ROCKVILLE, Md., March 10, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome, today
provided an operational update and reported financial results for
the year ended December 31, 2015.
"2015 was a milestone year for Synthetic Biologics. We made
important clinical progress in our lead microbiome-focused
programs, including the announcement of positive topline results
from the second Phase 2 clinical trial for SYN-010 which
demonstrated statistical significance in both primary and secondary
endpoints in patients suffering from irritable bowel syndrome with
constipation (IBS-C)," said Jeffrey
Riley, President and Chief Executive Officer Synthetic
Biologics. "We also reported positive topline results from the
first Phase 2a clinical trial demonstrating that SYN-004
successfully degraded residual intravenous (IV) ceftriaxone in
study participants without affecting the intended level of
antibiotic in the bloodstream."
Mr. Riley concluded, "We anticipate continued momentum in the
clinic during 2016 and look forward to reporting progress in two
ongoing Phase 2 clinical trials for SYN-004, including topline data
from the second Phase 2a clinical trial and an interim analysis of
blinded data by an independent monitor committee for the Phase 2b
proof-of-concept global study in the first half of 2016. Of
significant importance during 2016 is scheduling an end of Phase 2
meeting with the FDA regarding the SYN-010 IBS-C program, and our
plans to initiate Phase 3 clinical trials during the second half of
the year."
Microbiome-Focused Clinical Program
Progress
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Expect to initiate Phase 3 clinical trial(s) (2H 2016)
- Anticipate requesting end of Phase 2 meeting with FDA (Summer
2016)
- Reported positive topline data from second Phase 2 clinical
trial – 8-week extension study (1Q 2016)
- All patients who completed the second study showed a
statistically significant decrease in methane production (p=0.002)
from the beginning of the first Phase 2 study (Study 1 baseline;
Day 1) to the end of the second Phase 2 study (12 weeks of
treatment; Day 84), thus meeting the study's primary endpoint
- Topline data also showed improvements in secondary efficacy
endpoints, including:
- A statistically significant reduction in the mean IBS Symptom
Severity Score (IBS-SSS; p=0.0001) which includes abdominal pain,
bloating, stool frequency and quality of life scores, was observed
for all patients from Study 1 baseline to the end of the second
Phase 2 study
- An increase in the percentage of patients identified as Monthly
Responders, an FDA-defined composite measure incorporating
improvements in complete spontaneous bowel movements and abdominal
paini
- No serious adverse events were observed
- Reported positive topline data from first Phase 2 clinical
trial – 4-week acute study (4Q 2015)
- SYN-010 met its primary endpoint of lowering breath methane
compared to baseline in breath methane-positive IBS-C patients
- Improvement in clinical outcomes including stool frequency and
weekly abdominal pain
SYN-004 – Prevention of C. difficile infection (CDI),
antibiotic-associated diarrhea (AAD) and emergence of
antibiotic-resistant organisms:
- Expect to initiate Phase 3 clinical trial(s) (2H 2016)
- Continued enrollment in Phase 2b proof-of-concept clinical
trial
- Intended to evaluate the effectiveness of SYN-004 to prevent
CDI, C. difficile-associated diarrhea (CDAD) and AAD in
patients hospitalized with a lower respiratory tract infection and
receiving ceftriaxone for at least 5 days
- Anticipate enrolling approximately 370 patients at up to 75
global sites
- Anticipate an interim analysis of blinded data by an
independent monitor committee (1H 2016)
- Continued enrollment in second Phase 2a clinical trial
- Intended to evaluate the IV antibiotic-degrading effects and
safety of SYN-004 in the presence of the proton pump inhibitor
(PPI), esomeprazole, in healthy participants with functioning
ileostomies
- Anticipate reporting topline results (1H 2016)
- Reported positive topline data from first Phase 2a clinical
trial (4Q 2015)
- SYN-004 successfully degraded residual IV ceftriaxone in the
chyme of ten patients with functioning ileostomies without
affecting the intended level of IV ceftriaxone in the
bloodstream
Year Ended December 31, 2015
Financial Results
General and administrative expenses were $8.1 million for the year ended December 31, 2015, compared to $6.0 million for the same period in 2014. This
increase was primarily the result of increased employee costs,
audit fees related to additional procedures required under the
accelerated filer status, legal fees associated with SEC filings
and collaborative agreements, and stock-based compensation expense.
Non-cash charges related to stock-based compensation were
$2.1 million for the year ended
December 31, 2015, compared to
$1.6 million for the same period in
2014.
Research and development expenses increased to $32.9 million for the year ended December 31, 2015, from $14.5 million for the same period in 2014. This
increase of 127% was primarily the result of increased program
costs associated with expanded clinical development, manufacturing
and research activities within our microbiome-focused pipeline,
including the Company's Phase 2 C. difficile and IBS-C
clinical programs. In August 2015,
Synthetic Biologics entered into an Exclusive Channel Collaboration
(ECC) with Intrexon Corporation for the development of a treatment
for patients with phenylketonuria (PKU) and issued 937,500 shares
of common stock to Intrexon as payment of the technology access
fee, which resulted in a non-cash charge of $3.0 million. Research and development expenses
also included a $1.0 million non-cash
expense for achieving the third milestone set forth in the Prev ABR
LLC agreement with regard to the Company's C. difficile
program. Non-cash charges related to stock-based compensation were
$1.1 million for the year ended
December 31, 2015, compared to
$803,000 for the same period in
2014.
