PDS Biotechnology (NasdaqCM:PDSB) Q3 2025 Earnings Call November 13, 2025 08:00 AM ET Speaker5Greetings. Welcome to the PDS Biotechnology third quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. The question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. At this time, we'll turn the confer ...

Core Insights - The FDA granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of HPV-negative recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [2][6] - Bicara Therapeutics aims to advance its pivotal Phase 2/3 FORTIFI-HN01 trial and present additional data to characterize ficerafusp alfa's efficacy and tolerability [2][3] - The company reported a strong financial position with approximately $408 million in cash and investments as of September 30, 2025 [1][12] Clinical Development - Ficerafusp alfa is being evaluated in multiple clinical trials, including a Phase 1b expansion cohort for HPV-positive HNSCC patients and a Phase 1b cohort for metastatic colorectal cancer [6][12] - Data presented at recent conferences highlighted ficerafusp alfa's ability to improve anti-tumor effects and block transitions in tumor cells, supporting its potential in overcoming drug resistance [6][12] Financial Performance - For Q3 2025, research and development expenses increased to $33 million from $15.9 million in Q3 2024, primarily due to ongoing clinical trials [12][9] - General and administrative expenses rose to $7.7 million in Q3 2025 compared to $4.8 million in Q3 2024, reflecting increased personnel costs [12][9] - The net loss for Q3 2025 was $36.3 million, up from $17.5 million in the same quarter of the previous year [12][9] Upcoming Milestones - Bicara plans to present data from various Phase 1b expansion cohorts at upcoming conferences, including ESMO Asia 2025 and other events in 2026 [12][10] - The company is focused on executing enrollment for the FORTIFI-HN01 trial and further characterizing ficerafusp alfa's profile across different cohorts [2][12]

Company Overview - Summit Therapeutics is a biopharma company focused on developing ivonescimab, a novel therapeutic agent for non-small cell lung cancer (NSCLC) [3] - The company has exclusive rights to develop and commercialize ivonescimab in the US, Canada, Europe, and Japan under a license agreement with Akeso [3] Clinical Trials and Drug Development - Summit is conducting multiple clinical trials for ivonescimab, including HARMONi, HARMONi-3, and HARMONi-7, targeting various NSCLC treatment lines [1][8] - A new Phase 3 trial, HARMONi-GI3, is set to begin, focusing on colorectal cancer with an enrollment of approximately 600 patients [1] - Positive results from the HARMONi trial have led to plans for a Biologics License Application to the FDA in 4Q25 [8] Financial Insights and Insider Activity - Recent insider purchases include Co-CEOs Maky Zanganeh and Robert Duggan buying 26,680 shares each, and Board member Xia Yu purchasing 533,617 shares for nearly $10 million [9] - Analysts view Summit's stock as attractively valued, with a Moderate Buy consensus rating based on 14 reviews, including 10 Buy ratings [11] Analyst Perspectives - Analysts highlight ivonescimab's efficacy across various NSCLC subgroups, emphasizing its versatility and potential superiority over existing treatments [10] - The stock is currently priced at $18.66, with an average price target of $30.92, suggesting a potential one-year gain of 66% [11]

Summit Therapeutics ESMO Update & Q3 2025 Earnings Call October 20, 2025 8:00am ET Forward Looking Statement Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product ...

Core Insights - NuCana plc presented data at the European Society for Medical Oncology Congress 2025, demonstrating the synergistic effects of NUC-7738 in combination with PD-1 inhibitors in renal cell carcinoma [1][2] - The data reinforces the mechanism of action of NUC-7738, showing a favorable safety profile and significant tumor volume reduction in patients resistant to PD-1 inhibitors [3] Company Overview - NuCana is a clinical-stage biopharmaceutical company focused on improving cancer treatment outcomes through its ProTide technology, which transforms nucleoside analogs into more effective and safer medicines [5][6] - The company's pipeline includes NUC-7738, which disrupts RNA polyadenylation and targets multiple aspects of the tumor microenvironment, and NUC-3373, derived from 5-fluorouracil [6] Clinical Study Updates - The ongoing Phase 1/2 NuTide:701 clinical study is evaluating NUC-7738 as a monotherapy and in combination with pembrolizumab for melanoma patients, with an expansion to recruit an additional 28 patients approved by regulators [4][6] - Initial data from the NuTide:701 study indicates that NUC-7738 may sensitize various cancers to PD-1 inhibitor therapy, enhancing treatment options for patients [4][6]

