Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) Q4 2022 Earnings Call Transcript

Stephen Yoder: Roger, I’ll just say at a high level a couple of remarks and turn it over to Tom. So, we are considering that the current cash reach will allow us to get through the data, the 060 Elarekibep, that top line data, and that is absolutely a priority. It’s probably one and something we are extremely committed to getting through on the basis of our balance sheet, and as we mentioned, modest anticipated milestones from our existing collaborations. Mechanics of co-development are pretty clear. And we also believe it’s going to be a watershed moment for that program, leading to clinical validation and we will be prepared to manage financing a co-development opt-in at that time. Tom can talk again about the specific mechanics of what triggers our co-development opt-in and what we will have at the time, both internally and externally, to communicate publicly at the time we would communicate our opt-in decision.

Thomas Bures: At the time of the top line data readout, AstraZeneca would also need to give us a development plan, a going forward development plan that they would prepare in asthma, the indication of asthma for this program to get to BLA filing. With those two pieces of information, we have to make our codevelopment opt-in decision. The opt-in, we can at two levels, one at 25% with a cost share with a cost cap, and the other is a 50% without a cost cap. In either one of those scenarios, the benefit compared to not opting in, for example, is that we get an increased share of economics for the lifetime of the program as opposed to a defined period, if we don’t opt in. So, enhanced economics on the back end. And when we think about the opt in overall, again, I think one of the pieces that we think is very manageable for us, again, regardless of our profile, is at the time of the readout, assuming the data is good, the opt-in at 25% at a minimum is something that we will achieve or have an offset of future development milestones on this program that cover about 50% of the overall opt-in cost that we would have with AstraZeneca.

So that becomes a very attractive option for us on this program. And if again we think about the, again, like the multibillion dollar opportunity in asthma and the market it brings, not even to mention the potential for COPD or other respiratory indications, again, we see the pathway that dupilumab has forged and this again creates a great opportunity for us. And so, we very much value the co-development opt-in decision that we have.

Operator: Next question is coming from Jonathan Miller from Evercore ISI.

Jonathan Miller: Just to follow on Roger’s question there. Am I understanding right that the current cash mouths, you no longer anticipate €“ the current cash runway, you no longer anticipate to be sufficient to fund that 25% opt-in on its own and you would have to finance that when the time comes. And then just related to that, when you say you’re prepared to gate for the development for 220 and 400 in the interest of 060 advancement, can you give us some color on the timelines, how those timelines might change as we wait and when you would know whether or not you can move forward with those development programs in advance of the 060 readout?