ROCKVILLE, Md., Nov. 1, 2016 /PRNewswire/ -- Synthetic Biologics,
Inc. (NYSE MKT: SYN), a late-stage clinical company developing
therapeutics focused on the gut microbiome, provided an operational
update and reported financial results for the three months ended
September 30, 2016.
![Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.) Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)](https://photos.prnewswire.com/prnvar/20160105/319502LOGO)
"Clinical progress for our two lead gut microbiome-focused drug
candidates represent critical milestones for the company as we
continue our evolution from an early-stage development company to a
late-stage clinical development company focused on
commercialization," said Jeffrey
Riley, President and Chief Executive Officer of Synthetic
Biologics. "During the third quarter, we completed enrollment in
our Phase 2b proof-of-concept clinical trial to evaluate the
ability of ribaxamase to protect the gut microbiome from the
effects of certain commonly used intravenous beta-lactam
antibiotics for the prevention of C. difficile infection
(CDI), antibiotic-associated diarrhea (AAD) and the emergence of
antibiotic-resistant organisms. We were also the only commercial
company pursuing drug development to receive a government contract
from the Centers for Disease Control and Prevention to investigate
antimicrobial resistance. This grant will support our clinical
research aimed at determining whether ribaxamase may prevent
antibiotic-mediated microbial resistance in the gut microbiomes of
participants in our Phase 2b study. We look forward to sharing
top-line results from this trial during the first quarter of
2017."
Mr. Riley continued, "SYN-010, our therapeutic designed to
reduce methane in the gut and treat the underlying cause of
irritable bowel syndrome with constipation (IBS-C), continues its
rapid clinical progress. We held a held an End of Phase 2 meeting
with the FDA to determine the optimal clinical pathway to advance
SYN-010 into pivotal trials. We continue to collaborate with the
FDA and are developing a protocol for our Phase 2b/3 adaptive
clinical study which we plan to initiate during the first quarter
of 2017."
Clinical Program Progress
SYN-004 (ribaxamase): Prevention of CDI, AAD and the
emergence of antibiotic-resistant organisms:
- Completed enrollment in global Phase 2b placebo-controlled,
proof-of-concept clinical trial intended to evaluate the ability of
ribaxamase to prevent CDI, C. difficile-associated diarrhea
(CDAD), AAD and the emergence of antibiotic-resistant organisms in
patients hospitalized with a lower respiratory tract infection and
receiving intravenous (IV) ceftriaxone
- Enrolled 413 patients across global clinical sites
- Anticipate announcing topline results from Phase 2b
proof-of-concept clinical trial (1Q 2017)
- Awarded government contract from the Centers for Disease
Control and Prevention to determine SYN-004's ability to prevent
the emergence of antibiotic-resistant organisms in the gut
microbiome of patients enrolled in the Company's Phase 2b
proof-of-concept clinical trial
SYN-010: Treatment of irritable bowel syndrome with
constipation (IBS-C) – SYN-010:
- Held End of Phase 2 meeting with FDA and received guidance for
clinical study design and requirements for Phase 3 development
- Submitted Phase 2b/3 adaptive study protocol and corresponding
statistical analysis plan to FDA for first pivotal clinical trial
(3Q 2016)
- Plan to initiate Phase 2b/3 pivotal clinical trial (1Q
2017)
Third Quarter 2016 Financial Results
General and administrative expenses increased to $2.1 million for the third quarter of 2016, from
$1.6 million for the third quarter of
2015. This increase is primarily the result of increased
stock-based compensation, investor relations expenses and employee
salaries and benefits costs offset by lower consulting and legal
expenses. The charge related to stock-based compensation expense
was $524,000 for the third quarter of
2016, compared to $387,000 for the
third quarter of 2015.
Research and development expenses decreased to $7.0 million for the third quarter of 2016, from
$10.0 million for the third quarter
of 2015. This decrease is primarily the result of charges related
to our Exclusive Channel Collaboration (ECC) agreement with
Intrexon that we entered into in August
2015. In 2015, we issued 937,500 shares of our common stock
to Intrexon as payment of the technology access fee that resulted
in a non-cash charge of $3.0 million
for the third quarter of 2015. Research and development expenses
also include a charge related to non-cash stock-based compensation
expense of $422,000 for the third
quarter of 2016, compared to $259,000
for the same period last year.
