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.

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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])

On January 8, 2026 Kazia Therapeutics (NASDAQ: KZIA) reported that its Chief Executive Officer, John Friend, MD, will be in San Francisco next week to participate in meetings during the annual J.P. Morgan Healthcare Conference week (JPM Week).

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During the week, Kazia will connect with existing and prospective institutional investors, sell-side analysts, and strategic collaborators, including both established partners and potential new industry counterparties, as part of ongoing investor relations and business development outreach.

"We are entering JPM Week with strong strategic and clinical momentum," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "Following the successful completion of our recent financing, we are well capitalized to execute across multiple near-term catalysts, including an anticipated triple negative breast cancer clinical and biomarker update before the end of the month. At the same time, renewed industry focus on the PI3K/mTOR pathway—particularly in hormone receptor–positive, HER2-negative breast cancer—underscores the growing relevance of approaches that are designed to be differentiated and patient-friendly, such as paxalisib."

Anticipated Clinical and Program Updates

Kazia expects to provide a clinical and translational update before the end of the month from its ongoing Phase 1b trial evaluating paxalisib in advanced triple-negative breast cancer (TNBC). The update is anticipated to include additional clinical response observations, together with expanded circulating tumor cell (CTC) and CTC cluster biomarker analyses, further evaluating paxalisib’s potential impact on metastatic disease biology.

As previously reported, paxalisib treatment in advanced TNBC has been associated with rapid and sustained reductions in CTCs and CTC clusters, biomarkers increasingly linked to metastatic potential and adverse clinical outcomes. Notably, prior observations in the patient demonstrated that temporary interruption of paxalisib dosing was accompanied by a rebound increase in CTC clusters, with subsequent re-initiation again suppressing overall CTC count and cluster formation, supporting a mechanistically distinct and pharmacodynamically consistent contribution beyond that of immunotherapy alone.

The impending update could meaningfully expand the clinical and biological dataset supporting paxalisib in metastatic breast cancer, providing further context around treatment response, biological consistency, and translational relevance, and may further inform the broader development strategy for paxalisib across breast cancer subtypes.

In addition, Kazia plans to provide the first update on its potential first-in-class PD-L1 protein degrader program. This program is designed to leverage a novel and differentiated mechanism of action, reflecting evolving scientific strategies aimed at addressing biological complexity, resistance, and durability challenges in immune-based cancer therapies.

(Press release, Kazia Therapeutics, JAN 8, 2026, View Source [SID1234661869])

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.

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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])

On January 8, 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 positive initial data from the ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

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"We are excited about these initial Phase 1b data, the progress we made throughout 2025 and the year ahead. Our data continue to demonstrate that ELVN-001 has the potential to be the best-in-class active-site TKI for the treatment of CML and an important treatment option across all lines of therapy," said Helen Collins, M.D., Chief Medical Officer of Enliven. "Momentum has been building over the last year leading to significant interest in our Phase 3 clinical trial from sites all around the world. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026."

ELVN-001 Program Updates

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with CML.

Encouraging ELVN-001 Phase 1b Data by 24 Weeks

As of the cutoff date of December 22, 2025, 60 patients were enrolled in the initial cohorts of the Phase 1b trial. Patients were first enrolled in the 80 mg once daily (QD) cohort. Subsequent patients were randomized to either 60 mg QD or 120 mg QD.
Patients enrolled were heavily pretreated, consistent with patients from previously reported datasets. In these 60 patients:
53% of patients received four or more unique prior TKIs.
67% of patients received prior asciminib and 32% received prior ponatinib.
Despite the heavily pretreated patient population, the efficacy data below highlights that ELVN-001 continues to demonstrate the profile of a best-in-class active-site TKI.
Dose (number of patients)

80 mg QD (n=19)

60/120 mg QD (n=41)

Cumulative MMR

47% (n=19)

69% (n=26)

Achieved MMR

38% (n=16)

53% (n=17)

Maintained MMR

100% (n=3)

100% (n=9)

Deep Molecular Response (DMR)

16% (n=19)

35% (n=26)

As of the data cutoff in December:

In the 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. In these mature data, rates of MMR achievement (38%) and DMR (16%) compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs, including asciminib.
In the randomized 60 mg and 120 mg cohorts (n=41), 26 patients were evaluable for efficacy by 24 weeks, reflecting their more recent enrollment. In this cohort, highly encouraging rates of MMR achievement (53%) and DMR (35%) were observed.
Across all Phase 1b cohorts, 100% of evaluable patients in MMR at enrollment maintained, or deepened, their response.
As expected, robust clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response (efficacy or safety) within this range.
ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all evaluated doses. The safety profile observed in these Phase 1b cohorts remained consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified.
Expected 2026 Clinical Milestones for ELVN-001

Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial
Regulatory alignment with the FDA on dose selection and Phase 3 trial design
Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, in the second half of 2026
About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active-site TKI, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

(Press release, Enliven Therapeutics, JAN 8, 2026, View Source [SID1234661870])

On January 8, 2026 Verastem presented its corporate presentation.

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