Cempra Reports Third Quarter 2016 Financial Results and Provides Corporate Update
October 27 2016 - 4:15PM
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company
focused on developing antibiotics to meet critical medical needs in
the treatment of bacterial infectious diseases, today reported
financial results for the quarter ended September 30, 2016 and
provided an update on recent corporate developments. The company
will host a webcast and conference call today at 5:00 p.m. EDT.
Third Quarter 2016 and Recent Corporate
Highlights
- On October 25, Cempra completed enrollment in its ongoing Phase
3 study of fusidic acid as an oral treatment for acute bacterial
skin and skin structure infections. The company expects to have
topline data to report in the first quarter of 2017.
- On October 4, Cempra presented an analysis of patient data at
the Academy of Managed Care Pharmacy meeting. The presentation
included three abstracts based upon analyzing treatment failures
with existing antibiotics from more than 400,000 records of
patients diagnosed with community-acquired bacterial pneumonia
(CABP) in a large U.S. insurance claims database. This analysis
showed that more than one out of five adult CABP patients failed
initial antibiotic monotherapy, with the failure rate exceeding one
out of four for an elderly population with certain
comorbidities.
- On September 29, Cempra announced interim results showing
anti-NASH effects in the first six nonalcoholic steatohepatitis
(NASH) patients dosed with solithromycin in a Phase 2 study. After
90 days of solithromycin treatment, all six NASH patients had a
reduction in their nonalcoholic fatty liver disease activity score
(NAS), as well as alanine aminotransferase (ALT) reduction. Based
on the safety profile and activity seen in the first six patients,
Cempra plans to continue the Phase 2 study to obtain data from up
to 15 NASH patients. Enrollment is expected to complete in the
first quarter of 2017.
- On August 30, Cempra announced that the U.S. Food and Drug
Administration (FDA) scheduled a meeting of the Antimicrobial Drugs
Advisory Committee on November 4, 2016 in Silver Spring, Maryland,
to discuss the safety and efficacy of solithromycin in the
treatment of CABP. The FDA is currently reviewing New Drug
Applications (NDAs) for IV and oral solithromycin for CABP, with
PDUFA dates in late December.
- On August 25, Cempra announced the publication in Clinical
Infectious Diseases of its pivotal Phase 3 study, SOLITAIRE-IV,
comparing the efficacy and safety of intravenous-to-oral
solithromycin to intravenous-to-oral moxifloxacin for the treatment
of CABP. Both of Cempra’s pivotal Phase 3 studies have been
published in leading infectious disease journals.
- On August 23, Cempra announced that the European Medicines
Agency (EMA) had validated the company's marketing authorization
application (MAA) seeking approval of oral capsule and intravenous
formulations of solithromycin for the treatment of CABP. The EMA's
Committee for Medicinal Products for Human Use (CHMP) has begun its
assessment of solithromycin through the centralized review
procedure. If the CHMP review results in a positive opinion, the
next step would be for the European Commission to grant marketing
clearance for solithromycin, which would apply to all EU member
states.
- On August 11, Cempra appointed David Zaccardelli, Pharm.D. to
serve on the company's board of directors.
- On July 5, Cempra announced that the FDA had accepted for
filing Cempra’s two NDAs for intravenous and oral capsule
formulations of solithromycin in CABP. Having been granted
qualified infectious diseases product (QIDP) designation in 2013,
solithromycin’s NDAs have qualified for an eight month priority
review, with 2016 PDUFA dates of December 27 for the oral
formulation and December 28 for intravenous.
“Cempra continued an exceptional 2016 with
further progress in the third quarter, including FDA acceptance of
our NDAs for intravenous and oral capsule formulations of
solithromycin, the submission of our solithromycin MAA in Europe,
publication of our IV to oral Phase 3 solithromycin study in a
prestigious journal, and the announcement of exciting interim
results from our Phase 2 NASH study,” said Prabhavathi Fernandes,
Ph.D., president and chief executive officer of Cempra.
“The company is preparing for the potential
approval and 2017 launch of solithromycin and we look forward to
discussing the safety and efficacy profile of solithromycin, along
with the urgent and growing unmet medical need for a new macrolide
antibiotic, at our advisory committee meeting next week,” Fernandes
added.
Upcoming Clinical Development
Milestones
Solithromycin
- Solithromycin pediatric
- Patient enrollment for Phase 1b trial continues.
- Phase 2/3 pivotal trial with solithromycin for bacterial
infections in pediatric patients has been initiated. Global sites
have been added.
