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 September 30,
2016. The company also reported the completion and top-line results
of a Phase 1b study of omadacycline in patients with urinary tract
infections, as well as the completion of several important clinical
and manufacturing requirements for its planned NDA submission.
Phase 1b UTI Pharmacokinetic ResultsIn this
clinical study, patients with uncomplicated UTI received either
IV-to-oral or oral-only regimens of omadacycline over a period of
five days. Results showed that omadacycline achieved high steady
state concentrations in urine for all treatment regimens,
demonstrating proof-of-principle for the use of omadacycline in
UTI.
Clinical & Manufacturing NDA Registration
RequirementsThe company completed two required Phase 1
pharmacokinetic studies to support the planned regulatory filings
for omadacycline.
The first of the two Phase 1 studies assessed the concentration
of omadacycline in the lungs via bronchoalveolar lavage
(BAL). This study, conducted in healthy volunteer subjects,
demonstrated that omadacycline is able to penetrate into the lungs
and epithelial lining fluid, at concentrations higher than plasma.
The second Phase 1 study evaluated exposure levels of
omadacycline in patients with end-stage renal disease. This study
found that in these patients, omadacycline had similar
pharmacokinetic exposure profiles to healthy subjects, suggesting
that omadacycline can be used in subjects with renal impairment
without the need for dose adjustments.
All recently completed phase 1 studies demonstrate a safety and
tolerability profile consistent with prior oral and IV phase 1
studies of omadacycline.
The company has also completed production of all oral and IV
registration batches of omadacycline required for planned
regulatory submissions. The registration batches were
produced at commercial scale.
"With the continued progress we have made this quarter, we
remain on track to file our NDA for both community-acquired skin
and pneumonia indications in the first half of 2018,” said Michael
Bigham, Chairman and Chief Executive Officer, Paratek.
“Importantly, the promising data from our Phase 1b study in UTI
support developing a registration pathway for omadacycline in UTI,
the most common community-acquired bacterial infection. In
addition to the clinical progress this quarter, we also completed
important regulatory requirements that will support our planned
NDA. We are pleased with the progress we have made to date,
and remain excited about the eventful year ahead.”
Additional Q3 2016 Highlights
- Announced 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
- Initiation of a Phase 3 once-daily, oral-only study in acute
bacterial skin and skin-structure infection, or ABSSSI, and remains
on track to have top line data available as early as the second
quarter of 2017
- Phase 3 IV-to-oral study in community acquired bacterial
pneumonia, or CABP, remains on track to have top line data
available as early as the third quarter of 2017
Upcoming Milestones
- Hosting an R&D Day on November 17 in New York. More
information can be found here
http://lifesci.rampard.com/20161117/reg.jsp
Financial Results
For the quarter ended September 30, 2016, Paratek reported a net
loss of $23.6 million, or $1.04 per share, compared to a net loss
of $23.4 million, or $1.33 per share, for the same period in
2015.
Research and development expense for the quarter ended September
30, 2016 decreased modestly compared to the same period in 2015,
primarily due to the completion of our Phase 3 ABSSSI IV-to-oral
study. With the commencement of a Phase 3 once-daily,
oral-only study in ABSSSI in August 2016 and the initiation of
preparation activities for an NDA submission for omadacycline, the
Company expects the next several quarters of research and
development expense to return to the levels incurred during the
first half of 2016.
General and administrative expense for the quarter ended
September 30, 2016 is consistent with the same period in
2015. The expense incurred during the quarters ended
September 30, 2016 and 2015 were primarily driven by personnel
costs, professional and consulting services, including legal,
accounting and audit fees, and other administrative spend.
As of September 30, 2016, Paratek had cash, cash equivalents,
and marketable securities of $120.8 million. Based on current
assumptions, Paratek’s cash, cash equivalents and marketable
securities, as well as the $20.0 million available under a Loan
Agreement with Hercules, will enable the Company to fund operating
expenses and capital expenditure requirements through the
submission of a new drug application for omadacycline for the
treatment of ABSSSI and CABP, which is currently expected to occur
in the first half of 2018.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended September 30, 2016, will be
broadcast at 8:30 a.m. EST on November 2, 2016. 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: 877-407-9039 and international investors should dial:
201-689-8470. The conference ID is 13648499. Investors can also
access the call at
http://public.viavid.com/index.php?id=121674.
Replays of the call will be available through November 16, 2016.
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 13648499.
