UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 27, 2024 PIERIS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Nevada 001-37471 30-0784346 (State or other jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) Registrant's telephone number, including area code: 857-246-89 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37471 PIERIS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Nevada 30-07843 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to Commission File Number: 001-37471 PIERIS PHARMACEUTICALS, INC. FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Nevada 30-0784346 (S ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37471 PIERIS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Nevada 30-0784346 ( ...

Financial Data and Key Metrics Changes - Cash, cash equivalents, and investments totaled $48.4 million for the quarter ended March 31, 2023, down from $59.2 million at the end of 2022, reflecting funding operations during the first quarter [24] - The company's net loss was $13.2 million or $0.45 loss per share for the quarter ended March 31, 2023, compared to a net loss of $5.1 million or $0.07 loss per share for the same quarter in 2022 [44] - Research and development expenses were $13.4 million for the quarter ended March 31, 2023, down from $14.1 million for the same quarter in 2022, primarily due to lower clinical costs [66] Business Line Data and Key Metrics Changes - The ongoing Phase 1 study for PRS-220 is on track, with top-line data expected in the second half of the year [47] - The Elarekibep Phase 2a study in asthma is a top priority, with AstraZeneca committed to additional resources and expanding the clinical footprint [31][12] - PRS-400 is advancing towards clinical development candidate nomination later this year, supported by preclinical data showing its potential [60] Market Data and Key Metrics Changes - The asthma therapeutics market is currently valued in the multibillion-dollar range, with Elarekibep targeting this significant opportunity [33] - The company anticipates a meaningful uptick in patient enrollment for the Elarekibep study due to protocol amendments and expanded clinical sites [14] Company Strategy and Development Direction - The company is focused on advancing its inhaled biologics pipeline for respiratory diseases, with a strategic emphasis on PRS-220 and PRS-400 [29] - The company is considering various transactions, including a potential spinout of its immune-oncology programs, to facilitate ongoing development [62] - The company aims to leverage anticipated modest milestones from existing collaborations while assessing opportunities in the equities market [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash reach objectives through appropriate investment decisions and partnerships [25] - The company remains committed to its respiratory franchise and is prepared to gate future investments based on the outcomes of ongoing studies [42] - Management highlighted the importance of the upcoming data readouts, particularly for the pamrevlumab program, which could significantly impact the company's strategy [71] Other Important Information - The company reported an increase in interest income to approximately $400,000 for the quarter ended March 31, 2023, due to rising interest rates [26] - The first quarter is typically a higher cash-burning quarter due to annual bonuses and insurance payments, but the operating cash burn decreased by more than $8 million compared to the first quarter of 2022 [65] Q&A Session Summary Question: What is the path forward for the PRS-220 program if FibroGen's Phase 3 looks good? - Management indicated that the ongoing Phase 1 is budgeted and on plan, with top-line data expected by the end of the year. Positive results from pamrevlumab could lead to a strong inflection point for PRS-220 [47][49] Question: What will be considered if the pamrevlumab trial fails? - Management stated that understanding the reasons for missing the endpoint is crucial. They believe that targeting the lung directly with an inhaled Anticalin will achieve better results [79][80] Question: What is the timeline for strategic decisions regarding the PRS-343 program? - Management noted that while no specific discussions could be disclosed, there is real interest in the program, and they expect to provide updates towards the back half of 2023 [75][76]

