On December 29, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2025, as well as key clinical and corporate developments.

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"During fiscal 2025, our regulatory advancements accelerated driven by new opportunities for Multikine in Saudi Arabia and the green light we have received for our Confirmatory Registration trial in the U.S.," stated CEL-SCI CEO, Geert Kersten. "The Confirmatory Registration study required by the FDA is designed to confirm data from our prior Phase 3 study by evaluating Multikine in only those patients who showed the best type of tumor responses and survival in that study in a highly statistically significant manner. The long-term survival with our drug of 73% vs. only 45% without our drug, a huge improvement demonstrated in our prior Phase 3 study, significantly decreases risk associated with the development of Multikine as a cancer therapy. Preparations for this final registration study are ongoing, and we expect to commence enrollment in Spring 2026."

Clinical and Corporate Developments:

CEL-SCI is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028.
An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. CEL-SCI believes it has addressed all of the scientific questions posed by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia’s ambitious Vision 2030 goals to further advance the Kingdom’s global leadership in biotechnology.
CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts.
CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study.
A new study supports CEL-SCI’s strategy to seek early approval in the U.S. The third-party study recently published in Cancer Cell titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The data give further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June 2025, the FDA approved Merck’s KEYTRUDA (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine. Importantly, while Keytruda confers benefit in patients with a high levels of PD-L1, Multikine has been shown to significantly extend life in patients with low to zero levels of PD-L1. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.
Financial Results

During the fiscal year ended September 30, 2025, research and development expenses were $15.9 million, which decreased by approximately $2.3 million, or 13%, compared to the year ended September 30, 2024. General and administrative expenses in fiscal 2025 were $8.9 million, which increased by approximately $0.7 million, or 9%, compared to the year ended September 30, 2024. Net loss available to common shareholders decreased by $2.2 million to approximately $25.4 million for the twelve months ended September 30, 2025 from $27.6 million in fiscal 2024. The operating cash expenditures for the year were approximately $17.1 million. CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern. CEL-SCI raised gross proceeds of approximately $28.3 million in fiscal 2025 through the sale of common stock.

(Press release, Cel-Sci, DEC 29, 2025, View Source [SID1234661650])

On December 28, 2025 Senhwa Biosciences following its recent clinical collaboration with the multinational pharmaceutical company BeOne Medicines to explore combination therapy with its marketed PD-1 inhibitor in the challenging field of cold tumor treatment reported another major milestone. The Company’s first-in-class investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the globally recognized antibody-drug conjugate (ADC), Trastuzumab Deruxtecan (Enhertu), in a Phase 1b clinical trial. The study is designed for HER2-positive solid tumors and breast cancer patients, including those with HER2-low expression and metastatic breast cancer. Supported by the U.S. National Cancer Institute’s (NCI) NExT program, which funds multiple CX-5461 studies including combination strategies, Senhwa is positioning itself at the forefront of one of the most promising areas in oncology therapeutics, and this milestone marks CX-5461’s entry into the fast-growing ADC market.

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World’s First G4 Stabilizer Meets Leading ADC

CX-5461 is the world’s first and most advanced G-quadruplex (G4) stabilizer in development. It has shown promising activity in early-phase trials for breast cancer and other solid tumors in study sponsored by SU2C-CCTG in Canada. Its combination with Enhertu is expected to enhance treatment efficacy in HER2-low patients and offer new therapeutic possibilities.

Enhertu, co-developed by AstraZeneca and Daiichi Sankyo, is the first HER2-directed ADC approved for HER2-low and HER2-ultralow metastatic breast cancer. This innovative drug uses a monoclonal antibody to precisely target tumor cells and deliver the chemotherapy payload Deruxtecan directly into the tumor, enabling highly effective cancer cell killing while minimizing harm to healthy cells.

Entering a High-Growth Market

The global ADC market is projected to grow at a CAGR of 28.4%, reaching approximately USD 47 billion by 2029. Analysts believe that Senhwa’s clinical development strategy combining CX-5461 and Enhertu positions the company to directly tap into this high-growth and highly competitive oncology market.

Differentiated Advantage and Strategic Collaboration Potential

Although existing HER2-targeted therapies have transformed the treatment landscape for breast and gastric cancers, their efficacy in HER2-low solid tumors remains limited. Experts suggest that if CX-5461’s novel mechanism of action, when combined with ADC’s precise delivery platform, proves effective, it could break through current treatment barriers, expand indications to additional tumor types, and establish a clear competitive edge.

With global pharmaceutical companies racing into the ADC space, collaborations and licensing agreements have become mainstream. Should Senhwa’s combination therapy demonstrate strong clinical efficacy, it could attract strategic partnerships with major international pharma players, bringing in substantial licensing revenues and long-term collaboration opportunities.

