Spyre Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 7, 2024
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001636282-24-000037
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0001636282-24-000051
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
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A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (379)
Current report
Investing in our Common Stock involves a high degree of risk. Before you decide to invest in our common stock, you should consider carefully the risks described below, together with the other information contained in this Quarterly Report, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed financial statements and related notes. We believe the risks described below are the risks that are material to us as of the date of this Quarterly Report. If any of the following risks actually occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. In these circumstances, the market price of our Common Stock could decline, and you may lose all or part of your investment.
Current report
Below is a summary of the material risks to our business, our operations and an investment in our common stock. This summary does not address all of the risks that we face. Risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below and should be carefully considered, together with other information in this Quarterly Report in its entirety before making investment decisions regarding our common stock.
Current report
Risks Related to Our Financial Condition and Capital Requirements
Current report
•We will not be able to continue as a going concern if we are unable to raise additional capital when needed.
Current report
•We have never generated any revenue from product sales and may never be profitable.
Current report
•We anticipate that we will continue to incur significant losses for the foreseeable future.
Current report
•We may not be able to raise the capital that we need to support our business plans and raising additional capital may cause dilution to our stockholders and restrict our operations.
Current report
Risks Related to the Discovery, Development and Commercialization
Current report
•We face competition from companies that have developed or may develop competing programs.
Current report
•Our programs are in clinical and nonclinical stages of development and may fail or suffer delays.
Current report
•We are substantially dependent on the success of the SPY001,SPY002 and SPY003 programs.
Current report
•We may fail to achieve our projected development goals in the time frames we announce and expect.
Current report
•Any drug delivery device used may have its own regulatory development, supply, and other risks.
Current report
•We may not be successful in building a pipeline of product candidates with commercial value.
Current report
•Our studies and trials may be insufficient to support regulatory approval of any of our product candidates.
Current report
•We have limited experience in developing and commercializing diagnostics.
Current report
•Additional time may be required to obtain regulatory approval for our product candidates and future product candidates because of their status as combination products.
Current report
•If we are not successful in discovering, developing and commercializing our investigational products to achieve superior outcomes relative to the use of monotherapies or other combination therapies, our ability to achieve our strategic objectives would likely be impaired.
Current report
•Development of combination therapies may present more or different challenges than other therapies.
Current report
•We may encounter difficulties enrolling participants in our future clinical trials.
Current report
•Preliminary or “topline” data from our clinical trials may change as more data becomes available.
Current report
•Our current or future clinical trials may reveal significant adverse events or undesirable side effects.
Current report
•We may fail to capitalize on more profitable or potentially successful product candidates.
Current report
•Our current or future products may not achieve regulatory approval, market acceptance or commercial success.
Current report
•Some of our programs may compete with our other programs.
Current report
•The FDA may not accept data from clinical trials we conduct at sites outside the United States.
Current report
•FDA and comparable foreign regulatory approval processes are lengthy and time-consuming and we may not be able to obtain or may be delayed in obtaining regulatory approvals for our product candidates.
Current report
•We may not be able to meet requirements for chemistry, manufacturing and control of our programs.
Current report
•Our product candidates may face competition sooner than anticipated based on rules and regulations that may apply or government decisions with respect to our intellectual property.
Current report
•Even if we receive regulatory approval, we will be subject to extensive ongoing regulatory obligations.
Current report
•We may face difficulties from healthcare and other legislative reform measures.
Current report
•Our operations and arrangements with third-parties are subject to healthcare regulatory laws.
Current report
•We may be unable to offer products at competitive prices due to unfavorable regulations and/or policies.
Current report
•We may face criminal liability or other consequences if we violate U.S. and foreign trade regulations.
Current report
•Foreign governments may impose strict price controls, which may adversely affect our potential revenue.
Current report
•Any accelerated review designations we may pursue may not hasten development or regulatory review.
Current report
•Our ability to obtain and protect our patents and other proprietary rights is uncertain.
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Removed paragraphs (1)
Previous report
There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023 and in our registration statement on Form S-1 filed with the SEC on April 19, 2024 (the “Form S-1”). For a detailed description of our risk factors, refer to Part I, Item IA, “Risk Factors” of our Annual Report and the section titled “Risk Factors” of our Form S-1.