Hepion Pharmaceuticals, Inc. (HEPA): PESTLE Analysis [Nov-2025 Updated]

You're looking for a clear, actionable breakdown of the forces shaping Hepion Pharmaceuticals, Inc. (HEPA), and honestly, the landscape for a clinical-stage biotech is all about binary risk. Your investment thesis hinges entirely on Rencofilstat's clinical success and the regulatory environment, which is why we need to map the near-term risks and opportunities within the PESTLE framework. While political focus on liver disease offers tailwinds, the company must manage a high cash burn rate, estimated at around $8.5 million per quarter in 2025, while competing with next-generation technologies like GLP-1 agonists. We'll break down how critical IP protection, evolving MASH awareness, and the challenging capital market will defintely determine HEPA's strategic runway.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Political factors

Increased US government focus on liver disease (MASH/NASH) funding

The US government's commitment to tackling chronic liver disease, specifically Metabolic Dysfunction-associated Steatohepatitis (MASH), formerly NASH, creates a tailwind for companies like Hepion Pharmaceuticals. You should see this focus as a signal of long-term public health priority. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which is the primary NIH institute for this research, requested a substantial $2,310 million in the Fiscal Year (FY) 2025 President's Budget Request for its overall mission, which includes liver and digestive diseases.

Still, the immediate funding environment is politically constrained. As of early 2025, the Department of Health and Human Services (HHS), which includes the NIH, was operating under a Continuing Resolution (CR) through March 14, 2025, which holds funding at the prior year's enacted level. This means that while the intent is clear, the actual flow of new, increased grant money for basic MASH/NASH research may be temporarily delayed, affecting academic partners and the overall research ecosystem Hepion relies on.

The NIDDK-established NASH Clinical Research Network (NASH CRN) continues to operate, providing a federally-backed infrastructure for clinical and translational science in this area. This network is a defintely valuable resource for validating biomarkers and understanding disease progression, which is vital for Hepion's drug candidate, rencofilstat, which targets fibrosis and hepatocellular carcinoma (HCC).

Potential for faster FDA Orphan Drug designation pathways

The political and regulatory climate in 2025 is actively favoring faster development for serious conditions with unmet needs, which is a clear opportunity for Hepion Pharmaceuticals. The Food and Drug Administration (FDA) has been refining its expedited approval processes. In November 2025, the FDA Commissioner unveiled the new Plausible Mechanism Pathway, a concept designed to streamline the development and approval of therapies for ultra-rare conditions where randomized trials are not feasible.

Hepion Pharmaceuticals already holds a significant head start here: its lead asset, rencofilstat, received Fast Track designation from the FDA for the treatment of NASH in November 2021, and Orphan Drug designation for the treatment of Hepatocellular Carcinoma (HCC) in June 2022. The new FDA initiatives, coupled with existing designations, mean that if Hepion can generate compelling clinical data on its cyclophilin inhibitor, the regulatory path to market-the time-to-revenue-could be significantly shortened. This table outlines the key expedited pathways relevant to Hepion's pipeline:

Global trade tensions impacting supply chain for clinical trial materials

Global trade tensions, particularly with China and the European Union (EU), have become a material operational and financial risk for all clinical-stage biopharma companies in 2025, including Hepion. The US has imposed new tariffs that directly affect the cost and logistics of clinical trial materials.

Here's the quick math: The industry-wide annual cost increase from these tariffs is estimated to be between $10 billion and $20 billion. For a small, clinical-stage company like Hepion, which is already facing financial challenges (as evidenced by its Nasdaq delisting in May 2025 and proposed merger with Pharma Two B), this cost pressure is amplified. The tariffs specifically target key components:

• Tariffs of up to 25% on Active Pharmaceutical Ingredients (APIs) sourced from China.
• Tariffs of 15% on certain medicines imported from the EU.
• Increased costs for packaging materials and lab equipment, which are also subject to tariffs.

These trade restrictions can lead to delays at borders, force mid-study supplier changes, and increase the cost of producing the investigational drug (rencofilstat) and ancillary supplies for its trials, further straining an already tight cash runway.