Website InformationParatek 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, is the first in a new class of
tetracyclines known as aminomethylcyclines, with broad-spectrum
activity against Gram-positive, Gram-negative and atypical
bacteria. In June 2016 Paratek announced positive efficacy data in
a Phase 3 registration study in ABSSSI demonstrating the efficacy
and safety of intravenous (IV) to oral omadacycline compared to
linezolid. A Phase 3 registration study for community acquired
bacterial pneumonia (CABP) comparing IV-to-oral omadacycline to
IV-to-oral moxifloxacin was initiated in November 2015.
Enrollment continues on track to report top line data as early as
the third quarter of 2017. 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. Top line data are expected as early as the second quarter of
2017. Omadacycline has been granted Qualified Infectious
Disease Product designation and Fast Track status by the U.S. Food
and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated
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.
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 initiated two identical Phase 3
registration studies in December 2014 for sarecycline for the
treatment of moderate to severe acne vulgaris. Top line data are
expected in the first 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 trials, cash
resources, prospects and expected results, including statements
about the timing of advancing omadacycline and otherwise preparing
for clinical trials, 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 having the resources to execute on
our clinical trials. 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, which include, without limitation, risks related to
(i) our need for substantial additional funding to complete the
development and commercialization of our product candidates, (ii)
our ability to raise the capital to do so, (iii) our ability to
develop our drug candidates for potential commercialization, (iv)
the advancement of omadacycline Phase 3 trials for ABSSSI and CABP,
(v), (v) the potential for omadacycline to be successfully
developed for use as a first-line empiric monotherapy for patients
suffering from serious community-acquired bacterial infections,
(vi) the potential of omadacycline to become the primary antibiotic
choice of physicians for the treatment of serious
community-acquired bacterial infections, (vii) the ability of our
supply chain to provide adequate supply to satisfy our clinical and
commercial demand (viii) the potential use and effectiveness of
sarecycline for the treatment of acne and rosacea in the community
setting, and (ix) the timing of the Phase 3 program in
moderate-severe acne for sarecycline, risks that data to date and
trends may not be predictive of future results, risks related to
the conduct of our clinical trials, and risks that our clinical
trials and product candidates do not receive regulatory approval.
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, 2015, 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 endedSeptember
30, |
|
|
Nine months endedSeptember
30, |
|
|
2016 |
|
2015 |
|
|
2016 |
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
17,334 |
|
$ |
17,817 |
|
|
$ |
63,757 |
|
$ |
35,556 |
|
General and administrative |
|
5,949 |
|
|
5,795 |
|
|
|
19,896 |
|
|
14,347 |
|
Impairment of intangible asset |
|
- |
|
|
- |
|
|
|
- |
|
|
2,761 |
|
Changes in fair value of contingent
consideration |
|
(170 |
) |
|
(240 |
) |
|
|
(50 |
) |
|
(2,980 |
) |
Total operating
expenses |
|
23,113 |
|
|
23,372 |
|
|
|
83,603 |
|
|
49,684 |
|
Loss from
operations |
|
(23,113 |
) |
|
(23,372 |
) |
|
|
(83,603 |
) |
|
(49,684 |
) |
Other income and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(820 |
) |
|
(47 |
) |
|
|
(2,368 |
) |
|
(73 |
) |
Interest income |
|
309 |
|
|
- |
|
|
|
788 |
|
|
- |
|
Other income (expense), net |
|
(4 |
) |
|
(2 |
) |
|
|
1 |
|
|
3 |
|
Net loss |
$ |
(23,628 |
) |
$ |
(23,421 |
) |
|
$ |
(85,182 |
) |
$ |
(49,754 |
) |
Net loss per share - basic and
diluted |
$ |
(1.04 |
) |
$ |
(1.33 |
) |
|
$ |
(4.39 |
) |
$ |
(3.08 |
) |
Weighted average common
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
22,627,711 |
|
|
17,561,708 |
|
|
|
19,391,443 |
|
|
16,129,031 |
|
Condensed Consolidated Balance Sheets |
|
(unaudited) |
|
(in thousands) |
|
|
|
|
|
September
30,2016 |
|
|
December 31,2015 |
|
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
120,792 |
|
|
$ |
131,302 |
|
Total assets |
|
|
131,611 |
|
|
|
145,918 |
|
Working capital |
|
|
105,707 |
|
|
|
121,915 |
|
Total current
liabilities |
|
|
21,751 |
|
|
|
20,502 |
|
Long-term debt, less
current portion |
|
|
19,653 |
|
|
|
19,565 |
|
Total stockholders'
equity |
|
|
85,472 |
|
|
|
101,240 |
|
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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