On December 2, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported that 11 studies featuring the Breast Cancer Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions.

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"These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care," said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. "This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types."

Among the new findings to be presented, one study, "Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]," explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^*

"As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life," said primary study author Dr. Ruth O’Regan, MD. "The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects."

A full list of studies to be presented at the 2025 SABCS conference includes:

Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST
Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants.9*
Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision.10*
Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence.8^*
Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease.11*
Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns.12*
Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples.13*
Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including:

Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18]14
Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10]15
Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19]16
Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23]17
Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST
Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08]18
"The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test," said Schneiders. "With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients."

About the Breast Cancer Index Test

The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7

The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

(Press release, Hologic, DEC 2, 2025, View Source [SID1234661067])

On December 2, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a securities purchase agreement with certain established institutional and accredited investors for a private placement of equity securities (PIPE). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to the investors an aggregate of approximately $50.0 million of ordinary shares and prefunded warrants, at a purchase price per share that is the equivalent of $5.00 per ADS, each ADS representing 500 ordinary shares. The PIPE is structured as a straightforward equity investment with no common warrant coverage. The PIPE financing was led by healthcare-dedicated investors including Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management, LLC, alongside existing shareholders, including Jorey Chernett. The transaction is expected to close on Wednesday, December 3, 2025, subject to customary closing conditions.

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Konik Capital Partners, LLC is acting as the exclusive placement agent for the PIPE.

The net proceeds to the Company from the PIPE are expected to be approximately $46.5 million, after deducting placement agent’s fees and other estimated offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of its lead program paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor currently in clinical trials for both brain cancer and advanced breast cancer, advancing the PD-L1 degrader program, and for general corporate purposes. The Company expects the net proceeds from the PIPE, combined with the existing cash and cash equivalents, will extend its cash runway into the second half of 2028.

The securities sold in this PIPE are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements. Pursuant to the securities purchase agreement, the Company has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (SEC) within 30 days of the closing to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the securities described above under the resale registration statement will only be by means of a prospectus.

(Press release, Kazia Therapeutics, DEC 2, 2025, View Source [SID1234661049])

On December 2, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that at least twelve abstracts highlighting Signatera will be shared at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12.

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The presentations encompass aggregated data from more than 50,000 patients in real-world evidence and prospective clinical studies, demonstrating the prognostic and predictive power of Signatera across diverse breast cancer subtypes and settings. These include real-world studies of Signatera adoption and clinical impact at Yale, Houston Methodist and other leading institutions. Additional highlights include:

Signatera Genome study

In a real-world cohort of 227 patients with triple-negative, HR+/HER2- and HER2+ breast cancers, during surveillance Signatera Genome detected recurrence with a sensitivity and specificity of 100%.

Patients who were Signatera-positive within 3 months of surgery were at a significantly higher risk of distant disease recurrence (HR: 13.1, 95% CI: 1.4-122.1, P = 0.005).
Signatera positivity at any time post-definitive treatment was associated with significantly worse distant recurrence-free survival (HR: 221.2, 95% CI: 131.0-373.4, P <0.0001).
LEADER trial

This phase 2 randomized study aims to evaluate the efficacy of adding the CDK4/6 inhibitor, ribociclib, to adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer who test Signatera-positive during surveillance.

Patients with sustained MRD negativity remained disease-free during extended followup (12−month NPV: RFS=99%, DRFS=100%).
MRD-positive patients initiating ribociclib achieved high rates of ctDNA decrease or clearance, translating to delayed onset of distant recurrence (18.6 vs 5.4 from treatment start).
"We are proud to share our largest dataset for SABCS thus far, featuring the value of Signatera in risk stratification, the early detection of molecular relapse and treatment response monitoring," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The findings from these prospective clinical studies and real-world evidence add important context on how Signatera can provide personalized insights and optimize treatment across all breast cancer subtypes and indications, and the new data with Signatera Genome offer even greater promise for MRD testing."

