ROCKVILLE, Md., Aug. 3, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases, today provided an operational
update and reported financial results for the three months ended
June 30, 2016.
"In the second quarter we continued the transition from an
early-stage clinical development company to a late-stage clinical
development company focused on the commercialization of our two
lead GI microbiome-focused drug candidates," said Jeffrey Riley, Chief Executive Officer. "We held
an End of Phase 2 meeting with FDA and received guidance for
advancement to a pivotal clinical trial for SYN-010, designed to
treat an underlying cause of the symptoms associated with irritable
bowel syndrome with constipation (IBS-C)." Mr. Riley continued,
"The approval of the generic name 'ribaxamase' for SYN-004, the
announcement of positive clinical outcomes from a second Phase 2a
clinical trial and robust enrollment in our global Phase 2b
proof-of-concept clinical trial continued to fuel momentum for our
program designed to protect the gut microbiome and prevent C.
difficile infection (CDI), antibiotic-associated diarrhea (AAD)
and the emergence of antibiotic resistant organisms. To date, we
have enrolled 374 patients and anticipate announcing topline
results from our ongoing Phase 2b clinical trial for SYN-004 in
early 2017."
Microbiome-Focused Clinical Program Progress
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Held End of Phase 2 meeting with FDA and received guidance for
clinical study design and requirements for Phase 3 development
- Plan to initiate Phase 2b/3 pivotal clinical trial (1Q
2017)
- Presented detailed data during Digestive Disease Week® 2016
supporting previously reported positive outcomes from two Phase 2
clinical trials of SYN-010, including:
- Data demonstrating an inverse correlation between breath
methane Area Under Curve (AUC) and complete spontaneous bowel
movements (CSBMs) in study participants diagnosed with IBS-C
- Data demonstrating clear improvements in abdominal pain,
bloating and quality of life measures (IBS-SSS) in study
participants who were administered SYN-010
- Announced results from a separate randomized, open-label
Pharmacokinetic (PK) study demonstrating SYN-010 avoided desired
drug release in the stomach and delivered the antimethanogenic
lovastatin lactone into the lower small intestine and colon while
reducing systemic exposure to the cholesterol-lowering lovastatin
beta-hydroxyacid metabolite
SYN-004 (ribaxamase) - Prevention of CDI, AAD and the
emergence of antibiotic-resistant organisms:
- Received approval from United States Adopted Names Council
(USAN) for the generic name "ribaxamase" for SYN-004
- Continued enrollment in global Phase 2b proof-of-concept
clinical trial intended to evaluate the ability of ribaxamase to
prevent CDI, C. difficile-associated diarrhea (CDAD) and AAD in
patients hospitalized with a lower respiratory tract infection and
receiving intravenous (IV) ceftriaxone
- Enrolled 374 patients to date across global clinical sites;
enrollment expected through 3Q 2016
- Anticipate announcing topline results from Phase 2b
proof-of-concept clinical trial (1Q 2017)
- Announced positive results from second Phase 2a clinical trial
demonstrating a correlation of the 150 mg dose of ribaxamase, both
alone and in the presence of the proton pump inhibitor,
esomeprazole and the successful degradation of IV ceftriaxone to
levels that were near or below detectable without impacting
ceftriaxone plasma concentrations
- The 150 mg dose strength of ribaxamase was well tolerated by
all participants
Operational Update – Expanded Leadership Team
- Deb Mathews, PharmD, joined the
Company as Vice President, Medical Affairs, bringing broad
experience and strong leadership of clinical and medical affairs as
the Company begins to implement commercialization strategies
- Isaac J. Bright, MD, joined the
Company in the newly created position of Vice President, Corporate
Development, to lead all strategic corporate and business
development efforts for the Company's two lead microbiome-focused
drug candidates
Second Quarter 2016 Financial Results
General and administrative expenses decreased by 3% to
$2.1 million for the second quarter
of 2016, from $2.2 million for the
second quarter of 2015. This decrease is primarily the result
of lower legal fees offset by an increase in stock-based
compensation and increased employee costs associated with the
transition of the administrative and financial office to our
Maryland headquarters. The charge
related to stock-based compensation expense was $507,000 for the second quarter of 2016, compared
to $335,000 for the second quarter of
2015.
