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): August 10, 2016
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
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)) |
Item 2.02 Results of Operations and Financial Condition.
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.
Attached as Exhibit 99.1 is a copy of a press release of Pieris Pharmaceuticals, Inc. (the “Company”), dated August 10, 2016, announcing certain financial results for the second quarter ended June 30, 2016.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
99.1 Press release announcing financial results for the second quarter ended June 30, 2016, dated August 10, 2016.
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.
| Dated: August 11, 2016 | PIERIS PHARMACEUTICALS, INC. | |||||
| By: | /s/ Darlene Deptula-Hicks | |||||
| Name: | Darlene Deptula-Hicks | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press release announcing financial results for the second quarter ended June 30, 2016, dated August 10, 2016. | |
Exhibit 99.1
PRESS RELEASE
Pieris Pharmaceuticals Reports Financial Results and Provides Corporate
Update for the Second Quarter Ended June 30, 2016
Company to Host an Investor Conference Call on Thursday,
August 11, 2016 at 10:00 AM ET
BOSTON, MA, August 10, 2016 – Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer and other diseases, today reported financial results for the second quarter of 2016 and provided an update on the Company’s recent developments.
“During the second quarter, we strengthened our balance sheet and broadened our shareholder base, and continued to advance both our pipeline and partnerships, as part of our commitment to build a world-class protein biotherapeutic company. Our most advanced Anticalin® program, PRS-080, for anemia of chronic disease, is on track to complete the dosing in our ongoing Phase 1b single ascending dose study in anemia patients by year end. Our asthma program, PRS-060, which targets the clinically validated IL-4 receptor (IL-4Ra), as well as our lead immuno-oncology (IO) bispecific program, PRS-343, which targets CD137 and HER-2, are progressing through IND-enabling studies and remain on track for the initiation of a first-in-human study in the first half of 2017,” said Stephen Yoder, President and CEO. “We also strengthened our balance sheet last month when we closed a $16.5 million private placement financing, extending our financial runway by about one year, while also helping to bring in new and highly regarded institutional healthcare investors. Finally, we continue to advance our next generation immuno-oncology portfolio of multispecific therapeutic proteins, as well as our partnerships with Roche, Sanofi and Daiichi-Sankyo, while continuing to explore additional collaborations. We remain committed to the development of innovative immuno-oncology multispecifics, as evidenced by our recent PD-1 antibody in-license agreement, which will enable us to independently develop novel multispecifics centered on PD-1 blockade, a core component of the standard regimen in immuno-oncology.”
Second Quarter Highlights:
| • | Completed $16.5 million private placement financing, led by BVF Partners L.P. |
| • | Advancing PRS-080 through an ongoing Phase 1 single ascending dose study in anemia of chronic disease, with an expected completion of dosing by year end |
| • | Advancing PRS-060 through IND-enabling studies for moderate to severe asthma as an inhaled therapeutic, and towards a first-in-human study, expected to commence in 1H17 |
| • | Advancing PRS-343 through IND-enabling studies and towards a first-in-patient study for a range of HER-2 positive cancers, expected to commence in 1H17 |
| • | Initiated preclinical development of a novel multi-checkpoint blockade bispecific, PRS-332, comprising an anti-PD-1 antibody genetically linked to an existing Anticalin against an undisclosed checkpoint |
| • | Progressed our immuno-oncology R&D collaboration with Roche into lead candidate identification |
Second Quarter Financial Update:
Cash Position – Cash and cash equivalents totalled $40.4 million at June 30, 2016, compared to $29.3 million at December 31, 2015. This increase was driven primarily by the private placement financing, which was completed in June 2016.
R&D Expenses – Research and development expenses were $4.5 million for the quarter ended June 30, 2016, compared to $1.7 million for the quarter ended June 30, 2015. The $2.8 million increase was primarily attributable to a $1.1 million increase in CMC and pre-clinical development costs for our PRS-300 series and PRS-060 programs, and a $2.1 million increase in other R&D costs including a $1.0 million in-license fee, additional personnel-related costs, including stock-based compensation expense and other program costs. These were offset with a decrease in the PRS-080 program of $0.4 million as the Phase 1a trial has been completed and the Phase 1b trial has been initiated using existing drug supply.
G&A Expenses – General and administrative expenses for the quarter ended June 30, 2016 were $2.4 million, compared to $2.0 million for the quarter ended June 30, 2015. The $0.4 million increase in G&A expenses was due to primarily to an increase in personnel-related expenses, including stock-based compensation expense offset by a decrease in various other expenses.
