TIL Instil Bio Inc.

18.13
-0.51  -3%
Previous Close 18.64
Open 18.7
52 Week Low 14.42
52 Week High 29.49
Market Cap $2,334,112,820
Shares 128,743,123
Float 16,346,952
Enterprise Value $1,710,312,076
Volume 226,180
Av. Daily Volume 326,992
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Drug Pipeline

Drug Stage Notes
ITIL-168
Melanoma
Phase 2
Phase 2
Data presented at AACR April 10, 2021 noted 67% overall response rate and 19% complete response rate. Phase 2 trial to commence 2H 2021.

Latest News

  1. DALLAS, June 01, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced that management will present a company overview at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 9:30 a.m. ET.

    A live webcast of the presentation may be accessed at: https://wsw.com/webcast/jeff174/til/1707183 or by visiting the News & Events section of the Instil Bio website at www.instilbio.com. An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About Instil Bio

    Instil Bio, Inc…

    DALLAS, June 01, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced that management will present a company overview at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 9:30 a.m. ET.

    A live webcast of the presentation may be accessed at: https://wsw.com/webcast/jeff174/til/1707183 or by visiting the News & Events section of the Instil Bio website at www.instilbio.com. An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. Instil has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Contacts:

    Investor Relations

    1-972-499-3350



    www.instilbio.com



    Brendan Payne

    Stern Investor Relations

    1-212-362-1200





     



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  2. IPO in March 2021 raising $368M in gross proceeds

    Received orphan drug designation from the U.S. FDA for lead product candidate ITIL-168

    DALLAS, May 13, 2021 (GLOBE NEWSWIRE) -- 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, today reported its first quarter 2021 financial results and provided a corporate update.

    "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…

    IPO in March 2021 raising $368M in gross proceeds

    Received orphan drug designation from the U.S. FDA for lead product candidate ITIL-168

    DALLAS, May 13, 2021 (GLOBE NEWSWIRE) -- 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, today reported its first quarter 2021 financial results and provided a corporate update.

    "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 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) 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 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.



    INSTIL BIO, INC.

    SELECTED FINANCIAL DATA

    (Unaudited; in thousands, except share and per share amounts)

    Statements of Operations

     Three months ended March 31,
     2021 2020
    Revenue$  $44 
    Operating expenses:   
    Research and development14,424  2,007 
    General and administrative8,979  1,900 
    Total operating expenses23,403  3,907 
    Loss from operations(23,403) (3,863)
    Interest and other income (expense), net71  (226)
    Loss before income tax expense$(23,332) $(4,089)
    Income tax benefit204   
    Net loss$(23,128) $(4,089)
    Net loss per share, basic and diluted(0.66) (0.31)
    Weighted-average shares used in computing net loss per share, basic and

    diluted
    34,976,652  12,997,353 



    Selected Balance Sheet Data

     March 31, 2021 December 31, 2020
    Cash and cash equivalents$609,639  $241,714 
    Total assets696,142  319,012 
    Total liabilities30,989  26,645 
    Total stockholders' equity (deficit)665,153  (39,599)



    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, and the potential benefits of orphan drug designation to ITIL-168. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our prospectus dated March 18, 2021, as filed with the SEC on March 22, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts:

    Investor Relations Contact:

    Brendan Payne

    Stern Investor Relations

    1-972-499-3350



    www.instilbio.com

    Media Contact:

    1-833-446-7845 Ext. 1009



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  3. DALLAS, April 27, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL) received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy.

    "The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.

    Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon…

    DALLAS, April 27, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL) received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV with its ITIL-168 TIL therapy.

    "The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation," said Bronson Crouch, Chief Executive Officer of Instil.

    Orphan Drug Designation confers potential benefits to sponsors, including tax credits for qualified clinical testing, waiver of BLA user fees, and eligibility of market exclusivity for 7 years upon marketing approval.

    About ITIL-168

    ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. ITIL-168 is manufactured with Instil's proprietary, optimized, and scalable manufacturing process, which has been designed to capture and preserve the maximum diversity of each patient's TILs; the manufacturing process also offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. Instil plans to investigate ITIL-168 in a global phase 2 trial in advanced melanoma in 2021 and additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, and the potential benefits of orphan drug designation to ITIL-168. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our prospectus dated March 18, 2021, as filed with the SEC on March 22, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts

    Investor Relations Contact:

    1-972-499-3350



    www.instilbio.com

    Media Contact:

    1-833-446-7845 Ext. 1009

     



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  4. 67% overall response rate and 19% complete response rate in 21 patients

    All complete responders remained in remission at time of data cut-off

    DALLAS, April 12, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, presented clinical data from a compassionate use program for the treatment of metastatic melanoma at the American Association for Cancer Research (AACR) virtual meeting April 10 – 15, 2021. The presentation abstract and additional information is available on the AACR conference web site at www.aacr.org.

