On August 5, 2026 Caris Life Sciences, Inc. (Nasdaq: CAI), a leading TechBio company actively developing and commercializing solutions to transform healthcare, reported financial results for the quarter ended June 30, 2026.

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Second Quarter 2026 Financial Highlights

Reported total revenue of $263.7 million, an increase of 45% over the corresponding prior year period.
Completed approximately 59,200 clinical cases, an increase of approximately 18% over the corresponding prior year period, including approximately 48,300 MI Profile cases and approximately 10,700 Caris Assure cases.
Reported gross margin of 68%, an approximate 500 bps improvement over the corresponding prior year period.
Reported net loss of $0.6 million.
Reported positive Adjusted EBITDA of $55.7 million.
Reported positive net cash provided by operating activities of $28.5 million, and positive free cash flow of $6.4 million.
"This was a record quarter, with approximately 59,200 clinical cases, up more than 12% sequentially, reflecting sustained demand and the payoff from investments in our commercial engine," said David Dean Halbert, Founder, Chairman and CEO of Caris Life Sciences. "Our comprehensive approach gives every case real molecular depth, across more than 1.13 million patients with AI trained on it, that depth is what powers Caris Detect. And Detect doesn’t stop at finding cancer early, through what we call the Mutational Cleanse, we plan to turn an early signal into personalized immune targets, moving from early detection to early interception. It all comes back to one thing: making precision medicine a reality for every patient."

Recent Operating Highlights

Launched Caris Detect, a groundbreaking multi-cancer early detection blood test designed to uncover cancer signals at earlier, more treatable stages.
Launched and received MolDX approval for Caris ChromoSeq, Caris’ comprehensive whole genome tumor profiling assay for myeloid malignancies.
Launched Caris MI Clarity next-generation prognostic tool that leverages multimodal AI technology and computational pathology to deliver rapid, clinically actionable results for HR+/HER2−, postmenopausal, node-negative early-stage breast cancer patients.
Announced a share repurchase program of up to $100 million, of which approximately $82.1 million remains available for repurchase under the existing Board authorization.
Published a study on the Caris Lookback Program demonstrating the ongoing clinical value of comprehensive testing with Caris MI Cancer Seek.
Published a study showing that whole exome measurement of tumor mutational burden (TMB) results in increased overall survival compared to estimates derived from targeted gene panels.
Launched the Behind the Diagnosis campaign, spotlighting patient lives transformed by Caris’ comprehensive genomic testing.
Announced a dual listing on NYSE Texas.
Surpassed 1,130,000 total profiles and 845,000 total matched profiles through June 30, 2026. More than 783,000 whole transcriptome and 733,000 whole exome profiles through June 30, 2026.
Second Quarter 2026 Financial Results

Total revenue was $263.7 million for the three months ended June 30, 2026, compared to $181.4 million for the three months ended June 30, 2025, an increase of $82.3 million, or 45%.

The increase in total revenue was driven primarily by a 55% growth in molecular profiling services revenue, which was $252.3 million for the three months ended June 30, 2026, compared to $162.9 million for the three months ended June 30, 2025. The increase in molecular profiling services revenue was primarily driven by an increase in total clinical case volume and ASP improvements.

Gross profit, calculated as total revenue less cost of services, for the three months ended June 30, 2026 and 2025, was $179.6 million and $113.7 million, respectively, representing a gross margin of 68% and 63%, respectively.

Operating expenses were $152.7 million for the three months ended June 30, 2026, compared to $131.7 million for the three months ended June 30, 2025, an increase of $21.0 million, or 16%. The increase was primarily driven by headcount-related costs.

Net loss was $0.6 million for the three months ended June 30, 2026, as compared to a net loss of $71.8 million for the three months ended June 30, 2025. Net loss per share attributable to common shareholders, basic and diluted, was $0.00 for the three months ended June 30, 2026, as compared to a net loss per share attributable to common shareholders, basic and diluted, of $7.97 for the three months ended June 30, 2025.

Net cash provided by operating activities was $28.5 million for the three months ended June 30, 2026, as compared to net cash provided by operating activities of $7.3 million for the three months ended June 30, 2025, a 291% improvement. The improvement was driven by improved total clinical case volume and ASP improvements.

