Pieris Pharmaceuticals, Inc.

Greetings and welcome to the Purist Pharmaceuticals third quarter 2020 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. I would now like to turn the conference over to your host, Mr. Tom Burrs, Vice President of Finance. Please go ahead.

Thank you. Good morning, everyone, and thank you for joining us for our third quarter 2020 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. Keto Kaufman, our Chief Scientific Officer, and Shane Olo, our SVP and Head of Translational Science, 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.purist.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 Purist, 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.

Well, thank you, Tom, and thank you to everyone for joining us today for our third quarter 2020 earnings call. To begin, as a brief background on Puris, we have developed a proprietary class of next-generation therapeutic proteins called anticalins. Anticalin proteins are engineered human lipocalins, which are proteins that are naturally abundant in the body and serve to bind and transport various molecules. As anticalin proteins are smaller and typically more stable and engineerable than antibodies, they can offer unique advantages over other treatment options, such as inhaled delivery to treat respiratory disorders locally or the ability to create more complex bispecific formats to drive a desired biology, as we are doing in immuno-oncology. Turning to our pipeline, I first would like to give an update on our lead respiratory program, PRSO-60-1A, also known as AZD1402, which is an inhaled IL-4 receptor alpha antagonist that we are developing in collaboration with AstraZeneca for the treatment of moderate to severe asthma. I'm pleased to report that preparations for a global phase 2A study of that program are complete and that AstraZeneca has submitted the first clinical trial application for this study. Dependent upon regulatory approval, both site initiation and patient screening are expected to begin this year. We anticipate the first patient will be dosed with PRS-060 in the first quarter of next year, triggering a milestone payment from AstraZeneca, which we plan to formally announce. The Phase 2A study will test a dry powder formulation in a moderate uncontrolled asthmatic population at up to three dose levels and will be placebo-controlled. The study will evaluate the improvement relative to placebo of the forced expiratory volume in one second, also known as FEV1, over four weeks, in addition to assessing the safety and the pharmacokinetics of PRSO60. As a reminder, our phase one studies use the nebulized formulation of this drug candidate. Since there is no clinical experience of PRSO60 as a dry powder in asthmatics, the study will also include an initial part with four-week dosing of moderate controlled asthmatics to establish safety and pharmacokinetics before enrolling moderate asthmatics who are uncontrolled on standard of care. The study will enroll over 350 patients in up to four arms, including one placebo arm, and patient enrollment criteria include characteristics of T2 inflammation. Following the completion of Phase IIa, peers will have options to co-develop and subsequently to co-commercialize PRS-060 or AZ-D1402 in the United States alongside AstraZeneca. We are pleased to be able to communicate AstraZeneca's commitment to the continued clinical development of this program, and we continue to consider PRS-060 as a key value driver for purists, given the market opportunity, the differentiation potential, and the terms of our collaboration agreement with AstraZeneca. Apart from PRSO60, our collaboration with AstraZeneca includes four additional programs. And beyond the tangible progress we have just reported with PRSO60, we also are happy to report that last quarter, AstraZeneca initiated the fourth of these additional programs, taking full advantage of all available potential new project starts envisioned in the collaboration. The Alliance remains a highly collaborative one and we are appreciative of AstraZeneca for being an engaged and fully committed partner. Now, in addition to our respiratory collaboration with AstraZeneca, there are a number of proprietary preclinical respiratory programs we are working on. We were hoping to be able to disclose some additional details for one of these programs this year, but due to COVID related delays, And for strategic reasons, we are now planning to reveal these details next year after generating some additional data to support a more informed initial disclosure. And moving beyond our respiratory franchise, I would now like to give an update on our immuno-oncology programs. And our lead I.O. program and a key value driver in this franchise is PRS-343, our 4,1-BB HER2 bispecific that we are developing for the treatment of HER2-positive solid tumors. PRS343 is the only HER2-targeted adaptive immune system engager in clinical development and was specifically designed to drive 4,1-BB agonism in the tumor microenvironment in HER2-positive solid tumors while avoiding unwanted peripheral toxicity. Clinical data generated with PRS343 In each of our phase one studies, which is a monotherapy dose escalation study and a combination dose escalation study with atezolizumab provided under a drug supply agreement with Roche, they've demonstrated clinical benefit and compelling biomarker evidence in addition to demonstrating an acceptable safety and tolerability profile of 343. We presented additional results from both studies as part of an oral presentation session at the 2020 ESMO Virtual Congress in September, showing that PRS343 continued to demonstrate durable clinical benefit in the active dose cohorts, which includes a complete response confirmed, and in heavily pretreated patients across multiple