Hepion Bets Big on Novel RNA Tech in Risky Pivot to Cancer Diagnostics

MORRISTOWN, NJ – March 03, 2026 – Hepion Pharmaceuticals, a company in the midst of a profound strategic reinvention, has made a decisive move into the next generation of cancer detection. The company announced today it has in-licensed a novel circulating tumor RNA (ctRNA) biomarker assay from Cirna Diagnostics LLC, aiming to revolutionize the early diagnosis of hepatocellular carcinoma (HCC), the most common and deadly form of liver cancer.

The agreement signals a significant step in Hepion's transformation from a struggling drug developer into a focused precision diagnostics firm, a high-stakes pivot orchestrated by CEO Kaouthar Lbiati, MD. This new technology complements Hepion's recently acquired mSEPT9 DNA test, creating a two-pronged strategy to tackle a dire unmet need, as current surveillance methods for HCC can miss up to 75% of early-stage cancers when they are most treatable.

A High-Stakes Pivot into Precision Diagnostics

Hepion's move is as much about survival as it is about strategy. The company (OTCQB:HEPA), which has historically focused on developing therapies for liver diseases, has faced significant financial headwinds. Recent SEC filings have noted “substantial doubt about going concern status without further capital,” and its market capitalization sits below half a million dollars. This context frames the licensing deal not as a routine expansion, but as a make-or-break bet on a new identity and a burgeoning market.

Under Dr. Lbiati's leadership, the company is aggressively shedding its past to embrace the multi-billion-dollar liquid biopsy space. This shift was previously signaled by a 2025 licensing agreement with New Day Diagnostics for a suite of tests, including the mSEPT9 assay for HCC. The new deal with Cirna for its ctRNA platform solidifies this direction, focusing the company's remaining resources on becoming a key player in early cancer detection.

The financial terms of the Cirna deal reflect Hepion's cautious yet determined approach. An upfront payment of just $50,000, with future milestone payments totaling up to $6.85 million and low single-digit royalties, provides Hepion access to cutting-edge technology without a prohibitive initial cash outlay. It's a calculated risk designed to position the company for significant future value if the technology proves successful.

“Our diagnostic tests are designed to catch tumors early in high-risk patients and minimize later-stage diagnoses where prognosis is grim, thereby significantly improving the probability of survival in high-risk patients,” stated Dr. Lbiati in the press release.

The Next Wave in Cancer Detection

The technology at the heart of the deal represents a potential leap forward from existing liquid biopsy methods. Most current tests analyze circulating tumor DNA (ctDNA), fragments of genetic code shed by tumors into the bloodstream. The ctRNA assay, however, detects mutant RNA variants. Because RNA reflects active gene expression, it provides a real-time snapshot of a tumor's activity, potentially offering earlier and more specific signals than DNA.

“Circulating tumor RNA liquid biopsy offers a more abundant signal and detects mutations and splicing variants that are invisible to DNA-based tests,” explained Aejaz Sayeed, PhD, chief scientific officer at Cirna Diagnostics and a co-inventor of the platform. “Our ctRNA platform also sheds light on the ‘dark’ or regulatory genome and highlights novel noncoding elements associated with cancer.”

This technological edge is critical for tackling HCC, the sixth most common and third deadliest cancer globally. It disproportionately affects patients with underlying cirrhosis, a high-risk group that could benefit immensely from more sensitive and non-invasive surveillance. While the specific Cirna assay has been validated in several independent cohorts according to the company, it will still need to build a broader portfolio of public, peer-reviewed data to gain widespread clinical acceptance. However, the underlying science is gaining significant momentum, with multiple studies highlighting the potential of various RNA molecules as highly sensitive biomarkers for cancer.

Navigating a Competitive and Regulatory Gauntlet

Hepion is entering a fiercely competitive arena. The global liquid biopsy market is currently valued at over $10 billion and is dominated by giants like Grail, Guardant Health, and Exact Sciences. To carve out a niche, Hepion must successfully navigate a complex and evolving regulatory landscape.

The company plans a phased commercialization strategy, beginning with partnerships to launch the test through labs certified under the Clinical Laboratory Improvement Amendments (CLIA). This allows for market entry while gathering the real-world data needed for a more rigorous U.S. Food and Drug Administration (FDA) submission. This path has become more challenging, as the FDA began phasing in new rules in 2025 to regulate all in-vitro diagnostics, including lab-developed tests (LDTs) like Hepion's, as medical devices, demanding higher standards of proof for safety and effectiveness.

“We view Hepion Pharmaceuticals, under the leadership of Dr. Kaouthar Lbiati, as the ideal licensing partner to advance our innovative ctRNA liquid biopsy test,” commented Louis P. Kassa III, CEO of Cirna Diagnostics and its associated non-profit, the Hepatitis B Foundation.

Beyond Liver Cancer: A Platform's Broader Promise

While the immediate focus is on conquering the challenges of HCC detection, the true long-term value of the ctRNA platform may lie in its versatility. The press release highlights the technology as “disease-agnostic,” with Hepion securing rights to extend its use to other indications.

Dr. Sayeed noted its potential for a wide array of malignancies. “It has direct applications in lung, breast, pancreatic, and fusion-driven cancers, and potential utility across the full arc of clinical management, encompassing surveillance, treatment monitoring, prognosis, and therapy selection,” he explained.

This positions the ctRNA technology not just as a single-use test, but as a foundational platform for a suite of diagnostic products. If Hepion can successfully commercialize the HCC test, it could provide the clinical validation and revenue stream needed to expand into a multi-cancer early detection powerhouse, transforming the company's prospects and potentially impacting cancer care on a much broader scale.