ROCKVILLE, Md., Feb. 22, 2018 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: 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, 2017.
"In 2017, Synthetic Biologics achieved several important
milestones in the advancement of our late-stage pipeline of
best-in-class microbiome product candidates targeting the
prevention and treatment of life-threatening bacterial infections
and gut microbiome disorders. We are excited by the potential
of our clinical programs to improve patient outcomes and quality of
life and are working closely with the FDA to develop a path forward
for SYN-004 (ribaxamase), targeting an end of Phase 2 meeting with
the FDA during the second half of 2018," said Steven Shallcross, Interim Chief Executive
Officer and Chief Financial Officer. "We believe SYN-004, when
co-administered with certain intravenous beta-lactam antibiotics
may help prevent the onset of primary Clostridium difficile
infection (CDI), overgrowth of pathogenic organisms and the
emergence of antimicrobial resistance (AMR), thereby making current
antibiotic therapy more effective, and preventing life-threatening
infections which may result from antibiotic-mediated dysbiosis," he
added.
"In 2018, our priorities are to establish the optimal clinical
protocol for SYN-004's Phase 3 study design, in collaboration with
the FDA, and to continue to aggressively evaluate potential
strategic relationships to speed the advancement and maximize the
potential for success for our late-stage product candidates,
including both SYN-004 and SYN-010 for the treatment of IBS-C,"
concluded Shallcross.
Clinical Development and Operational Update
- Presented additional supportive results regarding several
exploratory endpoints from a Phase 2b
proof-of-concept clinical trial designed to evaluate SYN-004's
(ribaxamase) ability to protect the gut microbiome from
opportunistic bacterial infections and prevent the emergence of
antimicrobial resistance in the gut microbiome in 4Q 2017
- Plan to continue collaborative discussions with the FDA to
solidify details and components of the drug development plan and
regulatory pathway towards marketing approval for SYN-004
(ribaxamase) in the 1H 2018
-
- Anticipate End of Phase 2 meeting with FDA in the 2H 2018
- Plan to initiate Phase 3 clinical trial(s) in 2019
- Continue efforts to solidify clinical infrastructure to support
successful advancement of SYN-010, designed to treat an underlying
cause of the symptoms associated with irritable bowel syndrome with
constipation (IBS-C)
Year Ended December 31, 2017
Financial Results
General and administrative expenses decreased to $7.5 million for the year ended December 31, 2017, compared to $10.1 million for the year ended December 31, 2016. This decrease is primarily the
result of higher salary expense and related benefits costs incurred
in 2016 in connection with the transition of the administrative and
financial office to our Maryland
headquarters, and higher investor relations, consulting and legal
costs in 2016 related to our 2016 equity financing. The charge
relating to stock-based compensation expense was $2.0 million for the year ended December 31, 2017, compared to $2.4 million for the year ended December 31, 2016.
Research and development expenses decreased to $18.8 million for the year ended December 31, 2017, from $29.1 million for the year ended December 31, 2016. This decrease is primarily the
result of lower SYN-004 (ribaxamase) and SYN-010 program costs for
2017 as we plan for future Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs and seek to
secure the financial resources necessary for the completion of
these clinical trials. In addition, there were reductions in our
other research and development activities, offset by an increase in
indirect costs for medical affairs and manufacturing scale up
activities for SYN-004 (ribaxamase). Research and development
expenses also include a charge relating to non-cash stock-based
compensation expense of $1.4 million
for the year ended December 31, 2017,
compared to $1.6 million for the year
ended December 31, 2016.
Other income was $10.8 million for
the year ended December 31, 2017,
compared to other income of $11.4
million for the year ended December
31, 2016. Other income for the year ended December 31, 2017 is primarily due to non-cash
income of $10.7 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
December 31, 2016.
Cash and cash equivalents on December 31,
2017 were $17.1 million, a
decrease of $2.0 million from
December 31, 2016.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, February 22, 2018, at
8:30 a.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/1096/24584. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/24584, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a late-stage
clinical company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development are: (1)
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), overgrowth of pathogenic organisms
and the emergence of antimicrobial resistance (AMR), and (2)
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). The Company's
preclinical pursuits include an oral formulation of the enzyme
intestinal alkaline phosphatase (IAP) to treat both local GI and
systemic diseases as well as 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 potential of our clinical programs to improve
patient outcomes and quality of life, our belief that SYN-004, when
co-administered with certain intravenous beta-lactam antibiotics
may help prevent the onset of primary Clostridium difficile
infection (CDI), overgrowth of pathogenic organisms and the
emergence of antimicrobial resistance (AMR), thereby making current
antibiotic therapy more effective, and preventing life-threatening
infections which may result from antibiotic-mediated dysbiosis,
our potential for strategic relationships that maximize the
potential for success for our advanced product candidates, our plan
to continue collaborative discussions with the FDA to
solidify details and components of the drug development plan and
regulatory pathway towards marketing approval for SYN-004 in the 1H
2018, the anticipated end of Phase 2 meeting with FDA
in 2H 2018, our plan to initiate Phase 3 clinical trials(s) in 2019
and our continued solidification of our clinical structure to
support successful advancement of SYN-010 , 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)
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
December
31,
|
|
2017
|
|
2016
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
17,116
|
|
$
19,055
|
Prepaid
expenses and other current assets
|
827
|
|
2,515
|
Property
and equipment, net
|
872
|
|
905
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
18,838
|
|
$
22,498
|
Liabilities and
Stockholder's (Deficit) Equity
|
|
|
|
Total
liabilities
|
$
10,195
|
|
$
20,249
|
Series A
Convertible Preferred Stock
|
12,053
|
|
-
|
Synthetic Biologics, Inc. and subsidiaries (deficit)
equity
|
(3,410)
|
|
2,249
|
Total Liabilities
and Stockholders' (Deficit) Equity
|
$
18,838
|
|
$
22,498
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the years
ended
December 31,
|
|
|
2017
|
|
2016
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
7,467
|
|
$
10,143
|
Research
and development
|
|
18,784
|
|
29,109
|
Total Operating
Costs and Expenses
|
|
26,251
|
|
39,252
|
Loss from
Operations
|
|
(26,251)
|
|
(39,252)
|
Other
Income
|
|
|
|
|
Change
in fair value of warrant liability
|
|
10,738
|
|
11,412
|
Interest
income
|
|
21
|
|
37
|
Total Other
Income
|
|
10,759
|
|
11,449
|
Net
Loss
|
|
(15,492)
|
|
(27,803)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(318)
|
|
(548)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
|
$
(15,174)
|
|
$
(27,255)
|
Series A Preferred
Stock Dividends
|
|
(6,962)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
|
(22,136)
|
|
(27,255)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.18)
|
|
$
(0.29)
|
Weighted average
number of common shares outstanding - Basic
and Dilutive
|
|
124,366,059
|
|
94,290,436
|
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SOURCE Synthetic Biologics, Inc.