OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer NANTES, France, November 17, 2025 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotechnology company developing immunotherapies for cancer and autoimmune diseases, today announced that the Independent Data Monitoring Committee (IDMC) overseeing the Company’s internat ...

Core Insights - Precigen, Inc. announced third quarter 2025 financial results and business updates, highlighting the successful launch of PAPZIMEOS, the first FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP) [1][5][7]. Business Highlights - PAPZIMEOS received full FDA approval in August 2025, marking a significant advancement in treatment options for adults with RRP [6][7]. - The company has engaged over 90% of target institutions and registered over 100 patients in the PAPZIMEOS Patient Hub since the launch [2][6][7]. - Strong early interest and demand for PAPZIMEOS have been reported, with significant progress in private health insurance coverage, now covering over 100 million lives [5][6][7]. Financial Performance - Total revenues for Q3 2025 increased by $2.0 million compared to Q3 2024, primarily driven by collaboration and licensing revenue [8]. - Research and development expenses rose by $1.0 million, or 9%, due to increased manufacturing and regulatory costs related to PAPZIMEOS [9]. - Selling, General and Administrative (SG&A) expenses surged by $14.2 million, or 144%, largely due to costs associated with the commercialization of PAPZIMEOS [10]. - The company recorded a net loss attributable to common shareholders of $325.3 million for Q3 2025, significantly higher than the $24 million loss in Q3 2024, influenced by non-cash items [13][26]. Clinical and Market Developments - Long-term follow-up results from the pivotal clinical trial of PAPZIMEOS showed durable complete responses in 83% of patients after a median follow-up of 36 months [7]. - The company submitted a Marketing Authorization Application to the European Medicines Agency for PAPZIMEOS in November 2025, indicating plans for geographic expansion [6][7].

Core Insights - Elicio Therapeutics reported encouraging results from its Phase 2 AMPLIFY-7P study, indicating fewer disease progressions and deaths than projected, which may positively impact disease-free survival (DFS) [2][5] - The company updated its guidance for the DFS analysis to the first half of 2026 and believes its current cash position will support operations through this critical period [2][9] Recent Highlights - Elicio presented updated data showing that ELI-002 7P induced mutant KRAS-specific T cell responses in 99% of evaluable patients, with an 86% antigen response rate [6] - The company announced a planned investigator-initiated Phase 1 trial of ELI-002 7P in collaboration with Memorial Sloan Kettering Cancer Center, expected to begin in the first half of 2026 [6] - The Independent Data Monitoring Committee recommended continuing the Phase 2 study without modifications, confirming a favorable safety profile for ELI-002 7P [6] Financial Results - R&D expenses for Q3 2025 were $5.0 million, down from $7.2 million in Q3 2024, primarily due to reduced clinical trial costs [5][10] - General and administrative expenses decreased slightly to $3.0 million from $3.1 million year-over-year [7][10] - The net loss for Q3 2025 was $10.1 million, significantly lower than the $18.8 million loss in Q3 2024, with a net loss per share of $0.60 compared to $1.39 [8][10] Cash Position - As of September 30, 2025, Elicio had cash and cash equivalents of $20.6 million, which is expected to support operations through Q2 2026 [8][11][9] - The company raised approximately $11.1 million in gross proceeds since the beginning of Q3 2025, extending its cash runway [5][9] Future Plans - Elicio plans to request an End of Phase 2 meeting with the FDA to finalize the Phase 3 trial design for ELI-002 7P following the DFS analysis [4] - The company aims to expand ELI-002 to other indications, including mKRAS-positive lung cancer and other mKRAS-positive cancers [12][14]

Core Viewpoint - TriSalus Life Sciences, Inc. reported strong commercial performance in Q3 2025, highlighting its innovative approach in oncology and the integration of novel delivery technology with standard therapies [1] Financial Results - The company announced its financial results for the quarter ended September 30, 2025, indicating a positive trend in revenue generation and operational efficiency [1] Operational Update - TriSalus provided an operational update, emphasizing its investigational immunotherapeutic aimed at transforming treatment for patients with solid tumors, which reflects the company's commitment to advancing cancer care [1]

