UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 8, 2018
PIERIS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
Nevada | 001-37471 | EIN 30-0784346 | ||
(State of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
255 State Street, 9th Floor
Boston, MA 02109
United States
(Address of principal executive offices, including zip code)
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:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 ý
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. ☐
Item 1.01 Entry into a Material Definitive Agreement.
On February 8, 2018, Pieris Pharmaceuticals, Inc. (the “Company”) and its wholly-owned subsidiary Pieris Pharmaceuticals GmbH (together with the Company, “Pieris”), entered into a License and Collaboration Agreement (the “Collaboration Agreement”) and a Non-Exclusive Anticalin® Platform Technology License Agreement (the “License Agreement” and together with the Collaboration Agreement, the “Agreements”) with Seattle Genetics, Inc. (“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 Agreements, Seattle Genetics will pay Pieris a $30 million upfront fee, tiered royalties on net sales up to the low double-digits, and 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 US 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 Agreement ends upon the expiration of all of Seattle Genetics’ payment obligations under such Agreement. The 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 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 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 Agreements if the other party challenges the validity of any patents licensed under the Agreements, subject to certain exceptions. The License Agreement will terminate upon termination of the Collaboration Agreement, whether in its entirety or on a product-by-product basis
The foregoing description of the Agreements does not purport to be complete and is qualified in its entirety by reference to the Agreements, which Pieris intends to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2018. A copy of the press release announcing the Agreements is attached to this Current Report as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
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: February 9, 2018 | /s/ Allan Reine | |
Allan Reine | ||
Chief Financial Officer | ||
EXHIBIT INDEX
Exhibit No. Description
Pieris Pharmaceuticals and Seattle Genetics Announce
Multi-Program Immuno-Oncology Collaboration
-Companies to Evaluate Novel Bispecific Immuno-Oncology Agents that Combine Pieris’ Anticalin
Technology with Select Seattle Genetics Cancer-Targeted Antibodies-
Boston, MA and Bothell, WA (Marketwired)—02/09/2018 – Pieris Pharmaceuticals,
Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel
biotherapeutics through its proprietary Anticalin® technology platform for cancer,
respiratory and other diseases, and Seattle Genetics, Inc. (NASDAQ: SGEN), a global
biotechnology company developing innovative, targeted therapies for cancer, today
announced they have entered into a collaboration and license agreement with the goal of
developing multiple targeted bispecific immuno-oncology treatments for solid tumors and
blood cancers.
The collaboration leverages the expertise and core technologies of both companies to
develop novel Antibody-Anticalin fusion proteins. Pieris’ proprietary suite of agonistic
costimulatory Anticalin proteins, when fused to a tumor-targeting antibody, can activate
the immune system preferentially in the tumor microenvironment. Seattle Genetics,
through its industry-leading work in the field of antibody-drug conjugates (ADCs), has a
substantial portfolio of cancer targets and tumor-specific monoclonal antibodies from which
programs will be selected for the collaboration. The bispecific drug candidates in this
alliance will be designed to enable the patient’s immune cells to specifically attack tumors.
“As the industry leader in ADCs, we bring deep expertise in targeted cancer therapy
development to this collaboration with Pieris,” said Dennis Benjamin, Ph.D., Senior Vice
President of Research at Seattle Genetics. “Pieris’ Anticalin technology and Antibody-
Anticalin bispecific approach are intended to overcome the limitations of currently available
immuno-oncology products. This partnership leverages our cancer targets and tumor-
specific antibodies to explore multiple novel bispecific combinations, with the goal of
developing targeted therapies that improve outcomes for people with cancer.”
Under the terms of the agreement, Seattle Genetics will pay Pieris a $30 million upfront
fee, tiered royalties on net sales up to low double-digits, and up to $1.2 billion in total
success-based payments across three product candidates. The companies will pursue
multiple Antibody-Anticalin fusion proteins during the 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 US
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.
“Pieris was the first company to bring a tumor-targeted costimulatory bispecific to patients
with PRS-343, and we are looking forward to broadening our bispecific pipeline through
this alliance. Seattle Genetics is a compelling partner for Pieris with a long-standing
commitment to oncology,” said Stephen S. Yoder, President and CEO of Pieris. “The
collaboration combines the excellent protein engineering and translational capabilities of
both companies, utilizing Seattle Genetics’ tumor-targeted monoclonal antibodies and
Pieris’ Anticalin proteins to create novel bispecifics. This is our third significant alliance
since January 2017 and is in alignment with our goal to create a respiratory- and oncology-
focused commercial company.”