Heightened political scrutiny on drug pricing post-patent approval

The political environment for drug pricing is becoming increasingly hostile to tactics that extend market exclusivity and maintain high prices, which is a long-term risk for Hepion's eventual commercial model. In April 2025, the Senate Judiciary Committee advanced bipartisan bills aimed at curbing practices like product hopping (making minor changes to a drug to extend exclusivity) and pay-for-delay settlements (where a brand-name drugmaker pays a generic company to postpone launching a cheaper alternative).

Furthermore, the debate around the Most Favored Nation (MFN) pricing policy, which aims to mandate that US citizens pay the same price as the nation paying the lowest price, continues to generate volatility. Proponents of MFN argue it could reduce drug prices by 30% to 80%. While Hepion is years away from commercialization, the political momentum is clearly toward price control and competition. This means that the eventual pricing power for rencofilstat, should it be approved for MASH/NASH or HCC, will face greater political scrutiny than in previous decades. You must factor in a lower peak sales estimate due to this evolving political reality.

The challenge is balancing the reward for innovation-like the $10 billion Eli Lilly invested in Donanemab, an Alzheimer's drug-with the public need for affordable access. This political tug-of-war will define the profitability of any new drug Hepion brings to market.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Economic factors

Challenging biotech capital market for non-revenue companies.

You need to understand that the capital market for non-revenue, clinical-stage biotechs like Hepion Pharmaceuticals is exceptionally tight in 2025. Investors are no longer funding scientific potential alone; they demand clear, de-risked pipelines and strong clinical data.

The market has become extremely discerning, moving away from the high-exuberance funding levels of 2020 and 2021. This means that raising new capital through a public offering is difficult and often results in a significant dilution of existing shareholders. For Hepion Pharmaceuticals, this constrained environment is a major headwind, especially since they are not in a position to generate revenue yet. The focus is squarely on companies with late-stage clinical data, typically Phase 2 or Phase 3 results, which Hepion Pharmaceuticals currently lacks for its primary NASH program.

Here's the quick math on the market pressure:

• Biotech funding was down approximately 57% year-over-year by May 2025.
• Public market investors are wary of biotech startups with long development timelines.
• The IPO market is low, with a focus on commercial viability.

High cash burn rate, estimated at around $8.5 million per quarter in 2025.

The company is facing a critical cash runway issue, which is the direct result of a high operating expense (OpEx) against minimal cash reserves. Your concern about a high cash burn rate is defintely warranted. Hepion Pharmaceuticals' operating expense for the second quarter of 2025 (Q2 2025) was $8.5 million. This figure represents the quarterly cash burn needed to maintain operations and clinical activities, even after the company announced a strategic restructuring plan to cut costs by 60% in late 2023.

This burn rate is unsustainable given the company's cash position. As of September 30, 2025, Hepion Pharmaceuticals reported cash and equivalents of only $2.3 million. This cash reserve is insufficient to cover even one quarter of the Q2 2025 operating expenses and has led to the disclosure of 'substantial doubt about the company's ability to continue as a going concern' in its Q3 2025 filings.

The company's financial state is precarious.

Inflationary pressure on clinical trial operational costs, definitely rising.

Beyond the company's internal cash issues, the entire cost of running clinical trials is rising, which directly impacts Hepion Pharmaceuticals' ability to restart or fund any future trials. Global inflation and geopolitical factors are pushing up expenses across the board in 2025.

For a U.S.-based biotech, this is a double hit: the cost of supplies and the cost of patient care are both climbing. Average per-patient trial costs in the U.S. have risen by 12% compared to 2023. Furthermore, U.S. tariffs on Active Pharmaceutical Ingredients (APIs) and medical supplies, which range from 15% to 25%, have inflated input costs for early-phase trials by as much as 8% in some cases. This external pressure makes every dollar of the remaining cash go less far, compounding the resource constraints that forced the wind-down of the Phase 2b ASCEND-NASH trial.

Potential for large pharmaceutical partnerships based on Phase 2b data.

The most critical economic opportunity now lies in a strategic transaction, not in the drug's development timeline. Because of the resource constraints, Hepion Pharmaceuticals initiated a wind-down of its primary Phase 2b ASCEND-NASH trial in April 2024. This decision was based on the 'low probability of generating relevant efficacy data to support a registrational trial with our current cash resources.'

