Financial Data and Key Metrics Changes - As of March 31, 2025, the company had approximately $103.7 million in cash, cash equivalents, total bank deposits, and investments in marketable securities [14] - Revenues for Q1 2025 were approximately $2.3 million, a decrease from approximately $2.6 million in Q1 2024 [15] - R&D expenses for Q1 2025 were approximately $5.8 million, down from approximately $6.4 million in Q1 2024 [15] - The net loss for Q1 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared to a net loss of approximately $7.3 million in the same period of 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing its clinical immuno-oncology pipeline, particularly focusing on the anti-PVRIG antibody COM701, with a sub-trial initiated for patients with relapsed platinum-sensitive ovarian cancer [6][7] - The study aims to demonstrate a clinically meaningful improvement in median progression-free survival over placebo, targeting a three-month improvement [8] Market Data and Key Metrics Changes - AstraZeneca has initiated multiple Phase III trials in the TIGIT space, with significant potential revenue opportunities estimated at over $5 billion in lung cancer alone [10] - The eligible lung cancer patient population across G7 countries is estimated to exceed 500,000 patients based on 2025 epidemiological data [10] Company Strategy and Development Direction - The company is focused on advancing its early-stage and clinical immuno-oncology pipeline, with a strong emphasis on innovative therapies and strategic collaborations [4][12] - The leadership transition aims to ensure a solid foundation for the company's next phase of growth, with a commitment to addressing significant unmet medical needs in cancer treatment [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of their clinical trials on cancer patients' lives and highlighted the importance of their cash runway extending into 2027 [12][14] - The evolving clinical trial landscape, particularly in the context of ADCs and TIGIT studies, presents both challenges and opportunities for the company [9][10] Other Important Information - The company has a robust foundation with a talented management team and a commitment to advancing its innovative pipeline [4][12] - The cash runway is expected to support the advancement of key clinical trials and early-stage research without additional cash inflows [14] Q&A Session Summary Question: Impact of Merck's KEYNOTE B96 trial success on ovarian cancer strategy - Management noted that the success of Merck's trial indicates benefits from adding immune checkpoint inhibitors to standard care, which could open opportunities for COM701 in similar settings [17][19] Question: Interpretation of Roche's Skyscraper one data regarding TIGIT - Management discussed the challenges faced by the trial and emphasized the importance of patient population and study design in interpreting the results [20][24] Question: Data collection on tumor microenvironment features from the COM701 study - The company confirmed plans to collect data on tumor microenvironment features, although specific details were not disclosed [29][30] Question: Activity in PD-L1 positive patients and combinability with other treatments - Management indicated that COM701 has shown activity in both PD-L1 positive and negative patients, suggesting potential for combination therapies [33][35]

MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 milli ...

Châtillon, France, May 15, 2025 Combined General Meeting of June 11, 2025 Procedures for Obtaining Information and Preparatory Documents for the Combined General Meeting DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), will hold its Combined General Meeting (the “General Meeting”) on June 11, 2025, at 02:00 p.m. CEST (08:00 a.m EST) at the Company’s headquarters located at IRO Building, 107 Avenue de la République, ...

Châtillon, France, May 15, 2025 Combined General Meeting of June 11, 2025 Procedures for Obtaining Information and Preparatory Documents for the Combined General Meeting DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), will hold its Combined General Meeting (the “General Meeting”) on June 11, 2025, at 02:00 p.m. CEST (08:00 a.m EST) at the Company’s headquarters located at IRO Building, 107 Avenue de la République, ...

Anticipates initiating the Company's Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), in Q2 2025Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP) Targeting to close the ...

Marc Voigt, CEO of Immutep, stated, "Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in respons ...

