Earning Date, Transcript Summary & Report

Positive Point: Alaunos Therapeutics has demonstrated meaningful clinical responses in its TCR-T cell therapy, with the first patient treated showing positive results, indicating potential to bring hope to patients with high unmet clinical needs.

• Enrollment has been accelerated in comparison to the prior year, highlighting the enthusiasm shared by prospective patients.
• Enhanced screening, enrollment, and manufacturing protocols have been implemented, leading to faster patient accrual.
• Implementation of cryopreservation in the manufacturing process has increased flexibility for patient scheduling and treatment without compromising product quality.
• Alaunos aims to report interim results, including new data from multiple patients, in the third quarter of 2023, demonstrating progress towards important clinical milestones.

Positive Point: The company has strengthened its balance sheet through important financial and corporate steps, positioning itself as a Phase 2-ready company by the end of 2023.

• Full prepayment of the loan with Silicon Valley Bank eradicates debt obligations, enabling Alaunos to move forward unencumbered.
• Amended agreement with Precigen eliminates royalty and milestone obligations, potentially saving over $160 million, and unencumbers TCR-T assets, maximizing shareholder value and facilitating partnering discussions.
• Addition of Robert Hoffmeister to the Board of Directors brings expertise in cancer immunology and TCR therapies, enhancing the company's position in the field.
• Strategic financial decisions allow Alaunos to protect cash reserves and focus on advancing TCR platform targeting solid tumors.

Positive Point: Alaunos is making significant progress in expanding its industry-leading library of TCRs through the Hunter platform, aiming to increase the addressable market for therapeutic candidates.

• Hunter platform facilitates the discovery of proprietary TCRs targeting more HLAs and mutations, potentially delivering effective treatments to a larger number of patients.
• Expanded infrastructure for the Hunter platform increases throughput of TCR discovery, with new bioinformatics capabilities and advanced lab equipment improving screening rates.
• Rapid and high-throughput approach to generating TCRs enhances the value of the company's pipeline and may lead to out-licensing or partnering opportunities, potentially resulting in non-dilutive capital.
• Alaunos expects to grow the TCR library to 15 total TCRs this year, demonstrating a commitment to expanding the scope and potential impact of its TCR-T cell therapy.

Positive Point: Alaunos remains intentional with its capital utilization, making valuable investments to fulfill commitments to patients and create value for shareholders.

• Despite a net loss reported for the first quarter of 2023, Alaunos maintains confidence in its disruptive technology and unique science being recognized by investors.
• Operating cash burn aligns with expectations, reflecting increased manufacturing activities due to active enrollment in the TCR-T library Phase 1/2 trial.
• Elimination of the term loan with Silicon Valley Bank provides operational control over cash, releasing a restricted cash balance back to the company and eliminating additional interest expenses.
• Investor engagement in the biotech capital markets remains encouraging, with follow-on transactions outpacing the same period last year, indicative of support for companies with differentiated science like Alaunos.

Positive Point: The company is on track to revolutionize the treatment of solid tumors by weaponizing the immune system with powerful TCRs, demonstrating building momentum and interest in its TCRT platform.

• Encouraging translational data will be shared at the ASCO Annual Meeting, including safety, persistence, and efficacy data, illustrating the progress made in identifying new TCRs and strengthening the IP position.
• Alaunos has a dedicated team committed to producing therapies for patients in need, with multiple products manufactured simultaneously and a focus on generating partnering opportunities and increasing the addressable market through the Hunter platform.
• The company's disruptive technology has the potential to bring transformative changes to cancer treatment paradigms, instilling great confidence in the value of the TCR-T cell therapy developed by Alaunos.

Negative:

• Net loss increased from $9.8 million in Q1 2022 to $10 million in Q1 2023, resulting in a $0.04 net loss per share.
• Research and development expenses rose by 17% from $5.6 million in Q1 2022 to $6.5 million in Q1 2023, primarily due to increased manufacturing and TCR discovery activities.
• General and administrative expenses decreased by 10% from $3.5 million in Q1 2022 to $3.2 million in Q1 2023, indicating potential cost-cutting measures but still resulting in overall loss.
• Operating cash burn increased from $7.8 million in Q1 2022 to $9.4 million in Q1 2023, reflecting the active enrollment of patients in the TCR-T library Phase 1/2 trial.
• Despite optimistic statements about progress and momentum, the financial outlook remains uncertain with a projected operating cash outflow of $35-40 million for 2023.