Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a
biopharmaceutical company focused on the development and
commercialization of innovative therapies based upon tetracycline
chemistry, today reported financial results for the quarter ended
March 31, 2017.
"The announcement of positive top-line data in April from our
successful Phase 3 registration study in pneumonia was a critically
important milestone in the development of omadacycline,” said
Michael Bigham, Chairman and Chief Executive Officer, Paratek.
“Together, this study and our previously announced successful Phase
3 study in skin infections satisfy the regulatory filing
requirements of our special protocol assessments with the FDA. Our
plan is to submit for regulatory approval in the U.S. as early as
the first quarter of 2018 with an EMA submission later in 2018. In
addition, we recently announced a collaboration with Zai Lab to
develop, manufacture and commercialize omadacycline for the greater
China region. We also recently made thirteen presentations on
omadacycline, including two oral sessions, at the European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID).”
Recent Highlights
- Reported positive top-line efficacy and safety data in the
OPTIC study, a Phase 3 registration study of omadacycline in
CABP
- Enrollment nearly completed in the OASIS-2 study, a Phase 3
registration study of oral-only omadacycline in acute bacterial
skin and skin structure infections (ABSSSI) with top-line data now
expected by mid-July
- Narrowed the projected window to submit the New Drug
Applications for the oral and IV formulations with the U.S. Food
and Drug Administration from as early as the first half 2018 to as
early as the first quarter 2018
- Presented 11 posters and 2 oral sessions at ECCMID in Vienna,
Austria
- Signed a license and collaboration agreement with Zai Lab for
omadacycline in the People’s Republic of China, Hong Kong, Macau,
and Taiwan
- Reported positive top-line data from Allergan’s Phase 3 program
of sarecycline for the treatment of acne vulgaris
Upcoming Milestones
- Readout of top-line data from the oral-only ABSSSI study,
OASIS-2
- Presentation of omadacycline data at the American Society for
Microbiology conference, June 1-5 in New Orleans
Financial Results
Paratek reported a net loss of $27.7 million, or $1.14 per
share, for the quarter ended March 31, 2017 compared to a net loss
of $31.3 million, or $1.78 per share, for the same period in
2016.
Research and development expenses were $18.7 million for the
quarter ended March 31, 2017 compared to $24.3 million for the same
period in 2016. The decrease was primarily driven by lower clinical
study costs and reduced manufacturing production costs for
omadacycline.
General and administrative expenses were $8.4 million for the
quarter ended March 31, 2017 compared to $6.3 million for the same
period in 2016. The increase was primarily driven by an
increase in consulting and legal fees, employee compensation costs,
and other administrative expenses.
As of March 31, 2017, Paratek had cash, cash equivalents, and
marketable securities of $139.6 million. Based upon Paratek’s
current operating plan, the Company anticipates that its existing
cash, cash equivalents and marketable securities, the remaining
$10.0 million it may borrow under existing debt arrangements,
proceeds to be received under its existing controlled equity
offering agreements, and anticipated upfront and regulatory
milestone payments from its collaborations with Allergan and Zai
will enable the Company to fund its operating expenses and capital
expenditure requirements into the second quarter of 2019.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended March
31, 2017 will be broadcast at 8:30 a.m. EDT on May 4, 2017. The
live webcast can be accessed under "Events and Presentations" in
the Investor Relations section of Paratek’s website at
www.paratekpharma.com.
Domestic investors wishing to participate in the call should
dial: 877-407-0792 and international investors should dial:
201-689-8263. The conference ID is 13660676. Investors can also
access the call at
http://public.viavid.com/index.php?id=124062.
Replays of the call will be available through May 18, 2017.
Domestic investors can access the replay by dialing 844-512-2921
and international investors can access the replay by dialing
412-317-6671. The PIN code to access the replay is 13660676.
Website Information
Paratek routinely posts important information for investors on
the Investor Relations section of its website at
www.paratekpharma.com. Paratek intends to use this website as a
means of disclosing material, non-public information and for
complying with its disclosure obligations under Regulation FD.
Accordingly, investors should monitor the Investor Relations
section of Paratek’s website, in addition to following its press
releases, SEC filings, public conference calls, presentations and
webcasts. The information contained on, or that may be accessed
through, Paratek’s website is not incorporated by reference into,
and is not a part of, this document.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of innovative
therapies based upon its expertise in novel tetracycline chemistry.
Paratek's lead product candidate, omadacycline, when approved, will
be the first in a new class of tetracyclines known as
aminomethylcyclines, with broad-spectrum activity against
Gram-positive, Gram-negative and atypical bacteria. Omadacycline is
a new, once-daily oral and intravenous broad spectrum antibiotic
being developed for use as empiric monotherapy for patients
suffering from serious community-acquired bacterial infections,
such as acute bacterial skin and skin structure infections,
community-acquired bacterial pneumonia, urinary tract infections,
and other community-acquired bacterial infections, particularly
when antibiotic resistance is of concern to prescribing physicians.
Omadacycline has been granted Qualified Infectious Disease Product
designation and Fast Track status by the U.S. Food and Drug
Administration for the target indications.
In June 2016, Paratek announced positive efficacy data in a
Phase 3 registration study in acute bacterial skin and skin
structure infections (ABSSSI) demonstrating the efficacy and
general safety and tolerability of intravenous (IV) to once-daily
oral omadacycline compared to linezolid. In April 2017, Paratek
announced positive efficacy data in a Phase 3 registration study in
community-acquired bacterial pneumonia (CABP) demonstrating the
efficacy and general safety and tolerability of IV to once-daily
oral omadacycline compared to moxifloxacin. A Phase 3 registration
study in ABSSSI comparing once-daily oral-only dosing of
omadacycline to twice-daily oral-only dosing of linezolid was
initiated in August 2016. Enrollment of this study is nearly
complete, with top-line data from this study expected by mid-July.
