Company: LIMN
Filing Date: 2025-07-03
Form Type: 8-K
Source: 0001104659-25-065663
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Company: Liminatus Pharma, Inc.
Filing Date: 2025-07-03
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events

Liminatus Pharma, Inc. has entered into a Memorandum
of Understanding (MOU) to form a research and development consortium with Samda Biolab Co., Ltd. and INNOCS AI, aimed at advancing a novel
blood-based diagnostic kit for early detection of pancreatic cancer.

Liminatus Pharma recognizes the groundbreaking
potential of the CA19-9-combined INNOCS diagnostic platform jointly developed by Samda and INNOCS AI, and has resolved to actively participate
in the R& D consortium with a view to enhancing corporate value and accelerating entry into the precision oncology diagnostics market.

The INNOCS platform - powered by a deep learning
algorithm and a panel of 16 metabolomic biomarkers - demonstrates remarkable performance when paired with CA19-9. According to recent
clinical data from a cohort of 1,086 subjects (393 pancreatic cancer patients and 693 control subjects), the combined diagnostic approach
demonstrated a sensitivity of over 95% and specificity exceeding 99%, including detection of CA19-9-negative pancreatic tumors.

Liminatus Pharma is committed to contributing
clinical development expertise and regulatory guidance as part of the consortium. Upon entering the commercialization phase, Liminatus
Pharma will lead the regulatory approval process through both the U. S. Food and Drug Administration (FDA) and the Korean Ministry of Food
and Drug Safety (KMFDS).

By participating in this consortium, Liminatus
Pharma will proactively oversee the acquisition of larger clinical datasets essential for regulatory submissions. Prior to the initiation
of FDA filing, Liminatus Pharma intends to complete internal approval processes to support a definitive agreement encompassing investment,
commercialization, and go-to-market strategy.

If successfully commercialized, this blood-based
diagnostic kit could generate substantial economic value. The global pancreatic cancer diagnostics market is projected to reach $3 billion
by 2026, with the blood-based diagnostics segment expected to surpass $700 million and the high-risk population screening segment estimated
at over $100 million. As clinical guidelines shift to embrace multi-marker strategies, early entry into this space offers Liminatus Pharma
a pivotal opportunity for market leadership in metabolomics-driven cancer diagnostics.

Liminatus Pharma views this strategic partnership
as a critical milestone in its broader mission to transform cancer care through next-generation precision diagnostics. By leveraging the
complementary strengths of INNOCS AI’s artificial intelligence technology, Samda’s biomarker platform, and Liminatus