reported in the fourth quarter of 2024. Testing revenue was $135.8 million, an increase of 21% compared to $112.2 million in the fourth quarter of 2024, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.8 million, an increase of 27% compared to $3.0 million in the fourth quarter of 2024. Biopharmaceutical and other revenue was $1.0 million, a decrease compared to $3.5 million in the fourth quarter of 2024 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the fourth quarter of 2025 was 72.5%, compared to 66.4% in the fourth quarter of 2024. Non-GAAP gross margin was 75.1%, compared to 69.3% in the fourth quarter of 2024.

Operating expenses were $64.8 million for the fourth quarter of 2025. Non-GAAP operating expenses grew 12% to $65.1 million compared to $57.9 million in the fourth quarter of 2024.

Net income for the fourth quarter of 2025 was $41.1 million, an improvement of 705% compared to the fourth quarter of 2024, representing 29.3% of revenue compared to 4.3% in the same period in 2024. Diluted net earnings per common share was $0.51, an improvement of $0.45 compared to the fourth quarter of 2024. Non-GAAP diluted net earnings per common share was $0.53, an improvement of $0.17 compared to the fourth quarter of 2024. Net cash provided by operating activities in the fourth quarter of 2025 was $52.6 million, an improvement of $28.1 million compared to the same period in 2024.

Adjusted EBITDA for the fourth quarter of 2025 was $42.3 million, an improvement of 62% compared to the fourth quarter of 2024, representing 30.1% of revenue compared to 22.0% of revenue in the same period of 2024.

Full Year 2025 Financial Results

Total revenue for 2025 was $517.1 million, an increase of 16% compared to $445.8 million reported in 2024. Testing revenue was $493.2 million, an increase of 18% compared to $419.0 million in 2024, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $14.3 million, an increase of 5% compared to $13.7 million in 2024. Biopharmaceutical and other revenue was $9.7 million, a decrease compared to $13.2 million in 2024 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the full year 2025 was 70.1%, compared to 66.9% in 2024. Non-GAAP gross margin was 72.9%, compared to 70.0% in 2024.

Operating expenses were $304.8 million for the full year 2025. Non-GAAP operating expenses grew 7% to $244.6 million compared to $227.6 million in 2024.

Net income for the full year 2025 was $66.4 million, an improvement of 175% compared to 2024, representing 12.8% of revenue compared to 5.4% in 2024. Diluted net earnings per common share was $0.82, an improvement of $0.51 compared to 2024. Non-GAAP diluted net earnings per common share was $1.78, an improvement of $0.59 compared to 2024. Net cash provided by operating activities in 2025 was $136.3 million, an improvement of $61.2 million compared to 2024.

Adjusted EBITDA for the full year of 2025 was $142.5 million, an improvement of 55% compared to 2024, representing 27.6% of revenue compared to 20.6% of revenue in 2024.

2026 Financial Outlook

The company is reiterating 2026 total revenue guidance of 10% to 13% growth, or $570 million to $582 million, driven by testing revenue guidance of 14% to 16% growth, or $560 million to $570 million, excluding the contribution from new tests.

Further, adjusted EBITDA margin is expected to be approximately 25%.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA margin to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering via the following link:
View Source

(Press release, Veracyte, FEB 25, 2026, View Source [SID1234663000])