HER2-positive tumor types. Additionally, a significant expansion of CD8-positive T cells in the tumor microenvironment of responders and a substantial increase of soluble 401 observed in the active dose cohorts collectively suggest that 401 mediated target engagement is in fact driving clinical benefit. PRS343 showed an acceptable safety profile at all doses and schedules tested in each of these studies reinforcing the rationale for the intended mode of action of the drug candidate. These newly presented data reinforce our conviction in the significant potential of PRS343 to improve the lives of patients with few treatment options. And we look forward to bringing the program into the next phase of development in a proof-of-concept study in second-line gastric cancer in combination with ramiserumab and paclitaxel. As previously indicated, we signed a clinical trial collaboration agreement with Eli Lilly and Company last quarter, under which Lilly will supply us with ramiserumab. Now I will provide you with an update on the progress we have been making to remove the partial clinical hold that was placed on PRS343 studies by the United States Food and Drug Administration in July. In its issuance of the partial hold, FDA requested PERIUS to conduct robust in-use compatibility study, which is a laboratory-based study to assess the effects of dilution and any handling stress that might occur during pharmacy preparation, transport, and clinical administration of PRS-343. As a reminder, currently enrolled patients continue to receive treatment, although no new patients can be enrolled until resolution of this partial hold, and FDA did not cite any adverse events in patients as a reason for the partial hold. Today, I'm pleased to report that we have conducted and completed what we believe are the necessary studies in connection with resolving the partial hold. As part of the now completed studies, we have optimized the level of an existing excipient used during the clinical administration preparation process to enhance the stability of PRS-343 under prescribed as well as stressed conditions that could occur in preparation of 343 for patient administration in the real-world setting. We plan to submit these results to FDA today in the form of a Type A meeting request to elicit the agency's feedback on the adequacy of the stability data supporting the use of the existing excipient as a co-dialogant for PRS-343 and the clinical proposal to initiate continued development of PRS-343. We are confident that we have generated a robust data set, which will allow FDA to lift the hold after considering our forthcoming complete response letter, which we expect to submit in December pending a positive type A meeting. As a result of this decision to formally engage FDA via a type A meeting, we now expect to initiate the phase two study of PRS343 in combination with Rambacirumab and Paclitaxel next year. Although we are not able to initiate this trial this year as originally intended, our team has worked tirelessly to provide a viable path forward, and we believe the additional agency engagement that a Type A meeting entails is appropriate in view of the substantive advice on future clinical development we expect to receive from the agency through this process. And I look forward to providing an update on this matter at the appropriate time. Complementing PRS 343, our second most advanced 401 by specific program, which is PRS 344, progresses through the IND readiness stage as planned. We continue to anticipate filing an IND for this program together with Servier, our co-development partner for this program, next year. PRS 344 is a 401 PDL1 by specific where we hold U.S. rights under our alliance with Servier who holds ex-US rights. Additionally, within our Servier collaboration, we intend to complete non-GLP preclinical work for the second program in our alliance, PRS352, this year, before handing the program over to Servier, who would be responsible for further development of the program. PRS352 is a preclinical stage biologic program addressing undisclosed targets for immuno-oncology. Beyond our Servier collaboration, our CGEN collaboration also continues as planned, where CGEN continues the advancement of the first program within our alliance following the successful handover to CGEN last quarter, which generated a $5 million milestone payment as previously communicated. Now moving beyond our pipeline, I'll conclude with a few corporate updates. In the third quarter, we raised $9.7 million in net proceeds in an equity offering through our at-the-market or ATM facility. The block trade offering was with a new shareholder, Pontifax, and represents the only time we have used the facility to date. We believe this transaction provides a meaningful yet focused amount of working capital to advance the pipeline while further strengthening our shareholder base. And finally, I would like to mention that Ingmar Bruuns, formerly Senior Vice President and Head of Clinical Development at PIRIS, has moved on to pursue another opportunity. Ingmar has been an invaluable resource to me and the rest of the team during his three years at PIRIS, and we wish him all the best in his new venture. In the interim, we have dedicated clinical development advisors to support the execution of our near-term clinical objectives, together with our accomplished clinical operations and regulatory affairs teams. These resources will provide full coverage for our drug development needs while we continue to execute on an ongoing search for accomplished senior executive drug development leadership at the company. This concludes my prepared remarks, and I would now like to hand the call back to Tom to guide you through our third quarter 2020 financial results in more detail. Over to you, Tom.