PALVELLA THERAPEUTICS, INC. 10-K

Item 9A. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures Our management is responsible for establishing and maintaining “disclosure controls and procedures” as such term is defined in Rule 13a-15(e) of the Exchange Act, as well as for establishing and maintaining “adequate internal control over financial reporting” as such term is defined in Rule 13a-15(f) under the Exchange Act. Our system of internal controls over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the consolidated financial statements in accordance with generally accepted accounting principles. Because of the inherent limitations surrounding internal controls over financial reporting, our disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements would not be prevented or detected on a timely basis. Our management, under the supervision of and with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internal control over financial reporting and disclosure controls and procedures as of December 31, 2023. In making this assessment, management used the updated criteria set forth in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework. Based on our assessment under the COSO Internal Control-Integrated Framework, management believes that, as of December 31, 2023, our disclosure controls and procedures and internal control over financial reporting were effective. Management, including our principal executive officer and principal financial officer, has concluded that the financial statements and other financial information included in this Annual Report on Form 10-K fairly present in all material respects our financial condition, results of operations and cash flows as of, and for, the periods presented. Changes in Internal Control over Financial Reporting There have been no changes in internal control over financial reporting identified in connection with the evaluation of such internal control required by Rules 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. OTHER INFORMATION Not applicable. Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS Not applicable. 59 Table of Contents PART III Item 10. MANAGEMENT AND CORPORATE GOVERNANCE The information required by this Item 10 is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023. Item 11. EXECUTIVE OFFICER AND DIRECTOR COMPENSATION The information required by this Item 11 is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The information required by this Item 12 is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023. Item 13. CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS The information required by this Item 13 is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023. Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES The information required by this Item 14 is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of our fiscal year ended December 31, 2023. 60 Table of Contents PART IV Item 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES Item 15(a). The following documents are filed as part of this Annual Report on Form 10-K: Item 15(a)(1) and (2) See “Index to Consolidated Financial Statements” on page F-1 to this Annual Report on Form 10-K. Other financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto. Item 15(a)(3) Exhibits The following is a list of exhibits filed as part of this Annual Report on Form 10-K. Exhibit Number Exhibit Description Incorporated by Reference herein from Form or Schedule Filing Date SEC File / Registration Number 2.1 Acquisition Agreement, dated as of December 17, 2014, by and among the Registrant, Pieris AG and the former stockholders of Pieris AG named therein Form 8-K (Exhibit 2.1) December 18, 2014 333-190728 3.1 Amended and Restated Articles of Incorporation of the Registrant Form 8-K (Exhibit 3.1) December 18, 2014 333-190728 3.2 Certificate of Designation of Series A Convertible Preferred Stock Form 10-Q (Exhibit 3.1) August 11, 2016 001-37471 3.3 Certificate of Designation of Series B Convertible Preferred Stock Form 8-K (Exhibit 3.1) February 4, 2019 001-37471 3.4 Certificate of Designation of Series C Convertible Preferred Stock Form 8-K (Exhibit 3.1) November 4, 2019 001-37471 3.5 Certificate of Designation of Series D Convertible Preferred Stock Form 8-K (Exhibit 3.1) April 6, 2020 001-37471 3.6 Certificate of Designation of Series E Convertible Preferred Stock Form 8-K (Exhibit 3.1) May 21, 2021 001-37471 3.7 Amended and Restated Bylaws of the Registrant Form 8-K (Exhibit 3.2) December 18, 2014 333-190728 3.8 Amendment to the Amended and Restated Bylaws of the Registrant Form 8-K (Exhibit 3.1) September 3, 2019 001-37471 4.1 Form of Common Stock certificate Form 8-K (Exhibit 4.1) December 18, 2014 333-190728 4.2 Form of Common Stock certificate Form 10-K (Exhibit 4.2) March 23, 2016 001-37471 4.3 Description of Registered Securities Form 10-K (Exhibit 4.3) March 13, 2020 001-37471 10.1 2014 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.1) December 18, 2014 333-190728 10.2 Form of Stock Option Award Agreement under the Registrant’s 2014 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.2) December 18, 2014 333-190728 10.3 2016 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.1) July 1, 2016 001-37471 10.4 Form of Stock Option Award Agreement under the Registrant’s 2016 Employee, Director and Consultant Equity Incentive Plan # Form 10-K (Exhibit 10.4) March 30, 2017 001-37471 10.5 2018 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.1) July 26, 2018 001-37471 61 Table of Contents 10.6 Form of Stock Option Award Agreement under the Registrant’s 2018 Employee, Director and Consultant Equity Incentive Plan # Form S-8 (Exhibit 10.2) August 9, 2018 333-226733 10.7 Form of Stock Option Award Agreement under the Registrant’s 2020 Employee, Director and Consultant Equity Incentive Plan # Form S-8 (Exhibit 10.2) August 5, 2021 333-258502 10.8 2018 Employee Stock Purchase Plan # Form 8-K (Exhibit 10.2) July 26, 2018 001-37471 10.9 2023 Employee Stock Purchase Plan # Form 10-Q (Exhibit 10.2) August 10, 2023 001-37471 10.10 2019 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.1) July 31, 2019 001-37471 10.11 2020 Employee, Director and Consultant Equity Incentive Plan # Form 8-K (Exhibit 10.1) June 29, 2020 001-37471 10.12 2020 Employee, Director and Consultant Equity Incentive Plan, as amended # Form 8-K (Exhibit 10.1) June 29, 2021 001-37471 10.13 2020 Employee, Director and Consultant Equity Incentive Plan, as amended # Form 8-K (Exhibit 10.1) June 27, 2022 001-37471 10.14 2020 Employee, Director and Consultant Equity Incentive Plan, as amended # Form 8-K (Exhibit 10.1) June 26, 2023 001-37471 10.15 Research and Licensing Agreement by and between Pieris AG and Technische Universität München, dated as of July 26, 2007 + Form 10-K (Exhibit 10.10) March 30, 2015 333-190728 10.16 Collaboration Agreement by and among the Registrant, Pieris Pharmaceuticals GmbH, Les Laboratoires Servier and Institut de Recherches Internationales Servier, dated as of January 4, 2017 + Form 10-K/A (Exhibit 10.15) April 26, 2018 001-37471 10.17 Non-Exclusive Anticalin Platform Technology License Agreement by and among the Registrant, Pieris Pharmaceuticals GmbH, Les Laboratoires Servier and Institut de Recherches Internationales Servier, dated as of January 4, 2017 + Form 10-K/A (Exhibit 10.16) April 26, 2018 001-37471 10.18 First Amendment to the License and Collaboration Agreement by and between Les Laboratoires Servier, Institut de Recherches Internationales Servier, Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH, effective as of June 16, 2017 + Form 10-Q/A (Exhibit 10.4) April 26, 2018 001-37471 10.19 Letter Amendment to the License and Collaboration Agreement by and between Les Laboratoires Servier, Institut de Recherches Internationales Servier, Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH, effective as of January 3, 2020 + Form 10-K (Exhibit 10.16) March 13, 2020 001-37471 62 Table of Contents 10.20 License & Collaboration Agreement by and between Pieris Pharmaceuticals Inc., Pieris Pharmaceuticals GmbH & Pieris Australia Pty. Limited and AstraZeneca AB, dated as of May 2, 2017 + Form 10-Q/A (Exhibit 10.1) April 26, 2018 001-37471 10.21 Amendment No. 2, dated March 29, 2021, to the License & Collaboration Agreement by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.4) May 17, 2021 001-37471 10.22 Amendment No. 3, dated June 9, 2022, to the License & Collaboration Agreement by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.2) August 4, 2022 001-37471 10.23 Amendment No. 4, dated June 30, 2022, to the License & Collaboration Agreement by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.3) August 4, 2022 001-37471 10.24 Amendment No. 5, dated August 1, 2022, to the License & Collaboration Agreement by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.2) November 4, 2022 001-37471 10.25 Non-Exclusive Anticalin® Platform Technology License Agreement, by and between Pieris Pharmaceuticals Inc., Pieris Pharmaceuticals GmbH and Pieris Australia Pty. Limited and AstraZeneca AB, dated as of May 2, 2017 + Form 10-Q/A (Exhibit 10.2) April 26, 2018 001-37471 10.26 Amendment No. 1, dated March 29, 2021, to the Non-Exclusive Anticalin® Platform Technology License Agreement, dated May 2, 2017, by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.5) May 17, 2021 001-37471 10.27 Subscription Agreement, dated March 29, 2021, by and between the Registrant and AstraZeneca AB + Form 10-Q (Exhibit 10.6) May 17, 2021 001-37471 10.28 License and Collaboration Agreement by and among the Registrant, Pieris GmbH and Seagen, Inc., dated February 8, 2018 + Form 10-Q (Exhibit 10.1) May 10, 2018 001-37471 10.29 Amendment No. 1 to License and Collaboration Agreement by and among the Registrant, Pieris GmbH and Seagen, Inc., dated June 2, 2020 Form 10-Q (Exhibit 10.2) August 10, 2020 001-37471 10.30 Amended and Restated License and Collaboration Agreement, dated March 24, 2021, by and between the Registrant and Seagen Inc. + Form 10-Q (Exhibit 10.1) May 17, 2021 001-37471 10.31 Amendment No. 1, dated September 12, 2023, to the Amended and Restated License and Collaboration Agreement by and between the Registrant and Seagen Inc + Form 10-Q (Exhibit 10.3) November 14, 2023 001-37471 10.32 Subscription Agreement, dated March 24, 2021, by and between the Registrant and Seagen Inc. Form 10-Q (Exhibit 10.3) May 17, 2021 001-37471 10.33 Non-Exclusive Anticalin Platform Technology License Agreement by and among the Registrant, Pieris Pharmaceuticals GmbH and Seagen, Inc., dated February 8, 2018 + Form 10-Q (Exhibit 10.2) May 10, 2018 001-37471 10.34 Amendment No. 1 to Non-Exclusive Anticalin Platform Technology License Agreement by and among the Registrant, Pieris Pharmaceuticals GmbH and Seagen, Inc., dated June 2, 2020 Form 10-Q (Exhibit 10.3) August 10, 2020 001-37471 10.35 Exclusive Product License Agreement, dated April 24, 2021, by and among the Registrant, Pieris Pharmaceuticals GmbH and BP Asset XII, Inc. Form 10-Q (Exhibit 10.1) August 5, 2021 001-37471 63 Table of Contents 10.36 Research Collaboration and License Agreement, dated May 19, 2021, by and among the Registrant, Pieris Pharmaceuticals GmbH and Genentech, Inc. Form 10-Q (Exhibit 10.3) August 5, 2021 001-37471 10.37 Form of Indemnification Agreement by and between the Registrant and each of its current directors and executive officers # Form 8-K (Exhibit 10.10) December 18, 2014 333-190728 10.38 Employment Agreement by and between the Registrant and Stephen S. Yoder, dated as of December 17, 2014 # Form 8-K (Exhibit 10.15) December 18, 2014 333-190728 10.39 Employment Agreement by and between the Registrant and Ahmed Mousa, dated as of October 7, 2021 # Form 10-Q (Exhibit 10.1) November 2, 2021 001-37471 10.40 Employment Agreement by and between the Registrant and Tom Bures, dated as of October 7, 2021 # Form 10-Q (Exhibit 10.2) November 2, 2021 001-37471 10.41 Non-Employee Director Compensation Policy, as amended # Form 10-K (Exhibit 10.38) March 31, 2023 001-37471 10.42 Lease Agreement by and between Pieris GmbH and Hallbergmoos Grundvermögen GmbH, dated October 24, 2018 Form 10-K (Exhibit 10.30) March 18, 2019 001-37471 10.43 Amendment No. 1 to Lease Agreement by and between Pieris GmbH and Hallbergmoos Grundvermögen GmbH, dated May 21, 2019 (English translation) Form 10-K (Exhibit 10.31) March 13, 2020 001-37471 10.44 Amendment No. 2 to Lease Agreement by and between Pieris GmbH and Hallbergmoos Grundvermögen GmbH, dated February 13, 2020 (English translation) Form 10-K (Exhibit 10.32) March 13, 2020 001-37471 10.45 Amendment No. 3 to Lease Agreement by and between Pieris GmbH and Hallbergmoos Grundvermögen GmbH, dated May 19, 2020 (English translation) * 10.46 Amendment No. 4 to Lease Agreement by and between Pieris GmbH and Hallbergmoos Grundvermögen GmbH, dated December 15, 2023 (English translation) * 10.47 Form of Securities Purchase Agreement, dated December 17, 2014, by and among the Registrant and the Purchasers Form 8-K (Exhibit 10.1) December 23, 2014 333-190728 10.48 Form of Registration Rights Agreement, dated December 17, 2014, by and among the Registrant and the investors party thereto Form 8-K (Exhibit 10.2) December 23, 2014 333-190728 10.49 Form of Warrant to Purchase Common Stock, dated December 17, 2014, issued by the Registrant Form 8-K (Exhibit 10.3) December 23, 2014 333-190728 10.50 Securities Purchase Agreement, dated June 2, 2016, by and among the Registrant and the Investors named therein Form 8-K (Exhibit 10.1) June 6, 2016 001-37471 10.51 Registration Rights Agreement, dated June 2, 2016, by and among the Registrant and the Investors named therein Form 8-K (Exhibit 10.3) June 6, 2016 001-37471 10.52 Form of Warrant to purchase Common Stock, dated June 2, 2016, issued by the Registrant Form 8-K (Exhibit 10.2) June 6, 2016 001-37471 64 Table of Contents 10.53 Securities Purchase Agreement, dated November 