Company: MIRM
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001759425-25-000041
Chunk: 514

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-08-06
Form: 10-Q
Item: Part I, Item 8
Chunk 514
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 our ongoing clinical trials of our product candidates or any future clinical trials we may conduct, or changes in the development status of our product candidates;

•adverse results or delays in clinical trials;

•our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial; 

•adverse regulatory decisions, including failure to receive regulatory approval for our product candidates;

•changes in laws or regulations applicable to our approved medicines and our product candidates, including but not limited to clinical trial requirements for approvals;

•changes in the structure of health care payment systems;

•the failure to obtain coverage and adequate reimbursement of our approved medicines and our product candidates, if approved;

•adverse developments concerning our manufacturers;

•our inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;

•our inability to maintain or establish collaborations if needed;

•our ability to in-license, acquire, develop and market additional product candidates or approved medicines;

•management transitions and additions or departures of key scientific or management personnel;

•unanticipated serious safety concerns related to the use of our approved medicines or our product candidates;

•introduction of new products or services offered by us or our competitors; 

•announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•our ability to effectively manage our growth;

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•the size and growth, if any, of the markets for our approved medicines with approved indications;

•our ability to successfully enter new markets or develop additional product candidates;

•actual or anticipated variations in quarterly operating results;

•our cash position;

•our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

•publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts; 

•changes in the market valuations of similar companies;

•overall performance of the equity markets;

•issuances of debt or equity securities;

•sales of our common stock by us or our stockholders in the future;

•trading volume of our common stock;

•changes in accounting practices;

•ineffectiveness of our internal controls;

•disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

•significant lawsuits, including patent or stockholder litigation;

•geopolitical and macroeconomic developments, including the ongoing military conflicts, economic slowdowns, recessions, inflation, tariffs and trade