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics (CADL) is a clinical-stage biotech company focused on developing viral immunotherapy for difficult-to-treat cancers, utilizing two main platforms: HSV and adenoviral [1] Key Assets and Development Pipeline - The most advanced asset is CAN2409, an adenoviral platform targeting prostate cancer, with positive Phase 3 data recently unveiled and a BLA submission expected by the end of 2026 [2] - CAN2409 is also in development for non-small cell lung cancer (NSCLC) and pancreatic cancer, with fast track designation for all indications [3] - Another asset, CAN310, is a classical oncolytic virus in development for recurrent high-grade glioma [3] Clinical Data and Efficacy - CAN2409 has been administered to over 1,000 patients and shows synergy with radiation therapy, particularly in prostate cancer [4][5] - In NSCLC, a significant reduction of nearly 50% in tumor volume was observed in treated patients [6] - In recurrent high-grade glioma, median overall survival of at least 12 months was achieved with a single injection, compared to a median survival of 6-9 months in untreated patients [7] Discovery Platform - The Enlighten platform utilizes AI for data mining to design viral immunotherapies, aiming to combine with checkpoint inhibitors or cellular therapies for challenging cancers [7] Prostate Cancer Opportunity - Prostate cancer represents a multi-billion dollar opportunity due to the high prevalence and unmet medical need, especially in localized cases [11] - The trial included 745 patients, showing a 30% reduction in disease recurrence or death compared to placebo [14] - Significant effects on PSA levels, a key biomarker for recurrence, were noted, with a higher percentage of patients achieving pathological complete response [15] Safety and Tolerability - CAN2409 demonstrated a favorable safety profile, comparable to a prostate biopsy, with good tolerability among patients [15] Future Plans and Financials - Candel is ramping up CMC activities in preparation for commercial launch and is engaging with KOLs and medical affairs [16] - The company reported cash and cash equivalents of $92 million as of December, sufficient to support BLA submission in 2026 [22] Additional Insights - The pancreatic cancer trial indicated a significant improvement in median overall survival, with ongoing plans for a larger Phase 2 trial [17] - In lung cancer, adding CAN2409 to treatment for patients not responding to checkpoint inhibitors resulted in a median overall survival of 21 months, doubling expectations [20] Leadership and Achievements - The leadership team has extensive experience in drug development, and the company has exceeded its previous clinical milestones [21] Regulatory Engagement - Continuous discussions with the FDA regarding the BLA submission process are ongoing, focusing on CMC manufacturing and clinical package preparation [23][24]

Oncolytics Biotech (ONCY) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jon Patton - Director, IR & CommunicationWayne Pisano - Interim CEO & Chairman of the BoardThomas Heineman - Chief Medical OfficerChristophe Degois - VP, Business DevelopmentKirk Look - Chief Financial OfficerPatrick Trucchio - Managing Director Conference Call Participants Michael Freeman - Equity Research Analyst - Healthcare Operator Good afternoon, and welcome to OnClinic's Biotech's First Quarter Conference Ca ...

Oncolytics Biotech (ONCY) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to OnClinic's Biotech's First Quarter Conference Call. All participants are now in listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Pattern, Director of Investor Relations and Communication. Please go ahead. Speaker1 Thank you, operator. To ...

Core Viewpoint - Edesa Biotech, Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on its vitiligo drug candidate EB06, while reporting financial results that reflect a strategic pivot in operational activities towards this program [1][4]. Financial Overview - For the three months ended March 31, 2025, total operating expenses decreased by $0.6 million to $1.6 million compared to $2.2 million for the same period in 2024 [7] - The company reported a net loss of $1.6 million, or $0.30 per common share, for the quarter, an improvement from a net loss of $1.9 million, or $0.58 per common share, for the same quarter last year [8] - For the six months ended March 31, 2025, total operating expenses decreased by $0.6 million to $3.5 million compared to $4.1 million for the same period in 2024 [9] - The net loss for the six months was $3.2 million, or $0.74 per common share, compared to a net loss of $3.5 million, or $1.12 per common share, for the same period last year [11] Business Development - The company completed a $15 million equity financing to support the development of EB06, an anti-CXCL10 monoclonal antibody for vitiligo [2] - Edesa has initiated outreach to potential investigators and manufacturing activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients [2][6] - The planned Phase 2 study for EB06 is already approved in Canada, with drug manufacturing data expected to be submitted to the FDA in the second half of 2025 [6] Research and Development - Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025, primarily due to decreased external research expenses related to the investigational drug paridiprubart [9][16] - General and administrative expenses increased by $0.2 million to $1.2 million for the three months ended March 31, 2025, mainly due to increased salaries and related costs [9] Cash Position - As of March 31, 2025, Edesa had cash and cash equivalents of $13.9 million and working capital of $13.5 million [12]