Core Insights - Bolt Biotherapeutics reported its financial results for Q3 2025, highlighting its focus on developing BDC-4182, a next-generation Boltbody™ ISAC for cancer treatment, with initial clinical data expected in Q3 2026 [1][2][4] Financial Performance - The company had a cash balance of $38.8 million as of September 30, 2025, which is anticipated to fund key milestones into 2027 [4][10] - Collaboration revenue for Q3 2025 was $2.2 million, an increase from $1.1 million in Q3 2024 [10][12] - Research and Development (R&D) expenses decreased to $6.5 million in Q3 2025 from $13.8 million in Q3 2024, primarily due to reduced salary and clinical expenses [10][12] - General and Administrative (G&A) expenses were $3.3 million in Q3 2025, down from $3.8 million in Q3 2024 [10][12] - The loss from operations was $7.7 million for Q3 2025, compared to $16.4 million for the same quarter in 2024 [10][12] Clinical Development - BDC-4182 is currently in a Phase 1 dose escalation study targeting gastric and gastroesophageal cancer, with initial data expected in Q3 2026 [2][5] - Preclinical data presented at the SITC indicated that BDC-4182 stimulates a strong immune response leading to complete tumor regression [5] - The company is also developing next-generation ISACs targeting CEA and PD-L1, with promising preclinical results [5] Collaborations and Partnerships - Ongoing collaborations with Genmab and Toray focus on developing additional next-generation ISAC programs for cancer treatment [5][10] - The company is seeking a partner for further development of BDC-3042, a proprietary agonist antibody targeting dectin-2 [10]

November 12, 2025 Third Quarter 2025 Financial Results & Corporate Update This presentation is for investor relations purposes only - Not for product promotional purposes 1 Agenda | 1 | Opening Remarks | | --- | --- | | 2 | Q3 2025 Highlights & Recent Accomplishments | | 3 | Our Pipeline | | 4 | Capitalizing on Market Leadership | | 5 | CARVYKTI® Performance Overview | | 6 | Financial Performance | | 7 | Q&A | Ying Huang, PhD Chief Executive Officer Alan Bash President of CARVYKTI® Carlos Santos Chief Finan ...

ADDRI-sponsored trial in Australia planned to enroll approximately 50 patients, led by A/Prof Steven Kao and Dr Melvin Chin; part of Cyncado’s international program for mesotheliomaDover, DE and Sydney, Australia, Nov. 12, 2025 (GLOBE NEWSWIRE) -- AlphaTON Capital Corp (Nasdaq: ATON) and its wholly owned oncology-focused subsidiary Tarus Therapeutics, LLC, operating as Cyncado Therapeutics (Cyncado), today announced a non-binding Letter of Intent (LOI) between Australia’s Asbestos and Dust Diseases Research ...

Core Viewpoint - PDS Biotechnology Corporation has announced a securities purchase agreement to raise approximately $5.3 million through the sale of 5,800,000 shares of common stock at a price of $0.91 per share, with potential additional proceeds of up to $5.8 million from warrants [1][3] Group 1: Offering Details - The offering includes 5,800,000 shares of common stock or pre-funded warrants, with accompanying warrants to purchase an additional 5,800,000 shares at an exercise price of $1.00 per share [1][3] - The offering is expected to close on or about November 12, 2025, subject to customary closing conditions [1] - Craig-Hallum is acting as the exclusive placement agent for the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering are intended for the continuation of the VERSATILE-003 Phase 3 clinical trial, discussions with the FDA for protocol amendments, and other research and development expenses [3] Group 3: Financial Position - As of September 30, 2025, the company reported approximately $26.2 million in cash and cash equivalents, subject to final adjustments [4] Group 4: Regulatory Compliance - The offering is being made pursuant to a "shelf" registration statement on Form S-3, previously filed with the SEC [5] Group 5: Existing Warrants Amendment - The company will amend existing warrants issued in February 2025, reducing the exercise price from $1.50 to $1.00 per share, effective upon the closing of the offering [6] Group 6: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers, with a pivotal clinical trial for its lead program in advanced HPV16-positive head and neck squamous cell cancers [8][9]