This means the potential for a large pharmaceutical partnership is now an exit strategy-an acquisition, merger, reverse merger, or licensing deal-based on the existing data. Approximately 80 subjects completed their Day 365 visits in the discontinued ASCEND-NASH trial, providing a safety and efficacy data set that is the company's primary asset for attracting a partner. A large pharmaceutical company could license or acquire Rencofilstat to integrate this data into a new, fully-funded development program, mitigating their own early-stage development risk. This is the only clear path to maximizing stockholder value in the current environment.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Social factors

Growing public health awareness of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

The social landscape for MASH, formerly known as NASH, is shifting fast due to major drug approvals in 2024 and 2025. You should recognize that this growing public awareness is a double-edged sword for a company like Hepion Pharmaceuticals, Inc. On one hand, it validates the market need for their oral drug candidate, Rencofilstat. On the other, it means a much more crowded field.

The sheer scale of the patient population is driving this awareness. MASH affects an estimated 5% of the general adult population in the US, corresponding to over 22 million individuals. The high-risk segment, MASH with fibrosis (Stage 2 or Higher), is projected to nearly double, growing from 6 million to 12 million US individuals in the coming years, which is a huge pool of potential customers. The challenge remains that patient awareness is still low, reported at only 6.7% in the 2021-2023 period, meaning a vast majority of patients are undiagnosed.

Increased demand for non-invasive, oral treatments over injectables

Patient preference for an oral pill over a chronic injection is a powerful social driver in the MASH market. This is a clear opportunity for Hepion, whose Rencofilstat is an oral, once-daily drug candidate. The first FDA-approved MASH therapy, Rezdiffra (Madrigal Pharmaceuticals), is a once-daily oral treatment, setting the initial market preference. However, the accelerated FDA approval of Semaglutide (Novo Nordisk) in August 2025 for noncirrhotic MASH, which is a once-weekly subcutaneous injection, introduces a major injectable competitor.

The market is clearly signaling a preference for convenience, a factor Eli Lilly is also addressing by developing an oral GLP-1 pill to capture patients who are injection-averse. Hepion's oral delivery system is a key social advantage, as it generally improves patient compliance over long-term injectable therapies for chronic conditions. The MASH treatment market size in North America is projected to grow from US$ 3.70 billion in 2024 to US$ 17.15 billion by 2033, showing the massive commercial potential for any convenient, effective treatment.

Physician adoption risk due to existing, albeit limited, treatment options

The biggest near-term risk for Hepion is physician inertia and the competitive landscape, which is no longer an empty field. The 'graveyard of failed drugs' is now being replaced by a handful of approved and late-stage therapies.

The physician adoption decision now involves a comparative risk-benefit analysis against two approved drugs: Rezdiffra (oral) and Semaglutide (injectable). This is a tough spot for any Phase 2-stage drug. Hepion's Rencofilstat has shown promising Phase 2 data, specifically an average decline in liver stiffness of 6.02 kPa, or 28%, in advanced (F3) MASH patients at the 225 mg dose. But the financial decision to halt the Phase 2b ASCEND-NASH trial in April 2024 due to cash constraints, even with no reported safety issues, creates a major uncertainty flag for prescribers and partners. Physicians will favor the commercial certainty of Rezdiffra and Semaglutide.

Here's the quick math on the competitive landscape Hepion faces:

Focus on health equity in clinical trial recruitment across diverse populations

The social pressure to ensure health equity is a growing factor in clinical development, and it impacts the credibility of trial data. The traditional gold standard for MASH diagnosis, the liver biopsy, is invasive and costly, which inherently leads to a selection bias.

This bias often results in the underrepresentation of patient populations, particularly those from low- and lower-middle-income backgrounds, where the prevalence of the underlying condition (MASLD) is highest. For Hepion, demonstrating a commitment to health equity means:

• Using non-invasive tests (NITs) like FibroScan or ELF score to screen and recruit a more diverse patient base.
• Partnering with community health centers, not just tertiary hospitals, to reach a broader demographic.
• Actively addressing risk factors and disparities in MASH prevalence, a key topic in 2025 industry discussions.