The full list of presentations at SABCS includes:

December 10, 4:30 PM CT | RF3-04 (Oral Presentation)
Presenter: Heather A. Parsons
Tumor-informed circulating tumor DNA analysis to assess molecular residual disease for prognosis and prediction of benefit from palbociclib in the PALLAS trial

December 10, 5:00 PM CT | PS2-09-04
Presenter: Julia Foldi
Predicting outcomes for patients with mixed ductal/lobular carcinoma of the breast based on circulating tumor DNA positivity patterns

December 10, 5:00 PM CT | PS2-10-03
Presenter: Devora Isserfoff
Impact of Circulating Tumor DNA (ctDNA) monitoring on Patient Anxiety and Clinician Decision-Making in Early-Stage Breast Cancer (PACE-ctDNA)

December 10, 5:00 PM CT | PS2-08-21
Presenter: Amy J. Xu
Circulating tumor DNA (ctDNA) Dynamics in Early-stage Breast Cancer Patients (pts) with Brain Metastases

December 10, 5:00 PM CT | PS2-08-12
Presenter: Julia Foldi
Age-associated divergence in breast cancer: clinical, molecular, and genomic insights from a large real-world cohort

December 10, 5:00 PM CT | PS2-09-20
Presenter: Daniel Stover
Circulating Tumor DNA Dynamics and Anatomical Patterns of Relapse Following Curative Therapy in Early-Stage Breast Cancer

December 10, 5:00 PM CT | PS2-07-26
Presenter: Wassim McHayleh
Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer

December 11, 7:00 AM CT | PD6-07 (Poster Spotlight)
Presenter: Mark Jesus Magbanua
ctDNA dynamics is most predictive of response in treatment-sensitive response-predictive subtypes of breast cancer: Results from the I-SPY2 trial

December 11, 7:00 AM CT | PD5-01 (Poster Spotlight)
Presenter: Arielle J. Medford
Personalized circulating tumor DNA (ctDNA) testing, intervention, and temporal dynamics in ER+/HER2- early-stage breast cancer (LEADER)

December 11, 7:00 AM CT | PD9-01 (Poster Spotlight)
Presenter: Steffi Oesterreich
Comprehensive Genomic Landscape of Invasive Lobular Carcinoma Reveals Distinct Molecular Subtypes

December 11, 12:30 PM CT | PS3-01-05
Presenter: Banu Arun
Prevalence and Characterization of Germline CDH1 Mutations in a Large Real-World Breast Cancer Cohort

December 11, 5:00 PM CT | PS4-02-25
Presenter: Minhal Zaidi
Single Institution experience of longitudinal post-surgical circulating tumor DNA monitoring in patients with HER2+ breast cancer

(Press release, Natera, DEC 2, 2025, View Source [SID1234661068])

On December 2, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported its participation in the Evercore 8th Annual Healthcare Conference on Thursday in Miami.

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Evercore 8th Annual Healthcare Conference
December 4, 2025
10:50 a.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, and a replay will be archived on the website for approximately 90 days.

(Press release, Nkarta, DEC 2, 2025, View Source [SID1234661050])

On December 2, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported that it will showcase its latest research through 100 abstracts and presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place in Orlando, Florida and virtually from December 6-9. SCRI’s expansive network is represented by more than 50 researchers who serve as first authors and co-authors across over 15 research locations.

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A comprehensive list of SCRI abstracts and presentations at this year’s Annual Meeting & Exposition can be found here.

"This year’s ASH (Free ASH Whitepaper) Annual Meeting & Exposition marks a milestone for SCRI, with the largest number of accepted abstracts and presentations in our history," said David Spigel, MD, Chief Scientific Officer, SCRI. "This achievement reflects not only the significance of the research, but also the meaningful collaboration and unwavering commitment of the investigators across our network, all united to advance the science that transforms care for people facing blood cancers and blood disorders."

Noteworthy Presentations

Β-Thalassemia & Sickle Cell Disease

Haydar Frangoul, MD, MS, SCRI at TriStar Centennial Children’s Hospital, will present "First Results of Exagamglogene Autotemcel in Pediatric Patients Aged 5-11 Years with Transfusion-Dependent Β-Thalassemia or Sickle Cell Disease with Recurrent Severe Vaso-Occlusive Crises" in an oral presentation on Saturday, December 6 at 4:00 p.m. EST in OCCC – Chapin Theatre (W320).
Dr. Frangoul is also first author on an oral presentation titled, "Enhanced CD34+ Cell Mobilizations, Collections, and Comparable Safety Profile with Fixed Dose versus Weight-Based Plerixafor Dosing in Patients with Sickle Cell Disease Receiving Autologous CD34+ Base-Edited Hematopoietic Stem Cells in the Ongoing BEACON Study" on Monday, December 8 at 5:30 p.m. EST in Hyatt – Regency Ballroom R.
Leukemia

Nosha Farhadfar, MD, SCRI at Methodist Healthcare, is first author on an oral presentation alongside Stephen Strickland, MD, MSCI, SCRI, and Alireza Eghtedar, MD, SCRI at Colorado Blood Cancer Institute, titled, "Promising Results from an Ongoing Phase I Multicenter Study of Senti-202, a First-In-Class, CD33 and/or FLT3 & Not Endomucin, Selective Off-The-Shelf Logic Gated CAR NK Cell Therapy in Adults with Relapsed/Refractory Acute Myeloid Leukemia" on Monday, December 8 at 5:45 p.m. EST in OCCC – Valencia Room W415BC.
Lymphoma

