Pieris Pharmaceuticals Terminates Material Agreement

TL;DR

Pieris Pharma terminated a key deal, filing financials too. Big changes ahead?

AI Summary

On June 28, 2024, Pieris Pharmaceuticals, Inc. reported the termination of a material definitive agreement. The company also filed financial statements and exhibits as part of this 8-K filing.

Why It Matters

The termination of a material definitive agreement could signal a significant shift in the company's operational or strategic direction, potentially impacting future revenue streams or partnerships.

Risk Assessment

Risk Level: medium — Termination of a material definitive agreement can introduce uncertainty and impact future business prospects.

Key Players & Entities

• Pieris Pharmaceuticals, Inc. (company) — Registrant
• June 28, 2024 (date) — Date of earliest event reported
• 225 Franklin Street, 26th Floor Boston, MA 02110 (address) — Principal executive offices

FAQ

Key Financial Figures

• $0.001 — ge on which registered Common Stock , $0.001 par value per share PIRS The Nasdaq
• $15 million — potential aggregate milestones of up to $15 million upon first patient dosed in the Phase 2
• $40 million — potential aggregate milestones of up to $40 million upon first patient dosed in pivotal cli
• $200 million — gle, primary indications could be up to $200 million. Total commercial milestone potential o
• $415 million — are approved, could amount to more than $415 million. A potential additional aggregate amoun
• $130 million — al additional aggregate amount of up to $130 million in both developmental and commercial mi

Filing Documents

• pirs20240612_8k.htm (8-K) — 36KB
• 0001437749-24-022188.txt ( ) — 167KB
• pirs-20240628.xsd (EX-101.SCH) — 3KB
• pirs-20240628_def.xml (EX-101.DEF) — 11KB
• pirs-20240628_lab.xml (EX-101.LAB) — 15KB
• pirs-20240628_pre.xml (EX-101.PRE) — 11KB
• pirs20240612_8k_htm.xml (XML) — 3KB

02 Termination of a Material Definitive Agreement

Item 1.02 Termination of a Material Definitive Agreement On June 28, 2024, Les Laboratoires Servier and Institut de Recherches Internationales Servier (collectively, "Servier"), provided Pieris Pharmaceuticals, Inc. (the "Company") with a written notice of termination of the License and Collaboration Agreement between Servier, the Company, and Pieris Pharmaceuticals GmbH, dated January 4, 2017, and subsequently amended (the "Collaboration Agreement"). Pursuant to Section 7.1 of the Non-Exclusive Anticalin Platform Technology License Agreement, between Servier, the Company, and Pieris Pharmaceuticals GmbH, dated January 4, 2017 (the "Non-Exclusive License Agreement"), the Non-Exclusive License Agreement terminates upon termination of the Collaboration Agreement. The Collaboration Agreement and Non-Exclusive License Agreement (collectively, the "Agreements") will terminate effective December 27, 2024, or 180 days from the date on which Servier notified the Company of its intent to terminate the Agreements. Pursuant to the Agreements, Servier and the Company agreed to collaborate on the research, development, and commercialization of Anticalin-based therapeutics as part of the Company's immuno-oncology franchise, including S095012 (formerly, PRS-344), a 4-1BB/PD-L1 bispecific Mabcalin protein that was being developed worldwide by Servier. With this notice, Servier will discontinue and cease dosing in the Phase 1 clinical study of S095012. Servier's decision to terminate the Agreements was based on a potential safety concern in the S095012 Phase 1 clinical studies. The Company intends to review the safety data from the S095012 Phase 1 clinical study to understand the implications of the data. The Company does not intend to pursue any further development of S095012. The foregoing is only a summary of the material terms of the Agreements, does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreements, which were filed

01 Other Events

Item 8.01 Other Events. As announced on March 27, 2024, the Company implemented a strategy to maximize its ability to capture the potential milestones from its partnered 4-1BB bispecific Mabcalin (antibody-Anticalin fusion) protein immuno-oncology assets, while also maintaining the capability to consider strategic opportunities that it believes may increase stockholder value. The Company continues to remain eligible to receive potential milestone and royalty payments across its remaining partnered 4-1BB bispecific Mabcalin protein franchise resulting from its partnerships with Boston Pharmaceuticals and Pfizer, Inc. (formerly Seagen). This includes potential aggregate milestones of up to $15 million upon first patient dosed in the Phase 2 trials for SGN-BB228 and BOS-342, which are currently in Phase 1 clinical development, potential aggregate milestones of up to $40 million upon first patient dosed in pivotal clinical trials for SGN-BB228 and BOS-342, and total development milestone potential from the two clinical stage assets in single, primary indications could be up to $200 million. Total commercial milestone potential on the same assets, if they are approved, could amount to more than $415 million. A potential additional aggregate amount of up to $130 million in both developmental and commercial milestones exists if these programs are developed in additional indications.

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K, or Form 8-K, contains forward looking statements. Statements in this Form 8-K that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things statements relating to potentially considering strategic opportunities; anticipated timing, achievement, and receipt of milestone and/or royalty payments provided for in the Company's collaboration agreements; discontinuing development of S095012; the potential size of potential milestones and royalties; and the possible monetization of milestones and royalties. Actual results could differ from those projected in any forward-looking statement due to numerous factors. Such factors include, among others, expectations for achievement of contractual milestones; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses; the Company's cash runway may be reduced by unanticipated liabilities or decisions to opportunistically pursue strategic opportunities; the Company's ability to be successful in exploring and consummating one or more licensing or other transactions on attractive terms if at all for the Company's products in prior development; the Company's ability to maintain a lean and capable management team and board of directors over time; the Company's actual reductions in spending as compared to anticipated cost reductions; including in collaboration with other parties, the inherent uncertainties associated with developing new products or technologies, such as Anticalin based compounds, the Company's partners' ability to develop, complete clinical trials for, obtain approvals for and commercialize any of the Company's partnered product candidates; the Company's partners' ability to achieve expected market share if the drugs are approved and commercialized; uncertainty of overall market size of any of the Company's partnered product candidates; competition in the in

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. PIERIS PHARMACEUTICALS, INC. Dated: July 3, 2024 /s/ Tom Bures Tom Bures Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR