Instil Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
- None.
- Net loss per share increased from $8.29 in Q4 2022 to $24.00 in Q4 2023, and from $34.46 in full year 2022 to $24.00 in full year 2023.
- Restructuring and impairment charges significantly rose from $23.2 million in Q4 2022 to $72.0 million in Q4 2023.
- Research and development expenses decreased from $141.1 million in full year 2022 to $39.6 million in full year 2023.
- General and administrative expenses reduced from $62.2 million in full year 2022 to $47.6 million in full year 2023.
Instil Bio's financial results highlight a strategic pivot in their operations, with a significant reduction in research and development (R&D) expenses from $141.1 million in the previous year to $39.6 million. This could suggest a narrowing of focus or a scaling back of their pipeline, which investors typically interpret as a cost-saving measure or a sign of maturing product development stages. The closure of UK manufacturing and cessation of ITIL-306 clinical trial activities may raise concerns about the company's future revenue streams and product portfolio diversification.
The company's cash runway projection beyond 2026 indicates a comfortable liquidity position, potentially reducing the immediate risk of dilutive financing rounds. However, the drop in cash and cash equivalents from $43.7 million to $9.2 million year-over-year could be a point of concern, indicating a high burn rate that investors should monitor closely.
Instil's use of non-GAAP financial measures can be useful for investors to assess the company's operational performance by excluding non-recurring items. However, it's important for stakeholders to consider these alongside GAAP measures to get a full picture of financial health, as non-GAAP measures can sometimes obscure the impact of significant expenses.
The strategic collaboration in China to develop an autologous folate receptor α (FRα)-CoStAR enhanced TIL for non-small cell lung cancer is a positive move, tapping into one of the largest pharmaceutical markets. If successful, this collaboration could provide a significant competitive advantage and open up new revenue streams. However, the success of such collaborations is uncertain and the actual impact on the company's bottom line may take time to materialize.
Exploring opportunities to in-license or acquire novel therapeutic candidates is a common strategy to bolster a company's pipeline, particularly in areas with unmet medical needs. This approach can lead to rapid portfolio expansion and diversification, but it also comes with the risks associated with clinical development and regulatory hurdles.
The financial results also reflect a substantial decrease in net loss per share year-over-year, which may be viewed positively by the market as an indicator of improving operational efficiency. Nonetheless, the long-term impact of these changes on the stock's performance will largely depend on the successful commercialization of their product candidates and the company's ability to manage its operational expenses.
Instil Bio's decision to discontinue the ITIL-306 clinical trial and close its UK manufacturing operations could signal a strategic refocusing. For stakeholders in the biotech sector, such moves are indicative of a company prioritizing its resources towards more promising avenues or cutting losses on less successful ventures. The biotech industry is known for its high-risk, high-reward nature and Instil's restructuring efforts appear to be an attempt to mitigate risks and conserve capital.
While the company's cash runway is expected to extend beyond 2026, the biotech industry is capital-intensive and the ability to sustain operations without additional financing is a critical factor. Instil's current financial position may allow them to weather the high costs associated with clinical trials and the development of their pipeline without the immediate need for additional capital raises, which is generally a positive sign for investors.
It's also important to note the potential impact of the announced strategic collaboration in China. The Chinese market has a high incidence of non-small cell lung cancer and a successful trial could lead to significant market penetration. However, regulatory and market access challenges in China should not be underestimated.
DALLAS, March 21, 2024 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today reported its fourth quarter and full year 2023 financial results and provided a corporate update.
Recent Highlights:
- Announced entering into a strategic collaboration to develop an autologous folate receptor α (FRα)-CoStAR enhanced TIL for a potential investigator-initiated trial (IIT) in non-small cell lung cancer in China
- Announced a strategic update to the ITIL-306 program, including closure of Instil’s UK manufacturing and cessation of ITIL-306 clinical trial activities
- Exploring opportunities to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need
- Cash runway expected beyond 2026
Fourth Quarter and Full Year 2023 Financial and Operating Results:
As of December 31, 2023, Instil had
Research and development expenses were
General and administrative expenses were
Restructuring and impairment charges were
Net loss per share, basic and diluted were
Note Regarding Use of Non-GAAP Financial Measures
In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding restructuring and impairment charges and non-cash stock-based compensation expense. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.
About Instil Bio
Instil Bio Inc. (Nasdaq: TIL) is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil seeks to in-license/acquire and develop novel therapeutic candidates in diseases with significant unmet medical need. For more information visit www.instilbio.com.
