Hepion Pharmaceuticals, Inc.

HEPA Details

Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA)  is a clinical-stage biopharmaceutical company focused on treating chronic liver disorders such as liver fibrosis, hepatocellular carcinoma (HCC), viral hepatitis, and other liver infections. The company's primary drug, CRV431, aids in the decrease of liver fibrosis and inhibits the formation of cancerous tumors. It also has antiviral properties against chronic hepatitis virus infection (HBV, HCV and HDV). Recently, the CRV 431 drug has been shown to play a significant role in the comprehensive treatment of liver illnesses, from the early stages to the final stages.

Latest News:

• Step Towards Regulatory Approval: On December 21, 2021, the US Food and Drug Administration (FDA) has accepted HEPA's investigational new drug (IND) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (HCC) in the United States. The IND clearance allows CRV431 to go directly to Phase 2 to treat HCC.

Q3FY21 Results:

• No Visibility in Topline: HEPA didn't report any revenue in Q3FY21.
• Increase in R&D Expenses: The company incurred research and development (R&D) expenses of USD 5.80 million in Q3FY21 compared to USD 3.78 million in Q3FY20. Higher spending on ongoing studies and clinical trials, consulting fees, and increasing employee compensation costs contributed to the increase.
• Expansion of Net Losses: The company's net loss increased to USD 9.27 million in Q3FY21 from USD 6.24 million in Q3FY20.
• Cash and Debt Position: As of September 30, 2021, the company had cash and cash equivalents of USD 98.73 million and no outstanding debt.

Key Risks:

• Competition Risk: HEPA's prospects are significantly dependent on the commercial success of its sole product candidate, CRV431. It has invested a considerable amount of resources in its development, and if it fails to obtain the marketing approval or put an efficient manufacturing and distribution mechanism in place, its results of operations could be adversely impacted.
• Dependence On Third-party Manufacturers: HEPA does not have its manufacturing facility and depends on third-party suppliers to manufacture its drugs. It could jeopardize its capacity to meet product demand and, as a result, the company's overall performance.

HEPA Daily Technical Chart (Source: REFINITIV)

Stock Recommendation:

HEPA's stock price has declined 38.13% in the past twelve months and is currently leaning towards the lower band of its 52-week range of USD 1.12 to USD 3.18. The stock is currently trading below its 50 and 200 DMA levels, and its RSI Index is at 58.92.

Considering the correction in the stock price in the past twelve months, progress towards regulatory approval, and associated risks, we recommend a "Speculative Buy" rating on the stock at the current price of USD 1.36, up 10.16% as of December 22, 2021, 03:06 PM ET.

* The reference data in this report has been partly sourced from REFINITIV.

* All forecasted figures and industry information have been taken from REFINITIV.

*Depending upon the risk tolerance, investors may consider unwinding their positions in a respective stock once the estimated target price is reached.