Full Press Release Details
Synthetic Biologics Reports Third Quarter
2013 Financial Results and Operational Update
-- Conference Call Today, November
14, at 10 a.m. Eastern Time --
Rockville, MD, November 14, 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 and nine months ended September 30, 2013 and provided an operational update.
Recent Operational Highlights
During and since the third quarter of
2013, the Company has:
SYN-004 Product Candidate for the Prevention
of C. diff Infections
Phase II Study of Multiple Sclerosis
(MS) Candidate, Trimesta
Preclinical Monoclonal Antibody (mAb)
Program for Pertussis (Whooping Cough)
"This quarter has been a time of
well-paced progress for our preclinical and clinical programs, which position us to create significant value for shareholders going
forward. We remain on track to meet our milestones and believe we are well positioned to take advantage of meaningful catalysts
over the next several quarters," stated Jeffrey Riley, CEO of Synthetic Biologics.
Three and Nine Months Ended September
30, 2013 Financial Results
General and administrative expenses were
$1.9 million and $4.3 million for the three and nine months ended September 30, 2013, respectively, compared to $1.1 million and
$3.7 million for the same periods in 2012. These increases of 76% and 15%, respectively, are primarily the result of bad debt expense
of $763,000 associated with the determination that the note and interest receivables from the sale of Adeona Clinical Laboratory
are uncollectible. Non-cash charges related to stock-based compensation were $264,000 and $916,000 for the three and nine months
ended September 30, 2013, respectively, compared to $279,000 and $1.1 million for the same periods in 2012.
Research and development expenses were
$1.5 million and $3.8 million for the three and nine months ended September 30, 2013, respectively, compared to $763,000 and $1.7
million for the same periods in 2012. These increases of 93% and 124%, respectively, are primarily the result of additional employee
costs and increased program costs associated with our infectious disease programs. Non-cash charges related to stock-based compensation
were $74,000 and $286,000 for the three and nine months ended September 30, 2013, respectively, compared to $116,000 and $238,000
for the same periods in 2012.
Other expense was $3,000 for the three
months ended September 30, 2013, compared to other income of $10,000 for the same period in 2012. Other expense was $27,000 for
the nine months ended September 30, 2013, compared to other income of $22,000 for the same period in 2012.
Cash at September 30, 2013 was $5.1 million
compared to $10.0 million at December 31, 2012.
Synthetic Biologics will hold a conference
call today, Thursday, November 14, 2013, at 10:00 am EST. During the call, Jeffrey Riley, Synthetic Biologics' Chief
Executive Officer, will provide a brief quarterly update of the Company's multiple sclerosis program and its anti-infective
drug pipeline for infectious diseases, including SYN-004, its oral enzyme candidate for the prevention of C. difficile infections.
C. Evan Ballantyne, Synthetic Biologics' Chief Financial Officer, will review the Company's financial results for the
third quarter ended September 30, 2013.
Interested parties should call 1-877-870-4263
(U.S. toll free), 1-855-669-9657 (Canada toll free), or +1 412-317-0790 (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=96920. 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=96920
for 30 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics (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.
To download Synthetic Biologics'
investor relations mobile device app, which allows users access to the Company's SEC documents, press releases and events, please
click on the following links to download the IRapp on your iPhone and iPad or your Android mobile device.
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 our clinical programs,
the opportunities and our position 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 C. difficile infection, and our ability to create significant
shareholder value. 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, 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.
For further information, please contact:
Vice President, Corporate Communication
(734) 332-7800, Ext. 22
- Financial Tables Follow -
| Synthetic Biologics, Inc. and Subsidiaries |
| (in thousands, except share and per share amounts) |
| (Unaudited) |
| September 30, | December 31, | |||||||||||||||
| 2013 | 2012 | |||||||||||||||
| Assets | ||||||||||||||||
| Cash | $ | 5,145 | 9,954 | |||||||||||||
| Prepaid expenses and other current assets | 1,647 | 2,509 | ||||||||||||||
| Property and equipment, net | 157 | 223 | ||||||||||||||
| Long-term note receivable | - | 700 | ||||||||||||||
| Deposits and other assets | 4 | 37 | ||||||||||||||
| Total assets | $ | 6,953 | $ | 13,423 | ||||||||||||
| Liabilities and Stockholders' Equity | ||||||||||||||||
| Current liabilities | $ | 584 | $ | 395 | ||||||||||||
| Stockholders' equity | 6,369 | 13,028 | ||||||||||||||
| Total liabilities and stockholders' equity | $ | 6,953 | $ | 13,423 |
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Operating Costs and Expenses | ||||||||||||||||
| General and administrative | $ | 1,890 | $ | 1,073 | $ | 4,270 | $ | 3,717 | ||||||||
| Research and development | 1,475 | 763 | 3,796 | 1,696 | ||||||||||||
| Total operating costs and expenses | 3,365 | 1,836 | 8,066 | 5,413 | ||||||||||||
| Loss from Operations | (3,365 | ) | (1,836 | ) | (8,066 | ) | (5,413 | ) | ||||||||
| Other Income (Expense) | ||||||||||||||||
| Interest income | 11 | - | 32 | - | ||||||||||||
| Other income (expense) | (14 | ) | 10 | (59 | ) | 22 | ||||||||||
| Total other income (expense), net | (3 | ) | 10 | (27 | ) | 22 | ||||||||||
| Loss from Continuing Operations | (3,368 | ) | (1,826 | ) | (8,093 | ) | (5,391 | ) | ||||||||
| Income (Loss) from Discontinued Operations | - | (104 | ) | - | 389 | |||||||||||
| Net Loss | $ | (3,368 | ) | $ | (1,930 | ) | $ | (8,093 | ) | $ | (5,002 | ) | ||||
| Net Income (Loss) Per Share - Basic and Dilutive | ||||||||||||||||
| Continuing operations | $ | (0.08 | ) | $ | (0.05 | ) | $ | (0.18 | ) | $ | (0.16 | ) | ||||
| Discontinued operations | - | - | - | 0.01 | ||||||||||||
| Net Loss Per Share | $ | (0.08 | ) | $ | (0.05 | ) | $ | (0.18 | ) | $ | (0.15 | ) | ||||
| Weighted average number of common shares outstanding - Basic and Dilutive | 44,654,414 | 33,383,226 | 44,636,935 | 32,801,415 |