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TCRT

Alaunos Therapeutics, Inc.

Alaunos Therapeutics, Inc. Q2 FY2021 earnings call

August 9, 2021 · fiscal period ended 2021-06

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Summary

Generated 2021-08-09

Management highlights

• Heidi Hagen noted the company has transformed since the last call, with progress on TCR-T program: completed commissioning of cGMP clinical production unit and aseptic process validation in Houston, on track to dose patients in Phase 1/2 TCR-T library trial in Q4 2021. Ended H1 2021 with ~$76.7 million, executed $50M venture debt facility with $25M initial drawdown extending cash runway to Q4 2022. Search for permanent CEO near completion. • Raffaele Baffa discussed TCR-T library program milestones, initial tumor indications for the trial, manufacturing strategy with KBI Biopharm and in-house facility, preclinical data from ACR, update on Taiwan CAR-T trial with need for process development, COVID-19 impact in Taiwan, and consideration of partnerships for CAR-T program.

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Segment performance

No specific product segment financial performance with absolute revenue and contribution % provided in the transcript.

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Guidance

• On track to dose patients in Phase 1/2 TCR-T library trial in the fourth quarter of 2021. • Initial readouts from the trial expected in the first half of 2022. • $25 million initial tranche of the $50M venture debt facility extends cash runway into Q4 2022, well beyond time to generate initial clinical data from the Phase 1/2 TCR-T library trial.

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Risks

• COVID-19 outbreak in Taiwan presents added uncertainty to the timeline for process development in the Eden BioCell CAR-T trial as manufacturing facility operations are slowed due to employee restrictions. • Uncertainty in the length of time required for process development improvements in the Taiwan CAR-T trial, which may require up to 12 months.

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Q&A highlights

Q: For the Taiwan trial, can you please just discuss what the current manufacturing process was exactly and who runs it? And a second one, is there anything you can leverage from your own experience with manufacturing with TCR-T to help with the Eden BioCell program?

A: Ellee de Groot stated the Taiwan manufacturing process uses the rapid personalized manufacturing (RPM) process with Sleeping Beauty for genetic transfer, cells released shortly after and infused within two days; run by the TriArm team in Taiwan. Raffaele Baffa added the structural difference between CAR and TCR, and Heidi Hagen mentioned insights gained from TCR process development can be leveraged for the CAR-T process improvements.

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Key numbers

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Transcript

August 9, 2021

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