Cardiff Oncology, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Thank you, Robert, and I also have my colleague, Josh Muntner, our CFO here with us, and thank you for inviting us, and we look forward to the discussion.

Yes. We are quite pleased that we have reached a settlement with our licensor, our partner, Nerviano Medical Sciences, out of Italy. We had licensed the molecule from them back in 2017, and we had some dispute that we were litigating in the courts, but I'm pleased that that is over. We have an out-of-court settlement, and the two parties will mutually resolve each other of all claims. Some of the key highlights about this settlement are, number 1, that we will collaboratively focus on taking onvansertib forward in phase III for patients. I think that is the most important thing. We retain exclusive worldwide rights to the molecule and its development and all decision-making. We maintain our inventorship. There has been no changes to the patents. They continue to be Cardiff patents. The royalty rates remain the same.

There has been some extension in terms of the period of royalty, and we have filed an 8-K, so if anyone's interested, they should look into additional details about this resolution in the 8-K. We would continue to work collaboratively, seek their input, but final decision-making remains with us, and they have a board observer seat that they will also get as part of it, an observer seat.

The royalties are generally tied to valid claims, or patents. The prior agreement obviously was tied around the composition of matter patents that we had licensed back in 2017. With patent term extension, that term was to go to 2035. Without going into specific details, which we have not disclosed, that term has been extended.

Okay. It wasn't a term set in stone, but I'm saying that the patent term extension would have taken this to 2035, and now it's definitely been extended.

Yes. There are quite a few questions in one. I do want to start by just summarizing the promising data that we released at ASCO earlier, and especially in RAS mutated first line colorectal cancer, an indication which hasn't seen any new therapies come in for the last couple decades, almost. It's pretty much the standard of care has been chemo combinations with bevacizumab, which is an anti-angiogenic agent. As our data showed, that was a randomized controlled study with two different doses of onvansertib, our PLK1 inhibitor, along with two predominant standard of care regimens that are used. One is FOLFIRI/BEV, and the other one is FOLFOX/bevacizumab. Our benefit was predominantly in FOLFIRI/BEV.

Not for the first time, but this is the second time we showed that the drug, onvansertib, works best when combined with FOLFIRI and bevacizumab in first line. So, where we had reached an overall response rate of 72% versus 42% or so in the standard of care arms. Based on that, our discussions with the agency have been very productive. We have a dose that we would take forward. That is the 30-milligram dose, which showed the most benefit in combination with FOLFIRI/BEV. We have agreed on the regimen to take forward with the FDA, FOLFIRI/BEV, and they gave us guidance for a simplified trial design based on which we came back and have now designed the study as a one-to-one randomization to FOLFIRI/BEV, which is one of the standard of cares.

The second arm is 30 milligrams of onvansertib to be combined with FOLFIRI and bevacizumab in patients with first line prospectively selected for RAS mutations and all RAS mutations. That is the key. Our phase III design is currently designed to enroll around 640 patients between those two arms. The agency did allow us to go for accelerated approval should the data be compelling, which is based on overall response rate, as well as some durability. The same study can continue for full approval based on PFS too.

We have obviously not disclosed the entire statistical plan. However, I again want to remind you that in the data that we released at ASCO, by the way, our phase II is still ongoing, the PFS in the two standard of care arms was what has been previously reported between 11 to 12 months, and we have not reached median PFS in the onvansertib arm in combination with FOLFIRI/BEV. As of the time of ASCO results, we had not reached median PFS. It is difficult for me to go into all the details at this point to reveal that. But I will say that we have powered the study well for PFS. There is greater than 90% power that we should be able to show a difference in PFS that is clinically meaningful.