On November 13, 2024 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel cancer therapies, reported its third quarter 2024 financial results and provided a corporate update (Press release, Instil Bio, NOV 13, 2024, View Source [SID1234648278]).

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"Our recent license of SYN-2510 is a significant milestone for Instil, positioning us with a potentially best-in-class asset in one of the most significant areas of interest in oncology," said Bronson Crouch, CEO of Instil. "As we continue to build our internal team to operationalize the clinical development of SYN-2510, we are excited for the progress ImmuneOnco continues to make in advancing the program in its China trials."

Recent Highlights:

In-licensed SYN-2510/IMM2510 and SYN-27M/IMM27M: In August 2024, SyntBioTx, Inc., a wholly owned subsidiary of Instil, entered into a license and collaboration agreement with ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco") to in-license global development and commercialization rights outside of Greater China for SYN-2510/IMM2510, a potential best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M/IMM27M, a next-generation ADCC-enhanced CTLA-4 antibody. For SYN-2510/IMM2510, ImmuneOnco has identified a recommended Phase 2 monotherapy dose of 20 mg/kg Q2W, and is continuing patient enrollment in China to support dose optimization and dose expansion in multiple solid tumor cancers.
Clinical data update for SYN-2510/IMM2510 in China anticipated in 1H 2025: ImmuneOnco expects to provide a clinical data update for SYN-2510/IMM2510 monotherapy in multiple solid tumors in China in the first half of 2025. Approximately 65 additional patients have been dosed with SYN-2510/IMM2510 monotherapy in addition to the initial 33 patients reported in ImmuneOnco’s ASCO (Free ASCO Whitepaper) 2024 publication.
Initiation of Phase 1b/2 IMM2510/SYN-2510 studies expected in late 2024 and 1H 2025 in China by ImmuneOnco: Instil and ImmuneOnco announced in September 2024 that ImmuneOnco is accelerating clinical development of IMM2510/SYN-2510 into phase 1b/2 studies in China. IMM2510/SYN2510 will be administered in combination with chemotherapy in first-line NSCLC and TNBC, with anticipated start dates in late 2024 and 1H 2025, respectively.
U.S. clinical study of SYN-2510 in NSCLC targeted initiation in 2H 2025: Instil is targeting initiation of a U.S. study of SYN-2510 in NSCLC in 2H 2025.
Clinical update for SYN-27M/IMM27M in breast cancer from ImmuneOnco: Today, ImmuneOnco announced initial clinical results for patients with estrogen receptor positive (ER+) advanced breast cancer treated in the Phase 1 dose escalation of SYN-27M/IMM27M and the initiation of a Phase 2 clinical trial of SYN-27M/IMM27M for patients with ER+ breast cancer that failed after endocrine therapy or have recurred. Additionally, patient enrollment continues in the dose escalation study of the combination of SYN-27M/IMM27M and SYN-2510/IMM2510.
Third Quarter 2024 Financial and Operating Results:

As of September 30, 2024, Instil had cash, cash equivalents, marketable securities and long-term investments of $122.9 million, which consisted of $6.7 million in cash and cash equivalents, $113.7 million in marketable securities, and $2.6 million in long-term investments, compared to $175.0 million in cash, cash equivalents, marketable securities and long-term investments as of December 31, 2023, consisting of $9.2 million in cash and cash equivalents, $1.5 million in restricted cash, $141.2 million in marketable securities, and $23.2 million in long-term investments. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of September 30, 2024 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were $10.0 million for both the three and nine months ended September 30, 2024, compared to nil for both the three and nine months ended September 30, 2023.

Research and development expenses were $0.6 million and $10.7 million for the three and nine months ended September 30, 2024, respectively, compared to $8.5 million and $37.6 million for the three and nine months ended September 30, 2023, respectively.

General and administrative expenses were $10.7 million and $33.8 million for the three and nine months ended September 30, 2024, respectively, compared to $11.9 million and $36.7 million for the three and nine months ended September 30, 2023, respectively.

Restructuring and impairment charges were $2.4 million and $7.1 million for the three and nine months ended September 30, 2024, respectively, compared to $46.3 million and $71.8 million for three and nine months ended September 30, 2023, respectively.

Net loss per share, basic and diluted were $3.54 and $9.57 for the three and nine months ended September 30, 2024, respectively, compared to $10.37 and $22.01 for the three and nine months ended September 30, 2023, respectively. Non-GAAP net loss per share, basic and diluted, were $2.55 and $6.51 for the three and nine months ended September 30, 2024, respectively, compared to $2.53 and $8.87 for the three and nine months ended September 30, 2023, respectively.