Good day, ladies and gentlemen and welcome to the Pieris Pharmaceuticals to host first quarter 2023 investor call. All lines have been placed on a listen-only mode. 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 Bures, CFO. Sir, the floor is yours. Thank you. Good morning, everyone, and thank you for joining us for our 1st 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. Hitto Kaufmann, our Chief Scientific Officer, and Shane Olwill, 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.pieris.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 Pieris, 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. 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 Pieris undertakes no obligation to update any statements to reflect future events or circumstances. With that, I will now turn the call over to Steve. Well, 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 pre-clinical programs, which we believe carry transformative potential versus current modalities. Our top priority remains the study completion and readout from the elarekibep phase iia study in asthma. elarekibep is an oral inhaled IL-4 receptor alpha antagonist, also referred to as PRS-060 or AZD-1402, which is partnered with AstraZeneca. I will provide commentary on our two fully proprietary inhaled respiratory programs, PRS-220 and PRS-400, that Pieris is advancing alongside elarekibep. Pieris's Anticalin 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. In turning first to our top priority, elarekibep, we continue to work closely with our partner, AstraZeneca, who is enrolling the ongoing phase iia 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 screens. 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 4 weeks, the study's primary efficacy endpoint, are anticipated to be reported by the middle of 2024. This readout will focus on the 3-milligram 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-milligram DPI dose cohort in mild controlled asthmatics was successfully completed. That portion of the study enrolled all-comer moderate controlled asthmatics who received either 10 milligrams of elarekibep or placebo twice daily on top of background therapy, which was ICS/LABA over 4 weeks. This not only provides additional data supporting the elarekibep safety profile, but also enables higher doses to be evaluated in the future if needed. The elarekibep 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, elarekibep 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 elarekibep could address important shortcomings of currently approved drugs and transform how asthma is managed. With elarekibep 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. 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 has demonstrated superior on-target potency compared to pamrevlumab, which is an intravenously infused CTGF 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 elarekibep, 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 I 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 PRS-220 data at the ATS 2023 International Conference. In a poster session, presented data will show how PRS-220 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-1 antagonist being developed for the treatment of muco-obstructive 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-1 induced signaling on lung epithelial cells, thereby reducing mucus expression. 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 mucus hypersecretion in a therapeutic disease model. PRS-400 is advancing towards clinical development candidate nomination later this year. Turning now to our immuno-oncology pipeline, 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, Seagen, 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 pre-clinical and clinical data. First, in April, highly encouraging clinical results from the company's study of cinrebafusp alfa or PRS-343 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. Pieris 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/2 study of PRS-344 or S095012 which is a 4-1BB PD-L1 Mabcalin bispecific for the treatment of solid tumors. Next, within our Seagen 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 PRS-346, at the start of 2023. SGN-BB228 is a first in class CD228 and 4-1BB bispecific antibody Anticalin compound designed to provide a potent co-stimulatory bridge between tumor-specific T-cells and CD228 expressing tumor cells. Beyond this program, we are committed to delivering on two other programs with Seagen, for which we receive full reimbursement for internal and external spending on those programs. Lastly, within the immuno-oncology franchise, Boston Pharmaceuticals continue to advance BOS-342, also known as PRS-342, which is a 4-1BB GPC3 bispecific Mabcalin 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 human dosing on this program, and we believe that clinical entry of this program, which will be the fourth clinical stage 4-1BB bispecific 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. Cash, cash equivalents and investments totaled $48.4 million for the quarter ended March 31, 2023, compared to a cash and cash equivalents balance of $59.2 million for the year ended December 31, 2022, with the decrease being a result of funding operations during the first quarter this year. The first quarter historically is a higher cash burning quarter due to annual bonus and insurance payments that occur in this time frame. Compared to the first quarter of 2022, our operating cash burn decreased by more than $8 million. The company believes that operations are sufficiently funded for more than the next 12 months. As previously noted, our operating plans for the current year include the benefit of cost saving actions we have already taken, and we are prepared to gate future investments on PRS-220 and PRS-400, including certain phase ii readiness activities for PRS-220 and IND enabling activities for PRS-400 in the interest of achieving our top priority, namely obtaining the data for the elarekibep phase iia study in asthma. Based on the current timelines for AstraZeneca to deliver this study, we are confident we will be able to achieve our cash reach objectives by making appropriate investment decisions, leveraging anticipated modest milestones from existing collaborations. We will continue to pursue partnering discussions and assessing the opportunities of using the equities market to maintain pipeline progression while awaiting the elarekibep readout. Research and development expenses were $13.4 million for the quarter ended March 31, 2023, compared to $14.1 million for