Company: LIMN
Filing Date: 2025-07-28
Form Type: S-1/A
Source: 0001410578-25-001518
Chunk: 20

Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-28
Form: S-1/A
Chunk 20
---
 of our annual or interim financial statements. In such case, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting and our stock price may decline as a result. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses. Liminatus has no products approved for commercial sale and have not generated any revenue from product sales. Liminatus’s ability to become profitable depends upon our ability to generate revenue. To date, it has not generated any revenue from product sales, and it does not expect to generate any revenue from the sale of products in the near future. Liminatus’s business depends entirely on the successful development and commercialization of its product candidates. Liminatus currently generates no revenue from commercial sales of any products. Liminatus has no products approved for commercial sale and, after the business combination, it does not anticipate generating any revenue from product sales unless and until sometime after it has successfully completed clinical development and received marketing approval for the commercial sale of a product candidate, if ever. Liminatus’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve a number of objectives, including:

| ● | successful and timely completion of preclinical and clinical development of current and any future product candidates; |

| ● | timely receipt of marketing approvals from applicable regulatory authorities for current and any future product candidates for which it successfully completes clinical development; |

| ● | the extent of any required post-marketing approval commitments to applicable regulatory authorities; |

15

| ● | developing an efficient and scalable manufacturing process for current and any future product candidates, including establishing and maintaining commercially viable supply and manufacturing relationships with third parties to obtain finished products that are appropriately packaged for sale; |

| ● | successful launch of commercial sales following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more partners or collaborators; |

| ● | a continued acceptable safety profile following any marketing approval; |

| ● | commercial acceptance of current and any future product candidates as viable treatment options by patients, the medical community, and third-party payors; |

| ● | addressing any competing technological and market developments; |

| ● | identifying, assessing, acquiring, and developing new product candidates; |

| ● | obtaining and maintaining patent protection, regulatory exclusivity, and other intellectual property-related protection, both in the