Pieris Pharmaceuticals, Inc.

Ladies and gentlemen, and welcome to the Pierce Pharmaceuticals to host first quarter 2023 investor 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, CFO, sir. The floor is yours.

Thank you. Good morning, everyone, and thank you for joining us for our first quarter 2023 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, Fisho 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 issued 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 PURIS, including statements relating to the timing and progress of our clinical trials and preclinical programs, 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 Pierce 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. I will be providing an update on the progress we are making to advance our inhaled biologics pipeline for respiratory diseases. We continue to drive towards key catalysts in the next 12 to 15 months for our clinical and preclinical programs, which we believe carry transformative potential versus current modalities. Our top priority remains the study completion and readout from the Alerica VAP phase 2A study in asthma. Alericabep is an oral inhaled IL-4 receptor alpha antagonist, also referred to as PRS-060 or AZE-1402, which is partnered with AstraZeneca. In addition, I will provide commentary on our two fully proprietary inhaled respiratory programs, PRS-220 and PRS-400, at PRS's Advancy alongside Alericabep. Pierce's anti-Kalin platform may offer a fundamentally new approach to treating high-prevalence respiratory diseases by directly targeting the relevant lung tissue. Building upon clinically validated biology, our pipeline of therapeutics has the potential to provide increased clinical benefit, reduce side effects, and improve convenience. Our programs target large opportunities with significant unmet need that continue to be underserved by the biopharmaceutical industry. And turning first to our top priority, AlericaVep, we continue to work closely with our partner, AstraZeneca, who is enrolling the ongoing Phase 2A study for asthma as study sponsor. As we have previously communicated, AstraZeneca has committed additional clinically-focused resources to achieve study completion, including adding several new countries and a number of additional clinical sites that would bring the total to more than 100 sites across all geographies. AstraZeneca is on track with this plan to add three new geographies this quarter. With this broader clinical footprint and the important protocol amendments that became effective earlier this year, we are witnessing the positive impact in patient screenings. We anticipate this to result in a meaningful uptick in the rate of patients randomized into the study. Top-line results measuring placebo-adjusted FEV1 improvement at four weeks, the study's primary efficacy endpoint, are anticipated to be reported by the middle of 2024. This readout will focus on the 3 mg DPI dose versus placebo. Separate from these improvements in patient enrollment for the efficacy portion of the study, we were pleased to have announced that the safety review of the 10 mg DPI dose cohort in mild control asthmatics was successfully completed. That portion of the study enrolled all-comer moderate controlled asthmatics who received either 10 milligrams of Alericabep or placebo twice daily on top of background therapy, which was ICS LABA, over four weeks. This not only provides additional data supporting the Alericabep safety profile, but also enables higher doses to be evaluated in the future if needed. The Alericabep commercial opportunity remains substantial when considering the current multi-billion-dollar asthma therapeutics market. By directly targeting lung tissue through a convenient route of administration, AlericaBEP has the potential to provide a superior product profile, offering a route of administration that many patients and healthcare providers would prefer. If we are successful, we believe that AlericaBEP could address important shortcomings of currently approved drugs and transform how asthma is managed. With Alericabet being strongly supported by AstraZeneca's organizational commitment and with the increased resources provided, we look forward to obtaining study results. This important data set, alongside the delivery of a development plan and budget from AstraZeneca, will trigger our opt-in decision. Being in a position to opt in in co-development if the data are positive is a top priority for our company. Next, I would like to discuss two other highly differentiated inhaled respiratory programs that we are advancing, PRS-220 and PRS-400, both of which are fully proprietary. PRS-220 is an inhaled anticalin protein that targets connective tissue growth factor, or CTGF, for the treatment of idiopathic pulmonary fibrosis, IPF, and other forms of fibrotic lung disease and has best-in-class potential. Preclinically, PRS-220 is has demonstrated superior on-target potency compared to Pemrevlimab, which is an intravenously infused CTGS antagonist in late-stage clinical development. Critically, we believe that an inhaled route of administration provides for superior lung exposure and may lead to a superior clinical outcome