Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 35

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 35
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 pay all, or a portion of, out-of-pocket costs associated with our products in the absence of sufficient third-party coverage and adequate reimbursement; |

| • |     | the extent and strength of our marketing and distribution of such product candidate; |

| • |     | the timing of market introduction of such product candidate, as well as competitive products; |

| • |     | our ability to offer our product candidate for sale at competitive prices; |

| • |     | the competitiveness of existing approved therapies; |

| • |     | adverse publicity about our product or favorable publicity about competitive products; and |

| • |     | potential product liability claims. |

In addition, our lead product candidate, LB-102,is an N-methylated version of amisulpride, a drug already approved in certain parts of Europe for the treatment of schizophrenia, predominantly negative symptoms of 22

schizophrenia and dysthymia. While we are developing LB-102 for acute schizophrenia initially in the United States and potentially in other jurisdictions
where amisulpride is not approved, we currently plan to develop LB-102 to treat bipolar depression globally and if there is a recall, safety concern, or adverse regulatory action with respect to amisulpride in
Europe, it could prevent us from achieving or maintaining market acceptance of LB-102 or otherwise adversely affect our ability to successfully commercialize LB-102.
Furthermore, although LB-102 is structurally similar to amisulpride, which is an approved product in many countries outside of the United States, there can be no assurance that our ongoing and future clinical
trials will show similar results with respect to safety and/or efficacy.

Our efforts to educate the medical community and third-party
payors about the benefits of our product candidate may require significant resources and may never be successful. Even if our product candidate, if approved, is safe and effective for its approved indications, physicians and patients may not
immediately be receptive to such product candidate and may be slow to adopt it as an accepted treatment for the approved indications. If our current or future product candidates are approved, but do not achieve an adequate level of acceptance among
physicians, patients, and third-party payors, we may not generate meaningful revenue from our product candidate and may never become profitable.

We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Patient enrollment is a significant factor in the timing