the quarter ended March 31, 2022. The decrease was due primarily to lower clinical costs for cinrebafusp alfa and lower personnel costs, license fees and software costs. These lower costs were partially offset by higher overall program investments on PRS-220 and higher pre-clinical costs for discovery stage programs, both partnered and proprietary. General and administrative costs were $4 million for the quarter ended March 31, 2023, compared to $4.4 million for the quarter ended March 31, 2022. The period-over-period decrease was primarily driven by lower professional services, consulting and insurance costs. For the quarter ended March 31st, 2023, $2 million of grant income was recorded with respect to PRS-220, compared to $2.1 million for the quarter ended March 31st, 2022. The decrease was due to slightly lower overall costs incurred on PRS-220. In addition, interest income was $400,000, approximately $400,000 for the quarter ended March 31st, 2023, given the impact of rising interest rates over the last 12 months, compared to a de minimis amount in the quarter ended March 31st, 2022. Finally, the company's net loss was $13.2 million or $0.45 loss per share for the quarter ended March 31st, 2023, compared to a net loss of $5.1 million or $0.07 loss per share for the quarter ended March 31st, 2022. With that, I will hand the call back over to Steve. Well, thank you, Tom, and thank you for joining us all on the call today. We would now like to take the opportunity to open the call for any questions you might have. Thank you. The floor is now open for questions. If you do have a question, please press star one on your telephone keypad at this time. If your question has been answered, you can remove yourself from the queue by pressing one. Again, ladies and gentlemen, it's star one to ask a question on the phone. Our first question comes from Jonathan Miller from Evercore. Go ahead, Jonathan. Thanks so much for taking my question, guys. I would love to ask about the 220 program. Let's suppose that FibroGen's phase III looks good, looks great. What's your path forward for 220, given other constraints on bandwidth? How can you advance rapidly off of the healthy volunteer data coming, second half? Again, supposing the FibroGen study is supportive. Thanks, Jon. Thanks for the question. We continue to be very mindful of the upcoming FibroGen readout for pamrevlumab, and we are mindful of the guidance that that data will be presented by the middle of this year. We believe that we can cost effectively manage the progression of PRS-220 through that time and beyond that. As a reminder, the ongoing phase one is budgeted and is continued on plan, and we intend to finish that and announce top line data by the end of this year, in the second half of this year. For any related activities that are gating to phase iia, we can modestly keep those moving forward for the near term. We do believe that the pamrevlumab readout, which would be anticipated soon, will, if positive, lead to a very strong inflection point for PRS-220 and our story. We believe that we can leverage that inflection point to cost-effectively continue to advance the program towards the clinic. As we have always done, we've looked at different ways to access capital that leverages, whether it's the balance sheet, equities or partnering. We continue to see all of those as possible and things that we will continue to look over the next couple of weeks, couple of months in particular. We will be watching closely, and we look forward to, and we are rooting for that program, and we think that it will be further validation of the intervention point for CTGF and to treat IPF. We think a superior approach is to go locally. Okay, makes sense. Then I guess sort of relatedly, although, a different targets. For the PRS-343 program, which you had previously discontinued, for strategic reasons. You know, I'll agree that the AACR data looked really supportive. Again, if you're seeming more focused in the respiratory, direction now, I know you mentioned a bunch of different options in your prepared remarks for how to advance that program. Can you give us any color about any conversations you've been having already, and what the timeline would look like for you making some sort of strategic decision about PRS-343? Sure, Jon. Thanks. I'll start with just the data. I mean, the data that we presented at AACR, albeit a small data set, they were striking. In five patients who were all, you know, rather heavily pretreated, all had had HER2 therapies, checkpoint blockade, multiple patients had what is seen as one of the most amazing advancements in the HER2 space in some time with Enhertu. Our patients had progressed off of those therapies and responded. Not just responded, but had durable benefit in all, nearly all cases with this regimen on top of second-line standard of care ramucirumab, paclitaxel. Although the data set are small, they're compelling. We think that a number of groups appreciate that, ranging from potential investors, private investors, as we talked about a spin co option, to pharma, large and small. These things take time. I think no company knows that better than Pieris, who has a number of partnerships under its belt and knows that the right deal isn't rushed. We will continue to leverage what I would characterize as very real, very enthusiastic interest in the program that we will continue to pursue, given our strategic focus to use our balance sheet and our P&L on the respiratory franchise, as we had previously communicated and will continue to focus on going forward. I'm not going to comment on the specific discussions that wouldn't be appropriate, but I will just reiterate that interest is real, it's advancing, and I believe that there will be additional patients dosed with this drug in the future, and it won't be Pieris Inc. Stay tuned. I would say in terms of guidance, again, no deal is rushed, but I would say towards the back half of 2023 is a good line of sight to be able to talk more about that program. Okay, thanks so much. Thank you, Jon. Our next question comes from Matt Phipps from William Blair. Go ahead, Phipps. I'm sorry. Go ahead. No, no problem. Thanks for taking my question. Just curious, playing devil's advocate, if pamrevlumab fails in the primary endpoint of the ZEPHYRUS-1 trial, I guess what else would you be looking at that, you know, if there are maybe some secondary endpoints like lung fibrosis that would give you still confidence in the mechanism, but maybe just issues with obviously pamrevlumab itself or are there any other