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Dec 31, 2021
PDS Biotechnology Q4 2021 Earnings Report
PDS Biotechnology reported fourth-quarter and full-year 2021 financial results and provided a business update.
Key Takeaways
PDS Biotechnology reported a net loss of approximately $16.9 million for the year ended December 31, 2021. The company highlighted clinical progress on its lead oncology candidate, PDS0101, and the initiation of a Phase 2 clinical study by Mayo Clinic. They also strengthened their balance sheet by adding more than $52 million in 2021.
Achieved milestones in the VERSATILE-002 Phase 2 combination trial of PDS0101-KEYTRUDA® for recurrent and/or metastatic HPV16-associated head and neck cancer.
Initiated an investigator-initiated trial with Mayo Clinic for patients with HPV-associated oropharyngeal cancer at high risk of recurrence to evaluate PDS0101.
Announced encouraging preclinical data for the universal flu vaccine, demonstrating a potent neutralization response against multiple strains of the influenza virus.
Granted U.S. Patent Application for composition of matter and use of PDS0101, extending its U.S. patent protection into 2037.
PDS Biotechnology
PDS Biotechnology
Forward Guidance
PDS Biotech anticipates a productive 2022, with plans to announce additional data from ongoing Phase 2 oncology trials for PDS0101 and to progress at least one preclinical program, PDS0103, into the clinic.
Positive Outlook
- Announce additional data from ongoing Phase 2 oncology trials for PDS0101.
- Progress at least one preclinical program, PDS0103, into the clinic.
- Continue to advance clinical and pre-clinical programs.
- Leverage T-cell activating platforms to advance additional candidates.
- Advance towards full enrollment of 54 patients in the checkpoint inhibitor naïve patient cohort.
Challenges Ahead
- Dependence on additional financing to fund operations and complete development.
- Limited operating history makes it difficult to evaluate prospects.
- The timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune and Infectimune-based product candidates
- The future success of such trials
- Legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19.