Alaunos Therapeutics, Inc. Q4 FY2022 earnings call

• 2022 was transformational with TCR-T cell program advancing to clinic and first objective clinical response.
• In Q4 2022, filed IND amendment with enhancements: combined enrollment/screening protocols, no retesting tumor mutation after 6 months, added cryopreservation reducing manufacturing time to 26 days, and added 2 new TCRs doubling eligible patient pool.
• Drew Deniger discussed Hunter TCR discovery platform, adding TCRs, translational data guiding next-gen efforts, and multiplexing potential.
• Abhi Srivastava highlighted manufacturing progress: cGMP manufacturing of 3 patients' products, doubled capacity, implemented cryopreservation.

For the fourth quarter ended December 31, 2022, net loss was approximately $9.2 million (vs. $11.8 million in Q4 2021) with research and development expenses at $5.6 million (vs. $8.2 million in Q4 2021) and general and administrative expenses at $2.9 million (vs. $2.1 million in Q4 2021). For the full year 2022, net loss was $37.7 million (vs. $78.8 million in 2021). Collaboration revenue was $2.9 million (vs. $0.4 million in 2021). Research and development expenses for the full year were $25 million (vs. $49.6 million in 2021) and general and administrative expenses were $13.1 million (vs. $27.6 million in 2021). As of December 31, 2022, cash balances were approximately $53 million, including restricted cash of $13.9 million.

• Operating cash flows excluding debt service costs in 2023 expected to be $35M-$40M.
• Sufficient cash to fund R&D and operations into Q4 2023.
• Aim to be Phase 2 ready by end of 2023, with plans for multiple Phase 2 trials across solid tumor indications.
• Membrane-bound IL-15 TCR-T cell therapy program advancing towards IND submission later in 2023.

Actual results could differ from forward-looking statements due to risks and uncertainties associated with the biotech business, as detailed in SEC filings.

Q: Have there been additional patients dosed after patient three and regulatory approvals on IND amendments?

A: Kevin mentioned progress in enrollment, IND amendments had minimal comments from FDA.

Q: Expansion of multiplex TCR and scientific rationale?

A: Drew talked about multiplexing potential, one in five patients have multiple TCR matches, using Sleeping Beauty system, and IL-15 in development.

Q: Elaboration on TCR characteristics and functionality?

A: Kevin discussed translational assessments showing cells persisting with limited exhaustion, team memory stem cells, and functional cells in tumor biopsies.

Q: Business development opportunities and debt management?

A: Kevin mentioned active discussions with partners, and Mike Wong said debt will be fully repaid by August 2023.

Q: Phase 2 readiness criteria and enrollment target?

A: Kevin talked about safety, maximum tolerated dose, recommended Phase 2 dose as criteria, confident in enrolling 12-15 patients with current TCRs.

Q: Manufacturing timeline reduction?

A: Abhi discussed process development, automation, and cryopreservation aiding in reducing manufacturing time.