On December 9, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in relapsed/refractory AL Amyloidosis, reported the closing of its previously announced underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per share, and to certain investors in lieu of common stock, pre-funded warrants to purchase 490,196 shares of common stock at a price to the public of $5.09 per pre-funded warrant, which represents the per share public offering price for the common stock, less the $0.01 per share exercise price for each such pre-funded warrant. The net proceeds to Immix from the offering, after deducting the underwriting discounts, commissions and other offering expenses, were approximately $93.7 million.

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The financing includes leading U.S. biotechnology institutional investors and mutual funds.

Morgan Stanley acted as the sole book-running manager for the offering. Citizens Capital Markets and Mizuho acted as co-managers for the offering.

The securities in the registered offering were offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269100), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 3, 2023, and declared effective on January 11, 2023. A prospectus supplement and accompanying prospectus describing the terms of the registered offering was filed with the SEC and is available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by phone: 1-866-718-1649 or by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of 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.

(Press release, Immix Biopharma, DEC 9, 2025, View Source [SID1234661314])

On December 9, 2025 GC Genome, a leading clinical genomics and liquid biopsy company, reported that its study analyzing cell-free DNA (cfDNA) fragmentation patterns in 1,154 healthy individuals has been published in Clinical Chemistry (Impact Factor 6.3, 2025). The findings reveal key physiological factors that can interfere with cancer-associated cfDNA signals, offering a foundation for improving the accuracy of liquid biopsy tests.

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The study, conducted in collaboration with Professor Min-Jung Kwon and her team at Kangbuk Samsung Medical Center, examined correlations between cfDNA fragmentomic profiles and 65 clinical variables, including age and liver function markers. The goal was to identify potential confounders that could influence cfDNA-based cancer detection in individuals without cancer.

Study Overview

Healthy cohort: 1,154 noncancerous individuals who underwent routine health checkups
Clinical variables included: 65 demographic, hematologic, and biochemical parameters
Three fragmentomic features were derived: cfDNA concentration, short-fragment ratio (SFR), and frequency of cancer-enriched motifs(CEMs)
Key Findings

Liver enzymes(including AST, ALP, γ-GTP) and age were identified as major factors altering cfDNA fragmentation patterns.
Elevated AST or age closely resembled cancer-like fragmentomic signatures, blurring the distinction between noncancer and cancer profiles.
AST showed high similarity to fragmentation size patterns seen in lung cancer patients (cosine similarity = 0.98).
Age showed the highest similarity to cancer-like profiles among clinical variables (cosine similarity = 0.52).
Receiver Operating Characteristic (ROC) analysis confirmed that these physiological variables can act as confounders by reducing the specificity of cfDNA-based detection, potentially leading to false-positive results.
These findings demonstrate that non-cancer physiological factors can influence cfDNA signals, underscoring the need for confounder-aware modeling approaches in liquid biopsy development.

A GC Genome spokesperson stated:

"This study is significant because it uses large-scale data from healthy individuals to identify key confounders that influence cfDNA fragmentation patterns. These insights will play an important role in refining our Multi-Cancer Early Detection (MCED) test, ai-CANCERCH, particularly in reducing false-positive rates and improving test specificity."

About ai-CANCERCH

Launched in September 2023, ai-CANCERCH is an AI-based multi-cancer early detection(MCED) test powered by Lc-WGS. Using just 10 mL of blood, the test detects signals associated with multiple cancers. A major upgrade—expanding from 6 detectable cancers to 10 cancers (colorectal, lung, esophageal, liver, ovarian, pancreatic, biliary, breast, gastric, and head-and-neck)—is planned for January 2026.

(Press release, GC Genome, DEC 9, 2025, View Source [SID1234661330])

On December 9, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This is up from 60% in its report in November. The targeted number for the first unblinding of data is 45 subjects. Additional subjects beyond the 78% mark continue to be identified by site investigators. This update is as of December 3, 2025, as identification and recruitment are ongoing. The Company expects to complete treatment of the first 45 subjects in the first quarter of 2026.

