ROCKVILLE, Md., Nov. 1, 2017 /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 an operational
update and reported financial results for the three months ended
September 30, 2017.
"During the third quarter, we remained keenly focused on the
advancement of our two-lead microbiome-focused clinical programs,"
said Jeff Riley, President and Chief
Executive Officer of Synthetic Biologics. "Following the successful
completion of a Phase 2b proof-of-concept clinical study and the
announcement of Breakthrough Therapy Designation for SYN-004
(ribaxamase), we held an initial Type-B multidisciplinary meeting
with the U.S. Food and Drug Administration (FDA) to discuss the
overarching, high-level drug development plan and pathway towards
marketing approval for ribaxamase. We look forward to further
collaborative discussions with the FDA on the development of a
regulatory pathway forward for this novel approach to preventing
the onset of primary C. difficile infection and the
emergence of antimicrobial resistance."
Mr. Riley continued, "While continuing to focus on our clinical
development activities during the third quarter, we also
successfully strengthened our balance sheet with the announcement
of a privately placed $12 million
convertible preferred stock financing with an affiliate of MSD
Partners, L.P. We intend to build upon the momentum of the third
quarter and continue to seek to build value for our shareholders as
part our transition from an early-stage clinical development
company, to a late-stage company focused on the commercialization
of our two-promising microbiome-focused drug candidates."
Clinical Development & Operational Update
- Strengthened balance sheet with the closing of a $12 million privately placed convertible
preferred stock financing with an affiliate of MSD Partners, L.P.
in support of the continued late-stage advancement of our
microbiome-focused clinical programs (3Q 2017)
- Announced additional results from several exploratory endpoints
from SYN-004 (ribaxamase) Phase 2b proof-of-concept clinical trial
funded under a contract awarded to the Company from the Centers for
Disease Control and Prevention (CDC), demonstrating that SYN-004
(ribaxamase) prevented significant change to the presence of
certain AMR genes in the gut resistome of patients receiving
SYN-004 (ribaxamase) compared to placebo (3Q 2017)
- Expect to share additional results regarding several
exploratory endpoints from 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 (AMR) in the gut
microbiome (4Q 2017)
- Held a Type-B multidisciplinary meeting with the FDA to discuss
the high-level drug development plan and regulatory pathway towards
marketing approval for SYN-004 (ribaxamase) (3Q 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) (1Q 2018)
- Plan to initiate Phase 3 clinical trial(s) (2018)
- Continue 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)
Third Quarter 2017 Financial Results
General and administrative expenses decreased by 19% to
$1.7 million for the third quarter of
2017, from $2.1 million for the third
quarter of 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, along with a reduction of travel, registration fees
and legal expenses in 2017. The charge related to stock-based
compensation expense was $583,000 for
the third quarter of 2017, compared to $524,000 for the third quarter of 2016.
Research and development expenses decreased by 41% to
$4.1 million for the third quarter of
2017, from $7.1 million for the third
quarter of 2016. This decrease is primarily the result of lower
SYN-004 (ribaxamase) and SYN-010 program costs. In addition, there
were reductions in our other research and development activities,
offset by an increase in indirect costs for manufacturing and
medical affairs. Research and development expenses also include a
charge related to stock-based compensation expense of $317,000 for the third quarter of 2017, compared
to $422,000 for the third quarter of
2016.
Other expense was $5.1 million for
the third quarter of 2017, compared to other income of $0.7 million for the third quarter of 2016. Other
expense for the third quarter of 2017 is primarily comprised of
non-cash expense of $5.1 million from
the change in the fair value of warrants. The increase in the fair
value of the warrants was due to the increase in our stock price
from the prior quarter.
Cash and cash equivalents as of September
30, 2017 were approximately $21.1
million, an increase of $2.0
million from December 31,
2016.
Conference Call
Synthetic Biologics will hold a conference call today,
Wednesday, November 1, 2017, 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/1096/23123. An
archive of the conference call will be available for approximately
90 days at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/23123 beginning
approximately one hour after the call's conclusion.