Core Insights - NuCana plc announced new data on NUC-3373, showing favorable efficacy and safety in heavily pre-treated patients with advanced solid tumors, particularly in combination with pembrolizumab [1][2] - The latest data indicates a patient with metastatic melanoma remains progression-free at 23 months, demonstrating a durable partial response [1][4] - Preclinical data supports the immunogenic effects of NUC-3373, enhancing immune cell activation and tumor cell death [2][4] Company Overview - NuCana is a clinical-stage biopharmaceutical company focused on improving cancer treatment outcomes through its ProTide technology, which transforms conventional chemotherapy agents into more effective and safer medicines [3] - The company's pipeline includes NUC-7738 and NUC-3373, with NUC-3373 being evaluated in a Phase 1b/2 modular study in combination with pembrolizumab for advanced solid tumors [5] Clinical Study Findings - In the NuTide:303 study, NUC-3373 combined with pembrolizumab showed a 100% reduction in tumor lesion size in a patient with urothelial carcinoma and an 81% reduction in target lesions in a patient with metastatic melanoma resistant to prior therapy [4] - The combination therapy is noted for its favorable safety profile and evidence of durable disease control [2][4] Future Directions - The company is exploring optimal combinations and indications for further clinical studies of NUC-3373 while maintaining a cash runway into 2029 [2]

Core Insights - Moderna Inc. announced the presentation of clinical data for mRNA-4359 in combination with pembrolizumab for CPI-R/R melanoma at the 2025 European Society for Medical Oncology Congress [1] Group 1: Clinical Data - mRNA-4359 is an investigational cancer antigen therapy targeting immune escape pathways PD-L1 and IDO1, aiming to elicit T cell responses to kill tumor cells [2] - The study involved 29 participants receiving the combination therapy at doses of 400 µg (n=14) or 1,000 µg (n=15), administered every three weeks for up to nine doses [2] - The objective response rate (ORR) across evaluable patients was 24%, while the disease control rate (DCR) was 60% [2] Group 2: Efficacy in Specific Patient Population - Among patients with PD-L1+ tumors (TPS≥1%), the ORR was significantly higher at 67% (6 of 9 participants) [3] - The treatment induced peripheral antigen-specific T cell responses and novel T cell receptor clones, with the median duration of response (DOR) not yet reached [3] Group 3: Safety Profile - The combination of mRNA-4359 and pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events reported [4] - mRNA-4359 is also being evaluated in ongoing studies as a monotherapy and in combination with pembrolizumab for advanced melanoma and non-small cell lung cancer (NSCLC) [4] Group 4: Additional Developments - Moderna released preliminary immunogenicity data for the 2025-2026 mNEXSPIKE COVID-19 vaccine formula, showing over a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in specific age groups [5] - Following these announcements, MRNA stock rose by 3.54% to $27.78 [5]

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 with CPS ≥1, specifically for HPV-negative cases [1][2][3] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [10] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [8][10] Clinical Trial Insights - The BTD was supported by results from multiple Phase 1/1b dose cohorts, showing a median duration of response of 21.7 months and a median overall survival of 21.3 months, alongside a favorable safety profile [3] - The ongoing pivotal trial, FORTIFI-HN01, aims to enroll approximately 650 patients with R/M HNSCC, focusing on overall response rate and overall survival as primary endpoints [5][9] Industry Context - HPV-negative HNSCC is recognized as a distinct clinical indication with poor outcomes and limited treatment options, representing a significant unmet need in oncology [2][7] - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030, and approximately 80% of R/M HNSCC cases are HPV-negative [6][7]