Jeff Sharman, MD, SCRI at Willamette Valley Cancer Institute & Research Center I The US Oncology Network, serves as first author alongside co-authors John Burke, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, and Shachar Peles, MD, SCRI at Florida Cancer Specialists & Research Institute I The US Oncology Network, on an oral presentation titled, "Fixed Treatment Duration Subcutaneous Mosunetuzumab Monotherapy in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Interim Results from The Phase II MorningSun Study" on Saturday, December 6 at 9:45 a.m. EST in OCCC – Tangerine Ballroom F2.
Dr. Burke is first author alongside co-author Dr. Sharman on an oral presentation titled, "Fixed-Duration Subcutaneous Mosunetuzumab, with Maintenance Therapy, in Patients with Previously Untreated High-Tumor Burden Follicular Lymphoma: Longer Follow-Up and Exploratory Circulating Tumor DNA Analysis of The Phase II MorningSun Study" on Saturday, December 6 at 3:15 p.m. EST in OCCC – Tangerine Ballroom F2.
Other

James Essell, MD, SCRI at OHC I The US Oncology Network, is first author on an oral titled, "Remote Therapeutic Monitoring Reduces Hospitalization due to Infection in Patients Being Treated for Hematological Malignancy" on Saturday, December 6 at 10:30 a.m. EST in OCCC – W230.
Dr. Farhadfar will deliver "Safety and Feasibility of 0.6 mg/kg Every 4 Weeks Dosing of Axatilimab in Patients Treated in the AGAVE-201 Study" in an oral presentation on Saturday, December 6 at 2:15 p.m. EST in OCCC – W331.
In addition to scientific presentations, SCRI researchers will participate in and lead ASH (Free ASH Whitepaper) Annual Meeting & Exposition sessions, including:

Hans Lee, MD, SCRI, will moderate the session, Multiple Myeloma: Pharmacologic Therapies: Advances in Treatment Strategies for Relapsed/Refractory Multiple Myeloma, on Saturday, December 6 at 2:00 p.m. EST in OCCC – West Hall D1.
Dr. Burke will present "Engagement of Community Physicians in Clinical Trials" during the session, How Can Community-Based and Academic Hematologists Foster Clinical Trial Participation as Part of Patient Care? on Sunday, December 7 at 9:40 a.m. EST in Hyatt – Plaza Int’l HIJK.
Additional Poster Presentations with SCRI First Authors

Saturday, December 6

"Real-World Treatment Patterns, Factors Associated with Discontinuation and Toxicity Across Covalent BTK Inhibitors in First-Line Tx of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma," Dr. Burke, 5:30 p.m. – 7:30 p.m. EST, OCCC – West Halls B3-B4.
Sunday, December 7

"First-Line Consolidation with Cemacabtagene Ansegedleucel in Patients with Large B-Cell Lymphoma and Minimal Residual Disease after Response to Standard Therapy: The Pivotal, Randomized, Open‑Label Phase 2 ALPHA3 Study" and "Correlation Between Real-World Progression-Free Survival and Overall Survival among Patients with First-Line Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Receiving Covalent Bruton Tyrosine Kinase Inhibitors or B-Cell Lymphoma 2 Inhibitors," Dr. Burke, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
"Asciminib in Chronic Myeloid Leukemia in Chronic Phase: Efficacy and Safety Results of the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients with 1 Prior Tyrosine Kinase Inhibitor," M. Yair Levy, MD, SCRI at Texas Oncology I The US Oncology Network, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.
Monday, December 8

"Diverse Preferences for Treatment Options in Relapsed/Refractory Follicular Lymphoma: Survey Results from Patients in The United States," "Optimizing Processes for Adverse Event Management for Bispecific Antibodies for Diffuse Large B-Cell Lymphoma in Community Practice: Insights from a Quality Improvement Initiative," and "A First-In-Human Phase 1 Trial of LY4152199, A B-Cell Activation Factor Receptor T-Cell Engager Bispecific Antibody, in Patients with Previously Treated B-Cell Malignancies" Krish Patel, MD, SCRI, 6:00 p.m. – 8:00 p.m. EST, OCCC – West Halls B3-B4.

(Press release, Sarah Cannon Research Institute, DEC 2, 2025, View Source [SID1234661069])