2, 2019, by and among the Company and the Investors named therein Form 8-K (Exhibit 10.1) November 4, 2019 001-37471 10.54 Registration Rights Agreement, dated November 2, 2019, by and among the Company and the Investors named therein Form 8-K (Exhibit 10.3) November 4, 2019 001-37471 10.55 Form of Warrant to purchase Common Stock, dated November 2, 2019, issued by the Registrant Form 8-K (Exhibit 10.2) November 4, 2019 001-37471 10.56 Exchange Agreement, dated January 30, 2019, by and among the Registrant and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. Form 8-K (Exhibit 10.1) February 4, 2019 001-37471 10.57 Exchange Agreement, dated March 31, 2020, by and among the Registrant and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. Form 8-K (Exhibit 10.1) April 6, 2020 001-37471 10.58 Exchange Agreement by and among the Registrant and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P., and MSI BVF SPV, L.L.C., dated as of May 20, 2021 Form 8-K (Exhibit 10.1) May 21, 2021 001-37471 10.59 Open Market Sale Agreement, dated as of August 9, 2019, by and between Pieris Pharmaceuticals, Inc. and Jefferies LLC Form 10-Q (Exhibit 10.1) August 9, 2019 001-37471 10.60 Amendment No. 1 to Sales Agreement, dated November 4, 2022, by and between Pieris Pharmaceuticals, Inc. and Jefferies LLC Form 8-K (Exhibit 1.1) November 4, 2022 001-37471 10.61 Consulting Agreement by and between the Registrant and Ahmed Mousa, dated as of September 11, 2023. # Form 10-Q (Exhibit 10.2) November 14, 2023 001-37471 10.62 Amendment No. 1, dated December 11, 2023, to Consulting Agreement by and between the Registrant and Ahmed Mousa #* 10.63 Non-Qualified Stock Option Agreement by and between the Registrant and Hitto Kaufmann, Ph.D., dated as of August 30, 2019 # Form 10-Q (Exhibit 10.3) November 12, 2019 001-37471 10.64 Separation Agreement by and between the Registrant and Hitto Kaufmann, Ph.D., dated as of July 26, 2023. # Form 10-Q (Exhibit 10.1) November 14, 2023 001-37471 10.65 Employment Agreement by and between Pieris GmbH and Shane Olwill, Ph.D. dated May 9, 2011 #* 10.66 Amendments to the Employment Agreement by and between Pieris GmbH and Shane Olwill, Ph.D., dated between 2012-2021 #* 10.67 Retention Letter by and between Pieris GmbH and Shane Olwill, Ph.D., dated February 22, 2024 #* 21.1 List of Subsidiaries * 23.1 Consent of Ernst & Young LLP * 31.1 Certification of Stephen S. Yoder, Chief Executive Officer and President, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * 31.2 Certification of Thomas Bures, Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * 32.1 Certification of Stephen S. Yoder, Chief Executive Officer and President, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 ** 32.2 Certification of Thomas Bures, Chief Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 ** 97 Pieris Pharmaceuticals, Inc. Clawback Policy *# 101.INS Inline XBRL Instance Document * 101.SCH Inline XBRL Taxonomy Extension Schema Document * 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document * 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document * 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document * 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document * 104 Cover Page Interactive Data File (embedded within the Inline XBRL document and contained in Exhibit 101) * * Filed herewith ** Furnished herewith + Portions of the exhibit are omitted pursuant to Regulation S-K Item 601(b)(10)(iv). Copies of the unredacted exhibit will be furnished to the SEC upon request. # Indicates a management contract or compensatory plan Item 16. FORM 10-K SUMMARY We may voluntarily include a summary of information required by Form 10-K under this Item 16. We have elected not to include such summary information. 65 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized . PIERIS PHARMACEUTICALS, INC. March 29, 2024 By: /s/ Stephen S. Yoder Stephen S. Yoder Chief Executive Officer and President Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated below and on the dates indicated. Signature Title Date /s/ Stephen S. Yoder President, Chief Executive Officer and March 29, 2024 Stephen S. Yoder Director (Principal Executive Officer ) /s/ Thomas Bures Chief Financial Officer March 29, 2024 Thomas Bures (Principal Financial Officer and Principal Accounting Officer ) /s/ James Geraghty Chairman of the Board of Directors March 29, 2024 James Geraghty /s/ Michael Richman Director March 29, 2024 Michael Richman /s/ Maya R. Said, Sc.D. Director March 29, 2024 Maya R. Said, Sc.D. /s/ Peter Kiener, D.Phil. Director March 29, 2024 Peter Kiener, D.Phil. /s/ Christopher Kiritsy Director March 29, 2024 Christopher Kiritsy /s/ Ann Barbier, M.D., Ph.D. Director March 29, 2024 Ann Barbier, M.D., Ph.D. /s/ Matthew L. Sherman, M.D. Director March 29, 2024 Matthew L. Sherman, M.D. 66 Table of Contents PIERIS PHARMACEUTICALS, INC. Table of Contents Report of Independent Registered Public Accounting Firm (PCAOB ID: 000 42 ) F-2 Consolidated Balance Sheets as of December 31, 2023 and 2022 F-4 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022 F-5 Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023 and 2022 F-6 Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022 F-7 Notes to Consolidated Financial Statements F-8 F-1 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Pieris Pharmaceuticals, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Pieris Pharmaceuticals, Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles. Basis for Opinion These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. F-2 Table of Contents Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. Accrued and Prepaid Clinical Trial Expenses Description of the Matter As discussed in Note 2 to the consolidated financial statements, the Company records research and development expenses, which include expenses related to clinical trials, as incurred. The Company’s determination of clinical trial costs incurred, as well as the related accrued and prepaid expenses at each reporting period incorporates judgment and utilizes various assumptions. Such judgments and assumptions include an evaluation of the information provided to the Company by third parties on actual costs incurred but not yet billed, estimated project timelines and patient enrollment. Payments for these activities are based on the terms of the individual arrangements, which differ from the pattern of costs incurred. Auditing the Company’s accrued and prepaid clinical trial expenses was especially challenging due to the large volume of information received from multiple sources that perform service on the Company’s behalf. While the Company’s estimates of accrued and prepaid clinical trial expenses are primarily based on information received related to each study from its vendors, the Company may need to make an estimate for additional costs incurred based on management judgment. Additionally, due to the duration of the work performed under clinical trials and the timing of invoices received from vendors, the actual amounts incurred are not typically known at the time the financial statements are issued. How We Addressed the Matter in Our Audit To evaluate the accrued and prepaid clinical trial expenses, our audit procedures included, among others, testing the accuracy and completeness of the underlying data used in the estimates and evaluating the significant assumptions that are used by management to estimate the recorded accruals and prepayments. We corroborated the progress of research and development activities associated with clinical trials through discussion with the Company’s research and development personnel that oversee the research and development activities. We inspected the Company’s third-party contracts, amendments, and any pending change orders to assess the impact on amounts recorded. We also reviewed information received by the Company directly from vendors, which indicated the vendors' estimate of costs incurred to date. In addition, we performed analytics over fluctuations in accruals and prepaids by vendor throughout the period subject to audit and compared subsequent invoices received from third parties to amounts accrued. /s/ Ernst & Young LLP We have served as the Company's auditor since 2016. Boston, Massachusetts March 29, 2024 F-3 Table of Contents PIERIS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) December 31, December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $ 17,396 $ 38,635 Short term investments 8,970 20,534 Accounts receivable 572 5,810 Receivable from public grants 3,141 4,771 Other receivables 2,326 462 Assets held for sale, property and equipment 2,188 — Prepaid expenses and other current assets 4,087 3,212 Total current assets 38,680 73,424 Property and equipment, net — 16,992 Operating lease right-of-use assets, non-current — 3,705 Other non-current assets — 1,369 Total assets $ 38,680 $ 95,490 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 3,372 $ 4,154 Operating lease liabilities, current — 859 Accrued expenses and other current liabilities 8,550 10,746 Deferred revenues, current portion — 20,824 Total current liabilities 11,922 36,583 Deferred revenue, net of current portion — 18,734 Operating lease liabilities, non-current — 12,244 Total liabilities 11,922 67,561 Commitments and Contingencies Stockholders’ equity: Convertible preferred stock, $ 0.001 par value per share, 10,000,000 shares authorized and 15,617 shares issued and outstanding at December 21, 2023 and 2022 — — Common stock, $ 0.001 par value per share, 300,000,000 shares authorized and 98,935,025 and 74,519,103 shares issued and outstanding at December 21, 2023 and 2022, respectively 98 74 Additional paid-in capital 341,596 318,530 Accumulated other comprehensive income 28 ( 254 ) Accumulated deficit ( 314,964 ) ( 290,421 ) Total stockholders’ equity 26,758 27,929 Total liabilities and stockholders’ equity $ 38,680 $ 95,490 The accompanying notes are an integral part of these consolidated financial statements. F-4 Table of Contents PIERIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share data) Year Ended December 31, 2023 2022 Revenue Customer revenue $ 38,711 $ 25,469 Collaboration revenue 4,099 433 Total revenue 42,810 25,902 Operating expenses Research and development 41,801 52,982 General and administrative 16,853 16,394 Asset impairment 13,912 — Total operating expenses 72,566 69,376 Loss from operations ( 29,756 ) ( 43,474 ) Other income (expense) Interest income 1,851 721 Grant income 3,612 8,173 Other (expense) income ( 250 ) 1,303 Net loss $ ( 24,543 ) $ ( 33,277 ) Other comprehensive (loss) income: Foreign currency translation 208 ( 1,010 ) Unrealized gain (loss) on available-for-sale securities 74 ( 73 ) Comprehensive loss $ ( 24,261 ) $ ( 34,360 ) Net loss per share Basic and diluted $ ( 0.27 ) $ ( 0.45 ) Weighted average number of common shares outstanding Basic and diluted 90,064 74,172 The accompanying notes are an integral part of these consolidated financial statements. F-5 Table of Contents PIERIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS ’ EQUITY (In thousands) Accumulated Preferred shares Common shares Additional other Total No. of Share No. of Share paid-in comprehensive Accumulated Stockholders’ shares capital shares capital capital income (loss) deficit equity Balance as of January 1, 2022 16 $ — 72,222 $ 72 $ 306,998 $ 829 $ ( 257,144 ) $ 50,755 Net loss — — — — — — ( 33,277 ) ( 33,277 ) Foreign currency translation adjustment — — — — — ( 1,010 ) — ( 1,010 ) Unrealized loss on investments — — — — — ( 73 ) — ( 73 ) Stock based compensation expense — — — — 4,402 — — 4,402 Issuance of common stock resulting from exercise of stock options — — 46 — 95 — — 95 Issuance of common stock resulting from purchase of employee stock purchase plan shares — — 182 — 197 — — 197 Issuance of common stock pursuant to ATM offering program, net of $ 0.3 million in offering costs — — 2,069 2 6,838 — — 6,840 Balance at December 31, 2022 16 $ — 74,519 $ 74 $ 318,530 $ ( 254 ) $ ( 290,421 ) $ 27,929 Net loss — — — — — — ( 24,543 ) ( 24,543 ) Foreign currency translation adjustment — — — — — 208 — 208 Unrealized gain on investments — — — — — 74 — 74 Stock based compensation expense — — — — 3,349 — — 3,349 Issuance of common stock resulting from purchase of employee stock purchase plan shares — — 155 — 66 — — 66 Issuance of common stock pursuant to ATM offering program, net of $ 0.7 million in offering costs — — 24,261 24 19,651 — — 19,675 Balance at December 31, 2023 16 $ — 98,935 $ 98 $ 341,596 $ 28 $ ( 314,964 ) $ 26,758 The accompanying notes are an integral part of these consolidated financial statements. F-6 Table of Contents PIERIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2023 2022 Operating activities: Net loss $ ( 24,543 ) $ ( 33,277 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization (accretion) 1,904 2,770 Right-of-use asset (accretion) amortization ( 123 ) 10 Stock-based compensation 3,349 4,402 Asset impairment 13,912 — Realized investment gains ( 53 ) ( 376 ) Other non-cash transactions ( 124 ) ( 91 ) Changes in operating assets and liabilities: Accounts receivable 5,307 ( 2,624 ) Prepaid expenses and other assets 1,018 ( 1,358 ) Deferred revenue ( 39,967 ) ( 20,185 ) Accounts payable ( 789 ) ( 4,208 ) Accrued expenses and other current liabilities ( 2,336 ) ( 4,005 ) Lease liability, prior to operating lease termination ( 868 ) ( 990 ) Change in lease liability due to termination of operating lease ( 10,506 ) — Net cash used in operating activities ( 53,819 ) ( 59,932 ) Investing activities: Purchases of property and equipment ( 171 ) ( 1,041 ) Proceeds from maturity of investments 35,008 28,200 Purchases of investments ( 22,835 ) ( 48,395 ) Net cash provided by (used in) investing activities 12,002 ( 21,236 ) Financing activities: Proceeds from exercise of stock options — 95 Proceeds from employee stock purchase plan 66 197 Proceeds