Marker Therapeutics, Inc. Q3 FY2020 earnings call

• Initiated the first Marker-sponsored trial in post-transplant AML, with the first patient enrolled in the safety lead-in portion. • Progressed with the build-out of the new manufacturing facility, on track to complete construction by year-end and operational in early 2021. • Details on the AML trial: FDA lifted clinical hold in Feb 2020, safety lead-in to enroll ~6 patients (3 on zelenoleucel/MT-401 with legacy reagent, 3 on new reagent from alternative supplier). • Phase II trial objectives include evaluating relapse-free survival, complete remission rate, etc., in adjuvant and active disease settings post-allogeneic stem cell transplant. • Process improvements in manufacturing to maximize efficiencies, reducing manufacturing time by 50%, decreasing technical interventions, and increasing T cell production consistency.

• Enrolled first patient in AML trial and expect to treat by Q1 2021. • Plan to submit data to FDA to lift partial clinical hold on new reagent in Q1 2021. • Construction of cGMP manufacturing facility to complete in Q4 and begin treating first patient in H1 2021.

Q: Congrats on forward progress. Could you walk through logistics of enrolling lead-in patients, sourcing grafts, turnaround time from consent to treating, and if using new manufacturing process for lead-in patients?

A: Using new improved manufacturing process for Phase II trial. Enrollment process involves investigator submitting form, reviewing patient/donor info, scheduling donor (faster if matched-related, longer if matched-unrelated/haploidentical).

Q: Could you give updates on additional pancreatic cancer data following ASCO presentation?

A: Baylor completed enrollment of 13 patients in pancreatic Phase I study in June 2020; currently discussing timing to collect and release more longitudinal endpoints like overall survival.