Alaunos Therapeutics(TCRT) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of approximately $10 million, or a $0.04 net loss per share, compared to a net loss of approximately $9.8 million, or a $0.05 net loss per share for the same period in 2022, indicating a slight increase in losses [22] - Research and development expenses increased by 17% to approximately $6.5 million in Q1 2023 from approximately $5.6 million in Q1 2022, primarily due to increased manufacturing and TCR discovery activities [23] - General and administrative expenses decreased by 10% to approximately $3.2 million in Q1 2023 from approximately $3.5 million in Q1 2022, attributed to lower professional fees [24] - As of March 31, 2023, total cash balances were approximately $37.4 million, with an operating cash burn of approximately $9.4 million for Q1 2023, up from approximately $7.8 million in Q1 2022 [25][27] Business Line Data and Key Metrics Changes - The company is focused on advancing its TCR platform targeting solid tumors, with significant enhancements made to screening enrollment and manufacturing processes, facilitating faster patient accrual [3][4] - The TCR library Phase 1/2 trial is actively enrolling patients across six solid tumor indications, with expectations to treat between nine and twelve patients by the end of the year [5][6] Market Data and Key Metrics Changes - The company noted that investor engagement remains encouraging, with evidence pointing to supportive capital markets for companies with differentiated science [28] - The follow-on market has raised $7.3 billion by 60 follow-ons year-to-date, compared to $4.6 billion raised in 44 follow-ons at the same point in 2022, indicating a positive trend for biotech [36] Company Strategy and Development Direction - The company aims to become a Phase 2-ready company by the end of 2023, with recent corporate and capital changes supporting the belief in the upside potential of its TCR platform [1][6] - The amendment of the license agreement with Precigen eliminates all commercial sales-based royalties and milestone obligations, representing potential savings of over $160 million [7][9] - The company is expanding its TCR library through the Hunter platform, targeting more HLAs and new mutations to bolster its IP portfolio and pipeline [12][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their TCR-T platform to transform cancer treatment, highlighting early clinical responses and accelerated patient enrollment [33][35] - The management team is optimistic about the upcoming interim results in Q3, which are expected to provide a more comprehensive readout of clinical data [5][39] Other Important Information - The company fully prepaid its term loan with Silicon Valley Bank, allowing for complete operational control over cash and eliminating additional interest expenses [9][27] - The company has implemented cryopreservation in its manufacturing process, increasing flexibility for patient scheduling and treatment [3][4] Q&A Session Summary Question: Update on ASCO data presentation - Management confirmed that the poster will include data on the first three patients treated, but further details cannot be disclosed until the embargo lifts on May 25 [50] Question: Change in target enrollment for Phase 1 - Management clarified that the guidance remains unchanged, with the nine to twelve patients expected to complete Phase 1 including those treated in 2022 [55] Question: Confidence in interim update financing - Management expressed confidence that the cash runway will extend to the next data readout, while remaining opportunistic regarding fundraising options [56][57] Question: Interim readout patient dosing levels - Management indicated that multiple patients will be included in the clinical update in Q3, with flexibility in trial design regarding dosing levels [60] Question: Manufacturing capacity for Phase 2 - Management discussed a multipronged manufacturing strategy to increase capacity for Phase 2, utilizing both in-house and external resources [62][64] Question: Cash balance clarification - Management confirmed that the $13.9 million of restricted cash is included in the total cash balance of $37.4 million as of March 31, 2023 [80]