Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 70

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 70
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 of public policy regarding worldwide health concerns; |

| • |     | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S.      
 courts, allowing foreign competitors a better opportunity to create, develop, and market competing product candidates; |

| • |     | the claims of any patent issuing based on our patent applications may not provide protection against competitors 
 or any competitive advantages, or may be challenged by third parties;                                            |

| • |     | if enforced, a court may not hold that our patents, if they issue in the future, are valid, enforceable, and 
 infringed;                                                                                                   |

| • |     | we may need to initiate litigation or administrative proceedings to enforce and/or defend our patent rights which 
 will be costly whether we win or lose;                                                                            |

45

| • |     | we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property; |

| • |     | our trade secrets or proprietary know-how may be unlawfully disclosed, 
 thereby losing their trade secret or proprietary status;               |

| • |     | we may fail to adequately protect and police our trademarks and trade secrets; and |

| • |     | the patents of others may have an adverse effect on our business, including if others obtain patents claiming 
 subject matter similar to or improving that covered by our patent applications.                               |

Even if we receive regulatory approval for our product candidate, the regulatory authorities may also approve generic products that compete directly with our product candidate. Once an NDA is approved, the product covered thereby becomes a “listed drug” which can, in turn, be cited by potential competitors in support of approval of an Abbreviated New Drug Application, or ANDA. The FDA regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringingversions of a listed drug to facilitate the approval of an ANDA for generic substitutes. These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as our product candidate and that the generic product is bioequivalent to our product candidate. These generic equivalents could be significantly less costly than ours to bring to market and companies that produce generic equivalents may be able to offer their products at lower prices. Accordingly, competition from generic equivalents of our product candidate could materially adversely