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 June 30, 2016.
"Our clinical development program for omadacycline continues to
progress well. We have successfully completed our Phase 3
registration study in Acute Bacterial Skin and Skin Structure
infections (ABSSSI), and our Phase 3 study in community acquired
bacterial pneumonia (CABP) continues to progress according to plan.
With our progress to date, we remain on track to file a new drug
application for omadacycline in the United States in the first half
of 2018,” said Michael Bigham, Chairman and Chief Executive
Officer, Paratek. “In parallel, we are continuing to expand the
potential clinical applications of omadacycline. Enrollment
in our Phase 1b study with omadacycline for the treatment of
urinary tract infections (UTI) is nearly complete, with top-line
data expected in Q4; and we expect to initiate enrollment this
month in our Phase 3 study with omadacycline for the oral-only
treatment of ABSSSI.”
Recent Paratek Highlights
- Announced successful achievement of the primary and secondary
efficacy endpoints comparing omadacycline to linezolid in the
treatment of ABSSSI. Omadacycline met both the U.S. Food and
Drug Administration (FDA)-specified primary efficacy endpoint
of early clinical response as well as the European Medicines
Agency (EMA)-specified co-primary efficacy endpoint for
post-treatment evaluation.
- Phase 3 registration study evaluating omadacycline for the
treatment of CABP remains on track to report top-line data as early
as the third quarter of 2017.
Upcoming Milestones
- Dosing of first patient in oral-only Phase 3 study evaluating
omadacycline for the treatment of ABSSSI expected in August
2016.
- Announcement of top-line data from Phase 1b study evaluating
omadacycline for the treatment of UTI expected in the fourth
quarter of 2016. Enrollment in this study is nearly complete.
Financial ResultsFor the quarter ended June 30,
2016, Paratek reported a net loss of $30.3 million, or $1.69 per
share, compared to a net loss of $15.7 million, or $0.96 per share,
for the same period in 2015.
Research and development expenses were $22.1 million for the
three months ended June 30, 2016, compared to $11.0 million for the
same period in 2015. The increase in research and development
expense during the three months ended June 30, 2016 was primarily
the result of the Company’s ongoing clinical development of
omadacycline, notably from its Phase 3 studies for the treatment of
CABP and ABSSSI, a Phase 1b study for the treatment of UTI, and
other Phase 1 studies required for submission of the planned New
Drug Application.
During the current quarter, the Company incurred approximately
$11.4 million in expense associated with its Phase 3 studies for
the treatment of ABSSSI and CABP, including a Phase 3 oral-only
study, which represents an increase of $4.5 million compared to
$6.9 million in the same period in the prior year. This
increase is associated primarily with strong enrollment in the CABP
registration study, resulting in an increased recognition of
expenses related to contract research organization fees,
investigator fees, and costs associated with clinical sites and
laboratories, as well as study start-up costs for a planned Phase 3
oral-only study in ABSSSI. The Company also incurred $2.3
million in production costs for omadacycline registration batches
and manufacturing process validation work, which represents an
increase of $0.9 million compared to the same period in prior
year.
Also during the quarter, the Company incurred $5.9 million in
costs from omadacycline Phase 1 studies and other research and
development activities and $2.5 million in salaries and benefits,
including stock-based compensation, which represents an increase of
$4.6 million and $1.1 million, respectively, compared to the same
period in prior year, due to the conduct of additional Phase 1
studies and increased headcount.
The increase in general and administrative costs for the three
months ended June 30, 2016 was primarily due to growth in the
Company’s corporate infrastructure. Salaries and benefits,
including stock-based compensation, increased $1.9 million, and
professional and consulting services, including legal, accounting,
and audit fees, increased $1.1 million for the three months ended
June 30, 2016 compared to the same period in prior year.
