PDS Biotechnology Corporation (NASDAQ:PDSB) Q4 2022 Earnings Call Transcript

Lauren Wood: One of the things that we’re very interested in is seeing whether or not we can impact differentiating outcomes for patients earlier in disease. And so, we hope to see, in addition to whether or not we see tumor shrinkage and declines in circulating tumor DNA and whether or not those are predictive of disease recurrence, we would potentially design a randomized trial to look at PDS0101 alone versus PDS0101 in combination with KEYTRUDA in this neoadjuvant treatment setting. Merck has published studies examining KEYTRUDA alone in the neoadjuvant treatment setting with some preliminary evidence of tumor shrinkage and minimal pathologic response and we would hope to improve on that.

Frank Bedu-Addo: With both of them, there is a significant commercial opportunity in both trials. And so, the key here is really getting that basic information that will say, okay, yes, move forward. And if it’s yes move forward, how do we design that control trial based upon the information that we receive from both trials. So both provide us with a significant commercial opportunity that we are currently waiting for the data to make the next decision.

Operator: Thank you. We’ve reached the end of our question-and-answer session. I’d like to turn the floor back over to management for any further or closing comments.

Frank Bedu-Addo: Thank you very much. Well, thank you very much for joining us today on our fourth quarter and full year ended earnings conference call. So, while 2022 was the year of tremendous progress for both our clinical and preclinical development programs, 2023 is poised to be transformational for our platform technologies in PDS Biotech. I will reiterate that our key goal this year is to prioritize rapid commercialization of PDS0101 first in the VERSATILE-003 study. We have selected and completed manufacturing of PDS0101 at our preferred commercial manufacturer for VERSATILE-003. We will also progress activities needed to commercialize PDS0101 in combination with PDS0301. We will continue with activities necessary to progress PDS0103 to IND this year.

And we also plan to continue progressing discussions with NIAID towards hopefully getting PDS0202 for universal flu into the clinic. We thank you for your continued interest. And we will continue to update you as we advance through this exciting journey. Thank you very much.

Operator: Thank you. That does conclude today’s teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.