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

Stephen Yoder: On the first question, just to be clear that, yes, we are not factoring in our runway, the ability to opt-in on the back of positive clinical efficacy data for PRS-060 or Elarekibep, but we’ve never factored that in. So, again, we believe that data set will be a watershed moment for the program. And given the timeline for that data set to be delivered and all of the other optionality within our pipeline and our history of transacting with third parties to create significant shareholder value, we remain very optimistic and confident that we will be able to manage through that at the appropriate time. The second question was around gating expenses. Well, I will say at a high level, and I’ll turn it over to Tom, that we believe we still have time to manage those critical path activities to look at multiple options that we’re working on across our pipeline.

And as you can imagine, PRS-400, more early stage, is a lower cost investment relative to PRS-220. However, PRS-220 is going to continue to benefit heavily from the Bavarian grant through the Phase 1 study, and we are absolutely committed to completing the Phase 1 study, which is on plan. There will be some Phase 2 readiness activities that we will need to consider later in the year, second half of the year. And that’s probably all we can say about that. But, again, we have time to work through a lot of different options, including what we think could be a very informative readout from FibroGen’s pamrevlumab, which has been communicated by FibroGen as something that we be disclosed by the middle of this year. So, I guess another important piece.

Nonetheless, we do believe PRS-220 has already demonstrated best-in-class potential based on the preclinical data we’ve seen and also based on the fundamental biology where we believe you absolutely should interrogate this locally to have a meaningful clinical benefit.

Thomas Bures: Maybe I’ll just add one thing in terms of the overall spending. I’d say this doesn’t change for those two programs, the path that we’re on today. It just is going to impact that going forward, later this year, as Steve mentioned, right, and how quickly we’re able to continue to move those programs along. For example, we know a Phase 2 study for PRS-220 is something we would have to independently work to fund. So, certainly, some Phase 2 readiness type activities and starting that would make sense, again, in terms of gating that type of spending in order to make sure that we have sufficient runway to achieve the readout for Elarekibep. And it’s the same thing with PRS-400. There’s a lot of costs that come into play once you get to a development candidate nomination that you’re going to have to incur for CMC and tox work to bring that to an IND state.

So those are the types of costs that those programs continue. It’s just those larger expenditures, some of those cannot be incurred or committed to in the near term.

Jonathan Miller: On the oncology side of the business, obviously, most of this is off your balance sheet and it’s being done through existing collaboration agreements, which is great. I guess I’d love to get a sense for your expectation on milestone, funding potential there, is your cash crunch in any way going to impact the potential for those programs to develop with the collaborators?