Clinical Development - Pieris Pharmaceuticals has a clinical pipeline that includes elarekibep, an inhaled IL-4Rα antagonist for uncontrolled asthma, and PRS-220, an inhaled CTGF antagonist for idiopathic pulmonary fibrosis[22]. - The phase 2a asthma study for elarekibep is ongoing, with topline data expected by mid-2024[28]. - The first patient was dosed in the phase 1 study of PRS-220 in healthy volunteers in Q4 2022, with results expected in 2023[32]. - The ongoing phase 2a study of elarekibep includes a safety review and evaluation of adverse events compared to placebo[63]. - PRS-220 is in phase 1 clinical development, with a €14.2 million grant received to support its research and development[64]. - Elarekibep demonstrated a 36% relative reduction in FeNO at the 20 mg dose compared to placebo, with a p-value <0.0001, indicating significant efficacy in reducing eosinophilic airway inflammation[62]. - The inhaled route of administration for PRS-220 offers advantages over parenterally administered CTGF-targeted therapies[75]. - PRS-220 binds to CTGF with high affinity in the picomolar range, demonstrating higher affinity and more stable target engagement compared to the anti-CTGF antibody pamrevlumab[77]. - PRS-400, targeting Jagged-1, is being developed as an inhaled treatment for muco-obstructive lung diseases, aiming to improve quality of life by reducing mucus hypersecretion[83]. - Preclinical data for PRS-400 indicates potent inhibition of Jagged-1-induced Notch 2 signaling and reduction of major airway mucins, addressing key features of muco-obstructive lung diseases[84]. Financial Milestones and Collaborations - The company achieved a $13.0 million milestone related to the initiation of the phase 2a study for elarekibep and issued 3,584,230 shares to AstraZeneca for $10.0 million in a private placement[25]. - Pieris Pharmaceuticals has collaborations with major pharmaceutical companies, including a license agreement with AstraZeneca for respiratory diseases[25]. - The company has entered into a multi-program research collaboration with Genentech to develop locally delivered respiratory therapies[34]. - The company retains co-development and U.S. co-commercialization options for two discovery-stage programs in collaboration with AstraZeneca[30]. - A key development milestone was achieved in the Seagen collaboration, triggering a $5 million milestone payment for the SGN-BB228 program[97]. - Under the AstraZeneca Agreements, the company received an upfront payment of $45.0 million and is eligible for total potential milestones of up to $3.9 billion, including tiered royalties on sales[137]. - The Servier Agreements provided an upfront payment of €30.0 million (approximately $32.0 million) and potential milestone payments of up to €19.0 million during the collaboration[141]. - The Seagen Agreements included a $30 million upfront fee and potential success-based payments totaling up to $1.2 billion across three product candidates[144]. - The company entered into a product license agreement with Boston Pharmaceuticals, receiving an upfront payment of $10.0 million and potential milestone payments of up to $352.5 million[150]. - The Genentech Agreement included a $20 million upfront fee and potential additional milestone payments of approximately $1.4 billion across multiple programs[154]. Intellectual Property and Manufacturing - The company has a strong intellectual property position related to its Anticalin platform, which is crucial for addressing novel targets and diseases[24]. - The company has a patent portfolio that includes several issued U.S. patents and pending applications, with potential expiration dates ranging from 2023 to 2043[126]. - The company holds an exclusive license to multiple patents related to Anticalin proteins, with some expected to expire in 2029[128]. - The company is pursuing intellectual property protection for its drug candidates, which could provide exclusivity for up to 12 years in the U.S. for new biological entities[127]. - The company relies on third-party contract manufacturing organizations (CMOs) for the production of drug candidates, with no current plans to establish its own manufacturing facilities[116]. - The company has experienced reduced capacity from CMOs due to the COVID-19 pandemic, impacting its supply chain[118]. Market Potential and Competition - The asthma market includes over 300 million affected individuals globally, with significant economic impacts, including approximately $82 billion in costs in the U.S. in 2013[51]. - In 2021, about 55% of asthma patients over 12 years of age in the U.S. had moderate-to-severe asthma, indicating a substantial patient population for potential treatment[52]. - Omalizumab, a competitor drug, reported global sales of $3,734 million in 2022, highlighting the market potential for Anticalin-based therapies[52]. - The company faces intense competition in the pharmaceutical and biotechnology industries, with competitors developing products targeting the same diseases[102]. - The company faces significant competition from established therapies for respiratory diseases and cancer, with many competitors having greater financial and technical resources[106]. - There are multiple drugs in clinical development for respiratory diseases and cancer that may provide advantages over currently marketed therapies, posing a threat to the company's product candidates[105]. Regulatory Environment - The FDA regulates the drug approval process, requiring substantial time and financial resources for compliance with regulations[168]. - The company must submit progress reports on clinical trials to the FDA, with the potential for suspension or termination of trials based on safety concerns[180]. - The FDA conducts a preliminary review of all NDAs and BLAs within 60 days and informs the sponsor by the 74th day whether the application is sufficiently complete for substantive review[185]. - The approval process includes a pre-approval inspection of manufacturing facilities to ensure compliance with cGMPs[188]. - Products may receive accelerated approval if they provide meaningful therapeutic benefit over existing treatments, based on adequate and well-controlled clinical trials[199]. - The accelerated approval pathway is often used for serious or life-threatening diseases where traditional approval may take longer due to lengthy clinical trials[201]. - Sponsors of drugs granted accelerated approval must conduct post-marketing confirmatory studies to verify clinical benefits[202]. - The FDA may require sponsors to have a confirmatory trial underway prior to approval under recent amendments to the FDCA[203]. - The FDA has the authority to withdraw drug approval if post-approval studies fail to confirm predicted clinical benefits[204]. Strategic Development - The company aims to become a fully-integrated biotechnology company by commercializing Anticalin-based therapeutics targeting validated disease pathways[42]. - The company is actively seeking additional financing to support its operations and development activities[12]. - The company plans to actively seek additional collaboration partners that align with its corporate development strategy[134]. - The collaboration with AstraZeneca includes two undisclosed programs beyond elarekibep, with ongoing discovery work[86]. - The collaboration with Genentech focuses on locally delivered respiratory and ophthalmology therapies, with Pieris responsible for discovery research and Genentech for clinical development[87].

