Item 1.01: Entry into a Material Definitive Agreement.
On March 24, 2021, Pieris Pharmaceuticals, Inc. (“Pieris” or the “Company”) announced that Seagen Inc. (together with its affiliates, “Seagen”) had made a strategic equity investment in Pieris, and that the companies had entered into a combination study agreement (the “Combination Study Agreement”) to evaluate the safety and efficacy of combining Pieris’ cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, with Seagen’s TUKYSA® (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also entered into an Amended and Restated License and Collaboration Agreement (the “Amended Collaboration Agreement”), in which their existing immuno-oncology collaboration agreement has been amended relating to joint development and commercial rights for the second program in the alliance.
The combination of cinrebafusp alfa and TUKYSA could potentially address a high medical need in HER2 low-expressing gastric cancer patients who do not respond to traditional HER2-targeted therapies. Preclinical studies show that TUKYSA synergizes with cinrebafusp alfa to enhance its 4-1BB mediated immune cell stimulation. This effect was observed across a range of HER2 expressing cell lines (IHC3+, 2+ and 1+), including those where cinrebafusp alfa had limited single-agent activity.
Under the Amended Collaboration Agreement, Pieris’ option to co-develop and co-commercialize the second of three programs in the collaboration has been amended to provide it with a co-promotion option in the United States, with Seagen 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 option. In connection with the agreements described above, the Company and Seagen entered into a subscription agreement (the “Subscription Agreement” and together with the Combination Study Agreement and the Amended Collaboration Agreement, the “Agreements”) pursuant to which the Company agreed to issue to Seagen, and Seagen agreed to acquire from the Company, 3,706,174 shares of the Company’s common stock, $0.001 par value per share, for a total purchase price of thirteen million U.S. Dollars ($13,000,000), or $3.51 per share, in a private placement transaction pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended.
A copy of the Combination Study Agreement, the Amended Collaboration Agreement and the Subscription Agreement will be filed as exhibits to the Company’s quarterly report on Form 10-Q for the quarter ending March 31, 2021.