Hepion Pharmaceuticals(HEPA) - 2021 Q2 - Quarterly Report

PART I—FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and internal controls for the reported period Item 1. Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's business, accounting policies, financial instruments, and other relevant disclosures for the periods ended June 30, 2021 and December 31, 2020 Condensed Consolidated Balance Sheets The balance sheet shows a significant increase in cash and total assets as of June 30, 2021, primarily driven by a recent common stock offering, with total stockholders' equity also seeing a substantial rise while total liabilities experienced a modest increase | Metric | June 30, 2021 ($) | December 31, 2020 ($) | | :----------------------- | :-------------- | :------------------ | | Cash | $110,091,003 | $40,726,838 | | Total current assets | $113,673,189 | $42,634,299 | | Total assets | $119,753,280 | $48,645,253 | | Total current liabilities | $7,101,550 | $4,661,827 | | Total liabilities | $9,031,933 | $8,124,862 | | Total stockholders' equity | $110,721,347 | $40,520,391 | Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported no revenues for both periods, with net loss and comprehensive loss increasing significantly for the three and six months ended June 30, 2021, primarily due to higher research and development and general and administrative expenses, as well as a substantial increase in the change in fair value of derivative instruments and contingent consideration | Metric | 3 Months Ended June 30, 2021 ($) | 3 Months Ended June 30, 2020 ($) | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | | :------------------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenues | $— | $— | $— | $— | | Research and development | $4,185,942 | $2,950,340 | $7,684,597 | $5,587,671 | | General and administrative | $2,668,657 | $1,825,074 | $5,201,465 | $3,374,680 | | Total operating expenses | $6,854,599 | $4,775,414 | $12,886,062 | $8,962,351 | | Loss from operations | $(6,854,599) | $(4,775,414) | $(12,886,062) | $(8,962,351) | | Change in fair value of derivative instruments-warrants and contingent consideration | $(808,070) | $(69,095) | $(831,859) | $(108,775) | | Net loss and comprehensive loss | $(7,665,161) | $(4,940,080) | $(13,722,467) | $(9,166,697) | | Net loss per common share (Basic and Diluted) | $(0.10) | $(0.58) | $(0.21) | $(1.43) | Condensed Consolidated Statements of Changes in Stockholders' Equity Stockholders' equity significantly increased from December 31, 2020, to June 30, 2021, primarily due to the issuance of common stock, net of $82.1 million, and stock-based compensation expense, despite a net loss | Metric | December 31, 2020 ($) | June 30, 2021 ($) | | :-------------------------------- | :------------------ | :-------------- | | Total Stockholders' Equity | $40,520,391 | $110,721,347 | | Net loss (6 months ended June 30, 2021) | N/A | $(13,722,467) | | Stock-based compensation expense (6 months ended June 30, 2021) | N/A | $2,352,770 | | Issuance of common stock, net (6 months ended June 30, 2021) | N/A | $82,153,600 | | Accumulated Deficit | $(104,105,463) | $(117,827,930) | Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2021, the company experienced a substantial net increase in cash, primarily driven by significant cash provided by financing activities, which offset cash used in operating and investing activities | Cash Flow Activity | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(12,518,930) | $(7,789,316) | | Net cash used in investing activities | $(93,920) | $(9,242) | | Net cash provided by financing activities | $81,977,015 | $11,437,399 | | Net increase in cash | $69,364,165 | $3,638,841 | | Cash at end of period | $110,091,003 | $17,561,813 | Notes to Condensed Consolidated Financial Statements These notes provide detailed explanations of the company's operations, financial position, and accounting practices, covering business overview, basis of presentation, significant accounting policies, recent accounting pronouncements, stockholders' equity, fair value measurements, intangible assets, accrued liabilities, share-based payments, loss per share, and commitments and contingencies 1. Business Overview Hepion Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing drug therapies for chronic liver diseases, including NASH and viral hepatitis, with its lead cyclophilin inhibitor, CRV431, having achieved positive topline results from its Phase 2a NASH clinical trial and exploring CRV431 for COVID-19 - Hepion Pharmaceuticals, Inc. is a biopharmaceutical company developing drug therapy for chronic liver diseases, including fibrosis and hepatocellular carcinoma (HCC) associated with NASH, viral hepatitis, and other liver diseases[25] - The lead