Pieris Pharmaceuticals, Inc.

Greetings and welcome to the PRS Pharmaceuticals Inc. Q3 earnings 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. I would now like to turn the conference over to your host, Mr. Tom Burrows, CFO. Please go ahead, sir.

Good morning, everyone, and thank you for joining us for our third 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. Tim DeMuth, our chief medical officer, Keto Kaufman, our chief scientific officer, and Shane Orwell, our chief development officer, all of whom 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.peiris.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 PEIRIS, including statements relating 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 third quarter earnings call. I am pleased to report that as we continue to advance a very exciting pipeline on our own and together with our several great alliance partners, we ended the quarter with a healthy balance sheet of over $125 million, which Tom will discuss in greater detail later, and which will get us through key milestones next year. Among the most important of these milestones is the top-line data from the entire Phase IIa study of PRSO60 AZD1402, an inhaled dry powder formulation IL-4 receptor alpha inhibitor we are jointly developing with AstraZeneca for the treatment of moderate to severe asthma. Dosing has been completed in Part Ia of the global Phase IIa study of PRSO60. The objective of Part Ia is to evaluate the safety and pharmacokinetics of the dry powder formulation in moderate asthmatics controlled on standard of care over four weeks. Data unblinding and review will now follow, the outcome of which we will publicly disclose, gaining progression to the second part of the study, where efficacy will be assessed in moderate uncontrolled asthmatics. In part two of the study, AstraZeneca will evaluate the efficacy, safety, and pharmacokinetics of O60 over four weeks in moderate uncontrolled asthmatics having a T2 endotype, with the primary endpoint being FEV1 improvement compared to placebo. Upon reporting the top line results of the entire Phase IIa study next year, we will have the options to co-develop and separately co-commercialize PRS-060 in the United States. Beyond PRS-060, we continue to advance four early stage programs that we are working on together with AstraZeneca. Another respiratory pipeline catalyst we are looking forward to next year is initiating clinical development for our recently announced fully proprietary respiratory program, PRS220, an inhaled antitalin protein targeting CTGF, or connective tissue growth factor, for the treatment of idiopathic pulmonary fibrosis. We reported preclinical data for the program at the European Respiratory Society International Congress in September, providing the rationale and supportive data for the advantages of a local intervention against CTGF, such as with PRS220. Data presented on the drug-like properties for PRS220 demonstrated its suitability for delivery to the lungs via nebulization, the intended administration route. Additionally, the data showed that in head-to-head preclinical studies, PRS220 achieved greater target engagement and more efficient mitigation of lung fibrosis than pamrevlimab, a systemically administered monoclonal antibody against the same target and which has provided clinical validation via a randomized phase 2A study in IPF patients. These data support our thesis that a CTGF inhibitor locally administered through inhalation, like PRS220, may be a superior approach to a systemically administered antagonist. We will also be evaluating this program for post-COVID pulmonary fibrosis with the support of a grant approximating 17 million U.S. dollars from the state of Bavaria in Germany. The grant will support clinical readiness activities and initial clinical development for the program, including GLP tox studies, GMP manufacturing, and phase one clinical development. Before moving on to our immuno-oncology pipeline, I would also briefly like to mention the progress of the Genentech collaboration we signed earlier this year. We have now initiated joint discovery activities for the two committed programs, one in respiratory and one in ophthalmology, as part of the collaboration to discover, develop, and commercialize locally delivered therapies that leverage our proprietary Andy Kalin platform. We are excited to be working with an industry leader, Genentech, on these programs, and we look forward to giving additional updates on their progress in due course. With that, I would now like to give an update on our immuno-oncology pipeline, beginning with synribofusp-alpha. As a reminder, SYNRA, also known as PRS343, is a 4-1BB HER2 bispecific that we are currently developing for HER2 high and HER2 low gastric cancer and which is entering Phase II. The Phase II study design is comprised of 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 standard of care regimen, ramiserumab and paclitaxel, to be supported by a drug supply agreement with Lilly for ramiserumab, while the HER2-low arm will evaluate SINRA in combination with tucatinib a small molecule inhibitor of HER2 and HER3 to be supported by a drug supply agreement with cGen for 2-catenin. As previously reported, we plan to report initial efficacy data from the HER2 low arm next year, for which we are setting a bar of at least 40% objective response rate, or ORR, which is significantly higher than the 28% benchmark established by the standard of care. In addition to ORR, we will be evaluating duration of response, disease control rate, and safety. For the HER2 high arm, given the evolving treatment landscape, we have recently made a strategic decision to focus enrollment on a more homogenous patient population, namely those patients who have progressed after just one line of therapy. Given this change, we now expect to report data from this arm in 2023, which includes ORR, duration of response, disease control rate, as well as safety and tolerability. As we have previously guided, the bar for our go, no-go criteria for this HER2 high arm is a composite of measures, including an ORR of at least 50%. We and our advisors believe that a 50% response rate with a good durability and attractive safety profile would represent an important option for patients with HER2 high gastric cancer. Turning to our next IO program, we are nearing dosing of the first patient in the Phase 1-2 study of PRS344 or S095012, a 4-1BB PD-L1 bispecific, and we have received regulatory clearance to conduct the study in a number of jurisdictions. The global open-label dose escalation study will evaluate the safety, tolerability, and preliminary evidence of anti-tumor activity in patients with advanced solid tumors whose cancer progressed on standard of care treatment. PIRIS holds full U.S. rights for this program in collaboration with Servier, who holds ex-U.S. rights. Lastly, as part of our immuno-oncology update, I'm pleased to announce that we have initiated a second program within the bispecific immuno-oncology collaboration with C-GEN. a program that includes a co-promotion option for purists in the United States. Furthermore, CGEN is continuing to develop the first program, an undisclosed Annie Kalin-based buy specific. I would now like to hand the call back over to Tom, whom I would also like to congratulate on his recent promotion to Chief Financial Officer. Tom oversees all financial matters and capital markets-related activities at the company, including treasury, tax, financial planning, procurement, and investor relations. And lastly, I would also like to congratulate Ahmed Moza on his recent promotion to chief business officer. In his new role, Ahmed will head business development and portfolio strategy, in addition to serving as general counsel and Boston site head. Tom, please go ahead.