Driving Long-Term Value Creation

Analysts further note that the successful advancement of this trial would significantly enhance Senhwa’s international visibility in oncology, elevate the company’s market valuation, and deliver sustainable long-term returns for investors and shareholders.

HER2 has been validated as a critical oncogenic driver across multiple tumor types. By leveraging the innovative combination of CX-5461 and Enhertu, Senhwa aims to pioneer breakthrough therapies, capture a substantial share of the rapidly growing ADC market, and build a diverse oncology treatment platform. The company reiterated its commitment to strengthening its R&D pipeline, integrating next-generation ADC technologies with its proprietary drug candidates, and advancing toward its vision of becoming a leading Asia-based oncology innovator with a global footprint.

Senhwa Biosciences – CX-5461 NCI-NExT Program Clinical Trial Overview

No.

Study Title

Total Subjects

Primary Endpoints

Global Market Forecast

1

Pilot Study of Pidnarulex Pharmacodynamics
in Patients with Advanced Solid Tumors

Up to 40 subjects
HRD / Non-HRD (20 each)

Evaluation of RAD51 response and DNA damage response

2024: USD 362.2B
CAGR: 20%
2032: USD 1,557.4B

2

Phase 1b/2 Trial of Pidnarulex
in MYC Aberrant Lymphoma

Up to 50 subjects
Phase 1b: 36
Phase 2: 8–14

1. Safety and DLT evaluation on CX-5461
2. RP2D for on CX-5461
3. ORR
4. CX-5461 PK
5. Effect on MYC-aberrant lymphoma gene expression

2024: USD 4.9B
CAGR: 5.79%
2035: USD 8.9B

3

A Phase 1 and Randomized Phase 2 Trial
of Pidnarulex (CX-5461) and Cemiplimab (REGN2810)
in Refractory Microsatellite Stable Colorectal Cancer

Up to 86 subjects
Phase 1: 18
Phase 2: 68

1. CX-5461 RP2D combined with PD-1 inhibitor
2. Safety & tolerability for CX-5461 monotherapy & combination
3. PFS in refractory MSS CRC with liver metastases for CX-5461 monotherapy & combination

2025: USD 58.0B
CAGR: 15%
2035: > USD 250.0B

4

Phase 1b study
of Pidnarulex and Trastuzumab Deruxtecan
in patients with HER2 expressing Solid Tumors

Up to 36 subjects

1. MTD & RP2D determination for combination of CX-5461 and Trastuzumab Deruxtecan
2. Safety and tolerability in HER2-low and HR+ HER2-ultra-low breast cancer for combination of CX-5461 and Trastuzumab Deruxtecan

2023: USD 10.8B
CAGR: 28.4%
2029: USD 47.0B

(Press release, Senhwa Biosciences, DEC 28, 2025, View Source [SID1234661632])

On December 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported that it has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd. ("Lannacheng"). The two parties will leverage their respective resources and strengths to jointly advance the development of next-generation radionuclide drug conjugates (RDCs).

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Compared with conventional radiotherapy, RDCs utilize tumor antigen–specific ligands to deliver radionuclides directly to tumor lesions for targeted radiotherapy, thereby effectively reducing damage to surrounding healthy tissues. In contrast to antibody–drug conjugates (ADCs), the radionuclides in RDCs can also exert cytotoxic effects on neighboring tumor cells and the tumor microenvironment, even if those cells do not express the target antigen. This mechanism offers a potential advantage in overcoming tumor heterogeneity and drug resistance. In addition, this technology holds the potential to achieve theranostics—integrating both diagnosis and treatment.

With its advanced technology platforms and deep expertise, Harbour BioMed has built a solid foundation in antibody discovery and development. The company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapeutics. In the development of RDCs, fully human antibodies—characterized by low immunogenicity, superior tissue penetration, and high specificity and stability—can significantly enhance the efficiency of targeted delivery, thereby improving therapeutic efficacy while effectively reducing drug-related toxicity and side effects.

Founded in 2021, Lannacheng is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of integrated theranostic radiopharmaceuticals for oncology. The company’s R&D engine, enhanced by its proprietary pharmacokinetic optimization and dual-targeting drug development platforms, combines target validation, radioisotope selection, and linker design to improve pharmacokinetic profiles and advance the development of dual-targeting radiopharmaceutical candidates. Its strengths are further solidified through end-to-end integration of capabilities supported by its controlling shareholder, Dongcheng Biochem, including R&D resources, a stable supply of radioisotopes, and a GMP production facility currently under construction in Yantai. Together, these elements ensure a sustainable, scalable, and rapidly innovating radiopharmaceutical pipeline.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "We are very pleased to establish a long-term strategic collaboration with Lannacheng to jointly advance the development of next-generation RDCs. Harbour BioMed is committed to providing efficient and highly differentiated antibody solutions for innovative therapies through our globally leading Harbour Mice fully human antibody platform. This collaboration will deeply integrate Harbour BioMed’s expertise in antibody discovery with Lannacheng’s strengths in radiopharmaceutical R&D and commercialization, accelerating the development of more precise, effective and safe cancer therapies and bringing new hope to patients worldwide."

