PDSB - PDS Biotechnology Corp (PDSB) - FY2021 Reported With Clinical Trial Progress
FY2021 Results Were Within Expectations. PDS Biotech reported 4Q21 loss of $6.3 million or $(0.23) per share, bringing the FY2021 loss to $16.9 million or $(0.66) per share. On its quarterly conference call, the company discussed pipeline developments in several HPV-positive cancer trials, preclinical products, and its infectious disease platform. Cash at December 31, 2021 was $65.2 million.PDS0101 Has Recently Achieved Important Milestones The VERSATILE-002 trial is testing PDS0101 in combination with Keytruda (pembrolizumab), the PD-1 checkpoint inhibitor. The company has recently presented safety data, announced a preliminary efficacy milestone that allows the trial to continue to completion, and continues to enroll patients.NCI Triple Therapy Trial Reached Target Enrollment In One Of Its Study Arms. The Phase 2 Triple-Combination (PDS0101 with a checkpoint inhibitor and IL-12) study conducted by the National Cancer Institute (NCI) reached target enrollment for one of its two treatment arms. In this trial, 30 patients who had received at least one evaluation had achieved a median survival of 12 months, compared with historic survival of only about 4 to 6 months. Investigator Initiated Trial Moves PDS0101 To Earlier Treatment In February, PDS announced the initiation of an Investigator Initiated Trial (ITT) in HPV-associated oropharyngeal cancer, (HPV(+)OPSCC. This trial treats patients before surgery, early in the course of disease, rather than after treatment failure. PDS0101 will be given alone or in combination with Keytruda. We view the ITT using PDS0101 earlier in the treatment regimen as a positive development that could support use as a first-line therapy.Conclusion. The financial results for FY2021 show R&D and G&A expenses that were slightly lower than our estimates. The lead product, PDS0101, continues to make progress in several trials and several tumor types, which we believe supports our expectations for successful trial results. We are reiterating our Outperform rating and $22 price target. Read More >>