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Consolidated Financial Summary (IFRS) Fiscal 2025 Semi Annual

On July 31, 2025 Kyowa Hakko Kirin reported consolidated Financial Summary (IFRS) Fiscal 2025 (Press release, Kyowa Hakko Kirin, JUL 31, 2025, View Source [SID1234656876]).

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FibroBiologics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

On July 31, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported second quarter 2025 financial results and provided a corporate update (Press release, FibroBiologics, JUL 31, 2025, View Source [SID1234656320]).

Recent Highlights

Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs).
Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations.
Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile.
Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025.
Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease.
Upcoming Milestones

Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026.
Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026.
Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, said, "Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pending patents, is reinforced by the growing pre-clinical evidence supporting the potential of our fibroblast-based therapies. We believe this expanding IP position enhances our competitive advantage and supports our long-term strategy for innovation. As always, we remain focused on executing our clinical milestones and delivering meaningful value to both patients and shareholders as we advance toward our goal of transforming chronic disease treatments."

Financial Highlights for the Six Months Ended June 30, 2025

Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025, compared to approximately $1.9 million for the same period in 2024. The increase was primarily due to increased chemistry, manufacturing and control costs of $0.2 million for cell manufacturing activities; increased CRO costs of $0.9 million to prepare for a clinical trial; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies.
General and administrative expenses were approximately $5.2 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the same period in 2024. The increase was primarily due to increased expenses of $0.5 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million.
For the six months ended June 30, 2025, FibroBiologics reported a net loss of approximately $9.6 million compared to a net loss of approximately $7.6 million for the same period in 2024. The net loss for the six months ended June 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above.
Cash and cash equivalents totaled approximately $8.8 million at June 30, 2025.
For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected].

ImmuneOnco Announced Preliminary Safety & Efficacy Data from the Clinical Trial Studying IMM2510/AXN-2510, a PD-L1xVEGF Bispecific Antibody, in Combination with Chemotherapy in Front-line NSCLC in China

On July 31, 2025 ImmuneOnco Biopharmaceuticals reported preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China (Press release, ImmuneOnco Biopharma, JUL 31, 2025, View Source [SID1234655712]).

As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.

The IMM2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.

Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of IMM2510 in 1L NSCLC said： "IMM2510 has demonstrated early but compelling activity in front-line NSCLC patients. The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with IMM2510 in this setting."

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are delighted to witness the progress of IMM2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications."

Bronson Crouch, CEO of Instil said: "We are pleased with the preliminary clinical results of the combination of IMM2510/AXN-2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class. We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year."

BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

On July 31, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 31, 2025, View Source [SID1234655022]).

"The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer," stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. "We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site."

"The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We remain confident in our timeline for sharing top-line data in 2026."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO (Free ASCO Whitepaper) 2025, which evaluated the same combination in a similar MBC patient population . Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

H1 2025 results

On July 31, 2025 Ipsen reported first half 2025 financial results (Presentation, Ipsen, JUL 31, 2025, View Source [SID1234654821]).