Alaunos Therapeutics, Inc. Q2 FY2022 earnings call

• Kevin Boyle highlighted one-year anniversary at Alaunos, progress in TCR-T Library Phase 1/2 trial (moving to second dose level after safety review), expansion of manufacturing capacity, and partnership extension with NCI until 2025 for personalized cancer therapies.
• Drew Deniger discussed recent academic papers validating TCR-T approach, extension of CRADA with NCI, progress of membrane-bound IL-15 program, and hunTR platform for discovering TCRs.
• Abhishek Srivastava introduced himself as VP of Technical Operations, expressing excitement to support manufacturing capability enhancement.
• TCR-T Library Phase 1/2 trial details: enrolling patients with hotspot mutations in six solid tumor indications, first patient dosed in May at 5 billion TCR-T cells, moving to second dose level of 40 billion, and expected early data in Q3.
• Collaboration with Solasia Pharma: Solasia's Darvias approved in Japan for peripheral T-cell lymphoma, Alaunos eligible for sales-based milestones and royalties.

For the second quarter of 2022, net loss was approximately $9.9 million (or $0.05 net loss per share) compared to a net loss of approximately $22.7 million (or $0.11 net loss per share) in the second quarter of 2021. Research and Development expenses were $5.9 million in Q2 2022 vs. $13.6 million in Q2 2021, a decrease of 56%, primarily due to lower program-related costs, reduced employee expenses post-restructuring, and lower consulting expenses. General and Administrative expenses were $3.4 million in Q2 2022 vs. $9.1 million in Q2 2021, a decrease of 62%, mainly from reduced employee expenses and lower consulting/professional services. As of June 30, 2022, Alaunos had approximately $60 million in cash and cash equivalents, with cash runway sufficient to fund operations into Q2 2023. Operating cash burn for Q2 2022 was $8.2 million, down from $21.5 million in Q2 2021, a decrease of 62%.

• Continued progress in advancing TCR-T platform, with plans to present early data from TCR-T trial in Q3.
• Advancing personalized TCR-T therapy with NCI and moving membrane-bound IL-15 program towards IND filing in the second half of 2023.
• Focus on reducing cash burn by over 60% and optimizing manufacturing processes to support future clinical expansion.

No specific detailed risks discussed, but general risks associated with clinical trial outcomes, manufacturing challenges, and market adoption inherent in biotech development were implied.

Q: Clarify if the second patient has been dosed and when Q3 data will be presented.

A: Stay tuned for Q3 data, no specific details yet on second patient dosing.

Q: Update on the number of screened patients and match rate to TCRs in the library.

A: Over 500 patients screened for lung and colorectal indications, with a match rate over 5%.

Q: What is the limiting factor for patient treatment?

A: Currently, manufacturing is not the rate-limiting factor, with focus on process optimization to reduce manufacturing time.

Q: What is the current manufacturing time and potential for reduction?

A: Currently ~30 days, aiming to reduce by half through process development efforts.

Q: Details on Solasia's commercialization and royalty terms.

A: Royalty terms are in the low single digits, Solasia to speak on their commercialization plans.

Q: Details on safety review for moving to the second dose.

A: Safety review occurs after a 28-day window, pleased with the first patient's safety profile.

Q: Differences between Alaunos' approach and academic publications mentioned.

A: Alaunos uses a non-viral Sleeping Beauty system vs. retroviral in publications, with differences in lymphodepletion regimens and IL-2 use.