Summary of Xilio Therapeutics Conference Call Company Overview - **Company**: Xilio Therapeutics (NasdaqGS:XLO) - **Focus**: Development of novel masked biologics using proprietary protein engineering technology - **Key Products**: Velastigard (anti-CTLA-4), efarindodekin alfa (IL-12), XTX501 (PD-1/IL-2) Industry Context - **Industry**: Oncology, specifically focusing on immunotherapy for colorectal cancer - **Target Condition**: Microsatellite stable colorectal cancer (MSSCRC), which constitutes 95% of all colon cancers Key Data Updates - **SITC Conference**: Presented new clinical data for Velastigard in combination with Tislelizumab for MSSCRC - **Clinical Data**: - Velastigard demonstrated a **26% overall response rate** in late-line metastatic MSSCRC without liver metastases, compared to a **2% response rate** for Tislelizumab as monotherapy [8][9][10] - In a biomarker-defined population with high plasma tumor mutational burden (TMB), the overall response rate was **40%** [14][15] Biomarker Insights - **Plasma TMB**: - Approximately **55%** of MSSCRC patients have high plasma TMB (greater than 10 mutations per megabase) [12][15] - High plasma TMB correlates with better response rates to Velastigard and Tislelizumab combination therapy [12][14] - Plasma-based TMB assays are more sensitive and provide a comprehensive assessment compared to traditional tissue-based assays [11][19] Safety Profile - **Safety Data**: - Velastigard showed a **7% incidence of colitis**, significantly lower than traditional anti-CTLA-4 therapies [16][17] - Discontinuation rate for the combination therapy was only **5%**, indicating a favorable safety profile [17] Future Development Plans - **Partnerships**: Actively seeking partnerships to develop Velastigard in combination with PD-1, PD-L1, or newer PD-1 bispecifics [43][44] - **Regulatory Path**: Plans to assess the regulatory pathway for future development using plasma TMB as a predictive biomarker [43][44] - **Upcoming Milestones**: Additional phase two data for Velastigard expected in the first half of 2026 [47] Additional Clinical Programs - **Efarindodekin alfa**: Phase one data showed deep monotherapy responses and a well-tolerated safety profile [45] - **Masked T-cell Engagers**: Preclinical data demonstrated broad applicability and potential for reduced systemic toxicity [46] Conclusion - Xilio Therapeutics is positioned to leverage its innovative masking technology to address significant unmet medical needs in oncology, particularly in MSSCRC, with promising clinical data supporting the efficacy and safety of its lead product, Velastigard. The identification of plasma TMB as a predictive biomarker enhances the potential for targeted therapies in this patient population.

Core Insights - The company is focused on developing IMNN-001, a novel immunotherapy aimed at being the first approved treatment for frontline advanced ovarian cancer [1][3] - There is a strong sense of urgency and hope among stakeholders regarding the potential impact of IMNN-001 on women diagnosed with advanced ovarian cancer [2] Program Update - The company will provide updates on the IMNN-001 program, highlighting compelling data that supports its potential as a breakthrough treatment for newly diagnosed ovarian cancer patients [3] - Progress on the ongoing Phase III trial, OVATION III, will be shared, indicating significant milestones that bring the company closer to its goals [3]

Coherus Oncology Conference Call Summary Company Overview - Coherus Oncology transitioned to being solely an innovative oncology company after divesting its biosimilar business in Q2 2025, marking Q3 2025 as its first quarter focused exclusively on oncology [6][13] - The company reported $198 million in cash on its balance sheet at the end of Q3 2025, indicating strong financial management [13] Pipeline Programs Toripalimab (LOQTORZI) - Toripalimab is a next-generation PD-1 inhibitor with unique binding sites, demonstrating activity in low PD-L1 states [7] - Approved for front-line and second-line nasopharyngeal carcinoma in 2023, generating $11 million in revenue in Q3 2025, a 12% increase from Q2 2025 [17][19] - The drug has shown a strong hazard ratio, extending survival from 22 months to over 48 months in nasopharyngeal cancer patients [18] - The company aims for 10-15% revenue growth, targeting $150-$200 million by 2028 [20] - Adoption is strong among academic physicians, but community physicians require more education about the drug [21][22] - Combination strategies with other therapeutics are being explored to enhance treatment efficacy [15][16] CHS-114 (CCR8 Targeting) - CHS-114 is a highly selective molecule targeting CCR8, which plays a significant role in Treg cells within the tumor microenvironment [26][28] - The drug is designed to deplete Tregs, potentially allowing CD8 positive T cells to infiltrate tumors, which is crucial for effective immunotherapy [30][34] - The clinical program is strategically designed to evaluate efficacy across various cancers, including head and neck, gastric, and colorectal cancers [32][35] - The company is optimistic about the potential for CHS-114 to show significant activity in underserved tumor types [32] Casdozokitug - Casdozokitug is an anti-IL-27 molecule showing promising efficacy in liver cancer, with a focus on improving overall response rates and progression-free survival [50][51] - The company anticipates data from ongoing studies in the first half of 2026, which will inform the design of future phase two and three trials [47][48] Strategic Partnerships and Deals - Coherus has global rights to its products, allowing for flexibility in forming partnerships, particularly in Asian markets for liver cancer treatments [12][53] - The company is open to collaborations with other biotech firms to enhance the development of its products [40][41] - Upcoming deals are expected to validate the value of its assets and provide upfront funding to offset clinical costs [53][54] Key Catalysts and Future Outlook - The company is focused on delivering data in 2026 that will support the advancement of its pipeline products [34][46] - Coherus is positioned to leverage its scientific leadership and partnerships to enhance patient outcomes and drive growth [45][46] - The next 12-18 months are expected to be pivotal for the company, with significant updates anticipated from ongoing studies and potential partnerships [52][55]