molecule, CRV431, is a cyclophilin inhibitor targeting multiple pathologic pathways in liver disease progression, showing reductions in liver fibrosis, inflammation, and cancerous tumors in preclinical NASH models, and in vitro antiviral activity against hepatitis B, C, and D viruses[25][26] - The company announced positive topline results from its Phase 2a "Ambition" NASH clinical trial on July 13, 2021, meeting all primary endpoints and confirming CRV431 tolerability and dose range for future trials[30] - INDs for CRV431 have been approved for HBV (June 2018), NASH (July 2019), and COVID-19 (December 2020), with Phase 1 HBV data positive and Phase 2a NASH trial completed[27][29][32] 2. Basis of Presentation The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim reporting and include all necessary adjustments, with the company maintaining a strong cash position but having an accumulated deficit and expecting continued losses, necessitating future capital raises, while the COVID-19 pandemic has not materially impacted financial statements for the reported period, and a PPP loan was repaid in June 2021 - The unaudited condensed consolidated financial statements are prepared following SEC requirements and U.S. GAAP for interim reporting, including normal recurring adjustments[33] - As of June 30, 2021, the company had $110.1 million in cash, an accumulated deficit of $117.8 million, and working capital of $106.6 million, with cash used in operating activities of $12.5 million and a net loss of $13.7 million for the six months ended June 30, 2021[35] - The company expects to incur losses for several years and will require additional capital in the future to fund development and commercialization, with current cash balances believed to be sufficient for more than one year[35][36] - The COVID-19 pandemic has not had a material impact on the condensed financial statements for the three and six months ended June 30, 2021, and a PPP loan of $176,585 was repaid in full in June 2021[37][40] 3. Summary of Significant Accounting Policies This section outlines the company's key accounting policies, including the use of estimates, cash management, fair value measurements (with Level 3 inputs for derivatives and contingent consideration), property and equipment depreciation, goodwill and in-process R&D impairment testing (no impairment found), income taxes (with a full valuation allowance for U.S. deferred tax assets), contingencies, expensing of R&D costs, share-based payments valuation, foreign exchange translation, and segment reporting (single segment) - The company's significant accounting policies, including the use of estimates, cash, fair value of financial instruments, derivative financial instruments, property and equipment, goodwill and IPR&D, income taxes, contingencies, research and development, share-based payments, foreign exchange, and segment information, remain unchanged from the December 31, 2020 Annual Report on Form 10-K[42] - Derivative instruments (warrants) and contingent consideration are recorded at fair value, with valuations primarily using Level 3 inputs (unobservable inputs) such as stock price volatility and projected milestone achievement dates[46][51][96] - Goodwill ($1.87 million) and In-Process Research and Development (IPR&D) ($3.19 million) are indefinite-lived assets tested annually for impairment, with no impairment recorded for the six months ended June 30, 2021 and 2020[99][100] - Research and development costs are expensed as incurred, and the company maintains a full valuation allowance for its U.S. net deferred tax assets[63][69] 4. Recent Accounting Pronouncements The company adopted ASU No. 2020-06, which simplifies accounting for convertible instruments, on January 1, 2021, with an immaterial impact on its condensed consolidated financial statements - The company adopted ASU No. 2020-06, "Accounting for Convertible Instruments and Contracts in an Entity's Own Equity," on January 1, 2021, which simplifies accounting for certain financial instruments[78] - The impact of adopting ASU 2020-06 on the condensed consolidated financial statements was immaterial[78] 5. Stockholders' Equity and Derivative Liability — Warrants This section details the company's preferred stock, common stock, and warrant activities, highlighting the conversion of Series C preferred stock, the expiration of certain warrants, and the accounting for liability-classified warrants using the Black-Scholes model, with a significant common stock offering in February 2021 generating $82.1 million in net proceeds - As of June 30, 2021, there were 85,581 shares of Series A Convertible Preferred Stock and 1,807 shares of Series C Convertible Preferred Stock outstanding, with 10 Series C shares converted