from issuance of common stock resulting from ATM sales, net of $ 0.7 million and $0.3 million in transaction costs, respectively 19,729 6,922 Net cash provided by financing activities 19,795 7,214 Effect of exchange rate change on cash and cash equivalents 783 ( 5,175 ) Net decrease in cash and cash equivalents ( 21,239 ) ( 79,129 ) Cash and cash equivalents at beginning of period 38,635 117,764 Cash and cash equivalents at end of period $ 17,396 $ 38,635 Supplemental cash flow disclosures: Net unrealized gain (loss) on investments $ 74 $ ( 73 ) Property and equipment included in accounts payable $ — $ 193 The accompanying notes are an integral part of these consolidated financial statements. F-7 Table of Contents PIERIS PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. Corporate Information Pieris Pharmaceuticals, Inc., or the Company or Pieris, was founded in May 2013, and acquired 100 % interest in Pieris Pharmaceuticals GmbH (formerly Pieris AG, a German company which was founded in 2001 ) in December 2014. Pieris Pharmaceuticals, Inc. and its wholly-owned subsidiaries, hereinafter collectively Pieris, or the Company, is a biopharmaceutical company that, prior to July of 2023, discovered and developed Anticalin-based drugs to target validated disease pathways in unique and transformative ways. Pieris’ clinical pipeline consists of immuno-oncology, or IO, programs partnered with several major multi-national pharmaceutical companies. Pieris' corporate headquarters is located in Boston, Massachusetts. Pieris also maintains office space in Hallbergmoos, Germany. The Company’s core Anticalin technology and platform was developed in Germany. On July 18, 2023 , the Company announced its intention to explore engaging in one or more strategic transactions, including mergers, reverse mergers, acquisitions, other business combinations or sales of assets, or other strategic transactions. This decision was related to events that impacted the Company’s inhaled respiratory franchise, based upon AstraZeneca's discontinuation of enrollment of the Phase 2a study for elarekibep, an inhaled IL- 4Rα antagonist Anticalin protein to treat uncontrolled asthma. As part of this initiative, the Company engaged Stifel, Nicolaus & Company, Incorporated to serve as its advisor in its review of strategic transactions. Also on July 18, 2023 , the Company’s board of directors approved a reduction in the Company’s workforce by approximately 70 %. Since July of 2023, and through December 31, 2023, the Company took additional steps to reduce its operating footprint including terminating its remaining lease obligations in Germany and winding down its proprietary inhaled respiratory programs. The Company also has opted out and terminated programs where possible to reduce operating costs. Further reductions in the workforce have occurred based upon these actions. As a result, the Company has incurred approximately $ 7.5 million of severance costs and other related termination benefits in 2023 as the service period to earn such benefits is considered complete. The Company expects termination benefits to be paid through the end of 2024. On March 27, 2024, the Company announced the implementation of a new strategy along with relevant cost-saving measures that are expected to extend its cash runway into at least 2027, while maximizing its ability to capture the potential milestones from its partnered 4 - 1BB bispecific Mabcalin protein IO assets. The Company may be entitled to aggregate milestones of up to $ 20 million upon first patient dosed in the phase 2 trials for SGN- BB228, S095012 (formerly PRS- 344 ) and BOS- 342, which are all currently in phase 1 clinical development, and up to $ 55 million upon first patient dosed in pivotal clinical trials for SGN- BB228, S095012 and BOS- 342. To support this new strategy, the Company plans to discontinue all of its research and development efforts which it expects to complete by the middle of 2024, implement a workforce reduction that will impact additional employees and the executive leadership team which is expected to be implemented in the second quarter of 2024, and reduce the size of its Board of Directors, which is also expected to have implemented in the second quarter of 2024. In addition to the alliance management activities for its partnered programs, the Company remains committed to obtaining value for its products in prior development, including cinrebafusp alfa, as well as its proprietary platform capabilities by pursuing potential out-licensing or sales transactions. In addition to these potential transactions, the Company may also, from time-to-time, consider strategic opportunities that it believes may increase stockholder value. As of December 31, 2023 , cash, cash equivalents, and investments were $ 26.4 million. The Company’s net loss was $ 24.5 million and $ 33.3 million for the years ended December 31, 2023 and 2022 , respectively. The Company has incurred net losses since inception and had an accumulated deficit of $ 315.0 million as of December 31, 2023 . Net losses and negative cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders’ equity and working capital. The Company expects to continue to incur operating losses for the foreseeable future. The Company has historically devoted substantially all of its financial resources and efforts to research and development and general and administrative expenses to support the discovery and development of Anticalin-based drugs. Going forward, as part of the Company's decision to implement measures to maximize its ability to capture potential milestones from its partnered programs with Pfizer, Boston Pharmaceuticals, and Servier, the Company plans to discontinue all research and development efforts and reduce discretionary expenditures and other fixed or variable personnel costs. The Company believes that its currently available funds will be sufficient to fund its operations through at least the next twelve months from the issuance of this Annual Report on Form 10 -K. The Company's belief with respect to its ability to fund operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional funding. F- 8 Table of Contents 2. Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying consolidated financial statements of Pieris Pharmaceuticals, Inc. and its wholly-owned subsidiaries were prepared in accordance with U.S. GAAP. The consolidated financial statements include the accounts of all subsidiaries. All intercompany balances and transactions have been eliminated. The preparation of the financial statements in accordance with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and the related disclosures at the date of the financial statements and during the reporting period. Significant estimates are used for, but are not limited to, revenue recognition; deferred tax assets, deferred tax liabilities and valuation allowances; fair value of held for sale assets; beneficial conversion features; fair value of stock options, preferred stock, and warrants; and prepaid and accrued clinical trial expenses. Management evaluates its estimates on an ongoing basis. Actual results and outcomes could differ materially from management’s estimates, judgments, and assumptions. Foreign Currency Translation The financial statements of the Company’s foreign subsidiaries are translated from local currency into reporting currency, which is U.S. dollars, using the current exchange rate at the balance sheet date for assets and liabilities, and the weighted average exchange rate prevailing during the period for revenues and expenses. The functional currency for Pieris’ foreign subsidiaries is considered to be the local currency for each entity and, accordingly, translation adjustments for these subsidiaries are included in accumulated other comprehensive loss within stockholders’ equity. Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as other (expense) income, net in the consolidated statements of operations. Foreign currency gains and losses on available-for-sale investment transactions are recorded to other comprehensive income (loss) on the Company's balance sheet per Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 830, Foreign Currency Matters. Cash, Cash Equivalents and Investments The Company determines the appropriate classification of its investments at the time of purchase. All liquid investments with original maturities of 90 days or less from the purchase date and for which there is an active market are considered to be cash equivalents. The Company’s investments are comprised of money market, asset backed securities, government treasuries, and corporate bonds that are classified as available-for-sale in accordance with FASB ASC 320, Investments — Debt and Equity Securities . The Company classifies investments available to fund current operations as current assets on its balance sheets. Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in accumulated other comprehensive income (loss) on the Company’s balance sheets. Realized gains and losses are determined using the specific identification method and are included as a component of other income (expense). The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than temporary, the Company considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the investment before recovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, the severity and the duration of the impairment, and changes in value subsequent to period end. Concentration of Credit Risk and Off-Balance Sheet Risk The Company has no financial instruments with off‑balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that subject Pieris to concentrations of credit risk include cash and cash equivalents, investments, and accounts receivable. The Company’s cash, cash equivalents, and investments are held in accounts with financial institutions that management believes are creditworthy. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. Accounts receivable primarily consist of amounts due under strategic partnership and other license agreements with major multi-national pharmaceutical companies for which the Company does not obtain collateral. F- 9 Table of Contents Fair Value Measurement The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures , or ASC 820, established a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the financial instrument based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the financial instrument and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported or disclosed fair value of the financial instruments and is not a measure of the investment credit quality. Fair value measurements are classified and disclosed in one of the following three categories: • Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. • Level 2 utilizes quoted market prices in markets that are not active, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. • Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments measured at fair value on a recurring basis include cash equivalents and investments, if any ( Note 5 ). An entity may elect to measure many financial instruments and certain other items at fair value at specified election dates. Subsequent unrealized gains and losses on items for which the fair value option has been elected will be reported in net loss. The Company did not elect to measure any additional financial instruments or other items at fair value. Fair Values of Financial Instruments The fair value of cash, accounts receivable, and accounts payable approximates the carrying value of these financial instruments because of the short-term nature of any maturities. The Company determines the estimated fair values of other financial instruments, using available market information and valuation methodologies, primarily input from independent third party pricing sources. Accounts Receivable Accounts receivable are recorded net of allowances for credit losses and represent amounts due from strategic partners. The Company monitors and evaluates collectability of receivables on an ongoing basis and considers whether an allowance for credit losses is necessary. The Company determined that no such reserve is needed as of December 31, 2023 and 2022 . Historically, the Company has not had collectability issues. F- 10 Table of Contents Property and Equipment Property and equipment are recorded at acquisition cost, less accumulated depreciation and impairment. Depreciation on property and equipment is calculated using the straight-line method over the remaining estimated useful lives of the assets. Maintenance and repairs to these assets are charged to expenses as occurred. Substantially all of the Company's fixed assets are located in Germany. The estimated useful life of the different groups of property and equipment is as follows: Asset Classification Estimated useful life (in years) Leasehold improvements shorter of useful life or remaining life of the lease Laboratory furniture and equipment 8 - 14 Office furniture and equipment 5 - 13 Computer and equipment 3 - 7 If the criteria in ASC 360 Property, Plant and Equipment are met, a long-lived asset is classified as held for sale. The long-lived asset is reported at the lower of its carrying value or fair value less cost to sell beginning in the period the held for sale criteria are met. The carrying amount of the asset will be adjusted each reporting period for subsequent changes in fair value less cost to sell. A loss is recognized for any subsequent write-down to fair value less cost to sell. A gain is recognized for any subsequent increase in fair value less cost to sell, but not in excess of the cumulative loss previously recognized. Once classified as held for sale, depreciation and amortization are no longer recorded for any long-lived assets included in the disposal group. Impairment of Long-lived Assets The Company reviews its long-lived assets to be held and used