ROCKVILLE, Md., March 2, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company
developing therapeutics that preserve the microbiome to protect and
restore the health of patients, today provided a clinical programs
update and reported financial results for the year ended
December 31, 2016.
"2016 was a transformative and momentum-building year for
Synthetic Biologics," said Jeffrey
Riley, President and Chief Executive Officer. "In the past
12 months, we announced positive proof-of-concept clinical results
for our lead microbiome-focused programs representing significant
milestones for our company. Most recently, we announced positive
topline results from ribaxamase's global Phase 2b proof-of-concept
clinical trial which achieved its primary endpoint by demonstrating
a statistically significant reduction in the incidence of primary
C. difficile infection (CDI) compared to placebo,
positioning ribaxamase as a vanguard amongst microbiome-based
therapeutics pursuing clinical development for this indication in
Phase 2 trials or later. Data from this study also demonstrated
that ribaxamase significantly reduced the incidence of new
colonization by vancomycin-resistant enterococci (VRE) compared to
placebo, potentially expanding the utility of our compound as a
first line of defense against the development of antimicrobial
resistance (AMR) in the gut microbiome. We believe ribaxamase may
represent a disruptive yet simple approach to antibiotic therapy
that may directly lead to more effective and efficient use of
antibiotics."
Mr. Riley continued, "In 2017, we will look to build upon the
progress of the last year and are focused squarely on achieving the
important value-building milestones that lie ahead. Toward that
end, we expect to share additional results in the coming months
from several exploratory endpoints from our Phase 2b study focused
on ribaxamase's ability to prevent the emergence of antimicrobial
resistance in the gut microbiome. We will also be focused on
continuing the clinical advancement of SYN-010 for the treatment of
IBS-C, with our goal of initiating the Phase 2b/3 pivotal clinical
trial later this year."
Microbiome-Focused Clinical Program
Progress
SYN-004 – Prevention of C. difficile infection (CDI),
antibiotic-associated diarrhea (AAD) and emergence of antimicrobial
resistance (AMR):
- Awarded research contract from the Centers for Disease Control
and Prevention (CDC) to support research from Phase 2b clinical
trial to determine ribaxamase's ability to prevent the emergence of
antibiotic-mediated antimicrobial resistance (AMR) in the gut
microbiome (4Q 2016)
- Reported positive topline data from global Phase 2b
proof-of-concept randomized, double-blind, placebo controlled
clinical trial of 412 patients (1Q 2017)
- Achieved primary endpoint, demonstrating a statistically
significant relative risk reduction of 71.4% (p=0.045) in CDI rates
versus placebo
- Demonstrated a significant reduction in new colonization by
vancomycin-resistant enterococci (VRE) for patients receiving
ribaxamase versus placebo (p-value=0.0002)
- Demonstrated a positive trend (p-value=0.13) towards reducing
the incidence of antibiotic- associated diarrhea (AAD) from all
causes versus placebo
- Expect to share results from several exploratory endpoints
designed to evaluate ribaxamase's ability to protect the gut
microbiome from opportunistic bacteria and prevent the emergence of
antimicrobial resistance (AMR) in the gut microbiome (1H 2017)
- Anticipate requesting end of Phase 2 meeting with FDA (2H
2017)
- Expect to initiate Phase 3 clinical trial(s) (1H 2018)
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Confirmed key elements of Pivotal Phase 2b/3 clinical trial
pursuant to consultations with the FDA (1Q 2017)
- A 12-week, multi-center, double-blind, placebo-controlled,
adaptive design clinical trial
- A study population of approximately 840 adult subjects
diagnosed with IBS-C
- Evaluation of efficacy and safety of two dose strengths of
SYN-010 (21 mg and 42 mg) compared to placebo
- Conducted in approximately 150 clinical sites in North America
- Study subjects will be randomized in a 1:1:1 ratio, receiving
either 21 mg of SYN-010, 42 mg of SYN-010, or placebo
- Enrollment is open to all IBS-C patients; breath-methane will
be measured at baseline to ensure a comparable ratio of high-to-low
breath methane IBS-C patients in each treatment arm
- An interim futility analysis may be conducted when
approximately 50% of patients in each dosing arm have completed
treatment
- Plan to initiate first Phase 2b/3 adaptive pivotal clinical
trial (2017)
Operational Update
- Reinforced balance sheet with net proceeds of $23.3 million from November 2016 public offering to support the
continued clinical development of SYN-010, including initiation of
a planned Phase 2b/3 adaptive pivotal clinical trial
Year Ended December 31, 2016
Financial Results
General and administrative expenses were $10.1 million for the year ended December 31, 2016, compared to $8.1 million for the same period in 2015. This
increase is primarily the result of bank and legal fees related to
the November 2016 financing
associated with the warrant liability, increased employee costs,
costs associated with the transition of the administrative and
financial office to our Maryland
headquarters, and an increase in stock-based compensation. Non-cash
charges related to stock-based compensation were $2.4 million for the year ended December 31, 2016, compared to $2.1 million for the same period in 2015.