into 92 common shares during the six months ended June 30, 2021[79][80] - Warrants issued in connection with equity financings are deemed derivative instruments due to contingent put features and are recorded as a derivative liability, adjusted to fair value quarterly using the Black-Scholes option pricing model with Level 3 inputs[48][51][85][86][88] | Metric | December 31, 2020 ($) | June 30, 2021 ($) | | :--------------------------------------- | :------------------ | :-------------- | | Balance of derivative financial instruments liability | $11,673 | $3,532 | | Number of Warrants Outstanding | 102,642 | 98,328 | | Change in fair value of warrants (6 months ended June 30, 2021) | N/A | $(8,141) | - On February 16, 2021, the company completed an underwritten public offering of 44,200,000 shares of common stock at $2.00 per share, generating net proceeds of $82.1 million, intended for research and development and general corporate purposes[92] 6. Fair Value Measurements The company's contingent consideration and derivative liabilities related to warrants are measured at fair value using Level 3 inputs, with the fair value of contingent consideration increasing from $2.57 million to $3.41 million due to updated assumptions, including a reduced discount rate and increased probability of success for certain milestones | Description | Fair value (June 30, 2021) ($) | Fair value (December 31, 2020) ($) | | :-------------------------------- | :------------------------- | :--------------------------- | | Contingent consideration | $3,410,000 | $2,570,000 | | Derivative liabilities related to warrants | $3,532 | $11,673 | - Contingent consideration and derivative liabilities are classified as Level 3 fair value measurements, relying on significant unobservable inputs[94] - The fair value of contingent consideration increased by $840,000 for the six months ended June 30, 2021, due to management's review and adjustment of assumptions, including a reduced discount rate (7.0% from 8.0%), increased probability of success for milestone 2, and extended projected achievement dates for milestones 3 and 4[96][98] 7. Indefinite-lived Intangible Assets and Goodwill The company's indefinite-lived intangible assets consist of IPR&D valued at $3.19 million and goodwill at $1.87 million, with no impairment losses recorded for either asset during the six months ended June 30, 2021 and 2020 | Asset | Balance at December 31, 2020 ($) | Balance at June 30, 2021 ($) | | :-------------------------------- | :--------------------------- | :----------------------- | | CRV431 (IPR&D) | $3,190,000 | $3,190,000 | | Goodwill | $1,870,924 | $1,870,924 | - No impairment losses were recorded on IPR&D or goodwill during the six months ended June 30, 2021 and 2020[99][100] 8. Accrued Liabilities Accrued expenses significantly increased to $1.67 million as of June 30, 2021, from $0.66 million at December 31, 2020, primarily driven by increases in payroll and related costs, and stock-based compensation | Accrued Expense Category | June 30, 2021 ($) | December 31, 2020 ($) | | :------------------------ | :-------------- | :------------------ | | Payroll and related costs | $558,235 | $150,702 | | Stock-based compensation | $582,947 | $— | | Research and development | $361,964 | $438,856 | | Legal fees | $63,607 | $— | | Accrued taxes | $29,179 | $37,160 | | Professional fees | $52,200 | $— | | Other | $21,669 | $32,854 | | Total accrued expenses | $1,669,801 | $659,572 | 9. Accounting for Share-Based Payments The company recorded $2.35 million in stock-based compensation expense for the six months ended June 30, 2021, a substantial increase from the prior year, and due to insufficient shares available under the 2013 Equity Incentive Plan, certain option grants were classified as liability awards, requiring fair value remeasurement each period, with unrecognized compensation cost for non-vested options at $14.3 million | Expense Category | 3 Months Ended June 30, 2021 ($) | 3 Months Ended June 30, 2020 ($) | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | | :----------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | General and administrative | $994,022 | $310,718 | $1,705,613 | $316,628 | | Research and development | $400,877 | $83,893 | $647,157 | $86,229 | | Total stock-based compensation expense | $1,394,899 | $394,611 | $2,352,770 | $402,857 | - Due to insufficient shares available under the 2013 Equity Incentive Plan, certain stock option grants were accounted for as liability-classified awards, requiring fair value measurement each reporting period[103] - As of June 30, 2021, the unrecognized compensation cost related to non-vested stock options was $14.3 million, to be recognized over a weighted-average remaining vesting