Palvella Therapeutics, Inc 10-K/A, filed Jul 6, 2022
Palvella Therapeutics, Inc. (PVLA)
10-K/A
2022-07-06
For: 2021-12-31
View Original
Added on
April 10, 2026
About this 10-K/A
Palvella Therapeutics, Inc filed this 10-K/A on July 6, 2022, covering the fiscal year ended December 31, 2021.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
(Amendment No. 1)
(Mark One)
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the fiscal year ended December 31 , 2021
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the transition period from to
Commission file number: 001-37471
(Exact name of registrant as specified in its charter)
EIN | ||||||||
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| | The | |||||||
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ý
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ý
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ý No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||||||||
☒ | Smaller reporting company | |||||||||||||||||||
| Emerging growth company | ||||||||||||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ý
The aggregate market value of the registrant's common stock held by non-affiliates of the registrant on June 30, 2021, the last business day of the registrant’s most recently completed second fiscal quarter, based on the closing price on that date of $3.83, was $170,606,113 .
As of February 24, 2022, the registrant had 74,077,417 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Auditor Name: Ernst & Young LLP Auditor Location: Boston, Massachusetts Auditor ID: 00042
EXPLANATORY NOTE REGARDING THIS FORM 10-K/A
The sole purpose of this Amendment No. 1 on Form 10-K/A (the “Amendment”) is to amend the Annual Report on Form 10-K of Pieris Pharmaceuticals, Inc. (the “Company”) as filed with the Securities and Exchange Commission (the “SEC”) on March 2, 2022 (the “Original Filing”) to refile Exhibit 23.1, Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm (the “Auditor Consent”).
The Auditor Consent has been revised to include consent to the incorporation by reference of Ernst & Young LLP’s report dated March 1, 2022, with respect to the consolidated financial statements of the Company included in the Original Filing, of three additional registration statements filed by the Company which were omitted due to a scrivener's error: Form S-3 (File Nos. 333-256218 and 333-258497) and Form S-8 (File No. 333-258502). This Amendment does not otherwise modify, amend, or update in any way the disclosures contained in the Original Filing. Accordingly, this Form 10-K/A should be read in conjunction with the Original Filing and the Company’s other filings made with the SEC after the date of the Original Filing.
PART IV
| Item 15. | EXHIBITS, FINANCIAL STATEMENT SCHEDULES | |||||||
| Item 15(a). | The following documents were filed as part of the Original Filing: | |||||||
| Item 15(a)(1) and (2) | See “Index to Consolidated Financial Statements” on page F-1 to the Original Filing. 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 or incorporated by reference as part of the Original Filing and this Amendment and such exhibits are incorporated herein by reference. | ||||||||
Exhibit Number | Exhibit Description | Incorporated by Reference herein from Form or Schedule | Filing Date | SEC File / Registration Number | |||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| Amended and Restated Articles of Incorporation of the Registrant | Form 8-K (Exhibit 3.1) | December 18, 2014 | 333-190728 | ||||||||||||||||||||||||||
| Certificate of Designation of Series A Convertible Preferred Stock | Form 10-Q (Exhibit 3.1) | August 11, 2016 | 001-37471 | ||||||||||||||||||||||||||
| Certificate of Designation of Series B Convertible Preferred Stock | Form 8-K (Exhibit 3.1) | February 4, 2019 | 001-37471 | ||||||||||||||||||||||||||
| Certificate of Designation of Series C Convertible Preferred Stock | Form 8-K (Exhibit 3.1) | November 4, 2019 | 001-37471 | ||||||||||||||||||||||||||
| Certificate of Designation of Series D Convertible Preferred Stock | Form 8-K (Exhibit 3.1) | April 6, 2020 | 001-37471 | ||||||||||||||||||||||||||
Certificate of Designation of Series E Convertible Preferred Stock | Form 8-K (Exhibit 3.1) | May 21, 2021 | 001-37471 | ||||||||||||||||||||||||||
| Amended and Restated Bylaws of the Registrant | Form 8-K (Exhibit 3.2) | December 18, 2014 | 333-190728 | ||||||||||||||||||||||||||
| Amendment to the Amended and Restated Bylaws of the Registrant | Form 8-K (Exhibit 3.1) | September 3, 2019 | 001-37471 | ||||||||||||||||||||||||||
| Form of Common Stock certificate | Form 8-K (Exhibit 4.1) | December 18, 2014 | 333-190728 | ||||||||||||||||||||||||||
| Form of Common Stock certificate | Form 10-K (Exhibit 4.2) | March 23, 2016 | 001-37471 | ||||||||||||||||||||||||||
| Description of Registered Securities | Form 10-K (Exhibit 4.3) | March 13, 2020 | 001-37471 | ||||||||||||||||||||||||||
