Company to Host an Investor Conference Call on
Wednesday, November 7, 2018 at 8:00 AM EST
Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a
clinical-stage biotechnology company advancing novel
biotherapeutics through its proprietary Anticalin® technology
platform for respiratory, cancer and other diseases, today reported
financial results for the third quarter of 2018 ended September 30,
2018 and provided an update on the Company’s recent and future
developments.
“We are pleased to announce that PRS-060, an
IL-4 receptor alpha antagonist for moderate-to-severe asthma, was
safe and well-tolerated by healthy volunteers in a single ascending
dose Phase I study. This is the first clinical use of an inhaled
Anticalin protein and marks an important development milestone for
the Company. We continue to enroll subjects with mild asthma in a
multiple ascending dose Phase I study. Along with our partner
AstraZeneca, we anticipate reporting the data from the Phase I
studies at an upcoming medical meeting. For PRS-343, our 4-1BB/HER2
bispecific, we now intend to report initial data from a Phase I
study in the first half of next year, after completing the dose
escalation, to provide a more comprehensive data set,” said Stephen
S. Yoder, President and CEO of Pieris. “We look forward to
providing updates on our progress as we head into 2019.”
- PRS-060: PRS-060, an inhaled IL-4 receptor
alpha antagonist for moderate-to-severe asthma, was tested in 48
healthy volunteers at dose levels ranging from 0.25 mg to 400 mg in
a single ascending dose Phase I study. The drug candidate was safe
and well-tolerated in this study. Pieris continues to enroll
subjects with mild asthma and elevated levels of fractional exhaled
nitric oxide (FeNO) in a multiple ascending dose Phase I study.
This study will evaluate the safety, tolerability and FeNO-reducing
potential of PRS-060 versus placebo. The data from the PRS-060
Phase I studies will be presented at an upcoming medical meeting.
PRS-060 is the lead candidate in Pieris’ respiratory collaboration
with AstraZeneca. Pieris is sponsoring the Phase I studies and
AstraZeneca is funding the costs. AstraZeneca will conduct and fund
the Phase IIa study, after which Pieris will have separate options
to co-develop and co-commercialize the drug candidate.
- PRS-343: The Company continues to enroll and
treat patients in a Phase I dose-escalation study of PRS-343, a
4-1BB/HER2 bispecific for HER2-positive solid tumors, and now
intends to report initial data from the study in the first half of
2019, after completing the dose escalation, in order to provide a
more comprehensive data set. Our objective for the remaining
enrollment will be to favor patient selection across a range of
immunotherapy-responsive tumor types. The Company is screening
patients for the 11th cohort of the study, a dose level comparable
to approved dose levels of trastuzumab. In August, Pieris initiated
a trial with PRS-343 in combination with atezolizumab, and the
Company intends to report data from this trial in 2019.
- PRS-080: Pieris is planning to enroll and
complete dosing of the final patient in its Phase IIa multiple
ascending dose study of PRS-080, a half-life-optimized hepcidin
antagonist for anemia, by year end. In the ongoing trial, PRS-080
at both doses (4mg/kg and 8mg/kg) has not generated any observed
drug-related serious adverse events and has demonstrated
substantial iron mobilization and transferrin saturation (TSAT)
increases versus placebo. To date, there has been no conclusive
change in hemoglobin at either dose versus placebo. We remain
committed to completing the study and sharing the data with ASKA
and other potential partners for continued development. We intend
to report the full data set from the study in the first half of
2019.
- PRS-344: Pieris will present preclinical data
for PRS-344, a PD-L1/4-1BB antibody-Anticalin bispecific in
IND-enabling studies, at the Society for Immunotherapy of Cancer
(SITC) 2018 Annual Meeting in Washington, D.C. The poster, P375,
will be presented on November 9–10, 2018. PRS-344 is one of five
development programs in Pieris’ immuno-oncology alliance with
Servier.
- Board Appointments: In September 2018, Pieris
appointed Peter Kiener, D.Phil. to the Company's Board of
Directors. Dr. Kiener served in several executive roles, most
recently as the Chief Scientific Officer at Sucampo. In October
2018, Pieris also appointed Matthew L. Sherman, M.D. to the
Company’s Board of Directors. Dr. Sherman most recently served as
Executive Vice President and Chief Medical Officer at Acceleron
Pharma.
- Preclinical Pipeline: Pieris remains committed
to advancing several early-stage programs into the clinic and is on
track to file two immuno-oncology INDs, one for a proprietary drug
candidate and one as part of its collaboration with Servier, in
2019. The Company has also initiated two proprietary respiratory
programs.
Third Quarter Financial Update:
Cash Position - Cash, cash
equivalents and investments totaled $137.3 million as of
September 30, 2018, compared to a cash, cash equivalents and
investments balance of $82.6 million as of December 31,
2017. The increase was driven primarily by the $47.2 million in net
proceeds from the Company's February 2018 equity financing, the
$30.0 million in upfront payments received as part of the Seattle
Genetics immuno-oncology collaboration, and the $12.5 million
milestone payment from AstraZeneca that was triggered during the
fourth quarter of 2017 and received during the first quarter of
2018. The increase was partially offset by $35.7 million of
operating cash expenditures during the year.
R&D Expense - R&D
expenses were $11.4 million for the three months ended
September 30, 2018, compared to $6.3 million for the three
months ended September 30, 2017. R&D expenses were $28.5
million for the nine months ended September 30, 2018, compared
to $17.0 million for the nine months ended September 30, 2017.
The Company's increase in R&D expenses reflects preparation for
and advancement of clinical studies as well as advancement across
its pipeline of preclinical programs.
G&A Expense - G&A
expenses were $4.7 million for the three months ended
September 30, 2018, compared to $2.9 million for the three
months ended September 30, 2017. G&A expenses were $13.9
million for the nine months ended September 30, 2018, compared
to $11.2 million for the nine months ended September 30, 2017. The
Company's increase in G&A expenses reflects higher personnel
costs and professional services costs for audit and legal, as well
as an increase in general administrative costs to support the
growing business of the Company. On a nine-month basis, the
increase was partially offset by lower transaction fees for license
and collaboration agreements compared to amounts recorded in the
first half of 2017.
Interest Income - Interest
income was $0.5 million and $1.5 million for the three and nine
months ended September 30, 2018, respectively, compared to no
interest income earned in the comparable 2017 periods. The Company
began investing cash received from the collaboration agreements
signed in 2017 in the fourth quarter of 2017.
Other Income - Other income was
$1.1 million and $1.5 million for the three and nine months ended
September 30, 2018, respectively, compared to other expense of $1.7
million and $3.1 million for the three and nine months ended
September 30, 2017, respectively. The Company began investing cash
received from the collaboration agreements signed in 2017 in the
fourth quarter of 2017. The increase in income for the three- and
nine-month periods is a result of net foreign currency transaction
gains due to the strengthening of the U.S. dollar against the euro,
positively impacting the remeasurement of U.S. dollar denominated
monetary assets held in Germany.
Net Loss - Net
loss was $6.2 million or $(0.11) per share for the three months
ended September 30, 2018, compared to a net loss of $7.1
million or $(0.16) per share for the three months ended
September 30, 2017. Net loss was $15.1 million or $(0.29) per
share for the nine months ended September 30, 2018, compared
to a net loss of $25.1 million or $(0.58) per share for the nine
months ended September 30, 2017.
Conference Call:
Pieris management will host a conference call
beginning at 8:00 AM Eastern Standard Time on Wednesday,
November 7, 2018, to discuss the third quarter of 2018
financial results and provide a corporate update. Individuals 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, inhalable Anticalin proteins to treat
respiratory diseases 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 and our business and product development plans, including
the advancement of our proprietary and co-development programs into
and through the clinic and the expected timing for reporting data
or making IND filings related to our programs, and partnering
prospects for any such programs. 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, 2017 and the Company's Quarterly Reports on Form
10-Q.
|
|
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Company
Contact: |
|
Investor
Relations Contact: |
Pieris Pharmaceuticals,
Inc. |
|
Pieris Pharmaceuticals,
Inc. |
Dr. Allan Reine |
|
Maria Kelman |
SVP & Chief
Financial Officer |
|
Director of Investor
Relations |
+1 857 246 8998 |
|
+1 646 206 2555 |
reine@pieris.com |
|
kelman@pieris.com |
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PIERIS PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(unaudited, in thousands)
|
|
September
30,2018 |
|
December
31,2017 |
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
89,482 |
|
|
$ |
37,878 |
|
Short term investments |
|
47,822 |
|
|
34,751 |
|
Accounts receivable |
|
5,338 |
|
|
15,546 |
|
Prepaid expenses and other current assets |
|
4,207 |
|
|
1,615 |
|
Total current assets |
|
146,849 |
|
|
89,790 |
|
Property and equipment, net |
|
4,687 |
|
|
4,034 |
|
Long term investments |
|
— |
|
|
9,922 |
|
Other non-current assets |
|
121 |
|
|
130 |
|
Total Assets |
|
$ |
151,657 |
|
|
$ |
103,876 |
|
Liabilities and stockholders’ equity: |
|
|
|
|
Accounts payable |
|
$ |
2,693 |
|
|
$ |
2,452 |
|
Accrued expenses |
|
5,981 |
|
|
6,170 |
|
Deferred revenue, current portion |
|
31,920 |
|
|
37,153 |
|
Total current liabilities |
|
40,594 |
|
|
45,775 |
|
Deferred revenue, net of current portion |
|
60,770 |
|
|
46,542 |
|
Other long-term liabilities |
|
32 |
|
|
37 |
|
Total Liabilities |
|
101,396 |
|
|
92,354 |
|
Total stockholders’ equity |
|
50,261 |
|
|
11,522 |
|
Total liabilities and stockholders’ equity |
|
$ |
151,657 |
|
|
$ |
103,876 |
|
PIERIS PHARMACEUTICALS, INCCONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited, in thousands,
except per share data)
|
|
Three months ended September
30, |
|
Nine months ended September
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenues |
|
$ |
8,345 |
|
|
$ |
3,927 |
|
|
$ |
24,187 |
|
|
$ |
7,123 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
11,401 |
|
|
6,259 |
|
|
28,492 |
|
|
17,015 |
|
General and administrative |
|
4,748 |
|
|
2,852 |
|
|
13,878 |
|
|
11,190 |
|
Total operating expenses |
|
16,149 |
|
|
9,111 |
|
|
42,370 |
|
|
28,205 |
|
Loss from operations |
|
(7,804 |
) |
|
(5,184 |
) |
|
(18,183 |
) |
|
(21,082 |
) |
Interest income |
|
504 |
|
|
— |
|
|
1,491 |
|
|
— |
|
Other income (expense), net |
|
1,147 |
|
|
(1,729 |
) |
|
1,472 |
|
|
(3,097 |
) |
Loss before income taxes |
|
(6,153 |
) |
|
(6,913 |
) |
|
(15,220 |
) |
|
(24,179 |
) |
Provision for income tax |
|
— |
|
|
146 |
|
|
(148 |
) |
|
959 |
|
Net loss |
|
$ |
(6,153 |
) |
|
$ |
(7,059 |
) |
|
$ |
(15,072 |
) |
|
$ |
(25,138 |
) |
Basic and diluted net loss per share |
|
$ |
(0.11 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.58 |
) |
Basic and diluted weighted average shares outstanding |
|
54,089 |
|
|
44,387 |
|
|
52,721 |
|
|
43,624 |
|
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