period of approximately 2.3 years[107] 10. Loss per Share Basic and diluted net loss per common share increased for both the three and six months ended June 30, 2021, compared to the prior year, reflecting higher net losses and an increase in weighted-average common shares outstanding | Metric | 3 Months Ended June 30, 2021 ($) | 3 Months Ended June 30, 2020 ($) | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | | :--------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss attributable to common stockholders | $(7,665,161) | $(4,940,080) | $(13,727,754) | $(9,166,697) | | Weighted average common shares outstanding | 76,225,245 | 8,494,518 | 64,259,470 | 6,420,109 | | Net loss per share of common stock—basic and diluted | $(0.10) | $(0.58) | $(0.21) | $(1.43) | - Several outstanding securities, including preferred stock, stock options, and warrants, were excluded from the diluted EPS calculation as they were anti-dilutive[115] 11. Commitments and Contingencies The company has various contractual obligations, including leases for office and lab space, and is involved in legal proceedings, though no material adverse effect is currently expected, with operating lease liabilities and right-of-use assets recognized, and the company having employment agreements and a related party transaction for a laboratory study - The company has noncancelable operating leases for corporate office and research laboratory space, with future minimum rental payments totaling $475,664 as of June 30, 2021[116][123] - As of June 30, 2021, Right-Of-Use (ROU) assets were $0.4 million, current lease liabilities were $0.3 million, and non-current lease liabilities were $0.2 million, with a weighted average remaining lease term of 1.64 years[122] - The company is involved in legal proceedings but does not expect a material adverse effect on its financial condition or results of operations[117] - In May 2021, the company entered into a $60,000 agreement with the Baruch S. Blumberg Institute (BSBI) for a laboratory study, supervised by a company director, believed to be on favorable terms[125] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting its biopharmaceutical focus on liver diseases, the development of CRV431, and the use of its AI-POWR™ platform, detailing the financial performance, liquidity, and capital resources, emphasizing increased R&D and G&A expenses, a significant net loss, and the impact of a recent common stock offering on cash and working capital Business Overview Hepion Pharmaceuticals is a biopharmaceutical company developing CRV431 for chronic liver diseases like NASH, which is a growing global health concern with no approved treatments, and the company utilizes its proprietary AI-POWR™ platform to optimize clinical programs, identify novel indications, and improve patient and biomarker selection, aiming to accelerate drug development and mitigate risks - Hepion Pharmaceuticals is a biopharmaceutical company focused on developing drug therapy for chronic liver diseases, including fibrosis and hepatocellular carcinoma (HCC) associated with NASH, viral hepatitis, and other liver diseases, with CRV431 as its lead cyclophilin inhibitor[129] - NASH is a rapidly increasing global disease, estimated to affect 4-5% of the population, and is the leading reason for liver transplants in the USA, with no simple diagnostic tests or approved drugs[130] - The company has developed a proprietary AI tool, "AI-POWR™," to optimize clinical program outcomes, identify novel indications for CRV431, and potentially discover new targets and drug molecules, by using multi-omics data and machine learning to enhance patient and biomarker selection[131][132][133][134] Impact of COVID-19 The COVID-19 pandemic has not materially impacted the company's financial statements for the three and six months ended June 30, 2021, although a prolonged outbreak could have future adverse effects, and a Paycheck Protection Program (PPP) loan received in April 2020 was fully repaid in June 2021 - The COVID-19 outbreak has not had a material impact on the company's condensed financial statements for the three and six months ended June 30, 2021, but a prolonged outbreak could have a material adverse impact on future financial results and business operations[135] - A $176,585 loan received under the Paycheck Protection Program (PPP) in April 2020 was repaid in full, including interest, in June 2021[136] FINANCIAL OPERATIONS OVERVIEW Since inception through June 30, 2021, the company has accumulated a deficit of $117.8 million and has not generated revenue, expecting continued losses as product development is in early stages, with a February 2021 public offering raising $82.1 million in net proceeds to fund research and development and general