Business description of SCHOLAR-ROCK-HOLDING-CORP from last 10-k form

 

 

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the success, cost and timing of clinical trials for SRK-015, including the timing of completion of our Phase 1 clinical trial, and initiation, progress and completion of our Phase 2 clinical trial and future clinical trials for SRK‑015, and the results from these trials;

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the success, cost and timing of our other product development activities, preclinical studies and clinical trials, including for SRK-181, a recently announced product candidate for the treatment of cancers resistant to checkpoint blockade therapies, or CBTs, and the timing of the availability of the results of these studies and trials;

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our success in identifying and executing a development program for additional indications for SRK‑015, SRK-181 and our other programs;

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our ability to obtain funding for our operations, including funding necessary to complete further development and, upon successful development, if approved, commercialization of SRK‑015, SRK-181 or any of our future product candidates;

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the potential for our identified research priorities to advance our proprietary platform, development programs or product candidates;

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the timing, scope, or likelihood of our ability to obtain and maintain regulatory approval from the U.S. Food and Drug Administration, European Medicines Agency and other regulatory authorities for SRK‑015, SRK-181 and any future product candidates, and any related restrictions, limitations or warnings in the label of any approved product candidate;

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our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and the duration of such protection;

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our ability and the potential to successfully manufacture our product candidates for clinical trials and for commercial use, if approved;

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our ability to establish or maintain collaborations or strategic relationships, including our collaboration with Gilead;

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our ability to obtain additional funding when necessary;

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the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in combination with others;

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our expectations related to the use of our cash reserves;

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the impact of laws and regulations;

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developments and projections relating to our competitors and our industry;

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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, including our expected use of proceeds from our initial public offering; and

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other risks and uncertainties, including those listed under the caption “Risk Factors”.