Hepion Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>Hepion Pharmaceuticals filed its 2023 10-K, detailing its financial status and business operations.</b>

AI Summary

Hepion Pharmaceuticals, Inc. (CTRVP) filed a Annual Report (10-K) with the SEC on April 16, 2024. Hepion Pharmaceuticals, Inc. filed its 2023 Form 10-K on April 16, 2024. The company's fiscal year ends on December 31st. Hepion Pharmaceuticals was formerly known as ContraVir Pharmaceuticals, Inc. The company's principal business address is 399 Thornall Street, First Floor, Edison, NJ 08837. The business phone number is 732-902-4000.

Why It Matters

For investors and stakeholders tracking Hepion Pharmaceuticals, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Hepion Pharmaceuticals' financial performance and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's financial health, understand its business model, and evaluate potential risks and opportunities.

Risk Assessment

Risk Level: medium — Hepion Pharmaceuticals, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, posing inherent risks to financial performance and market success.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Hepion Pharmaceuticals' current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-04-16 — Filing Date (Filed as of date)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• Hepion Pharmaceuticals, Inc. (company) — Filer name
• ContraVir Pharmaceuticals, Inc. (company) — Former company name
• Edison, NJ (location) — Business address city and state
• 08837 (location) — Business address ZIP code
• 732-902-4000 (phone) — Business phone number

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government agencies, which can impact product development, approval, manufacturing, and marketing.
• Financing and Liquidity Risks [high — financial]: The company may require additional financing to fund its operations and development programs, and there is no assurance that such financing will be available on favorable terms.
• Research and Development Risks [high — operational]: Drug development is a lengthy, expensive, and uncertain process, with a high rate of failure. Clinical trial results may not be positive.

Industry Context

Hepion Pharmaceuticals operates in the biopharmaceutical sector, focusing on the development of novel therapies for liver diseases. This industry is characterized by long development timelines, significant capital requirements, and stringent regulatory hurdles.

Regulatory Implications

The pharmaceutical industry is heavily regulated by bodies such as the FDA. Companies must adhere to strict guidelines for drug development, clinical trials, manufacturing, and marketing to ensure product safety and efficacy.

What Investors Should Do

1. Analyze the company's cash burn rate and future funding needs.
2. Evaluate the progress and potential of the company's drug pipeline.
3. Assess the competitive landscape and regulatory environment for Hepion's target indications.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-04-16: 10-K Filing Date — Date Hepion Pharmaceuticals filed its annual report.

Year-Over-Year Comparison

This is the 2023 annual report filing (10-K), following previous filings which would include quarterly reports (10-Q) and other material events.

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share HEPA The Nasdaq Capital Marke
• $0.7 million — e restructuring charge of approximately $0.7 million in the fourth quarter of 2023. Addition
• $2.0 million — ued in March 2022, and (2) a payment of $2.0 million to Ciclofilin shareholders, including a
• $0.8 million — ders, including a payment to our CEO of $0.8 million and other Hepion employees of $0.2 mill
• $0.2 m — 8 million and other Hepion employees of $0.2 million, which such payment being made in
• $1.0 million — made in January 2022, (ii) a payment of $1.0 million upon the positive read out of the first
• $5.0 million — the Phase IIb trial, (iii) a payment of $5.0 million upon initiation of the first Phase III
• $8.0 million — on for CPI-431-32; and (v) a payment of $8.0 million upon the regulatory approval by the U.S

Filing Documents

• hepa-20231231.htm (10-K) — 1327KB
• hepa-q4202310xkxex211.htm (EX-21.1) — 4KB
• hepa-q4202310xkxex231.htm (EX-23.1) — 2KB
• hepa-q4202310xkxex232.htm (EX-23.2) — 3KB
• hepa-q4202310xkxexx311.htm (EX-31.1) — 10KB
• hepa-q4202310xkxexx312.htm (EX-31.2) — 10KB
• hepa-q4202310xkxexx321.htm (EX-32.1) — 5KB
• hepa-q4202310xkxexx322.htm (EX-32.2) — 5KB
• hepa-q4202310xkxex971.htm (EX-97.1) — 53KB
• hepa-20231231_g1.jpg (GRAPHIC) — 11KB
• 0001583771-24-000003.txt (&nbsp;) — 6733KB
• hepa-20231231.xsd (EX-101.SCH) — 49KB
• hepa-20231231_cal.xml (EX-101.CAL) — 64KB
• hepa-20231231_def.xml (EX-101.DEF) — 249KB
• hepa-20231231_lab.xml (EX-101.LAB) — 570KB
• hepa-20231231_pre.xml (EX-101.PRE) — 427KB
• hepa-20231231_htm.xml (XML) — 753KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 13 Item 1B. Unresolved Staff Comments 39 Item 1C. Cybersecurity 39 Item 2.

Properties

Properties 40 Item 3.

Legal Proceedings

Legal Proceedings 40 Item 4. Mine Safety Disclosures 40 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 41 Item 6. [Reserved] 41 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 41 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 48 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 49 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 73 Item 9A.

Controls and Procedures

Controls and Procedures 73 Item 9B. Other Information 74 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 75 PART III Certain information called for by Part III (Items 10, 11, 12, 13 and 14) has been omitted as Registrant intends to file with the Securities and Exchange Commission not later than 120 days after the close of its fiscal year a definitive Proxy Statement pursuant to Regulation 14A. 76 PART IV Item 15. Exhibits and Financial Statement Schedules 77 Item 16. Form 10-K Summary 78

SIGNATURES

SIGNATURES 79 1 Table of Contents Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this Annual Report about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan" and "would." For example, statements concerning financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from any results, levels of activity, performance or achievements expressed or implied by any forward-looking statement. We do not assume any obligation to update forward-looking statements as circumstances change and thus you should not unduly rely on these statements. Any forward-looking statements are qualified in their entirety by reference to the risk factors discussed throughout this Annual Report. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: Market conditions; Our capital position; Our ability to compete with larger better financed pharmaceutical companies; Our uncertainty of developing marketable products; Our ability to develop and commercialize our products; Our ability to ob

BUSINESS

ITEM 1. BUSINESS Overview We are a biopharmaceutical company headquartered in Edison, New Jersey, focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma ("HCC") associated with non-alcoholic steatohepatitis ("NASH"), viral hepatitis, and other liver diseases. Our cyclophilin inhibitor, rencofilstat (formerly CRV431), is being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. NASH is the form of liver disease that is triggered by what has come to be known as the "Western diet", characterized especially by high-fat, high-sugar, and processed foods. Among the effects of a prolonged Western diet is fat accumulation in liver cells (steatosis) which is described as NAFLD and can predispose cells to injury. NAFLD may evolve into NASH when the fatty liver begins to progress through stages of cell injury, inflammation, fibrosis, and carcinogenesis. People who develop NASH typically have additional predisposing conditions such as diabetes and hypertension, but the exact biochemical events that trigger and maintain the progression are not well known. Many people in the early stages of disease do not have significant clinical symptoms and therefore are unaware that they have it. Once NASH is diagnosed, it is a major health concern as the liver often becomes fibrotic and puts individuals at increased risk of developing cirrhosis and other complications. Individuals with advanced liver fibrosis have a significantly higher risk of developing liver cancer, although cancer may also arise in some patients before significant hepatitis or fibrosis. NASH is increasing worldwide at an alarming rate due to the spread of the Western diet, obesity, and other related conditions. Approximately 4-5% of the global population is estimated to have NASH, including the USA, and NASH

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View this 10-K filing on SEC EDGAR