Financial Data and Key Metrics Changes - As of September 30, 2025, cash and cash equivalents were $5.3 million, with a net loss for Q3 2025 of $3.4 million, or $1.16 per share, compared to $4.8 million, or $3.76 per share in Q3 2024 [25][26] - R&D expenses were $1.9 million for Q3 2025, down from $3.3 million in the same period last year, primarily due to the completion of the OVATION 2 study [25][26] - G&A expenses were $1.6 million in Q3 2025, down from $1.7 million in the same period last year [26] Business Line Data and Key Metrics Changes - The OVATION 3 trial is actively recruiting, with strong investigator enthusiasm and enrollment surpassing internal targets [9][12] - The MRD study has seen 25 patients randomized to date, with plans to cap enrollment at 30 patients [19][20] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in ovarian cancer, with 300,000 new cases globally each year and 13,000 deaths annually in the U.S. alone [5][6] - The OVATION 3 trial is designed to meet regulatory expectations for approval in Europe, focusing on overall survival as a primary endpoint [10][50] Company Strategy and Development Direction - The company is focused on advancing its proprietary IL-12 immunotherapy, IMNN-001, through the OVATION 3 pivotal phase III trial [4][5] - The strategy includes a multi-pronged approach to navigate the biotech capital markets, combining non-dilutive partnerships with prudent equity raises [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum of the OVATION 3 trial and the transformative potential of IMNN-001 for ovarian cancer treatment [5][12] - The company is well-positioned to extend its runway through value-enhancing non-dilutive transactions, with cash projected to last through mid-Q1 2026 [23] Other Important Information - The NASDAQ compliance matter is closed, with shareholder equity confirmed above the required threshold [24] - The company has received positive reactions regarding potential partnerships, although no imminent agreements are in place [22] Q&A Session Summary Question: Clarification on interim analysis and approval - Management clarified that positive results in interim analyses could lead to full approval for the group being tested, with the trial continuing for broader indications [32][34] Question: P-value requirements for interim analysis - Management explained that the determination of stopping the trial for efficacy is complex and involves various operating characteristics rather than a fixed P-value [35][36] Question: Pain management protocol for IMNN-001 administration - It was confirmed that a prophylactic pain management protocol is mandated for all patients to ensure comfort during drug administration [38][40] Question: Durability of response and mechanism of action - Management discussed the durability of IL-12 expression and its effects on the immune system, emphasizing the localized delivery of the drug to minimize systemic adverse events [43][46] Question: Update on OVATION 2 trial and site overlap with OVATION 3 - Management indicated that an update on the OVATION 2 trial is expected by the end of the year, and there will be significant overlap in sites between OVATION 2 and OVATION 3 [58][63]

Core Insights - Candel Therapeutics reported strong progress in its clinical pipeline and plans to submit a Biologics License Application (BLA) for CAN-2409 in Q4 2026 [2][4][10] Financial Results - For Q3 2025, research and development expenses were $8.5 million, up from $5.4 million in Q3 2024, primarily due to increased manufacturing and regulatory costs [11] - General and administrative expenses rose to $4.7 million in Q3 2025 from $3.3 million in Q3 2024, driven by higher commercial readiness costs [12] - The net loss for Q3 2025 was $11.3 million, compared to a net loss of $10.6 million in Q3 2024 [13] - Cash and cash equivalents as of September 30, 2025, were $87.0 million, down from $102.7 million at the end of 2024, but expected to fund operations into Q1 2027 [14][26] Clinical Developments - Candel presented positive data from the phase 3 trial of CAN-2409 in localized prostate cancer, showing improved disease-free survival (DFS) [4][6] - The company plans to initiate a pivotal phase 3 trial of CAN-2409 in non-small cell lung cancer (NSCLC) in Q2 2026 [4][10] - Encouraging survival data from the phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG) was reported, with updated median overall survival of 11.8 months [4][10][20] Strategic Initiatives - Candel secured a $130 million term loan facility with Trinity Capital, with $50 million drawn at closing, to support its clinical trials and operations [2][4][10] - The company strengthened its Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, enhancing its commitment to scientific excellence [2][4][10] Upcoming Milestones - The company anticipates updated data on long-term survivors from its phase 2 study in NSCLC in Q1 2026 and plans to submit the BLA for CAN-2409 in prostate cancer in Q4 2026 [8][10]

Novel combination with neoadjuvant eftilagimod alfa (efti) achieves significant 51.5% tumour hyalinization/fibrosis across multiple soft tissue sarcoma subtypes including rare and highly aggressive tumours with poor prognosisEarly translational data show a strong immune system activation inline with efti’s mode of action with statistically-significant increases in multiple cytokines and chemokines High levels of key immune proteins in EFTISARC-NEO including interferon-gamma (IFN-γ) correlate with pathologic ...

