ROCKVILLE, Md., May 5, 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 three months ended March 31,
2016.
"Our momentum from 2015 carried into the first quarter of 2016,
as we continued to make important clinical progress in our
microbiome-focused programs. During the quarter, we announced
positive topline results from the second Phase 2 clinical trial of
SYN-010 in patients with IBS-C. We are scheduled to present
detailed data supporting previously reported positive topline data
from both SYN-010 Phase 2 clinical trials in a poster presentation
at DDW 2016 later this month. We also look forward to holding an
end of Phase 2 meeting with the FDA this summer to discuss
late-stage clinical trials of our SYN-010 program," said
Jeffrey Riley, President and Chief
Executive Officer of Synthetic Biologics. "With this sustained
progress, we are well positioned to initiate Phase 3 clinical
trials of SYN-010 during the second half of this year."
Mr. Riley continued, "We've also made important strides with our
program to prevent C. difficile infection and
antibiotic-associated diarrhea. Patient enrollment is complete in
the second Phase 2a clinical trial designed to evaluate the GI
antibiotic-degrading ability and the safety of SYN-004 in the
presence of a proton pump inhibitor. In addition, patient
recruitment in our Phase 2b proof-of-concept clinical trial for
SYN-004 has been strong as we have enrolled approximately 185
patients in this global clinical trial. We look forward to further
progress in our SYN-004 clinical trials and are expecting topline
results from the second Phase 2a clinical trial during the second
quarter of 2016 and an interim analysis of blinded data performed
by an independent data monitoring committee for the Phase 2b
clinical trial this summer."
Microbiome-Focused Clinical Program
Progress
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Plan to initiate Phase 3 clinical trial(s) (2H 2016)
- Intend to hold an end of Phase 2 meeting with FDA (Summer
2016)
- Mark Pimentel, MD, FRCP(C),
Director of the GI Motility Program and Laboratory at Cedars-Sinai,
scheduled to present detailed data supporting previously reported
positive topline data from two Phase 2 clinical trials in a poster
presentation at DDW 2016 (May 2016)
- Reported positive topline data from second Phase 2 clinical
trial – 8-week open-label treatment of all patients with SYN-010
(42 mg) (1Q 2016), including:
- A statistically significant decrease in methane production
(p=0.002) from the beginning of the first Phase 2 clinical trial to
the end of the second Phase 2 clinical trial, meeting the primary
endpoint
- 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 baseline of the first Phase 2
randomized clinical trial to the end of the second Phase 2
open-label clinical trial
- 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
- Received Type C meeting responses from FDA regarding late-stage
aspects of clinical pathway (2Q 2016)
SYN-004 – Prevention of C. difficile infection (CDI),
antibiotic-associated diarrhea (AAD) and emergence of
antibiotic-resistant organisms:
- Plan to initiate Phase 3 clinical trial(s) (1H 2017)
- Continued enrollment in Phase 2b proof-of-concept clinical
trial
- Intended to evaluate the ability of SYN-004 to prevent CDI,
C. difficile-associated diarrhea (CDAD) and AAD in patients
hospitalized with a lower respiratory tract infection and receiving
intravenous (IV) ceftriaxone
- A randomized, placebo-controlled clinical trial designed to
enroll up to ~370 patients at up to 75 global clinical sites
- Enrolled approximately 185 patients across global sites to
date
- Anticipate an interim analysis of blinded data performed by an
independent data monitoring committee (Summer 2016)
- Completed enrollment in second Phase 2a clinical trial
- Intended to evaluate the GI antibiotic-degrading ability 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 (2Q 2016)
Quarter Ended March 31, 2016
Financial Results
General and administrative expenses were $2.4 million for the three months ended
March 31, 2016, compared to
$1.7 million for the same period in
2015. This increase was primarily the result of increased employee
costs associated with the transition of the administrative and
financial office to Maryland
headquarters, and increased legal fees and stock-based compensation
expense. Non-cash charges related to stock-based compensation were
$643,000 for the three months ended
March 31, 2016, compared to
$582,000 for the same period in
2015.