2026 Financial Outlook and Guidance

Caris Life Sciences now expects full year 2026 revenue to be in the range of $1.03 billion to $1.04 billion, representing growth of 27% to 28% compared to full year 2025 and reaffirms its guidance to clinical therapy selection volume growth of approximately 20% compared to full year 2025.

Conference Call Information

Event: Caris Second Quarter 2026 Financial Results Conference Call
Date: Wednesday, August 5, 2026
Time: 3:30 p.m. CT (4:30 p.m. ET)
Webcast Link: View Source

Accompanying materials will be posted on our investor relations website at View Source prior to the conference call. A replay of the conference call will be available on our investor relations website shortly after the conclusion of the call.

(Press release, Caris Life Sciences, AUG 5, 2026, View Source [SID1234669745])

On August 5, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"The second quarter was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said Rick Fair, Chief Executive Officer of Enliven. "The updated Phase 1 data support ELVN-001’s potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy."

ELVN-001 Program Highlights
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with chronic myeloid leukemia (CML).

In June 2026, the Company announced positive data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377). The data were presented in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Highlights include:
61% overall major molecular response (MMR) and 48% MMR achievement by 24 weeks in the 80 mg once daily (QD) Phase 1b cohort.
Response rates were higher in earlier-line patients, with 67% overall MMR and 55% achieving MMR by 24 weeks among patients with only one or two prior unique tyrosine kinase inhibitors (TKIs).
Patients previously treated with asciminib achieved response rates comparable to the overall efficacy-evaluable population.
Favorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeks, as of the March 10, 2026 cutoff.
Key outcomes from the End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA):
80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.
ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician’s choice of an ATP-competitive TKI.
Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
FDA granted Fast Track Designation to ELVN-001.
Collectively, these data and regulatory milestones continue to support advancement of ELVN-001 into the planned ENABLE-2 Phase 3 trial, which the Company expects to initiate in the second half of 2026.
Second Quarter 2026 Financial Results

Cash position: As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2 million, which is expected to provide cash runway into 2030.
Research and development (R&D) expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $21.5 million for the second quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $8.2 million for the second quarter of 2026, compared to $7.1 million for the second quarter of 2025.
Net loss: Enliven reported a net loss of $32.5 million for the second quarter of 2026, compared to a net loss of $25.3 million for the second quarter of 2025.

(Press release, Enliven Therapeutics, AUG 5, 2026, View Source [SID1234669744])

On August 5, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2α-biased bispecific fusion protein, in combination with bevacizumab versus investigator’s choice of therapy, in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment.

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This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation immuno-oncology (IO) therapies in overcoming colorectal cancer—a classic ‘immune-cold’ tumor. Previously initiated studies of IBI363 include a pivotal Phase 2 clinical study (NCT07217301) in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-center, Phase 3 clinical study (NCT06797297) in IO-resistant squamous non-small cell lung cancer (NSCLC) has also been initiated. As part of a license and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialize IBI363/TAK-928 in the U.S. Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China.

This trial (NCT07722494) is a multicenter, randomized, open-label, Phase 3 clinical study designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator’s choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are planned to be enrolled. The primary endpoint of this study is overall survival (OS). This study is being conducted in China where Innovent holds development and commercialization rights for IBI363/TAK-928.

At the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, data from a Phase 1 clinical study of IBI363 for the treatment of advanced colorectal cancer was presented as an oral presentation. IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile. [link]

Among patients treated with IBI363 in combination with bevacizumab (n=73), the overall confirmed objective response rate (cORR) was 15.1%, and the disease control rate (DCR) was 61.6%. With a median follow-up of 9.9 months, the progression-free survival (PFS) reached 4.7 months. With a median follow-up of 9.4 months, overall survival (OS) data remained immature, with only 13 events (17.8%) observed.
The overall safety profile was clinically manageable, and no new safety signals were observed. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) in the combination therapy group was 35.6%. The most common TRAEs were arthralgia, anemia, rash, and hypothyroidism.
Based on updated long-term follow-up data from the above study, IBI363 in combination with bevacizumab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in May 2026. The proposed indication is for patients with advanced microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal cancer (CRC) who have progressed on ≥ 2 lines of prior standard therapy. The updated study results are planned for presentation at a future international academic conference or publication in an international academic journal.

