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Xilio Therapeutics Highlights Upcoming Milestones and Recent Corporate Updates

On January 8, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported upcoming milestones and recent corporate updates.

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"2025 was marked by robust execution at Xilio as we delivered on key priorities across our deep portfolio of differentiated I-O therapies, demonstrated additional clinical validation of our masking technology and further strengthened our financial position through strategic partnerships and our recent equity financing," said René Russo, Pharm.D., president and chief executive officer of Xilio. "In the year ahead, we have a strong foundation to advance our potential best-in-class bispecific PD-1/IL-2 and T cell engager programs toward the clinic and maximize the value of our vilastobart and efarindodekin alfa programs through strategic partnerships."

Xilio also announced the appointment of Sara Bonstein as chair of the board of directors, following the retirement of Paul Clancy. Dr. Russo continued, "Sara has been an invaluable member of our board since 2021 and brings more than two decades of executive leadership in finance, corporate strategy and business operations in the biotechnology industry, as well as extensive experience advancing novel therapies from discovery through commercialization. I look forward to continuing to partner with Sara as we advance our pipeline of masked immuno-oncology therapies through development. On behalf of the entire board, I’d also like to express my gratitude to Paul for his leadership and contributions as chair, which have been instrumental in helping shape Xilio over the past five years."

Ms. Bonstein added, "During my tenure, Xilio has made significant progress demonstrating validation for its novel masking technology through strategic partnerships with Gilead and AbbVie as well as promising clinical data for its most advanced programs. I am excited to chair the board and look forward to working closely with the management team to advance the company’s deep portfolio of differentiated I-O therapies."

Corporate Updates

In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead Sciences, Inc. The Series B warrants were issued in connection with a follow-on public offering in June 2025.

Xilio today announced:

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The achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.
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The nomination of a development candidate for its masked T cell engager program targeting the tumor-associated antigen for CLDN18.2, which has broad potential as a target for gastric, pancreatic, esophageal and lung cancers.
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The appointment of Sara M. Bonstein as chair of the board of directors of Xilio. Ms. Bonstein has served as a member of Xilio’s board of directors since August 2021 and succeeds Paul Clancy, who retired from the board of directors on January 6, 2026. Ms. Bonstein has more than 10 years of experience as a chief financial officer for public biotechnology companies, and she currently serves as chief financial officer of Insmed, Inc. where she oversees key financial functions including capital raising, investor relations, accounting, treasury, financial planning and analysis and procurement. Earlier in her career, Ms. Bonstein held finance roles of increasing responsibility at Eli Lilly & Company and Johnson & Johnson. Ms. Bonstein holds a B.S. in finance from The College of New Jersey and an M.B.A. from Rider University.

Anticipated Milestones

Xilio’s anticipated upcoming milestones include:

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Submit an investigational new drug (IND) application for XTX501 in the middle of 2026
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Report initial Phase 1 data for XTX501 in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration
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Nominate a development candidate for the STEAP1 program (masked T cell engager with co-stimulation) in the first half of 2026
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Advance at least two masked T cell engager programs into IND-enabling studies and submit IND applications for those programs in 2027
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Deliver the Phase 1/2 option data package to Gilead for the efarindodekin alfa program in the first half of 2027

Financial Guidance

As of December 31, 2025, Xilio estimates that it had cash and cash equivalents of $137.5 million, including $35.8 million in gross proceeds received in the fourth quarter of 2025 from the exercise of Series B warrants.

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of December 31, 2025 will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2027.

The cash and cash equivalents information provided above is based on preliminary unaudited information and management estimates for the year ended December 31, 2025, is not a comprehensive statement of the company’s financial results as of and for the fiscal year ended December 31, 2025 and may change. Xilio’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, this preliminary estimate.

(Press release, Xilio Therapeutics, JAN 8, 2026, View Source [SID1234661857])

Xencor Highlights Corporate Priorities and 2026 Pipeline Milestones

On January 8, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported corporate priorities and 2026 pipeline advancement milestones for its clinical-stage portfolio of novel XmAb drug candidates.

"Xencor designs proteins that enable potential first-in-class and best-in-class medicines for patients, and we are building on momentum from 2025, when we presented encouraging clinical data from our portfolio of T-cell engagers and TL1A antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We are excited to be evaluating a pipeline of five wholly owned clinical-stage XmAb drug candidates and have plans this year to begin the first-in-human study of our TL1A x IL23p19 bispecific antibody for development in inflammatory bowel disease."

"Throughout 2026, we plan to present key clinical data and program updates as we advance our oncology programs toward late-stage development and present clinical proof-of-concept data for our autoimmune programs. We are also starting the year with a strong balance sheet to execute our plans, and we look forward to several updates, potential regulatory achievements and milestones across multiple partner programs."

Four Novel XmAb T-Cell Engagers in Solid Tumor Oncology and B-Cell Depletion for Autoimmune Disease

XmAb819 (ENPP3 x CD3), a novel, 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). Initial results from an ongoing Phase 1 study in advanced ccRCC indicated that XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (RECIST v1.1) as best response with a 70% disease control rate. The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-escalation continues. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) during 2026
Initiate a pivotal study of XmAb819 in ccRCC during 2027
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. In 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541. Nine patients had received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses (RECIST v1.1) were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors. We plan to:

Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate a pivotal study of XmAb541 during 2027
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in an ongoing Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. We plan 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 development for patients with idiopathic inflammatory myopathies (IIM). In the fourth quarter of 2025, Xencor initiated a Phase 1 proof-of-concept study of XmAb657 for patients with IIM. We plan to:

Provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26
Two Differentiated, Potentially Best-in-Class Therapeutic Options for Inflammatory Bowel Disease

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. Patient enrollment in the study is ongoing. We plan to:

Present final results from the Phase 1 study of XmAb942 in healthy volunteers in 1H26
Provide an update on progress achieved in the XENITH-UC study near 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. XmAb412 was selected as the lead candidate in 2025. We plan to:

Present preclinical characterization of XmAb412 in 1H26
Initiate a first-in-human study of XmAb412 in 2H26
Preliminary Cash Position and Financial Guidance

Xencor’s broad development portfolio is supported by a strong financial position. Xencor ended the fourth quarter of 2025 with unaudited cash, cash equivalents and marketable debt securities expected to be approximately $611 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2028.

