Conference date: November 9, 2016 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2016 (Q3, third quarter)
Overview: Revenue in the quarter came from grants and collaboration as Inovio continues to move therapies towards FDA approval. As previously announced, there will be a slight delay getting Inovio's most advanced therapy into its pivotal Phase 3 trial.
Basic data (GAAP):
Revenue was $12.5 million, up sequentially from $6.2 million, but down from $24.2 million in the year-earlier quarter.
Net income was negative $20.8 million, down sequentially from negative $18.7 million, and down from $5.6 million year-earlier.
EPS (earnings per share, diluted) was negative $0.28, down sequentially from negative $0.26, and down from $0.07 year-earlier.
CEO Dr. Joseph Kim said "Our workplace mantra is patients are waiting... There will often be detours with extra steps to take ..."
A pivotal Phase III study of VGX-3100 was planned for initiation in Q4 2016 by Inovio, which completed its post Phase 2 meetings with the FDA and EMA about the trial. But the FDA has placed the trial on hold apparently related to manufacturing the delivery device, not to the data from prior trials. Was prepared to initiate the trial in November, now not until at least Q1 2017. See FDA Requests Additional Information for details.
A Phase 2 study of VGX-3100 for vulvar neoplasia (VIN) is planned for 2017.
Inovio created a subsidiary, Geneos Therapeutics, to develop cancer therapies based on personalized neo-antigens. Operating capital will be independently secured by Geneos.
Licensed a foot-and-mouth disease vaccine to Plumbline Life Sciences, which will fund development.
Inovio completed enrollment of 22 subjects in the Phase I study of our HPV-driven cancer immunotherapy, INO-3112, in head & neck cancer patients. Expects to report interim immune response and safety data in 4Q 2016. 3112 is licensed to MedImmune, which will start an additional combination trial in 2017.
Inovio is developing Ebola vaccines, including a dMAb (DNA-based monoclonal antibody) version. Interim INO-4212 Phase 1 data on 75 healthy volunteers showed it was safe and generated strong immune responses. An additional 125 healthy subjects have been enrolled. Antibody data for the second stage should be available in Q1.
Inovio initiated a Phase 1 trial for its Zika vaccine, GLS-5700, in July. That is in partnership with GeneOne Life Science. All 40 subjects have been dosed. Interim immune response and safety data may be available in Q4 2016. May also look for a larger company to partner with. Zika is on the priority voucher list. Also started a second study in healthy volunteers in Puerto Rico that is double-blind and placebo controlled.
Inovio’s phase I trial to evaluate safety and tolerability of PENNVAX®-GP, the company’s "universal" DNA vaccine for HIV completed enrollment. The trial will measure immune responses following administration of the vaccine in four groups of healthy subjects receiving the vaccine with and without an immune activator (DNA IL-12). This 94-patient study is being conducted by the HIV Vaccines Trial Network (HVTN) and funded by the National Institute of Allergy and Infectious Diseases (NIAID)." Data should be available in the first half of 2017.
Inovio’s partner for its DNA vaccine for Middle East Respiratory Syndrome (MERS), GeneOne Life Science Inc., Phase I trial is now fully enrolled. MERS has no current treatment. Data should be reported in Q4 2016.
Ongoing studies include INO-1400 in HTERT breast, lung and pancreatic cancer has now been extended to more tumor types: head & neck squamous cell, ovarian, colorectal, gastric and esophageal cancers. Enlarging to 5 trial sites with 54 subjects. Interim immune response data from first indications in 2017. The final readout will be in 2018, but could start later stage studies based on earlier cohort data. Believes it will be combined with other vaccines and checkpoint inhibitors, with more information to be provided in Q1.
A Phase 1 trial for INO-1800 for Hepatitis B is ongoing, with preliminary data possible in 2017.
Completed enrollment of 62 subjects in the phase I study of our INO-5150 prostate cancer immunotherapy. We expect to report interim immune response and safety data in 4Q 2016.
Initiated a Phase 1 trial for INO-8000 for hepatitis C partnered with the NCI and Mayo Clinic. Will measure safety, tolerability, and immune response.
Inovio is developing a set of DNA-based vaccines that allow cells to create monoclonal antibodies (dMAb technology). During the quarter Inovio announced it has positive pre-clinical results from a dMAb vaccine for Dengue fever. Inovio's Chikungunya dMAB vaccine showed good preclinical results.
A new product, INO-5400, will be added to the pipeline in 2016, in combination with a checkpoint inhibitor, targeting an as yet unannounced type of cancer.
MedImmune continues to work towards getting its INO-3112 for cancers caused by HPV, in combination with other immunotherapy molecules, into a Phase 2 trial.
Inovio also has a variety of other vaccines in clinical or preclinical study. See the Inovio Pipeline for an overview.
R&D expense was $27.0 million. General and administrative expense was $5.8 million. Gain on sale of assets of $0 million. Total operating expenses were $32.7 million. Operating profit negative $20.2 million. Loss on investment $1.0 million. Interest and other income $0.4 million. Loss from fair value of stock warrants $0 million
Cash and equivalents balance (including short-term investments) ended at $119.7 million, down sequentially from $134.5 million. $4.2 million was raised by selling common shares. Liability in common stock warrants $1.8 million.
Cash is adequate to fund all key initiatives.
AZ and MedImmune comments on i-o drugs? Just with respect to INO-3112. Our partnership with them is strong. We expect it to continue. We will present data in a poster later this week.
Zika visibility, applying for funding? Can't comment. But our studies are garnering attention from the funders. We are in early discussions with them. New data could provide new interest. We wanted to respond to the infection as rapidly as possible, we did not start fast just to get funding.
Next Zika update? Preclinical data will be published this quarter. By year end we expect early immune and safety data on the US/Canada healthy virus study. Puerto Rico study is enrolling as planned; we should have updates in 2017.
Shelf life testing for VGX-3100? We are waiting for the FDA letter, but are preparing what we can.
Geneos plans? We will own 100%, but the business will be independent, but based on our DNA therapy platform for personalized cancer therapy. This is a rapidly growing field. Any separate listing of the company would be very far down the line.
Enlargement of VGX-3100 study? Based on discussions with the FDA. We had a prior range between 350 and 400. If we get off clinical hold we will share the details of the design. We are doing the most expedient path to get the trial started. We hope to have a 3 year shelf life.
Burn rate once you start the 3100 trial? 2016 net burn for full year is about $60 million. In 2017 we expect to go up about 10% net, with some grants offsetting some spend. The next MedImmune milestone would be for starting the Phase 2 combination study some time in 2017.
Ebola emergency use application? In 2017 we plan to approach the FDA and other regulators about getting our Ebola vaccine approved for emergency use. The path will likely include the animal rule.
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