Professor Kefeng Ding from the Second Affiliated Hospital of Zhejiang University School of Medicine, the principal investigator of this study, stated: "Colorectal cancer is a common gastrointestinal malignancy that poses a severe threat to human health. Worldwide, it ranks third in incidence and second in mortality among all malignant tumors[1]. Approximately 86% of colorectal cancers are in an immune-desert or immune-suppressed state, rendering them unresponsive to traditional immune checkpoint inhibitors (ICIs)[2]. For patients with colorectal cancer who have failed standard therapy, treatment options are limited, survival is short, and there remains a huge unmet clinical need[3-5]. As a PD-1/IL-2α-biased bispecific molecule, IBI363’s dual antitumor mechanism—blocking PD-1 while stimulating tumor-specific CD8⁺ T cells (TST cells)—holds the promise of turning ‘cold’ tumors ‘hot’. Early data for IBI363 in combination with bevacizumab in late-line treatment have demonstrated encouraging, breakthrough efficacy along with tolerable safety, showing potential to become a novel immunotherapy for colorectal cancer. I will work closely with other investigators to advance and complete this pivotal clinical study, steadily generating high-quality clinical data to provide colorectal cancer patients with a more effective treatment option."

Professor Tao Zhang from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "For patients with advanced colorectal cancer (CRC), treatment options become extremely limited after the failure of second-line or later therapies. In particular, patients with MSS CRC—who represent the vast majority of colorectal cancer cases—are largely insensitive to current immune checkpoint inhibitors. Chemotherapy or anti-angiogenic agents offer limited efficacy and fail to deliver durable disease control, leaving patients in urgent need of effective late-line treatment options. IBI363, featuring a unique PD-1/IL-2α-biased dual immuno-activation mechanism, holds the potential to overcome the immunosuppressive state of ‘cold tumors.’ The early clinical data for IBI363 in combination with bevacizumab are highly encouraging. As a clinician, I look forward to the initiation and progress of the Phase 3 clinical study, hoping it will soon bring meaningful treatment choices and renewed hope of survival to patients with late-line colorectal cancer."

Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "IBI363 represents the evolutionary direction of next-generation immunotherapy—not only potentially improving on the survival benefits of existing IO therapies, but also striving to overcome ‘cold’ tumors that traditional IO treatments cannot effectively address. Early clinical data demonstrate that IBI363 in combination with bevacizumab achieves significant responses and long-term survival benefits in non-MSI-H/pMMR advanced colorectal cancer, validating its unique mechanism and broad-spectrum potential. Currently, the first batch of core indications for IBI363 has smoothly entered pivotal registration clinical trials. We look forward to offering a new choice for colorectal cancer patients and bringing hope to broader unaddressed areas in immunotherapy."

About MSS/pMMR Colorectal Cancer

Colorectal cancer (CRC) is one of the most common malignancies worldwide, with MSS/pMMR being the predominant subtype, accounting for approximately 95% of advanced CRC cases. For patients with advanced MSS/pMMR CRC who have failed standard therapies, there remains a significant unmet medical need. Treatment options are limited, and prognosis remains poor (mPFS 1.9~5.6 months, mOS 6.4~10.8 months[3-5]).

About IBI363/TAK-928 (PD-1/IL-2α-biased bispecific fusion protein)

IBI363 is a first-in-class PD-1/IL-2α-biased bispecific antibody fusion protein being co-developed by Innovent Biologics and Takeda (Takeda R&D code: TAK-928). It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation.

IBI363 is being evaluated in a series of clinical trials globally, including:

A pivotal Phase 2 study in China in previously untreated acral and mucosal melanoma
A global, multi-center Phase 3 study in immunotherapy-resistant squamous NSCLC
A pivotal Phase 3 study in China in advanced CRC refractory or intolerant to standard treatment
In parallel, multiple Phase 1b/2 trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types.

IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363/TAK-928 globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide outside of the U.S. and greater China.

(Press release, Innovent Biologics, AUG 5, 2026, View Source [SID1234669743])

On August 5, 2026 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the second quarter of 2026 and recent business highlights.

