Company: LIMN
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001104659-25-010605
Chunk: 172

Company: Liminatus Pharma, Inc.
Filing Date: 2025-02-07
Form: 424B3
Chunk 172
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ays in receiving approval from regulatory authorities to initiate Liminatus’s clinical trials;

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interruptions in preclinical studies due to restricted or limited operations at the CROs conducting such studies;

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interruptions or delays in the operations of the FDA or other domestic or foreign regulatory authorities, which may impact review and approval timelines;

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delays in receiving the supplies, materials and services needed to conduct clinical trials and preclinical research;

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changes in regulations as part of a response to the COVID-19 pandemic which may require Liminatus to change the ways in which Liminatus’s clinical trials are conducted, which may result in unexpected costs or require Liminatus to discontinue the clinical trial altogether;

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interruptions or delays to Liminatus’s development pipeline;

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delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel; and

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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