Inovio Pharmaceuticals, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah. Well, first of all, thanks very much for the invitation. It is nice to be here today. Inovio is a clinical stage company. We are focused on developing DNA medicines to help treat and prevent HPV related diseases, cancer, and infectious diseases. As Eric mentioned, we have got a very exciting PDUFA date coming up in a few weeks time, on October 30 for our lead program, which is INO-3107, for the treatment of recurrent respiratory papillomatosis or RRP. Following on behind that, also based on our DNA medicines platform, we have a deep clinical pipeline of other candidates.

Yeah. DNA medicines have been around for quite a while, and what makes Inovio different is really our delivery system. We start off by identifying target proteins that we want to produce within the body. We then optimize them using our proprietary algorithms, and then we insert the optimized sequence into a circular molecule of DNA called a plasmid. Then we use our proprietary delivery system called CELLECTRA to enable the DNA plasmids to enter the cells. CELLECTRA works by very brief electrical pulses, which open pores in the cell membrane and allow the DNA plasmids to enter the cell, and then the pores close back up again. These are really rapid electrical pulses, millisecond pulses.

Once the plasmids are in the cell, they are transcribed into mRNA, then translated into protein, and then depending on how we've designed the protein, they can either be secreted from the cell or processed within the cell for antigen presentation. Our DNA medicines platform is very flexible. We can produce pretty much any kind of protein, and then we can use that protein to either drive an immune response. DNA medicine is particularly good at driving T cell responses, which is important for treating cancer and virally mediated diseases. It is also very good at producing sustained protein levels. This is particularly good for treating diseases where you've got a missing or a defective protein and you need to supply that protein. Those are really the core advantages of the platform.

We use our CELLECTRA devices to either deliver our DNA medicines to either skin or muscle cells. With the muscle cells, it is pretty similar to an IM injection, but then followed by these rapid electrical pulses, which enable the DNA plasmids to enter the cell. It is a very simple, straightforward administration. Our device consists of a base station, a handset, a single use disposable needle array. You insert the plasmid drug cassette into the single use needle array, attach it to the handset, remove the safety cap, apply it to the deltoid muscle that you previously used an alcohol wipe on, and then it is a single button press. That injects the plasmid, delivers the electrical pulses, whole process is over in seconds.

Any healthcare provider can be trained to use it, and patients tell us whilst there is mild to moderate injection site discomfort, that resolves pretty quickly within 5 to 10 minutes. Patients tell us overall, it's a very tolerable process. A key thing about DNA medicines though is unlike other T cell generating approaches like viral vectors, you don't get the systemic kind of responses, systemic flu-like symptoms that you can get with other systems. After the injection site discomfort resolves, we really see very, very few adverse events.

That really depends on the territory. In the U.S., it's regulated as a combination product, so it doesn't have a separate approval. Ex U.S., the device can be regulated independent. For instance, in the EU, we have CE marking for the device already.

Yeah. I think investors are perhaps not quite appreciating how close we are to bringing the first DNA medicine potentially to approval and commercialization, and then the deep pipeline that follows behind based on the platform. I think we have a lot of exciting potential catalysts coming up.

Yeah. I think RRP is really a great opportunity for DNA medicines because it's really leveraging a core strength of the platform, this ability to generate antigen-specific T cells that can go after the virus that causes RRP. RRP is caused by HPV 6 and 11. Inovio has had a long history of working in the HPV space, and we've demonstrated the ability to eliminate the virus in other HPV-related indications. It was a combination of our expertise in HPV treatment, a disease with really high unmet need as well, and then really leveraging this ability to drive the strong T cell response.