Pieris Pharmaceuticals, Inc.

Ladies and gentlemen, and welcome to the Paris Pharmaceuticals Inc. Third Quarter Earnings Call. All lines have been placed on a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Tom Burrs. Sir, the floor is yours.

Thank you. Good morning, everyone, and thank you for joining us for our third 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. It's O'Coffman, 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.pyrus.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 PIRIT, including statements related to the timing and progress of our clinical trials and preclinical programs, including the anticipated timing for the 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 third quarter 2022 earnings call. Today, I will give an update on how our lead programs are progressing. what upcoming catalysts to expect, and exciting new programs we have announced recently. We are driving towards numerous catalysts and inflection points over the next year across both our respiratory and our IO franchises. More specifically, within respiratory, in addition to preparing for the Phase 2A readout and subsequent opt-in decision for Alericabep, also known as PRSO60 or AZD1402, we are advancing a pipeline of wholly-owned, highly differentiated inhaled respiratory products. Similarly, within IO, we are expecting to have initiated expansion of PRS344 in co-development with Servier while anticipating clinical starts of 401BB-based IO assets by collaborators CGEN and Boston Pharmaceutical as we continue to be a leader in the realm of targeted 401BB co-stimulation. By early next year, we expect there will be three 401BB co-stimulations MABCALEN, or antibody anticalin fusion bispecifics in active clinical development. But before I go into these details, I will give a more in-depth overview on the respiratory franchise. In the Phase IIa trial of the dry powder-formulated iliricabep, an inhaled IL-4 receptor alpha inhibitor that we are developing with AstraZeneca for the treatment of moderate to severe asthma, I'm pleased to report that AstraZeneca has completed the enrollment of Part 1B, which is the safety of the 10 milligram cohort, while enrollment continues for Part 2, which is efficacy of the 3 milligram cohort versus placebo. AstraZeneca also is making great strides in addressing enrollment challenges encountered for the efficacy portion of this study. During last quarter's earnings update, we announced that AstraZeneca was pursuing regulatory and ethical submissions across all jurisdictions where the study is active with the objective of improving speed of enrollment and focusing enrollment into the three milligram cohort. AstraZeneca has since completed these submissions in all territories with acceptance and implementation tracking according to expectations. With these changes being implemented, top line results from this study are expected to be recorded in third quarter of next year. These results will include the safety data of the 1 milligram, 3 milligram, and 10 milligram dose cohorts and efficacy data from the 3 milligram cohort. As a reminder, the primary endpoint in this study is FEV1 improvement at four weeks versus placebo. This important data set alongside a development plan and a budget from AstraZeneca will trigger an opt-in decision for either 25% or 50% of cost sharing. Being in a strong position to opt-in if data are positive remains one of the highest company priorities for the coming year. Also within the AstraZeneca Alliance, we do continue to advance two discovery stage programs alongside IlliricaBEP. We retain co-development and U.S. co-commercialization options for these two programs. I would now like to spend some time discussing the fully proprietary inhaled respiratory programs we are developing, PRS-220 and PRS-400, given that the data we have generated so far with IlliricaBEP have strengthened our conviction in the validity and differentiation of our inhaled therapeutic protein approach. Earlier this week, we announced the dosing of the first subject in the phase one study of PRS-220, an inhaled antichalin protein targeting connective tissue growth factor, or CTGF, for the treatment of idiopathic pulmonary fibrosis and other forms of fibrotic lung disease. The study will evaluate the safety, tolerability, and pharmacokinetics of an oral inhaled nebulized formulation of PRS-220 in healthy volunteers. This is the second inhaled antichalin-based program we are bringing into the clinic, and we expect to report the outcome of this study next year. As a reminder, this work is partially funded by a grant from the Bavarian Ministry of Economic Affairs, Regional Development, and Energy within the framework of the Bavarian Therapy Strategy