PDS Biotechnology(US:PDSB)2021-05-13 17:44Financial Data and Key Metrics Changes - For Q1 2021, the company reported a loss from operations of approximately $3 million, an improvement from a loss of approximately $4 million in Q1 2020, resulting in a net loss of $0.14 per share compared to $0.39 per share in the previous year [38] - Research and development expenses decreased to approximately $1.4 million in Q1 2021 from $2 million in Q1 2020, a reduction of about 28% [39] - General and administrative expenses also saw a decline, totaling approximately $1.6 million in Q1 2021 compared to approximately $2.1 million in Q1 2020, a decrease of about 19% [39] - The company started 2021 with approximately $28.8 million in cash and ended the quarter with approximately $25 million after using about $3.8 million in operations [40] Business Line Data and Key Metrics Changes - The company is advancing its Versamune-based immuno-oncology pipeline, particularly focusing on the lead oncology candidate PDS0101, which is currently in three Phase II clinical trials for advanced HPV-associated cancers [7][8] - The ongoing National Cancer Institute-led trial of PDS0101 achieved a preliminary efficacy benchmark with at least 40% of patients showing tumor regression, which is a significant improvement over standard treatments [9][10] Market Data and Key Metrics Changes - The HPV cancer market is substantial, with approximately 43,000 new cases annually in the U.S., and the incidence of HPV-associated cancers continues to rise, particularly head and neck cancers [21] - The company anticipates that the ongoing clinical trials will provide critical data to support the commercialization of PDS0101 in various HPV-associated cancers [20] Company Strategy and Development Direction - The company aims to position PDS0101 for rapid market penetration by evaluating it in all HPV-associated cancers and combining it with standard-of-care treatments [20] - The strategy includes maintaining low cash burn rates while advancing oncology development programs and leveraging non-dilutive financing for infectious disease products [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of the Versamune platform in oncology, with upcoming data presentations expected to validate its efficacy [42][71] - The company is focused on building partnerships to expand its immuno-oncology pipeline, leveraging proof-of-concept data from ongoing trials [68][69] Other Important Information - The company announced a commitment of approximately $60 million from the Brazilian Ministry of Science, Technology and Innovation to support the clinical development of a Versamune-based COVID-19 vaccine [25] - The company is also developing a universal flu vaccine in collaboration with the University of Kentucky, with preclinical studies underway [26] Q&A Session Summary Question: Importance of T-cells and geographical reach of the COVID program - Management highlighted the significance of T-cells in robust immunity against COVID-19 and the potential for broader geographical reach as data becomes available [45][46] Question: Data expectations for PDS0101 - Management indicated that data from approximately 20 to 25 patients would be available soon, with an abstract to be released by ASCO on May 19 [51][52] Question: Regulatory considerations for VERSATILE study - Management anticipates a randomized Phase II trial design for registration, focusing on objective response rates and duration of response as key endpoints [62] Question: Gating factors for COVID-19 trial initiation - The completion of the manufacturing process by Farmacore is a key gating item for initiating human clinical trials in Brazil [66] Question: Potential for partnerships with third-party companies - Management acknowledged the potential for partnerships to develop additional immuno-oncology products using the Versamune platform [68][69]