About Anticalin® Therapeutics:
Anticalin® proteins are derived from lipocalins, small human proteins that naturally bind,
store and transport a wide spectrum of molecules. Anticalin® proteins feature the typical
four-loop variable region and a rigidly conserved beta-barrel backbone of lipocalins, which,
together, form a shapeable cup-like binding pocket. Proprietary to Pieris, Anticalin®
proteins are a novel class of protein therapeutics validated in the clinic and by partnerships
with leading pharmaceutical companies. Anticalin® is a registered trademark of Pieris.
About Pieris Pharmaceuticals:
Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-
based drugs to target validated disease pathways in a unique and transformative way. Our
pipeline includes immuno-oncology multi-specifics tailored for the tumor microenvironment, an
inhaled Anticalin® protein to treat uncontrolled asthma and a half-life-optimized Anticalin®
protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics
validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin®
is a registered trademark of Pieris. For more information, visit www.pieris.com.
For more information visit www.pieris.com.
About Seattle Genetics:
Seattle Genetics is an innovative biotechnology company dedicated to improving the lives
of people with cancer through novel antibody-based therapies. The company’s industry-
leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of
antibodies to deliver cell-killing agents directly to cancer cells. Seattle
Genetics commercializes ADCETRIS® (brentuximab vedotin) for the treatment of several
types of CD30-expressing lymphomas. The company is also advancing a robust pipeline
of novel therapies for solid tumors and blood-related cancers designed to address
significant unmet medical needs and improve treatment outcomes for patients. More
information can be found at www.seattlegenetics.com and follow @SeattleGenetics on
Twitter.
Pieris Forward Looking Statements Disclaimer:
This press release contains forward-looking statements as that term is defined in Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Statements in this press release that are not purely historical are forward-looking statements.
Such forward-looking statements include, among other things, references to novel
technologies and methods; our business and product development plans; the timing and
progress of our studies, including the timing of enrollment and dosing of PRS-343 patients
and PRS-060 healthy subjects, the enrollment of patients in the PRS-080 multi-dose trial; our
liquidity and ability to fund our future operations; our ability to achieve certain milestones and
receive future milestone or royalty payments; or market information. Actual results could
differ from those projected in any forward-looking statements due to numerous factors. Such
factors include, among others, our ability to raise the additional funding we will need to
continue to pursue our business and product development plans; the inherent uncertainties
associated with developing new products or technologies and operating as a development
stage company; our ability to develop, complete clinical trials for, obtain approvals for and
commercialize any of our product candidates, including our ability to recruit and enroll
patients in our studies; our ability to address the requests of the FDA; competition in the
industry in which we operate and market conditions. These forward-looking statements are
made as of the date of this press release, and we assume no obligation to update the
forward-looking statements, or to update the reasons why actual results could differ from
those projected in the forward-looking statements, except as required by law. Investors
should consult all of the information set forth herein and should also refer to the risk factor
disclosure set forth in the reports and other documents we file with the SEC available at
www.sec.gov, including without limitation the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 2016 and the Company's Quarterly Reports on Form 10-Q.
Seattle Genetics Forward Looking Statements Disclaimer:
Certain of the statements made in this press release are forward looking, such as those,
among others, relating to the research, development, and therapeutic and commercial
potential of Anticalin-based products. Actual results or developments may differ materially
from those projected or implied in these forward-looking statements. Factors that may
cause such a difference include the possibility that the referenced product candidates may
not be feasible to develop, may not show utility in treating cancer, may not have the desired
activity or may be associated with adverse events that limit their use in which case Seattle
Genetics may not realize the anticipated benefits from the collaboration. More information
about the risks and uncertainties faced by Seattle Genetics is contained under the caption
“Risk Factors” included in Exhibit 99.1 to the company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission in January 31, 2018. Seattle Genetics
disclaims any intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Contacts at Pieris:
Company Contact: Investor Relations Contact:
Pieris Pharmaceuticals, Inc. The Trout Group
Allan Reine Thomas Hoffmann
SVP and Chief Financial Officer +1-646-378-2931
+1-857-444-4276 thoffmann@troutgroup.com
reine@pieris.com
Media Contact
Trophic Communications
Gretchen Schweitzer
+49 89 238 87730
schweitzer@trophic.eu
Contacts at Seattle Genetics:
Investor Relations: Media:
Peggy Pinkston Tricia Larson
VP, Investor Relations Sr Director, Corporate Communications
425-527-4160 425-527-4180
ppinkston@seagen.com tlarson@seagen.com
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