PDS Biotechnology(US:PDSB) Globenewswire·2025-05-14 11:30Core Viewpoint - PDS Biotechnology Corporation is advancing its clinical programs, particularly the VERSATILE-003 Phase 3 trial for its investigational therapy Versamune® HPV targeting HPV16-positive head and neck squamous carcinoma, while also reporting improved financial results for Q1 2025 compared to the previous year [3][4][6]. Clinical Updates - The VERSATILE-003 Phase 3 clinical trial has been initiated to evaluate Versamune® HPV in recurrent/metastatic HPV16-positive head and neck squamous carcinoma, with site activations progressing, including the addition of Mayo Clinic sites [4]. - The trial is designed to include approximately 350 patients and is a two-arm controlled trial with a 2:1 randomization, focusing on median overall survival as the primary endpoint [6]. - The company received FDA Fast Track designation for the combination of Versamune® HPV and pembrolizumab in recurrent/metastatic head and neck squamous carcinoma [6]. Financial Results - For Q1 2025, the reported net loss was approximately $8.5 million, or $0.21 per share, a decrease from a net loss of $10.6 million, or $0.30 per share, in Q1 2024 [6][7]. - Research and development expenses were $5.8 million in Q1 2025, down from $6.7 million in Q1 2024, primarily due to lower clinical trial expenses [7]. - Total operating expenses for Q1 2025 were $9.1 million, compared to approximately $10.1 million in Q1 2024 [8]. Cash Position - As of March 31, 2025, the company's cash balance was $40 million, a slight decrease from $41.7 million as of December 31, 2024 [8][16]. - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing, with potential for an additional $11 million from warrant exercises [6]. Upcoming Events - Three abstracts on Versamune® HPV have been selected for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, scheduled for May 30-June 3, 2025 [6].