Pieris Pharmaceuticals, Inc.

Pseudocles continues to advance PRS-342 or BOS-342, which is a 4,1-BB-GPC3 bispecific MAP-Kalin compound towards the clinic, with Phase I expected to begin in the coming months. We are eligible to receive a more nominal 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 401 by specific from our IO 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 and cash equivalents and investments total $59.2 million for the quarter ended December 31, 2022, and this does not include the $5 million CGN milestone payment, which was received in February of 2023. The year-end cash balance is compared to a cash and cash equivalence balance of $117.8 million for the year ended December 31, 2021, with the overall decrease during the course of 2022 being a result of the need to fund operations. The company believes operations are sufficiently funded for more than the next 12 months. Research and development expenses were $53 million for the year ended December 31, 2022, compared to $66.7 million for the year ended December 31, 2021. This decrease is due to the lower overall program costs for both L-aricopep and cinrobifus-alpha, as well as due to lower manufacturing costs across other late-stage respiratory and immuno-oncology programs, lower license fees, and lower consulting costs. These lower costs were partially offset by higher clinical costs for PRS-220, and PRS-344 or S095012. Higher preclinical spending was also incurred on PRS-400, and there's an increase in personnel and travel costs. Next, general and administrative costs were $16.4 million for the year ended December 31, 2022, compared to $16.6 million for the year ended December 31, 2021. The period-over-period decrease was driven primarily by lower personnel, facilities, and audit and tax costs, partially offset by higher business development, travel, and amortization of deferred costs related to revenue recognition. Moving on to other income, for the year ended December 31, 2022, $8.2 million of grant income was recorded with respect to PRS 220, compared to $3.7 million for the year ended December 31, 2021. The increase is due to high overall costs incurred on PRS-220 as the program progressed into Phase I clinical studies, along with a full year of grant funding eligibility in 2022 compared to 2021, the year in which the grant was awarded. The company's net loss was $33.7 million, or a $45 loss per share for the year ended December 31, 2022, compared to a net loss of 45.7 million, or a 71 cent loss per share for the year ended December 31, 2021. With respect to my remarks that we believe operations are sufficiently funded for more than the next 12 months, I wanted to make a few additional comments. First, we believe in the immense commercial potential of our respiratory programs, and that inhaled biologics can yield transformative therapies not possible by other modalities. We remain committed to our mission and are evaluating opportunities to support the long-term development of therapeutic candidates such as PRS-220 and PRS-400. However, we cannot ignore the more constrained environment in which we are operating, and we continue to reduce our cost profile as evidenced by the significantly reduced cash burns approximately $22 million in the second half of 2022, compared to more than $40 million in the first half, while having meaningfully advanced our two proprietary respiratory programs, PRS-220 and PRS-400. Although our operating plans for the current year include the benefit of cost-saving actions we have already taken, we are prepared to gate future investments on PRS-220 and PRS-400, including certain Phase II readiness activities for PRS-220 and IMD-enabling activities for PRS-400 in the interest of achieving our top priority, namely, obtaining data from the ELERECABEP Phase IIa study in asthma. Based on the current timelines for AZ to deliver this study, we are confident we will be able to achieve our cash reach objective on the basis of our current balance sheet, making cost-saving decisions as needed, and being supported by anticipated modest milestones from existing collaborations. For that, I'll now hand the call back over to Steve.

Thank you, Tom, and thank you all for joining us on the call today. We would now like to open the call for any questions.