Corporate Updates Accessibility StatementSkip Navigation - Establishes joint venture with Hemispherian AS to advance GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers - - Phase 1/2a clinical trial of GLIX1 expected to commence in Q1 2026 - - Management to host conference call today, November 24, at 8:30 am EST - TEL AVIV, Israel, Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company ...

Q3 2025 Business Update and Financial Results November 13 2025 This document contains data pertaining to the Company's potential markets and the industry and environment in which it operates. Some of this data comes from external sources that are recognized in the field or from Company's estimates based on such sources. This presentation discusses product candidates that are under clinical development, and which have not yet been approved for marketing by the U.S. Food and Drug Administration or the Europea ...

Biotech firm Propanc lines up $100 million to fund crypto treasury and cancer therapy push https://t.co/x0vTrZbR8D ...

Core Insights - Intensity Therapeutics, Inc. reported its third quarter 2025 financial results and provided updates on its clinical studies, particularly focusing on its lead product candidate INT230-6, which is designed for intratumoral cancer therapy [1][4]. Corporate Update - The INVINCIBLE-4 Study, a Phase 2 trial for early-stage triple-negative breast cancer, has paused new patient enrollment due to localized skin irritation in some patients. The company plans to amend the protocol and resume enrollment in Q1 2026 [2][8]. - The INVINCIBLE-3 Study, a Phase 3 trial for specific soft tissue sarcoma subtypes, has also paused new site activations and patient enrollments due to funding constraints, with 21 patients enrolled prior to the pause. The company continues to treat existing patients and plans to restart the study once funding is secured [3][8]. - A manuscript detailing the Phase 1/2 IT-01 study results was published in eBioMedicine, highlighting the safety and efficacy of INT230-6 in treating advanced solid tumors [4][5]. Financial Results - Research and development expenses for Q3 2025 were $1.6 million, down from $2.2 million in Q3 2024, primarily due to reduced costs associated with the INVINCIBLE-3 Study [6]. - General and administrative expenses decreased to $1.2 million in Q3 2025 from $1.4 million in Q3 2024, attributed to lower consulting expenses [6]. - The net loss for Q3 2025 was $2.7 million, an improvement from a net loss of $3.5 million in the same period last year [7]. Capital Raises and Cash Runway - The company raised a total of $13.6 million since the beginning of Q3 2025, extending its cash runway until the end of Q1 2027 [5][8]. - Recent fundraising included $7.5 million raised in Q3 2025 and an additional $4 million in a registered direct offering in October 2025 [9]. Clinical Efficacy of INT230-6 - In heavily pretreated patients with advanced disease, INT230-6 achieved a disease control rate of 75% and a median overall survival of 11.9 months, significantly better than historical data [9]. - In a subset of metastatic sarcoma patients, the median overall survival was reported at 21.3 months [9]. - The treatment demonstrated a qualitative decrease in proliferating cancer cells and an increase in activated T-cells in the tumor microenvironment, with no dose-limiting toxicities reported [9][10].

Core Insights - Intensity Therapeutics, Inc. announced the publication of its phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers, demonstrating promising efficacy and safety of its investigational product INT230-6 [1][4][5] Study Results - The phase 1/2 trial showed a disease control rate of 75% (48 out of 64 patients) and a median overall survival (mOS) of 11.9 months, which is significantly better than historical mOS of 4 to 7 months for similar patient populations [4][5] - In a subset of metastatic sarcoma patients treated with INT230-6, the mOS was reported at 21.3 months [4] - An exploratory analysis indicated that patients receiving INT230-6 at doses treating more than 40% of their tumor burden had an 83.3% disease control rate and an mOS of 18.7 months, compared to 50% and 3.1 months for those treated with less than 40% [4] Mechanism of Action - INT230-6 utilizes a diffusion process for local treatment, directly injected into tumors, leading to tumor cell death and systemic immune activation [4][6] - The treatment resulted in a qualitative decrease in proliferating cancer cells and an increase in activated T-cells within the tumor microenvironment [4][5] Safety Profile - The trial reported no dose-limiting toxicities among the 64 patients, with only 10.9% experiencing grade 3 adverse events and no grade 4 or 5 treatment-related adverse events [4][5] - Pharmacokinetic data showed over 95% of active cytotoxic agents remained localized within the injected tumors, indicating a favorable safety profile [5] Future Directions - The company plans to initiate randomized controlled studies, including a Phase 3 trial in sarcoma, to further evaluate the efficacy of INT230-6 [5][10]

