Company: LIMN
Filing Date: 2025-01-16
Form Type: POS AM
Source: 0001104659-25-003835
Chunk: 173

Company: Liminatus Pharma, Inc.
Filing Date: 2025-01-16
Form: POS AM
Chunk 173
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 or forced furlough of government or contractor personnel; and

•

refusal of the FDA to accept data from clinical trials in affected geographies outside of the United States.

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TABLE OF CONTENTS

The COVID-19 pandemic continues to pose a threat on Liminatus’s ability to effectively conduct Liminatus’s business operations as planned and there can be no assurance that Liminatus will avoid a material impact on Liminatus’s business from the spread of COVID-19 or its consequences, including disruption to Liminatus’s business and downturns in business sentiment generally or in Liminatus’s industry or due to shutdowns that may be requested or mandated by federal, state and local governmental authorities.

Additionally, certain third parties with whom Liminatus engages or may engage, including collaborators, contract organizations, third-party manufacturers, suppliers, clinical trial sites, regulators and other third parties are similarly adjusting their operations and assessing their capacity in light of the COVID-19 pandemic. If these third parties experience shutdowns or continued business disruptions, Liminatus’s ability to conduct its business in the manner and on the timelines presently planned could be materially and negatively impacted. For example, as a result of the COVID-19 pandemic, there could be delays in the procurement of materials or manufacturing supply chains for one or more of Liminatus’s product candidates, which could delay or otherwise impact Liminatus’s preclinical studies and Liminatus’s planned clinical trials. Additionally, all of Liminatus’s preclinical studies are conducted by CROs, which could be discontinued or delayed as a result of the pandemic. It is also possible that the disproportionate impact of COVID-19 on hospitals and clinical sites will have an impact on recruitment and retention for Liminatus’s planned clinical trials. CROs have also made certain adjustments to the operation of such trials in an effort to ensure the monitoring and safety of patients and minimize risks to trial integrity during the pandemic in accordance with the guidance issued by the FDA and may need to make further adjustments in the future that could impact the timing or enrollment of Liminatus’s clinical trials. These adjustments may not be effective, may increase costs and may have unforeseen effects on the enrollment, progress and completion of these trials and the findings from these trials. While Liminatus is currently continuing Liminatus’s clinical trials and preclinical studies, Liminatus may experience delays in the completion of Liminatus’s clinical trials, preclinical activities and subject enrollment, may need to