Pieris Pharmaceuticals, Inc.

Good morning, ladies and gentlemen, and welcome to the PRS Pharmaceuticals second quarter earnings call. I will now turn the program over to Tom Burrs, Chief Financial Officer.

Good morning, everyone, and thank you for joining us for our second quarter 2022 conference call and corporate update. On the call today, we have Steve Yoder, our President and CEO, who will provide a corporate overview and outlook on our pipeline, Hito Kaufman, our Chief Scientific Officer, and Shane Olwell, our Chief Development Officer, who will be available for Q&A. You can access the press release released this morning on the Investor Relations page of our website at www.PIRIS.com. Before we begin, I'd like to caution that comments made during this conference call may contain forward-looking statements involving risks and uncertainties regarding the operations and future results of operations of PIRIS, including statements related to the timing and progress of our clinical trials and preclinical programs, including the anticipated timing for reporting of data, our partnerships and our financial position, and actual results or events may differ materially from those expressed or implied by such forward-looking statements. Factors that might cause such differences are described in our filings with the SEC, including our annual, quarterly, and current reports. The information being presented is only accurate as of today and PEIRS undertakes no obligation to update any statements to reflect future events or circumstances. With that, I will now turn the call over to Steve.

Thank you, Tom, and thank you to everyone for joining us today for our second quarter 2022 earnings call. Before diving into the detailed updates from today's earnings release, I would like to acknowledge the tough economic climate, not least for small cap biotech companies like PEIRS. While we are excited about the high-value potential of our programs and their continued advancement, along with the fact that we have several committed alliance partners to help advance this pipeline, we have not been spared the tough decision-making that goes along with being a resource-constrained company in this market environment. The challenges of drug development require the need to focus, which is our guiding principle, as we continue to prioritize our lead respiratory program PRSO60 or AZD1402. These themes will be reflected during today's call as we cover an update of our pipeline, the outlook over the coming quarters, and the ability of our balance sheet and cost-effective program structures to deliver on our goals. Turning to our pipeline, I would first like to give an update on our lead respiratory program, which I just mentioned, PRSO60 or AZD1402, an inhaled IL-4 receptor alpha inhibitor that we are developing with AstraZeneca for the treatment of moderate to severe asthma. AstraZeneca is conducting the Phase IIa study with a dry powder formulation. Having successfully completed the safety portion of the 1 milligram and 3 milligram cohorts in moderate asthmatics controlled on standard of care last year, AstraZeneca is currently enrolling the 1 milligram and 3 milligram efficacy dose cohorts. In this part of the study, PRSO60 is being administered twice a day on top of standard of care regimen in moderate uncontrolled asthmatic patients, randomized across two doses and one placebo arm. Additionally, AstraZeneca is currently enrolling the 10 milligram safety portion of the Phase IIa study, randomized between treatment to placebo. In last quarter's earnings update, we communicated there was a heightened risk of a delay in the availability of top-line results from the Phase IIa study, given geopolitical and pandemic-driven challenges. We are now guiding that, following a timeline re-forecast by AstraZeneca, accounting for the challenges of recruiting for respiratory clinical trials caused by the continued impact of COVID-19, the top-line results for the Phase IIa study are now expected to be reported by the third quarter of 2023. This updated timeline follows a significant amount of analysis and is informed by two important updates to the study, which I will now explain in more detail. First, AstraZeneca is simplifying the protocol to relieve site burden and increase recruitment rates. This includes changes such as broadening ICS or LABA, the standard of care combinations, and allowing separate devices, modifying FEV1 criteria, and broadening exacerbation criteria to cite a few examples. Second, AstraZeneca will be focusing the efficacy phase on the three milligram dose, which is anticipated to be a dose that represents an optimal composite of efficacy and commercial attractiveness based on data from prior studies and the modeling of the three milligram dose, as well as CMC considerations. In connection with the aforementioned trial amendments intended to boost enrollment rates, AstraZeneca will then cease enrollment of the one milligram cohort and will no longer be enrolling a 10 milligram efficacy cohort. AZ remains committed to completing enrollment of the ongoing 10 milligram safety cohort. Accordingly, the top line results to be reported next year will include the safety data for all three dose cohorts, that is the 1 milligram, 3 milligram, which have both passed the safety gate, and the 10 milligram, which is ongoing, the efficacy data from the 3 milligram cohort, which we continue to believe is appropriately powered versus placebo for a proof of concept study assessing FEV1 improvement, and some limited efficacy data from the 1 milligram