Research and development expenses decreased to $29.1 million for the year ended December 31, 2016, from $32.9 million for the same period in 2015. This
decrease is primarily the result of decreased program costs
associated with clinical development programs and research
activities within our pathogen-specific microbiome-focused
pipeline, including our IBS-C and Pertussis programs offset by an
increase in C. difficile program costs and an increase in
manufacturing costs. In 2015, we entered into an ECC with Intrexon
Corporation for the development of a treatment for patients with
PKU. Pursuant to the ECC, we issued 937,500 shares of our common
stock in August 2015 to Intrexon
Corporation as payment for the technology access fee that resulted
in a non-cash charge of $3.0 million.
Research and development expenses for 2015 also include a
$1.0 million non-cash expense for
achieving the third milestone as set forth in the Asset Purchase
Agreement with Prev ABR LLC, dated November
28, 2012. Prev ABR LLC exercised its option to receive the
milestone payment in shares of our common stock that were issued in
April 2015. Research and development
expenses also include a charge relating to non-cash stock-based
compensation expense of $1.6 million
for the year ended December 31, 2016,
compared to $1.1 million for the year
ended December 31, 2015.
Other income was $11.4 million for
the year ended December 31, 2016,
compared to other expense of $3.8
million for the same period in 2015. Other income for the
year ended December 31, 2016 is
primarily due to non-cash income of $11.4
million from the change in fair value of warrants. The
decrease in the fair value of warrants was due to the decrease in
our stock price from the year ended December
31, 2015.
Cash and cash equivalents on December 31,
2016 were $19.1 million, a
decrease of $1.8 million from
December 31, 2015.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, March 2, 2017, 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/1096/19873. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/19873, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics designed to preserve the
microbiome to protect and restore the health of patients. 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
(CDI), antibiotic-associated diarrhea (AAD) and the emergence of
antimicrobial resistance (AMR). 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 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 belief that ribaxamase may represent a
disruptive yet simple approach to antibiotic therapy that may
directly lead to more effective and efficient use of
antibiotics, the reporting of additional
results in the coming months from several exploratory endpoints
from our Phase 2b study focused on ribaxamase's ability to prevent
the emergence of antimicrobial resistance in the gut
microbiome, anticipated request of an end of Phase 2 meeting
with FDA for SYN-004 and the timing of the request, expected
initiation of Phase 3 clinical trials for SYN-004 and the
initiation of the first Phase 2b/3 adaptive pivotal
clinical trial for SYN-010 and the timing of the initiation,
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 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,
|
|
2016
|
|
2015
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
19,055
|
|
$
20,818
|
Prepaid
expenses and other current assets
|
2,515
|
|
9,519
|
Property
and equipment, net
|
905
|
|
494
|
Deposits
and other assets
|
23
|
|
14
|
Total
Assets
|
$
22,498
|
|
$
30,845
|
Liabilities and
Equity
|
|
|
|
Current
liabilities
|
$
19,757
|
|
$
15,575
|
Long-term deferred rent
|
492
|
|
267
|
Total
stockholders' equity
|
2,249
|
|
15,842
|
Total Liabilities
and Stockholders' Equity
|
$
22,498
|
|
$
30,845
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the years
ended
December 31,
|
|
|
2016
|
|
2015
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
10,143
|
|
$
8,074
|
Research
and development
|
|
29,109
|
|
32,906
|
Total Operating
Costs and Expenses
|
|
39,252
|
|
40,980
|
Loss from
Operations
|
|
(39,252)
|
|
(40,980)
|
Other Income
(Expense)
|
|
|
|
|
Change
in fair value of warrant liability
|
|
11,412
|
|
(3,811)
|
Interest
income
|
|
37
|
|
6
|
Other
income (expense)
|
|
-
|
|
-
|
Total Other Income
(Expense), net
|
|
11,449
|
|
(3,805)
|
Net
Loss
|
|
(27,803)
|
|
(44,785)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(548)
|
|
(1,048)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(27,255)
|
|
$
(43,737)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.29)
|
|
$
(0.54)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
|
94,290,436
|
|
80,705,692
|
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SOURCE Synthetic Biologics, Inc.