12 31 moderate asthmatics controlled on standard-of-care therapy (medium dose ICS with LABA) were dosed twice daily over four weeks randomized across two dose levels and placebo (1:1:1) Safety review performed of the following (compared to placebo): Changes in laboratory markers (immune biomarkers, clinical chemistry, and hematology) Pharmacokinetics Potential Large Market Opportunity in Moderate-to-Severe Asthma not Addressed by ICS/LABA before Injectable Biologics 3 5 INTERMITTENT AND MILD MILD-TO-MODERAT ...

Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) Q4 2022 Results Earnings Conference Call March 29, 2023 8:00 AM ET Company Participants Thomas Bures - Senior Vice President and Chief Financial Officer Stephen Yoder - President and Chief Executive Officer Mary Fitzgerald - Vice President, Project Leader Elarekibep Conference Call Participants Roger Song - Jefferies Jonathan Miller - Evercore ISI Rob Andrew - William Blair & Company Operator Hello and welcome to the Pieris Pharmaceuticals, Inc. Year-End 2022 Confe ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37471 PIERIS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Nevada 30-0784346 (State o ...

Financial Data and Key Metrics Changes - Cash and cash equivalents and investments totaled $69.8 million for the quarter ended September 30, 2022, down from $117.8 million for the quarter ended December 31, 2021, due to funding operations in the current year [23] - R&D expenses were $13.6 million for the quarter ended September 30, 2022, compared to $18.9 million for the same quarter in 2021, reflecting lower program costs and manufacturing costs [24] - G&A expenses were $3.9 million for the quarter ended September 30, 2022, slightly down from $4.1 million for the same quarter in 2021 [25] - The overall net loss was $9.7 million, or a $0.13 loss per share, for the quarter ended September 30, 2022, compared to a net loss of $16.5 million, or a $0.24 loss per share, for the same quarter in 2021 [27] Business Line Data and Key Metrics Changes - The company is advancing a pipeline of inhaled respiratory products, including elarekibep, PRS-220, and PRS-400, with significant progress reported in clinical trials [6][7][13][15] - The Phase IIa trial of elarekibep is ongoing, with AstraZeneca completing enrollment of the safety cohort and continuing enrollment for the efficacy cohort [9][10] - PRS-220 has entered Phase I study, targeting idiopathic pulmonary fibrosis, with results expected next year [13] - PRS-400, a new inhaled program, is being developed for muco-obstructive lung diseases, with promising preclinical data [15][17] Market Data and Key Metrics Changes - The company is focusing on both respiratory and immuno-oncology (IO) franchises, with multiple clinical programs expected to initiate in the coming year [6][18] - The IO pipeline includes PRS-344, which is in a Phase I/II study, and several partnered programs with Seagen and Boston Pharmaceuticals [18][20][21] Company Strategy and Development Direction - The company aims to achieve multiple inflection points across its clinical programs over the next year, particularly in respiratory and IO franchises [6][18] - The strategy includes leveraging partnerships for funding and development, with a focus on non-dilutive capital sources [21] - The company is committed to disciplined pipeline investments to support ongoing clinical trials and development [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about upcoming catalysts and the potential for positive data from ongoing trials, particularly for elarekibep and PRS-344 [6][11][18] - The management highlighted the importance of external partnerships in mitigating financial risks and enhancing development capabilities [21] - There is a focus on maintaining a strong cash runway into the second quarter of 2024, supported by anticipated milestone payments [23][52] Other Important Information - The company has received grant funding from the Bavarian Ministry of Economic Affairs to support the development of PRS-220 [14] - The management emphasized the significance of safety data from the 10 mg cohort of elarekibep for future dosing decisions [45][50] Q&A Session Summary Question: What clinical development does the runway guidance include? - The runway includes ongoing costs for PRS-220 and PRS-344, with limited costs for PRS-060 as it is funded by AstraZeneca [33] Question: What can be expected from the Phase I study of PRS-220? - The study will generate safety and tolerability data, with additional preclinical data to support the program's advancement [37][38] Question: Any preference for tumor types in PRS-344 enrollment? - There is no PD-L1 cutoff; all solid tumors are being enrolled, with backfilling options available for specific indications [41][43] Question: What are the enrollment trends for elarekibep? - Enrollment is expected to improve due to broader lifestyle changes, increased site engagement, and protocol amendments [49] Question: Will the 10 mg safety data influence future dosing decisions? - Confirmed safety at the 10 mg level will be crucial, and efficacy readouts will guide decisions on potential dose increases [50]