Xenetic Biosciences, Inc. Reports Full Year 2024 Financial Results

On March 19, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the year ended December 31, 2024 (Press release, Xenetic Biosciences, MAR 19, 2025, View Source [SID1234651264]).

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Recent Highlights

Extended its collaborations with the University of Virginia and Scripps Research through 2025;

Entered into a Clinical Trial Services Agreement with PeriNess Ltd. to manage investigator initiated exploratory studies of DNase I in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors; and

Continued pursuit of other strategic collaborations to advance the Company’s technology.

"Over the course of 2024, our team made notable advancements across multiple fronts. We continued to establish and present a growing body of preclinical data that supports the use of our DNase-based technology across several cancer indications. Additionally, we continued to engage institutional partners to drive our development strategies forward including investigator-initiated studies and partnering on various other efforts. Leveraging these relationships allows us to advance our technology toward the clinic while utilizing our resources efficiently and minimizing our internal investment. Looking ahead to 2025, we are executing on our initiatives as we progress toward an IND and Phase 1 clinical trial and look forward to an exciting year," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed.

Summary of Financial Results for Fiscal Year 2024

Net loss for the year ended December 31, 2024 was approximately $4.0 million. Research and development expenses for the year ended December 31, 2024 decreased by approximately $0.2 million, or 5.9%, to $3.3 million from $3.5 million in the prior year period. This decrease was primarily due to decreased spending in connection with the Company’s DNase process development efforts. Royalty payments received from the Company’s sublicense with Takeda Pharmaceuticals Co. Ltd in the year ended December 31, 2024 were approximately $2.5 million, relatively flat with that of the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024 were $3.4 million, decreasing by approximately $0.1 million, or 4.1%, compared to the prior year. The decrease was primarily due to a reduction in legal and accounting costs during the year ended December 31, 2024 compared to the prior year. These decreases were substantially offset by certain severance and benefits expensed in connection with a separation agreement entered into during the second quarter of 2024.

The Company ended the year with approximately $6.2 million of cash.

Actinium Pharmaceuticals to Host Investor KOL Call with Dr. Ehab Atallah of the Medical College of Wisconsin and Provide a Pipeline Update Highlighting Revamped Clinical Programs and Expanded Market Opportunities for Actimab-A and Iomab-ACT with Clinical Data in 2H:2025

On March 19, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that it will host a KOL call that will feature Dr. Ehab Atallah, Professor of Medicine at the Medical College of Wisconsin and principal investigator of the Actimab-A + CLAG-M combination trial in patients with relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Actinium Pharmaceuticals, MAR 19, 2025, View Source [SID1234651266]). Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium’s cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium will provide a pipeline update to highlight 3 separate potential multi-billion-dollar blockbuster market opportunities for its targeted radiotherapies including the following:

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Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including AML and myelodysplastic syndromes (MDS) across multiple treatment settings
Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)
Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes
To register for the KOL Call & Pipeline Update please use the following link:

View Source

Sandesh Seth, Actinium’s Chairman and CEO, said, "We have made significant progress across our pipeline in the first quarter of 2025 achieving several important milestones. We are excited to highlight the large multi-billion-dollar market opportunities for Actimab-A in myeloid malignancies and now solid tumors, as well as cell and gene therapy conditioning with Iomab-ACT. With cash runway into 2027, we are in an excellent position to advance our programs, and we are excited to deliver validating data in the second half of 2025."

Theriva™ Biologics to Present at the 2025 NeauxCancer Conference

On March 19, 2025 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Company’s Management will be attending and presenting at the Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer 2025 Conference being held March 27th-29th, 2025 at The Roosevelt New Orleans Hotel in New Orleans, LA (Press release, Theriva Biologics, MAR 19, 2025, View Source [SID1234651267]).

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A company presentation will take place during the conference’s Innovation track on Friday, March 28th at 9:00am. NeauxCancer conference’s Innovation track spotlights the most promising emerging biotech and healthcare companies advancing detection, treatment, and cures across critical oncology areas.

Theriva’s management team will be available for one-on-one meetings during the conference, interested investors should contact Theriva’s investor relations representative as below.

Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the
European Lung Cancer Congress 2025

On March 19, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 Phase III trial (Press release, Immutep, MAR 19, 2025, View Source [SID1234651268]). The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.

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The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, "We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date."

Details for the poster presentation:
Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number: 131TiP
Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time: 26 March 2025, 13:50 CET

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alpha (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

Servier and Black Diamond Therapeutics Announce Global Licensing Agreement for BDTX-4933, A Targeted Oncology Therapy

On March 19, 2025 Servier, an independent global pharmaceutical group governed by a non-profit foundation, and Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors (Press release, Black Diamond Therapeutics, MAR 19, 2025, View Source [SID1234651252]). Under this global agreement, Servier will develop and commercialize BDTX-4933, a small molecule designed by Black Diamond Therapeutics to address unmet medical needs in RAF/RAS-mutant solid tumors.

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"At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time," said Claude Bertrand, Executive Vice-President of R&D at Servier. "We look forward to accelerating the development of this therapy as a potential best-in-class treatment for cancer patients."

"This agreement supports our mission to advance oral cancer therapies designed to give patients the opportunity for longer, healthier, and more active lives," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Servier’s commitment to innovation and deep expertise in oncology make it an ideal partner for Black Diamond as we work to develop breakthrough cancer treatments."

Under the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including non-small cell lung cancer (NSCLC), with potential applications in other solid tumors. Black Diamond Therapeutics will receive an upfront payment of $70 million and will be eligible to receive up to $710 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.

Currently in Phase 1 development, BDTX-4933 is uniquely designed to target RAS and RAF alterations in solid tumors. The dose escalation and expansion cohort first-in-human study aims at evaluating safety and tolerability, the preliminary recommended Phase 2 dose, and antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.