|12 Months Ended|
Dec. 31, 2017
|Subsequent Events [Abstract]|
License and Collaboration Agreement and Non-Exclusive Anticalin Platform Technology License Agreement with Seattle Genetics
On February 8, 2018, the Company, together with Pieris GmbH, entered into a License and Collaboration Agreement and a Non-Exclusive Anticalin Platform Technology License Agreement (collectively the “Seattle Genetics Agreements”) with Seattle Genetics, pursuant to which the parties will develop multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers.
Under the terms of the Seattle Genetics Agreements, Seattle Genetics paid Pieris a $30 million upfront fee, tiered royalties on net sales up to the low double-digits, and will pay up to $1.2 billion in total success-based payments across three product candidates. The companies will pursue multiple antibody-Anticalin fusion proteins during a research phase, and Seattle Genetics has the option to select up to three therapeutic programs for further development. Prior to the initiation of a pivotal trial, Pieris may opt into global co-development and U.S. commercialization of the second program and share in global costs and profits on a 50/50 basis. Seattle Genetics will solely develop, fund and commercialize the other two programs. Seattle Genetics may also decide to select additional candidates from the initial research phase for further development in return for the payment to Pieris of additional fees, milestone payments, and royalties.
The term of each of the Seattle Genetics Agreements ends upon the expiration of all of Seattle Genetics’ payment obligations under such Agreement. The License and Collaboration Agreement may be terminated by Seattle Genetics in its entirety for convenience beginning 12 months after its effective date upon 90 days notice or, for any program where a pivotal study has been initiated, upon 180 days notice. Any program may be terminated at Seattle Genetics’ option. If any program is terminated by Seattle Genetics after a pre-defined pre-clinical stage, Pieris will have full rights to continue such program. If any program is terminated by Seattle Genetics prior to such pre-defined pre-clinical stage, Pieris will have the right to continue to develop such program, but will be obligated to offer a co-development option to Seattle Genetics for such program. The License and Collaboration Agreement may also be terminated by Seattle Genetics or Pieris for an uncured material breach by the other party upon 90 days notice, subject to extension for an additional 90 days if the material breach relates to diligence obligations and subject, in all cases, to dispute resolution procedures. The License and Collaboration Agreement may also be terminated due to the other party’s insolvency and may in certain instances, including for reasons of safety, be terminated on a product-by-product basis. Each party may also terminate the Seattle Genetics Agreements if the other party challenges the validity of any patents licensed under the Seattle Genetics Agreements, subject to certain exceptions. The Non-Exclusive Anticalin Platform Technology License Agreement will terminate upon termination of the License and Collaboration Agreement, whether in its entirety or on a product-by-product basis.
Other License Agreement Updates
Our collaboration with Roche
On February 26, 2018, pursuant to the Roche Agreement, as amended, Roche provided notice to Pieris of its extension of the research term of the Roche Agreement to continue until August 31, 2018.
Our collaboration with Daiichi Sankyo
Daiichi Sankyo Company Limited (“Daiichi Sankyo” or "Daiichi") partnered with Pieris to research, develop and commercialize two Anticalin therapeutics pursuant to a May 31, 2011 Collaboration Research and Technology Licensing Agreement (the “DS Collaboration Agreement”).
On May 8, 2017, Daiichi Sankyo discontinued the development of one of those two therapeutics, a PSCK9 program (DS-9001), after having advanced this program to first-in-human studies for strategic reasons. Consequentially, this Anticalin program, including respective intellectual property rights, were transferred back to Pieris.
The second of these two therapeutic programs pursued under the DS Collaboration Agreement is an Anticalin protein directed to calcitonin gene-related peptide (“CGRP”) for therapeutic use in the treatment of migraine headaches. The CGRP program is in the IND-enabling stage and Pieris previously reported Daiichi Sankyo’s decision to initiate a GLP toxicity study in connection with this program.
Due to Daiichi Sankyo’s strategic prioritization and commercial reasons related to competing CGRP inhibitors in advanced stages of development, Daiichi Sankyo provided notice to Pieris on March 1, 2018 of its termination of the CGRP program. Pre-clinical data regarding this CGRP antagonizing Anticalin protein indicate that it has good drug-like properties, including strong target affinity, the ability to neutralize the biological activity of CGRP in vitro, and the ability to inhibit vasodilation, a cause of migraine pain, in rat skin following subcutaneous administration of the antagonist. In connection with the termination of the development of the CGRP program, and under the terms of the DS Collaboration Agreement, Daiichi Sankyo is obligated to carry out certain activities to facilitate transfer of activities, regulatory filings, materials, data, agreements and other matters to Pieris in connection with the return to Pieris of the development program related to the CGRP program. Pieris intends to diligently review the data associated with the program and consider its strategic options thereafter.
The foregoing summary of the terms relating to the DS Collaboration Agreement, including with respect to Daiichi Sankyo’s termination of such DS Collaboration Agreement with respect to the CGRP program, is qualified in its entirety by the terms of the DS Collaboration Agreement, which were filed with the SEC as exhibit 10.7 to the Form 10-K filed on March 30, 2017. The contents of such exhibit are hereby incorporated by reference.
As a result of the termination of the DS Collaboration Agreement, the Company is no longer eligible for future research, development and regulatory milestones.
Underwritten Public Offering
In February 2018, the Company completed an underwritten public offering of its common stock in which it sold 6,325,000 shares of Common Stock, including the exercise in full by the underwriters of their option to purchase an additional 825,000 shares of Common Stock, to the public at a price of $8.00 per share. The offering was completed under the shelf registration statement that was filed on Form S-3 and declared effective by the SEC on August 3, 2016. Net proceeds of the underwritten public offering, after deducting the underwriting discounts and commissions, were $47.6 million, excluding offering expenses of approximately $0.3 million incurred by the Company.
The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
Reference 1: http://www.xbrl.org/2003/role/presentationRef