Hepion Pharmaceuticals, Inc. (HEPA): Marketing Mix Analysis [Dec-2025 Updated]

You're digging into Hepion Pharmaceuticals, Inc.'s strategy right now, and honestly, what you'll find is a company that executed a hard pivot in 2025. Forget the old drug pipeline; the focus is now squarely on commercializing in-licensed diagnostic tests, like those for celiac disease and respiratory viruses, after selling off Rencofilstat. This transition explains why the books showed \$0 million in revenue for Q3 2025, even as they eye markets worth billions. To really grasp how they plan to turn those CE-marked tests into cash flow across Europe and the US, you need to look closely at the new Product, Place, Promotion, and Price structure we've mapped out below.

Hepion Pharmaceuticals, Inc. (HEPA) - Marketing Mix: Product

You're looking at the product portfolio of Hepion Pharmaceuticals, Inc. following a major strategic pivot in 2025. The company has essentially traded its former primary drug development focus for an immediate revenue-generating pathway via in-licensed diagnostic assets. This shift defines the current product offering.

In-Licensed Diagnostic Tests for Celiac Disease, H. Pylori, and HCC

Hepion Pharmaceuticals entered into a binding Letter of Intent on May 7, 2025, with New Day Diagnostics LLC to in-license a suite of diagnostic tests. The tests for celiac disease, respiratory multiplex, and H. pylori currently hold CE marks, making them eligible for sale in the European Union right now. The combined addressable market for these diagnostics is stated to exceed $15 billion. The company paid $525,000 in cash and $270,629 in common stock for this license, with potential milestone payments reaching up to $17.15 million. Still, the Q3 2025 Form 10-Q reported Revenues: $0 million, indicating that commercialization efforts are just starting to ramp up, or have not yet generated sales in that period. Defintely, the focus is on getting these CE-marked products to market.

Here's a breakdown of the market scope for the specific diagnostic tests covered under the agreement:

Respiratory Multiplex Diagnostic Test for COVID-19, Influenza A/B, and RSV

The Respiratory Panel RT-PCR Multiplex CE-IVD is designed for the efficient, simultaneous detection of three major respiratory pathogens from a single sample. This product targets a significant segment of the overall diagnostic opportunity. The market it addresses is valued at $5.6 billion and is expected to expand at a compound annual growth rate of 6.6% through 2029.

Primary Drug Candidate, Rencofilstat, and its Patent Assets Were Sold in 2025

The company's former lead drug candidate, Rencofilstat, a cyclophilin inhibitor previously in Phase 2 development for NASH, is no longer part of the active product line. Hepion Pharmaceuticals finalized the sale of all patent assets and related data for Rencofilstat to Panetta Partners Limited on May 26, 2025. This transaction removes the development and associated research and development expenses for the drug, which contributed to the reduced Loss from operations of $(1.7) million in Q3 2025, down from a loss of $(48.4) million in the prior year's comparable period (based on 2024 10-K data). Stockholders now hold Contingent Value Rights (CVRs) tied to Rencofilstat's future success, which include specific financial triggers:

• Payment of $500,000 upon FDA approval of the first new drug application.
• Payment of $1,000,000 when net sales of an approved drug product exceed $350,000,000.
• Payment of $3,000,000 when net sales surpass $750,000,000.

Focus is Now on Commercializing CE-Marked Diagnostic Products

The current product strategy is entirely centered on the commercialization of the in-licensed diagnostic tests in European Union countries, leveraging the existing distributor network established by New Day Diagnostics. This is a clear pivot to generate near-term revenues, as stated by the Executive Chairman. The company recorded an impairment loss of $402,746 in Q3 2025, which was attributed to delayed market entry affecting cash flow projections for these licensed assets. The total potential value from milestones related to these diagnostics is $17.15 million, separate from the CVRs on Rencofilstat.

Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Marketing Mix: Place

The Place strategy for Hepion Pharmaceuticals, Inc. centers on a phased geographic rollout, prioritizing near-term revenue generation in established markets where regulatory hurdles for their diagnostic portfolio are already cleared. The initial commercialization focus is explicitly set on the European Union (EU) and UK markets for their in-licensed diagnostic tests. This approach is designed to quickly bring products to market by capitalizing on existing infrastructure rather than building a proprietary sales force from scratch.

The chosen distribution channel for these diagnostic tests is direct-to-market, which is facilitated by leveraging the CE marks already obtained for several key products. This means Hepion Pharmaceuticals is utilizing the established distributor network relationships that New Day Diagnostics has in place across the EU. The combined addressable market for these CE-marked diagnostics is stated to exceed $15 billion.

Concurrently, Hepion Pharmaceuticals is pursuing U.S. regulatory submissions for these same diagnostic tests to expand market access into the United States. This dual-market strategy acknowledges the immediate revenue potential in Europe while working toward the larger, though more regulated, U.S. market. As of November 11, 2025, the company's stock price was $0.07, with a market capitalization of $783K.

The specific diagnostic tests driving this initial European distribution strategy are:

• Respiratory Panel RT-PCR Multiplex CE-IVD.
• H. pylori CE-IVD.
• CeliaCare CE-IVD.

