Pieris Pharmaceuticals, Inc.

Greetings and welcome to the PRS Pharmaceuticals Second Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tom Burr, Vice President, Finance. Thank you. You may begin.

Good morning, everyone, and thank you for joining us for our second quarter 2021 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, Vito Kauffman, our chief scientific officer, and Shane Olwell, our chief development officer, who will be available for Q&A. We also have on the line Tim Demuth, our chief medical officer, who joined us just this week, who will introduce himself later in the call. You can access the press release released this morning on the investor relations page of our website at www.Puris.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 related to the timing and progress of our clinical trials and preclinical programs, 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. I will now turn the call over to Steve.

Thank you, Tom, and thank you to everyone for joining us today for our 2021 second quarter earnings call. I want to begin by extending a warm welcome to Dr. Tim DeMuth, who Tom just noted joined as our chief medical officer and who comes with deep clinical development experience. While Tim understandably will be in listening mode for the Q&A session during this call, he will provide some prepared remarks before Q&A on what attracted him to Peirce. I also want to congratulate Shane, whom all of you know, on his recent appointment as Chief Development Officer. Tim, Shane, and Hito Kaufman, our Chief Scientific Officer, also on the call today, who has been doing a terrific job driving our innovative Annie Kalin platform the past two years. They're the perfect complements in our quest to build and position novel therapeutic proteins that translate great science into transformative medicines for patients. Now, turning to our accomplishments, In the last few months, I'm pleased to update you on the significant progress we have made, most notably signing a strategic partnership with industry leader Genentech, bringing in an additional $20 million as an upfront payment, along with more than $1.4 billion in potential milestone payments, plus tiered royalties on commercialized programs. We also unveiled our proprietary respiratory program, PRS-220, for idiopathic pulmonary fibrosis, or IPF, alongside a $17 million grant from the Bavarian government to evaluate the program in post-COVID pulmonary fibrosis as well. With Genentech, we have a multi-program research collaboration to discover, develop, and commercialize locally delivered respiratory and ophthalmology therapies that leverage our proprietary anticalin technology. We will be responsible for discovery research and early preclinical development of initial programs and Genentech will be responsible for IND-enabling activities, clinical development, and commercialization of those programs. We now have multiple academic and industry respiratory alliances, and we remain deeply committed to inhaled biologics, which have already shown benefit in the clinic within our AstraZeneca alliance. To partner with a company like Genentech reinforces we are achieving a high bar on scientific leadership, And we're pleased to do this not only for inhaled biologics, but also another local application, namely ophthalmology via intraocular delivery. I'm also excited to discuss our most recently disclosed proprietary respiratory asset, PRS-220, which we unveiled last quarter. PRS-220 is this inhaled anticalin protein targeting CTGF, or connective tissue growth factor, for the treatment of IPF. There is a clear unmet need for IPF, which affects 3 to 5 million people worldwide and about 130,000 people in the U.S. each year. Median survival is 2 to 5 years from the time of diagnosis, and currently approved treatments provide very modest benefit while carrying significant side effects. We believe this unmet need can be best addressed through a local inhaled approach, which would allow for targeted delivery directly into the lungs and potentially avoid the systemic side effects seen with current standard of care. CTGF is a clinically validated target with data indicating that inhibition of CTGF reduces the decline in lung function among patients with IPF while being safe and well tolerated. Yet there may be limits to treatments that target CTGF systemically. A systemically administered CTGF treatment requires IPF patients who have limited mobility to leave their homes for treatment given via intravenous infusion. An inhaled approach, on the other hand, could be conveniently administered at home. Additionally, systemic treatment requires an inefficient high dose, while an inhaled approach would likely be much more efficient. And with PRS220, we seek to repeat the paradigm of PRS060, in which we select a validated target that has been shown to work in the clinic via a systemic intervention against the target, And we then create a more efficient inhaled local intervention with the promise of a lower dose, a more convenient administration route, and potentially improved therapeutic window. We look forward to presenting initial preclinical data for PRS-220 at this year's European Respiratory Society International Congress on September 5th in a poster presentation. And also for PRS-220, I want to mention that we received this grant from the state of Bavaria in Germany for approximately $17 million to evaluate the program for post-COVID pulmonary