for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related asset. Any write-downs are treated as permanent reductions in the carrying amount of the assets. Revenue Recognition Pieris has entered into several licensing agreements with collaboration partners for the development of Anticalin therapeutics against a variety of targets. The terms of these agreements provide for the transfer of multiple goods or services which may include: (i) licenses, or options to obtain licenses, to Pieris’ Anticalin technology and/or specific programs and (ii) research and development activities to be performed on behalf of or with a collaborative partner. Payments to Pieris under these agreements may include upfront fees (which include license and option fees), payments for research and development activities, payments based upon the achievement of certain milestones, and royalties on product sales. There are no performance, cancellation, termination or refund provisions in any of the arrangements that could result in material financial consequences to Pieris. As the Company's intellectual property assets are considered to be located in Germany, the Company records all consolidated revenue in its subsidiary, Pieris Pharmaceuticals, GmbH. Collaborative Arrangements The Company considers the nature and contractual terms of an arrangement and assesses whether the arrangement involves a joint operating activity pursuant to which it is an active participant and exposed to significant risks and rewards with respect to the arrangement. If the Company is an active participant and exposed to the significant risks and rewards with respect to the arrangement, it accounts for these arrangements pursuant to ASC 808, Collaborative Arrangements , or ASC 808, and applies a systematic and rational approach to recognize revenue. The Company classifies payments received as revenue and payments made as a reduction of revenue in the period in which they are earned. Revenue recognized under a collaborative arrangement involving a participant that is not a customer is presented as Collaboration Revenue in the Statement of Operations. Revenue from Contracts with Customers In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled in exchange for these goods and services. To achieve this core principle, the Company applies the following five steps: 1 ) identify the customer contract; 2 ) identify the contract’s performance obligations; 3 ) determine the transaction price; 4 ) allocate the transaction price to the performance obligations; and 5 ) recognize revenue when or as a performance obligation is satisfied. The Company evaluates all promised goods and services within a customer contract and determines which of such goods and services are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. F- 11 Table of Contents Licensing arrangements are analyzed to determine whether the promised goods or services, which often include licenses, research and development services and governance committee services, are distinct or whether they must be accounted for as part of a combined performance obligation. If the license is considered not to be distinct, the license would then be combined with other promised goods or services as a combined performance obligation. If the Company is involved in a governance committee, it assesses whether its involvement constitutes a separate performance obligation. When governance committee services are determined to be separate performance obligations, the Company determines the fair value to be allocated to this promised service. Certain contracts contain optional and additional items, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. An option that is considered a material right is accounted for as a separate performance obligation. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. A contract may contain variable consideration, including potential payments for both milestone and research and development services. For certain potential milestone payments, the Company estimates the amount of variable consideration by using the most likely amount method. In making this assessment, the Company evaluates factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the milestone. Each reporting period the Company re-evaluates the probability of achievement of such variable consideration and any related constraints. Pieris will include variable consideration, without constraint, in the transaction price to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. For potential research and development service payments, the Company estimates the amount of variable consideration by using the expected value method, including any approved budget updates arising from additional research or development services. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price among the performance obligations on a relative standalone selling price basis unless a portion of the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct good or service that forms part of a single performance obligation. The Company allocates the transaction price based on the estimated standalone selling price of the underlying performance obligations or in the case of certain variable consideration to one or more performance obligations. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs to complete the respective performance obligation. Certain variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated to each performance obligation are consistent with the amount the Company would expect to receive for each performance obligation. When a performance obligation is satisfied, revenue is recognized for the amount of the transaction price, excluding estimates of variable consideration that are constrained, that is allocated to that performance obligation on a relative standalone selling price basis. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. For performance obligations consisting of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non- refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. Revenue recognized under an arrangement involving a participant that is a customer is presented as Customer Revenue. F- 12 Table of Contents Milestones and Royalties The Company aggregates milestones into four categories: (i) research milestones, (ii) development milestones, (iii) commercial milestones and (iv) sales milestones. Research milestones are typically achieved upon reaching certain success criteria as defined in each agreement related to developing an Anticalin protein against the specified target. Development milestones are typically reached when a compound reaches a defined phase of clinical research or passes such phase, or upon gaining regulatory approvals. Commercial milestones are typically achieved when an approved pharmaceutical product reaches the status for commercial sale, including regulatory approval. Sales milestones are certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. There is uncertainty that the events to obtain the research and development milestones will be achieved given the nature of clinical development and the stage of the Company’s technology. The Company has thus determined that all research and development milestones will be constrained until it is deemed probable that a significant revenue reversal will not occur. For revenues from research and development milestones, payments will be recognized consistent with the recognition pattern of the performance obligation to which they relate. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Commercial milestones and sales royalties are determined by sales or usage-based thresholds and will be accounted for under the royalty recognition constraint as constrained variable consideration. The Company calculates the maximum amount of potential milestones achievable under each collaboration agreement and discloses such potential future milestones for all current collaborations using such a maximum calculation. Contract Balances The Company recognizes a contract asset when the Company transfers goods or services to a customer before the customer pays consideration or before payment is due, excluding any amounts presented as a receivable (i.e., accounts receivable). A contract asset is an entity’s right to consideration in exchange for goods or services that the entity has transferred to a customer. The contract liabilities (i.e., deferred revenue) primarily relate to contracts where the Company has received payment but has not yet satisfied the related performance obligations. In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all Company obligations under the agreement have been fulfilled. Costs to Obtain and Fulfill a Contract with a Customer Certain costs to obtain customer contracts, including success-based fees paid to third -party service providers, and costs to fulfill customer contracts are capitalized in accordance with FASB ASC 340, Other Assets and Deferred Costs , or ASC 340. These costs are amortized to expense on a systemic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates. The Company will expense the amortization of costs to obtain customer contracts to general and administrative expense and costs to fulfill customer contracts to research and development expense. Research and Development Research and development expenses are charged to the statement of operations as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, pre-clinical and clinical costs, contract services, consulting, depreciation and amortization expense, and other related costs. Costs associated with acquired technology, in the form of upfront fees or milestone payments, are charged to research and development expense as incurred. F- 13 Table of Contents Income Taxes The Company applies ASC Topic 740 Income Taxes , which established financial accounting and reporting requirements for the effects of income taxes that result from the Company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and operating losses and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted statutory tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Where the Company determines that it is more likely than not that some portion or all of the deferred tax assets will not be realized in the future, the deferred tax assets are reduced by a valuation allowance. The Company records interest and penalties related to uncertain tax positions as part of income tax expense. The Tax Cuts and Jobs Act (TCJA) subjects a U.S. shareholder to tax on global-intangible low tax income (GILTI) earned by certain foreign subsidiaries. The Company has made an accounting policy election to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. Stock-based Compensation The Company measures share-based payments in accordance with ASC Topic 718, Stock Compensation . Pieris records its stock-based compensation expense over the requisite service period and records forfeitures as they occur. Determining the appropriate fair value model and related assumptions requires judgment, including estimating share price volatility and expected terms of the awards. For employee options, the fair value measurement date is generally on the date of grant and the related compensation expense is recognized on a straight-line basis over the requisite service period of the awards, less expense for actual forfeitures. The Company uses the Black-Scholes option pricing model to determine the estimated fair value for stock-based awards. Option-pricing models require the input of various subjective assumptions, including the option’s expected life, expected dividend yield, price volatility, risk free interest rate and forfeitures of the underlying stock. Due to the limited operating history of the Company as a public entity and a lack of company specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid dividends, but may elect pay out dividends to stockholders in the future if we determine that there is sufficient cash and investments to achieve our near and long-term objectives. All excess tax benefits and tax deficiencies are recorded as income tax expense or benefit in the Company's statement of operations and comprehensive loss. For the years ended December 31, 2023 and 2022 , the Company did not record an income statement benefit for excess tax benefits as a valuation allowance is also required on these amounts. Government Grants The Company recognizes grants from governmental agencies when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received. The Company evaluates the conditions of each grant as of each reporting period to evaluate whether the Company has reached reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant will be received as a result of meeting the necessary conditions. Grants are recognized in the consolidated statements of operations on a systematic basis over the periods in which the Company recognizes the related costs for which the government grant is intended to compensate. Specifically, grant income related to research and development costs is recognized as such expenses are incurred. Grant income is included as a separate caption within Other income (expense), net in the consolidated statements of operations. F- 14 Table of Contents Leases The Company accounts for leases pursuant to ASC 842 Leases (Topic 842 ) , or ASC 842. As a lessee, the Company is required to recognize (i) a lease liability, which is a lessee's obligation to make lease payments arising from a lease, measured on a discounted basis; and (ii) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term for all leases (with the exception of short-term leases) at the commencement date. The Company determines if an arrangement is a lease at inception. The Company’s contracts are determined to contain a lease within the scope of ASC 842 when all of the following criteria based on the specific circumstances of the arrangement are met: ( 1 ) there is an identified asset for which there are no substantive substitution rights; ( 2 ) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and ( 3 ) the Company has the right to direct the use of the identified asset. In addition, the Company does not apply the recognition requirements in the lease standard to short-term leases (a lease that at commencement date has a lease term of 12 months or less and does not contain a purchase option that it is reasonably certain to exercise) and does not separate lease and non-lease components for all asset classes. Any variable components of lease costs are excluded from lease payments and are recognized in the period incurred, including increases to rent based on German Consumer Price Index, or CPI. