Company: RPTX
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030405
Chunk: 148

Company: Repare Therapeutics Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 7
Chunk 148
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 preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each product candidate’s commercial potential. We will need to raise substantial additional capital in the future. Our clinical development costs are expected to increase significantly as we commence clinical trials. We anticipate that our expenses will increase substantially, particularly due to the numerous risks and uncertainties associated with developing product candidates, including the uncertainty of: 

•the scope, rate of progress, and expenses of our ongoing research activities as well as any preclinical studies, clinical trials and other research and development activities; 

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•establishing an appropriate safety profile; 

•successful enrollment in and completion of clinical trials; 

•whether our product candidates show safety and efficacy in our clinical trials; 

•receipt of marketing approvals from applicable regulatory authorities; 

•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; 

•obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; 

•commercializing product candidates, if and when approved, whether alone or in collaboration with others; and 

•continued acceptable safety profile of products following any regulatory approval. 

Any changes in the outcome of any of these variables with respect to the development of our product candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on other product candidates. For example, if the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our ongoing and planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. 

General and Administrative Expenses 

General and administrative expense consists primarily of employee related costs, including salaries, bonuses, benefits, share-based compensation and other related