The Company plans to submit its new drug application (NDA) in the
U.S. as early as the first quarter of 2018 with an EMA submission
later in 2018.
In addition to its Phase 3 program for omadacycline, a Phase 1B
study in uncomplicated urinary tract infections (UTI) was initiated
in May 2016 and positive top-line PK proof-of-principle data was
reported in November 2016. The Company plans to begin enrolling
patients in a proof-of-concept Phase 2 study of omadacycline in
acute pyelonephritis, the most common subset of complicated urinary
tract infections, as early as December 2017.
In October 2016, Paratek announced a research agreement with the
U.S. Department of Defense to explore the utility of omadacycline
against pathogenic agents causing infectious diseases of public
health and biodefense importance including plague and anthrax.
In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary
of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a
License and Collaboration Agreement. Under the terms of the
Agreement, the Company granted Zai an exclusive license to develop,
manufacture, and commercialize omadacycline in the People’s
Republic of China, Hong Kong, Macau and Taiwan, for all human
therapeutic and preventative uses, other than biodefense. Zai will
be responsible for the development, manufacturing and
commercialization of the licensed product in the licensed
territory, at its sole cost with certain assistance from the
Company.
Paratek's second Phase 3 product candidate, sarecycline, is a
well-tolerated, once-daily oral, narrow spectrum
tetracycline-derived antibiotic with potent anti-inflammatory
properties for the potential treatment of acne and rosacea in the
community setting. Allergan owns the U.S. rights for the
development and commercialization of sarecycline. Paratek retains
all ex-U.S. rights. Allergan and Paratek reported positive results
from two identical Phase 3 registration studies of sarecycline for
the treatment of moderate to severe acne vulgaris in March 2017.
Allergan has publicly announced plans to submit an NDA in the U.S.
in the second half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking StatementsThis press release
contains forward-looking statements including statements related to
our overall strategy, product candidates, clinical studies,
prospects, potential and expected results, including statements
about the timing of advancing omadacycline and otherwise preparing
for clinical studies, the timing of enrollment in our clinical
studies and our reporting of the results of such studies, the
potential for omadacycline to serve as an empiric monotherapy
treatment option for patients suffering from ABSSSI, CABP, UTI, and
other bacterial infections when resistance is of concern, the
prospect of omadacycline providing broad-spectrum activity, and our
ability to obtain regulatory approval of omadacycline. All
statements, other than statements of historical facts, included in
this press release are forward-looking statements, and are
identified by words such as "advancing," "believe," "expect," "well
positioned," "look forward," "anticipated," "continued," and other
words and terms of similar meaning. These forward-looking
statements are based upon our current expectations and involve
substantial risks and uncertainties. We may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in our forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Our actual results and the timing
of events could differ materially from those included in such
forward-looking statements as a result of these risks and
uncertainties. These and other risk factors are discussed
under "Risk Factors" and elsewhere in our Annual Report on Form
10-K for the year ended December 31, 2016, and our other filings
with the Securities and Exchange Commission. We expressly
disclaim any obligation or undertaking to update or revise any
forward-looking statements contained herein.
PARATEK PHARMACEUTICALS, INC. |
|
|
|
Condensed Consolidated Statements of
Operations |
|
(unaudited) |
|
(in thousands, except loss per share
data) |
|
|
|
|
Three months endedMarch
31, |
|
|
2017 |
|
2016 |
|
Revenue: |
|
|
|
|
|
|
Royalty
Revenue |
$ |
18 |
|
$ |
— |
|
Total Revenue |
|
18 |
|
|
— |
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
18,657 |
|
|
24,288 |
|
General
and administrative |
|
8,363 |
|
|
6,339 |
|
Changes
in fair value of contingent consideration |
|
(231 |
) |
|
105 |
|
Total operating
expenses |
|
26,789 |
|
|
30,732 |
|
Loss from
operations |
|
(26,771 |
) |
|
(30,732 |
) |
Other income and
expenses: |
|
|
|
|
|
|
Interest
expense |
|
(1,132 |
) |
|
(730 |
) |
Interest
income |
|
240 |
|
|
191 |
|
Other
(loss) income, net |
|
(7 |
) |
|
— |
|
Net loss |
$ |
(27,670 |
) |
$ |
(31,271 |
) |
Net loss
per share - basic and diluted |
$ |
(1.14 |
) |
$ |
1.78 |
|
Weighted average common
shares outstanding |
|
|
|
|
|
|
Basic and
diluted |
|
24,196,158 |
|
|
17,615,754 |
|
Condensed Consolidated Balance Sheets |
(unaudited) |
(in thousands) |
|
|
|
|
March 31,2017 |
|
|
December 31,2016 |
|
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
139,587 |
|
|
$ |
128,038 |
|
Total assets |
|
|
147,365 |
|
|
|
135,732 |
|
Working capital |
|
|
124,164 |
|
|
|
111,688 |
|
Total current
liabilities |
|
|
18,635 |
|
|
|
20,412 |
|
Long-term debt, less
current portion |
|
|
39,060 |
|
|
|
38,974 |
|
Common stock and
additional paid-in-capital |
|
|
493,576 |
|
|
|
451,970 |
|
Accumulated
deficit |
|
|
(408,713 |
) |
|
|
(380,362 |
) |
Total stockholders'
equity |
|
|
84,809 |
|
|
|
71,592 |
|
CONTACTS:
Media:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com
Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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