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term and based on observable market data points. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The Company typically only includes an initial lease term in its assessment of a lease agreement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. The expected lease term includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. Assumptions made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease. When a lease is terminated in its entirety, the corresponding lease liability and right-of-use asset are adjusted to zero. Any difference between the carrying amounts of the right-of-use asset and lease liability as compared to the termination payment is recorded in the statement of operations as a gain or loss. Contingencies Accruals are recorded for loss contingencies when it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously. Considering facts known at the time of the assessment, the Company determines whether potential losses are considered reasonably possible or probable and whether they are estimable. Based upon this assessment, the Company carries out an evaluation of disclosure requirements and considers possible accruals in the financial statements. Segment Reporting Operating segments are identified as components of an enterprise where separate discrete financial information is evaluated by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company operates as a single segment dedicated to the discovery and development of biotechnological applications and the Company’s chief operating decision maker, or CODM, makes decisions based on the Company as a whole. The Company has determined that its CODM is its Chief Executive Officer. Earnings per Share Basic earnings per share attributable to common stockholders is calculated by dividing net loss attributable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. F- 15 Table of Contents Diluted earnings per share attributable to common stockholders is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share attributable to common stockholders' calculation, preferred stock, stock options, unvested restricted stock, and warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. Recent Accounting Pronouncements Not Yet Adopted The Company has considered recent accounting pronouncements and concluded that they are either not applicable to the business, or that the effect is not expected to be material to the audited consolidated financial statements as a result of future adoption. F- 16 Table of Contents 3. Revenue General The Company has not generated revenue from product sales. The Company has generated revenue from contracts with customers (option, license and collaboration agreements), which include upfront payments for licenses or options to obtain licenses, payments for research and development services and milestone payments. During the years ended December 31, 2023 and 2022 , respectively, the Company recognized revenue from the following strategic partnerships and other license agreements (in thousands): Year Ended December 31, 2023 2022 AstraZeneca $ 8,399 $ 9,117 Pfizer 15,134 8,287 Servier 4,099 5,359 Genentech 12,697 3,139 Boston Pharmaceuticals 2,481 — Total Revenue $ 42,810 $ 25,902 Under the Company´s existing strategic partnerships and other license agreements, the Company could receive the following potential milestone payments (in millions) as of December 31, 2023 : Research, Development, Regulatory & Commercial Milestones Sales Milestones Pfizer $ 759 $ 450 Servier 107 99 Boston Pharmaceuticals 85 265 Total potential milestone payments $ 951 $ 814 Strategic Partnerships Genentech On May 19, 2021, the Company and Genentech, Inc., or Genentech, entered into a Research Collaboration and License Agreement, or the Genentech Agreement, to discover, develop and commercialize locally delivered respiratory and ophthalmology therapies that leverage the Company’s proprietary Anticalin technology. Upon signing the Genentech Agreement, Genentech paid the Company a $ 20 million upfront fee. In addition, the Company may be eligible to receive additional milestone payments across multiple programs, as well as tiered royalty payments on net sales at percentages ranging from the mid-single to low double-digits, subject to certain standard reductions and offsets. Under the terms of the Genentech Agreement, the Company was responsible for discovery and preclinical development of two initial programs. In April and May 2023 , Genentech and the Company decided to discontinue the discovery-stage programs in ophthalmology and respiratory, respectively, for scientific reasons. Pursuant to this decision, the material right performance obligations related to the target swaps for these programs also expired. Based on these decisions, there aren't any active performance obligations remaining under the collaboration and the Company recognized all remaining revenue, or $12.5 million, under the collaboration in the second quarter of 2023 . The Genentech Agreement also provided an option to select additional programs, at Genentech's discretion, for a fee and this option expires in May 2024. If Genentech exercises its option to start additional programs, the Company would be eligible to receive additional milestone payments, as well as tiered royalty payments on net sales, subject to certain standard reductions and offsets. Genentech’s options to nominate two additional collaboration targets of their choosing is subject to the legal availability of the target to be researched. As of December 31, 2023 , any variable consideration related to the exercise of such options is considered fully constrained. F- 17 Table of Contents Boston Pharmaceuticals On April 24, 2021, the Company and BP Asset XII, Inc., or Boston Pharmaceuticals, a subsidiary of Boston Pharma Holdings, LLC, entered into an Exclusive Product License Agreement, or the BP Agreement, to develop PRS- 342, a 4 - 1BB/GPC3 preclinical immuno-oncology Anticalin-antibody bispecific fusion protein. Under the terms of the BP Agreement, Boston Pharmaceuticals exclusively licensed worldwide rights to PRS- 342. The Company received an upfront payment of $ 10.0 million and is further entitled to receive development, regulatory and sales-based milestone payments, tiered royalties up to low double-digits on sales of PRS- 342 and a percentage of consideration received by Boston Pharmaceuticals in the event of a sublicense of a program licensed under the BP Agreement or a change of control of Boston Pharmaceuticals. The Company also contributed $ 4.0 million toward manufacturing activities. The Company completed all performance obligations in 2021, at which point the revenue was recorded from the upfront payment. In August 2023, the first patient was dosed in the Boston Pharmaceuticals sponsored Phase 1/2 study for BOS- 342 in hepatocellular carcinoma, or HCC, for which the Company received a milestone payment. Pfizer  On February 8, 2018, the Company entered into a license and collaboration agreement, or the Pfizer Collaboration Agreement (formerly the Seagen Collaboration Agreement), and a non-exclusive Anticalin platform technology license agreement, or the Pfizer Platform License (formerly the Seagen Platform License), and together with the Pfizer Collaboration Agreement, the Pfizer Agreements (formerly the Seagen Agreements), with Pfizer (formerly Seagen), pursuant to which the agreed to develop multiple targeted bispecific IO treatments for solid tumors and blood cancers. Under the terms of the Pfizer Agreements, the companies pursued multiple Anticalin-antibody fusion proteins during the research phase. The Pfizer Agreements provide Pfizer a base option to select up to three programs for further development. Prior to the initiation of a pivotal trial, the Company may opt into global co-development and U.S. commercialization of the second program and share in global costs and profits on an equal basis. Pfizer will solely develop, fund and commercialize the other two programs. Pfizer may also decide to select additional candidates from the initial research phase for further development in return for the payment to us of additional fees, milestone payments, and royalties. On March 24, 2021, the Company announced that Pfizer made a strategic equity investment in Pieris, and that the companies had entered into a Second Pfizer Amendment (formerly Second Seagen Amendment), in which their existing immuno-oncology collaboration agreement has been amended relating to joint development and commercial rights for one program in the alliance. Under the Second Pfizer Amendment, Pieris’ option to co-develop and co-commercialize one of three programs in the collaboration was converted to a co-promotion option in the United States, with Pfizer solely responsible for the development and overall commercialization of that program. Pieris will also be entitled to increased royalties from that program in the event that it chooses to exercise the co-promotion option. In connection with the agreements described above, the Company and Pfizer entered into a subscription agreement, or the Pfizer Subscription Agreement (formerly the Seagen Subscription Agreement), pursuant to which the Company agreed to issue to Pfizer, and Pfizer agreed to acquire from the Company, 3,706,174 shares of the Company’s common stock for a total purchase price of $ 13.0 million, or $ 3.51 per share, in a private placement transaction pursuant to Section 4 (a)( 2 ) of the Securities Act of 1933, as amended. The Pfizer Subscription Agreement includes a provision to the effect that Pfizer may ask the Company to file a registration statement to register the resale of the shares issued to Pfizer, at any time beginning on the date that is 60 calendar days from the date of issuance of the shares. The Company assessed the ASC 606 implications of the Pfizer Subscription Agreement and concluded that the fair value of the shares on a per share basis was $ 2.61 per share as of the transaction date. This resulted in a premium paid for the shares of $ 3.3 million, all of which was recorded in deferred revenue upon contract execution and allocated to the remaining performance obligations. F- 18 Table of Contents In the second quarter of 2022, the Company recorded approximately $ 1.5 million in revenue related to completion of the performance obligation for the expiration of the target swap under the second program in the collaboration. Under the Pfizer Agreements, the Company is eligible to receive various research, development, commercial and sales milestones. There is uncertainty that the events to obtain the research and development milestones will be achieved given the nature of clinical development and the stage of the Company’s technology. The Company has thus determined that all research and development milestones will be constrained until it is deemed probable that a significant revenue reversal will not occur, with the exception of the $ 5.0 million milestone as described in the following paragraph. In January 2023, the Company achieved a milestone for the first program in the collaboration for $ 5.0 million. The Company evaluated the recognition of the milestone under ASC 606 and concluded that the constraints on the milestone no longer existed as of December 31, 2022 and therefore recorded the full $ 5.0 million as revenue for the year ended December 31, 2022. In September 2023 , Pfizer and the Company entered into an amendment of the Second Pfizer Amendment that provides Pfizer with collaboration product licenses and no changes to the amounts achievable under the collaboration agreement. The effect of the September 2023 amendment was to transfer responsibility for substantially all activities previously performed by the Company to Pfizer. Subsequently, in December 2023, the transfer of the programs was fully approved by the combined joint steering committee. Accordingly, the Company recognized revenue of approximately $ 10.1 million for the delivery on its performance obligations related to the two programs for the year ended December 31, 2023 . With this amendment, the Company has satisfied all remaining obligations under the collaboration. AstraZeneca On May 2, 2017, the Company entered into a license and collaboration agreement, or the AstraZeneca Collaboration Agreement, and a non-exclusive Anticalin platform technology license agreement, or AstraZeneca Platform License, and together with the AstraZeneca Collaboration Agreement, the AstraZeneca Agreements with AstraZeneca AB, or AstraZeneca, which became effective on June 10, 2017, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the AstraZeneca Agreements the parties agreed to advance several novel inhaled Anticalin proteins. In addition to the Company’s former lead inhaled drug candidate, PRS- 060/AZD1402, or the AstraZeneca Lead Product, the Company and AstraZeneca, under the original terms of the AstraZeneca Collaboration Agreement, would also collaborate to progress four additional novel Anticalin proteins against undisclosed targets for respiratory diseases, or the AstraZeneca Collaboration Products, and together with the AstraZeneca Lead Product, the AstraZeneca Products. As of June 2023, the AstraZeneca Lead