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"We are executing a focused strategy to build a leading hematology company, which starts with bringing RYTELO to more eligible patients impacted by LR-MDS in the U.S. Our team delivered a third consecutive quarter of RYTELO demand growth, and in the first half of 2026, grew net revenue by 24% while decreasing total operating expenses by 4% compared to the same period last year," said Harout Semerjian, President and Chief Executive Officer of Geron. "With an estimated 8,000 second-line LR-MDS patients in the U.S., we see a meaningful opportunity to continue growing demand for RYTELO in 2026 and beyond. We also have the opportunity to create additional long-term value by expanding access to RYTELO in other geographies, advancing our Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis and pursuing strategic innovation to develop and commercialize new therapies for people living with blood cancers."

Recent Business Highlights

Reported RYTELO net product revenue of $57.5 million in the second quarter of 2026.
Grew RYTELO demand by 5% in the second quarter 2026, compared to the first quarter 2026.
Increased ordering accounts by roughly 8% in the second quarter 2026 to approximately 1,575.
Presented the first real-world evidence study of RYTELO in patients with lower-risk myelodysplastic syndromes (LR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The retrospective portion of the investigator-sponsored study, conducted at the Moffitt Cancer Center, reported safety and clinical efficacy of imetelstat in advanced, heavily transfusion-dependent patients with LR-MDS, including patients with extensive prior therapies and after luspatercept failure. The efficacy, safety and tolerability observed were generally consistent with findings from the Phase 3 IMerge trial in a broader patient population.1
Presented two abstracts studying imetelstat in relapsed/refractory myelofibrosis at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including an updated overall survival analysis from the Phase 2 IMbark trial compared with real-world data.
Broadened the leadership team with the appointment of Chinmaya Rath as Chief Business Officer.

Second Quarter 2026 Financial Results

Cash and Marketable Securities

As of June 30, 2026, Geron had approximately $326.9 million in cash, cash equivalents, restricted cash and marketable securities, compared to $341.0 million as of March 31, 2026, which provides the Company with cash for the foreseeable future.

Net Loss

For the three months ended June 30, 2026, the Company reported a net loss of $16.7 million, or $0.02 per share, compared to $16.4 million, or $0.02 per share, for the three months ended June 30, 2025. The increase in net loss is directly attributable to non-cash inventory-related expenses, which were partially offset by an increase in RYTELO net product revenue for the quarter.

Revenues

Total product revenue, net for the three months ended June 30, 2026, was $57.5 million, compared to $49.0 million for the three months ended June 30, 2025.

Costs and Operating Expenses

Total costs and operating expenses for the three months ended June 30, 2026, were $70.0 million, compared to $61.5 million for the three months ended June 30, 2025. The increase is primarily due to non-cash inventory-related expenses.

Cost of goods sold was approximately $9.2 million for the three months ended June 30, 2026, compared to $1.2 million for the three months ended June 30, 2025, which consisted of costs to manufacture and distribute RYTELO. The increase is primarily due to non-cash inventory-related expenses.

Research and development expenses for the three months ended June 30, 2026, were $22.0 million, compared to $21.7 million for the same period in 2025. The increase in research and development expenses was a result of investments in manufacturing and was partially offset by lower headcount costs from the workforce reduction in December 2025.

Selling, general and administrative expenses for the three months ended June 30, 2026, were $38.9 million, compared to $38.6 million for the same period in 2025. We continue to invest in our RYTELO commercialization strategy while managing lower general and administrative expenses primarily due to a decrease in personnel expense as a result of the workforce reduction in December 2025.

2026 Financial Guidance

For fiscal year 2026, the Company expects RYTELO net product revenue to be in the range of $220 million to $240 million. Geron also expects total operating expenses to be between $230 million and $240 million. Total operating expenses include non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, inventory write-offs, depreciation and amortization.

Based on current operating plans and assumptions, the Company believes that its existing cash, cash equivalents, restricted cash and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, August 5, 2026, to discuss business updates and second quarter 2026 financial results.

A live webcast of the conference call will be available on the "Investors & Media" page of the Company’s website at www.geron.com. A replay of the webcast will be archived and available on the Company’s website.

