ROCKVILLE, Md., Aug. 10, 2015 /PRNewswire/ --
- Achieved Planned Milestones for Company's Lead
Microbiome Drug Candidates
- Enhanced Senior Management Team to Maximize Strategic
Opportunities
- Strengthens Balance Sheet to Support Microbiome Clinical
Trials
- Conference Call Today, August 10,
2015, at 8:30 a.m.
EDT
Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage
company focused on developing therapeutics to protect the
microbiome while targeting pathogen-specific diseases, reported
financial results for the three and six months ended June 30, 2015, and provided an operational
update.
"We continue to successfully execute against our planned
milestones and are encouraged by the progress of our two lead
microbiome drug candidates," said Jeffrey
Riley, Chief Executive Officer. "We initiated Phase 2a
clinical trials for SYN-004, which is designed to protect the gut
microbiome from the effects of certain commonly used intravenous
(IV) antibiotics for the prevention of C. difficile
infection and antibiotic-associated diarrhea (AAD). We also
initiated a Phase 2 clinical trial for SYN-010 to evaluate the
efficacy in reducing the production of methane in the gut which is
perceived as the underlying cause of pain, bloating and
constipation associated with irritable bowel syndrome
and constipation (IBS-C)."
Mr. Riley added, "This continued progress combined with investor
interest related to the microbiome enabled us to strengthen our
balance sheet with net proceeds of $42.6
million in a successful July public offering. Our increased
cash position provides resources to support our lead microbiome
drug candidates' continued progress in the clinic. And, with the
recent additions of industry veterans with proven track records to
our management team, we are better positioned to develop
operational and commercial strategies as we navigate through
clinical trials. Looking ahead, we feel confident that we will
achieve our milestones and look forward to reporting important
microbiome program developments including, topline data from the
two SYN-004 Phase 2a trials and topline data from the first SYN-010
Phase 2 trial. Accomplishing each of these milestones would
position us to create value for our shareholders while we work to
address significant unmet medical needs with our novel microbiome
drug candidates."
Clinical Program Progress
Prevention of C. difficile infection and AAD –
SYN-004:
- Dosed first participant in second Phase 2a clinical trial to
evaluate the GI antibiotic-degrading effects and safety of SYN-004
in the presence of the proton pump inhibitor (PPI),
esomeprazole
- Reported data from first four of 12 expected participants in
first Phase 2a open-label clinical trial; data showed that SYN-004
degraded IV ceftriaxone in the chyme of the four healthy
participants with functioning ileostomies without affecting
ceftriaxone in the bloodstream
- Expect topline data from first Phase 2a clinical trial (3Q
2015)
- Plan to initiate a Phase 2b proof-of-concept clinical trial (3Q
2015); anticipate enrolling approximately 370 patients at up to 75
global sites; anticipate interim analysis of blinded data (2H
2015)
- Expect topline data from second Phase 2a clinical trial (2H
2015)
IBS-C – SYN-010:
- Initiated first Phase 2 clinical trial to evaluate change from
baseline in breath methane, as determined by a lactulose breath
test, in methane-positive patients with IBS-C after seven days of
treatment with one of two formulations of SYN-010 compared with
placebo
- Expect topline data from first Phase 2 clinical trial (2H
2015)
- Plan to initiate second Phase 2 clinical trial (2H 2015);
expect topline data (1H 2016)
TrimestaTM, an oral estriol drug for the treatment
of relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS:
- Amended license and clinical trial agreements with University of California, Los Angeles (UCLA) in July
2015
- Informed by UCLA that MRI analyses
are ongoing to evaluate changes in the brain that correlate with
improvements seen in clinical outcomes
- Expect to report topline MRI data 30 days following receipt of
this data from UCLA
- A separate UCLA-led, multi-center
U.S. Phase 2 trial is underway focused exclusively on cognition
utilizing Trimesta with a variety of currently marketed MS
drugs
Pertussis (whooping cough) – SYN-005:
- Seeking non-dilutive funding to support preclinical and
clinical development (ongoing)
Operational Update – Expanded Leadership Team
- Steven A. Shallcross named Chief
Financial Officer, Treasurer and Secretary, bringing operational,
financial and international biotech industry experience, as well as
an established track record of leading the financial development
and strategy for several publicly traded biotech companies
- Klaus Gottlieb, MD, FACG, joined
the Company as Vice President, Clinical & Regulatory Affairs,
bringing his knowledge of clinical pathways to commercialize
products for the treatment of GI diseases
- Maureen Early joined the team in
a newly created position of Vice President, Commercial, to lead all
commercial and marketing efforts
Three and Six Months Ended June 30,
2015 Financial Results
General and administrative expenses increased to $2.2 million and $3.9
million for the three and six months ended June 30, 2015, respectively, compared to
$1.8 million and $2.9 million for the same periods in 2014. The
increase of approximately 22% for the three months ended
June 30, 2015 is primarily the result
of increased employee costs and legal fees, offset by a decrease in
stock-based compensation expense. The increase of approximately 34%
for the six months ended June 30,
2015 is primarily the result of increased employee costs,
legal fees and audit fees related to the additional procedures
required under the accelerated filer status. Non-cash charges
related to stock-based compensation were $335,000 and $915,000 for the three and six months ended
June 30, 2015, respectively, compared
to $645,000 and $899,000 for the same periods in 2014.
