On November 4, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the third quarter ended September 30, 2025.

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"We delivered another outstanding quarter of testing revenue growth and adjusted EBITDA margin expansion, enabling us to raise both our revenue and profitability guidance," said Marc Stapley, Veracyte’s chief executive officer. "We continue to advance our mission of transforming cancer care by generating high-quality evidence and clinical insights that reinforce the value of our tests and our market leadership. The strong momentum we have seen this year, combined with our upcoming TrueMRD and Prosigna LDT launches, gives us confidence in delivering durable, long-term growth from our broad portfolio of tests covering the care continuum in multiple indications."

Key Financial Highlights

For the three-month period ended September 30, 2025, as compared to the same period in 2024:

Increased total revenue by 14% to $131.9 million and testing revenue by 17% to $127.8 million.
Increased total volume by 18% to 45,888 tests and testing volume by 19% to 43,679 tests.
Grew Decipher revenue by 26% to $82.2 million and Afirma revenue by 7% to $43.2 million.
Grew Decipher volume by 26% to approximately 26,700 tests and Afirma volume by 13% to approximately 17,000 tests.
Recorded GAAP net income of $19.1 million, or 15% of revenue, including $6.7 million of loss related to the deconsolidation of the SAS entity.
Delivered adjusted EBITDA of $39.7 million, or 30% of revenue.
Generated $44.8 million of cash from operations to end the quarter with $366.4 million of cash, cash equivalents, and short-term investments as of September 30, 2025.
Raised full year revenue guidance to $506 million to $510 million, including raising testing revenue guidance to $484 million to $487 million or 16% year-over-year growth.
Key Business Highlights

Presented at ASTRO 2025 nine Decipher-focused abstracts, including the first validation data from the BALANCE trial that demonstrated the PAM50 molecular signature predicts hormone therapy benefit in men with recurrent prostate cancer using Decipher GRID.
Announced data published online in Cell from the STAMPEDE trial showing that the Decipher Prostate Genomic Classifier predicts chemotherapy benefit in patients with metastatic prostate cancer in an effort to help patients avoid unnecessary toxicity.
Launched the Afirma v2 transcriptome to improve the efficiency of the Afirma testing business, while providing a platform for future product launches, such as Prosigna LDT.
Supported the presentation of twelve abstracts covering clinical Afirma GSC data and research with Afirma GRID at the 2025 American Thyroid Association Annual Meeting.
Completed NIGHTINGALE clinical utility trial enrollment for the Percepta Nasal Swab test.
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."

Third Quarter 2025 Financial Results

Total revenue for the third quarter of 2025 was $131.9 million, an increase of 14% compared to $115.9 million reported in the third quarter of 2024. Testing revenue was $127.8 million, an increase of 17% compared to $109.5 million in the third quarter of 2024, driven by growth in our Decipher Prostate and Afirma tests. Product revenue was $3.3 million, an increase of 4% compared to $3.2 million in the third quarter of 2024. Biopharmaceutical and other revenue was $0.8 million, a decrease compared to $3.1 million in the third quarter of 2024 given the restructuring and liquidation proceedings of Veracyte SAS.

Total gross margin for the third quarter of 2025 was 69%, compared to 68% in the third quarter of 2024. Non-GAAP gross margin was 73%, compared to 71% in the third quarter of 2024.

Operating expenses were $68.3 million for the third quarter of 2025. Non-GAAP operating expenses grew 2% to $58.6 million compared to $57.6 million in the third quarter of 2024.

Net income for the third quarter of 2025 was $19.1 million, an improvement of 26% compared to the third quarter of 2024, including a $6.7 million loss from the deconsolidation of the Veracyte SAS entity. Diluted net earnings per common share was $0.24, an improvement of $0.05 compared to the third quarter of 2024. Non-GAAP diluted net earnings per common share was $0.51, an increase of $0.18 compared to the third quarter of 2024. Net cash provided by operating activities in the first nine months of 2025 was $83.7 million, an improvement of $33.2 million compared to the same period in 2024.

