Mission Statement, Vision, & Core Values of Hepion Pharmaceuticals, Inc. (HEPA)

When you look at the Mission Statement, Vision, and Core Values of Hepion Pharmaceuticals, Inc. (HEPA), you're not just reading a corporate document; you're analyzing a financial survival guide written in real-time by a company that had to execute a massive strategic pivot in 2025.

How do a company's core values hold up when a nine-month net loss of over $7.62 million forces a complete shift from high-risk drug development to commercial diagnostics? The old mission-focused on AI-driven therapeutic development for liver disease-was effectively retired in May 2025 when they sold their lead drug asset, Rencofilstat, and pivoted to in-license diagnostic tests for a combined addressable market exceeding $15 billion. Are they still driven by scientific rigor, or is the new, defintely pragmatic vision simply cash-flow survival?

The answer is critical, especially since the company reported only $2,321,078 in cash at the end of Q3 2025, plus they immediately recorded a $402,746 impairment loss on those new diagnostic assets.

Hepion Pharmaceuticals, Inc. (HEPA) Overview

You're looking for a clear picture of Hepion Pharmaceuticals, Inc. (HEPA), and honestly, the story is one of a dramatic, high-stakes pivot. This is no longer the clinical-stage biotech focused on liver disease; it's now a diagnostics company fighting for a viable business model.

Hepion Pharmaceuticals, originally spun-off from Synergy Pharmaceuticals in 2014, spent years focused on developing its lead drug candidate, rencofilstat, a cyclophilin inhibitor for chronic liver diseases like non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). But as of May 2025, the company executed a full strategic shift, selling off all rencofilstat assets for a nominal amount and pivoting entirely to developing and commercializing medical diagnostics.

The company is now focused on in-licensed diagnostic tests, including those for celiac disease, respiratory multiplex (COVID-19/Influenza A/B and RSV), and H. pylori. This pivot means that as of the latest reporting, the company's current sales are virtually $0. To understand the context of this massive change, you can find a deeper dive into the company's foundation and strategy here: Hepion Pharmaceuticals, Inc. (HEPA): History, Ownership, Mission, How It Works & Makes Money.

Here's the quick math on the shift: they cut the old business to the bone to fund the new one. That's a high-risk move.

2025 Financial Performance: A Cost-Cutting Retreat

Forget talk of record-breaking revenue; the 2025 fiscal year data tells a story of aggressive cost control and critical liquidity challenges. The company reported a net loss of $472,506 for the third quarter ended September 30, 2025, contributing to a nine-month net loss of $7,620,965. This is a significant drop in losses year-over-year, but it was achieved by nearly halting the core business.

The financial performance is defined by the strategic retreat from drug development. Research and Development (R&D) expenses plunged by 97%, dropping to just $0.4 million for the nine months ended September 30, 2025. This dramatic reduction slashed the operating cash burn for the nine-month period to $2.9 million, down from $17.1 million in the prior year.

• 9M 2025 Net Loss: $7,620,965.
• Cash on Hand (Sep 30, 2025): $2,321,078.
• Total Liabilities (Sep 30, 2025): $415,808.

To be fair, the balance sheet shows total liabilities of only $415,808 against stockholders' equity of $3,324,432 at the end of Q3 2025. Still, management has disclosed substantial doubt about the company's ability to continue as a going concern without securing additional capital. Plus, the initial pivot to diagnostics hit a snag, with the company recording an immediate $0.4 million impairment loss on the in-licensed assets from New Day Diagnostics.

Hepion Pharmaceuticals: The Ambition of a New Leader

While Hepion Pharmaceuticals is not currently a market leader-the company was delisted from Nasdaq and now trades on the OTCQB, reflecting its precarious financial state-its ambition is to become one in the diagnostics space. The move to commercial diagnostics from high-risk, long-cycle drug development is a calculated attempt to find a faster path to revenue and market relevance.

The company's original vision was to transform the treatment landscape for debilitating liver conditions using its AI-driven drug development platform. Now, the focus is on a commercial model that can generate sales sooner, moving from a pure R&D burn to a sales-driven operation. This is a defintely a high-stakes transition. The success of this new direction hinges entirely on their ability to commercialize the in-licensed tests and overcome the initial impairment setback. You need to look closely at the execution of this diagnostics strategy to understand whether this pivot will ultimately make Hepion a leader, or simply a footnote.

