Alaunos Therapeutics, Inc. Q3 FY2021 earnings call

• Strategically restructured the organization to focus on advancing the TCR-T cell platform, right-sizing the team while maintaining R&D. - Completed engineering and process qualification runs at the in-house CGMP clinical production unit (CPU) in October 2021, aiming to treat patients in the first half of 2022. - TCR-T platform has multiple programs, including supporting the lead TCR-T library trial, advancing the membrane bound aisle 15 program, and developing an in-house TCR discovery platform. - TCR-T library platform uses non-viral Sleeping Beauty technology and an extensive TCR library to target multiple solid tumor indications. - Completed commissioning and process validation of the Houston facility's CGMP CPU, with screening of patients for the Phase 1/2 TCR-T library study underway at MD Anderson Cancer Center. - Plan to file an IND in the next few months to include new TCRs in library trials.

For the third quarter of 2021, ZIOPHARM reported a net loss of approximately $22.7 million or $0.11 net loss per share, compared to a net loss of approximately $20.3 million or $0.10 net loss per share in the third quarter of 2020. Research and development expenses totaled approximately $14.5 million in 2021, an increase of 4% from $14 million in 2020. General and administrative expenses were approximately $8.2 million in 2021, up from $6.4 million in 2020. Total operating expenses in 2021 were approximately $22.7 million, an increase of 12% from 2020. Cash and cash equivalents as of September 30, 2021, were approximately $91.7 million, with a cash runway extending into the second quarter of 2023.

• Anticipates cash burn going forward will be less than $15 million per quarter. - Cash runway extends into the second quarter of 2023. - Committed to entering the clinic with the TCR-T library program and generating clinical data in 2022.

• Uncertainty surrounding FDA IND review for the TCR-T library study. - Risks related to clinical trial timelines and patient enrollment. - Dependence on successful execution of in-house manufacturing and R&D efforts.

Q: What are the gating factors to starting the phase 1 plus 2 study now that in-house manufacturing is progressing, and how will operating expenses change in Q4 and 2022?

A: Cash burn anticipated to be less than $15M per quarter; need FDA IND clearance for next step.

Q: What else needs to be complete or qualified before dosing first patient in TCR-T trial?

A: Waiting for FDA review; already screening patients.

Q: Plan for commercial manufacturing of TCR-T?

A: Commercial manufacturing is years away, no strategy communicated yet.

Q: Retention strategies post-restructuring?

A: Incentive stock option grants to align team, no unforeseen departures.

Q: Adding new TCRs to IND before clearance?

A: Planning to add TCRs in a manner not linked to IND submission timeline.

Q: Update on NCI visit?

A: Raffaele and team to visit NCI later that week, no current update to share.