Research and development expenses increased to $7.5 million and $14.0
million for the three and six months ended June 30, 2015, respectively, compared to
$2.8 million and $5.6 million for the same periods in 2014. The
increases of approximately 165% and 152% for the three and six
months ended June 30, 2015,
respectively, are primarily the result of increased program costs
associated with expanded clinical development, manufacturing and
research activities for our microbiome-focused pipeline, including
the Company's C. difficile and IBS-C programs. For the six
months ended June 30, 2015, research
and development expenses also include a $1.0
million expense for achieving the third milestone as set
forth in the Asset Purchase Agreement with Prev ABR LLC, dated
November 28, 2012, related to the
C. difficile program. Prev ABR LLC exercised its option to
receive the milestone payments in shares of Synthetic Biologics'
common stock that were issued in April
2015. Non-cash charges related to stock-based compensation
were $252,000 and $498,000 for the three and six months ended
June 30, 2015, respectively, compared
to $210,000 and $318,000 for the same periods in 2014.
Other expense was $3.9 million and
$8.0 million for the three and six
months ended June 30, 2015,
respectively, compared to other income of $95,000 and $96,000
for the same periods in 2014. Other expense for the three and six
months ended June 30, 2015 was
primarily the result of a non-cash charge of $3.9 million and $8.0
million, respectively, related to the change in fair value
of warrants due to the increase in the stock price from the
previous quarter. There was no non-cash income or expense relating
to fair value warrants for the three and six months ended
June 30, 2014.
Cash and cash equivalents at June 30,
2015 was $4.8 million.
Subsequent to the end of the second quarter, a public offering was
completed for net proceeds of approximately $42.6 million. The strengthened balance sheet
provides the Company with the resources to fund its clinical
development programs.
Conference Call
Synthetic Biologics will hold a conference call today,
Monday, August 10, 2015, 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/1096/9809. An
archive of the call will be available for approximately 90 days at
the same URL, https://www.webcaster4.com/Webcast/Page/1096/9809,
beginning approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a
microbiome-focused, clinical-stage company developing therapeutics
to protect the microbiome while targeting pathogen-specific
diseases. The Company's lead candidates in Phase 2 development
include SYN-004 which is designed to protect the gut microbiome
from the effects of certain commonly used intravenous (IV)
antibiotics for the prevention of C. difficile infection and
antibiotic-associated diarrhea (AAD), and SYN-010 which is intended
to reduce the impact of methane producing organisms in the gut
microbiome to treat the underlying cause of irritable bowel
syndrome with constipation (IBS-C). In addition, the Company is
developing a Phase 2 oral estriol drug for the treatment of
relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS, and a monoclonal antibody combination for the
treatment of Pertussis. For more information, please visit
Synthetic Biologics' website at www.syntheticbiologics.com.
This 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 timing of planned
Phase 2 clinical trials and expected date of data from clinical
trials, continued successful execution against planned milestones,
expected achievement of milestones and impact of achievement of
milestones. Important factors that could cause actual results to
differ materially from those reflected in Synthetic Biologics'
forward-looking statements 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,
to be commenced or completed on time or to achieve desired results,
a failure of Synthetic Biologics' clinical trials to receive
anticipated funding, a failure of Synthetic Biologics' products for
the prevention and treatment of diseases to be successfully
developed or commercialized, Synthetic Biologics' inability to
maintain its licensing agreements, a failure to successfully
integrate new management and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2014 and any other filings with the
SEC. 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
|
|
|
June
30,
|
|
December
31,
|
|
2015
|
|
2014
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
4,757
|
|
$
17,525
|
Prepaid
expenses and other current assets
|
6,955
|
|
1,548
|
Property
and equipment, net
|
107
|
|
65
|
Deposits
and other assets
|
18
|
|
6
|
Total
Assets
|
$
11,837
|
|
$
19,144
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
Current
liabilities
|
$
25,498
|
|
$
9,588
|
Synthetic Biologics, Inc. and subsidiaries equity
(deficit)
|
(13,661)
|
|
9,556
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
11,837
|
|
$
19,144
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
June 30,
|
|
For the six months
ended
June 30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
2,222
|
|
$
1,814
|
|
$
3,935
|
|
$
2,936
|
Research
and development
|
7,508
|
|
2,837
|
|
14,002
|
|
5,554
|
Total Operating
Costs and Expenses
|
9,730
|
|
4,651
|
|
17,937
|
|
8,490
|
Loss from
Operations
|
(9,730)
|
|
(4,651)
|
|
(17,937)
|
|
(8,490)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Change
in fair value of warrant
liability
|
(3,895)
|
|
-
|
|
(8,047)
|
|
-
|
Interest
income
|
2
|
|
-
|
|
3
|
|
1
|
Other
income (expense)
|
-
|
|
95
|
|
-
|
|
95
|
Total Other Income
(Expense), net
|
(3,893)
|
|
95
|
|
(8,044)
|
|
96
|
Net
Loss
|
(13,623)
|
|
(4,556)
|
|
(25,981)
|
|
(8,394)
|
Net Loss
Attributable to Non-controlling Interest
|
-
|
|
-
|
|
-
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(13,623)
|
|
$
(4,556)
|
|
$
(25,981)
|
|
$
(8,394)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.19)
|
|
$
(0.08)
|
|
$
(0.36)
|
|
$
(0.14)
|
Net Loss Per Share
Attributable to Synthetic Biologics,
Inc. and
Subsidiaries
|
$
(0.19)
|
|
$
(0.08)
|
|
$
(0.36)
|
|
$
(0.14)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
73,736,829
|
|
58,453,528
|
|
72,674,650
|
|
58,348,153
|
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SOURCE Synthetic Biologics, Inc.