On November 12, 2025 Pillar Biosciences, Inc., the leader in Decision Medicine, reported the launch of oncoReveal Lymphoid, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories to perform rapid tumor profiling of lymphoid malignancies.

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The oncoReveal Lymphoid panel interrogates 84 genes of interest, including full coding DNA sequence (CDS) of 29 genes with a single-tube, fully automatable NGS workflow that can be performed by any NGS-equipped molecular laboratory.

"We are excited to launch oncoReveal Lymphoid, specifically designed to meet the needs of local laboratories looking for rapid and efficient NGS-based testing solutions to help interrogate lymphomas," said ShiPing Zou, Sr. Director of Product Management at Pillar Biosciences. "oncoReveal Lymphoid is compatible with our current heme-oncology offerings including oncoReveal Myeloid and oncoReveal Heme Fusion. "Together, this suite of products provides full coverage of heme oncology tumor profiling needs for molecular pathology labs."

Pillar’s oncoReveal Lymphoid panel uses their proprietary Stem-Loop Inhibition-Mediated amplification (SLIMamp) technology, a tiled amplicon-based library prep chemistry designed to provide highly accurate genetic profiles down to 2% variant allele frequency (VAF). oncoReveal Lymphoid is powered by PiVAT, an automated secondary bioinformatics software that supports the identification of somatic mutations from DNA with high sensitivity and specificity. Pillar Biosciences’ proprietary PiVAT technology is fully compatible with third-party clinical reporting solutions.

(Press release, Pillar Biosciences, NOV 12, 2025, View Source [SID1234659850])

On November 12, 2025 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 third quarter of 2025.

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Total revenue in the third quarter grew 26% year-over-year to $36.2 million, and Galleri revenue grew 29% year-over-year to $32.8 million. U.S. Galleri revenue was $32.6 million, representing 28% growth year-over-year. Net loss for the quarter was $89.0 million. Gross loss was $13.7 million. Non-GAAP adjusted gross profit was $20.0 million, and non-GAAP adjusted EBITDA was $(71.7) million.1

"We remain very pleased by Galleri’s commercial uptake with 39% growth in Galleri test volume in the third quarter. Our teams continue to build awareness of Galleri among providers and patients, and recent data from our registrational PATHFINDER 2 study adds to the evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have also made key recent strides in opportunities beyond the U.S., led by our strategic collaboration with Samsung to bring Galleri to key Asian markets, as well as Galleri’s commercial introduction in Canada. Looking ahead, we anticipate completing our PMA submission for Galleri to the FDA in the first quarter of 2026."

For the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $36.2 million, an increase of $7.5 million or 26%.
Net loss: Net loss was $89.0 million, an improvement of $36.7 million or 29%.
Gross loss: Gross loss was $13.7 million, an improvement of $8.5 million or 38%.
Adjusted gross profit1: Adjusted gross profit was $20.0 million, an increase of $8.2 million or 69%.
Adjusted EBITDA1: Adjusted EBITDA was $(71.7) million, an improvement of $36.5 million or 34%.
Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $547.1 million as of September 30, 2025.
Recent business highlights include:

Positive results from PATHFINDER 2 and SYMPLIFY studies add to the evidence base for the effectiveness of multi-cancer early detection.
Positive detailed performance and safety results from the pre-specified analysis of the first approximately 25,000 participants in the registrational PATHFINDER 2 study were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Congress 2025 in October:
Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year
Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations)
Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options
More than half of the new cancers detected by Galleri were stage 1 or 2 and more than two-thirds were detected at stages 1-3
Galleri positive predictive value ("PPV"), or the likelihood of receiving a cancer diagnosis following a positive test result, was 61.6%
Specificity was 99.6%, translating to a false positive rate of 0.4%
Cancer signal of origin accuracy was 92%, leading to efficient diagnostic workups
Diagnostic resolution took a median of 46 days, and only 0.6% of all participants had an invasive procedure and invasive procedures were two times more common in participants with cancer than in those without
No serious, study-related adverse events were reported
Positive long-term results from an extended registry follow-up of the SYMPLIFY study with the University of Oxford were presented at the Early Detection of Cancer Conference ("EDCC") in October. A previous primary analysis, published in The Lancet Oncology, followed participants until diagnostic resolution or up to nine months and demonstrated Galleri’s PPV was 75.5%. Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales.
The updated analysis presented at EDCC showed that approximately one-third of participants initially believed to have a false positive result were later diagnosed with cancer during the subsequent follow up period
This reduction in false positives resulted in an increase of Galleri’s PPV in this symptomatic population to 84.2%
Announced a collaboration with Medcan, a global leader in proactive health and wellness services, to provide access to the Galleri test at Medcan’s clinics. Additionally, Manulife Canada announced it now offers access to Galleri, in partnership with Medcan, to eligible life insurance customers through its innovative Manulife Vitality program.
Announced a strategic collaboration with Samsung in October to bring the Galleri test to key Asian markets. Subject to execution of definitive agreements, the parties will work as exclusive partners to commercialize Galleri in Korea, and possibly other key Asian markets, including Japan and Singapore. In addition, the parties intend to explore potential additional strategic and operational collaborations. Samsung has also agreed to make an equity investment of $110 million in GRAIL, subject to closing conditions.
Completed a private placement of equity in October resulting in gross proceeds of approximately $325 million, before deducting placement agents’ fees and other expenses. Including proceeds from this transaction, GRAIL’s cash position of more than $850 million provides runway into 2030.

