Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 34

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 34
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 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 the safety and efficacy of newer 
 products;                                                                                                       |

| • |     | the clinical indications for which our product is approved and the scope of efficacy/safety claims that we may 
 make for the product;                                                                                          |

| • |     | any restrictions on the use of our product, and the prevalence and severity of any adverse effects; |

| • |     | any distribution and use restrictions imposed by the FDA as part of a mandatory REMS with respect to such product 
 candidate or to which we agree under a voluntary risk management plan;                                            |

| • |     | the availability of adequate coverage and reimbursement by third parties, such as insurance companies and other 
 healthcare payors, and by government healthcare programs, including Medicare and Medicaid;                      |

| • |     | the willingness of patients to