| 2014 Employee, Director and Consultant Equity Incentive Plan | # | Form 8-K (Exhibit 10.1) | December 18, 2014 | 333-190728 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 2016 Employee, Director and Consultant Equity Incentive Plan | # | Form 8-K (Exhibit 10.1) | July 1, 2016 | 001-37471 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 2018 Employee, Director and Consultant Equity Incentive Plan | # | Form 8-K (Exhibit 10.1) | July 26, 2018 | 001-37471 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 2018 Employee Stock Purchase Plan | # | Form 8-K (Exhibit 10.2) | July 26, 2018 | 001-37471 | |||||||||||||||||||||||||
| 2019 Employee, Director and Consultant Equity Incentive Plan | # | Form 8-K (Exhibit 10.1) | July 31, 2019 | 001-37471 | |||||||||||||||||||||||||
| 2020 Employee, Director and Consultant Equity Incentive Plan | # | Form 8-K (Exhibit 10.1) | June 29, 2020 | 001-37471 | |||||||||||||||||||||||||
| 2020 Employee, Director and Consultant Equity Incentive Plan, as amended | # | Form 8-K (Exhibit 10.1) | June 29, 2021 | 001-37471 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| License and Transfer Agreement by and between the Company and Enumeral Biomedical Holdings, Inc dated as of April 18, 2016 | ± | Form 10-Q/A (Exhibit 10.1) | July 20, 2016 | 001-37471 | |||||||||||||||||||||||||
| Definitive License and Transfer Agreement by and between the Company and Enumeral Biomedical Holdings, Inc. dated as of June 6, 2016 | ± | Form 10-Q (Exhibit 10.1) | August 11, 2016 | 001-37471 | |||||||||||||||||||||||||
| Amendment No.1 to Definitive License and Transfer Agreement by and between the Company and Enumeral Biomedical Holdings, Inc. effective as of January 3, 2017 | Form 10-K (Exhibit 10.14) | March 30, 2017 | 001-37471 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 10.3) | August 10, 2020 | 001-37471 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| Combination Study Agreement, dated March 24, 2021, by and between the Registrant and Seagen Inc. | Form 10-Q (Exhibit 10.2) | May 17, 2021 | 001-37471 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| Clinical Trial Collaboration and Supply Agreement by and among the Registrant and Eli Lilly and Company, dated August 10, 2020 | Form 10-Q (Exhibit 10.1) | November 4, 2020 | 001-37471 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| Non-Employee Director Compensation Policy, as amended | # | Form 10-K (Exhibit 10.39) | March 2, 2022 | 001-37471 | |||||||||||||||||||||||||
| Agreement of Sublease by and between Berenberg Capital Markets LLC and the Registrant, dated as of August 27, 2015 | Form 10-Q (Exhibit 10.3) | November 13, 2015 | 001-37471 | ||||||||||||||||||||||||||
| Subtenant Recognition and Attornment Agreement, by and among Pieris Pharmaceuticals, Inc., 225 State Street, LLC, and Berenberg Capital Markets LLC, dated as of May 31, 2019 | Form 10-Q (Exhibit 10.29.1) | August 9, 2019 | 001-37471 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| Managing Director Services Agreement by and between Pieris Pharmaceuticals GmbH and Hitto Kaufmann, Ph.D., dated as of August 30, 2019 | # | Form 10-Q (Exhibit 10.2) | November 12, 2019 | 001-37471 | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| Form of Non-Qualified Stock Option Agreement by and between the Registrant and Tim Demuth, M.D., Ph.D. | Form S-8 (Exhibit 10.3) | August 5, 2021 | 333-258502 | ||||||||||||||||||||||||||
| Corporate Code of Ethics and Conduct and Whistleblower Policy | Form 10-K (Exhibit 14.1) | March 31, 2021 | 001-37471 | ||||||||||||||||||||||||||
| List of Subsidiaries | Form 10-K (Exhibit 10.39) | 44622 | 001-37471 | ||||||||||||||||||||||||||
| Consent of Ernst & Young LLP | * | ||||||||||||||||||||||||||||
| Certification of Stephen S. Yoder, Chief Executive Officer and President, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||||||||||||||||||||||||||
| Certification of Thomas Bures, Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | * | ||||||||||||||||||||||||||||
| 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 | ** | ||||||||||||||||||||||||||||
| Certification of Thomas Bures, Chief Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 | ** | ||||||||||||||||||||||||||||
| 101.INS | XBRL Instance Document | * | |||||||||||||||||||||||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document | * | |||||||||||||||||||||||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | Form 10-K (Exhibit 101.CAL) | March 2, 2022 | 001-37471 | |||||||||||||||||||||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | Form 10-K (Exhibit 101.DEF) | March 2, 2022 | 001-37471 | |||||||||||||||||||||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | * | |||||||||||||||||||||||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | * | |||||||||||||||||||||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | * | |||||||||||||||||||||||||||