(Press release, Grail, NOV 12, 2025, View Source [SID1234659849])

On November 12, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that members of company management will participate in the following investor events:

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Jefferies London Healthcare Conference
Format: Hybrid presentation (slides & moderated Q&A) and one-on-one investor meetings
Presentation Date/Time: Wednesday, November 19, 2025, at 4:00 PM GMT
Location: London, UK

37th Annual Piper Healthcare Conference
Format: One-on-one investor meetings
Date: December 2-4, 2025
Location: New York, NY

A live webcast of the Jefferies event can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.

(Press release, Tyra Biosciences, NOV 12, 2025, View Source [SID1234659848])

On November 12, 2025 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal second quarter ended September 30, 2025, and provided an update on recent developments.

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Key Highlights

Maintained Nasdaq Listing: Compliance matters resolved, Aethlon remains in good standing with Nasdaq.
Clinical Progress: Recruitment underway for Cohort 2 of the Australian oncology trial under amended protocol.
Scientific Advancement: Ongoing collaboration with UCSF on Long COVID research, with a manuscript in preparation for peer-reviewed journal.
Technology Development: Initiated evaluation of Hemopurifier compatibility with a simplified blood treatment system
Operational Efficiency: Operating expenses reduced by 48%, reflecting disciplined cost management.
Clinical and Corporate Update

Clinical Progress in Cancer Trial

Aethlon continues to advance its clinical, scientific, and operational initiatives in support of its mission to develop therapeutic devices for cancer and infectious diseases. Nasdaq compliance matters have been resolved, and the company remains listed on the Capital Market.

Recruitment has begun for the second cohort of the Australian oncology trial of the Hemopurifier is underway under the amended protocol that allows patients receiving combination therapies with Pembrolizumab (Keytruda) or Nivolumab (Opdivo). The study is designed to evaluate safety, feasibility, and dose-finding in patients with solid tumors who have not responded to PD-1 therapy. Additional cohorts will examine whether sequential Hemopurifier treatments decrease extracellular vesicle (EV) concentrations and enhance the body’s immune response against tumor cells.

As previously reported, the laboratory of Professor Georges Grau at the University of Sydney analyzed EVs and lymphocyte counts in samples from patients in the first cohort before and after Hemopurifier treatment. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and inhibition of the body’s T cells, which are important for killing tumor cells. Two of the three participants in the trial showed decreases in large EVs, also known as microvesicles, following the Hemopurifier treatment. Decreases were observed in large and small platelet-derived EVs in two of the three patients. We observed decreases in the subset of large EVs carrying PD-L1 in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with lack of response to anti-PD-1 agents.

Decreases were observed in seven out of ten microRNAs examined in two of the three participants following a single 4-hour Hemopurifier treatment. MicroRNAs are one component of the cargo of extracellular vesicles, previously reported to promote cancer growth and metastasis.

Improvements in laboratory ratios associated with responses to immunotherapy including Neutrophil, Lymphocyte, Monocyte, Albumin and Systemic Immune-Inflammation were observed in at least two participants after a single 4-hour treatment. Increases were noted in total T cell numbers, CD8 and CD4 T cell subsets, and tumor specific T cells (CD137 +ve) in participants following Hemopurifier treatment without a consistent pattern in terms of timing of improvement.

Additional data from the subsequent two cohorts will help determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.

We believe the unmet need remains significant: currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors are believed to contribute to both cancer progression and resistance to anti-PD-1 therapies.

The study’s primary endpoint is safety. The study will enroll approximately 9 to 18 participants. Eligible patients with solid tumors with stable or progressive disease receive escalating doses of Hemopurifier treatment across sequential cohorts – one, two, and three Hemopurifier treatments administered over the course of a single week. In addition to evaluating safety, the study is designed to assess whether reducing the concentration of EVs may improve the body’s own natural ability to attack tumor cells. These exploratory findings are expected to inform the design of future efficacy and safety trials, including a Premarket Approval (PMA) study.

Scientific Collaboration in Long COVID Research and Technology Development

Analysis of EV cargo from Long COVID patient samples continues in collaboration with the University of California, San Francisco (UCSF). These studies build on prior findings showing that the Hemopurifier can bind and remove large and small EVs from Long COVID patients. A manuscript detailing these results is being prepared for submission to a peer-reviewed journal.

