Alaunos Therapeutics, Inc. Q1 FY2023 earnings call

Key Points

• Kevin Boyle discussed the TCR-T library Phase 1/2 trial, which is a basket trial targeting driver mutations across six solid tumor indications. They've made enhancements to screening, enrollment, and manufacturing processes, including cryopreservation, facilitating faster patient accrual. Early translational data from the first three patients will be presented at ASCO. Amended license agreement with Precigen eliminates royalties and milestones, saving over $160M. Full prepayment of SVB loan and release of restricted cash.
• Drew Deniger highlighted the Hunter platform, a TCR discovery platform expanding the library by adding TCRs targeting more HLAs and mutations to increase the addressable market for therapeutic candidates. They aim to grow the library to 15 TCRs this year with new bioinformatics and lab equipment.
• Mike Wong provided financial updates: Net loss in Q1 2023 was ~$10M vs ~$9.8M in 2022. R&D expenses up 17%, G&A down 10%. Cash runway expected to extend to Q4 2023 with cash resources to fund operations and R&D.

There is no traditional product segment breakdown. Financials for Q1 2023: Net loss was approximately $10 million (vs $9.8 million in Q1 2022). R&D expenses were ~$6.5 million (up 17% due to increased manufacturing and TCR discovery). G&A expenses were ~$3.2 million (down 10% due to lower professional fees). Cash balance as of March 31, 2023, was approximately $37.4 million, with operating cash burn in Q1 2023 at ~$9.4 million.

Forward-Looking Statements

• Expect operating cash outflows in 2023 excluding debt service to be between $35 million to $40 million, with sufficient cash into Q4 2023.
• Anticipate treating 9-12 patients by end of 2023 to complete Phase 1 of the TCR-T library trial.
• Interim trial readout with new clinical data on multiple patients expected in the third quarter.

Actual results could differ materially from forward-looking statements due to risks and uncertainties associated with the company's business, as set forth in the most recent public filings with the SEC.

Q: Update on ASCO data, specifically efficacy of patient 3.

A: Limited by embargo, data to be released on May 25, poster at ASCO includes data on the first three patients treated, more detailed information will be provided in the third quarter.

Q: Change in Phase 1 enrollment target.

A: Guidance has not changed; 9-12 patients dosed by end of year aligns with previous 12-15 patient target, with strong RPI engagement.

Q: Confidence that interim data will positively impact cash.

A: Cash runway aligns with trial data, continuing to be good stewards of capital and considering fundraising options.

Q: Patients dosed in third quarter readout.

A: Trial design is flexible, multiple patients expected in the third quarter update.

Q: Manufacturing capacity for Phase 2.

A: Investing in a multipronged manufacturing strategy, considering in-house, CDMO, or hybrid approaches.

Q: Hunter platform partnerships.

A: Excited about the Hunter platform's high TCR discovery success rate, proprietary TCRs for potential partnerships to attract non-dilutive funding.

Q: Restricted cash inclusion in cash balance.

A: $13.9 million restricted cash is included in the $37.4 million total cash balance, with cash runway extending to Q4 2023.