On August 5, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, was the first to demonstrate the isolation and analysis of >99% pure circulating tumor-derived DNA (ctDNA), reported the publication of the first peer-reviewed paper describing the technology in detail – entitled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy1".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not cancer cells. Volition’s new technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produced >99% pure cancer associated plasma DNA sequence sets for liquid biopsy.

Mr. Gael Forterre, Chief Licensing Officer, Volition added:

"We are delighted that the paper detailing this breakthrough technology has been peer reviewed and published.

"We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of this technology, "Capture-Seq", and indeed are in the process of undertaking technical evaluations with potential licensors.

"We believe the potential use cases for Capture-Seq represent a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately $23 billion2 for the human Multi-Cancer Early Detection (MCED) use, and over $13 Billion2 for Minimum Residual Disease (MRD)."

Dr Jake Micallef, Chief Scientific Officer, Volition commented:

"Distinguishing cancer derived plasma DNA from healthy DNA when the two are mixed is problematic as they are chemically similar. As the cancer DNA may make up 1% or less of the total DNA, it is extremely problematic.

"Our manuscript describes a new liquid biopsy chemistry for isolating CTCF-DNA from plasma. Our work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery; that there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of a cancer patient is derived from cancer cells – i.e. it is virtually pure circulating tumor-derived DNA.

"Removal of background normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy. I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer testing and monitoring in recent years.

"In this published paper we report a new, two-step method for preparing pure circulating tumor DNA data sets for cancer patients:

physical enrichment of the sample; and
bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.
"This new method produced >99% pure ctDNA sequencing data sets for blood samples from cancer patients and, whilst we capture a subset of the ctDNA (i.e. not all the ctDNA in a sample), it is virtually pure cancer DNA.

"These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. Capture-Seq shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease (MRD).

"We are fast-tracking the development of Capture-Seq conducting further studies, including competing conditions and larger sample sets and working with oncology Key Opinion Leaders.

"Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology."

Dr Andrew Retter, Medical Consultant, Volition commented:

"From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional controls.

"We have also subsequently reported data from a blinded validation cohort of 81 subjects (colorectal and lung cancer patients = 59, healthy controls = 22) and are extremely encouraged by the results; the early-stage cancer detection of 95% of stage I and II cancers is particularly noteworthy.

"For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to Multi-Cancer Early Detection (MCED) fulfilling a significant unmet clinical need.

"We also believe that Capture-Seq has the potential to play a role in cancer management, including but not limited to, Minimal Residual Disease detection and treatment monitoring, either alone or potentially in combination with other technologies too."

Pamart, D., et al. Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy. Clin Epigenet (2026). View Source
Data on File : Volition TAM Model

(Press release, VolitionRX, AUG 5, 2026, View Source [SID1234669747])

On August 5, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total revenue in the second quarter grew 26% year-over-year to $44.7 million, and Galleri test revenue for the quarter grew 24% year-over-year to $42.6 million. Galleri test volume for the quarter grew 35% year-over-year to more than 61,000. Galleri test revenue in the first half of 2026 grew 30% year-over-year to $82.5 million. Galleri test volume in the first half of 2026 grew 42% year-over-year to more than 117,000. Net loss for the second quarter was $110.2 million. Gross loss was $12.6 million. Non-GAAP adjusted gross profit was $21.6 million, and non-GAAP adjusted EBITDA was $(90.3) million.1

"GRAIL continues to execute across our clinical and commercial priorities. We presented detailed performance, safety, and clinical utility results from the NHS-Galleri and PATHFINDER 2 studies at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies in the screening population. We also expanded access through new and existing partnerships," said Josh Ofman, Chief Executive Officer at GRAIL. "Following our PMA submission earlier this year, we anticipate an FDA advisory committee in the fall."

For the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $44.7 million, an increase of $9.1 million or 26%.
Net loss: Net loss was $110.2 million, an improvement of $3.7 million or 3%.
Gross loss: Gross loss was $12.6 million, an improvement of $5.2 million or 29%.
Adjusted gross profit1: Adjusted gross profit was $21.6 million, an increase of $5.4 million or 34%.
Adjusted EBITDA1: Adjusted EBITDA was $(90.3) million, an increase in adjusted EBITDA loss of $11.9 million or 15%.
_______________________________
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures.

Cash position: Cash, cash equivalents, and short-term marketable securities totaled $861.6 million as of June 30, 2026.

Recent business highlights include:

Presented detailed results from the two largest multi-cancer early detection (MCED) studies completed to date, NHS-Galleri and PATHFINDER 2, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May.

Clinical utility results from the NHS-Galleri trial showed:
While Galleri did not result in a significant decrease in combined Stage III and IV cancers, it did show reduced Stage IV diagnoses of 12 prespecified aggressive cancers by 22% and 26% in the second and third screening rounds, respectively, demonstrating a substantial reduction in late-stage cancer diagnoses. A Stage IV reduction was also observed across all cancers.
Adding Galleri to standard-of-care screening increased cancer detection fourfold.
The addition of Galleri resulted in a 128% increase in the number of Stage I and II screen detected cancers.
Galleri detected 366 Stage I and II cancers, more than the 290 cancers of any stage detected through the entirety of the U.K.’s standard-of-care cancer screening program in the control arm.
Of the 937 cancers detected by Galleri, approximately 70% were Stage I through III, approximately 40% were Stage I and II, and approximately 20% were Stage I.
Further, the addition of Galleri was associated with a 25% reduction in cancers diagnosed after emergency presentation.
Overall, these data support the potential of MCED screening at population scale to identify cancers before symptoms appear — when they can be treated more easily and are potentially curable.
Findings from PATHFINDER 2 showed:
Adding Galleri to recommended screenings, enabled approximately 60% of cancers to be identified by screening. This represents a 6.5x increase in number of cancers detected as compared with USPSTF A & B recommended screenings (breast, cervical, colorectal, and lung) and a 3x increase in number of cancers detected as compared with USPSTF A, B & C ratings (breast, cervical, colorectal, lung and prostate).
53% of newly detected cancers were identified in Stage I and II and more than two-thirds were identified at Stages I through III. Nearly half were cancers without recommended screening options.
The test accurately identified the Cancer Signal Origin (CSO) more than 90% of the time, enabling efficient diagnostic workups.
Overall, the results demonstrated substantially increased cancer detection with robust performance and a favorable safety profile.

Completed the expansion of our field sales and medical teams to continue to drive commercial momentum for the Galleri test.

Announced a collaboration with Priority Health to make the Galleri test available to its self-insured employer groups, making it the first Michigan health plan to enable employer groups to add Galleri to their existing cancer screening coverage. The health plan serves more than 1.4 million members across Michigan and beyond and previously launched coverage for Galleri in its Thrive and Thrive Plus Medicare Advantage plans in 2025.

In June, GRAIL completed a previously announced $110 million equity financing with Samsung C&T Corporation and Samsung Electronics Co., Ltd. through the purchase of GRAIL common stock. GRAIL and Samsung C&T intend to collaborate to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore, subject to regulatory approvals and other conditions.

GRAIL anticipates the U.S. Food and Drug Administration (FDA) will hold an advisory committee in the fall to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection blood test. The PMA submission is focused on test performance and safety results from 25,000 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow-up and from the prevalent screening round (first year) of the 140,000-participant NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any MCED test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in clinical trials to the updated version that has been submitted to the FDA for pre-market approval.
Conference Call and Webcast
A webcast and conference call will be held today, August 5, 2026, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.

(Press release, Grail, AUG 5, 2026, View Source [SID1234669746])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])