The market size and growth projections for these specific tests underscore the importance of this distribution focus:

Corporate operations for Hepion Pharmaceuticals are based in Morristown, New Jersey. The official headquarters address is listed as 55 Madison Avenue, PMB No. 4362, Suite 400, Morristown, NJ 07960, United States of America. The company profile indicates a total employee count of 22, supporting the management and operational needs of this commercialization pivot.

Hepion Pharmaceuticals, Inc. (HEPA) - Marketing Mix: Promotion

You're looking at a company in a major pivot, so the promotion strategy centers on communicating this new direction, which is a shift from drug therapy development to commercializing diagnostics for near-term revenue generation. The core promotional message is built around the immediate availability of CE-marked tests in Europe and the UK, while simultaneously signaling progress toward U.S. regulatory submissions for these same products. This strategy is designed to capture attention in a market segment with significant potential value.

The target for this promotional push is the addressable market size for the in-licensed diagnostic tests, which is stated as more than $15 billion. This number forms a key part of the narrative used to engage potential partners, distributors, and investors, underscoring the scale of the opportunity Hepion Pharmaceuticals is now promoting.

The proprietary AI-POWR™ platform, which stands for Artificial Intelligence - Precision Medicine; Omics; World database access; and Response and clinical outcomes, is being positioned as a differentiator that supports the diagnostic test development and future commercialization efforts. While historically tied to the rencofilstat drug program, its current promotional utility is in validating the company's technological depth in the diagnostics space, suggesting an advanced approach to test refinement and application.

The appointment of Dr. Kaouthar Lbiati as Interim Chief Executive Officer, effective June 16, 2025, is itself a promotional event signaling a new chapter. Her background is used to bolster confidence in the commercialization aspect of the strategy. Honestly, her experience is the proof point for the 'how' of the near-term revenue goal.

• Brings over 15 years of global leadership experience.
• Secured regulatory approvals in diverse international markets.
• Contributed to the launch of breakthrough treatments like Jevtana®.
• Contributed to the launch of breakthrough treatments like Symbicort®.
• Experience includes advancing therapies to global commercialization.

The investor relations communication reflects the operational reality following the delisting from Nasdaq on May 12, 2025, and the subsequent application to the OTCQB completed on June 25, 2025. The promotional messaging to the investment community is now firmly grounded in the diagnostics business model, moving away from the prior drug development focus, which saw the ASCEND-NASH clinical trial wound down by August 2024. As of the third quarter of 2025, Hepion Pharmaceuticals reported $0 million in revenues, with a loss from operations of $(1.7) million and a net loss of $(1.0) million. The stock, trading on OTC markets as of November 26, 2025, had a price of $0.06 and a Market Cap of $699,543. Finance: draft 13-week cash view by Friday.

Hepion Pharmaceuticals, Inc. (HEPA) - Marketing Mix: Price

You're looking at pricing for Hepion Pharmaceuticals, Inc. (HEPA) as the company pivots hard into diagnostics. This isn't about setting a price for a novel drug candidate anymore; it's about getting market traction for in-licensed tests in competitive spaces. The pricing strategy here must reflect the immediate need for revenue generation, especially given the financial backdrop.

Financially, the picture for the third quarter of 2025 shows the transition is still in process. Hepion Pharmaceuticals, Inc. (HEPA) reported $0 million in revenue for Q3 2025. Also, the bottom line reflects the operational status, with Q3 2025 EBIT coming in at -$527.9K and Net Income at -$472.51K. To compound the transition challenges, an asset impairment of $402,746 was recorded in Q3 2025, directly tied to the delayed market entry for those licensed assets. That's a real hit to the books when you're trying to establish a new commercial footing.

The pricing decisions are anchored by the size of the markets Hepion Pharmaceuticals, Inc. (HEPA) is targeting with its new diagnostic portfolio. You need to price to capture value in these segments:

The immediate focus for generating near-term revenue is leveraging the CE marks for European Union and UK sales. This means pricing needs to be competitive against existing diagnostic solutions in those regions, balancing perceived clinical utility against established competitor pricing. The strategy involves moving quickly where regulatory hurdles are lower.

Effective pricing for these diagnostics must consider several competitive factors. You can't just look at the total market size; you have to look at what the competition is charging for similar multiplex or single-analyte tests. Pricing must compete in the celiac disease and H. pylori diagnostic markets, valued at $457 million and $700 million, respectively. Here's the quick math on where the revenue opportunity lies:

• Respiratory multiplex market is estimated at $5.6 billion.
• H. pylori market is valued at $700 million.
• Celiac disease market is valued at $457 million.
• Strategy emphasizes near-term revenue in Europe and UK.

Since the company is focused on generating revenue now, financing options or credit terms might be less about customer financing and more about structuring favorable payment terms with distributors or healthcare providers to accelerate cash conversion cycles. What this estimate hides is the actual cost of goods sold (COGS) for the in-licensed tests, which directly impacts the margin you can build into the final price.

Finance: draft 13-week cash view by Friday.