Research and development expenses decreased by 5% to
$7.2 million for the second quarter
of 2016, from $7.5 million for the
second quarter of 2015. This decrease is primarily the result of
decreased Phase 2 program costs associated with clinical
development programs, manufacturing and research activities within
our microbiome-focused pipeline. Research and development expenses
also include a charge related to non-cash stock-based compensation
expense of $400,000 for the second
quarter of 2016, compared to $252,000
for the second quarter of 2015.
Other income was $3.5 million for
the second quarter of 2016, compared to other expense of
$3.9 million for the second quarter
of 2015. Other income for the second quarter of 2016 is due to
non-cash expense of $3.5 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 year ended December 31,
2015. Non-cash expense related to the increase of fair value
of warrants for the second quarter of 2015 was $3.9 million.
Conference Call
Synthetic Biologics will hold a conference call today,
Wednesday, August 3, 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 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/1096/16339. An
archive of the conference call will be available for approximately
90 days at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/16339, beginning
approximately one hour after the call's conclusion.
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 (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
momentum for Synthetic Biologics' program designed to protect the
gut microbiome and prevent CDI, AAD and the emergence of antibiotic
resistant organisms, the anticipated announcement of topline
results from Synthetic Biologics ongoing Phase 2b proof-of–concept
clinical trial of ribaxamase, 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
|
|
|
June
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
|
Cash and
cash equivalents
|
|
$
10,049
|
|
$
20,818
|
Prepaid
expenses and other current assets
|
|
5,774
|
|
9,519
|
Property
and equipment, net
|
|
482
|
|
494
|
Deposits
and other assets
|
|
26
|
|
14
|
Total
Assets
|
|
$
16,331
|
|
$
30,845
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
Current
liabilities
|
|
$
15,173
|
|
$
15,575
|
Synthetic Biologics,
Inc. and subsidiaries equity (deficit)
|
|
2,294
|
|
16,051
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
|
$
16,331
|
|
$
30,845
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
For the three
months ended
June 30,
|
|
For the six months
ended
June 30,
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$
2,147
|
|
$
2,222
|
|
$
4,573
|
|
$
3,935
|
Research
and development
|
|
7,164
|
|
7,508
|
|
15,319
|
|
14,002
|
Total Operating
Costs and Expenses
|
|
9,311
|
|
9,730
|
|
19,892
|
|
17,937
|
Loss from
Operations
|
|
(9,311)
|
|
(9,730)
|
|
(19,892)
|
|
(17,937)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
|
Change
in fair value of warrant
liability
|
|
3,513
|
|
(3,895)
|
|
3,015
|
|
(8,047)
|
Interest
income
|
|
34
|
|
2
|
|
35
|
|
3
|
Total Other Income
(Expense), net
|
|
3,547
|
|
(3,893)
|
|
3,050
|
|
(8,044)
|
Net
Loss
|
|
(5,764)
|
|
(13,623)
|
|
(16,842)
|
|
(25,981)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(82)
|
|
-
|
|
(315)
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(5,682)
|
|
$
(13,623)
|
|
$
(16,527)
|
|
$
(25,981)
|
Net Loss Per Share
- Basic
|
|
$
(0.06)
|
|
$
(0.19)
|
|
$
(0.18)
|
|
$
(0.36)
|
Net Loss Per Share
- Dilutive
|
|
$
(0.10)
|
|
$
(0.19)
|
|
$
(0.21)
|
|
$
(0.36)
|
Weighted average
number of common shares outstanding - Basic
|
|
91,015,733
|
|
72,736,829
|
|
90,921,243
|
|
72,674,650
|
Weighted average
number of common shares outstanding - Dilutive
|
|
93,930,540
|
|
72,736,829
|
|
92,651,215
|
|
72,674,650
|
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-second-quarter-2016-operational-highlights-and-financial-results-300308721.html
SOURCE Synthetic Biologics, Inc.