Core Insights - PDS Biotechnology Corporation announced positive clinical and translational data for its investigational immunotherapies PDS0101 and PDS01ADC at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting their potential in treating advanced cancers [1][3][13] Group 1: Clinical Data and Presentations - The studies were conducted under a collaborative research and development agreement with the National Cancer Institute, featuring one rapid oral abstract and two poster presentations at SITC 2025 [2] - PDS0101 demonstrated strong clinical activity across three phase 2 trials, establishing a link between immune signatures and clinical response, supporting future biomarker-guided optimization [6][4] Group 2: Mechanisms of Action - PDS01ADC reprograms natural killer (NK) cells to enhance their cancer-killing capabilities and promotes the generation of stem cell-like killer T cells and memory T cells, contributing to long-lasting anti-tumor activity [8][11] - Analysis of 50 patients with advanced HPV16-positive cancers showed significant immune activation and increases in pro-inflammatory cytokines, which are crucial for T cell recruitment and potency [9] Group 3: Future Development and Trials - PDS Biotech is advancing PDS0101 in a phase 3 clinical trial in combination with Keytruda for HPV16-positive recurrent/metastatic head and neck cancer, while PDS01ADC is being evaluated in multiple phase 2 trials for various cancer types [13][17] - The findings from SITC 2025 strengthen the scientific foundation of the company's immunotherapy platforms and support ongoing regulatory and clinical milestones [13][17]

Core Insights - Aptevo Therapeutics has presented preclinical data for its trispecific antibody candidate, APVO451, at the Society for Immunotherapy of Cancer Annual Meeting, highlighting its potential in treating hard-to-treat solid tumors [1][2]. Company Update - APVO451 is designed to address the challenge of immune suppression in solid tumors, such as urothelial, breast, and pancreatic cancers, by utilizing a proprietary CRIS-7-derived CD3 binding domain [2][3]. - The molecule aims to activate the intratumoral immune system, enhancing the ability to target and kill tumor cells effectively [3]. Key Findings from the Presentation - APVO451 demonstrated local activation of T-cells and antigen-presenting cells (APCs) only when bound to the target protein, nectin-4, indicating a favorable safety profile [4]. - The candidate showed dual immune re-activation by stimulating T-cell effector functions and restoring APC function, addressing a common failure point in solid tumor treatments [4]. - In tumor models simulating suppression, APVO451 was more effective in eliminating nectin-4-positive tumor cells compared to standard CD3 T-cell engagers, suggesting its potential to overcome suppressive tumor environments [4]. Next Steps - Aptevo is advancing APVO451 through ongoing preclinical studies to support IND-enabling work and future clinical development targeting nectin-4-expressing solid tumors [5]. About APVO451 - APVO451 is a trispecific ADAPTIR-FLEX therapeutic candidate designed to engage CD3 and CD40, aiming to restore immune engagement in suppressive solid tumors while minimizing off-tumor activation [6]. About Aptevo Therapeutics - Aptevo Therapeutics is a clinical-stage biotechnology company focused on developing novel bispecific and trispecific immunotherapies for cancer treatment, with two clinical candidates currently in trials [7].

Core Insights - HCW Biologics Inc. announced the latest data for its first-in-class immune checkpoint inhibitor, HCW11-040, at the SITC2025 conference, highlighting its potential in treating cancer and age-related diseases [1][3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation and age-related diseases [4][6] - The company has developed a new drug discovery technology, the TRBC platform, which allows for the creation of various classes of immunotherapeutic compounds [6] Product Candidate Details - HCW11-040 is a multi-functional fusion protein that combines IL-15 and IL-7 domains with a TGF-β trap, demonstrating PD-1/PD-L1 blocking activity comparable to pembrolizumab in preclinical studies [2][5] - Preclinical data indicates that HCW11-040 significantly expands and activates TPEX cells and enhances anti-tumor activity of human peripheral blood mononuclear cells against cancer cells without causing excessive inflammatory responses [3][5] Development Plans - The company plans to advance additional IND-enabling studies for HCW11-040, including the establishment of a high-expression manufacturing cell bank and preclinical toxicology studies [3]