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Walter Klemp, Chairman and CEO of Moleculin, commented, "We continue to see blinded clinical activity tracking within our expected range, based on historical responses of the trial arm equivalents. With this update, we are quickly approaching the 45th subject, which we expect to be in the first quarter of 2026, to be treated and support the first unblinding in Part A of the MIRACLE trial shortly thereafter. This increase in subjects consented in one month is highly encouraging and demonstrates the enthusiasm of investigators around Europe and the US. Although we saw early enrollment at some sites in Europe being impacted by bed shortages, we are now seeing this situation improve in certain EU countries. Moving toward our first unblinding milestone, we are excited about Annamycin’s potential to fill a major gap in AML treatment. We believe we’re well on our way to determining if Annamycin has the potential to offer a much-needed, safer, and more effective option for patients facing this devastating disease."

Mr. Klemp continued, "While the 45 subject data is not designed to hold statistical significance, we expect to see that at least one of the two arms of Annamycin (at two different dosages) plus cytarabine outperforms cytarabine plus placebo, the control arm. That could be a strong indicator that the MIRACLE trial is on track to support approval of Annamycin. We will continue to recruit the remaining 45 subjects for the full 90 subjects of Part A while we are unblinding the first 45 subjects. The second unblinding should provide enough data to decide on which dose of Annamycin to proceed with into Part B of the MIRACLE trial."

MIRACLE Trial Progress and Next Steps

The MIRACLE study (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a Phase 2B/3, global multi-center, randomized, double-blind, placebo-controlled, adaptive designed clinical trial whereby data from the 2B (Part A) portion will be combined with the Phase 3 (Part B) portion for purposes of measuring its primary efficacy endpoint. The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (90 subjects). The first early unblinding will yield 30 subjects treated with Annamycin (190mg/m2 and 230 mg/m2) in combination with HiDAC and 15 subjects treated with just HiDAC plus placebo. Before each unblinding, trial data will be subject to audit, database lock and review.

The currently consented subjects are from sites across seven countries, providing a diverse base of patient population. Subjects are identified, consented, screened, enrolled, treated and then evaluated in that order with subjects possibly withdrawing from the trial at any point of this process. The Company expects to reach the recruitment and treatment of the first 45 subjects in the first quarter of 2026 and to complete Part A of the MIRACLE trial with up to 90 patients within the first half of 2026.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Annamycin also benefits from composition of matter patent protection through 2040 with the potential to extend that protection as far as 2045. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

(Press release, Moleculin, DEC 9, 2025, View Source [SID1234661315])

On December 9, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO (Free ESMO Whitepaper) Asia Congress.

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Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.

Promising Pathologic Complete Response (pCR) Rate

Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%. pCR, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes upon surgical resection, is considered the "gold standard" surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival benefits.

High Rate of Major Pathologic Response (MPR)

The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%. This suggests that the cadonilimab-based regimen induces substantial tumor regression in the majority of patients.

100% R0 Resection Rate

All patients who underwent surgery achieved an R0 resection (microscopically margin-negative resection), providing a solid foundation for curative intent and potentially reducing the risk of recurrence.

Significant Tumor Downstaging

Among all evaluable patients, 85.7% achieved downstaging of the primary tumor (ypT), and 75.0% achieved nodal downstaging (ypN). These results confirm the efficacy of the cadonilimab regimen in reducing tumor burden and lowering the pathological stage, thereby improving the conditions for successful surgical intervention.

Manageable Safety Profile with Good Tolerability

Treatment-related adverse events were consistent with the known safety profiles of the SOX regimen and immune checkpoint inhibitors. No new or unexpected safety signals were observed, indicating an overall manageable and favorable safety profile.

In perioperative treatment of resectable G/GEJ adenocarcinoma, chemotherapy remains the standard therapy for locally advanced gastric cancer. However, chemotherapy has limited efficacy. Cadonilimab, the first PD-1/CTLA-4 bispecific antibody, works by synergistically activating the immune system, achieving a dual blockade of the tumor immune suppressive microenvironment. This mechanism provides a stronger anti-tumor effect compared to PD-1/L1 monotherapies.