- Phase 3 trial for solithromycin in urogenital gonorrhea is
ongoing.
- Enrollment of the Phase 2 NASH trial is ongoing.
- FDA Antimicrobial Drugs Advisory Committee to discuss
solithromycin November 4, 2016.
Fusidic acid
- Data from Phase 3 study in ABSSSI expected in first quarter of
2017.
- An exploratory trial for Taksta in patients with refractory
bone or joint infections is ongoing.
Financial Results for the Three Months
Ended September 30, 2016
For the quarter ended September 30, 2016, Cempra
reported a net loss of $32.3 million, or $0.62 per share, compared
to a net loss of $27.6 million, or $0.63 per share for the third
quarter in 2015. Research and development expense in the third
quarter of 2016 was $21.1million, a decrease of 10.2% compared to
$23.5 million in the third quarter of 2015. The lower R&D
expense was primarily due to a decrease of clinical trial expenses
for solithromycin and reduced fusidic acid clinical trial supply
purchases. General and administrative expense was $15.0 million
compared to $5.8 million in the third quarter of 2015, driven
primarily by commercial readiness activities and increased
headcount as the company continues to plan for commercialization of
solithromycin in 2017.
As of September 30, 2016, Cempra had cash and
equivalents of $248.9 million and 52.4 million shares outstanding.
In the third quarter, the company utilized its ATM financing
facility with the sale of approximately 1.6 million shares
resulting in net proceeds of approximately $29.2 million.
Conference Call and Webcast
Cempra management will host a webcast and
conference call regarding this announcement at 5:00 p.m. EDT today.
The live call may be accessed by dialing 877-377-7553 for domestic
callers and 253-237-1151 for international callers and using
conference number: 7622650. A live webcast of the call will be
available from the investor relations sections of the company
website at www.cempra.com, and will be archived there for 30 days.
A telephone replay of the call will be available by dialing
855-859-2056 for domestic callers, or 404-537-3406 for
international callers, and entering the conference number:
7622650.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical
company focused on developing antibiotics to meet critical medical
needs in the treatment of bacterial infectious diseases. Cempra's
two lead product candidates are currently in advanced clinical
development. Solithromycin has been successfully evaluated in two
Phase 3 clinical trials for community acquired bacterial pneumonia
(CABP) and applications for approval for both intravenous and oral
capsule formulations have been accepted for review by the FDA and
the EMA. Solithromycin is licensed to strategic commercial partner
Toyama Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings
Corporation, for certain exclusive rights in Japan. Solithromycin
is also in a Phase 3 clinical trial for uncomplicated urogenital
urethritis caused by Neisseria gonorrhoeae or chlamydia. Cempra is
contracted with BARDA for the development of solithromycin for
pediatric use. Three formulations, intravenous, oral capsules and a
suspension formulation are in a Phase 1b trial in children from
birth to 17 years of age. Fusidic acid is Cempra's second product
candidate, which is being developed for acute bacterial skin and
skin structure Infections (ABSSSI) and is also in an exploratory
study for chronic oral treatment of refractory infections in bones
and joints. Both products seek to address the need for new
treatments targeting drug-resistant bacterial infections in the
hospital and in the community. Cempra has also synthesized novel
macrolides for non-antibiotic uses such as the treatment of chronic
inflammatory diseases, endocrine diseases and gastric motility
disorders. Cempra was founded in 2006 and is headquartered in
Chapel Hill, N.C. For additional information about Cempra please
visit www.cempra.com.
Please Note: This press release
contains forward-looking statements regarding future events. These
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to
differ materially. These risks and uncertainties include, among
others: our and our strategic commercial partners' ability to
obtain FDA and foreign regulatory approval of our product
candidates, including solithromycin; our ability to commercialize
and launch, whether on our own or with a strategic partner, any
product candidate that receives regulatory approval; our ability to
produce and sell any approved products and the price we are able to
realize for those products; our ability to retain and hire
necessary employees and to staff our operations appropriately; the
unpredictability of the size of the markets for, and market
acceptance of, any of our products, including solithromycin and
fusidic acid; the costs, sources of funds, enrollment, timing,
regulatory review and results of our studies and clinical trials
and those of our strategic commercial partners; our need to obtain
additional funding and our ability to obtain future funding on
acceptable terms; our anticipated capital expenditures and our
estimates regarding our capital requirements; results of our
preclinical studies and clinical trials are not predictive of
results from subsequent clinical trials for any possible therapy;
the possible impairment of, or inability to obtain, intellectual
property rights and the costs of obtaining such rights from third
parties; our ability to compete in our industry; our dependence on
the success of solithromycin and fusidic acid; innovation by our
competitors; and our ability to stay abreast of and comply with new
or modified laws and regulations that currently apply or become
applicable to our business. The reader is referred to the documents
that we file from time to time with the Securities and Exchange
Commission.
