J. Joseph Kim is unflappable when skeptics point out that the DNA technology his company is banking on to make a COVID-19 vaccine remains experimental, even after nearly 40 years of research and development, going back to his days as a graduate student at the University of Pennsylvania.
“This is a new platform, new technology,” Kim said Monday before leading an earnings call on Inovio Pharmaceuticals, the biotech he cofounded and heads as CEO in Plymouth Meeting. “Just like all new technology, you’re not there until you’re there.”
That long-sought breakthrough is within reach with Inovio’s coronavirus vaccine, Kim and other company executives said during the media briefing. Results from the initial small study in humans are now being reviewed by independent experts in preparation for publication in a journal. Larger, definitive human trials are expected to begin next month.
The company, while not profitable, has seen its market capitalization balloon to $371 million on June 30, compared with $89.5 million at the end of last year. Inovio’s stock price has also soared more than 500% this year, to about $20 a share. (The closing price Monday in Nasdaq trading was down 6% to $18.99.)
“We are very proud of our response to this evolving pandemic,” Kim said during the briefing.
But biotech development is always a gamble, and the pandemic has heightened the risks as more than 100 companies around the world race to develop an immunization. Here are some of the hurdles facing Inovio.
How well does it really work?
Inovio’s technology is based on the pioneering work of company cofounder David Weiner, now a vice president of the Wistar Institute, which is collaborating on the Inovio vaccine.
The approach involves injecting a synthetic coronavirus gene into the patient. The gene instructs cells to make a signature coronavirus protein that triggers an immune response.
DNA vaccines are relatively fast and economical to produce compared with conventional technologies. But, historically, feeble immune responses have been the Achilles’ heel — a big reason a DNA vaccine has never made it to market anywhere in the world. Inovio says its patented delivery device, which briefly opens skin cells with a mild electric shock, helps boost the immune response.
In June, Inovio announced “positive” results from the early-stage trial: 34 out of 36 study participants showed signs of an immune response. But the news was so lacking in detail that it won a frosty reception on Wall Street.
Since then, some market analysts have downgraded their advice from “hold” to “sell” and urged investors to curb their enthusiasm, at least until Inovio releases detailed data.
“Risk/reward seems less palatable here,” wrote analyst Stephen Willey at the investment firm Stifel.
Inovio has been awarded millions of dollars by the Gates Foundation and other philanthropies, as well as the U.S. Department of Defense. But it was snubbed by the federal Operation Warp Speed, which is designed to accelerate development, manufacture and distribution of vaccines and diagnostics. The company claimed it was selected in a news release headline, but the finer print explained that it was chosen for a study in rhesus monkeys set up under Warp Speed.
“Inovio investors must be wondering why the company has not been chosen for one of the $1 billion handouts that other pharmaceutical companies like Johnson and Johnson, GlaxoSmithKline — and even comparably sized rival Novavax — have received,” opined the financial news website FXStreet.
Hype vs. hope
By law, businesses are supposed to be careful about making speculative statements, lest investors be misled. But it’s a fuzzy, fraught area, and Inovio has been accused of hyping its nascent COVID-19 vaccine.
In March, during a public meeting with President Donald Trump and pharma executives, Kim touted Inovio’s “innovative, 21st-century platform” that enabled it to whip up its vaccine candidate in a mere three hours. Soon after, an analyst who is shorting Inovio’s stock accused the firm of “serial stock promotion.” And soon after that, two separate groups of shareholders filed lawsuits in federal court in Pennsylvania, accusing Kim and Inovio of exaggerated claims and financial improprieties.
“Almost all biotech companies of our size have encounters with these kinds of lawsuits,” Kim said during an interview.
Inovio also has an ongoing legal fight with united, which has manufactured Inovio’s experimental vaccines for malaria, the Zika virus, MERS, and more. Inovio contends that VGX is not able to scale up enough to make the COVID-19 vaccine and should be forced to share its proprietary technology with other suppliers. A Montgomery County Common Pleas Court judge disagreed.
During Monday’s earnings call, Inovio executives said they are finalizing partnerships with suppliers in the United States and are on track to make one million doses of coronavirus vaccine this year, and $100 million in 2021.