compared to a systemically administered approach in this pathway. Based on these potential benefits, the convenience of at-home delivery via inhalation as well as the potential to combine PRS-220 with current standard of care for IPF, we believe PRS-220 could have best-in-class potential for this serious disease. As with Alericabep, we believe that PRS-220 could represent a tremendous commercial opportunity for our company. We continue to administer PRS-220 according to plan to subjects in a Phase I study that is evaluating the safety, tolerability, and pharmacokinetics, or PK, in healthy volunteers. We expect to report phase one study results in the second half of this year. This study, along with other ongoing activities, is supported by a meaningful grant from the Bavarian government. We are also excited to present new preclinical PRS220 data at the ATS 2023 International Conference. In a poster session, presented data will show how PRS220 significantly reduced collagen deposition in a silica-induced lung fibrosis model when delivered by inhalation. This presentation will be on Sunday, May 21st. Next, I want to provide an update on PRS-400, an inhaled jagged one antagonist being developed for the treatment of mucoobstructive lung disease. Our enthusiasm for this program is based on the large market opportunity represented by mucus-driven respiratory diseases and is supported by preclinical data showing that PRS-400 can regulate mucus production in the lung. PRS-400 is designed to block the JAG1 notch signaling locally in the lung via oral inhalation with the objective of reversing goblet cell metaplasia, hyperplasia, and mucus plugging, as well as increasing the number of ciliated cells. Unlike other interventions that aim to reduce mucus burden, PRS-400's mode of action is independent of stimulus, which we believe offers applicability across a broader patient population. Previously presented preclinical data at the European Respiratory Society, or ERS, meeting in 2022 showed that in vitro, PRS-400 drug candidates can penetrate mucus-coated epithelia to potently inhibit jagged one-induced signaling on lung epithelial cells, thereby reducing mucus expression. And on May 22nd, later this month, we will be presenting preclinical data at the ATS 2023 International Conference, demonstrating that PRS-400 reduces inflammation-driven goblet cell metaplasia and mucous hypersecretion in a therapeutic disease model. PRS-400 is advancing towards clinical development candidate nomination later this year. Turning now to our immuno-oncology pipelines, we remain committed to delivering with our partners on the several programs that they support and are advancing. With the benefit of our existing collaborators, which include Servier, CGEN, and Boston Pharmaceuticals, our immuno-oncology pipeline is being advanced in a cost-efficient manner, and we believe multiple opportunities exist to generate value from this portfolio based on promising preclinical and clinical data. First, In April, highly encouraging clinical results from the company's study of synribofus alpha or TRS343 in second line and beyond HER2 positive gastric cancer were presented at the AACR annual meeting. The results presented there showed an unconfirmed 100% objective response rate and a promising emerging durability profile in the five patients enrolled into that study. Prior to these promising results being available, enrollment in the study had been discontinued for strategic reasons. PIRIS is now considering a range of transactions, from an immuno-oncology-focused spin-out to traditional partnering transactions to facilitate the continuation of this program, given the emerging transformative activity generated in gastric cancer and the exciting potential of this program in other HER2 settings. Moving beyond PRS-343. In our collaboration with Servier, we continue to progress in the dose escalation portion of the Phase I-II study of PRS-344 or S095012, which is a 4-1BPBL1 MAPK1 bispecific for the treatment of solid tumors. Next, within our C-GEN collaboration, we earned a $5 million milestone payment when the first patient was dosed in a Phase I study for SGN-BB228, also known as PRS346, at the start of 2023. SGN-BB228 is a first-in-class CD228, 401B bispecific antibody antitalin compound designed to provide a potent co-stimulatory bridge between tumor-specific T-cells and CD228-expressing tumor cells. And beyond this program, we are committed to delivering on two other programs with CGEN for which we receive full reimbursement for internal and external spending on those programs. And lastly, within the immuno-oncology franchise, Boston Pharmaceuticals continue to advance BOS342, also known as PRS342, which is a 4-1-BB-GPC3 bispecific map-cabling compound towards the clinic, with Phase I expected to begin in the coming months. we are eligible to receive a modest milestone payment upon the first in-human dosing on this program. And we believe that clinical entry of this program, which would be the fourth clinical stage 401B by specific from our franchise, offers additional long-term upside. This concludes my prepared remarks, and I will now hand the call back to Tom. Thank you, Steve.