As of June 30, 2016, Paratek had cash, cash equivalents, and
marketable securities of $150.4 million. Based on current
assumptions, Paratek’s cash, cash equivalents and marketable
securities, as well as the $20.0 million available to us under the
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 the Company currently expects
to occur in the first half of 2018.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended June 30, 2016, will be
broadcast at 8:30 a.m. EST on August 4, 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 using conference ID 13635898. International
investors should dial: 201-689-8470 using conference ID
13641904. Investors can also access the call at
http://public.viavid.com/index.php?id=120479.
Replays of the call will be available through August 18, 2016.
Domestic investors can access the replay by dialing 877-870-5176.
International investors can access the replay by dialing
858-384-5517. The PIN code to access the replay is 13641904.
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 data in a Phase
3 registration study in ABSSSI demonstrating the efficacy, safety
and tolerability of the once-daily oral and IV formulations of
omadacycline compared to linezolid. A Phase 3 registration study
for community acquired bacterial pneumonia (CABP) comparing
omadacycline to moxifloxacin was initiated in November 2015 and top
line data is expected as early as the third quarter of 2017. A
phase 1b study in uncomplicated urinary tract infections (uUTI) was
initiated in May 2016. Omadacycline has been granted QIDP 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.
For more information, visit www.paratekpharma.com.
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.
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 studies for ABSSSI, (v)
the advancement of omadacycline Phase 3 study for CABP, (vi)
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, (vii) the
potential of omadacycline to become the primary antibiotic choice
of physicians for the treatment of serious community-acquired
bacterial infections, (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 commencement of a 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 ended June 30, |
|
Six months ended June 30, |
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
Research and
development |
|
22,135 |
|
|
10,998 |
|
|
|
46,423 |
|
|
17,739 |
|
General and
administrative |
|
7,602 |
|
|
4,281 |
|
|
|
13,941 |
|
|
8,552 |
|
Impairment of
intangible asset |
|
- |
|
|
- |
|
|
|
- |
|
|
2,761 |
|
Changes in fair value
of contingent consideration |
|
15 |
|
|
400 |
|
|
|
120 |
|
|
(2,740 |
) |
Total operating
expenses |
|
29,752 |
|
|
15,679 |
|
|
|
60,484 |
|
|
26,312 |
|
Loss from
operations |
|
(29,752 |
) |
|
(15,679 |
) |
|
|
(60,484 |
) |
|
(26,312 |
) |
Other income and
expenses: |
|
|
|
|
|
Interest expense |
|
(818 |
) |
|
(25 |
) |
|
|
(1,548 |
) |
|
(25 |
) |
Interest income |
|
288 |
|
|
- |
|
|
|
479 |
|
|
- |
|
Other income (loss),
net |
|
(1 |
) |
|
5 |
|
|
|
(1 |
) |
|
5 |
|
Net loss |
|
(30,283 |
) |
|
(15,699 |
) |
|
|
(61,554 |
) |
|
(26,332 |
) |
Net loss per share -
basic and diluted |
$ |
(1.69 |
) |
$ |
(0.96 |
) |
|
$ |
(3.47 |
) |
$ |
(1.71 |
) |
Weighted average common
shares outstanding |
|
|
|
|
|
Basic and diluted |
|
17,895,301 |
|
|
16,372,694 |
|
|
|
17,755,528 |
|
|
15,400,819 |
|
Condensed Consolidated Balance Sheets |
(unaudited) |
(in thousands) |
|
|
|
June 30, 2016 |
|
December 31, 2015 |
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
150,403 |
|
|
$ |
131,302 |
|
Total assets |
|
|
159,423 |
|
|
|
145,918 |
|
Working capital |
|
|
126,642 |
|
|
|
121,915 |
|
Total current
liabilities |
|
|
28,494 |
|
|
|
20,502 |
|
Long-term debt, less
current portion |
|
|
19,625 |
|
|
|
19,565 |
|
Total stockholders'
equity |
|
|
106,456 |
|
|
|
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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