Currently, cadonilimab’s clinical value in gastric cancer is scientifically well-established. Beyond its ongoing phase III clinical trial in the perioperative setting, cadonilimab combined with chemotherapy as a first-line treatment for advanced gastric cancer (with survival benefits across the PD-L1 expression levels) has been approved for commercialization in China. Additionally, a pivotal phase III trial exploring cadonilimab in combination with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer is currently ongoing and is expected to offer a new therapeutic option for later-line gastric cancer. Collectively, these pivotal phase III studies will expand the use of cadonilimab, paving the way for a comprehensive gastric cancer treatment options that spans from advanced, unresectable gastric cancer to early-stage, resectable disease.

(Press release, Akeso Biopharma, DEC 9, 2025, View Source [SID1234661331])

On December 9, 2025 Novartis reported results showing that one in four patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) remained progression-free for four or more years following treatment with Kisqali (ribociclib) plus endocrine therapy (ET)1. Results were from a pooled, post-hoc exploratory analysis of first-line patients in the MONALEESA trials and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on December 11, 2025.

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Metastatic breast cancer is cancer that has spread beyond the breasts to other parts of the body. Long-term progression-free survival benefit with Kisqali was observed in patients regardless of their menopausal status and was achieved even in a proportion of patients with unfavorable prognostic factors (liver involvement, ≥ 3 metastatic sites)1. Patients had a median progression-free survival of 6.8 years1. The median overall survival was not estimable.

Kisqali has demonstrated statistically significant overall survival (OS) across all three Phase III MONALEESA trials2-12.

"The latest MONALEESA analysis shows that 1 in 4 patients with metastatic disease remained progression-free for four years or more. Our biomarker analyses demonstrate clinical and genomic factors potentially associated with these outstanding responses, highlighting the importance of precision medicine in identifying which patients may derive the greatest benefit from CDK4/6 inhibitors," said Dr. Pedram Razavi, Breast Medical Oncologist and Director of Translational Oncology Partnership Program at Memorial Sloan Kettering Cancer Center, who is the author and presenter of the analysis at SABCS.

"Kisqali continues to deliver on its promise of potentially offering more time for people living with advanced breast cancer," said Mark Rutstein, Global Head of Oncology Development at Novartis. "The results from the long-term analysis provide continued confidence in the clinical benefit of Kisqali for metastatic breast cancer patients."

Patient and Biomarker Characteristics Associated with Long-Term Response
The post-hoc exploratory analysis of the MONALEESA-2, -3 and -7 trials in first-line HR+/HER2- MBC aimed to identify clinical characteristics and biomarkers of patients who experienced long-term response with Kisqali1.

Characteristic Long-term
Responders (LTR)
(n=153) Non-LTR
(n=349) Directional insight
Median age (years) 59.3 58.0 Comparable across groups
Postmenopausal (%) 78 78 Balanced by menopausal status
De novo disease (%) 43 40 Similar baseline disease presentation
≥ 3 metastatic sites (%) 30 43 Fewer high-burden cases among LTRs
Liver involvement (%) 16 26 Less frequent among LTRs
Bone-only disease (%) 24 20 Slightly more common among LTRs
Mean ctDNA fraction 0.05 0.13 Lower circulating tumor DNA in LTRs
CCND1 alteration (%) 2 10 Less frequent among LTRs
TP53 alteration (%) 3 12 Less frequent among LTRs
Luminal A subtype (%) 38 25 Higher prevalence among LTRs

NATALEE 5-year Data Reinforce Sustained Benefit in Reducing Distant Recurrence

Additionally, Novartis is presenting a sub-analysis from the five-year NATALEE trial that showed Kisqali plus a nonsteroidal aromatase inhibitor (NSAI) continues to result in improved distant disease-free survival (DDFS) compared to NSAI alone13. This was consistent across key subgroups with node-positive and node-negative disease, reinforcing Kisqali plus NSAI as a treatment option to help reduce the risk of recurrence for the broadest population of HR+/HER2- early breast cancer (EBC) patients.

(Press release, Novartis, DEC 9, 2025, View Source [SID1234661316])