cohort, given that patients will continue to be randomized into the 1 milligram cohort until the aforementioned protocol amendments become active. We believe that these study design updates will allow AstraZeneca to run a more focused and efficient study without compromising on what we believe is the key cohort of the study in which we think will ensure a well-informed co-development opt-in decision following review of the Phase IIa data next year. Beyond PRSO 6-0, we continue to work on two discovery stage programs with AstraZeneca for which we recently extended our research term. We retain co-development and U.S. co-commercialization options for each of these two programs. Beyond our partnered respiratory pipeline, we are making high-impact investments on a focused set of proprietary assets. Our most advanced proprietary asset is PRS220, a proprietary inhaled anticalin protein targeted connective tissue growth factor, or CTGF, for the treatment of idiopathic pulmonary fibrosis, which continues to move forward according to plan. I'm pleased to report that a regulatory filing seeking authorization for a first in human clinical study has been submitted. Pending approval, we expect PRS220 will enter a phase one study in healthy volunteers as an oral inhaled nebulized formulation later this year with the study outcome anticipated next year. I would now like to give a brief update on our IO pipeline beginning with what has been our flagship 401 bispecific program for several years, which is our 401 HER2 bispecific PRS343, SINRIVA plus alpha, or SINRA for short, which has been in a phase two study for both HER2 high and separately HER2 low gastric cancer. As a reminder, in a phase one escalation study, SINRA had shown clear single-agent activity, especially demonstrating meaningful activity in HER2-expressing gastric cancer patients. We believe the publicly disclosed clinical data from SINRA revalidated 401 as a clinical intervention point, leading to several additional third-party approaches to localized 401 agonism. Despite the progress we have made on this program since it entered clinical development as the first clinical stage 401 by specific, We have made a strategic pipeline decision to cease enrollment of this program in order to focus our resources, and we are now conducting an orderly wind down of this program. Although we will no longer be advancing this program towards approval, the clinical data we have generated with CNRA have been of great value, giving both PIRIS and its partners conviction in our 401 based by specifics franchise more broadly. I want to sincerely thank the team who has worked tirelessly on bringing SINRA forward, to the patients that have participated in our trials, and to the investigators who have worked with us on the clinical development of this drug candidate. Speaking of our broader 401 franchise, we continue to enroll the Phase 1-2 study of PRS-344, also known as S095012, which is a 401 Andy Kalin-based bispecific for the treatment of solid tumors that we are developing in collaboration with Servier. We expect to have data from the study to inform expansion on a select number of jointly vetted indications by year end. We continue to believe this program has the potential to drive clinical benefit, and we are narrowing in on what indications we would like to pursue. Indication selection criteria include an efficient development approach, combining a high probability of success to both proof of concept and BLA filing, along with a consideration for biology, regulatory path, and financial considerations. As a reminder, we retain full U.S. rights for this program, and we receive royalties on any ex-U.S. sales by Serviega. Beyond PRS344, Servier is also continuing the development of PRS352 or S095025 in OX40 PD-L1 bispecific. I would like to quickly end on a brief update on some of our other collaborations with other programs within our oncology franchise. First, Boston Pharmaceuticals continues to advance PRS342 or BOS342 a 401GPC3 bispecific towards the clinic. We expect phase one to begin in the first half of 2023, which would trigger a milestone payment. Additionally, CJEN continues to make great progress advancing the first program within our alliance, which is an undisclosed co-stimulatory bispecific. We are pleased with the progress of the program, for which we hope to share additional details later this year. CJEN also continues the development of a second program in the collaboration. and we retain a co-promotion option in the United States for one of the programs in the Alliance. Beyond oncology, Genentech Discovery Stage Collaboration we initiated last year continues to be a source of excitement for us, further bolstering our respiratory pipeline while investigating a new application for our technology in ophthalmology, in addition to additional platform investments. As a final update, I would like to mention that Dr. Tim Demut, who has served as Senior Vice President and Chief Medical Officer, will be leaving the company, and I would like to thank Tim for his contributions to PIRIS and to wish him all the best in his future endeavors. As we stay focused on PRS-060, partnered with AstraZeneca, PRS-344, partnered with Servier, and PRS-220, which will soon enter a phase one study in Healthy Volunteers, we're fortunate to have a great stable of partners to complement a solid talent base at Purist to advance several programs through multiple clinical readouts within the next 12 months. This concludes my prepared remarks, and I would now like to hand the call over to Tom.