1. Data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress: Komrokji RS, et al. "Real-world Outcomes of Imetelstat: Interrogating Safety, Efficacy and Predictors of Response in Heavily Pretreated Lower-Risk MDS Patients." Poster PF670. June 11-14, 2026, Stockholm, Sweden.

About RYTELO (imetelstat)
RYTELO (imetelstat) is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at View Source

(Press release, Geron, AUG 5, 2026, View Source [SID1234669742])

On August 5, 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 second quarter ended June 30, 2026.

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"We are excited to present XmAb819 results at ESMO (Free ESMO Whitepaper) this fall and for other fast-approaching key milestones across our wholly owned clinical pipeline," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Enrollment remains on track for updates later this year for XmAb942 in the XENITH-UC study and for our two B-cell depleting bispecifics, plamotamab and XmAb657, in their respective Phase 1 studies. And we recently started the Phase 1 study of XmAb412, our first XenLock bispecific antibody, and plan to have healthy participant data in the first half of 2027. Xencor’s focus on clinical execution and data delivery is setting us up for an accelerating tempo of anticipated readouts in 2027 and beyond."

"Consistent with our focus on efficient clinical decision-making, we have prioritized the ongoing combination study of XmAb541 and XmAb808, which provides tumor-targeted co-stimulation through CD28 agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541. CLDN6 remains a challenging tumor target, and we hope to expand upon an emerging therapeutic window through the orthogonal targeting provided by XmAb808."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a potential first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma

Clear cell renal cell carcinoma (ccRCC): On track to initiate a registration enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027.
•Phase 1 results for patients with advanced ccRCC were accepted for a proffered paper oral presentation at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, to be held October 23-27 in Madrid, Spain. The presentation during ESMO (Free ESMO Whitepaper) will focus on dose levels in intravenous expansion cohorts under evaluation as recommended Phase 3 doses (RP3D).

•Dose escalation of subcutaneous administration in advanced ccRCC is ongoing with evaluation for further development expected prior to a registration enabling study.
•A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026.
•A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is currently being planned.

Additional tumors with high ENPP3 expression
•A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026.

XmAb541 (CLDN6 x CD3) in combination with XmAb808 (B7-H3 x CD28), in Phase 1 clinical development for T-cell engagement of Claudin-6 expressing tumors, including high-grade serous ovarian cancer

XmAb541 development in the ongoing Phase 1 dose-escalation study in combination with XmAb808 has been prioritized. XmAb541 monotherapy expansion cohorts at the putative RP3D (60 mg dosed every 3 weeks) in high-grade serous ovarian carcinoma (TPS≥50) and germ cell tumors are expected to complete enrollment by year end, with the data supporting combination development with XmAb808. The Phase 1 dose-escalation study of XmAb541 and XmAb808 is ongoing and expected to reach the combination’s target dose range in 2027. Prioritization of the combination is anticipated to reduce projected overall XmAb541 program expense for 2027 and 2028.

XmAb541 Clinical Data
•Emerging data from XmAb541 monotherapy indicate clinical activity to date at the putative RP3D in heavily-pretreated patients, with an approximate 14% overall response rate (ORR) in patients with ovarian cancer and an approximate 28% ORR in patients with germ cell tumors, which supports further evaluation in combination with XmAb808 to provide tumor-targeted CD28 agonism and additional T-cell stimulation.
•Potential additional anti-tumor activity was observed at doses above 60 mg, but reversible hearing impairment limited XmAb541 drug exposure due to the frequency of dose interruptions and dose reductions. Hearing impairment is potentially on target for CLDN6, which is expressed on cochlear hair cells.
•Cytokine release syndrome (CRS) has been low grade and no cases of Grade ≥3 CRS were reported at any dose level. At the putative RP3D, Grade 1 CRS was reported in approximately 14% of patients, and Grade 2 CRS was reported in approximately 17%.
•No other clinically significant safety signals were observed, and the profile is supportive of future outpatient administration.
•Based on monotherapy data, in July 2026 the U.S. FDA granted Fast Track designation to XmAb541 for the treatment of patients with germ cell tumors who have relapsed following two or more lines of platinum therapy or were refractory to prior platinum therapy.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, Xencor presented data demonstrating the co-expression of CLDN6 and B7-H3 on high-grade serous ovarian carcinoma cells. Preclinical testing demonstrated that XmAb808 promoted durable T-cell-directed killing of cancer cells with XmAb541, enhanced XmAb541-induced killing by exhausted T cells, and enhanced anti-tumor activity of XmAb541. CLDN6 and B7-H3 have low expression overlap on normal tissues, potentially localizing T-cell co-stimulation to tumor cells.

