Business description of GALECTO-INC from last 10-k form

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We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.

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We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.

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Our business is highly dependent on the success of our product candidates, GB0139, GB1211 and GB2064, as well as any other product candidates that we advance into the clinic. All of our product candidates may require significant additional preclinical and clinical development before we may be able to seek regulatory approval for and launch a product commercially.

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We are modifying the protocol of our Phase 2b clinical trial of GB0139 and such modification may not be satisfactory to regulatory agencies, institutional review boards, the data monitoring safety board or patients, or otherwise allow us to conduct a successful trial.

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If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected, and these delays may cause us to reprioritize our planned trials and use of funds for planned trials.

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Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our earlier clinical trials, if any, or preclinical studies.

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The design or execution of our ongoing and future clinical trials may not support marketing approval.

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We may not be successful in our efforts to identify or discover additional product candidates in the future.

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We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

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Even if we obtain approval by the U.S. Food and Drug Administration of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.

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Obtaining and maintaining our patent protection depends on compliance with document submission, fee payment and various other procedural requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

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We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.

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The global pandemic of the novel coronavirus disease, COVID-19, has, and may continue to, adversely impact our business, including delays to our preclinical studies and clinical trials and these delays may cause us to reprioritize our planned trials and the use of funds for planned trials.

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There has been no prior public market for our common stock, the stock price of our common stock may be volatile or may decline regardless of our operating performance and you may not be able to resell your shares at or above the initial public offering price.

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If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

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the success, cost and timing of our product development activities and planned initiation and completion of clinical trials of our lead product candidate, GB0139, including our ability to enroll patients in our ongoing Phase 2b randomized, double-blind placebo-controlled clinical trial of GB0139 at anticipated rates and our ability to complete such trial with fewer dosage groups;