Alaunos Therapeutics, Inc. Q4 FY2021 earnings call

Key Points:

• Kevin Boyle joined 6 months ago, with progress on TCRT program for solid tumors. TCRT library study at MD Anderson, first patient consented, anticipating Q2 2022 dosing. Raffaele Baffa departed as CMO, leveraging Chris Bowden's expertise.
• Drew Deniger: Extension of CRADA with NCI for personalized TCRT, progress on IL-15 program, Hunter platform for TCR discovery, plan to expand TCR library.
• Mike Wong: Reviewed financial results, including Q4 and full-year 2021 financials, cash position, and runway.

For the fourth quarter ended December 31, 2021, net loss was approximately $11.8 million or $0.05 net loss per share, compared to a net loss of approximately $22.8 million or $0.11 net loss per share in Q4 2020. Research and development expenses were approximately $8.2 million in Q4 2021 vs. $14 million in Q4 2020 (decrease of 41%). General and administrative expenses were approximately $2.1 million in Q4 2021 vs. $8.8 million in Q4 2020 (decrease of 76%). For the full year ended December 31, 2021, net loss was approximately $78.8 million or $0.37 net loss per share, compared to a net loss of approximately $80 million or $0.38 net loss per share in 2020. Research and development expenses decreased by 6% to approximately $49.6 million in 2021 vs. $52.7 million in 2020. General and administrative expenses were approximately $27.6 million in 2021 vs. $27.7 million in 2020 (slight decrease). As of December 31, 2021, Alaunos had approximately $76.1 million in cash and cash equivalents. Cash burn for the full year 2021 was $61.5 million, with cash runway sufficient to fund operations into Q2 2023.

Forward-Looking Statements:

• Anticipate operating cash flow for 2022 to be between $40 million and $45 million.
• Dosing first patient in Q2 2022 for the Phase 1-2 TCRT library trial at MD Anderson.
• Progressing the membrane bound IL-15 program towards an IND filing in 2023 and planning to present preclinical data at a major scientific conference later in 2022.

Risks:

• Uncertainties in clinical trial enrolment due to patient availability, insurance, and scheduling.
• Regulatory challenges in obtaining approvals for TCRT therapies.
• Market adoption uncertainties for new cell therapy products.

Q: Chris Howerton asked about clinical development plans post-CMO change and TCR library cadence.

A: Kevin Boyle stated no wholesale changes expected, with focus on accruing patients in the Phase 1-2 trial and TCR library expansion likely in the second half of 2022 due to the process taking 6-12 months.

Q: Arthur He inquired about expansion of TCR mutation and NCI agreement.

A: Drew Deniger confirmed flexibility in expanding TCR mutation within the current trial, and Kevin Boyle mentioned the NCI partnership for personalized TCRT with more details to come later in 2022.

Q: Thomas Flaten asked about manufacturing capacity and data release.

A: Kevin Boyle noted GMP suite capacity but emphasized enrolment isn't typically one patient per month, with data likely presented at a scientific conference.

Q: Yale Jen asked about first patient tumor type, TCR library HLAs, and dose rationale.

A: Kevin Boyle said first patient details would be shared after safety period, Drew Deniger noted 10 TCRs in the library with 8 different HLAs, and Kevin Boyle explained dose levels were based on safety and efficacy review, with same dose levels anticipated across indications initially.