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 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
expectation of further collaborative discussions with the
FDA on the development of a regulatory pathway forward for SYN-004
(ribaxamase), the intent to build upon the momentum of
Synthetic Biologics' third quarter and continue to build
value for shareholders, Synthetic Biologics'
plans to initiate Phase 3 clinical trial(s) in 2018 for SYN-004
(ribaxamase), the expectation of sharing additional results
regarding several exploratory endpoints from the SYN-004
Phase 2b proof-of-concept clinical trial, and the expectation of
continuing to solidify Synthetic Biologics'
clinical infrastructure to support successful advancement of
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, Synthetic Biologics'
product candidates demonstrating safety and effectiveness, as well
as results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to
complete them on time and achieve desired results and benefits,
Synthetic Biologics' clinical trials continuing enrollment as
expected, Synthetic Biologics' ability to obtain regulatory
approvals for commercialization of product candidates or to comply
with ongoing regulatory requirements, regulatory limitations
relating to Synthetic Biologics' ability to promote or
commercialize its product candidates for specific indications,
acceptance of its product candidates in the marketplace and the
successful development, marketing or sale of Synthetic Biologics'
products by competitors that render Synthetic Biologics' products
obsolete or non-competitive, Synthetic Biologics' ability to
maintain its license agreements, the continued maintenance and
growth of Synthetic Biologics' patent estate, Synthetic
Biologics becoming and remaining profitable, Synthetic
Biologics' ability to establish and maintain collaborations,
Synthetic Biologics' ability to obtain or maintain the capital
or grants necessary to fund its research and development
activities, a loss of any of Synthetic Biologics' key
scientists or management personnel, and other factors described in
Synthetic Biologics' Annual Report on Form 10-K for the year ended
December 31, 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,
|
|
2017
|
|
2016
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
21,050
|
|
$
19,055
|
Prepaid
expenses and other current assets
|
1,263
|
|
2,515
|
Property
and equipment, net
|
943
|
|
905
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
23,279
|
|
$
22,498
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
Total
liabilities
|
$
17,951
|
|
$
20,249
|
Series A
Convertible Preferred Stock
|
11,992
|
|
-
|
Synthetic Biologics, Inc. and subsidiaries equity
(deficit)
|
(6,664)
|
|
2,249
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
23,279
|
|
$
22,498
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
September 30,
|
|
For the nine
months ended
September 30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,705
|
|
$
2,095
|
|
$
5,440
|
|
$
6,668
|
Research
and development
|
4,137
|
|
7,061
|
|
15,028
|
|
22,380
|
Total Operating
Costs and Expenses
|
5,842
|
|
9,156
|
|
20,468
|
|
29,048
|
Loss from
Operations
|
(5,842)
|
|
(9,156)
|
|
(20,468)
|
|
(29,048)
|
Other Expense
(Income)
|
|
|
|
|
|
|
|
Change
in fair value of warrant
liability
|
(5,092)
|
|
666
|
|
2,157
|
|
3,681
|
Interest
income
|
4
|
|
1
|
|
7
|
|
36
|
Total Other
Expense (Income), net
|
(5,088)
|
|
667
|
|
2,164
|
|
3,717
|
Net
Loss
|
(10,930)
|
|
(8,489)
|
|
(18,304)
|
|
(25,331)
|
Net Loss
Attributable to Non-controlling Interest
|
(8)
|
|
(136)
|
|
(280)
|
|
(451)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(10,922)
|
|
$
(8,353)
|
|
$
(18,024)
|
|
$
(24,880)
|
Series A Preferred
Stock Dividends
|
(6,901)
|
|
-
|
|
(6,901)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
$
(17,823)
|
|
$
(8,353)
|
|
$
(24,925)
|
|
$
(24,880)
|
Net Loss Per Share
– Basic & Dilutive
|
$
(0.14)
|
|
$
(0.09)
|
|
$
(0.20)
|
|
$
(0.27)
|
Weighted average
number of common shares outstanding during the period – Basic &
Dilutive
|
128,279,674
|
|
91,441,687
|
|
122,950,397
|
|
91,095,990
|
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SOURCE Synthetic Biologics, Inc.