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Synthetic Biologics Reports 2017 Year End Operational Highlights and Financial Results - Company Provides Update on Late-stage Microbiome-focused Product Candidates - - Conference Call Today

Key Takeaway: Synthetic Biologics Reports 2017 Year End Operational Highlights and Financial Results - Company Provides Update on Late-stage Microbiome-focused Product Candidates - - Conference Call Today, February 22, 2018, at 8:30 a.m. (EST) - MD, February 22, 2018 - Synthetic Biologic

Full Press Release Details

Synthetic Biologics Reports 2017 Year
End Operational Highlights and Financial Results
- Company Provides Update on Late-stage
Microbiome-focused Product Candidates -
- Conference Call Today, February
22, 2018, at 8:30 a.m. (EST) -
MD, February 22, 2018 - Synthetic Biologics, Inc. (NYSE American: SYN),
a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients,
today provided a clinical programs update and reported financial results for the year ended December
"In 2017, Synthetic Biologics achieved
several important milestones in the advancement of our late-stage pipeline of best-in-class microbiome product candidates targeting
the prevention and treatment of life-threatening bacterial infections and gut microbiome disorders. We are excited by the potential
of our clinical programs to improve patient outcomes and quality of life and are working closely with the FDA to develop a path
forward for SYN-004 (ribaxamase), targeting an end of Phase 2 meeting with the FDA during the second half of 2018," said
Steven Shallcross, Interim Chief Executive Officer and Chief Financial Officer. "We believe SYN-004, when co-administered
with certain intravenous beta-lactam antibiotics may help prevent the onset of primary Clostridium difficile infection (CDI),
overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), thereby making current antibiotic therapy
more effective, and preventing life-threatening infections which may result from antibiotic-mediated dysbiosis," he added.
"In 2018, our priorities are to establish
the optimal clinical protocol for SYN-004's Phase 3 study design, in collaboration with the FDA, and to continue to aggressively
evaluate potential strategic relationships to speed the advancement and maximize the potential for success for our late-stage product
candidates, including both SYN-004 and SYN-010 for the treatment of IBS-C," concluded Shallcross.
Clinical Development and Operational
Year Ended December 31, 2017 Financial
General and administrative expenses decreased
to $7.5 million for the year ended December 31, 2017, compared to $10.1 million for the year ended December 31, 2016. This decrease
is primarily the result of higher salary expense and related benefits costs incurred in 2016 in connection with the transition
of the administrative and financial office to our Maryland headquarters, and higher investor relations, consulting and legal costs
in 2016 related to our 2016 equity financing. The charge relating to stock-based compensation expense was $2.0 million for the
year ended December 31, 2017, compared to $2.4 million for the year ended December 31, 2016.
Research and development expenses decreased
to $18.8 million for the year ended December 31, 2017, from $29.1 million for the year ended December 31, 2016. This decrease is
primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2017 as we plan for future Phase 3 (SYN-004) and
Phase 2b/3 (SYN-010) clinical programs and seek to secure the financial resources necessary for the completion of these clinical
trials. In addition, there were reductions in our other research and development activities, offset by an increase in indirect
costs for medical affairs and manufacturing scale up activities for SYN-004 (ribaxamase). Research and development expenses also
include a charge relating to non-cash stock-based compensation expense of $1.4 million for the year ended December 31, 2017, compared
to $1.6 million for the year ended December 31, 2016.
Other income was $10.8 million for the
year ended December 31, 2017, compared to other income of $11.4 million for the year ended December 31, 2016. Other income for
the year ended December 31, 2017 is primarily due to non-cash income of $10.7 million from the change in fair value of warrants.
The decrease in the fair value of warrants was due to the decrease in our stock price from December 31, 2016.
Cash and cash equivalents on December 31,
2017 were $17.1 million, a decrease of $2.0 million from December 31, 2016.
Synthetic Biologics will hold a conference
call today, Thursday, February 22, 2018, at 8:30 a.m. (EST). The dial-in information for
the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15
minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/24584.
An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/24584, for 90
days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American:
SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of
patients. The Company's lead candidates poised for Phase 3 development are: (1) SYN-004 (ribaxamase) which is designed to protect
the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C.
difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2)
SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause
of irritable bowel syndrome with constipation (IBS-C). The Company's preclinical pursuits include an oral formulation of
the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases as well as monoclonal antibody therapies
for the prevention and treatment of pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU).
For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
This release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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,
and include statements regarding the potential of our clinical programs to improve patient outcomes and quality of life, our belief
that SYN-004, when co-administered with certain intravenous beta-lactam antibiotics may help prevent the onset of primary Clostridium
difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), thereby making
current antibiotic therapy more effective, and preventing life-threatening infections which may result from antibiotic-mediated
dysbiosis, our potential for strategic relationships that maximize the potential for success for our advanced product candidates,
our plan to continue collaborative discussions with the FDA to solidify details and components of the drug development plan and
regulatory pathway towards marketing approval for SYN-004 in the 1H 2018, the anticipated end of Phase 2 meeting with FDA in 2H
2018, our plan to initiate Phase 3 clinical trials(s) in 2019 and our continued solidification of our clinical structure to support
successful advancement of SYN-010 , and the potential benefits of SYN-004 and SYN-010. These forward-looking statements are based
on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results
to differ materially from current expectations 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, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits,
a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure
of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its
material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products
and other factors described in Synthetic Biologics' most recent Form 10-K and its other filings with the SEC, including subsequent
periodic reports on Forms 10-Q and 8-K. 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:
Synthetic Biologics, Inc. (Corporate and
Vincent I. Perrone, Director Corporate Communication, (240)
Feinstein Kean Healthcare (Media)
Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@fkhealth.com
- Financial Tables Follow -
Synthetic Biologics, Inc. and Subsidiaries
(in thousands, except share and per share amounts)
Consolidated Balance Sheets
December 31,
2017 2016
Assets
Cash and cash equivalents $ 17,116 $ 19,055
Prepaid expenses and other current assets 827 2,515
Property and equipment, net 872 905
Deposits and other assets 23 23
Total Assets $ 18,838 $ 22,498
Liabilities and Stockholder's (Deficit) Equity
Total liabilities $ 10,195 $ 20,249
Series A Convertible Preferred Stock 12,053 -
Synthetic Biologics, Inc. and subsidiaries (deficit) equity (3,410 ) 2,249
Total Liabilities and Stockholders' (Deficit) Equity $ 18,838 $ 22,498
Condensed Consolidated Statements of Operations
For the years ended December 31,
2017 2016
Operating Costs and Expenses
General and administrative $ 7,467 $ 10,143
Research and development 18,784 29,109
Total Operating Costs and Expenses 26,251 39,252
Loss from Operations (26,251 ) (39,252 )
Other Income
Change in fair value of warrant liability 10,738 11,412
Interest income 21 37
Total Other Income 10,759 11,449
Net Loss (15,492 ) (27,803 )
Net Loss Attributable to Non-controlling Interest (318 ) (548 )
Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries $ (15,174 ) $ (27,255 )
Series A Preferred Stock Dividends (6,962 ) -
Net Loss Attributable to Common Stockholders (22,136 ) (27,255 )
Net Loss Per Share - Basic and Dilutive $ (0.18 ) $ (0.29 )
Weighted average number of common shares outstanding - Basic and Dilutive 124,366,059 94,290,436
Last updated: Feb 22, 2018