CEMPRA, INC.
SELECTED FINANCIAL INFORMATION
Condensed
Consolidated Balance Sheets(unaudited; in
thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
|
|
|
2016 |
|
|
2015 |
|
|
|
|
Assets |
|
|
|
|
Current assets |
|
|
|
|
|
Cash and
equivalents |
|
|
248,917 |
|
|
|
153,765 |
|
|
Receivables |
|
|
4,531 |
|
|
|
7,639 |
|
|
Prepaid
expenses |
|
|
792 |
|
|
|
573 |
|
|
Total current
assets |
|
|
254,240 |
|
|
|
161,977 |
|
|
Furniture, fixtures and
equipment, net |
|
|
59 |
|
|
|
90 |
|
|
Deposits |
|
|
146 |
|
|
|
73 |
|
|
Total assets |
|
|
254,445 |
|
|
|
162,140 |
|
|
Liabilities |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts
payable |
|
|
12,531 |
|
|
|
9,635 |
|
|
Accrued
expenses |
|
|
2,090 |
|
|
|
1,475 |
|
|
Accrued
payroll and benefits |
|
|
3,679 |
|
|
|
2,337 |
|
|
Current
portion of long-term debt |
|
|
6,667 |
|
|
|
4,444 |
|
|
Total
current liabilities |
|
|
24,967 |
|
|
|
17,891 |
|
|
Deferred revenue |
|
|
11,326 |
|
|
|
11,326 |
|
|
Long-term debt |
|
|
10,300 |
|
|
|
15,258 |
|
|
Total liabilities |
|
|
46,593 |
|
|
|
44,475 |
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity (Deficit) |
|
|
|
|
|
Common
stock |
|
52 |
|
|
|
44 |
|
|
Additional paid-in
capital |
|
|
613,345 |
|
|
|
436,643 |
|
|
Accumulated
deficit |
|
|
(405,545 |
) |
|
|
(319,022 |
) |
|
Total shareholders’
equity |
|
|
207,852 |
|
|
|
117,665 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders’ equity |
|
|
254,445 |
|
|
|
162,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statement of
Operations |
|
|
|
(unaudited; in thousands, except loss per share
data) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
Revenues |
|
|
3,972 |
|
|
|
2,497 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D |
|
|
21,096 |
|
|
|
23,541 |
|
G&A |
|
|
15,021 |
|
|
|
5,848 |
|
Total Operating
Expenses |
|
|
36,117 |
|
|
|
29,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(32,145 |
) |
|
|
(26,892 |
) |
Other income (expense),
net |
|
|
(167 |
) |
|
|
(679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
|
(32,312 |
) |
|
|
(27,571 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
|
(32,312 |
) |
|
|
(27,571 |
) |
Basic and diluted net
loss per share |
|
|
(0.62 |
) |
|
|
(0.63 |
) |
Basic and diluted
weighted average shares |
|
|
52,073 |
|
|
|
43,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
Revenues |
|
|
|
10,071 |
|
|
|
21,514 |
|
|
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D |
|
|
|
60,643 |
|
|
|
73,334 |
|
|
G&A |
|
|
|
35,333 |
|
|
|
16,230 |
|
|
Total Operating Expenses |
|
|
95,976 |
|
|
|
89,564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(85,905 |
) |
|
|
(68,050 |
) |
|
Other
income (expense), net |
|
|
(618 |
) |
|
|
(1,906 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss and comprehensive loss |
|
|
(86,523 |
) |
|
|
(69,956 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common shareholders |
|
|
(86,523 |
) |
|
|
(69,956 |
) |
|
Basic and
diluted net loss per share |
|
|
(1.74 |
) |
|
|
(1.61 |
) |
|
Basic and
diluted weighted average shares |
|
|
49,617 |
|
|
|
43,427 |
|
|
Contact:
John Bluth
Cempra, Inc.
(984) 209-4534
jbluth@cempra.com
Investor Contact:
Robert H. Uhl
Westwicke Partners, LLC
(858) 356-5932
robert.uhl@westwicke.com
Media Contacts:
Melyssa Weible
Elixir Health PR
(201) 723-5805
mweible@elixirhealthpr.com
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