Core Viewpoint - PDS Biotechnology Corporation has completed the VERSATILE-002 Phase 2 trial for PDS0101 in combination with pembrolizumab, showing promising results that lead the company to seek an expedited approval pathway in the ongoing VERSATILE-003 Phase 3 trial [1][2][3]. Clinical Update - The VERSATILE-002 trial demonstrated a median overall survival (mOS) of 39.3 months for patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [4]. - Progression-free survival (PFS) was reported at 6.3 months for the same patient group [4]. - The company plans to amend the ongoing VERSATILE-003 trial to potentially reduce its size while maintaining statistical power, with mOS remaining the primary endpoint for full FDA approval [4][3]. Financial Results - For Q3 2025, the company reported a net loss of $9.0 million, or $0.19 per share, a decrease from a net loss of $10.7 million, or $0.29 per share, in Q3 2024 [5][16]. - Research and development expenses were $4.6 million, down from $6.8 million in the same quarter of the previous year, attributed to lower manufacturing and clinical expenses [6][16]. - General and administrative expenses increased to $3.6 million from $3.4 million year-over-year, primarily due to higher professional fees [7][16]. Cash Position - As of September 30, 2025, the company's cash balance was $26.2 million, a decrease from $41.7 million as of December 31, 2024 [8][15]. - The company raised approximately $5.3 million by selling 5,800,000 shares and accompanying warrants on November 12, 2025 [9]. Additional Clinical Developments - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting the immunological properties of PDS0101 and PDS01ADC [4]. - Preliminary results from the colorectal cancer cohort of the Phase 2 clinical trial with PDS01ADC met the criteria for expansion to Stage 2, confirming at least 6 of 9 objective responses [4].

Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with significant updates expected at the ESMO Immuno-Oncology Congress in December 2025 [1][5][2] MDNA11: IL-2 Superkine Program - The updated clinical data from the Phase 1/2 ABILITY-1 Study for MDNA11 will be presented, showcasing its potential as a leading IL-2 therapy [5] - A new clinical trial, NEO-CYT, will evaluate MDNA11 in combination with checkpoint inhibitors for high-risk melanoma patients prior to surgery [1][5] - The primary endpoint of the NEO-CYT trial is Major Pathologic Response (MPR), which is predictive of long-term survival outcomes [5] MDNA113: First-in-Class Anti-PD-1-IL-2 Bispecific Superkine - MDNA113 is being evaluated in non-human primate studies, with plans for a first-in-human clinical trial to start in 2026 [1][12] - The bispecific therapy is designed to enhance safety and efficacy through proprietary technologies [12] - Preclinical data presented at AACR 2025 supports its development potential in cancers affecting over 2 million patients annually [5][12] Intellectual Property Update - Six new patents have been issued or allowed across multiple jurisdictions, protecting various superkine assets, including the anti-PD1 x IL-2 program [1][7] Financial Overview - As of September 30, 2025, the company reported cash and cash equivalents of $15.7 million, providing a runway into at least mid-2026 [8] - Total operating costs for the quarter were $5.5 million, consistent with the previous year, with a noted increase in R&D expenses to $4.1 million due to expanded clinical activities [9][11] - The net loss for the quarter was $4.9 million, compared to a loss of $4.2 million in the same period last year [10]

Core Insights - Innate Pharma reported strong execution across key programs, including FDA clearance for TELLOMAK-3, advancing lacutamab towards Phase 3 and potential accelerated approval in Sézary syndrome [2][13] - The company is on track for dose-escalation data from IPH4502 in the first half of 2026 and expects monalizumab PACIFIC-9 results in the second half of 2026 [2][5] - The cash position as of September 30, 2025, was €56.4 million, providing a runway until the end of Q3 2026 [5][17] Pipeline Highlights - Lacutamab is progressing towards Phase 3 initiation in H1 2026 after FDA clearance for the TELLOMAK-3 trial [5][13] - IPH4502, a Nectin-4 ADC, is in Phase 1 with enrollment progressing well and pharmacologically active dose reached [5][14] - Monalizumab PACIFIC-9 trial is ongoing, with data expected in H2 2026 [9][20] Financial Results - Revenues for the first nine months of 2025 were €2.3 million, down from €10.2 million in the same period in 2024 [18] - Financial liabilities amounted to €24.8 million as of September 30, 2025 [17] Corporate Update - The company is prioritizing investments in high-value clinical assets, including IPH4502, lacutamab, and monalizumab [3][20] - A redundancy plan is in place to streamline the organization, expected to be completed in the first half of 2026 [23]