ROCKVILLE, Md., May 15, 2013 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused
on the prevention and treatment of serious infectious diseases,
today reported financial results for the three months ended
March 31, 2013 and summarized
operational highlights.
Operational Highlights
Emphasis on C. difficile (C. diff) Infection Prevention
(SYN-004)
- In the U.S. each year, 24 million patients are administered IV
antibiotics[1] which may be excreted into the
gastrointestinal (GI) tract where they can upset the natural
balance of the microbiome allowing for the overgrowth of C.
difficile which causes diarrhea, colitis and may result in
death.
- SYN-004 is being developed as an oral enzyme product to be
co-administered with IV beta-lactam antibiotics. SYN-004 is
expected to:
- Remain in the GI tract to degrade certain beta-lactam
antibiotics
- Protect the healthy microflora from the overgrowth of C.
diff
- In 2012, over 13 million patients were treated with IV
beta-lactam antibiotics that may be covered by
SYN-004.[1]
- Phase I and II studies of over 200 subjects treated with 1st
generation candidate demonstrated safety, tolerability, and
preservation of the normal GI microflora when co-administered with
certain penicillins.
Infectious Disease Specialist Joins
Scientific Advisory Board
- Brad Spellberg, M.D., is an
Associate Professor of Medicine, David
Geffen School of Medicine in the Division of General
Internal Medicine at Harbor-UCLA Medical Center, and Associate
Program Director for Internal Medicine Residency Training Program,
Harbor-UCLA Medical Center and LA BioMed.
- Dr. Spellberg has worked closely with the Infectious Diseases
Society of America (IDSA) to focus attention on the rising public
health crisis caused by increasing antibiotic resistance and
decreasing new antibiotic development.
Trimesta™ for Relapsing-Remitting
Multiple Sclerosis (MS)
- Continuing the 164-patient, randomized, double-blind,
placebo-controlled, multi-center Phase II clinical trial evaluating
the efficacy and safety of oral estriol (Trimesta™) for the
treatment of relapsing-remitting MS in women. The primary endpoint
is relapse rate at two years.
- Through our wholly owned subsidiary, we hold the exclusive
worldwide license to U.S. Patent 8,372,826 and 6,936,599 and
pending patents for multiple sclerosis and other autoimmune
diseases covering the uses of its drug candidate, Trimesta™.
- During the first quarter of 2013, U.S. Patent No. 8,372,826 was
issued to the Regents of the University of
California which includes claims to the use of our drug
candidate, Trimesta™ (oral estriol), in combination with glatiramer
acetate injection (Copaxone®).
- Copaxone® is the number one selling drug for MS with
approximately $4 billion in annual
sales. Currently marketed exclusively by Teva Pharmaceutical
Industries Ltd., Copaxone® is expected to face generic competition
as certain patent terms begin to expire in
2014.[2]
Upcoming Milestones
- C. difficile program:
- Initiation of cGMP manufacturing expected during 3rd
quarter of 2013
- Initiation of clinical trials expected during 2nd
half of 2014
- Relapsing-remitting MS clinical trial:
- Final patient's final visit expected in January 2014
- Top-line results expected in the first half of 2014
"As we begin 2013, we are focused on building our infectious
disease platform. We are especially excited about SYN-004, a
2nd generation preventative treatment for C.
difficile, to be co-administered with IV beta-lactam
antibiotics. While Phase I and II studies of a 1st
generation candidate demonstrated safety, tolerability and
preservation of the normal GI microflora when co-administered with
certain penicillins, we anticipate that SYN-004 should have a
broader spectrum of activity including, penicillins as well as most
cephalosporins. There is great potential for SYN-004 to protect the
healthy microflora in the GI tract from the overgrowth of C.
diff," said Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics.
"As a novel prevention for C. diff, SYN-004 is a
break-through candidate for Synthetic Biologics. With over 13
million patients treated with certain IV beta-lactam antibiotics in
2012, these antibiotics have become a mainstay in hospital
infection management. We are working hard to accelerate the
development of this program in order to provide a prophylactic
treatment intended to prevent C. diff infections," concluded
Mr. Riley.
Three Months Ended March 31,
2013 Financial Results
General and administrative expenses were $1.1 million for the three months ended
March 31, 2013, compared to
$1.5 million for the same period in
2012. The decrease of 24% is primarily the result of lower
consultant and legal fees, and non-cash stock based compensation.