Hepion Pharmaceuticals, Inc. (HEPA) Mission Statement

You're looking for the foundational principles that guide Hepion Pharmaceuticals, Inc.'s operational and capital allocation decisions, especially after the significant strategic pivot in 2025. A company's mission statement is its North Star, and for Hepion, it defines a clear, two-pronged approach: to develop and commercialize AI-driven therapeutics to address significant unmet medical needs in chronic liver diseases and related conditions, ultimately improving patient outcomes. This statement is crucial because it maps their long-term goal-drug development-to their immediate action-the commercialization of diagnostic tools.

The company's market capitalization, sitting around $825,043 as of November 2025, with a stock price of about $0.07, tells you the market is valuing the potential of this mission, not current revenue, which was $0 in 2023. This is a classic biotech scenario, but the mission now includes a near-term revenue stream via diagnostics, which is a critical shift. You should be evaluating the mission through the lens of their recent strategic adaptability, which is a core, unstated value.

For more on the market's reaction to this change, you can check out Exploring Hepion Pharmaceuticals, Inc. (HEPA) Investor Profile: Who's Buying and Why?

Core Component 1: Develop and Commercialize AI-Driven Therapeutics

The first core component centers on innovation, using technology to derisk the notoriously expensive and lengthy drug development process. Hepion uses its proprietary Artificial Intelligence-Powered Drug Development (AI-POWR™) platform, which integrates machine learning and deep learning to analyze complex biological data. This isn't just a buzzword; it's a strategic choice to select patients who will defintely respond to therapies and decode disease pathways more efficiently.

Their lead candidate, Rencofilstat, a cyclophilin inhibitor, is the prime example of this therapeutic focus. While the Phase 2b ASCEND-NASH trial was wound down, the company is still positioned around this AI-driven discovery engine. The pivot in May 2025, where they licensed diagnostic tests for celiac disease, respiratory multiplex, H. pylori, and hepatocellular carcinoma (HCC), shows a commercialization focus that is now broader than just Rencofilstat, aiming for immediate cash flow.

• Use AI-POWR™ to select responsive patients.
• Commercialize diagnostics for near-term revenue.
• Rencofilstat remains a core therapeutic asset.

Core Component 2: Address Significant Unmet Medical Needs in Chronic Liver Diseases

This is the patient-centric core of the mission, focusing on non-alcoholic steatohepatitis (NASH), fibrosis, and hepatocellular carcinoma (HCC). These are areas with high mortality and limited treatment options, representing a massive global market. The commitment here is demonstrated by the regulatory endorsements Rencofilstat received: the U.S. Food and Drug Administration (FDA) granted it Fast Track designation for NASH in November 2021 and Orphan Drug designation for HCC in June 2022. These designations aren't handed out lightly; they validate the drug's potential to treat serious conditions with high unmet need.

The company's commitment to quality is reflected in the clinical data from the completed Phase 2a AMBITION-NASH trial, which showed reductions in the liver enzyme ALT (a marker of inflammation) and PRO-C3 (a marker of fibrosis) after only 28 days of dosing. Even with the ASCEND-NASH trial winding down, data from the approximately 80 subjects who completed their Day 365 visits will still provide significant safety and efficacy information, driving future development decisions. Honestly, the focus is on diseases that affect half a billion people worldwide, so the need is clear.

Core Component 3: Ultimately Improving Patient Outcomes

The final component is the ultimate measure of success: tangible patient benefit. For a biopharma company, this means getting a drug approved, but for Hepion in 2025, it also means providing better diagnostic tools. The New Day Diagnostics LLC agreement, executed in May 2025, is a direct action to fulfill this component, offering tests for immediate patient use, especially those with CE marks eligible for sale in Europe.

This strategic move is all about improving outcomes by providing earlier diagnosis, which is often the first and most critical step in managing chronic diseases like HCC. Here's the quick math on the shift: developing Rencofilstat to market takes billions and a decade; distributing a licensed diagnostic test with a CE mark can generate revenue and impact patient care now. The core value of ethics and compliance, which the company reinforces through its Corporate Governance, ensures that both the drug development process and the commercialization of these new diagnostic products adhere to the highest standards, protecting the patient. That's what smart capital is looking for in a turnaround story.

