We are a clinical-stage biopharmaceutical company developing an innovative cell therapy pipeline of autologous tumor infiltrating lymphocyte, or TIL, therapies to treat patients with cancer. We are advancing our lead TIL product candidate, ITIL-168, to treat advanced melanoma. We plan to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration and, if authorized to proceed, initiate a Phase 2 trial in the second half of 2021. We anticipate obtaining topline safety and efficacy data in 2023. This Phase 2 trial, if successful, has the potential to support a biologics license application (BLA) submission in 2023. We plan to initiate Phase 1 trials of ITIL-168 in additional indications with unmet medical need, including cutaneous squamous cell carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma and cervical cancer, in the first half of 2022. ITIL-168 will be manufactured in our company-operated facilities for our clinical trials and commercial sale, if approved.

We are also developing a novel class of genetically engineered TIL therapies using our Co-Stimulatory Antigen Receptor, or CoStAR, platform. These modified TILs still rely on their native patient-specific T cell receptors (TCRs) to bind to tumor neoantigens, but have been enhanced to express novel CoStAR molecules, which bind to shared tumor-associated antigens and provide potent costimulation to T cells within the microenvironment. This approach has the potential to bring TIL therapy to patients with cancer types that have been historically resistant to immunotherapy. We anticipate submitting an IND for our lead CoStAR-TIL product candidate, ITIL-306, in the first half of 2022.

(Note: Instil Bio priced its upsized IPO on March 18, 2021, in line with its upsized terms filed earlier on that date in an S-1/A: 16 million shares were priced at $20 – the top of its new $19-to-$20 range – to raise $320 million. In its SEC filing on March 18, Instil Bio increased the number of shares to 16 million from 13.9 million, and raised the price range to $19 to $20, up from $17 to $19 initially.)