PDSB - PDS Biotechnology Corp (PDSB) - Moving Forward With Clinical Milestones On The Horizon
Significant Data Was Presented In 2Q21. PDS Biotechnology reported 2Q21 loss of $0.6 million or $(0.03) per share. Importantly, interim Phase 2 data from the lead trial for PDS0101 presented at the ASCO conference showed strong indications of efficacy. Additional data from this PDS0101 trial and two other Phase 2 trials are expected to be announced around 4Q/1H22. Increased Cash Allows Clinical Trials To Move Forward. During 2Q21, the company completed an offering that raised about $52 million in gross proceeds. Cash on hand at June 30, 2021 was $74.7 million. This gives the company sufficient operating cash to continue current operations and new clinical trials. Two additional Versamune platform products, PDS102 and PDS103, are expected to move to clinical trials in 1H22.PDS0101 Has Three Ongoing Trials. PDS0101 is the lead product in the Versamune platform. Initial data from a Phase 2 trial in HPV16-associated cancer was presented at the ASCO conference in June 2021. This trial is testing PDS0101 in combination with two other immune modulating drugs (the bifunctional checkpoint inhibitor bintrafusp, and Il-12 as an immune cytokine). The data showed showing a strong tumor reduction with an ongoing survival benefit. Additional data from this trial is expected in late 2021 to early 2022.Data From Three PDS0101 Trials Expected In The Next Year. PDS0101 was developed to stimulate a strong immune response against the HPV16 antigen. It is currently in three clinical Phase 2 trials in cancers caused by infection with HPV16. A second Phase 2 trial tests PDS0101 in combination with the checkpoint inhibitor Keytruda (penbrolizumab) in head and neck cancer. The third trial tests PDS0101 in combination with chemotherapy and radiation for advanced cervical cancer. These trials are expected to report data in late 2021 through 1H22.Conclusion: We view the interim data presentation at the ASCO conference as an early indication of efficacy and look forward to the additional data in 2021/2022. In our view, the data provides proof-of-concept for PDS0101 and the company's Versamune technology platform. We reiterate our Outperform rating and price target of $17 per share. Read More >>