On May 10, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a leading T-cell receptor (TCR) cell therapy company advancing a clinical-stage pipeline of therapeutics for solid tumors, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Alaunos Therapeutics, MAY 10, 2023, View Source [SID1234631408]).

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"Our TCR-T Library Phase 1/2 trial continues to garner significant interest among patients, physicians and investigators," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We’ve been actively enrolling patients and manufacturing cryopreserved products, and we expect to report interim clinical data in the third quarter of this year. As we work to fully realize the long-term potential of our TCR-T platform, we have simplified our corporate structure with the full prepayment of our loan with SVB and the recent agreement with Precigen. We are now moving forward unencumbered by debt or these potential royalties as we seek to transform the treatment of solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 trial actively enrolling patients: Alaunos continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR driver mutations across six solid tumor indications. Early translational data from the first three patients treated in the program will be highlighted in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023. Alaunos currently expects to provide an interim data update on multiple new patients in the third quarter of this year as the Company advances the program towards Phase 2 readiness with a recommended Phase 2 dose anticipated by year end 2023.

Manufactured multiple cryopreserved products: In the first quarter of 2023, Alaunos enhanced its manufacturing process to move from fresh to cryopreserved cell product enabling greater flexibility for patient scheduling and treatment. To date, the Company has manufactured multiple cryopreserved products with viability, purity and TCR positivity comparable to our prior process.

Completed full prepayment of amended loan and security agreement with Silicon Valley Bank (SVB): In May 2023, Alaunos fully prepaid the remaining amounts owed under its term loan with SVB, which was $11.0 million as of March 31, 2023. With no remaining obligations due to SVB, the restricted cash balance of $13.9 million as of March 31, 2023, has also been released.

Amended exclusive license agreement with Precigen, Inc.; Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations: In April 2023, Alaunos amended its exclusive license agreement with Precigen. Under the terms of the amended agreement, Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations, while Precigen regains the rights to its CAR-T and IL-12 assets. The amended agreement eliminated all commercial sales-based royalties and milestone obligations, in alignment with Alaunos’ focus on its priority TCR-T programs.

Expanded infrastructure of hunTR TCR discovery platform to increase throughput; expect to add three new TCRs in 2023: In the first quarter of 2023, Alaunos significantly increased the throughput potential of its hunTR TCR discovery platform to further accelerate TCR discovery and validation. New lab equipment and advanced bioinformatics capabilities have multiplied the screening throughput while maintaining a high success rate of TCR discovery. The Company expects to add three new TCRs to its library, potentially bringing the total number of unique TCRs to 15 by the end of 2023.

Appointed Robert Hofmeister, PhD, MS, to Board of Directors: In March 2023, Alaunos appointed Robert J. Hofmeister, PhD, MS, to the Company’s board of directors. Dr. Hofmeister brings deep expertise in the discovery and development of engineered T-cell receptor therapies as well as a background in cellular immunology and translational science. He is currently Chief Scientific Officer of a stealth early-stage biotechnology company and was most recently Chief Scientific Officer at TCR2 Therapeutics.

First Quarter Ended March 31, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $6.5 million for the first quarter of 2023, compared to $5.6 million for the first quarter of 2022, an increase of approximately 17%. The increase was primarily due to incremental manufacturing activities related to the TCR-T Library Phase 1/2 trial and hunTR research efforts of $1.7 million, partially offset by a $0.7 million decrease in employee-related expenses.

General and Administrative Expenses: General and administrative expenses were $3.2 million for the first quarter of 2023, compared to $3.5 million for the first quarter of 2022, a decrease of approximately 10%. The decrease was primarily due to lower professional fees of $0.2 million.

Net Loss: Net loss was $10.0 million, or $(0.04) per share, for the first quarter of 2023, compared to a net loss of $9.8 million, or $(0.05) per share, for the first quarter of 2022.

Cash, Cash Equivalents and Restricted Cash: As of March 31, 2023, Alaunos had approximately $37.4 million in cash balances, which included restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating outflows, excluding debt service costs, for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into the fourth quarter of 2023.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, May 10, 2023, at 9:00 a.m. ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The event will be archived on the Company’s website for approximately 30 days after the call.