Up over 40% in just a little more than five months: That's the kind of year it's been so far for Inovio Pharmaceuticals Inc. (NASDAQ:INO) stock. The clinical-stage biotech announced its first-quarter results on May 9. Investors were less interested in what happened in the last quarter than they were in what's in store for the company in the days ahead. Here are five things management highlighted in Inovio's earnings call.
1. The phase 3 study of VGX-3100 is on track
Inovio's lead candidate, cervical dysplasia vaccine VGX-3100, appears to be right on track to begin a pivotal phase 3 study later this year. CEO Joseph Kim said that Inovio had "constructive" meetings with both U.S. and European regulators related to the end of phase 2 testing for the immunotherapy. The biotech is now finishing the details for the phase 3 study.
Kim stated that Inovio has pre-qualified nearly 150 trial sites in 25 countries. The company's manufacturing partners are already preparing to be ready for the late-stage study. Inovio anticipates that between 350 and 400 patients will participate in phase 3 testing of VGX-3100.
2. Interim results are coming this year for phase 1 studies of INO-5150 and INO-1400
VGX-3100 might be the main story right now for Inovio, but the biotech has other potential cancer drugs waiting in the wings. Kim specifically pointed out INO-5150. The immunotherapy is currently in a phase 1 study focusing on treatment of prostate cancer. INO-5150 targets antigens associated with prostate cancer: prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA).
According to Kim, Inovio expects to complete enrollment for the phase 1 study by the end of June. He indicated that 60 patients will participate in the study. Inovio plans to announce interim results from the clinical trial by the end of 2016.
The company also expects to have interim results for the phase 1 study of INO-1400 by the end of the year. Inovio initially targeted pancreas, lung, and breast cancer in the INO-1400 study. Now, however, the focus has expanded to include head and neck squamous-cell, ovarian, colorectal, gastric, and hepatocellular and esophageal cancer.
3. The MedImmune collaboration is going well
Inovio isn't going solo for all of its pipeline candidates. AstraZeneca's (NYSE:AZN) MedImmune subsidiary is funding development for INO-3112. The immunotherapy is a combination of VGX-3100 plus DNA-based immune activator encoded for interleukin 12 (IL-12).
Kim stated that Inovio expects additional immune response data from the phase 1 study of INO-3112 later this year. He also added that a study with MedImmune will be initiated before the end of 2016 "combining an Inovio immunotherapy product with another immuno-oncology technology."
AstraZeneca/MedImmune shelled out $27.5 million last year to Inovio for exclusive rights to INO-3112. Inovio stands to gain up to $700 million in milestone payments plus double-digit tiered royalties.
4. There's plenty of potential in the infectious-disease pipeline
A lot of buzz for Inovio lately has come from its infectious-disease pipeline. Inovio expects to become the first company to begin human testing of a potential vaccine for the Zika virus later this year. Kim thinks government funding could be available in the future for further Zika vaccine development.
Inovio also is working on an Ebola virus vaccine. The company received a $45 million grant from the U.S. Department of Defense's Defense Advanced Research Projects Agency to develop a preventive vaccine and treatment for Ebola. Inovio announced interim data from a phase 1 clinical trial of its potential Ebola vaccine in the first quarter. Kim said that the company will fully analyze the data from the study and release the findings in a publication when the final results are ready.
Kim expressed excitement over the potential for his company's infectious-disease program. While there's a lot of focus on VGX-3100 and the other cancer immunotherapies in Inovio's pipeline, the vaccines in development for Zika, Ebola, and other infectious diseases could be major successes for the company in the future.
5. It's in solid financial shape
Because Inovio still has no products on the market, its financial position to continue development of candidates in the pipeline is of paramount importance. The company's CFO, Peter Kies, reported good news on that front.
Inovio had cash, cash equivalents, and short-term investments totaling $146.8 million at the end of the first quarter. That amount should be sufficient to fund the phase 3 testing of VGX -3100 and development of other candidates in the pipeline.
The AstraZeneca/MedImmune partnership helps, since Inovio doesn't have to spend its own cash for INO-3112 development. And federal grants for the Ebola vaccine program (as well as potentially for the Zika vaccine development) will allow Inovio to stretch its funds out for a longer period as well.