Core Insights - Sona Nanotech Inc has reported significant first-in-human results for its targeted hyperthermia therapy, demonstrating tumor elimination in most patients with advanced melanoma who were unresponsive to standard immunotherapy [1][4][8] - The company is transitioning from preclinical research to clinical development, marking a pivotal moment in its growth [3][10] Study Results - The early feasibility study involved ten patients with late-stage melanoma, with eight showing responses and six achieving complete responses [4][8] - Biopsies taken from treated tumors indicated no presence of melanoma within two weeks post-treatment [5] Therapy Mechanism - The therapy utilizes nanoparticles inserted into tumors, activated by a near-infrared laser, which selectively heats cancer cells to around 45 degrees Celsius, causing apoptosis without damaging healthy cells [6][7] - This method enhances the immune system's ability to recognize and attack cancer cells, addressing the limitations of traditional immunotherapies [8][9] Future Plans - The company plans to advance into a Canadian clinical trial, pending Health Canada approval, with insights from the early study informing the next steps [10][14] - Key milestones include further histological analysis and updates on the direction of future studies, with a focus on expanding the therapy's application beyond melanoma [13][14]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Arcus Biosciences Inc. announced new monotherapy data for casdatifan in late-line metastatic clear cell renal cell carcinoma (ccRCC) [1] - The drug trials are part of a Phase 1/1b study with four cohorts, showing promising results in terms of overall response rate and progression-free survival [1][2] Efficacy Data - In the 100mg tablet cohort, casdatifan demonstrated a 35% confirmed overall response rate (ORR) with median progression-free survival (mPFS) not yet reached after one year of follow-up [2] - Pooled data from 121 patients indicated a confirmed ORR of 31% and a median PFS of 12.2 months, which is significantly longer than existing treatments [3] Safety Profile - At the data cut-off on August 15, 2025, 81% of patients experienced disease control, with 74% of confirmed responders remaining on treatment [4] - No unexpected safety signals were reported, and the safety profile of casdatifan was deemed acceptable and manageable across all doses [4][5] Market Reaction - Following the announcement, Arcus Biosciences shares rose by 7.87% to $14.40, trading within a 52-week range of $6.50 to $18.98 [5]

Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [29] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [29] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [29] Business Line Data and Key Metrics Changes - The company is focusing investments on three high-value clinical assets: IPH4502, Lacutamab, and Monalizumab, which are expected to create meaningful value and transform care [5][31] - IPH4502 is currently in phase one development, with enrollment progressing well and expected to complete by the end of Q1 2026 [12][15] - Lacutamab is close to finalizing the phase three protocol, with potential for accelerated approval in Sézary syndrome [16][21] Market Data and Key Metrics Changes - The company identified approximately 1,000 Sézary syndrome patients in the U.S., with around 300 new cases each year, representing a significant market opportunity for Lacutamab [24] - The total agreement for Monalizumab with AstraZeneca is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [28] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets, aligning its strategy, science, and investments [5][31] - The company is exploring partnerships and investor support to advance Lacutamab towards phase three, with a focus on maximizing value for both patients and shareholders [21][39] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic refocus and the potential of the clinical pipeline to deliver value for patients and shareholders [31] - The restructuring plan is fully embedded into the cash runway, ensuring financial visibility until the end of Q3 2026 [55] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a role as an advisor to the R&D Committee of the Board of Directors, ensuring continued collaboration [6] - The company is actively collecting additional market data for Lacutamab and plans to share insights at a focused investor event by the end of the year [26] Q&A Session Questions and Answers Question: What should we take away on the potential of targeting NK cells now that ANKET® assets are not included in your prioritization today? - Management clarified that while NK cells are not the main priority, they are still working on NK cell programs and will base future decisions on clinical data [33][35] Question: Any commentary on where Sanofi is with the assets that they currently are developing? - Management indicated that Sanofi continues to progress the BCMA-targeted ANKET® and updates are expected soon [38] Question: Regarding the phase three start for Lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch? - Management confirmed they are actively working with investors and partners to keep options open for advancing Lacutamab into phase three [39][40] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted that IPH4502 could be effective in urothelial cancer patients who became refractory to enfortumab vedotin, with potential for accelerated market approval [41][42] Question: Can you provide an update on how enrollment has been progressing for IPH4502? - Management reported that enrollment is going extremely well, with plans to finish by Q1 2026 and a pool of data expected from 50-60 patients [46][48]

Pipeline and Programs - Crescent Biopharma is developing CR-001, a PD-1 x VEGF bispecific antibody with the same mechanism of action (MoA) as ivonescimab, with an IND expected in 4Q25[7, 9] - CR-002 and CR-003 are Antibody-Drug Conjugates (ADCs) with topoisomerase inhibitor payloads, targeting undisclosed solid tumor targets, with CR-002's IND expected in mid-2026[7, 9] - CR-001 is designed to reproduce ivonescimab's established pharmacology and has the potential to move to frontline use in the $50 billion+ PD-(L)1 immunotherapy market[9] Market and Clinical Data - The anti-PD-(L)1 global sales reached $50 billion in 2024, with Keytruda leading with approximately $30 billion in revenue across 20+ oncology indications[9, 25, 26] - Ivonescimab demonstrated superiority in Progression-Free Survival (PFS) over pembrolizumab in a Phase 3 Non-Small Cell Lung Cancer (NSCLC) trial, with a PFS Hazard Ratio (HR) of 0.51[27, 28] - Ivonescimab at 9 months showed 56% progression-free survival compared to pembrolizumab's 40%[28] Financial and Corporate - Crescent Biopharma was launched with assets discovered and developed by Paragon Therapeutics, which was founded by Fairmount Funds in 2021[8] - Prior companies founded using Paragon's antibody technology have collectively raised >$2 billion[8] - Current cash is expected to fund operations through 2027, supporting key milestones such as the CR-001 IND in 4Q25 and initial clinical data in 2H26[3, 97]