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 XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy.
•Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period in 2H27. The primary endpoint of XENITH-UC is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.

XmAb412 (TL1A x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways in autoimmune and inflammatory disease, in Phase 1 development and enrolling healthy participants
•XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports high-concentration, low viscosity and citrate-free formulation suitable for subcutaneous dosing. XmAb412 is Xencor’s first novel bispecific antibody developed using the XenLock platform.
•Xencor initiated a first-in-human study of XmAb412 in the third quarter of 2026 and plans to present initial data from the study in 1H27.

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 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies, systemic scleroderma and Sjögren’s disease
•Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.
Recent Partnership Developments
•Alexion: In July 2026, Xencor announced that it will receive $105 million from Alexion pursuant to a settlement agreement that resolves the previously disclosed dispute regarding U.S. royalties from sales of Ultomiris. Under the settlement agreement, Alexion is obligated to pay Xencor in two equal installments. The first $52.5 million payment is anticipated in August 2026, the second $52.5 million payment within 14 days following the one-year anniversary of the date of the settlement agreement, and Alexion will have no further obligation to pay royalties on U.S. sales of Ultomiris. Xencor expects to continue receiving royalties on ex-U.S. sales of Ultomiris under the existing terms of its license agreement with Alexion. Ultomiris is a drug being developed and commercialized by Alexion and is its registered trademark.

•Zenas BioPharma: In May 2026, Zenas submitted a biologics license application (BLA) to the U.S. FDA for obexelimab in IgG4-related disease, and Xencor received a $10 million regulatory milestone payment in June 2026 in connection with this BLA submission. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas, and under the license agreement, Xencor is eligible to receive up to $450 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography.
Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $420 million and $440 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 Second Quarter Ended June 30, 2026

Cash, cash equivalents and marketable debt securities totaled $486.4 million as of June 30, 2026, compared to $610.8 million as of December 31, 2025.

Revenue for the second quarter ended June 30, 2026 was $51.2 million, compared to $43.6 million for the same period in 2025. Revenue earned in the second quarter of 2026 was primarily milestone revenue from Zenas BioPharma and royalty revenue from Alexion and Incyte.

As the Settlement Agreement with Alexion resolved the uncertainty surrounding the variable consideration associated with U.S. Ultomiris royalties, the Company recognized $27.6 million of royalty revenue during the second quarter ended June 30, 2026, representing royalty attributable to U.S. Ultomiris sales during the dispute period through June 30, 2026. The remaining $77.4 million of settlement consideration relates to royalty rights for periods subsequent to June 30, 2026 and will be recognized in the third quarter of 2026.

Research and development (R&D) expenses for the second quarter ended June 30, 2026 were $71.9 million, compared to $61.7 million for the same period in 2025. Increased R&D spending for the second quarter of 2026 compared to 2025 is primarily due to increased spending on pipeline programs, partially offset by lower stock-based compensation expense.

General and administrative (G&A) expenses for the second quarter ended June 30, 2026 were $16.4 million, compared to $15.1 million for the same period in 2025. G&A spending for the second quarter of 2026 compared to 2025 remained relatively consistent.

Other income, net, for the second quarter ended June 30, 2026 was $15.1 million, compared to $2.1 million for the same period in 2025. Increased other income, net, for the second quarter of 2026, compared to 2025, is primarily due to unrealized gains on an equity security.

Net loss attributable to Xencor for the second quarter ended June 30, 2026 was $21.7 million, or $(0.29) on a fully diluted per share basis, compared to net loss of $30.8 million, or $(0.41) on a fully diluted per share basis, for the same period in 2025.

(Press release, Xencor, AUG 5, 2026, View Source [SID1234669734])