indications you might consider as well? Thanks, Matt. I mean, I'll start at a high level and I'm happy to turn it over to Shane to add just a bit of color. I would say that if the trial is negative, if the pamrevlumab phase III ZEPHYRUS-1 trial is negative, of course we would wanna understand the reason for missing the endpoint. For example, lower than expected efficacy may not be a reason to stop development as we believe that targeting the lung directly with an inhaled Anticalin will achieve a better inhibition of the actions of CTGF. It will be a function of when one could access the data at a deeper level. While there are other indications beyond IPF that could be relevant, including progressive fibrotic interstitial lung disease, we do believe that the PRAISE data are pretty compelling and that that is showing the validation of IPF as a high priority indication for a CTGF intervention. That still in our view remains the top indication to pursue. We will again with caution on not wanting to scoop the conference next week or in 2 weeks at ATS. We will be presenting additional data that support a, I think, a compelling rationale for a local approach, and that's pre-clinical data. We will have news that will, and press release that will detail that in due course coinciding with the poster being released later this month. Shane, you're welcome to provide any additional more color on how we'd be thinking through a gray zone or other outcomes that are not a positive top line hit on FVC for pamrevlumab. Sure. Thanks, Matt, for the question. Just to remind, people that, you know, pamrevlumab did show striking activity in the phase ii PRAISE study. There was a significant impact at the FVC level. They also had some additional assessments, including quantitative lung fibrosis. Another measure that you're actually reducing, slowing down the disease progression. When we consider the pamrevlumab data, we will certainly look at those primary and secondary endpoints. We'll also look at the behavior of placebo within the study. Just to point out a few things where, you know, we feel that we are differentiated. CTGF is expressed at high levels in the system. We don't believe that that plays any role in the lung fibrosis. However, if you actually administer a drug systemically, like with pamrevlumab, there will be a large target sink there, and only a portion of the drug administered will actually make its way to the lung, the site of disease. By administering our drug by inhalation, we're gonna have better lung exposure, and we feel it's very important. One of the things that FibroGen has presented is a subpopulation analysis of their study where, by their own admission, they feel they may be underdosing some patients. They had identified a trough level which they felt would give maximal efficacy. However, with the current dosing regimen, only about half of the patients will actually receive that. By, you know, by our more potent molecule, it's got a higher affinity for the target, so it's more potent than pamrevlumab. We, via our administration route, we have the ability to deliver the drug more effectively. By our dosing regimen, we can ensure that we are also over what we believe is the optimal dosing. I think there are some significant differences. Along with that, from a clinical strategy perspective, there's the opportunity to differentiate as well. One of the things that FibroGen and Pam have decided to do with pamrevlumab is go without standard of care, and we see the opportunity to go with standard of care. Some strategic decisions there. Notwithstanding all of that, we're big believers in the pathway and the data that FibroGen have generated through that phase ii phase. We just have to wait like everyone else for the phase III data and review it when it comes in the middle of the year. Yeah. Thanks, Shane. Just quickly remind me, the phase I is nebulized, and you, that is what you plan to take forward as well? Our phase I study is with a nebulizer. The nebulizer technology has moved on dramatically. These handheld devices are pretty portable. And the delivery time is just a matter of minutes. When we talk to key opinion leaders and consider the primary primary research, we believe that a nebulized delivery is appropriate for the IPF population. Great. One last question. I know you mentioned 344 collaboration with Servier. I'm sorry if I missed it. Are you planning on sending results for that anytime soon? Are you kind of waiting also to see the landscape shake out with those targets from some competitor programs? Yeah. Thanks, Matt. It's Steve here again. I think you've had 2 points to your question around the timing. Maybe timing for data, timing for decision on expansion. I think, you know, as I said before, you know, phase I escalation can take time. It's hard to predict when one gets to an RP2D or an optimal biologic dose. We continue to advance the program with Servier as planned, as budgeted, and we will, you know, continue to look at the data over the, you know, the middle and the second half of this year to inform OBD, RP2D and potential expansion. There is flexibility in the, in the, in the collaboration around how one could parse out the expansion and prioritize expansion, whether to commit expansion. We will be looking at firstly our data. We will of course also secondarily be looking at or importantly, the competitive landscape. We expect additional data to come out of medical conferences over the second half of the year. Of course we have to look at our overall strategy where as we said, we are continuing to prioritize our respiratory franchise. I think good data will be rewarded and we're continuing to work through the all-important first part of escalation. We're not yet ready to talk about the data publicly, but once we can, we will and we will likely put that out in the context of a medical conference together with Servier. Great. Thanks, Steve. Thanks, Matt. Thank you. That was the last question. I would now like to turn it back to Steve Yoder for any closing remarks. No other remarks other than to thank everyone again for your attention and for your continued support of our company. We are truly excited by the promise of our inhaled biologics pipeline and the opportunity to improve outcomes for patients with respiratory diseases. We look forward to updating you on our progress as we go forward. Thanks everyone and have a great day. Thank you. This does conclude today's conference. We thank you for your participation. You may disconnect your lines at this time and have a wonderful day.