(Press release, Xencor, JAN 8, 2026, View Source [SID1234661856])

Delevering Novel Therapies for RAS/MAPK pathway-driven cancers

On January 8, 2026 Verastem presented its corporate presentation.

(Presentation, Verastem, JAN 8, 2026, View Source [SID1234661855])

Revolution Medicines Announces FDA Breakthrough Therapy Designation for Zoldonrasib

On January 8, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib, a RAS(ON) G12D-selective inhibitor, for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.

The Breakthrough Therapy Designation is based on data from the monotherapy cohort of the Phase 1 RMC-9805-001 clinical trial evaluating zoldonrasib in patients with advanced KRAS G12D solid tumors. Results from the monotherapy cohort of the trial have demonstrated a robust clinical profile, including encouraging antitumor activity and acceptable safety and tolerability.

"The Breakthrough Therapy Designation for zoldonrasib, our RAS(ON) G12D-selective covalent inhibitor – the first ever granted for an investigational drug specifically targeting the RAS G12D mutation – underscores the significant unmet need for patients with KRAS G12D cancers, which currently lack any approved targeted therapies," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "This recognition expands upon prior designations for the RAS(ON) multi-selective inhibitor daraxonrasib and G12C-selective inhibitor elironrasib, further recognizing the promise of our first three clinical-stage RAS(ON) inhibitors as potentially transformative therapies for people living with RAS-addicted cancers."

Zoldonrasib is an innovative tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. Revolution Medicines is evaluating zoldonrasib as a monotherapy and combination treatment across multiple tumor types and lines of therapy.

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. Pursuant to FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 197,000 people diagnosed in the U.S. each year.1,2,3 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.

(Press release, Revolution Medicines, JAN 8, 2026, View Source [SID1234661854])

Personalis Reports Select Preliminary Fourth Quarter and Full Year 2025 Results and Recent Highlights

On January 8, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported certain unaudited preliminary financial and operational results for the fourth quarter and full year ended December 31, 2025.

Fourth Quarter Strategic and Operational Highlights

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Secured Milestone Medicare Coverage: Received Medicare coverage approval for the surveillance of cancer recurrence in breast cancer patients, a key catalyst for clinical revenue and market share growth in the MRD space.
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Published Landmark TRACERx Data: Announced the publication of one of the largest and most comprehensive non-small cell lung cancer (NSCLC) patient cohorts to date in the journal Cell, demonstrating the clinical importance of Personalis’ ultrasensitive MRD approach.
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Validation of ctDNA Dynamics: Published VHIO data in Clinical Cancer Research titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," further reinforcing the clinical validity of the NeXT Personal platform in a broad array of cancer types.
Preliminary Full Year 2025 Financial Results

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Total Revenue: Expected to be in the range of $69.0 to $70.0 million compared with $84.6 million for 2024.
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Clinical Momentum: Clinical test revenue reached approximately $2.0 million, more than doubling the $0.8 million reported in 2024.
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Volume Outperformance: Clinical test volume reached approximately 16,233 tests, a nearly 400% increase over the 3,285 tests delivered in 2024. This performance exceeded the company’s internal growth targets by more than 20% and signals a significant shift in market adoption for ultrasensitive MRD testing.
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Core Revenue Streams: Pharma tests, services, and all other customers contributed approximately $49.0 million to $50.0 million. Revenue from enterprise sales (Natera) and population sequencing (the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP)) totaled approximately $18.0 million.
Preliminary Fourth Quarter 2025 Financial Results

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Quarterly Revenue: Expected to be in the range of $17.0 million to $18.0 million.●
Accelerating Volume: Delivered 6,183 clinical tests in the fourth quarter, representing a 41% sequential increase over the third quarter of 2025.
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Clinical Revenue: Preliminary clinical test revenue of approximately $0.9 million, compared with $0.2 million in the prior year period.
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Core Revenue Streams: Pharma tests, services, and all other customers contributed approximately $11.6 million to $12.6 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $4.5 million.
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Strong Liquidity: Ended the year with approximately $240.0 million in cash, cash equivalents, and short-term investments. This includes approximately $109.0 million in net proceeds from the company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $8.43 per share.
CEO Commentary

"Personalis championed a defining year in 2025 demonstrating that our Win-in-MRD strategy is working," said Chris Hall, Chief Executive Officer and President. "While we entered the year with an ambitious goal to grow clinical volumes by 30% to 40% sequentially through the year, we ultimately surpassed those targets with nearly 400% clinical volume growth over last year. This exponential growth, culminating in over 16,000 tests, proves that oncologists are increasingly demanding the ultrasensitivity that NeXT Personal has pioneered."

Hall continued: "Securing Medicare coverage for breast cancer surveillance in the fourth quarter was a pivotal milestone that transforms our commercial trajectory. With a fortified balance sheet of ~$240 million of cash, we enter 2026 with the capital and the clinical evidence required to expand our sales footprint, secure reimbursement coverage for additional indications, and continue to execute on our Win-in-MRD strategy."

The above preliminary unaudited financial results are preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2025, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

(Press release, Personalis, JAN 8, 2026, View Source [SID1234661853])