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])

On December 2, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025.

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The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative.

Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg).

Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-γ). Data cut-off date for efficacy results was 15 September 2025.

Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center noted, "Evaluating two biologically active doses allowed us to integrate clinical response data with meaningful pharmacodynamic readouts. In keeping with Project Optimus principles, the study generated rigorous comparative data in heavily pretreated metastatic breast cancer patients showing consistent efficacy measures and immune-activation signals across both arms, reinforcing efti’s novel mechanism of action and the clinical potential of this immunotherapy-chemo combination."

Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD.

(Press release, Immutep, DEC 2, 2025, View Source [SID1234661102])