Full Press Release Details
Synthetic Biologics Reports First Quarter
2013 Financial Results
Rockville, MD, May 15, 2013 -
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)
Infectious Disease Specialist Joins
Scientific Advisory Board
TrimestaTM for Relapsing-Remitting
Multiple Sclerosis (MS)
"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.
-- Financial Tables to Follow--
Synthetic Biologics, Inc. and Subsidiaries
(in thousands, except share and per share amounts)
| 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 |
For further information, please contact:
Vice President, Corporate Communication
(734) 332-7800, Ext. 22
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
Teva Pharmaceutical Industries Ltd. Form 20-F filed with the SEC for the year ended December 31, 2012.