On May 13, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company developing tumor infiltrating lymphocytes, or TIL, therapies for the treatment of patients with cancer, reported its first quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2021, View Source [SID1234583996]).

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"In March of 2021, Instil completed an initial public offering to support the development of our TIL therapies. We believe that our continued investment in cell manufacturing and process science will enable the development of our current and future product candidates, with a goal of providing broad patient access," said Bronson Crouch, Chief Executive Officer of Instil. "We recently presented clinical data from our compassionate use program at the AACR (Free AACR Whitepaper) conference and received orphan drug designation from the U.S. Food and Drug Administration for ITIL-168 in melanoma. We continue to advance ITIL-168 towards a potentially registration-enabling Phase 2 clinical trial in advanced melanoma, which we expect to initiate in the second half of this year."

First Quarter 2021 Highlights and Upcoming Anticipated Milestones

Corporate:

Completed Initial Public Offering: On March 23, 2021, Instil closed its initial public offering of 18,400,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,400,000 shares of common stock at the public offering price of $20.00 per share. The gross proceeds of the offering were $368 million, before underwriting discounts and commissions and other offering expenses payable by Instil. The Company’s common stock now trades on the Nasdaq Global Select Market under the symbol "TIL."
Clinical and Regulatory:

Orphan Drug Designation for ITIL-168: On April 27, 2021 Instil received orphan drug designation from the U.S. Food and Drug Administration for the treatment of melanoma stages IIB to IV for its ITIL-168 TIL product candidate.
American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting: Presented late-breaking e-Poster on clinical data from a compassionate use program for the treatment of metastatic melanoma at the AACR (Free AACR Whitepaper) virtual meeting April 10 – 15, 2021.
Upcoming Phase 2 Clinical Trial: Instil expects to initiate a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma and begin enrolling patients in the second half of 2021.
Manufacturing:

Facility Readiness for Clinical Trials: Manufacturing facilities in the United Kingdom are functional and ready to support clinical manufacturing for the upcoming ITIL-168 clinical trial, with additional capacity expected to come online later this year. Instil also expects U.S. clinical manufacturing to be online in the first half of 2022.
First Quarter 2021 Financial and Operating Results

As of March 31, 2021, cash and cash equivalents totaled $609.6 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of March 31, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $2.0 million for the same period in 2020.

General and administrative expenses for the three months ended March 31, 2021 were $9.0 million, compared to $1.9 million for the same period in 2020.