Charges related to stock-based compensation were $353,000 for the three months ended March 31, 2013, compared to $499,000 for the same period in 2012.
Research and development expenses were $1.1 million for the three months ended
March 31, 2013, compared to
$386,000 for the same period in 2012.
The increase of 190% is primarily the result of additional employee
costs and increased program costs associated with our infectious
disease programs. Charges related to stock-based compensation were
$103,000 for the three months ended
March 31, 2013, compared to
$9,000 for the same period in
2012.
Other income was $12,000 for the
three months ended March 31, 2013,
compared to $5,000 for the same
period in 2012.
Cash as of March 31, 2013 was
$8.5 million compared to $9.9 million as of December 31, 2012.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of biologics for the prevention
and treatment of serious infectious diseases. The Company is
developing an oral enzyme for the prevention of C. difficile
infections, and a series of monoclonal antibody therapies for the
treatment of Pertussis and Acinetobacter infections. In
addition, the Company is developing a drug candidate for the
treatment of relapsing-remitting multiple sclerosis and cognitive
dysfunction in multiple sclerosis. For more information, please
visit Synthetic Biologics' website at
www.syntheticbiologics.com.
Copaxone® is a registered trademark of Teva Pharmaceutical
Industries Ltd.
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 our continued focus of
our efforts in the field of synthetic biology and advancing our
clinical programs, the opportunities in the infectious disease
market, the anticipated timing and results of our development
efforts and the expected size of the future market for sales of
therapies for CDI , Pertussis and Acinetobacter. 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 our therapeutics, a
failure of our clinical trials to be commenced or completed on time
or to achieve desired results, a failure of our clinical trials to
receive anticipated funding, a failure of our monoclonal antibodies
for the treatment of infectious diseases to be successfully
developed or commercialized, our inability to maintain our
licensing agreements, including our agreement with Intrexon, or a
failure by us or our strategic partners to successfully
commercialize products and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2012 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.
Synthetic Biologics, Inc. and
Subsidiaries
|
(in
thousands, except share and per share amounts)
(Unaudited)
|
|
Condensed Consolidated Balance
Sheets
|
|
March
31,
|
|
December 31,
|
|
2013
|
|
2012
|
Assets
|
|
|
|
Cash
|
$
8,520
|
|
$
9,954
|
Prepaid expenses and other current
assets
|
2,234
|
|
2,509
|
Note receivable, current
|
700
|
|
-
|
Property and equipment, net
|
215
|
|
223
|
Long-term note receivable
|
-
|
|
700
|
Deposits and other assets
|
15
|
|
37
|
Total
assets
|
$
11,684
|
|
$
13,423
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current liabilities
|
$
196
|
|
$
395
|
Stockholders' equity
|
11,488
|
|
13,028
|
Total
liabilities and stockholders' equity
|
$
11,684
|
|
$
13,423
|
|
Condensed Consolidated Statements of
Operations
|
|
For the
three months ended
March 31,
|
|
2013
|
|
2012
|
Operating Costs and Expenses
|
|
|
|
General and administrative
|
$
1,122
|
|
$
1,468
|
Research and development
|
1,118
|
|
386
|
Total
operating costs and expenses
|
2,240
|
|
1,854
|
Loss
from Operations
|
(2,240)
|
|
(1,854)
|
Other
Income
|
|
|
|
Interest income
|
11
|
|
-
|
Other income
|
1
|
|
5
|
Total
other income
|
12
|
|
5
|
Loss
from Continuing Operations
|
(2,228)
|
|
(1,849)
|
Income
from Discontinued Operations
|
-
|
|
649
|
Net
Loss
|
$
(2,228)
|
|
$
(1,200)
|
Net
Income (Loss) Per Share - Basic and Dilutive
|
|
|
|
Continuing operations
|
$
(0.05)
|
|
$
(0.06)
|
Discontinued operations
|
-
|
|
0.02
|
Net
Income (Loss) Per Share
|
$
(0.05)
|
|
$
(0.04)
|
Weighted average number of common shares
outstanding - Basic and Dilutive
|
44,601,396
|
|
32,003,164
|
[1] This information is an estimate derived from the
use of information under license from the following IMS Health
Incorporated information service: CDM Hospital database for full
year 2012. IMS expressly reserves all rights, including rights of
copying, distribution and republication.
[2] Teva Pharmaceutical Industries Ltd. Form 20-F
filed with the SEC for the year ended December 31, 2012.
SOURCE Synthetic Biologics, Inc.