fibrosis. The grant will support clinical readiness activities and initial clinical development for the program, including GLP talk studies, GMP manufacturing, and phase one clinical development. We are planning to initiate clinical development for PRS-220 next year. Moving on to our multi-program AstraZeneca partnership focused on inhaled anticalins to treat respiratory disease, AstraZeneca continues to enroll in dose patients in the first part of the two-part phase 2A study of PRS-060 or AZD1402, which is an inhaled DPI formulation IL-4 receptor alpha inhibitor that we are jointly developing for the treatment of moderate to severe asthma. As a reminder, Part 1 of the study is evaluating the safety and the pharmacokinetics of the dry powder formulation of O60 in moderate asthmatics controlled on standard of care asthmotherapy over four weeks. In Part 2 of the study, whose initiation we will announce publicly, AstraZeneca will evaluate the efficacy, safety, and pharmacokinetics of PRS-O60 over four weeks in moderate uncontrolled asthmatics having a T2 endotype. with the primary endpoint being FEV1 improvement compared to placebo. We are looking forward to announcing the results of this study next year, at which time we will have the options to co-develop and separately co-commercialize the drug in the United States. In addition to O60, we have four early stage programs we are working on with AstraZeneca, which continue to advance and about which we will provide updates at an appropriate time. Turning now to our immuno-oncology franchise, I am pleased to report that we are planning to dose the first patient in the SINRA-BFUSP-alpha Phase 2 trial in the coming weeks. As a reminder, SINRA-BFUSP-alpha, or SINRA, is a 4-1BB HER2 bispecific that we are currently developing for HER2-high and HER2-low gastric cancer. In Phase 1 studies, the drug showed single-agent activity, biomarker data supportive of its mechanism of action, and an acceptable safety profile. SINRA also showed activity in patients with immunologically cold tumors, as well as those with HER2 low-expressing tumors, both of which represent high unmet medical needs. The Phase II study design will involve two 20-patient arms, one with HER2 high patients and one with HER2 low patients. The HER2 high arm will evaluate SINRA in combination with the current second-line standard of care regimen, ramiserumab and paclitaxel, and is supported by a drug supply agreement with Lilly for ramiserumab. The HER2 low arm will evaluate SINRA in combination with tucatinib-tucisa, a small molecule inhibitor of HER2 and HER3, and is supported by a drug supply agreement with C-GEN. Given the high prevalence of gastric cancer in Asia, we will be enrolling the study in South Korea in addition to the U.S. We will continue to monitor the evolving treatment landscape closely, in particular in the HER2 high landscape, and will maintain a high bar for the planned go-no-go analysis of this study in each setting. We will be evaluating a number of efficacy measures, including objective response rate, ORR, duration of response, and safety. In the HER2 high arm, we are setting the ORR target at a minimum of 50%, and in the HER2 low arm, we are setting the ORR target at a minimum of 40%. Both targets are higher than the 28% benchmark for ORR established by the standard of care in these settings. We remain confident, based on the data we have generated in our Phase I studies, that we can achieve these goals. Beyond SINRA is our second most advanced IO asset, PRS344, or Servier discloses S0950125. PRS-344 is a 4-1-BB-PD-L-1 bispecific we are co-developing with Servier and where we, PRS, hold full U.S. rights. We are planning to dose the first patient in the Phase I study of PRS-344 this year, and we continue to make great progress towards this goal. This global open-label Phase I dose escalation study will evaluate the safety, tolerability, and preliminary evidence of antitumor activity of 344 in patients with advanced solid tumors whose cancer progressed on standard-of-care treatment. PRS34 is designed to activate 4-1-BB on tumor-specific T-cells when bridging to PD-L1-expressing cells within the tumor microenvironment or the draining lymph nodes, and thereby avoid the systemic toxicities previously reported with other 4-1-BB bispecifics. Given this power of the IO-IO intervention, several considerations are critical to achieving an optimal therapeutic window. First, PRS344 has a low nanomolar potency and a several-fold reduced affinity for 401 compared to PD-L1, which is important given the bifunctional agonism of 401 versus the antagonism potential of PD-L1 blockade. Second, there is a silenced IgG4-FC backbone to avoid undesirable peripheral immune complex formation. Third, it exhibits bivalency on 401 to remain inactive peripherally, yet has a potent 401 activation potential when bridging to PD-L1 positive cells, allowing it to avoid disrupting peripheral immune surveillance while driving 401 engagement locally. Overall, we believe This bispecific target combination has already shown some remarkable benefit in clinical development, yet we believe PRS344 has the potential to improve upon this, and we are looking forward to beginning this study soon. This concludes my prepared remarks, and I would now like to let Tim introduce himself before I hand the call back over to Tom, who will then guide you through our second quarter 2021 financial results. Over to you, Tim.