Core Insights - Tango Therapeutics will present three posters at the SITC Annual Meeting 2025, showcasing the first clinical data on the novel CoREST inhibitor TNG260 in non-small cell lung cancer [1][2] Group 1: Company Overview - Tango Therapeutics is a clinical-stage biotechnology company focused on discovering and delivering precision cancer medicines [4] - The company utilizes the genetic principle of synthetic lethality to develop therapies targeting critical cancer-related pathways [4] Group 2: Clinical Trials and Research - TNG260 is a first-in-class, highly selective CoREST complex inhibitor currently being evaluated in combination with pembrolizumab during the dose expansion phase of the Phase 1/2 trial [2] - The trial is enrolling patients with STK11-mutant/RAS wild type lung cancer, which represents approximately 10% of lung adenocarcinoma [2] - The accepted abstracts for poster presentations include studies on the safety, tolerability, pharmacokinetics, and efficacy of TNG260 in combination with pembrolizumab, as well as its ability to sensitize STK11-mutant tumors to anti-PD-1 therapy [3][4]

Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: September 24, 2025 Key Points Commercial Performance - **EYLEA HD Performance**: - 5% sequential growth in demand in Q1 and 16% in Q2 attributed to effective commercial execution and physician-patient education [4][5] - Demand is expected to increase further once headwinds are resolved, particularly regarding reimbursement and prefilled syringe preferences [5][6] - Upcoming PDUFA dates: late October for prefilled syringe and late November for RVO and Q4 dosing [8] Pipeline Developments - **DUPIXENT**: - Strong performance across all eight approved indications, with ongoing growth in established indications like asthma and new launches in COPD, CSU, and bullous pemphigoid [15][16] - 70% of top-tier pulmonologists have prescribed DUPIXENT for COPD, indicating positive reception [18] - Strategic focus on lifecycle opportunities and adjacent type 2 pathways to maintain growth post-DUPIXENT exclusivity expiration in 2031 [21][23] - **Oncology Pipeline**: - Recent approvals for bispecifics, with a focus on Linezyth for multiple myeloma [24] - Plans to launch studies in earlier lines of treatment, combining Linezyth with carfilzomib, expected by the end of 2025 [26][28] - **Complement and Factor XI Programs**: - Promising data in myasthenia gravis (MG) with a focus on quarterly dosing advantages [35] - Factor XI program aims to reduce bleeding risks associated with anticoagulants, with ongoing Phase 3 studies [39][40] R&D and Capital Allocation - **R&D Investment Strategy**: - Focus on internal R&D as a primary capital allocation priority, with a robust pipeline driving long-term shareholder value [50][52] - Share repurchase program and dividend implementation to enhance shareholder returns [51] - **External Innovation**: - Active exploration of licensing and collaboration opportunities, though M&A remains a secondary focus [50][55] Market Outlook and Strategic Vision - **Pipeline Potential**: - The breadth and depth of the pipeline are viewed as unprecedented, with confidence in the ability to drive future growth [57][58] - Ongoing preclinical opportunities in various therapeutic areas, including genetics and rare diseases, are expected to yield significant advancements [59] Regulatory and Competitive Landscape - **Biosimilars Impact**: - Gradual uptake of existing biosimilars noted, with potential for increased pricing pressure as more entrants are expected in 2026 [11][12] - **DTC Advertising Restrictions**: - Generalized communication from the administration regarding DTC advertising, with no specific implications for Regeneron noted [19] Conclusion - Regeneron Pharmaceuticals is positioned for continued growth through its strong product pipeline, strategic R&D investments, and proactive market engagement. The company remains focused on addressing competitive pressures while leveraging its innovative capabilities to enhance patient outcomes and shareholder value.