Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 32

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 32
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 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. |

21

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 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