Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 32

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 32
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 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 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 21

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