Research and development expenses were $8.2 million for the three months ended
March 31, 2016, compared to
$6.5 million for the same period in
2015. This increase was primarily the result of increased Phase 2
program costs associated with expanded clinical development,
manufacturing and research activities within our microbiome-focused
pipeline. Non-cash charges related to stock-based compensation were
$409,000 for the three months ended
March 31, 2016, compared to
$246,000 for the same period in
2015.
Other expense was $497,000 for the
three months ended March 31, 2016,
compared to $4.2 million for the same
period in 2015. Other expense for the three months ended
March 31, 2016 was due to non-cash
expense of $498,000 from the change
in fair value of warrants. The increase in the fair value of the
warrants was due to the increase in the stock price from the year
ended December 31, 2015. Non-cash
expense related to fair value of warrants for the three months
ended March 31, 2015 was $4.2 million.
Cash and cash equivalents at March 31,
2016 were $15.1 million,
compared to $20.8 million at
December 31, 2015.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, May 5, 2016, at
4:30 p.m. (EDT). 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/1096/14380. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/14380, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead product
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) beta-lactam antibiotics for the
prevention of C. difficile infection (CDI) and
antibiotic-associated diarrhea (AAD). In collaboration with
Intrexon Corporation, the Company is also developing preclinical
stage monoclonal antibody therapies for the prevention and
treatment of pertussis and novel discovery stage biotherapeutics
for the treatment of phenylketonuria (PKU). For more information,
please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This press 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 reporting
of additional data supporting the previously reported positive
topline data from both Phase 2 clinical trials of SYN-010 at DDW,
the reporting of progress in the two ongoing Phase 2 clinical
trials for SYN-004, holding an end of Phase 2 meeting with the FDA
regarding SYN-010, continued enrollment in Phase 2b
proof-of-concept clinical trial for SYN-004 which is anticipated to
enroll up to 370 patients at up to 75 global sites, anticipated
interim analysis of blinded data form the Phase 2b trial this
summer by an independent data monitoring committee, anticipated
reporting of topline results from the second Phase 2a clinical
trial of SYN-004 in the second quarter of 2016 and the potential
benefits of SYN-004 and SYN-010. These forward-looking statements
are based on management's expectations and assumptions as of the
date of this press release and are subject to a number of
substantial risks and uncertainties, many of which are difficult to
predict and could cause actual results to differ materially and
adversely from current expectations and assumptions from
those set forth, projected 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 that was filed with the U.S. Securities and Exchange
Commission (SEC) on March 10, 2016,
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 revise or 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
|
|
March
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
15,100
|
|
$
20,818
|
Prepaid
expenses and other current assets
|
7,116
|
|
9,519
|
Property
and equipment, net
|
501
|
|
494
|
Deposits
and other assets
|
26
|
|
14
|
Total
Assets
|
$
22,743
|
|
$
30,845
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities
|
$
17,526
|
|
$
15,575
|
Long-term deferred rent
|
240
|
|
267
|
Total
stockholders' equity
|
4,977
|
|
15,003
|
Total Liabilities
and Stockholders' Equity
|
$
22,743
|
|
$
30,845
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the three
months ended
March 31,
|
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
2,426
|
|
$
1,713
|
Research
and development
|
|
8,155
|
|
6,494
|
Total Operating
Costs and Expenses
|
|
10,581
|
|
8,207
|
Loss from
Operations
|
|
(10,581)
|
|
(8,207)
|
Other Income
(Expense)
|
|
|
|
|
Change
in fair value of warrant liability
|
|
(498)
|
|
(4,152)
|
Interest income
|
|
1
|
|
1
|
Total Other
Expense, net
|
|
(497)
|
|
(4,151)
|
Net
Loss
|
|
(11,078)
|
|
(12,358)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(233)
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(10,845)
|
|
$
(12,358)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.12)
|
|
$
(0.17)
|
Weighted average
number of common shares outstanding during the period - Basic and
Dilutive
|
|
90,826,752
|
|
72,673,959
|
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.
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SOURCE Synthetic Biologics, Inc.