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

So we wouldn’t expect to see a significant increase there until later in the year when countries have approved the protocol on the sites that are involved in the study. So we would expect to see that happening towards the mid half of the year. So, Q2, Q3. So that’s just, unfortunately, how long it takes to get countries involved and then sites active. I hope that answers your question.

Rob Andrew: Just one other question, The dupilumab success in COPD was mentioned in the call. Could you just kind of remind us of the mechanics of what a decision to pursue an additional indication would be kind of as it relates to the original deal and opt-ins or additional indications treated separately when it comes to those kinds of decisions if there were a decision to pursue any additional indications such as COPD.

Stephen Yoder: As I mentioned, we are enthusiastic about the dupilumab data as in past other so-called T2 interventions, say, on IL-5 receptor have not produced such robust results. So, we do believe that this continues to validate IL-4Rα as the quintessential intervention point for T2 asthma, in particular stratifying as we continue to stratify patients. And as it relates to the codevelopment opt-in, we do believe there are multiple features of the codevelopment opt-in that actually facilitate Pieris being able to participate in significant upside on additional indications that makes sense for oral/inhaled administration, including COPD. Tom can talk about some of those mechanics, but some of the components that would allow us to participate should we choose to opt-in, even if the time of the opt-in, it’s not clear exactly when additional indications may be pursued. So with that, I’ll turn it over to Tom for some more of those details.

Thomas Bures: As it relates to an indication like COPD, for example, the development plan that AstraZeneca could give us, I think that is something where we’ll have to talk with them about whether they would go right after COPD right now. So, lots of discussions to still yet happen. But it would be clear, or it is very clear that the development opt-in decision is for the indication of asthma, so that’s the primary indication. However, any opt-in decisions that we take, whether it be, again, say, do nothing, the 25% or the 50%, the resulting economics apply for all future indications. So, if we’re opting in, for example, at a 50% level and we’re going to get a gross margin share, that will apply to all indications because there’s no way to split whether it’s going to be asthma or COPD or other indications in the future.

So the economic upside for AZ’s decision to expand to other indications is going to be very clear in terms of what the economic benefit would be. From a cost perspective, overall, the development plans in terms of what they give us initially, that sort of comprises the biggest piece of our sort of known commitment. There are mechanisms in the contract by which these additional costs are obligations to us where that development pattern would come into play. And we know we’re going to have those obligations. But some of it could be part of, again, like an ongoing budget or some of it could be deferred until later in terms of the overall contract timeline. So it’s a little bit more nuanced in terms of how the cost obligation comes in. But I guess I would say that’s helpful in terms of €“ we know we get the economics and then it’s just a little bit more how we pay for that.

Stephen Yoder: I would just sum up to say we would welcome additional investment in other indications as a codevelopment partner alongside AstraZeneca. We would not meet any such ambitions with fear or trepidation. It would be manageable investments based on mechanics of the contract in our view, which would allow significant growth for the program, which allows significant economic upside for Pieris.