Wu Xiaoming, General Manager of Lannacheng, stated: "We are delighted to establish a long-term strategic collaboration with Harbour BioMed to jointly advance the R&D and translation of next-generation radiopharmaceuticals. Lannacheng is committed to leveraging our systematic radiopharmaceutical technology platform, comprehensive industrial capabilities, and global collaboration network to provide efficient, innovative, and differentiated integrated solutions for tumor diagnosis and treatment. This collaboration will fully combine Lannacheng’s strengths in radiopharmaceutical R&D and commercialization and Harbour BioMed’s deep expertise in antibody discovery. Together, we aim to accelerate the development of more precise, effective, and safe cancer treatment therapies, bringing new hope to patients worldwide."

(Press release, Harbour BioMed, DEC 28, 2025, View Source [SID1234661633])

On December 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596. The applications seek to initiate two corresponding Phase Ib/Ⅱ clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (pPCL), respectively.

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CT0596 is an allogeneic CAR T-cell therapy targeting BCMA, developed based on CARsgen’s proprietary THANK-u Plus platform. Through the knockout of genes such as NKG2A, TRAC, and B2M, CT0596 is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product’s efficacy and safety profile.

Investigator-initiated trials (IIT) for CT0596 have already been conducted in China to explore its clinical potential in treating R/R MM and pPCL. Data from the first-in-human study, presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, demonstrated a favorable safety profile and encouraging efficacy signals for CT0596. As of August 31, 2025, all 8 patients with R/R MM who received CT0596 infusion were evaluable for efficacy, with a median follow-up of 4.14 months. Six patients achieved a partial response (PR) or better: 3 achieved complete response/stringent complete response (CR/sCR) (all received full-dose lymphodepletion), 1 achieved very good partial response (VGPR), and 2 achieved PR. Four patients experienced Grade 1 cytokine release syndrome (CRS), with no Grade 2 or higher CRS observed. No immune effector cell-associated neurotoxicity syndrome (ICANS), GvHD, dose-limiting toxicities, treatment discontinuations, or deaths were reported.

Previously, the company also disclosed preliminary clinical data for CT0596 in relapsed/refractory pPCL. Two heavily pretreated pPCL patients with high disease burden and rapid progression both achieved sCR after receiving CT0596 treatment.

The IND applications mark the commencement of the registration clinical development phase for CT0596, which holds the potential to offer a new treatment option for patients with R/R MM and pPCL.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or primary plasma cell leukemia (pPCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by plasma cells.

(Press release, Carsgen Therapeutics, DEC 28, 2025, View Source [SID1234661634])

On December 26, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that its board of directors has determined to effect a one-for-16 reverse stock split of Adicet’s common stock, par value $0.0001 per share.

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The reverse stock split ratio approved by the board of directors is within the previously disclosed range of ratios for a reverse stock split authorized by the stockholders of the company at the 2025 Special Meeting of Stockholders of Adicet held on December 19, 2025. The reverse stock split will take effect at 12:01 a.m. Eastern Time on December 30, 2025, and Adicet’s common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market as of the opening of trading on December 30, 2025. The CUSIP number of 007002207 will be assigned to Adicet’s common stock when the reverse stock split becomes effective.

When the reverse stock split becomes effective, every sixteen (16) of Adicet’s issued shares of common stock will be combined into one issued share of common stock, without any change to the par value per share. This will reduce the number of outstanding shares of common stock from approximately 153.3 million shares to approximately 9.6 million shares. The reverse stock split will not affect the absolute number of Adicet’s authorized shares of common stock, which will remain at 300,000,000, but the total number of shares of Adicet’s common stock available for future issuance will increase.

Proportional adjustments will also be made to the number of shares of common stock awarded and available for issuance under Adicet’s equity incentive plans, as well as the exercise price and the number of shares issuable upon the exercise or conversion of Adicet’s outstanding stock options and other equity securities under Adicet’s equity incentive plans. All outstanding pre-funded warrants will also be adjusted in accordance with their terms, which will result in proportionate adjustments being made to the number of shares issuable upon exercise of such warrants and to the exercise prices of such warrants, as applicable.

No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise be entitled to receive fractional shares will automatically be entitled to receive cash in lieu of such fractional share.

Stockholders with shares held in book-entry form or through a bank, broker, or other nominee are not required to take any action and will see the consequence of the reverse stock split reflected in their accounts on or after December 30, 2025. Such beneficial holders may contact their bank, broker, or nominee for more information.

The reverse stock split is intended to enable Adicet to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.

(Press release, Adicet Bio, DEC 26, 2025, View Source [SID1234661629])