    "Despite the recent advances in immunotherapy…

    67% overall response rate and 19% complete response rate in 21 patients

    All complete responders remained in remission at time of data cut-off

    DALLAS, April 12, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, presented clinical data from a compassionate use program for the treatment of metastatic melanoma at the American Association for Cancer Research (AACR) virtual meeting April 10 – 15, 2021. The presentation abstract and additional information is available on the AACR conference web site at www.aacr.org.

    "Despite the recent advances in immunotherapy for solid tumors, many patients do not receive clinical benefit or experience relapse after an initial remission," said Robert Hawkins, MBBS FRCP, PhD, Chief Strategy Advisor to Instil and presenting study author. "In this compassionate use setting in which patients had exhausted all other available therapies, a one-time treatment with TILs was able to induce a remission in more than half of the treated patients."

    "This presentation highlights the potential for ITIL-168 to produce deep and durable remissions in patients with advanced melanoma," said Bronson Crouch, Chief Executive Officer of Instil. "We eagerly anticipate beginning a global Phase 2 clinical trial investigating ITIL-168 for the treatment of advanced melanoma later this year."

    In this compassionate use program, 21 patients with stage IV cutaneous melanoma were treated between 2011 and 2019 at the Christie Hospital in Manchester, United Kingdom with TILs manufactured by Instil. All TIL products were generated in Instil's company-operated, in-house manufacturing facilities in Manchester.

    Among the 21 patients, 14 (67%) achieved an objective response, with four (19%) achieving a complete response. All complete responders remained in remission at the time of data cutoff with those remissions ranging in duration from 30 months to over 80 months from TIL infusion. With a median duration of follow-up of 52.2 months, the median overall survival was 21.3 months with nearly half of patients experiencing long term survival. Side effects of treatment were largely transient, self-limited and generally attributable to the lymphodepleting chemotherapy regimen and post-TIL IL-2 treatment.

    The company plans to submit these results for peer-reviewed publication in 2021.

    Instil expects to begin a Phase 2 trial of ITIL-168 in advanced melanoma patients in the second half of 2021. The company anticipates obtaining topline safety and efficacy data in 2023, which could support the submission of a BLA to the FDA in 2023 and a Marketing Authorization Application to the European Medicines Agency in 2024.

    Poster Information:

    Title: Clinical Feasibility and Treatment Outcomes with Unselected Autologous Tumor Infiltrating Lymphocyte Therapy in Patients with Advanced Cutaneous Melanoma

    Session Type: E-Poster Session

    Session Title: Adoptive Cell Therapy

    Abstract Number: LB150

    About ITIL-168

    ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. ITIL-168 is manufactured with Instil's proprietary, optimized, and scalable manufacturing process, which has been designed to capture and preserve the maximum diversity of each patient's TILs; the manufacturing process also offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. Instil plans to investigate ITIL-168 in a global phase 2 trial in advanced melanoma in 2021 and additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings,  including in our prospectus dated March 18, 2021, as filed with the  SEC on March 22, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts

    Investor Relations Contact:

    1-972-499-3350

     

    www.instilbio.com 

    Media Contact:

    Jennifer Fox

    1-833-446-7845 Ext. 1009

     



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  5. DALLAS, March 23, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil"), a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, today announced the closing of its previously announced 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, before underwriting discounts and commissions and other offering expenses payable by Instil, are approximately $368.0 million. Instil's common stock is listed on the Nasdaq Global Select…

    DALLAS, March 23, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil"), a clinical-stage biopharmaceutical company focused on developing an innovative cell therapy pipeline of autologous TIL therapies for the treatment of patients with cancer, today announced the closing of its previously announced 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, before underwriting discounts and commissions and other offering expenses payable by Instil, are approximately $368.0 million. Instil's common stock is listed on the Nasdaq Global Select Market under the ticker symbol "TIL."

    Morgan Stanley, Jefferies and Cowen acted as joint book-running managers for the offering. Truist Securities acted as lead manager for the offering.

    The offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at ; Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by emailing ; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (833) 297-2926 or by email at .

    A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Contacts

    Investor Relations Contact:



    www.instilbio.com

    1-972-499-3350

    Media Contact:

    Jennifer Fox

    1-833-446-7845 Ext. 1009



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