Equity markets have been volatile this year due to macroeconomic and geopolitical factors. Many of the world's largest corporations haven't escaped the sell-off, and it's hard to predict what's next. Even so, Wall Street has high hopes for some companies.
Take Verve Therapeutics ( VERV -0.43% ) , a small-cap, clinical-stage biotech. Based on the drugmaker's average price target of $24.
43 (according to Yahoo! Finance), the stock could soar by 321% in the next 12 months. That isn't unheard of in the exciting biotech industry, but before rushing to buy Verve Therapeutics' shares, here's what investors need to know about the company. Verve Therapeutics recently hit a milestone Clinical-stage biotech stocks can experience significant value increases due to promising clinical or regulatory news.
If Verve Therapeutics has any chance of soaring by more than 300% in the next year, the company will have to impress the market with its leading candidate, VERVE-102. This product is nowhere close to approval, but can it make enough progress to match the Street's estimates? Notably, Verve Therapeutics recently announced positive results from a Phase 1b clinical trial for VERVE-102 as a potential treatment for heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease. HeFH is a genetic disease that causes elevated levels of LDL cholesterol (LDL-C) -- also known as "bad" cholesterol -- which, in high concentration, can lead to severe cardiovascular issues.
During the study, a single injection of VERVE-102, an in vivo gene editing therapy, led to a mean LDL-C reduction of 53% in patients. The medicine also showed a reasonable safety profile. These results look promising, especially when considering VERVE-102's potential target market.
Verve Therapeutics estimates that there are approximately three million patients in the U.S. and the European Union with HeFH, and 31 million globally.
While treatment courses exist, they typically focus on lowering LDL-C levels. VERVE-102, with just one infusion, could address the problem at its source -- a one-time curative option might be a game changer in this area. That said, it will still be a while before VERVE-102 is approved.
Verve Therapeutics plans to start phase 2 in the second half of the year. Further, it could still encounter clinical and regulatory setbacks. For all those reasons (and more), Verve Therapeutics' recent clinical success "only" led to a 24% share price increase in one day.
Is there any upside left for the stock? Verve Therapeutics is unlikely to see its share price double -- let alone quadruple -- in the next year. There won't be much more significant progress for VERVE-102 in this period, while its other pipeline candidates, which are still in early-stage studies, are unlikely to have a bigger impact on its stock performance than its leading program. Still, that doesn't mean the stock isn't a good investment.
Should investors consider adding shares of the gene editing specialist to their portfolios? Like most clinical-stage biotech companies , Verve Therapeutics is far too risky for most investors and isn't worth the trouble, at least not yet. True, it has the backing of a pharmaceutical giant, Eli Lilly, with which it is partnering to develop VERVE-102. That makes it less likely that Verve Therapeutics will run into funding issues -- something that can severely damage a small drugmaker's prospects.
It's also true that Verve Therapeutics' approach could set a new standard of care for HeFH and some related cardiovascular diseases. Even so, it will take at least a couple of years before VERVE-102 starts Phase 3 studies, assuming everything goes as expected for the company. If Verve Therapeutics encounters significant headwinds with its leading program, investors could be left with (almost) worthless shares.
So, while the stock has considerable upside potential, provided everything goes as planned, there is also ample downside risk. Risk-averse investors should watch this one unfold from the sidelines for now, despite Wall Street's lofty expectations..