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Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

 

 

 

 

 

Registrant’s telephone number, including area code: 857-246-8998

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

 

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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.  ☐

 

 

 

As of May 31, 2023, Pieris Pharmaceuticals, Inc.'s (the “Company”) certain unaudited financial results included a cash balance of $53.2 million. 

 

The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” furnished hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

 

 

On June 21, 2023, the Company issued a press release announcing that partner AstraZeneca yesterday communicated to the Company its decision to discontinue and cease dosing in the ongoing clinical studies of elarekibep, an inhaled IL-4 receptor alpha inhibitor under development for the treatment of asthma. This decision was based on lung findings from a non-clinical 13-week GLP toxicology study with dry powder inhaler-formulated elarekibep, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development. AstraZeneca’s decision was made independent of any data from the Phase 2a study. The Company will expedite a review of the implications of the data and AstraZeneca’s decision on the program and will review its overall corporate priorities prior to sharing a further update. 

 

A copy of the press release issued by the Company is attached as Exhibit 99.1 to this report and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

 

 

 

(d) Exhibits.

 

 

 

 

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.