Adjusted EBITDA for the third quarter of 2025 was $39.7 million, an improvement of 45% compared to the third quarter of 2024, representing 30.1% of revenue compared to 23.6% of revenue in the same period of 2024.

2025 Financial Outlook

The company is raising full-year 2025 testing revenue guidance to $484 million to $487 million, or 16% year-over-year growth, from prior guidance of $477 million to $483 million. Adjusting for the impact of the paused Envisia test, the guidance implies 17% to 18% year-over-year testing revenue growth. The company is also raising full-year 2025 total revenue guidance to $506 million to $510 million, or 14% year-over-year growth, from prior guidance of $496 million to $504 million.

Additionally, the company is raising guidance for 2025 adjusted EBITDA as a percentage of revenue to over 25% from the 23.5% prior guidance.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA as a percentage of revenue 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, NOV 4, 2025, View Source [SID1234659376])

On November 4, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the first presentation of patient-reported outcomes data from the Phase 2 portion of the ARROS-1 Phase 1/2 clinical trial of zidesamtinib, an investigational ROS1 inhibitor, as well as encore pivotal efficacy and safety data from the ARROS-1 trial, during two poster presentations at the 2025 IASLC ASCO (Free ASCO Whitepaper) North America Conference on Lung Cancer being held December 5-7, 2025 in Chicago.

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Details of the poster presentations are as follows:

Title: Patient-Reported Outcomes and Health-Related Quality of Life of TKI Pre-Treated and TKI-naïve Patients with Advanced ROS1-Positive NSCLC Treated with Zidesamtinib: Examination of ARROS-1 Phase 2 Trial Data
Abstract Number: PP01.41
Presenting Author: Melissa Laurie, Pharm.D., M.S., M.B.A.1
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

Title: Zidesamtinib in Patients With Advanced Metastatic ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Tyrosine Kinase Inhibitors (TKI): Pivotal Efficacy and Safety Data From the Phase 1/2 ARROS-1 Trial
Abstract Number: PP01.32
Presenting Author: Stephen V. Liu, M.D.2
Session Date and Time: Saturday, December 6, 2025, 4:00-5:30 p.m. ET

1 Nuvalent, Inc., Cambridge, MA, USA; 2Georgetown University, Washington, DC, USA

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC. Nuvalent completed its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC in the third quarter of 2025 and continues to engage with the U.S. Food and Drug Administration (FDA) on potential opportunities for line-agnostic expansion.

(Press release, Nuvalent, NOV 4, 2025, View Source [SID1234659394])

On November 3, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported new clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Updated data will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 6-9 in Orlando, Florida, as an oral presentation on Monday, December 8, at 11:45 a.m. ET.

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"AML is among the largest hematology indications for which a T cell engager is not available, so we are pleased to share new data for CLN-049 that demonstrate compelling potential for patients with relapsed or refractory AML, a population that urgently needs new treatment options," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "As detailed in the abstract, initial results from our Phase 1 study showed clinically meaningful anti-leukemic activity, including complete responses, with a composite complete response (CRc) rate of 31% at the highest dose level explored thus far. Importantly, responses were also observed regardless of baseline genetic risk, even among patients with TP53-mutated AML where prognosis is notably poor. In the broad population of patients with relapsed or refractory AML and MDS assessed, the safety profile was manageable. These initial results demonstrate CLN-049’s broad potential to offer a potent, flexible, and differentiated therapeutic strategy. We look forward to sharing updated data at ASH (Free ASH Whitepaper)."

