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): March 9, 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 2.02 Results of Operations and Financial Condition.
On March 9, 2018, Pieris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing certain financial results for the fiscal year ended December 31, 2017. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information set forth under this “Item 2.02. Results of Operations and Financial Condition,” including the exhibit attached 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press release announcing financial results for the year ended December 31, 2017, dated March 9, 2018.
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: March 9, 2018 | /s/ Allan Reine | |
Allan Reine | ||
Chief Financial Officer | ||
PRESS RELEASE
PIERIS PHARMACEUTICALS REPORTS FULL-YEAR 2017
FINANCIAL RESULTS AND CORPORATE UPDATE
COMPANY TO HOST AN INVESTOR CONFERENCE CALL ON
FRIDAY, MARCH 9, 2018 AT 8:00 AM EST
BOSTON, MA -- (Marketwired) -- 03/09/18 -- 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, announced today
financial results for its fiscal year ended December 31, 2017, and provided a corporate update:
• PRS-343: Pieris continues to advance PRS-343, a tumor-targeted 4-1BB-based immuno-
oncology (IO) bispecific, through a phase 1, dose-escalation study, with initial safety,
tolerability, pharmacokinetic and pharmacodynamic data expected in the second half of 2018.
This program is the first bispecific T cell costimulatory agonist to enter clinical development.
• PRS-060: The company continues to enroll healthy subjects in a first-in-human study for
PRS-060, an IL-4 receptor alpha antagonist, which began during the fourth quarter of 2017.
PRS-060 is the lead product in the company’s respiratory alliance with AstraZeneca. Pieris is
sponsoring the phase 1 study, while AstraZeneca is responsible for funding its costs. Initial
data from the phase 1 study are expected in the fourth quarter of 2018. AstraZeneca will
sponsor and continue to fund clinical development of PRS-060 through phase 2a, after which
the company may exercise an option to co-develop PRS-060. Pieris also has an option for
U.S. co-commercialization rights for this program.
• PRS-080: Pieris continues to enroll dialysis-dependent patients with functional iron
deficiency anemia in a phase 2a study for PRS-080. Pieris intends to report safety and
pharmacodynamic data from this study, including the change in hemoglobin levels after five
weekly doses of PRS-080, in the second half of 2018. If data are positive, the company will
seek to partner PRS-080 in territories outside of those for which ASKA Pharmaceutical Co.
has an exclusive option (Japan and certain other Asian territories).
• Seattle Genetics Collaboration: On February 9, 2018, the company announced a multi-
program IO-focused alliance with Seattle Genetics. The collaboration leverages the expertise
and core technologies of both companies to develop novel Antibody-Anticalin bispecific
fusion proteins utilizing Seattle Genetics' tumor-targeted monoclonal antibodies and Pieris'
costimulatory engaging Anticalin proteins. Under the collaboration, Seattle Genetics will pay
Pieris a $30 million upfront fee. Pieris has the potential to receive up to $1.2 billion in
success-based payments in addition to royalties up to the double digits in connection with the
sales of commercialized products, as well as an option to co-develop and commercialize one
of the programs in the U.S.
• Equity Financing: In February 2018, the company completed an underwritten public
offering in which it sold 6,325,000 shares of common stock, including the full exercise of the
over-allotment of an additional 825,000 shares, to the public at a price of $8.00 per share. Net
proceeds of the underwritten public offering, after deducting the underwriting discounts and
commissions and financing costs, were $47.3 million.
• Cash Position: Cash, cash equivalents and investments totaled $82.6 million as of
December 31, 2017. This amount excludes payment of a $12.5 million milestone from
AstraZeneca achieved in the fourth quarter of 2017, the $47.3 million in net proceeds from
the February 2018 equity financing, and the $30.0 million upfront payment due from Seattle
Genetics.
“2017 was a transformational year for Pieris, as we advanced our lead respiratory and IO drug
candidates into the clinic, while advancing PRS-080 into a phase 2a study and entering into two
major alliances, in respiratory diseases and IO, bringing increased validation to our R&D
strategy while retaining commercial rights on several partnered programs and strengthening our
cash position,” said Stephen S. Yoder, President and CEO. “This momentum continued into 2018
as we signed a significant IO collaboration agreement with Seattle Genetics. We are developing
three clinical-stage programs, data from all of which are projected to be available later this year.
