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Synthetic Biologics Reports Third Quarter 2014 Financial Results and Operational Highlights -- Company Completes $18.9 Million Net Registered Direct Offering; Finalizes Plans for Start of Clinical Trials in C. difficile

Key Takeaway: Synthetic Biologics Reports Third Quarter 2014 Financial Results and Operational Highlights -- Company Completes $18.9 Million Net Registered Direct Offering; Finalizes Plans for Start of Clinical Trials in C. difficile and C-IBS -- -- Conference Call Today, November 14, 2

Full Press Release Details

Synthetic Biologics Reports Third Quarter
2014 Financial Results and Operational Highlights
-- Company Completes $18.9 Million
Net Registered Direct Offering;
Finalizes Plans for Start of Clinical
Trials in C. difficile and C-IBS --
-- Conference Call Today, November
14, 2014, at 8:30 a.m. (EST); U.S. Participants Call (888) 347-5280 or
MD, November 14, 2014 - 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
Relapsing-Remitting Multiple Sclerosis
(RRMS) - Trimesta (oral estriol)
Constipation-Predominant Irritable Bowel
Syndrome (C-IBS) - SYN-010 Statin-Class Oral Compound
Pertussis (Whooping Cough) - SYN-005
Monoclonal Antibody (mAb) Combination
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
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
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
For further information, please contact:
Synthetic Biologics: Kris Maly, VP, Corporate
Communication, (734) 332-7800, info@syntheticbiologics.com
Media: Wendy Emanuel, Wellspring Communications,
Inc., (773) 255-9580, wendy@wellspringcom.com
- 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 Share Attributable 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
Last updated: Nov 14, 2014