Company: PRME
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001628280-25-008884
Chunk: 104

Company: Prime Medicine, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 104
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, some of our competitors may have ongoing clinical trials for product candidates that would treat the same indications as our current or future product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

Patient enrollment is also affected by other factors, some of which may include:

•severity of the disease under investigation;

•size of the patient population and process for identifying patients, including proximity and availability of clinical trial sites for prospective patients with conditions that have small patient pools;

•design of the trial protocol, including efforts to facilitate timely enrollment in clinical trials;

•availability and efficacy of approved medications for the disease under investigation;

•availability of genetic testing for potential patients and ability to monitor patients adequately during and after treatment;

•ability to obtain and maintain patient informed consent;

•risk that enrolled patients will drop out before completion of the trial;

•eligibility and exclusion criteria for the trial in question;

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•perceived risks and benefits of the product candidate under investigation and gene editing as a therapeutic approach; and

•patient referral practices of physicians.

In addition, our ability to successfully initiate, enroll and complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries, some of which may include:

•difficulty in establishing or managing relationships with CROs and physicians;

•different standards for the conduct of clinical trials;

•different standard-of-care for patients with a particular disease;

•difficulty in locating qualified local consultants, physicians and partners; and

•potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatment and of gene editing technologies.

Enrollment delays in our clinical trials may result in increased development costs for our current or future product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. If we or our collaborators have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials or entire clinical programs, any of which would have an adverse effect on our business, financial condition, results of operations and prospects.

The gene editing field is relatively new and is evolving rapidly, making us subject to additional development challenges and risks. We are focusing our research and development efforts on gene editing using Prime Editing technology, but other gene editing technologies may be discovered that provide significant advantages over Prime Editing, which could materially harm our business.

To date,