In addition, we continue to build long-term value by advancing multiple preclinical IO programs
with the intention to file two new INDs in 2019, while engaging in a broad research effort
developing novel Anticalin proteins against multiple targets in both IO and respiratory diseases.
We look forward to sharing data across our pipeline later this year.”
Fiscal Year Financial Update:
Cash Position - Cash, cash equivalents and investments totaled $82.6 million as of
December 31, 2017, compared to a cash balance of $29.4 million as of December 31, 2016. The
increase was driven primarily by a $45.0 million upfront payment received as part of the
AstraZeneca respiratory alliance, a €30.0 million (approximately $32.0 million) upfront payment
received from Servier, and a $2.8 million option payment received from ASKA. This was offset
by $39.3 million of operating cash expenditures during the year.
R&D Expense - R&D expenses were $22.3 million for the year ended December 31, 2017,
compared to $19.7 million for the year ended December 31, 2016. The Company's increase in
R&D expenses reflects advancement across its pipeline of programs as well as preparation for
and advancement of clinical studies.
G&A Expense - G&A expenses for the year ended December 31, 2017 were $17.6 million,
compared to $8.9 million for the year ended December 31, 2016. The increase in the 2017 period
as compared to the corresponding period in 2016 is attributable in part to transaction fees
associated with the company’s partnership agreements and investments in our G&A functions
including personnel costs, recruiting costs, and professional services (audit, tax, legal and
communications) to support the growing business.
Net Loss - Net loss was $17.6 million or $(0.40) per share for the year ended December 31,
2017, compared to a net loss $22.8 million or $(0.55) per share for the year ended December 31,
2016.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM Eastern Standard Time on
Friday, March 9, 2018, to discuss the full year financial results and provide a corporate update.
You can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010
(International). An archived replay of the call will be available by dialing +1-877-660-6853
(US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #:
13661472.
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.
Forward Looking Statements
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 and dosing healthy subjects; 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.
(tables to follow)
PIERIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31,
2017
December 31,
2016
Assets:
Cash and cash equivalents $ 37,878 $ 29,356
Short term investments 34,751 —
Accounts receivable 15,546 57
Prepaid expenses and other current assets 1,615 3,260
Total current assets 89,790 32,673
Property and equipment, net 4,034 2,264
Long term investments 9,922 —
Other non-current assets 130 126
Total Assets $ 103,876 $ 35,063
Liabilities and stockholders’ equity:
Accounts payable $ 2,452 $ 2,386
Accrued expenses 6,170 3,719
Deferred revenue, current portion 37,153 2,275
Total current liabilities 45,775 8,380
Deferred revenue, net of current portion 46,542 1,409
Other long-term liabilities 37 47
Total Liabilities 92,354
9,836
Total stockholders’ equity 11,522 25,227
Total liabilities and stockholders’ equity $ 103,876 $ 35,063
PIERIS PHARMACEUTICALS, INC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Years Ended December 31,
2017 2016
Revenues $ 25,275 $ 5,831
Operating expenses
Research and development 22,285 19,699
General and administrative 17,584 8,891
Total operating expenses 39,869 28,590
Loss from operations (14,594 ) (22,759 )
Interest income, net 152 2
Other income (expense), net (2,102 ) 120
Loss before income taxes (16,544 ) (22,637 )
Provision for income tax 1,103 162
Net loss $ (17,647 ) $ (22,799 )
Basic and diluted net loss per share $ (0.40 ) $ (0.55 )
Basic and diluted weighted average shares outstanding 43,931 41,713
Company Contact: Investor Relations Contact:
Allan Reine The Trout Group
SVP & Chief Financial Officer Thomas Hoffmann
+1-857-444-4276 +1-646-378-2931
reine@pieris.com thoffmann@troutgroup.com
Media Inquiries:
Trophic Communications
Gretchen Schweitzer
+49 89 238 87730
schweitzer@trophic.eu
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