NetScientific's portfolio company, PDS Biotechnology Corporation, has provided a business update and reported financial results for the second quarter of 2024. PDS Biotech is aligning with the FDA to initiate a Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC. The trial will investigate the combination of Versamune® HPV + pembrolizumab compared to pembrolizumab, reflecting updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial. The company has initiated preparatory activities for the trial, which is planned to start in Q4 2024.
The VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC has shown encouraging survival, disease control response rates, and safety data. Updated data from this trial will be presented at the European Society for Medical Oncology (ESMO) 2024 Congress in September. Additionally, the company has provided a survival data update from the ongoing VERSATILE-002 trial, with a median overall survival of 30 months.
PDS Biotech has also announced the acceptance of abstracts presenting updated results from trials evaluating treatment of high-risk locally advanced cervical cancer and biochemically recurrent prostate cancer. In terms of financial results, the company reported a net loss of approximately $8.3 million for the second quarter of 2024, a decrease from the previous year, primarily due to lower operating expenses. Research and development expenses decreased, as did general and administrative expenses. The company's cash and cash equivalents as of June 30, 2024, totaled approximately $57.7 million.
For more information, please refer to the full version of PDS Biotech's announcement.