On May 16, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported financial results for the first quarter ended March 31, 2022 (Press release, Alaunos Therapeutics, MAY 16, 2022, View Source [SID1234614656]).
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"Dosing of the first patient in our TCR-T Library Phase 1/2 trial speaks to the dedication of our entire team and reaffirms our commitment to execution. We are working to continue enrolling patients in the trial and expect to provide an initial look at data later this year," commented Kevin S. Boyle, Sr., Chief Executive Officer. "We are honored to have two posters supporting our TCR-T platform targeting solid tumors at the upcoming ASGCT (Free ASGCT Whitepaper) and ASCO (Free ASCO Whitepaper) conferences. We believe we have positioned Alaunos for success and look forward to continued progress."
Recent Developments and Upcoming Milestones
TCR-T Library Trial: In May 2022, the Company announced that it had dosed the first patient with non-viral TCR-T cells in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications. This is a major milestone for Alaunos as it also represents the first clinical product manufactured and administered to a patient using the Company’s in house cGMP manufacturing facility.
The study is being conducted at The University of Texas MD Anderson Cancer Center and is an open label, dose escalation study, with patients to be treated in one of three dosing cohorts: 5×109, 4×1010, or 1×1011 TCR-T cells. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers that have a matching human leukocyte antigen (HLA) and hotspot mutation pairing in Alaunos’ TCR-T library. The main study objectives are to define the maximum tolerated dose, recommended phase 2 dose and safety profile. The Company will present a trial in progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and expects to report initial data in the second half of 2022. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735.
Presenting preclinical data supporting membrane bound IL-15 (mbIL-15) at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: Today, the Company will present preclinical data for its mbIL-15 program at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting. The poster titled, "Stem-cell memory TCR-T cells targeting hotspot EGFR, KRAS and p53 neoantigens generated through co-expression of membrane-bound Interleukin-15" highlights the potential of mbIL-15 to establish long-lived tumor-specific TCR-T cells. The Company intends to file an IND application for this program in the second half of 2023.
First Quarter Ended March 31, 2022 Financial Results
Research and Development Expenses: Research and development expenses were $5.6 million for the first quarter of 2022, compared to $13.3 million for the first quarter of 2021, a decrease of approximately 58%. The decrease was primarily due to lower program-related costs as a result of the winding down of our IL-12 and CAR-T programs and lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021.
General and Administrative Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022, compared to $8.2 million for the first quarter of 2021, a decrease of approximately 57%. The decrease was primarily due to lower employee related expenses due to our reduced headcount following our strategic restructuring event in the third quarter of 2021 and a decrease in consulting and professional services expenses.
Net Loss: Net loss was $9.8 million, or $(0.05) per share, for the first quarter of 2022, compared to a net loss of $21.6 million, or $(0.10) per share, for the same period in 2021.
Cash and Cash Equivalents: As of March 31, 2022, Alaunos had approximately $68.3 million in cash and cash equivalents. The Company anticipates its cash runway will be sufficient to fund operations into the second quarter of 2023. Operating cash burn for the first quarter of 2022 was $7.8 million compared to $15.3 million in the first quarter of 2021, a decrease of $7.5 million or 49%.
Conference Call and Webcast
The conference call can be accessed by dialing 844-309-0618 (United States) or 661-378-9465 (International) with the conference code 2495623. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. After the live webcast, the event will be archived on the Company’s website for approximately 30 days after the call.