Other income was $0.7 million for
the third quarter of 2016, compared to other income of $4.1 million for the third quarter of 2015. Other
income for the third quarter of 2016 is due to non-cash income of
$0.7 million from the change in fair
value of warrants. The decrease in the fair value of the warrants
was due to the decrease in our stock price from the prior quarter.
Non-cash income related to the decrease of fair value of warrants
for the third quarter of 2015 was $4.1
million.
Cash and cash equivalents as of September
30, 2016 were $4.5
million.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, November 1, 2016, at
8:30 a.m. EDT. The dial-in
information for the call is as follows: U.S. toll free:
1-888-347-5280 and 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/1096/17818. An
archive of the call will be available for approximately 90 days at
the same URL https://www.webcaster4.com/Webcast/Page/1096/17818,
beginning approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics focused on the gut
microbiome. The Company's lead candidates poised for Phase 3
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 (ribaxamase) 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, antibiotic-associated diarrhea (AAD)
and the emergence of antibiotic-resistant organisms. 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 includes forward-looking statements on
Synthetic Biologics' current expectations and projections about
future events. 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. These statements
are based upon current beliefs, expectations and assumptions and
are subject to a number of risks and uncertainties, many of which
are difficult to predict and include statements regarding the
continued transition from an early-stage clinical development
company to a late-stage clinical development company, the continued
collaboration with FDA for SYN-010, the anticipated announcement of
topline results from Synthetic Biologics' ongoing Phase 2b
proof-of–concept clinical trial , timing and design of a planned
Phase 2b/3 pivotal clinical trial and the results to be achieved
from the products. 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, the ability of Synthetic
Biologics to successfully design protocols and statistical analysis
plans to support the execution of its trials, 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
|
|
|
September
30,
|
|
December
31,
|
|
2016
|
|
2015
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
4,549
|
|
$
20,818
|
Prepaid
expenses and other current assets
|
3,091
|
|
9,519
|
Property
and equipment, net
|
582
|
|
494
|
Deposits
and other assets
|
26
|
|
14
|
Total
Assets
|
$
8,248
|
|
$
30,845
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities
|
$
14,010
|
|
$
15,575
|
Long-term deferred rent
|
214
|
|
267
|
Total
stockholders' equity
|
(5,976)
|
|
15,003
|
Total Liabilities
and Stockholders' Equity
|
$
8,248
|
|
$
30,845
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
September 30,
|
|
For the nine
months ended
September 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
2,095
|
|
$
1,604
|
|
$
6,668
|
|
$
5,539
|
Research
and development
|
7,061
|
|
10,046
|
|
22,380
|
|
24,048
|
Total Operating
Costs and Expenses
|
9,156
|
|
11,650
|
|
29,048
|
|
29,587
|
Loss from
Operations
|
(9,156)
|
|
(11,650)
|
|
(29,048)
|
|
(29,587)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Change
in fair value of
warranty liability
|
666
|
|
4,141
|
|
3,681
|
|
(3,906)
|
Interest
income
|
1
|
|
2
|
|
36
|
|
5
|
Total Other Income
(Expense), net
|
667
|
|
4,143
|
|
3,717
|
|
(3,901)
|
Net
Loss
|
(8,489)
|
|
(7,507)
|
|
(25,331)
|
|
(33,488)
|
Net Loss
Attributable to
Non-controlling
Interest
|
(136)
|
|
(773)
|
|
(451)
|
|
(733)
|
Net Loss
Attributable to
Synthetic Biologics, Inc. and
Subsidiaries
|
$
(8,353)
|
|
$
(6,774)
|
|
$
(24,880)
|
|
$
(32,775)
|
Net Loss Per Share
- Basic
|
$
(0.09)
|
|
$
(0.08)
|
|
$
(0.27)
|
|
$
(0.42)
|
Net Loss Per Share
- Dilutive
|
$
(0.09)
|
|
$
(0.12)
|
|
$
(0.27)
|
|
$
(0.42)
|
Weighted average
number of
common shares outstanding -
Basic
|
91,441,687
|
|
85,974,751
|
|
91,095,990
|
|
77,300,375
|
Weighted average
number of
common shares outstanding -
Dilutive
|
91,441,687
|
|
87,585,103
|
|
91,095,990
|
|
77,300,375
|
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SOURCE Synthetic Biologics, Inc.