"AML remains a devastating and poor prognosis disease with fragmented treatment options, particularly for relapsed or refractory patients," said Mohammad Maher Abdul Hay, MD, Director, Clinical Leukemia Program, Perlmutter Cancer Center, and Director, Blood & Marrow Transplantation and Cellular Therapy Program, NYU Langone Health. "CLN-049 has the potential to be widely applicable to a broad population because it targets the extracellular domain of both mutated and non-mutated FLT3, expressed on malignant blasts in more than 80% of patients with AML. These initial results point to the potential of a FLT3-directed T cell engager to expand treatment options for patients through a unique approach, and are especially encouraging from the dose escalation phase of an ongoing study."Oral Presentation Details

Title: Preliminary Anti-leukemia Activity from A Phase 1 Study of CLN-049, a Novel Anti-FLT3 x Anti-CD3 Bispecific T-Cell Engager, in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Menin Inhibitors and FLT3 Inhibitors in AML
Session Date: December 8, 2025
Session Time: 10:30 a.m.-12:00 p.m. ET

Room: OCCC – Chapin Theater (320)

Publication Number: 768

Efficacy Results

As of the June 2025 data cutoff, 40 patients (34 AML, 6 MDS) were enrolled without regard to FLT3 cell surface expression across 7 cohorts (target dose range 1.5-12 μg/kg), and 29 patients with AML were efficacy evaluable (≥1 response assessment). Patients with AML had received a median of 2 prior therapies (range: 1-8).

For AML, response was assessed using ELN 2022 criteria. Efficacy endpoints include complete response (CR) rate, composite complete response (CRc) rate (CR/CRi/CRh), and overall response rate (ORR) (CRc + MLFS + PR).

CLN-049 achieved promising anti-leukemic activity in this heavily pretreated AML population:

•
Anti-leukemic activity was observed at target doses ≥6 μg/kg (n=23, all AML), with a CRc rate of 30%, and ORR of 57%.
•
At the highest target dose studied thus far of 12 μg/kg (n=13), CRc rate was 31% and ORR was 69%.
•
In 9/23 patients achieving bone marrow blasts <5%, 33% (n=3) patients were MRD negative by flow cytometry; relapse was not observed in MRD-negative patients, and 1 patient has remained on study for >6 months.
•
Responses were observed in patients with AML regardless of baseline genetic risk. Notably, among 5 patients with TP53-mutated AML treated at 12 μg/kg, 4 responses (2 CRh, 2 MLFS) were observed.

Dose escalation continues in this ongoing Phase 1 study.

Safety Results

As of the June 2025 data cutoff, the data indicate a manageable safety profile in a broad population of patients with r/r AML and MDS (n=40):

•
The most common treatment-emergent adverse events (TEAEs) included cytokine release syndrome (CRS) (40%), infusion-related reaction (35%), and febrile neutropenia, pneumonia, stomatitis, white blood cell count decrease (17.5% each).
•
All CRS events were limited to Grade 1 or 2; the majority occurred after a step-up dose (SUD) or target dose 1. One case of Grade 1 ICANS was reported in association with Grade 2 CRS after a 6 μg/kg SUD. Neither CRS nor ICANS led to treatment discontinuation.

•
Grade ≥3 TEAEs occurring in >10% of patients included febrile neutropenia, white blood cell count decrease (17.5% each), and pneumonia (12.5%).
Live and Virtual Investor Event

Cullinan Therapeutics will host an in-person event for analysts and institutional investors on Monday, December 8, at 8:00 p.m. ET, during which David Sallman, MD, Associate Member, Myeloid Section Head, Moffitt Cancer Center & Research Institute, will participate in a discussion of the CLN-049 data shared at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition with members of Cullinan Therapeutics management. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.

Investors and analysts are invited to register to attend in person by emailing Nick Smith, Head of Investor Relations ([email protected]). A webcast will be available via the events page of the Company’s investor relations website at View Source

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 bispecific T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common form of acute leukemia in adults.1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.3 Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.4 Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.8 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

On November 3, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that results from its pivotal Phase 3 ARES trial evaluating Xervyteg (MaaT013) in patients with gastrointestinal acute Graft-versus-Host Disease refractory to steroids and refractory or intolerant to ruxolitinib (SR GI-aGvHD) will be presented in an oral session at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition that will take place December 6-9, 2025, in Orlando, Florida, USA. This marks the ninth consecutive year that MaaT Pharma’s clinical data has been selected for presentation at ASH (Free ASH Whitepaper) annual meeting, and the first time the Company will present its Phase 3 results at a medical congress.