Hepion Pharmaceuticals, Inc. (HEPA) Vision Statement

You need to understand that for a small-cap biotech like Hepion Pharmaceuticals, the vision is not a static poster on the wall; it's a living document that bends to financial reality. The direct takeaway here is that Hepion's vision has decisively pivoted from a pure-play drug developer to a precision diagnostics company, a move driven by a critical need for near-term revenue and financial sustainability.

Honestly, the market is a trend-aware realist, and so should you be. The company's strategic shift in 2025 is a clear action to map near-term risk. They sold their primary therapeutic asset, rencofilstat, in May 2025 for a nominal amount, effectively exiting the costly Phase 2 drug development game in favor of a faster-to-market diagnostics model. This is a survival move, not a growth one, but it does create a new, actionable vision.

Pivoting to Precision Diagnostics for Near-Term Sustainability

The core of the new vision is to become a leader in precision diagnostics, a major shift from the original focus on non-alcoholic steatohepatitis (NASH) therapeutics. This pivot is a direct response to the intense capital requirements and long timelines of drug development. The company's cash position at September 30, 2025, was only about $2.32 million, which simply isn't enough to fund a full-scale Phase 2b trial. Here's the quick math: with quarterly General and Administrative expenses at $527,902, that cash runway is short, which is why management explicitly stated there is substantial doubt about continuing as a going concern without new capital.

The new diagnostic focus is already concrete, not just a plan. Hepion Pharmaceuticals in-licensed tests from New Day Diagnostics LLC in May 2025, paying $525,000 in cash and $270,629 in stock. These tests are for high-demand areas, and some already have CE marks for sale in Europe. This is a clear, actionable path to revenue generation, which is now the most critical component of their near-term vision.

• Focus on celiac disease diagnostics.
• Developing respiratory multiplex tests (COVID-19/Flu A/B/RSV).
• Targeting H. pylori and hepatocellular carcinoma (HCC) diagnostics.

Mission: Translating AI-Driven Heritage to Diagnostics

The company's stated mission is still rooted in using Artificial Intelligence (AI) to address significant unmet medical needs. While the original mission was to develop AI-driven therapeutics for chronic liver diseases, the new application is in diagnostics. They are trying to translate their AI-POWR™ platform, which once guided drug development, into a tool for better, faster diagnostic test development and commercialization.

To be fair, the original drug, rencofilstat, did show some promise, with the U.S. Food and Drug Administration (FDA) granting Fast Track designation for NASH in November 2021 and Orphan Drug designation for HCC in June 2022. But that's history now. The new mission is about leveraging that scientific heritage to offer innovative solutions for improved liver health, specifically through diagnostic tools for conditions like HCC. The key is execution in this new, less capital-intensive field. You can dive deeper into the financial implications of this pivot by reading Breaking Down Hepion Pharmaceuticals, Inc. (HEPA) Financial Health: Key Insights for Investors.

Core Values: Ethical Governance and Financial Resilience

A company's core values are defintely tested most when its financial health is under pressure. Hepion Pharmaceuticals' stated commitment to the highest standards of ethics and behavior in its corporate governance becomes crucial when facing a crisis. This is what provides a foundation of trust for new partners and investors as they navigate the pivot.

The financial reality of 2025 underscores the need for resilience and transparency. The net loss for the nine months ended September 30, 2025, was approximately $7.62 million, a significant improvement from the $11.64 million loss a year prior, but still a substantial burn. This reduction is largely because Research and Development (R&D) expenses dropped to zero for the third quarter, a stark reflection of the strategic shift away from drug trials. Their value system must now prioritize the prudent management of the remaining $3.32 million in stockholders' equity and a rapid, ethical commercialization of the new diagnostic assets to survive.

Next Step: Evaluate the sales forecasts for the newly licensed diagnostics to project a 12-month cash flow model.