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,” “future,” “intends,” “may,” “plans,” “potential,” “projects,” “exploring” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying our ability to acquire and develop new product candidates with compelling data, the therapeutic potential of our product candidates, our research, development and regulatory plans for our product candidates, including the timing of our ongoing and potential future preclinical studies and future clinical trials and the availability of data therefrom, our expectations concerning the closure of our UK manufacturing and clinical operations and the related reduction in force and the benefits thereof, expectations concerning our collaboration and the generation of preclinical and clinical data therefrom, our expectations regarding our capital position, resources, and balance sheet, and the potential impact thereof on development of any product candidates, and other statements that are not historical fact. 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, including risks and uncertainties associated with acquiring product candidates, the costly and time-consuming product development process and the uncertainty of clinical success; the risks inherent in successfully manufacturing cell therapy products and relying on collaborators and other third parties for manufacturing; the risks and uncertainties related to successfully initiating, enrolling, completing and reporting data from clinical studies, including a collaborator-led IIT in China, as well as the risks that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials and that our product candidates may otherwise not be effective treatments in their planned indications; risks associated with reliance on third-party collaborators, and our ability to achieve the expected benefits of the closure of our UK manufacturing and clinical operations; risks related to macroeconomic conditions, including as a result of international conflicts, U.S.-China trade and political tensions, interest rates, inflation, and other factors, which could materially and adversely affect our business and operations; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process and the sufficiency of our cash resources; and other risks and uncertainties affecting Instil and our plans and development programs, including those discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 to be filed with the SEC, as well as our other filings with the SEC. Additional information will be made available in other filings that we make from time to time with the SEC. 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. These forward-looking statements speak only as the date hereof, and we disclaim any obligation to update these statements except as may be required by law.
Contacts:
Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com
| INSTIL BIO, INC. SELECTED FINANCIAL DATA (Unaudited; in thousands, except share and per share amounts) Consolidated Statements of Operations | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 1,983 | $ | 20,722 | $ | 39,604 | $ | 141,056 | |||||||
| General and administrative | 10,872 | 12,910 | 47,553 | 62,235 | |||||||||||
| Restructuring and impairment charges | 165 | 23,167 | 72,012 | 23,167 | |||||||||||
| Total operating expenses | 13,020 | 56,799 | 159,169 | 226,458 | |||||||||||
| Loss from operations | (13,020 | ) | (56,799 | ) | (159,169 | ) | (226,458 | ) | |||||||
| Interest income | 2,195 | 1,796 | 8,866 | 3,655 | |||||||||||
| Interest expense | (1,980 | ) | (745 | ) | (5,209 | ) | (1,883 | ) | |||||||
| Other (expense) income, net | (120 | ) | 1,299 | (575 | ) | (564 | ) | ||||||||
| Loss before income tax benefit | (12,925 | ) | (54,449 | ) | (156,087 | ) | (225,250 | ) | |||||||
| Income tax benefit | — | 605 | — | 2,073 | |||||||||||
| Net loss | $ | (12,925 | ) | $ | (53,844 | ) | $ | (156,087 | ) | $ | (223,177 | ) | |||
| Net loss per share, basic and diluted | $ | (1.99 | ) | $ | (8.29 | ) | $ | (24.00 | ) | $ | (34.46 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 6,503,913 | 6,493,641 | 6,503,913 | 6,475,631 | |||||||||||
| Selected Consolidated Balance Sheet Data | |||||
| December 31, 2023 | December 31, 2022 | ||||
| Cash, cash equivalents, restricted cash, marketable securities and long-term investments | $ | 175,018 | $ | 260,920 | |
| Total assets | $ | 325,630 | $ | 482,128 | |
| Total liabilities | $ | 99,801 | $ | 118,523 | |
| Convertible preferred stock and stockholders’ equity | $ | 225,829 | $ | 363,605 | |
| Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited; in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Net loss | $ | (12,925 | ) | $ | (53,844 | ) | $ | (156,087 | ) | $ | (223,177 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense | 4,553 | 6,643 | 18,166 | 30,441 | |||||||||||
| Restructuring and impairment charges | 165 | 23,167 | 72,012 | 23,167 | |||||||||||
| Non-GAAP net loss | $ | (8,207 | ) | $ | (24,034 | ) | $ | (65,909 | ) | $ | (169,569 | ) | |||
| Net loss per share, basic and diluted | $ | (1.99 | ) | $ | (8.29 | ) | $ | (24.00 | ) | $ | (34.46 | ) | |||
| Adjustments: | |||||||||||||||
| Non-cash stock-based compensation expense per share | 0.70 | 1.02 | 2.79 | 4.70 | |||||||||||
| Restructuring and impairment charges | 0.03 | 3.57 | 11.07 | 3.58 | |||||||||||
| Non-GAAP net loss per share, basic and diluted* | $ | (1.26 | ) | $ | (3.70 | ) | $ | (10.14 | ) | $ | (26.18 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 6,503,913 | 6,493,641 | 6,503,913 | 6,475,631 | |||||||||||
* Non-GAAP net loss per share, basic and diluted may not total due to rounding.
FAQ
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