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"For the ninth consecutive year, MaaT Pharma is proud to present data at ASH (Free ASH Whitepaper), reaffirming our position as the undisputed leader in microbiotherapy for hematology-oncology. The ARES study demonstrated a clinically meaningful and durable benefit in patients with gastrointestinal aGvHD, further validating our approach and its potential to redefine the standard of care in this high unmet need," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

The ARES trial met its primary endpoint and topline results were announced in January 2025. At the upcoming ASH (Free ASH Whitepaper) annual meeting, the Company will detail secondary endpoints, such as GI-ORR at D56 and Month 3 (M3), and some safety data. Final results, including 1-year overall survival, are expected by the end of 2025.

In the single-arm ARES study, 66 adult patients with GI-aGvHD refractory to steroids and refractory to ruxolitinib were treated with Xervyteg (MaaT013) as third-line treatment across 50 European sites in 6 countries (Austria, Belgium, France, Germany, Italy and Spain). The vast majority of patients included in the study (91%, n=60) presented with severe gastrointestinal aGvHD, classified as grade III (58%, n=38) or grade IV (33%, n=22). Among them, 86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib.

Efficacy data to be presented at the ASH (Free ASH Whitepaper) annual meeting is summarized below (see here for full abstract) – (up to the data cut-off of November 11, 2024):

GI-Overall Response Rate at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (25/66 patients, 38%) and very good partial response (VGPR) (13/66 patients, 20%).
Overall Response Rate (all organs) at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (24/66 patients, 36%) and VGPR (12/66 patients, 18%).
GI-ORR at Day 56 was maintained in 49% (31/ 63 patients) and prevalently consisted of CR (37%)
GI-ORR at 3 months was 44% (27/ 62 patients), with a prevalence of GI-CR (36%).
Average duration of response was 6.4 months
Probability of overall survival (OS) at 12 months:
The estimated OS was 54% with a median follow-up of 140.5 days (median survival not reached).
The estimated OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond (67% vs 28% respectively, p <0.0001), demonstrating Xervyteg (MaaT013)’s significant survival benefit in refractory GI-aGvHD.
The median OS of responders was not reached while it was 54 days in non-responders.
Xervyteg (MaaT013) is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision anticipated in the second half of 2026.

Details of the Oral Presentation:

Title: MaaT013 for ruxolitinib-refractory acute graft-versus-host disease with gastrointestinal involvement: Results from the ARES phase III trial
Publication Number: 817
Presenting Author: Prof. Malard, MD, hematology professor at Saint-Antoine Hospital and Sorbonne University, lead investigator for the Phase 3 ARES trial
Session Date: December 8, 2025
Presentation Time: 10:30 AM – 10:45 AM
Session Name: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Clinical and Translational Insights
Room: OCCC – Sunburst Room (W340)
Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th SITC (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
November 19-21, 2025 – SFGM-TC annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event, Paris, France
December 6-9, 2025 – 67th ASH (Free ASH Whitepaper) annual meeting in Orlando, FL, USA

(Press release, MaaT Pharma, NOV 3, 2025, View Source [SID1234659267])

On November 3, 2025 Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical stage oncology company, reported that data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in participants with previously treated chronic myeloid leukemia (CML) has been selected for oral presentation on December 8, 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, FL. The company will host a conference call and webcast for investors at 4:30pm ET following the ASH (Free ASH Whitepaper) presentation.

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The abstract is now available on the ASH (Free ASH Whitepaper) website and details are summarized below. A more expansive and updated dataset from the CARDINAL trial will be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December.