Other income was $3.8 million for
the year ended December 31, 2015,
compared to other income of $718,000
for the same period in 2014. Other expense for the year ended
December 31, 2015 was primarily due
to non-cash expense of $3.8 million
from the change in fair value of warrants. The increase in fair
value of the warrants was due to the increase in our stock price
from the year ended December 31,
2014.
Cash at December 31, 2015 was
$20.8 million compared to
$17.5 million at December 31, 2014.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, March 10, 2016, at
4:30 p.m. (EST). The dial-in
information for the call is as follows, U.S. toll free:
1-888-347-5280 or International: +1 412-902-4280. Participants are
asked to dial in 15 minutes before the start of the call to
register. The call will also be webcast over the Internet at
https://www.webcaster4.com/Webcast/Page/1096/13874. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/13874, for 60 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development are: (1) SYN-010 which is intended to reduce
the impact of methane producing organisms in the gut microbiome to
treat an underlying cause of irritable bowel syndrome with
constipation (IBS-C) and (2) SYN-004 which is designed to protect
the gut microbiome from the effects of certain commonly used
intravenous (IV) antibiotics for the prevention of C.
difficile infection and antibiotic-associated diarrhea (AAD).
In collaboration with Intrexon Corporation (NYSE: XON), the Company
is also developing preclinical stage monoclonal antibody therapies
for the prevention and treatment of Pertussis and discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 In
some cases forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions, and include statements
regarding the expected initiation of Phase 3 clinical trials for
SYN-010 and SYN-004 and the timing of the initiation, the
anticipated continued momentum in the clinic during 2016, the
reporting of progress in the two ongoing Phase 2 clinical trials
for SYN-004, the scheduling of an end of Phase 2 meeting with the
FDA regarding SYN-010, continued enrollment in Phase 2b
proof-of-concept clinical trial for SYN-010, anticipated enrollment
of 370 patients at up to 75 global sites, anticipated interim
analysis of blinded data by an independent monitor committee
in the first half of 2016, continued enrollment in the second Phase
2a clinical trial of SYN-004, anticipated reporting of topline
results from the Phase 2a clinical trial of SYN-004 in the first
half of 2016 and the potential benefits of SYN-004 and SYN-010.
These forward-looking statements are based management's,
expectations and assumptions as of the date of this press release
and are subject to a number of risks and uncertainties, many of
which are difficult to predict that could cause actual results to
differ materially from current expectations and assumptions from
those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ
materially from current expectations include, among others, a
failure to receive the necessary regulatory approvals for
commercialization of Synthetic Biologics' therapeutics, a failure
of Synthetic Biologics' clinical trials, and those conducted by
investigators, for SYN-004 and SYN-010 to be commenced or completed
on time or to achieve desired results and benefits, a failure of
Synthetic Biologics' clinical trials to continue enrollment as
expected or receive anticipated funding, a failure of Synthetic
Biologics to successfully develop, market or sell its products,
Synthetic Biologics' inability to maintain its material licensing
agreements, or a failure by Synthetic Biologics or its strategic
partners to successfully commercialize products and other factors
described in Synthetic Biologics' most recent Form 10-K and its
other filings with the SEC, including subsequent periodic reports
on Forms 10-Q and 8-K. The information in this release is provided
only as of the date of this release, and Synthetic Biologics
undertakes no obligation to update any forward-looking statements
contained in this release on account of new information, future
events, or otherwise, except as required by law.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Condensed
Consolidated Balance Sheets
|
|
December
31,
|
|
2015
|
|
2014
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
20,818
|
|
$
17,525
|
Prepaid
expenses and other current assets
|
9,519
|
|
1,548
|
Property
and equipment, net
|
494
|
|
65
|
Deposits
and other assets
|
14
|
|
6
|
Total
Assets
|
$
30,845
|
|
$
19,144
|
Liabilities and
Equity
|
|
|
|
Current
liabilities
|
$
15,575
|
|
$
9,588
|
Long-term deferred rent
|
267
|
|
-
|
Total
stockholders' equity
|
15,003
|
|
9,556
|
Total Liabilities
and Stockholders' Equity
|
$
30,845
|
|
$
19,144
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the years
ended
December 31,
|
|
2015
|
|
2014
|
Operating Costs
and Expenses
|
|
|
|
General
and administrative
|
$
8,074
|
|
$
6,013
|
Research
and development
|
32,906
|
|
14,489
|
Total Operating
Costs and Expenses
|
40,980
|
|
20,502
|
Loss from
Operations
|
(40,980)
|
|
(20,502)
|
Other Income
(Expense)
|
|
|
|
Change
in fair value of warrant liability
|
(3,811)
|
|
620
|
Interest
income
|
6
|
|
3
|
Other
income (expense)
|
-
|
|
95
|
Total Other Income
(Expense), net
|
(3,805)
|
|
718
|
Net
Loss
|
(44,785)
|
|
(19,784)
|
Net Loss
Attributable to Non-controlling Interest
|
(1,048)
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$ (43,737)
|
|
$
(19,784)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.54)
|
|
$
(0.32)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
80,705,692
|
|
61,945,356
|
i A Monthly Responder is defined as a patient
who has a Weekly Response in at least 50% of the weeks of treatment
during the month. A Weekly Responder is defined as a patient who
experiences a decrease in weekly average score for worst abdominal
pain in the past 24 hours of at least 30% compared with Study 1
Baseline and a stool frequency increase of 1 or more CSBM per week
compared with Study 1 Baseline.
Logo - http://photos.prnewswire.com/prnh/20160105/319502LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-2015-year-end-operational-highlights-and-financial-results-300234362.html
SOURCE Synthetic Biologics, Inc.