Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 31

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 31
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 is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are
commercialized.

With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may
involve additional product testing, administrative review periods, and agreements with pricing authorities.

Even if we eventually
complete clinical trials and receive approval of an NDA or comparable foreign marketing application for our product candidate, the FDA or comparable foreign regulatory authority may grant approval contingent on the performance of costly additional
clinical trials and/or the implementation of REMS, which may be required because the FDA believes it is necessary to ensure safe use of the product after approval.

20

If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates, including for other indications, may be harmed, and our ability to generate revenues will be materially impaired. Even if our product candidate receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable. We have never commercialized a product candidate for any indication. Even if our product candidate is approved by the appropriate regulatory authorities for marketing and sale, our product candidate may not gain acceptance among physicians, patients, third-party payors, and others in the medical community. If our product candidate for which we obtain regulatory approval does not gain an adequate level of market acceptance, we may not generate sufficient product revenue or become profitable. Further, the number of patients that our product candidate is designed to treat may be smaller than expected. The degree of market acceptance of our product candidate, if approved and commercialized, will depend on a number of factors, some of which are beyond our control, including:

| • |     | the pricing and cost-effectiveness of our product candidate, as well as the ease of administration, time burden, 
 and market acceptance;                                                                                           |

| • |     | the safety, efficacy, and tolerability of our product candidate; |

| • |     | acceptance of our approach to precision psychiatry by patients, the medical community, and third-party payors; |

| • |     | changes in the standard of care for targeted indications and the reluctance of physicians to switch their 
 patients’ current standard of care;                                                                       |

| • |     | the reluctance of patients to switch from their existing therapy regardless of