Failure to recruit a diverse population could lead to questions about Rencofilstat's efficacy and safety across all demographic groups, which is a major regulatory and commercial hurdle. You must defintely address this in any future trial design.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Technological factors

The technological landscape for Hepion Pharmaceuticals, Inc. is defined by a significant pivot in 2025. The core takeaway here is that the company's innovative drug technology, Rencofilstat, was ultimately overwhelmed by a faster, better-funded competitive field, forcing a strategic shift toward its proprietary Artificial Intelligence (AI) diagnostics platform. You need to understand the value of the AI technology separate from the failed drug asset.

Rencofilstat's novel cyclophilin inhibition mechanism for fibrosis treatment

Rencofilstat was a technologically distinct asset, an oral small molecule designed to inhibit Cyclophilin B (CypB), an enzyme critical in regulating collagen production and fibrosis. This was a novel mechanism of action (MOA) in the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), aiming to directly address the liver scarring (fibrosis) that leads to cirrhosis. The challenge was translating this novel MOA into a pivotal clinical outcome fast enough to secure funding and beat the market leaders.

The company sold all patent assets, know-how, and clinical data related to Rencofilstat in May 2025. This sale, for a nominal amount plus a contingent value right (CVR), effectively ended the MASH drug development program. This move was a direct result of the high cost of Phase 2b trials; the company simply ran out of runway, citing resource constraints when it wound down the ASCEND-NASH trial in April 2024. It's a stark reminder that in biotech, a good mechanism isn't defintely enough without the capital to prove it.

Use of Artificial Intelligence (AI) to accelerate patient recruitment for trials

Hepion's most valuable remaining technological asset is its proprietary AI platform, AI-POWR™ (Artificial Intelligence - Precision Medicine; Omics; World database access; and Response/clinical outcomes). While initially deployed to de-risk the Rencofilstat program, the platform itself is a core technological capability that Hepion still owns and is now leveraging for its new focus on precision diagnostics. This AI-driven approach integrates multi-omic data-genomics, proteomics, metabolomics-with clinical trial results to identify specific patient responders.

This AI-POWR™ technology was used to fine-tune patient selection for the ASCEND-NASH trial, which helped in generating cleaner, more targeted data from the 151 subjects who were randomized before the trial's wind-down. Here's the quick math: using AI to target a responder population can save tens of millions of dollars by reducing the required target enrollment (which was 336 subjects for ASCEND-NASH).

Need for robust biomarker development to track drug efficacy precisely

The development of robust, non-invasive biomarkers (a technological need across all MASH drug development) was a key objective for Hepion, driven by its AI-POWR™ platform. In the Phase 2a AMBITION study, the platform successfully identified and validated early efficacy signals using two key biomarkers: ALT (a liver enzyme marker of inflammation) and ProC3 (a marker of fibrosis formation).

This ability to identify drug-specific biomarkers is now the foundation of the company's new business model in diagnostics. The technology is shifting from drug development to test development for diseases like celiac disease, respiratory multiplex, and hepatocellular carcinoma (HCC). The technological proof-of-concept from the MASH program-that AI can find a signal in the noise-is the only thing that survived the Rencofilstat termination.

Competition from gene therapies and next-generation GLP-1 agonists in MASH

The primary technological risk that materialized for Hepion was the sheer scale and efficacy of competing MASH treatments, particularly the next-generation GLP-1 receptor agonists. These drugs, originally for diabetes and obesity, have shown compelling liver benefits. This external technological force effectively made Rencofilstat's path to market untenable, especially given Hepion's limited cash resources, which stood at only $2.3 million as of September 30, 2025.

The competitive landscape is now dominated by major players and highly effective mechanisms that address the underlying metabolic drivers of MASH, not just the resulting fibrosis. This is a crucial distinction and a technological hurdle that cyclophilin inhibition could not overcome alone.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Legal factors

Critical need for strong intellectual property (IP) protection for Rencofilstat.

The legal landscape for Hepion Pharmaceuticals' intellectual property (IP) has fundamentally changed in 2025. The critical need for the company to defend its Rencofilstat patents is now a historical note, replaced by the legal management of its divestiture.