| * | Filed herewith | ||||||||||||||||||||||||||||
| ** | Furnished herewith | ||||||||||||||||||||||||||||
| ± | Confidential treatment received as to portions of the exhibit. Confidential materials omitted and filed separately with the SEC. | ||||||||||||||||||||||||||||
| + | 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 | ||||||||||||||||||||||||||||
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. | |||||||||||
| July 6, 2022 | By: | /s/ Stephen S. Yoder | |||||||||
| Stephen S. Yoder | |||||||||||
| Chief Executive Officer and President | |||||||||||
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the following Registration Statements:
(1)Registration Statements (Form S-3 Nos. 333-212439 and 333-235350),
(2)Registration Statement (Form S-8 No. 333-204487) pertaining to the Pieris Pharmaceuticals, Inc. 2014 Employee, Director and Consultant Equity Incentive Plan,
(3)Registration Statement (Form S-8 No. 333-209308) pertaining to the Pieris Pharmaceuticals, Inc. 2014 Employee, Director and Consultant Equity Incentive Plan and Inducement Stock Option Award for Louis Matis, M.D.,
(4)Registration Statement (Form S-8 No. 333-213771) pertaining to the Pieris Pharmaceuticals, Inc. 2016 Employee, Director and Consultant Equity Incentive Plan,
(5)Registration Statement (Post-Effective Amendment to Form S-1 on Form S-3 No. 333-202123),
(6)Registration Statement (Form S-8 No. 333-221497) pertaining to Inducement Stock Option Awards for Claude Knopf, Allan Reine, M.D, and Ingmar Bruns, M.D., Ph.D,
(7)Registration Statement (Form S-8 No. 333-226733) pertaining to the Pieris Pharmaceuticals, Inc. 2018 Employee, Director and Consultant Equity Incentive Plan,
(8)Registration Statement (Form S-8 No. 333-226735) pertaining to the Pieris Pharmaceuticals, Inc. 2018 Employee Stock Purchase Plan,
(9)Registration Statement (Form S-8 No. 333-233194) pertaining to the Pieris Pharmaceuticals, Inc. 2019 Employee, Director and Consultant Equity Incentive Plan,
(10)Registration Statement (Form S-8 No. 333-234625) pertaining to the Non-Qualified Stock Option Agreement, dated August 30, 2019, and
(11)Registration Statement (Form S-8 No. 333-243735) pertaining to the Pieris Pharmaceuticals, Inc. 2020 Employee, Director and Consultant Equity Incentive Plan;
(12)Registration Statements (Form S-3 Nos. 333-256218 and 333-258497)
(13)Registration Statement (Form S-8 No. 333-258502) pertaining to the Pieris Pharmaceuticals, Inc. 2020 Employee, Director and Consultant Equity Incentive Plan, as amended and the Inducement Stock Option Award for Tim Demuth, M.D., Ph.D.
of our report dated March 1, 2022, with respect to the consolidated financial statements of Pieris Pharmaceuticals, Inc. included in this Annual Report (Form 10-K) of Pieris Pharmaceuticals, Inc. for the year ended December 31, 2021.
/s/ Ernst & Young LLP
Boston, Massachusetts
March 1, 2022
Exhibit 31.1
CERTIFICATIONS UNDER SECTION 302
I, Stephen S. Yoder, certify that:
1. I have reviewed the Amendment No. 1 to the Annual Report on Form 10-K/A of Pieris Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: July 6, 2022
| /s/ Stephen S. Yoder | |||||
| Stephen S. Yoder | |||||
| Title: | Chief Executive Officer and President (principal executive officer) | ||||
Exhibit 31.2
CERTIFICATIONS UNDER SECTION 302
I, Thomas Bures, certify that:
1. I have reviewed the Amendment No. 1 to the Annual Report on Form 10-K/A of Pieris Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Dated: July 6, 2022
| /s/ Thomas Bures | |||||
| Thomas Bures | |||||
| Title: | Senior VP, Chief Financial Officer and Treasurer (principal financial officer) | ||||
Exhibit 32.1
CERTIFICATIONS UNDER SECTION 906
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), the undersigned officer of Pieris Pharmaceuticals, Inc., a Nevada corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
The Amendment No. 1 to the Annual Report on Form 10-K/A for the year ended December 31, 2021 (the “Amendment”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Amendment fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: July 6, 2022 | /s/ Stephen S. Yoder | |||||||
| Stephen S. Yoder | ||||||||
| Title: | Chief Executive Officer and President | |||||||
| (principal executive officer) | ||||||||
Exhibit 32.2
CERTIFICATIONS UNDER SECTION 906
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), the undersigned officer of Pieris Pharmaceuticals, Inc., a Nevada corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:
The Amendment No. 1 to the Annual Report on Form 10-K/A for the year ended December 31, 2021 (the “Amendment”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Amendment fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: July 6, 2022 | /s/ Thomas Bures | |||||||
| Thomas Bures | ||||||||
| Title: | Senior VP, Chief Financial Officer and Treasurer | |||||||
| (principal financial officer) | ||||||||