Product and three of the four AstraZeneca Collaboration Products had been discontinued. The first two discovery-stage programs were previously discontinued in 2022, which led to approximately $ 9.7 million in revenue recognized due to these discontinuations. Elarekibep and the third discovery-stage program were discontinued in the second quarter of 2023. The discontinuation of the third discovery program led to recognition of $ 4.0 million of revenue in the quarter ended June 30, 2023, while there was no revenue recognized as a result of the discontinuation of elarekibep. The Company was responsible for advancing the AstraZeneca Lead Product through its phase 1 study, with the associated costs funded by AstraZeneca. The parties would collaborate thereafter to conduct a phase 2a study in asthma patients, with AstraZeneca continuing to fund development costs. After completion of a phase 2a study, Pieris had the option to co-develop the AstraZeneca Lead Product and also had a separate option to co-commercialize the AstraZeneca Lead Product in the United States. For the AstraZeneca Collaboration Products, the Company was responsible for the initial discovery of the novel Anticalin proteins, after which AstraZeneca would take the lead on continued development of the AstraZeneca Collaboration Products. The Company had the option to co-develop two of the four AstraZeneca Collaboration Products beginning at a pre-defined preclinical stage and would also have the option to co-commercialize these two programs in the United States, while AstraZeneca would be responsible for development and commercialization of the other programs worldwide. On July 17, 2023, AstraZeneca notified the Company of its intention to terminate the AstraZeneca Collaboration Agreement and the AstraZeneca Platform License, effective October 15, 2023. AstraZeneca’s decision to terminate the AstraZeneca Agreements was based on non-clinical safety findings in a 13 -week toxicology study of elarekibep in non-human primates previously disclosed by the Company. As a result of this, the remaining amount of current deferred revenue, or $ 3.5 million, related to the fourth discovery-stage program was recognized in revenue as of September 30, 2023. With the termination of the AstraZeneca Agreements, there are no more active programs or performance obligations related to the collaboration. Following the termination date, the Company determined that it would not continue development of the programs under the AstraZeneca Agreements. F- 18 Table of Contents The Company incurred $ 1.6 million of third -party success fees to obtain the contract with AstraZeneca. Upon adoption of ASC 606, the Company capitalized $ 1.1 million in accordance with ASC 340. In accordance with the termination of the AstraZeneca Agreements and recognition of remaining revenue, the Company also amortized the remaining deferred transactions costs to obtain the contract, or $ 0.3 million. Amortization for the year ended December 31, 2022 was $ 0.3 million. Servier In 2017, the Company entered into a license and collaboration agreement, or Servier Collaboration Agreement, and a non-exclusive Anticalin platform license agreement, or Servier Platform License, and together with the Servier Collaboration Agreement, the Servier Agreements with Les Laboratoires Servier and Institut de Recherches Internationales Servier, or Servier, pursuant to which the Company and Servier agreed to initially pursue five bispecific therapeutic programs. The intention of the collaboration and defined programs was to combine antibodies from the Servier portfolio with one or more Anticalin proteins based on the Company's proprietary platform to generate innovative IO bispecific drug candidates, or the Collaboration products. In the first quarter of 2022, the Company satisfied the performance obligation related to the material right for S095025 (PRS- 352 ) , which led to point-in-time recognition of revenue for $ 4.9 million of revenue previously deferred. In the fourth quarter of 2022, Servier discontinued development of S095025 based upon a strategic portfolio review. Since inception, four of the five initially committed programs have been discontinued by Servier. The Company does not presently intend to continue development of the four discontinued programs but retains full rights to advance the development and commercialization of those products on a world-wide basis in the future. In July 2023, the Company notified Servier of its decision to opt out of co-development and commercialization of S095012 (PRS- 344 ), a 4 - 1BB/PD - L1 bispecific Mabcalin protein, in the U.S. Servier retains exclusive, even as to the Company, worldwide rights to the program, including the right to continue to advance development and potential commercialization of S095012 (PRS- 344 ) in the U.S. As a result of the Company's decision to opt out of co-development, the Company will be entitled to increased royalty rates and potential royalties and milestones, if any, for S095012 (PRS- 344 ) under the terms of the Servier Agreement. With the decision to opt out of co-development of S095012 (PRS- 344 ), the Company recognized the remaining revenue under the collaboration, or $ 4.7 million, in 2023 and there are no more active co-development programs under the collaboration. Contract Balances The Company receives payments from its collaboration partners based on payments established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under each arrangement. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right is unconditional. There were no additions to deferred revenue during the year ended December 31, 2023 and reductions to deferred revenue were $ 39.7 million for the year ended December 31, 2023 . 4. Grant Income One of the Company's proprietary respiratory assets is PRS- 220, an oral inhaled Anticalin protein targeting connective tissue growth factor, or CTGF, was being developed as a local treatment for idiopathic pulmonary fibrosis, and other forms for fibrotic lung disorders. In June 2021, the Company received a €14.2 million (approximately $ 17.0 million) grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy (the Bavarian Grant) supporting research and development for post-acute sequelae of SARS-CoV- 2 infection (PASC) pulmonary fibrosis, or PASC-PF, also known as post-COVID- 19 syndrome pulmonary fibrosis, or “long COVID”. The Bavarian Grant provides partial reimbursement for qualifying research and development activities on PRS- 220, including drug manufacturing costs, activities and costs to support an IND filing, and phase 1 clinical trials costs. The Bavarian Grant provides reimbursement of qualifying costs incurred through December 2023, with submission for reimbursements allowed through February 2024, which was successfully completed by the Company. The timing follows the expected development timeline of this program. Qualifying costs incurred may exceed the annual grant funding thresholds. In addition, the Company is required to communicate if there is a change in control or other event that would impact the continuation of PRS- 220 to the Bavarian project agency, in which case the Company may be required to refund some or all amounts received under the grant. F- 19 Table of Contents 5. Cash, Cash Equivalents and Investments As of December 31, 2023 , cash, cash equivalents and investments comprised funds in depository, money market accounts and U.S. treasury securities. As of December 31, 2022 , cash, cash equivalents and investments comprised funds in depository, money market accounts, U.S. and foreign treasury securities, asset-backed securities and corporate bonds. The following table presents the cash equivalents and investments carried at fair value in accordance with the hierarchy defined in Note 2 at December 31, 2023 . Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) December 31, 2023 Money market funds, included in cash equivalents $ 13,224 $ 13,224 $ — $ — Investments - US treasuries 8,970 8,970 — — Total $ 22,194 $ 22,194 $ — $ — Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) December 31, 2022 Money market funds, included in cash equivalents $ 17,618 $ 17,618 $ — $ — Investments - US treasuries 3,573 3,573 — — Investments - Foreign treasuries 896 896 — — Investments - Asset-backed securities 499 — 499 — Investments - Corporate bonds 15,566 — 15,566 — Total $ 38,152 $ 22,087 $ 16,065 $ — Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. The Company validates the prices provided by its third -party pricing services by reviewing their pricing methods and obtaining market values from other pricing sources, as needed. After completing its validation procedures, the Company did not adjust any fair value measurements provided by the pricing services as of December 31, 2023 . Investments at December 31, 2023 consist of the following (in thousands): Contractual maturity (in days) Amortized Cost Unrealized gains Unrealized losses Fair Value Investments US treasuries 4 - 51 $ 8,969 $ 1 $ — $ 8,970 Total $ 8,969 $ 1 $ — $ 8,970 The Company recorded realized losses from the maturity of available-for-sale securities of $ 0.1 million and realized gains of $ 0.4 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 , there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period. F- 20 Table of Contents 6. Assets Held for Sale, Property and Equipment As of December 31, 2023 , assets held for sale are summarized as follows (in thousands): December 31, 2023 Laboratory furniture and equipment $ 1,967 Office furniture and equipment 221 Assets held for sale $ 2,188 At the end of the third quarter of 2023, as part of the Company's strategic process for maximizing the value of assets, the Company committed to a plan to prepare and sell all property and equipment held at the Hallbergmoos, Germany location. The sale of the assets was deemed probable as a result of management's decision, including the estimated timing of sale which was determined to be within a year of the decision. As a result of this decision, the property and equipment met the criteria for held-for-sale accounting. The Company recorded impairment charges totaling $ 13.9 million, of which $ 1.8 million related to impairment of its right-of-use asset under the Hallbergmoos Lease (see Note 13 ) with the remaining related to a complete write-off of leasehold improvements and a partial impairment of the Company's other long-lived assets. The remaining $ 2.2 million in net book value of its long-lived assets represents the Company's best estimate of the fair value less costs to sell that could be recovered related to lab and office equipment and furniture as part of the Company's initiative to monetize all remaining assets. As the estimated selling price less costs to sell are based primarily on unobservable inputs as they relate to the location and condition of the specific lab equipment and furniture, they are classified in Level 3 in the fair value hierarchy. In the first quarter of 2024, the Company conducted an auction, with the assistance of a third party, of its assets held for sale. After the conclusion of the auction, the Company has recovered substantially all of the total net book value of the assets held for sale. The Company has further plans to sell all remaining assets in the second quarter of 2024. As of December 31, 2022 , property and equipment are summarized as follows (in thousands): December 31, 2022 Laboratory furniture and equipment $ 11,970 Office furniture and equipment 1,861 Computer equipment 364 Leasehold improvements 12,444 Property and equipment, cost 26,639 Accumulated depreciation ( 9,647 ) Property and equipment, net $ 16,992 Depreciation expense was $ 1.8 million and $ 2.3 million for the years ended December 31, 2023 and 2022 , respectively. There were no other changes in accumulated depreciation other than the foreign currency impact. F- 21 Table of Contents 7. Accrued Expenses Accrued expenses and other current liabilities consisted of the following (in thousands): Years Ended December 31, 2023 2022 Compensation expense $ 6,448 $ 3,015 Research and development fees 968 5,758 Accrued accounts payable 558 1,245 Other current liabilities 363 483 Accrued license obligations 213 245 Total $ 8,550 $ 10,746 The compensation expense line item in the above table includes both severance and benefit costs associated with the Company's corporate restructuring actions announced in 2023, inclusive of those employees retained as the service period to earn such benefits is considered complete. The Company recognized restructuring expenses consisting of one -time cash severance payments and other employee-related costs. Severance pay and related costs for certain retained employees are estimated to be paid through the end of 2024. The Company recorded these restructuring charges based on each employee’s role to the respective research and development and general and administrative operating expense categories on its consolidated statements of operations and comprehensive loss. The following table includes a roll forward of the restructuring activity and payments recorded for the year ended December 31, 2023 ( in thousands): Severance and Benefits Costs Restructuring expenses $ 7,523 Cash payments $ ( 2,418 ) Balance at December 31, 2023 $ 5,105 8. Income Taxes The Company reported a loss before income taxes consisting of the following (in thousands): Years Ended December 31, 2023 2022 Domestic $ ( 9,818 ) $ ( 11,765 ) Foreign ( 14,726 ) ( 21,512 ) Loss before income taxes $ ( 24,544 ) $ ( 33,277 ) The components of the provision for income taxes are as follows (in thousands): Years Ended December 31, 2023 2022 Current: Federal $ — $ — State — — Foreign — — Total current — — Deferred: Federal — — State — — Foreign — — Total deferred — — Provision for income taxes $ — $ — The reconciliation of the federal statutory rate to the Company’s effective tax rate is as follows: 2023 2022 Federal income tax rate 21.0 % 21.0 % Foreign rate differential 0.7 % 5.0 % State tax, net of federal benefit 3.8 % 2.0 % Share-based awards compensation ( 2.1 )% ( 2.2 )% Permanent items ( 2.1 )% 0.3 % Other ( 1.0 )% 1.0 % Release of uncertain tax position 22.7 % — % Credits 0.8 % 1.2 % Change in valuation allowance ( 43.8 )% ( 28.3 )% Effective income tax rate — % — % F- 22 Table of Contents The components of deferred tax assets and liabilities related to net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income taxes purposes were as follows (in thousands): Years Ended December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 67,496 $ 54,845 Share-based awards compensation 2,624 3,112 Accrued expenses 461 216 R&D Credits 644 413 Depreciation and other 479 384 Unrealized foreign currency ( 377 ) 359 Capitalized R&D 1,165 952 Lease liability — 3,541 Total deferred tax assets 72,492 63,822 Deferred tax liabilities: Right-of-use asset — ( 3,270 ) Accrued expenses — — Total deferred tax liabilities — ( 3,270 ) Less: valuation allowance: ( 72,492 ) ( 60,552 ) Net deferred tax asset $ — $ — The Company operates in multiple jurisdictions. Accordingly, the Company files U.S. federal and state income tax returns as well as returns in multiple foreign jurisdictions. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax-planning strategies in making this assessment. Management believes it is more likely than not that the results of future operations will not generate sufficient taxable income in the United States or in its foreign jurisdictions to realize the full benefits of its deferred tax assets. As of December 31, 2023 , the Company continues to maintain a full valuation allowance against all net deferred tax assets. The cumulative amount of earnings of our foreign subsidiaries are expected to be permanently invested in the foreign subsidiaries. Deferred taxes have not been provided on the excess of book basis over tax basis, or the excess tax basis over book basis in the shares of our foreign subsidiaries because these basis differences are not expected to reverse in the foreseeable future and are essentially permanent in duration. Our intention is to reinvest the earnings of the foreign subsidiaries indefinitely. The increase in the valuation allowance of deferred tax assets of $ 11.9 million for the year ended December 31, 2023 was primarily a result of the operating losses generated in current tax year. As of December 31, 2023 , the Company had net operating loss carryforwards for U.S. federal income tax purposes of $ 43.4 million and net operating loss carryforwards for state income tax purposes of $ 46.7 million. Federal tax loss carryforwards that were created prior to December 31, 2017 expire through 2037 and federal losses created after that date do not expire. State loss carryforwards expire starting in 2035. Pursuant to Section 382 of the Internal Revenue Code of 1986, or the Code, and similar state tax law, certain substantial changes in the Company’s ownership may result in a limitation on the amount of net operating loss and tax credit carryforwards that may be used in future years. Utilization of the net operating loss and tax credit carryforwards may be subject to an annual limitation under Section 382 of the Code due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and tax credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a Section 382 study through December 31, 2020. Based on the study, the Company underwent an ownership change for Section 382 purposes which occurred in February 2018. As a result of the ownership change, the Company’s net operating loss and tax credit carryforwards as of the ownership change dates are subject to limitation under Section 382; however, these limitations are not expected to result in any of the impacted net operating loss and tax credit carryforwards to expire unutilized. Any net operating losses or tax credits generated after the February 2018 change are not subject to this annual limitation. However, subsequent ownership changes, as defined by Section 382, may potentially further limit the amount of net operating loss and tax credit carryforwards that could be utilized to offset future taxable income and tax. The Company is currently open to examination under the statute of limitations by the Internal Revenue Service and state jurisdictions for the tax years ended 2019 through the current year. Carryforward tax attributes generated in years past may still be adjusted upon future examination if they have or will be used in a future period. The Company is not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. F- 23 Table of Contents As of December 31, 2023 , the Company had German corporate income tax and trade tax net operating loss carryforwards of approximately $ 187.6 million and $ 183.7 million respectively. Under current German laws, tax loss carryforwards may only be used to offset any relevant later assessment period (calendar year) of $1.2 million plus 60% of the exceeding taxable income and trade profit of such period and do not expire. In addition, certain transactions, including transfers of shares or interest in the loss holding entity, may result in the partial or total forfeiture of tax losses existing at that date. Partial or total forfeiture of tax losses may further occur in corporate reorganizations of the loss holding entity. As of December 31, 2023, the Company had gross U.S. federal and state research and development and other tax credit carryforwards of $ 0.5 million and $ 0.1 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2042 and 2037, respectively. As of December 31, 2022, the Company had gross U.S. federal and state research and development and other tax credit carryforwards of $ 0.3 million and $ 0.1 million, respectively, which may be available to offset future tax liabilities and begin to expire in 2042 and 2037, respectively. The Company accounts for uncertain tax positions pursuant to ASC 740, Income Taxes , which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured at the largest amount of benefit that is more likely than not (determined by cumulative probability) of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest and penalties, if any, related to uncertain tax positions in income tax expense. No interest and penalties related to uncertain tax positions were accrued at December 31, 2023 and December 31, 2022 . On December 22, 2017, the Tax Cuts and Jobs Act, or the TCJA, was signed into law. Under the TCJA provisions, effective with tax years beginning on or after January 1, 2022, taxpayers can no longer immediately expense qualified research and development expenditures. Taxpayers are now required to capitalize and amortize these costs over five years for research conducted within the United States or 15 years for research conducted abroad. The following table sets forth a reconciliation of the beginning and ending amounts of unrecognized tax benefits, excluding the impact of interest and penalties, for the year ended December 31, 2023 (in thousands): Unrecognized tax benefits at December 31, 2022 $ 5,363 Decrease as a result of a lapse of the applicable statute of limitations ( 5,363 ) Unrecognized tax benefits at December 31, 2023 $ — The Company does not expect unrecognized tax benefits to change significantly over the next twelve months. The full amount of unrecognized tax benefits would impact the effective rate, subject to valuation allowance considerations, if recognized. 9. Stockholders ’ equity The Company had 300,000,000 shares authorized and 98,935,025 and 74,519,103 shares of common stock issued and outstanding as of December 31, 2023 and December 31, 2022 , respectively, with a par value of $ 0.001 per share. The Company had 10,000,000 shares authorized and 15,617 shares of preferred stock issued and outstanding as of December 31, 2023 and 2022 . Preferred stock has a par value of $ 0.001 per share, and consists of the following tranches: • Series A Convertible, 85 shares issued and outstanding at December 31, 2023 and 2022 • Series B Convertible, 4,026 shares issued and outstanding at December 31, 2023 and 2022 • Series C Convertible, 3,506 shares issued and outstanding at December 31, 2023 and 2022 • Series D Convertible, 3,000 shares issued and outstanding at December 31, 2023 and 2022 • Series E Convertible, 5,000 shares issued and outstanding at December 31, 2023 and 2022 Common Stock Each share of the Company’s common stock is entitled to one vote and all shares rank equally as to voting and other matters. Dividends may be declared and paid on the common stock from funds legally available therefor, if, as and when determined by the Board of Directors. F- 24 Table of Contents Preferred Stock The Company has issued multiple series (Series A through E) of preferred stock to certain entities affiliated with Biotechnology Value Fund, L.P., or BVF. In each case, each share Preferred Stock is convertible into 1,000 shares of the Company's common stock (subject to adjustment as provided in the Certificate of Designation for each series) at any time at the option of the holder, provided that the holder is prohibited from converting the Preferred Stock into shares of the Company's common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99 % of the total number of shares of Common Stock then issued and outstanding, or the Beneficial Ownership Limitation. The holder may reset the Beneficial Ownership Limitation to a higher or lower number, not to exceed 19.99 % of the total number of common shares issued and outstanding immediately after giving effect to a conversion, upon providing written notice to the Company. Any such notice providing for an increase to the Beneficial Ownership Limitation will be effective 61 days after delivery to the Company. Series A, Series B, Series C, Series D and Series E Preferred Stock rank senior to the Company’s common stock; senior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as junior to the five series of Preferred Stock; in parity with each other and with any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as in parity with the existing five series of Preferred Stock; and junior to any class or series of capital stock of the Company created after the designation of and specifically ranking by its terms as senior to the existing five series of Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, subject to the rights of holders of, holders are entitled to receive a payment equal to $ 0.001 per share of Preferred Stock pursuant to the rights and preferences discussed above, plus an additional amount equal to any dividends declared but unpaid on such shares. However, if the assets of the Company are insufficient to comply with the preceding sentence, then all remaining assets of the Company shall be distributed ratably to holders of the shares of the existing five series of Preferred Stock. For each series of Preferred Stock, the Company designated the requisite number of shares of its authorized and unissued preferred stock as a specific series of Preferred Stock and filed a Certificate of Designation with the Nevada Secretary of State. Shares of Preferred Stock generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Preferred Stock is required to amend the terms of the Certificate of Designation for each respective series of Preferred Stock. Holders of Preferred Stock are entitled to receive any dividends payable to holders of the Company's common stock subject to the rights and preferences discussed above, in each case, as to distributions of assets upon the Company’s liquidation, dissolution or winding up whether voluntarily or involuntarily and/or the right to receive dividends. Series A Preferred Stock In June 2016, the Company entered into a securities purchase agreement for a private placement of the Company’s securities with a select group of institutional investors, or the 2016 PIPE. The 2016 PIPE sale transaction, by the Company, consisted of 8,188,804 units at a price of $ 2.015 per unit for gross proceeds, to the Company, of approximately $ 16.5 million. After deducting for placement agent fees and offering expenses, the aggregate net proceeds from the private placement was approximately $ 15.3 million. In connection with the 2016 PIPE, the Company issued 3,225,804 shares of common stock and 4,963 shares of Series A Preferred Stock to the 2016 PIPE investors. Series B Preferred Stock On January 30, 2019, the Company and certain entities affiliated with BVF entered into an exchange agreement pursuant to which BVF agreed to exchange an aggregate of 5,000,000 shares of the Company’s common stock owned by BVF for an aggregate of 5,000 shares of Series B Preferred Stock. Series C and 2019 Private Placement In November 2019, the Company entered into a securities purchase agreement for a private placement, or the Purchase Agreement with a select group of institutional investors, including lead investor BVF as well as existing and new investors, or Investors. The private placement consisted of 9,014,960 units, at a price of $ 3.55 per unit, or the Financing, for gross proceeds of approximately $ 32.0 million, and net proceeds to the Company of approximately $ 31.0 million. Each unit consists of (i) one share of the Company’s common stock or 0.001 shares of non-voting convertible preferred stock, or Series C Preferred Shares, and together with the Common Shares, or Shares, and (ii) one immediately-exercisable warrant to purchase one share of the Company’s common stock with an exercise price of $ 7.10 , or Exercise Price. F- 25 Table of Contents If (i) the initial public disclosure of the phase 2a Study of elarekibep that includes the “p” value achieved for the primary endpoint of such study reveals top-line data on the primary efficacy endpoint in the phase 2a Study with a “p” value below 0.05 (i.e., p < 0.05 ) in at least one dose level; and (ii) the 10 -day volume