Net Loss – Net loss was $5.9 million or ($0.14) per share for the quarter ended June 30, 2016, compared to a net loss $3.5 million or ($0.12) per share for the quarter ended June 30, 2015.
Conference Call:
Pieris management will host a conference call beginning at 10:00 AM Eastern Time on Thursday, August 11, 2016, to discuss the second quarter 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) and providing the conference ID: 13603006. An archived replay of the call will be available by dialling +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International).
About Pieris
Pieris Pharmaceuticals 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 micro-environment, an inhaled Anticalin to treat uncontrolled asthma and a half-life-optimized Anticalin to treat anemia. Proprietary to Pieris, Anticalins are a novel class of protein therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. Anticalin®, Anticalins® are registered trademarks of Pieris. For more information visit www.pieris.com.
Company Contact:
Pieris Pharmaceuticals, Inc.
Darlene Deptula-Hicks
SVP & Chief Financial Officer
+1-603-553-5803
deptula@pieris.com
Investor Relations Contact:
The Trout Group
Thomas Hoffmann
+1-646-378-2931
thoffmann@troutgroup.com
Media Inquiries:
Gretchen Schweitzer
+49 172 861 8540
gschweitzer@macbiocom.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, 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; 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, 2015 and the Company’s Quarterly Reports on Form 10-Q.
(tables to follow)
PIERIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2016 | 2015 | |||||||
| (Unaudited) | ||||||||
| Assets: |
||||||||
| Cash and cash equivalents |
$ | 40,374,433 | $ | 29,349,124 | ||||
| Prepaid expenses and other current assets |
3,505,890 | 2,311,385 | ||||||
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| Total current assets |
43,880,323 | 31,660,509 | ||||||
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| Property and equipment, net |
2,446,917 | 2,162,771 | ||||||
| Other noncurrent assets |
127,336 | 126,781 | ||||||
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| Total Assets |
$ | 46,454,576 | $ | 33,950,061 | ||||
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| Liabilities and stockholders’ equity: |
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| Accounts payable |
$ | 1,638,220 | $ | 1,058,536 | ||||
| Accrued expenses |
2,325,395 | 1,739,380 | ||||||
| Deferred revenue, current portion |
2,455,728 | — | ||||||
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| Total current liabilities |
6,419,343 | 2,797,916 | ||||||
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| Deferred revenue, net of current portion |
2,701,626 | — | ||||||
| Other long-term liabilities |
42,063 | 23,852 | ||||||
| Total Liabilities |
9,163,032 | 2,821,768 | ||||||
| Total stockholders’ equity |
37,291,544 | 31,128,293 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 46,454,576 | $ | 33,950,061 | ||||
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PIERIS PHARMACEUTICALS, INC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenues |
$ | 1,072,862 | $ | 160,244 | $ | 2,319,506 | $ | 377,864 | ||||||||
| Operating expenses |
||||||||||||||||
| Research and development |
4,500,097 | 1,725,592 | 8,159,532 | 3,250,222 | ||||||||||||
| General and administrative |
2,368,217 | 1,969,082 | 4,336,100 | 4,363,405 | ||||||||||||
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| Total operating expenses |
6,868,314 | 3,694,674 | 12,495,632 | 7,613,627 | ||||||||||||
| Loss from operations |
(5,795,452 | ) | (3,534,430 | ) | (10,176,126 | ) | (7,235,763 | ) | ||||||||
| Interest expense, net |
— | (53 | ) | — | (4,223 | ) | ||||||||||
| Other income, net |
(87,801 | ) | 4,484 | 131,819 | 5,253 | |||||||||||
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| Loss before income taxes |
(5,883,253 | ) | (3,529,999 | ) | (10,044,307 | ) | (7,234,733 | ) | ||||||||
| Provision (benefit) for income tax |
— | — | — | — | ||||||||||||
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| Net loss |
$ | (5,883,253 | ) | $ | (3,529,999 | ) | $ | (10,044,307 | ) | $ | (7,234,733 | ) | ||||
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| Basic and diluted net loss per share |
$ | (0.14 | ) | $ | (0.12 | ) | $ | (0.25 | ) | $ | (0.25 | ) | ||||
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| Basic and diluted weighted average shares outstanding |
40,862,608 | 29,429,522 | 40,347,816 | 29,361,566 | ||||||||||||
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##END##