to Combat the COVID-19 Pandemic, or also known as Biotherapy 2020. Beyond PRS-220, we recently unveiled another proprietary inhaled respiratory program at the 2022 European Respiratory Society's International Congress called PRS-400, which is an inhaled JAGD1 antagonist we are developing for the treatment of muco-obstructive lung diseases. A wealth of third-party data supports that upregulation of the JAGD1 notch signaling can cause goblet cell metaplasia, hyperplasia, mucus hypersecretion, and mucus plugging. It also shows that downregulation of this pathway can drive goblet cells toward a ciliary phenotype. However, systemically administered drugs targeting notch signaling have caused systemic side effects and tolerability issues such as GI toxicities. PRS-400 is designed to block JAG1 notch signaling locally in the lung via oral inhalation with the objective of reversing, independent of stimulus, goblet cell metaplasia, hyperplasia, and mucous plugging, as well as increasing the number of ciliated cells. Preclinical data presented at ERS showed that in vitro, multiple PRS400 drug candidates can penetrate mucus-coated epithelia to potently inhibit JAG1-induced signaling on lung epithelial cells, thereby reducing mucin expression. We also achieved in vivo proof of concept with PRS400 candidates in an IL-13-induced mucus hypersecretion mouse model, not only by significantly improving mucus score and reducing goblet cell numbers, but also by significantly increasing a key marker of ciliary cells. We are excited about this program because it follows the same local treatment approach via inhalation we are taking with Aliricabep and PRS220. Moreover, JAG1 represents a highly translatable target that we believe has significant potential to treat a variety of mucobstructive diseases, and there is a strong rationale for a local inhaled intervention given the desire to avoid GI toxicities. We are continuing to work on this program in preclinical work and look forward to giving further updates in due course. Turning now to our I.O. franchise, our MAP-KALIN by specifics pipeline also has some exciting updates, including a new partnered program announcement and upcoming first in human trial starts for program, multiple partnered programs. First, I want to note that enrollment of the dose escalation portion of the Phase 1-2 study of PRS344, or S095012, remains ongoing. PRS344 is a 4,1-BBPDL1, MAPK1 bispecific, for the treatment of solid tumors we are developing in co-development with Servier, and it is our lead I.O. program. We expect to present data from the study at a medical meeting next year for this program. As a reminder, we retain full U.S. rights for this program, and we will receive royalties on any ex-U.S. sales. Beyond PRS-344, Servier is continuing development of PRS-352, or S095025, which is an AUX-40 PD-L1 bispecific for which Servier has global rights. We also continue to work on a number of programs as part of our I.O. collaboration with CGEM, And I am pleased to announce the unveiling of the first of those programs, which is SGN BB228, also known as PRS346, at the upcoming CITSE conference next week. SGN BB228 is a first-in-class 401BB CD228 bispecific MAP-Kalen compound. The I&E for the phase one study for this program has recently been accepted, and CGEN plans to initiate this study in the coming months, at which point we will receive a milestone payment from CGEN. Beyond this program, CGEN continues to develop a second undisclosed bispecific program and has recently nominated the third bispecific program for initiation within the collaboration. As a reminder, we have a U.S. co-promotion option for one program in this three-program collaboration. Turning to our most recent IO partnership, in the next six months, we also expect the initiation of the Phase I study of PRS342 or BOS342, which is a 4,1-BbGPC3 bispecific MAP-Kalin compound licensed by Boston Pharmaceuticals, which is being developed in solid tumors. Both the C-GEM program and the Boston Pharmaceuticals program represent a broadening of our clinical 401 footprint in immuno-oncology. We are excited to have the support of our many partners in advancing the various applications of the anti-K-1 technology. Among these several partners is Genentech, with whom we signed a discovery stage collaboration for one respiratory target and one ophthalmology target last year, and which continues to progress. In addition to contributing R&D know-how and resources, our partnerships have served and continue to serve as an important source of non-dilutive capital, the importance of which cannot be overstated in these current markets. This concludes my prepared remarks, and I would now like to hand the call back over to Tom.