Hepion Pharmaceuticals, Inc. (HEPA) Core Values

You're looking at Hepion Pharmaceuticals, Inc. (HEPA) right now and seeing a company in the middle of a massive strategic shift, so understanding their core values isn't just about reading a plaque; it's about mapping their real-world actions. The company's financial and operational moves in 2025 tell you exactly what they prioritize. They've moved from a focus on a single drug candidate to a diversified diagnostics platform, which is a huge change, but it's anchored by a clear, pragmatic set of principles.

This pivot, while challenging, shows a defintely strong commitment to three core values: Strategic Adaptability, Innovation in Patient Care, and Ethical Governance. These values are what you need to track as they execute on their new business model.

Strategic Adaptability

A biopharma company's ability to pivot when a core program stalls is the ultimate test of its resilience, and that's what Strategic Adaptability is all about. It means not falling in love with a single asset, but rather committing to shareholder value and patient need above all else. Hepion Pharmaceuticals demonstrated this value by completely overhauling its business model in 2025.

Here's the quick math on their shift: After winding down the ASCEND-NASH clinical trial for Rencofilstat in early 2025, the company faced significant financial constraints. Instead of folding, they executed a major pivot to commercializing diagnostic tests. This pivot was formalized in May 2025 with a binding letter of intent and subsequent license agreement with New Day Diagnostics for tests covering celiac disease, respiratory multiplex (like COVID/Flu/RSV), H. pylori, and hepatocellular carcinoma (HCC).

This move was a clear action to create near-term revenue generation, a necessity given the nine-month net loss of $7,620,965 through September 30, 2025. They also proactively addressed compliance issues by implementing a 1-for-50 reverse stock split in March 2025 and, after receiving a delisting notification from Nasdaq, successfully transitioned to the OTCQB Venture Market in June 2025. That's a textbook example of a company fighting to stay in the game for its shareholders.

• Sold Rencofilstat assets for a nominal amount in May 2025.
• Secured diagnostics license for near-term revenue generation.
• Transitioned to OTCQB in June 2025 to maintain public trading.

Innovation in Patient Care

While the business model shifted, the commitment to Innovation in Patient Care remained, moving from drug discovery to high-impact diagnostics. Hepion Pharmaceuticals' initial mission was to develop AI-driven therapeutics for chronic liver diseases, using their AI-POWR™ platform to decode disease and select responsive patients. Even as they sold their primary drug asset, Rencofilstat, the new focus on diagnostics is still directly tied to unmet clinical needs.

The licensed diagnostic tests are for conditions like celiac disease and HCC, which require timely and accurate diagnosis. For example, the celiac, respiratory multiplex, and H. pylori tests already have CE marks, meaning they are eligible for sale in Europe and the UK, which speaks to a focus on commercializing validated, high-quality tools. This is a smart, pragmatic form of innovation-using established, market-ready products to build a commercial base while still targeting serious diseases like HCC, which was a focus of their original drug pipeline.

The appointment of Dr. Kaouthar Lbiati as Interim Chief Executive Officer in June 2025, an executive with over 15 years of global leadership experience in advancing innovative therapies, further signals a commitment to this value. Her background in securing regulatory approvals and reimbursement is exactly what the new diagnostics focus needs to succeed.

Ethical Governance

For any company, especially one undergoing a significant restructuring, maintaining investor trust and internal compliance is critical. Ethical Governance is the core value that underpins this trust. Hepion Pharmaceuticals has a clear commitment to achieving the highest possible standards of ethics and behavior in its corporate governance and workplace.

This commitment is not just a statement; it's an operational framework. The company has an Anonymous Ethics and Compliance Hotline, effective since January 2016, which is overseen by the Audit Committee. This mechanism allows for the confidential reporting of any wrongdoing or impropriety, which is a crucial check for a small, publicly traded entity. Also, the company's cash position of $2,321,078 as of September 30, 2025, is being carefully managed, with Q3 2025 operating expenses significantly reduced, including a drop of Research & Development expense to zero for the quarter, while General and Administrative expense was only $527,902. This financial discipline, while a necessity, is also a demonstration of responsible stewardship of investor capital.

You can read more about the investor perspective on their recent shifts and challenges here: Exploring Hepion Pharmaceuticals, Inc. (HEPA) Investor Profile: Who's Buying and Why?