Inovio Pharmaceuticals (INO -5.47%) tends to stir up strong feelings among investors. Bulls would be quick to point out that the stock is up over 430% so far this year, an impressive gain by any standard. Bears would likely counter that those gains were made in the first half of 2020. Inovio has lost much of its steam in recent months.
Regardless of what you think about Inovio, there's no question that the next few weeks and months will be very important for the biotech stock. Here are three critical catalysts on the way for Inovio.
1. Start of phase 2/3 study of INO-4800
Inovio has repeatedly stated that it plans to begin a phase 2/3 study of coronavirus vaccine candidate INO-4800 in September. But the clock is ticking to meet that goal.
What's the holdup? The company must first receive a thumbs-up from the Food and Drug Administration before it can advance INO-4800 into the next phase of clinical testing.
Inovio CEO Joseph Kim recently stated that the biotech will use the intermediary phase 2/3 process to determine what dose to administer to participants in the phase 3 portion. He said that the phase 3 part of the study is designed similarly to those of other COVID-19 vaccine candidates already in late-stage testing.
2. External funding deal
Inovio ended the second quarter in a pretty good cash position. The company reported nearly $372 million in cash, cash equivalents, and short-term investments as of June 30, 2020. However, Inovio's expenses will be much higher if it conducts a large late-stage clinical trial for INO-4800 and manufactures large quantities of the vaccine to secure supply agreements.
The company will almost certainly need more money. Kim said at the Cantor 2020 Global Virtual Healthcare Conference last week that an external funding deal is on the way to support the phase 2/3 study of INO-4800. Perhaps most importantly, Kim stated that the company expects to announce third-party funding this month.
Several of Inovio's rivals have secured funding from Operation Warp Speed, the U.S. government program established to accelerate the development of coronavirus vaccines. However, Inovio could be in discussions with other players to help fund its late-stage study. Based on Kim's comments, investors shouldn't have to worry about another stock offering. Kim said that the funding would be non-dilutive.
3. Key results for VGX-3100
With all of the buzz about INO-4800, it's sometimes easy to forget that Inovio's lead pipeline candidate is actually VGX-3100. And the company expects to announce important results for the DNA medicine soon.
Inovio should report results from the phase 3 study of VGX-3100 in treating human papillomavirus (HPV)-related precancerous cervical dysplasia in the fourth quarter of this year. Depending on those results, the company could be in a position to move forward with a regulatory filing next year.
That's not the only upcoming milestone for VGX-3100. Inovio also expects to announce full data from its phase 2 clinical studies of VGX-3100 in treating HPV-related anal and vulvar dysplasia in Q4. The biotech already reported positive interim results from these studies.
Big news and big moves
Each of these three developments could provide significant catalysts for Inovio. If the company receives a green light from the FDA for advancing INO-4800 plus a major external funding deal over the next couple of weeks, the stock would likely soar. We could even see a short squeeze unfold, considering that around 31% of Inovio's outstanding shares are sold short. Positive results for VGX-3100 later this year would be the icing on the cake.
On the other hand, investors won't react very well if there are significant delays or bad news on any of these fronts. Inovio seems destined for big news and big moves -- one way or the other.