weighted average stock price commencing on the trading day immediately after the initial public disclosure is at least three percent more than the Exercise Price, ((i) and (ii), collectively, the “Performance Condition”), then the warrants will be exercisable for a period of 60 days from the date of the initial data disclosure and may only be exercised for cash. Otherwise, the warrants will be exercisable for a period of five years from the date of issuance, or Exercise Date. If the Performance Condition has not been met and the last reported sale price of the Company’s common stock immediately prior to the Expiration Date was greater than the Exercise Price, then the warrants shall be automatically deemed exercised on a cashless basis on the Expiration Date. Upon issuance, each Series C Preferred Share included an embedded beneficial conversion feature as the market price of the Company’s common stock on the date of issuance of the Series C convertible Preferred Stock was $ 3.43 per share. As a result, the Company recorded the intrinsic value of the beneficial conversion feature of $ 2.8 million as a discount on the Series C convertible preferred stock at issuance. As the Series C Preferred Shares are immediately convertible upon issuance and do not include a stated redemption date, the discount was immediately accreted as a deemed dividend. Series D Preferred Stock Conversion On March 31, 2020, the Company and certain entities affiliated with BVF entered into an exchange agreement pursuant to which, on April 1, 2020, BVF exchanged an aggregate of 3,000,000 shares of the Company’s common stock owned by BVF for an aggregate of 3,000 shares of Series D Preferred Stock. Series E Preferred Stock Conversion On May 20, 2021, the Company and certain entities affiliated with BVF entered into an exchange agreement pursuant to which, BVF exchanged an aggregate of 5,000,000 shares of the Company’s common stock owned by BVF for an aggregate of 5,000 shares of Series E Preferred Stock. Open Market Sales Agreement In August 2021, the Company established an at-the-market program, or ATM Program, under a sales agreement with Jefferies LLC, pursuant to which the Company may offer and sell shares of its common stock, par value $ 0.001 per share, from time to time, up to an aggregate amount of gross sales proceeds of $ 50.0 million. In November 2022, the sales agreement was amended to provide for an increase in the aggregate offering amount, such that under the ATM Program, as amended, the Company may offer and sell shares of its common stock, from time to time, up to an aggregate amount of gross sales proceeds of $ 75.0 million. The ATM Program, as amended, is offered under a shelf registration statement on Form S- 3 that was filed with and declared effective by the SEC in August 2021. For the year ended December 31, 2023 , the Company sold 24.3 million shares for gross proceeds of $ 20.3 million under the ATM Program at an average stock price of $ 0.84 . For the year ended December 31, 2022 , the Company sold 2.1 million shares for gross proceeds of $ 7.2 million under the ATM Programs and the predecessor ATM program at an average stock price of $ 3.46 . As of the filing of this Annual Report on Form 10 -K, the Company will be subject to the SEC general instructions of Form S- 3 known as the “baby shelf rules.” Under these instructions, the amount of funds the Company can raise through primary public offerings of securities in any 12 -month period using its registration statement on Form S- 3 is limited to one - third of the aggregate market value of the shares of the Company’s common stock held by non-affiliates. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of its common stock using its Form S- 3, including under the ATM Program, until such time as its public float exceeds $75 million. 10. Net Loss per Share Basic net loss per share is calculated by dividing net income (loss) by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, stock options, and warrants are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. For the years ended December 31, 2023 and 2022 , and as calculated using the treasury stock method, approximately 39.4 million and 38.4 million of weighted average shares, respectively, were excluded from the calculation of diluted weighted average shares outstanding as their effect was antidilutive. F- 26 Table of Contents 11. Stock and Employee Benefit Plans Employee, Director and Consultant Equity Incentive Plans At the 2020 Annual Shareholder Meeting, held on June 23, 2020, the stockholders approved the 2020 Employee, Director and Consultant Equity Incentive Plan, or the 2020 Plan. The 2020 Plan originally permitted the Company to issue up to 3,500,000 shares of common stock pursuant to awards granted under the 2020 Plan. Upon approval of the 2020 Plan, the 2019 Employee, Director and Consultant Equity Incentive Plan, or the 2019 Plan, was terminated; all unissued options were canceled and no additional awards will be made thereunder. All outstanding awards under the 2019 Plan will remain in effect and any awards forfeited from the outstanding awards will be allocated back into the 2020 Plan. The 2020 Plan, similar to the 2019 Plan, provided for the grant of stock options, restricted and unrestricted stock awards, and other stock-based awards to employees of the Company, non-employee directors of the Company, and certain other consultants performing services for the Company as designated by either the Board of Directors or the compensation committee of the Board of Directors. At the 2021 Annual Meeting of Stockholders, held on June 25, 2021, the Company’s stockholders approved the first amendment to the 2020 Plan to add 2,250,000 shares for issuance under the 2020 Plan, which increased the total permitted for issuance under the 2020 Plan to 5,750,000 . At the 2022 Annual Meeting of Stockholders, held on June 22, 2022, the Company’s stockholders approved the second amendment to the 2020 Plan to add an additional 3,000,000 shares for issuance under the 2020 Plan. At the 2023 Annual Meeting of Stockholders held on June 21, 2023, the Company's stockholders approved a third amendment to the 2020 Plan to add 6,000,000 shares of common stock for issuance under the 2020 Plan, which increased the total permitted for issuance under the 2020 Plan to 14,750,000 . The 2020 Plan permits the Company to issue up to 14,750,000 shares reserved for issuance pursuant to the 2020 Plan and any additional shares which may be issued if awards outstanding under the Company’s 2014, 2016, 2018 and 2019 Plans are canceled or expire. The Company’s stock options have a maximum term of 10 years from the date of grant. Stock options granted may be either incentive stock options or nonqualified stock options and the exercise price of stock options must be at least equal to the fair market value of the common stock on the date of grant. The Company’s general policy is to issue shares of common stock upon the exercise of stock options. The Company estimates the fair value of each stock award on the grant date using the Black-Scholes option-pricing model based on the following assumptions: Years Ended December 31, 2023 2022 Risk free interest rate 3.33 % - 4.11 % 1.43 % - 3.39 % Expected term (in years) 5.5 - 5.73 5.5 - 5.73 Dividend yield — — Expected volatility 79.5 % - 98.6 % 79.9 % - 81.1 % The weighted-average fair value of the 3,727,942 and 3,075,282 options granted during the years ended December 31, 2023 and 2022 was $ 0.85 and $ 1.96 , respectively. As of December 31, 2023 , there were 9,284,808 shares available for future grant under the 2020 Plan. The following table summarizes stock option activity for employees and non-employees: Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Life (in years) (in thousands) Outstanding, December 31, 2022 13,430,366 $ 3.21 $ — Granted 3,727,942 1.22 — Canceled/Forfeited 2,655,237 2.65 — Outstanding, December 31, 2023 14,503,071 $ 2.80 5.90 $ — Vested or expected to vest, December 31, 2023 14,503,071 $ 2.80 5.90 $ — Exercisable, December 31, 2023 10,292,063 $ 3.21 4.75 $ — F- 27 Table of Contents Periodically, the Company grants inducement options, which are awards outside of stockholder-approved stock option plans, and which are awarded as an inducement material to the executive officers or other personnel entering senior leadership roles with the Company. The terms of inducement option awards were substantially the same as those issued under our 2020 Plan. These awards are excluded from the table above. The following table summarizes stock option activity for these inducement options (in thousands): Weighted- Weighted- Average Aggregate Average Remaining Intrinsic Number of Exercise Contractual Value Options Price Life (in years) (in thousands) Outstanding, December 31, 2022 300,000 $ 4.65 $ — Granted — $ — $ — Canceled/Forfeited — $ — $ — Outstanding, December 31, 2023 300,000 $ 4.65 5.67 $ — Vested or expected to vest, December 31, 2023 300,000 $ 4.65 5.67 $ — Exercisable, December 31, 2023 300,000 $ 4.65 5.67 $ — Employee Stock Purchase Plans At the 2023 Annual Meeting of Stockholders, the Company’s stockholders approved the 2023 Employee Stock Purchase Plan, or the 2023 ESPP, which replaces the former 2018 Employee Stock Purchase Plan, or 2018 ESPP. The 2023 ESPP provides eligible employees with the opportunity to purchase shares of the Company's common stock at a discount of 85 % of the lower closing market price of the common stock at the beginning date or ending date of each purchase period, on a tax-favored basis, through regular payroll deductions in compliance with federal tax regulations. The Company has reserved 750,000 shares of common stock for issuance under the 2023 ESPP. Total shares purchased under the 2023 ESPP and 2018 ESPP plan were 154,656 and 181,466 for the years ended December 31, 2023 and 2022 , respectively. Total Stock-based Compensation Expense Total stock-based compensation expense is recorded in operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows (in thousands): Years Ended December 31, 2023 2022 Research and development $ 1,190 $ 1,905 General and administrative 2,159 2,497 Total stock-based compensation $ 3,349 $ 4,402 As of December 31, 2023 , the total unrecognized compensation cost related to all non-vested awards was $ 4.3 million. The unrecognized compensation cost would be recognized over a remaining weighted-average period of 2.24 years. 12. License Agreement TUM License The Company and the Technical University of Munich, or TUM, initiated discussions in the second quarter of 2018 to clarify, expand and restructure the research and licensing agreement with TUM, the TUM License, including the parties’ obligations under the TUM License. The TUM License assigns or exclusively licenses to the Company certain intellectual property related to the Company's Anticalin platform technology. The parties' discussions relate to revised commercial terms and to re-initiating additional collaborations between faculty at TUM and Pieris. While an amended and restated license agreement has not yet been completed, the Company may enter into an amendment reflecting the parties discussions. These discussions may also lead to an increase in the Company's collaborative research activities with TUM. F- 28 Table of Contents 13. Leases In August 2015, the Company entered into a sublease to lease approximately 3,950 square feet in Boston, Massachusetts, which expired on December 31, 2022. The Company did not extend the sublease. The Company generally conducts its operational functions in the United States remotely. In October 2018, Pieris Pharmaceuticals GmbH entered into a lease for office and laboratory space located in Hallbergmoos, Germany, or the Hallbergmoos Lease. Pieris GmbH moved its operations to the Hallbergmoos facility in February 2020. The Hallbergmoos Lease was subsequently amended in May 2019 and February 2020. The Hallbergmoos Lease, as amended, provided an initial rental term of 12.5 years, and a rental area of approximately 105,000 square feet. In December 2023, Pieris Pharmaceuticals GmbH entered into an agreement to terminate the Hallbermoos Lease, or the Lease Termination Agreement. Under the terms of the Lease Termination Agreement, Pieris Pharmaceuticals GmbH terminated the Hallbergmoos Lease in exchange for a termination fee of approximately €9.7 million, and vacated the majority of the premises by December 31, 2023, while continuing to occupy, through June 2024, a limited portion of the office space and using another portion of the former lab space to house its assets being held for sale. Cash paid for amounts included in the measurement of the lease liabilities were $ 2.2 million and $ 2.4 million for the years ended December 31, 2023 and 2022 , respectively, all of which were incurred prior to the lease termination. The Hallbergmoos Lease included $ 11.5 million of tenant improvements allowance for normal tenant improvements which was incurred prior to commencing the lease. The Company capitalized the leasehold incentives which were included in Property and equipment, net on the Consolidated Balance Sheet and were amortized on a straight-line basis over the shorter of the useful life or the remaining lease term. The leasehold improvement were subsequently fully impaired in the third quarter of 2023. The following table summarizes operating lease costs included in operating expenses (in thousands): Year Ended December 31, 2023 2022 Operating lease costs $ 1,169 $ 1,356 Variable lease costs (1) 679 737 Total lease cost $ 1,848 $ 2,093 ( 1 ) Variable lease costs include certain additional charges for operating costs, including insurance, maintenance, taxes, utilities and other costs incurred, which are billed based on both usage and as a percentage of the Company’s share of total square footage. These costs also included costs associated with increases rent expense based on CPI. F-29