ROCKVILLE, Md., Nov. 14, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific
therapies for serious infections and diseases, with a focus on
protecting the microbiome, today reported financial results for the
three and nine months ended September 30,
2014, and provided an operational update.
"We've made meaningful progress with each of the programs in our
pipeline, and we look forward to reporting the achievement of
several milestones in the next six months, including the C.
difficile and C-IBS programs entering the clinic and the MS
program completing ongoing MRI brain scan analyses," said
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "With the completion of a capital
raise of $18.9 million in net
proceeds with select institutional investors, we strengthened our
cash position and added a new biotech investor to our strong
existing shareholder base. All of these efforts strengthen
Synthetic Biologics' position for future growth and success, which
we believe significantly increases value for our shareholders."
Clinical Programs Update
Prevention of C. difficile (C. diff) Infections –
SYN-004 Oral Beta-Lactamase Enzyme
- Clinical drug manufacturing under cGMP guidelines commenced in
the third quarter with a vastly improved process utilized by
supplier Evonik.
- Preclinical data further validating the SYN-004 approach were
presented at two scientific forums – IDWeek and the 54th
Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC).
- U.S. Notice of Allowance for the first composition of matter
patent directly related to SYN-004's unique properties was
issued.
- Phase 1a and 1b clinical studies remain on track to initiate
within the next 30 days.
- Topline data from Phase 1 studies expected before year-end
2014.
Relapsing-Remitting Multiple Sclerosis (RRMS) – Trimesta™
(oral estriol)
- Expanded efficacy and safety results from the
investigator-initiated Phase 2 trial evaluating adjunctive Trimesta
in women with RRMS including positive results on cognitive and
disability scores at 12 months, attesting to Trimesta's unique
neuroprotective properties, were presented at the ACTRIMS-ECTRIMS
meeting in Boston in September by
the trial's lead investigator.
- A separate Phase 2 trial focused exclusively on cognition
utilizing Trimesta with a variety of currently marketed MS drugs,
including Copaxone®, Avonex®, Betaseron®, Extavia®, Rebif®,
Gilenya®, Aubagio® and Tecfidera®, is enrolling patients at four
sites in the United States.
- Active discussions with a number of potential strategic
partners may accelerate development of this innovative therapy for
relapsing-remitting MS in women.
- MRI brain scan analyses are ongoing to evaluate changes in the
brain that correlate with improvements seen in clinical outcomes;
topline data expected during the first quarter of 2015.
Constipation-Predominant Irritable Bowel Syndrome (C-IBS) –
SYN-010 Statin-Class Oral Compound
- Strengthened Clinical Advisory Board (CAB) to support the
development of SYN-010; CAB is comprised of prominent
gastrointestinal (GI) key opinion leaders: Mark Pimentel, M.D., (Chair), William Chey, M.D., Gail
M. Comer, M.D., Anthony J.
Lembo, M.D., and Philip
Schoenfeld, M.D., MSEd, MSc.
- In September, announced the SYN-010 statin-class formulation at
an IBS Investor Day in New York.
Keynote speaker, Dr. Pimentel, provided an overview of the clinical
development strategy for clinical candidate SYN-010.
- Anticipating a 505(b)(2) regulatory pathway for SYN-010, a
corporate Investigational New Drug (IND) application is expected to
be filed with the FDA in the first quarter of 2015 with the
initiation of a Phase 2 clinical trial of SYN-010 in C-IBS
anticipated in the first half of 2015.
Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody
(mAb) Combination
- SYN-005 was granted U.S. Orphan Drug Designation by the FDA for
the treatment of Pertussis.
- Increased awareness of SYN-005's novel mAbs combination
designed to target and neutralize pertussis toxin were the topic of
an oral presentation at ICAAC. Neutralizing pertussis toxin is
anticipated to decrease morbidity and mortality in critically ill
infants.
- An IND is expected to be filed in 2015, with plans to initiate
a Phase 1 clinical trial in second half of 2015.
Three and Nine Months Ended September
30, 2014 Financial Results
General and administrative expenses were $1.2 million and $4.2
million for the three and nine months ended September 30, 2014, respectively, compared to
$1.9 million and $4.3 million for the same periods in 2013. These
decreases of approximately 36% and 3%, respectively, are primarily
the result of bad debt expense of $763,000 associated with the note and interest
receivables from the sale of Adeona Clinical Laboratory that were
determined uncollectible during the quarter ended September 30, 2013, which, for the nine months
ended September 30, 2014, was offset
by supplemental compensation granted by the Board of Directors to
executive officers and increased stock-based compensation expense.
Non-cash charges related to stock-based compensation were
$377,000 and $1.3 million for the three and nine months ended
September 30, 2014, respectively,
compared to $264,000 and $916,000 for the same periods in 2013.