corporate purposes - From inception through June 30, 2021, the company has an accumulated deficit of $117.8 million and has not generated any revenue from operations, expecting to incur additional losses for several years[137] - A public offering on February 16, 2021, of 44,200,000 common shares at $2.00 per share, resulted in net proceeds of $82.1 million, intended to fund research and development activities and general corporate purposes[138] - Product development efforts are in early stages with high completion risk due to uncertainties in clinical testing, regulatory approval, capital raising, and competition[139] CRITICAL ACCOUNTING POLICIES AND ESTIMATES There were no significant changes to the company's critical accounting policies and estimates during the six months ended June 30, 2021, as previously described in its Annual Report on Form 10-K for the year ended December 31, 2020 - No significant changes occurred to the company's critical accounting policies and estimates during the six months ended June 30, 2021[141] OFF-BALANCE SHEET ARRANGEMENTS The company had no off-balance sheet arrangements as of June 30, 2021 - The company had no off-balance sheet arrangements as of June 30, 2021[142] RECENT ACCOUNTING PRONOUNCEMENTS Information regarding recent accounting pronouncements is detailed in Note 4 of the Notes to Condensed Consolidated Financial Statements - Recent accounting pronouncements are discussed in Note 4 of the Notes to Condensed Consolidated Financial Statements[143] JOBS Act The company's status as an emerging growth company ended on December 31, 2020, but it expects to qualify as a "smaller reporting company" for the foreseeable future, retaining certain exemptions from reporting requirements - The company's status as an emerging growth company ended on December 31, 2020[144] - The company expects to qualify as a "smaller reporting company" for the foreseeable future, which allows for certain exemptions from reporting requirements[144][145] RESULTS OF OPERATIONS The company reported no revenues for both periods, with operating expenses, particularly research and development and general and administrative, significantly increasing for both the three and six months ended June 30, 2021, leading to a larger net loss compared to the prior year Comparison of the three months ended June 30, 2021 and 2020 For the three months ended June 30, 2021, the company reported no revenues and an increased net loss of $7.67 million, up from $4.94 million in the prior year, driven by a $1.2 million increase in R&D expenses and a $0.9 million increase in G&A expenses, primarily due to higher clinical trial costs, consulting, employee compensation, and stock-based compensation | Metric | 3 Months Ended June 30, 2021 ($) | 3 Months Ended June 30, 2020 ($) | Change ($) | | :------------------------------------------------- | :--------------------------- | :--------------------------- | :------- | | Revenues | $— | $— | $— | | Research and development | $4,185,942 | $2,950,340 | $1,235,602 | | General and administrative | $2,668,657 | $1,825,074 | $843,583 | | Loss from operations | $(6,854,599) | $(4,775,414) | $(2,079,185) | | Change in fair value of derivative instruments-warrants and contingent consideration | $(808,070) | $(69,095) | $(738,975) | | Net loss | $(7,665,161) | $(4,940,080) | $(2,725,081) | - Research and development expenses increased by $1.2 million, primarily due to higher costs for ongoing studies and clinical trials ($0.6 million), consulting ($0.3 million), employee compensation ($0.2 million), and stock-based compensation ($0.3 million), partially offset by a decrease in CMC-related costs ($0.3 million)[147] - General and administrative expenses increased by $0.9 million, mainly due to higher stock-based compensation ($0.7 million), insurance ($0.1 million), consulting ($0.2 million), and miscellaneous costs ($0.2 million), partially offset by a decrease in foreign taxes ($0.2 million)[148] Comparison of the six months ended June 30, 2021 and 2020 For the six months ended June 30, 2021, the company reported no revenues and a net loss of $13.72 million, an increase from $9.17 million in the prior year, primarily driven by a $2.1 million increase in R&D expenses and a $1.8 million increase in G&A expenses, largely due to increased clinical trial activities, consulting, employee compensation, and stock-based compensation | Metric | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | Change ($) | | :------------------------------------------------- | :--------------------------- | :--------------------------- | :------- | | Revenues | $— | $— | $— | | Research and development | $7,684,597 | $5,587,671 | $2,096,926 | | General and administrative | $5,201,465 | $3,374,680 | $1,826,785 | | Loss from operations | $(12,886,062) | $(8,962,351) | $(3,923,711) | | Change in fair value of derivative instruments – warrants and contingent consideration | $(831,859) | $(108,775) | $(723,084) | | Net loss | $(13,722,467) | $(9,166,697) | $(4,555,770) | - Research and development expenses increased by $2.1 million, primarily due to higher costs for ongoing studies and clinical trials ($0.6 million), consulting ($0.5 million), employee compensation ($0.4 million), and stock-based compensation ($0.6 million)[151] - General and administrative expenses increased by $1.8 million, mainly due to higher stock-based compensation ($1.4 million), insurance ($0.2 million), consulting ($0.3 million), and miscellaneous costs ($0.4 million), partially offset by decreases in professional fees ($0.1 million) and foreign taxes ($0.2 million)[152] Liquidity and Capital Resources The company's working capital significantly increased to $106.6 million as of June 30, 2021, primarily due to an $82.1 million net proceeds from a February 2021 common stock offering, and despite substantial cash used in operating activities, the financing activities led to a net increase in cash, bringing the total cash balance to $110.1 million, though the company expects continued operating losses and will require additional capital in the future - Working capital increased by $68.6 million to $106.6 million as of June 30, 2021, compared to $38.0 million as of June 30, 2020, primarily due to the February 2021 common stock offering[153] | Cash Flow Activity | 6 Months Ended June 30, 2021 ($) | 6 Months Ended June 30, 2020 ($) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(12,518,930) | $(7,789,316) | | Net cash provided by financing activities | $81,977,015 | $11,437,399 | | Net increase in cash | $69,364,165 | $3,638,841 | | Cash at end of period | $110,091,003 | $17,561,813 | - The February 2021 common stock offering generated net proceeds of $82.1 million, which the company intends to use for research and development activities and general corporate purposes[158] - The company had an accumulated deficit of $117.8 million as of June 30, 2021, expects significant operating losses for several years, and will require additional capital in the future, although current cash is sufficient for more than one year[159][160] Item 3. Quantitative and Qualitative Disclosures About Market Risk This item is not applicable to the company for the reported period - Item 3, Quantitative and Qualitative Disclosures About Market Risk, is not applicable[162] Item 4. Controls and Procedures As of June 30, 2021, the company's disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting, with no changes in internal control over financial reporting occurring during the quarter, and the company is actively remediating these weaknesses by utilizing external consultants, hiring additional accounting staff, implementing software solutions, and engaging third-party consultants for process review - As of June 30, 2021, the company's disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[163] - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the three months ended June 30, 2021[164] - Remediation efforts include utilizing external consultants to review the internal control environment, hiring a Director of Financial Reporting and two staff accountants, implementing software for stock-based compensation and public company reporting, using external consultants for non-routine accounting and tax issues, and engaging a third-party consultant for business process internal controls[166][169] PART II—OTHER INFORMATION This section provides other information, including risk factors, exhibits, and signatures for the quarterly report Item 1A. Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Form 10-K for the year ended December 31, 2020 - No material changes from the risk factors disclosed in the company's Form 10-K for the year ended December 31, 2020[171] Item 6. Exhibits This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications, XBRL documents, and the cover page interactive data file - Exhibits include certifications from the Chief Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2), XBRL Instance Document (101.INS), XBRL Taxonomy Extension Schema (101.SCH), Calculation Linkbase (101.CAL), Definition Linkbase (101.DEF), Label Linkbase (101.LAB), Presentation Linkbase (101.PRE), and Cover Page Interactive Data File (104)[176] SIGNATURES The report is duly signed on behalf of Hepion Pharmaceuticals, Inc. by its Chief Executive Officer, Robert Foster, and Chief Financial Officer, John Cavan, on August 16, 2021 - The report is signed by Robert Foster, Chief Executive Officer, and John Cavan, Chief Financial Officer, on August 16, 2021[176]