"We are pleased that data from our CARDINAL trial have been selected for oral presentation at ASH (Free ASH Whitepaper). These data further validate the potential of TERN-701 to be a new, game-changing therapy for CML. The 24 weeks MMR achievement rate with TERN-701 is unprecedented, trending at least two times higher than the rates reported in other Phase 1 studies of CML therapies that are approved or in development," said Amy Burroughs, chief executive officer of Terns.

"Importantly, TERN-701 also achieved consistently high overall (cumulative) MMR rates in key, difficult to treat patient subgroups while maintaining an encouraging safety profile. These emerging data strongly reinforce our conviction that TERN-701 has the potential to be a best-in-disease therapy, with broad opportunity across all CML treatment lines. We look forward to sharing additional data in December," added Ms. Burroughs.

The ASH (Free ASH Whitepaper) abstract published today reports data from the ongoing dose escalation and dose expansion parts of the CARDINAL study of TERN-701 in patients with previously treated CML. As of the June 30th, 2025, cutoff date, 55 patients were enrolled. Highlights include:

•
  Of 32 efficacy-evaluable patients:

•
Overall (cumulative) major molecular response (MMR) rate of 75% (24/32) by 24 weeks, with 64% (14/22) achieving MMR and 100% (10/10) maintaining MMR

•
Overall (cumulative) MMR by 24 weeks in difficult to treat patient subgroups:

•
  69% (11/16) in patients with lack of efficacy to last tyrosine kinase inhibitor (TKI)

•
  60% (6/10) in patients who had prior asciminib

•
  67% (8/12) in patients with prior asciminib / ponatinib / investigational TKI

•
No patients had lost MMR at the time of data cutoff

•
  Enrolled patients had heavily pretreated, refractory disease:

•
Median of 3 prior TKIs

•
35% had ≥4 prior TKIs

•
56% and 44% had baseline BCR::ABL1 >1% and >10%, respectively

•
64% discontinued their last TKI due to lack of efficacy

•
36% had prior asciminib treatment, 25% had prior ponatinib and/or an investigational TKI (olverembatinib / ELVN-001)

•
13% with BCR::ABL1 mutations (9% with T315I and 4% with F317L)

•
  Encouraging safety profile:

•
87% (48/55) patients remained on treatment as of the data cut-off; with discontinuations due to disease progression (n=4), adverse events (n=1), and consent withdrawal/lost to follow up (n=2)

•
No dose-limiting toxicities (DLTs) were observed in dose escalation and a maximum tolerated dose (MTD) was not reached

•
The majority (74%) of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship

•
Most common TEAEs were diarrhea (22%), headache (18%) and nausea (16%), all Grade 1 or 2

•
Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (7%) and thrombocytopenia (4%)

•
TERN-701 exposures were approximately dose proportional across the dose range

Details for the ASH (Free ASH Whitepaper) oral presentation are as follows:

Title: CARDINAL: A Phase 1 study of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for patients with previously treated CML

Presenter: Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center

Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes

Session Date: December 8, 2025

Session Time: 2:45 – 4:15pm ET

Presentation Time: 2:45 – 3:00pm ET

Following the full presentation at the ASH (Free ASH Whitepaper) Annual Meeting, the presentation materials will be made available on the Terns website.

Company Conference Call and Webcast Information

Terns will host a conference call and webcast for investors at 4:30pm ET on December 8, 2025 following the oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting. Members of the Terns management team will discuss the TERN-701 data from CARDINAL and next steps in the development of TERN-701.

Webcasts can be accessed in the investor relations section of the Company’s website. A replay of the event will be available for a limited time.

About TERN-701 and CARDINAL Clinical Trial

TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with previously treated chronic phase (CP) CML. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities (DLTs) observed up to the maximum dose of 500 mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm.

(Press release, Terns Pharmaceuticals, NOV 3, 2025, View Source [SID1234659283])