On May 26, 2025, Hepion Pharmaceuticals sold all patent assets, knowhow, clinical trial data, and drug product related to Rencofilstat to Panetta Partners Limited for a nominal amount. This transaction essentially removed the primary asset from the company's IP portfolio, shifting the legal focus from patent defense (which previously included composition-of-matter patents that could have provided exclusivity until 2044) to managing the Contingent Value Right (CVR) agreement.

The CVR is the new legal instrument of value for Rencofilstat, representing a defined future payment structure for Hepion's stockholders. This structure introduces a new legal risk: potential disputes over the interpretation or fulfillment of the CVR milestones, which is a common post-merger or divestiture litigation area. Here's the quick math on the potential payouts:

The company now needs to defintely focus its legal resources on the in-licensed diagnostic tests, ensuring the validity and freedom-to-operate of the new IP, which is less complex but still vital for the new business model.

Strict FDA and EMA compliance for Phase 3 trial design and execution.

The requirement for strict FDA and European Medicines Agency (EMA) compliance for a Phase 3 drug trial is no longer relevant, as Hepion Pharmaceuticals wound down its Phase 2b ASCEND-NASH clinical trial in April 2024. The company has pivoted to a business model focused on commercializing diagnostic tests, which means the regulatory compliance burden has shifted from drug development to in-vitro diagnostics (IVD).

The new legal compliance focus is on:

• Maintaining CE marks for the in-licensed celiac, respiratory multiplex, and H. pylori diagnostic tests, which makes them eligible for immediate sale in Europe.
• Securing and maintaining US Food and Drug Administration (FDA) clearance or approval for the diagnostic tests for the US market.
• Ensuring the quality management systems and manufacturing processes for the diagnostic tests comply with global IVD standards, such as the FDA's Quality System Regulation (QSR) and the European IVD Regulation (IVDR).

The shift to diagnostics offers a faster path to potential revenue generation compared to the long-term, capital-intensive Phase 3 drug development process, especially considering the company's Q2 2025 net income loss of -$1.04 million.

Litigation risk related to clinical trial data integrity or patent challenges.

While the risk of litigation over Rencofilstat patent challenges has been transferred to Panetta Partners Limited, the company faces new and evolving litigation risks in 2025. The most immediate legal exposure stems from the significant corporate restructuring and financial distress.

The delisting of Hepion Pharmaceuticals' shares from Nasdaq in May 2025 and the subsequent quotation on the OTC Markets Group increases the risk of shareholder class action lawsuits. Such actions typically allege breaches of fiduciary duty or misrepresentation related to the stock's collapse and the failure of the Rencofilstat program.

Plus, the general life sciences sector is seeing a rise in litigation, with patent case filings rebounding and increasing by 22.2% in 2024. Although Hepion has divested its core drug IP, it must still manage the legal risk associated with its prior clinical trial data, which was sold, and the new diagnostic products, which will face competitive IP scrutiny in markets like the Respiratory Panel RT-PCR Multiplex, a $5.6 billion market.

Evolving global data privacy laws (e.g., GDPR, CCPA) impacting patient data handling.

The pivot to commercializing diagnostic tests immediately increases Hepion Pharmaceuticals' exposure to global data privacy laws, particularly the General Data Protection Regulation (GDPR) in Europe and the California Consumer Privacy Act (CCPA) in the US. Diagnostic testing inherently involves the processing of protected health information (PHI) and personally identifiable information (PII).

Since the in-licensed diagnostic tests have CE marks and are eligible for sale in European Union countries, GDPR compliance is now a critical operational and legal necessity. This regulation imposes stringent requirements on how the company handles data from EU citizens, including explicit consent and data localization rules. Failure to comply can result in fines up to 4% of annual global revenue or €20 million, whichever is higher.

In the US, the company must ensure its data handling practices for diagnostic test results comply with the Health Insurance Portability and Accountability Act (HIPAA) and its Security Rule, as well as state-specific laws like the CCPA, which grants California consumers rights over their personal information. The general trend shows data privacy as a 'hot-button area' driving class action filings, so a proactive legal strategy here is paramount. Finance: draft a compliance budget for HIPAA/GDPR legal counsel by end of next quarter.

