PDS Biotechnology Corp Q4 FY2023 earnings call

• Dr. Frank Bedu-Addo discussed advancements with PDS01ADC, IL-12 Fused Antibody Drug Conjugate Clinical Programs, and PDS0101 Phase 2 programs. Highlighted data from Phase 2 trials, leading to prioritizing the triple combination of Versamune HPV, PDS01ADC, and KEYTRUDA in HNSCC. Introduced new leadership members: Lars Boesgaard as CFO and Dr. Kirk Shepard as CMO. - Lars Boesgaard reviewed financial results, noting R&D, G&A, and operating expense details, and cash position.

For the year ended December 31, 2023, net loss was approximately $42.9 million, or $1.39 per basic and diluted share, compared to a net loss of $40.9 million, or $1.43 per basic and diluted share in 2022. Research and development expense decreased to $27.8 million in 2023 from $29.4 million in 2022, while general and administrative expenses increased to $15.3 million from $12.2 million. Total operating expenses in 2023 were $43 million, a 3.3% increase from 2022. Net interest expense rose to $1.3 million in 2023 from $0.4 million in 2022. Cash balance as of December 31, 2023 was $56.6 million.

• Cash balance as of December 2023 is $56.6 million. Expect operating burn of approximately $8 million per quarter. Without initiating the triple combination pivotal study, burn expected to continue through first two to three quarters of 2024, then slight decrease. Pulled down ~$19 million under the ATM in first quarter of 2024. Plans for key updates in 2024 including VERSATILE-002 update, IMMUNOCERV trial update, neoadjuvant trial data, and filing IND for PDS0103.

Q: Given you're prioritizing PDS01ADC triple combo study over VERSATILE-003, how are you thinking OpEx management differently for the rest of the year as a result of the switch? And secondly, as we're thinking about the rest of this year and into 2025, what are your biggest milestones or data readouts in the next 12 to 18 months?

A: Dr. Frank Bedu-Addo discussed milestones like VERSATILE-002 update, IMMUNOCERV trial update, neoadjuvant trial data, and filing IND for PDS0103. Lars Boesgaard mentioned operating burn of ~$8 million per quarter, expected to continue through first two to three quarters of 2024 with slight decrease after.

Q: Can you please clarify the 38% CRM triplet has been confirmed for resist, and if there's going to be another update to that in 2024, that could be informative to how you think of your next study for the triplet? Maybe just a related question, what steps remain in finalizing the registration enabling study for the triplet? And is there an end of Phase 2 meeting there that you feel you're prepared for, or is there some additional work you have to do given the PD-1 that was used in your earlier study has to be now changed to KEYTRUDA?

A: Dr. Frank Bedu-Addo discussed the triple combination study results, safety data, and regulatory discussions with the FDA, mentioning alignment with FDA guidance and key opinion leaders.

Q: VERSATILE-003, the data that came out of that was that the KEYTRUDA with HPV+, HPV16+, head and neck squamous cell, the combination with the KEYTRUDA was best in the CPI-naive, and that's why VERSATILE-003 was going to go forward in the naive. And the last guidance we had was back in November, October, first patient by year, but obviously that's done. So 003 is wrapped up, it's done, it's not going forward. So, then on the triple combo, 001 plus the commercial checkpoint inhibitor plus the ADC, the CPI refractory patients, I think the plan had been for that -- that was going to be for the CPI refractory, is that trial still going forward?

A: Dr. Frank Bedu-Addo explained the decision to prioritize the triple combination over VERSATILE-003, discussing data-driven decision making and the role of each component in the trials.

Q: Is the Phase 2 combo trial, PDS0101ADC plus docetaxel and metastatic cancer - castration-resistant prostate cancer with the NCI, it's a Phase 2 trial. Is that still ongoing?

A: Dr. Frank Bedu-Addo stated that the Phase 2 trial is still ongoing while the company is focused on moving the triple combination into the pivotal trial.