Research and development expenses increased to $3.7 million and $9.2
million for the three and nine months ended September 30, 2014, respectively, compared to
$1.5 million and $3.8 million, for the same periods in 2013. These
increases of 150% and 144%, respectively, are primarily the result
of increased program costs associated with expanded research,
clinical development and manufacturing activities within our
pathogen-specific pipeline, including the Company's C.
difficile, C-IBS and Pertussis programs. Non-cash charges
related to stock-based compensation were $232,000 and $550,000 for the three and nine months ended
September 30, 2014, respectively,
compared to $74,000 and $286,000 for the same periods in 2013.
Other income was $1,000 and
$97,000 for the three and nine months
ended September 30, 2014,
respectively, compared to other expense of $3,000 and $27,000,
for the same periods in 2013.
Cash at September 30, 2014 was
$3.3 million compared to $14.6 million at December
31, 2013. In addition, on October 16,
2014, Synthetic Biologics closed a registered direct
offering with select institutional investors for net proceeds of
approximately $18.9 million.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, November 14, 2014, at
8:30 a.m. EST, during which Mr. Riley
will provide an operational update and C.
Evan Ballantyne, Synthetic Biologics' Chief Financial
Officer, will review the Company's financial results for the three
and nine months ended September 30,
2014.
Interested parties should call 1-888-347-5280 (U.S. toll free),
1-855-669-9657 (Canada toll free),
or +1 412-902-4280 (International), fifteen minutes before the
start of the call to register. Registered callers on the toll free
line may ask to be placed in the queue for the Question &
Answer Session. The call will also be webcast over the Internet at
http://www.videonewswire.com/event.asp?id=100975. If you are unable
to participate during the live conference call, the webcast will be
available for replay at the same URL,
http://www.videonewswire.com/event.asp?id=100975, for 30 days after
the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
biotechnology company developing pathogen-specific therapies for
serious infections and diseases, with a focus on protecting the
microbiome. The Company is developing an oral biologic to protect
the gastrointestinal (GI) microflora from the effects of
intravenous (IV) antibiotics for the prevention of C.
difficile infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS) and a monoclonal antibody combination for
the treatment of Pertussis. 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. 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 advancing Synthetic
Biologics' clinical programs and achieving milestones, the ability
to achieve future growth and success and increase shareholder
value, and the anticipated timing of the Synthetic Biologics'
clinical trials, filing of INDs and release of results. The
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from those set
forth or implied by any forward-looking statements. 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, or a failure by Synthetic Biologics or its
strategic partners to successfully commercialize products and other
factors described in Synthetic Biologics' report on Form 10-K for
the year ended December 31, 2013 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
|
|
|
September
30,
|
|
December
31,
|
|
2014
|
|
2013
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$ 3,286
|
|
$
14,625
|
Prepaid
expenses and other current assets
|
1,382
|
|
1,591
|
Property
and equipment, net
|
67
|
|
37
|
Deposits
and other assets
|
6
|
|
4
|
Total
Assets
|
$ 4,741
|
|
$
16,257
|
Liabilities and
Equity
|
|
|
|
Current
liabilities
|
$
984
|
|
$
1,027
|
Synthetic Biologics, Inc. and subsidiaries equity
|
3,757
|
|
15,230
|
Total Liabilities
and Equity
|
$ 4,741
|
|
$
16,257
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
September 30,
|
|
For the nine
months ended
September 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,218
|
|
$
1,890
|
|
$
4,154
|
|
$
4,270
|
Research
and development
|
3,693
|
|
1,475
|
|
9,247
|
|
3,796
|
Total Operating
Costs and Expenses
|
4,911
|
|
3,365
|
|
13,401
|
|
8,066
|
Loss from
Operations
|
(4,911)
|
|
(3,365)
|
|
(13,401)
|
|
(8,066)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Interest
income
|
1
|
|
11
|
|
2
|
|
32
|
Other
income (expense)
|
-
|
|
(14)
|
|
95
|
|
(59)
|
Total Other Income
(Expense), net
|
1
|
|
(3)
|
|
97
|
|
(27)
|
Net
Loss
|
(4,910)
|
|
(3,368)
|
|
(13,304)
|
|
(8,093)
|
Net Loss
Attributable to
Non-controlling
Interest
|
-
|
|
-
|
|
-
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$ (4,910)
|
|
$ (3,368)
|
|
$ (13,304)
|
|
$
(8,093)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.08)
|
|
$
(0.08)
|
|
$
(0.23)
|
|
$
(0.18)
|
Net Loss Per
ShareAttributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(0.08)
|
|
$
(0.08)
|
|
$
(0.23)
|
|
$
(0.18)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
58,453,528
|
|
44,654,414
|
|
58,356,025
|
|
44,636,935
|
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SOURCE Synthetic Biologics, Inc.