Alaunos Therapeutics, Inc. Q1 FY2022 earnings call

• Successfully dosed the first patient in the Phase 1/2 TCR-T Library trial, a basket trial targeting hotspot mutations across six solid tumor indications. The patient has non-small cell lung cancer and has cleared the 28-day safety window.
• Two posters accepted at upcoming scientific conferences: one at ASGCT later today and one at ASCO in early June.
• Phase 1/2 TCR-T Library trial is enrolling patients at MD Anderson Cancer Center based on matching neo antigen HLA pairings in the TCR-T library, which consists of 10 TCRs (4 KRAS, 5 TP53, 1 EGFR).
• Research and development team making progress in TCR discovery using proprietary Hunter hunTR.
• Scientific Advisory Board realigned and strengthened with key opinion leaders in TCR-T cell therapy.
• First clinical product dosed to the first patient was fully manufactured using in-house cGMP suite, a significant accomplishment.

For the first quarter of 2022, Alaunos reported a net loss of approximately $9.8 million or $0.05 net loss per share. Research and Development expenses were approximately $5.6 million, a decrease of 58% compared to the first quarter of 2021. General and Administrative expenses were approximately $3.5 million, a decrease of 57% compared to the same period in 2021. As of March 2022, the company had approximately $68.3 million in cash and cash equivalents, and the operating cash burn for the first quarter of 2022 was $7.8 million, a decrease of $7.5 million or 49% compared to the first quarter of 2021. Revenue contribution details were not explicitly broken down by product segment as the company is focused on clinical progress and pipeline development rather than traditional product revenue segments.

• Anticipates operating cash burn for 2022 to be between $40 million and $45 million.
• Plans to continue working with MD Anderson to consent and enroll patients in the Phase 1/2 TCR-T Library trial.
• Intends to invest in a multi-pronged manufacturing strategy to increase capacity.
• Membrane bound IL-15 program aims to advance towards an IND filing in the second half of 2023.
• Seeks to continue expanding the TCR library using the hunTR discovery platform, with the goal of enrolling 10 to 15 patients in the Phase 1/2 TCR-T Library trial based on Bayesian design and learning from patient treatment.

• Actual results could differ materially from forward-looking statements due to risks and uncertainties associated with the company's business, as set forth in recent public filings with the SEC.
• Manufacturing process may face challenges such as the learning curve for newly hired employees in the non-viral manufacturing approach.
• Patient accrual and trial progress may be affected by factors such as matching neo antigen HLA pairings and patient eligibility for the trials.

Q: For completing the TCR-T Phase 1/2 study, how many patients do you need to enroll?

A: In part, it will be determined by the number of patients enrolled at given dose levels and what is found out through the Bayesian design. Directionally, somewhere between 10 and 15 patients will likely be seen from an early Phase 1a perspective, and the number will also be influenced by treating patients with different indications and using different TCRs.

Q: The trial is designed such that you hit at least a couple of patients with each indication, or since it's an all comers trial, is that part of the goal or is the goal more to make sure that you can evaluate all of the 10 TCR irrespective of what indication it is?

A: The goal is not necessarily to use alternative TCRs, but there is value in treating different patients in different indications and using different TCRs, which will be a continuous learning process as the trial progresses.

Q: How should we think about the ability to expand the trial with the current GMP facility with successful implementation of those first two strategies? How many patients a month do you think you could treat?

A: Will update folks later as we successfully execute upon those two initiatives. Not quite ready to share the exact number of patients per month right now, but we have multiple strategies to increase manufacturing throughput, including hiring additional staff and implementing SOPs for simultaneous production, with a learning curve of around three to six months for newly hired employees.

Q: What needs to be done before between now and filing of the IND in the second half of 2023 for the membrane bound IL-15 program?

A: Need to do the manufacturing runs and the regulatory strategy, and the lion's share of preclinical data is completed and very encouraging, with the poster presentation at ASGCT today covering much of the preclinical data.

Q: How should we think about output for hunTR? How do we think about hunTR in terms of shared neoantigen output and then also, your thoughts on unique neoantigens?

A: We're able to find TCRs targeting neoantigens from most of the patients we screened, are increasingly focused on TP53, KRAS and EGFR to grow the library, and are nowhere near close to the plateau of biologically available TCRs, with interest in both shared neoantigens and unique neoantigens.