Hepion Pharmaceuticals, Inc. (HEPA) - PESTLE Analysis: Environmental factors

You're looking at Hepion Pharmaceuticals, Inc. (HEPA) and need to know where the environmental risks and opportunities land, especially since the company is clinical-stage. The core takeaway is that Hepion's environmental footprint is currently minimal, but the regulatory and investor pressure from the Environmental, Social, and Governance (ESG) movement is a very real, near-term financial risk you can't ignore.

As a biopharma company focused on drug development, not large-scale manufacturing, Hepion's direct environmental impact (Scope 1 and 2 emissions) is inherently small. Still, the company is exposed to supply chain and regulatory risks. This is a critical distinction from a manufacturing-heavy peer like Pfizer or Merck.

Need for sustainable sourcing of drug manufacturing materials.

While Hepion is a clinical-stage company, meaning its manufacturing is small-scale and outsourced, the pressure for sustainable sourcing is still a factor through its contract development and manufacturing organizations (CDMOs). The larger pharmaceutical industry is rapidly moving toward Green Chemistry principles to reduce solvent use and energy consumption. Any future commercial-scale production of Rencofilstat will be instantly judged against these new standards.

Here's the quick math: a major CDMO's shift to a more sustainable process, like adopting continuous manufacturing to decrease energy consumption by up to 20%, could translate to lower long-term cost of goods sold (COGS) for Hepion. But, if a CDMO fails to comply with new sustainability mandates, it creates a supply chain risk for Hepion's drug substance (DS) and drug product (DP).

For now, the risk is indirect, but defintely real.

Compliance with environmental regulations for laboratory waste disposal.

Compliance with US Environmental Protection Agency (EPA) regulations for hazardous waste pharmaceuticals is a non-negotiable operational cost. The key regulation is 40 CFR Part 266 Subpart P (the Pharmaceuticals Rule), which is being adopted and enforced by state-level agencies in 2025.

This rule imposes strict, uniform standards on the accumulation, storage, and disposal of hazardous waste pharmaceuticals, and crucially, it includes a nationwide ban on the sewering (flushing down the drain) of any hazardous waste pharmaceuticals. As of August 2025, 14 US states had not yet fully adopted Subpart P, meaning compliance is a patchwork, state-by-state challenge for any clinical trial network Hepion uses.

This impacts how Hepion manages its clinical trial materials and laboratory waste, which includes expired or unused Rencofilstat. The cost of compliant disposal is a fixed, rising expense that eats into the company's tight cash runway.

Investor pressure for Environmental, Social, and Governance (ESG) reporting transparency.

Investor demand for transparent ESG reporting is intensifying across the entire biopharma sector in 2025. While Hepion's current focus is on survival and clinical milestones, its small $825,043 market capitalization (as of 11/20/2025) and recent delisting from Nasdaq (now on OTCQB) make it highly sensitive to investor sentiment. Institutional investors, including major funds, are increasingly using ESG scores to filter out non-compliant companies, even micro-caps.

Failure to even acknowledge ESG risks can deter new capital. This is a capital-raising risk, not an operational one, but it is critical given the company's financial position.

Here's the financial context:

• Cash and Cash Equivalents (Q3 2025): $2.3 million.
• Net Loss (Q3 2025): $0.472506 million.
• Cash Burn Rate: Extremely high relative to cash on hand.

Any perceived governance or environmental risk that delays a financing round is an existential threat. ESG is a new form of due diligence for capital markets.

Minimal direct environmental impact compared to manufacturing-heavy pharma firms.

Hepion Pharmaceuticals operates primarily as a research and development entity, using an Artificial Intelligence (AI) platform, AI-POWR, to drive its clinical programs. This model minimizes its direct environmental footprint. The company does not own or operate large-scale chemical synthesis plants or formulation facilities. This is a clear advantage over a fully integrated pharmaceutical company.

The environmental impact is largely limited to:

• Laboratory waste from R&D activities.
• Disposal of unused or expired Rencofilstat from clinical trials.
• Energy consumption in its corporate and lab office spaces.

This low-impact profile is an opportunity; it means a future ESG report could focus heavily on the 'S' (Social) and 'G' (Governance) pillars, which is easier and cheaper to manage than the 'E' (Environmental) for a company of this size. The risk is manageable, but the perception is not.

Your next step: Track the HEPA Q3 2025 SEC filing for the updated cash position and the Rencofilstat Phase 2b data readout timeline.