We also initiated an evaluation to study the compatibility of the Hemopurifier with an alternative blood treatment system that uses a single small-lumen catheter and simplified blood pump compared to traditional hemodialysis setups. This research could lead to simplified system for performing Hemopurifier treatments in Oncology units in the future.

Operational Achievements

Operating expenses decreased by 48% during the quarter, reflecting the Company’s ongoing efforts to reduce costs while advancing its clinical and research programs.

"We remain focused on executing our clinical and research strategy while maintaining operational discipline," said James Frakes, CEO and CFO of Aethlon Medical. "Our ongoing trial progress, research collaborations, and technology initiatives continue to support our long-term goal of developing therapeutic solutions for cancer and life-threatening infectious diseases."

Financial Results for the Fiscal Second Quarter Ended September 30, 2025

As of September 30, 2025, Aethlon had a cash balance of approximately $5.8 million.

Consolidated operating expenses for the three months ended September 30, 2025 were approximately $1.5 million, down by approximately $1.4 million or 48%, from $2.9 million in the same period in 2024. The decreases were reflected across payroll, general and administrative and professional fees.

Payroll and related expenses decreased by approximately $778,000, reflecting lower headcount, reduced bonus accruals, and absence of prior-year severance charges.
General and Administrative expenses declined by approximately $437,000 driven by lower clinical trial costs, in part due to a $218,000 R&D tax incentive, as well as reductions in supplies, insurance, and other operational costs.
Professional fees decreased by approximately $177,000, mainly from reduced investor relations and contract labor expenses, partially offset by higher legal, tax, audit and financial services costs.
As a result of these factors, operating loss for the quarter decreased to $1.5 million compared to $2.8 million in the prior-year period.

Other income totaled $22,730 for the three months ended September 30, 2025, compared to $95,146 in the prior-year period. In both quarters, other income was primarily interest income earned on cash balances.

The consolidated balance sheets for September 30, 2025 and March 31, 2025, along with the consolidated statements of operations for the three and six months ended September 30, 2025 and 2024, are included at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, November 12, 2025, at 4:30 p.m. ET to review the Company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

(Press release, Aethlon Medical, NOV 12, 2025, View Source [SID1234659847])

On November 12, 2025 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 third quarter ended September 30, 2025, and provided a business update, including highlights of pipeline progress.

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"We continue to make great progress advancing the ENABLE Phase 1 trial of ELVN-001 in people living with CML. I’m pleased to report that during the quarter, we completed enrollment of the randomized Phase 1b portion of the ENABLE trial and achieved key readiness milestones across multiple geographies, positioning us to rapidly launch our Phase 3 trial globally next year," said Sam Kintz, Co-Founder and Chief Executive Officer of Enliven. "Since we announced our positive, updated ENABLE data in June, we have had oral presentations at multiple medical meetings, which is a testament to the strength of the data and the potential for ELVN-001 as a selective active-site inhibitor. Additionally, we are pleased that the CML community continues to validate our work and enthusiastically supports ELVN-001 as we move through clinical trials. We remain focused on clinical execution as we look to initiate our Phase 3 pivotal trial in 2026."

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

Completed enrollment of the randomized Phase 1b cohorts of the ongoing ENABLE trial of ELVN-001 in CML (NCT05304377).
Presented encore data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 at several medical meetings, including:
An oral and poster presentation at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Houston, Texas, on September 3, 2025.
An oral presentation at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 27th Annual John Goldman Conference on Chronic Myeloid Leukemia: Biology and Therapy in Estoril, Portugal, on October 10, 2025.
An oral presentation at the German, Austrian, and Swiss Societies for Hematology and Medical Oncology (DGHO) in Cologne, Germany, on October 25, 2025.
Featured in an oral presentation titled, ELVN-001 for the treatment of CML with and without T315I mutation: a Phase 1 trial in Japan, at the 87th Annual Meeting of the Japanese Society of Hematology (JSH) in Kobe, Japan, on October 10, 2025.
Remains on track to initiate a Phase 3 pivotal trial of ELVN-001 in 2026.
Upcoming Medical Meeting Presentations

The Company recently announced that data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 in a subset of CML patients with atypical fusion transcripts will be presented at the 67th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida. Andreas Hochhaus, M.D., will present the data in a poster presentation on December 7, 2025.

Upcoming Investor Conference Participation

Management will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025, at 2:00 p.m. GMT. The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at View Source The webcast will be archived for a period of 90 days following the conclusion of the live event.

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $477.6 million, which is expected to provide cash runway into the first half of 2029.
Research and development (R&D) expenses: R&D expenses were $18.2 million for the third quarter of 2025, compared to $21.3 million for the third quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $6.9 million for the third quarter of 2025, compared to $5.8 million for the third quarter of 2024.
Net Loss: Enliven reported a net loss of $20.1 million for the third quarter of 2025, compared to a net loss of $23.2 million for the third quarter of 2024.
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 inhibitor, 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.

About the ENABLE Trial

The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and 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. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

(Press release, Enliven Therapeutics, NOV 12, 2025, View Source [SID1234659846])