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Synthetic Biologics Reports 2018 Year End Operational Highlights and Financial Results -- Enrollment is Ongoing in Phase 2b Investigator-Sponsored Clinical Study of SYN-010, for the Treatment of IBS-C; Topline Data Reado

Key Takeaway: Synthetic Biologics Reports 2018 Year End Operational Highlights and Financial Results -- Enrollment is Ongoing in Phase 2b Investigator-Sponsored Clinical Study of SYN-010, for the Treatment of IBS-C; Topline Data Readout Anticipated in 2H 2019 -- -- Conference Call Wednes

Full Press Release Details

Synthetic Biologics Reports 2018 Year
End Operational Highlights and Financial Results
-- Enrollment is Ongoing in Phase
2b Investigator-Sponsored Clinical Study of SYN-010,
for the Treatment of IBS-C; Topline
Data Readout Anticipated in 2H 2019 --
-- Conference Call Wednesday, February
27, 2019, at 4:30 p.m. (EST) --
Rockville, MD, February 27, 2019 -
Synthetic Biologics, Inc. (NYSE American: SYN), a clinical-stage
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 31, 2018.
"During the fourth quarter, we remained
sharply focused on executing our strategy to advance and demonstrate the significant value of our portfolio of GI and microbiome-focused
clinical assets," stated Steven A. Shallcross, Chief Executive and Financial Officer. "We are pleased to report that
patient enrollment is continuing for our investigator-sponsored Phase 2b clinical trial of SYN-010, our modified-release formulation
of lovastatin lactone designed to treat an underlying cause of irritable bowel syndrome with constipation. We believe data derived
from this study will solidify our existing clinical outcomes data, including dose-response, and potentially simplify future registration
studies. We anticipate a topline data readout from this study in the second half of 2019."
Mr. Shallcross continued, "During
the fourth quarter, we also announced the results of our End-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA)
during which key elements of a Phase 3 clinical program were confirmed to support a marketing application for SYN-004 for the prevention
of Clostridium difficile infection (CDI). In parallel, we continue to evaluate strategies to pursue a secondary clinical
indication for SYN-004 in a specialized patient population which may allow for a more narrow and less costly clinical development
pathway. One such indication is the prevention of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant
(HCT) recipients, where protection of the gut microbiome from antibiotic damage may provide a distinct benefit to patient outcomes.
Discussions with key opinion leaders who are experts in allogeneic HCT are ongoing, and we look forward to sharing updates and
progress for this potential indication."
"With the steps we have taken at
the end of the fourth quarter to fortify our long-term financial footing, we have created a strong foundation upon which to execute
our strategy to advance and showcase the value of our late stage clinical assets. Our entire organization is excited and committed
to achieving the important clinical development milestones we have established for 2019," concluded Mr. Shallcross.
Clinical Development and Operational
Year Ended December 31, 2018 Financial
General and administrative expenses decreased
to $5.7 million for the year ended December 31, 2018, compared to $7.5 million for the year ended December 31, 2017. This decrease
of 24% is due to the decreased stock-based compensation expense related to forfeitures and share price, along with the reduction
of salary, travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge relating
to stock-based compensation expense was $1.0 million for the year ended December 31, 2018, compared to $2.0 million for the year
ended December 31, 2017.
Research and development expenses decreased
to $11.8 million for the year ended December 31, 2018, from $18.8 million for the year ended December 31, 2017. This decrease of
37% is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2018 since no clinical trials were ongoing
during the year. The research and development costs incurred during the quarter were primarily related to planning for future Phase
3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs as we sought to secure the financial resources necessary for the completion
of these clinical trials. We anticipate research and development expense to increase due to the ongoing Phase 2b investigator-sponsored
clinical trial for SYN-010 and development activities associated with the potential initiation of a Phase 1/2 investigator-sponsored
clinical trial for the prevention of aGVHD in HCT recipients for SYN-004. Research and development expenses also include a charge
relating to non-cash stock-based compensation expense of $1.1 million for the year ended December 31, 2018, compared to $1.4 million
for the year ended December 31, 2017.
Other income was $4.2 million for the year
ended December 31, 2018, compared to other income of $10.8 million for the year ended December 31, 2017. Other income for the year
ended December 31, 2018 is primarily due to non-cash income of $4.1 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, 2017.
In connection with the issuance and subsequent conversions of the Series B Convertible Preferred Stock
in 2018 and the issuance of the Series A Convertible Preferred Stock in 2017, the Company recognized non-cash deemed dividends
of $11.7 million and $6.9 million respectively, for the beneficial conversion feature resulting from the intrinsic value of the
Series B and Series A conversion options as of the issuance date.
Cash and cash equivalents on December
31, 2018 were $28.9 million, an increase of $11.8 million from December 31, 2017.
Synthetic Biologics will hold a conference
call today, Wednesday, February 27, 2019, at 4:30 p.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/1096/29346.
An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/29346,
for 90 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American:
SYN) is a clinical-stage company developing therapeutics that preserve the microbiome to protect and restore the health of patients.
The Company's lead candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV)
beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI),
overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD)
in allogeneic hematopoietic cell transplant (HCT) recipients, 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 SYN-020, 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. 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 belief that data derived from the investigator-sponsored Phase 2b clinical trial of SYN-010
will solidify Synthetic Biologics' existing clinical outcomes data, including dose-response, and potentially simplify future
registration studies, anticipated topline data readout from the investigator-sponsored Phase 2b clinical trial of SYN-010 in the
second half of 2019, anticipated initiation of a Phase 1/2 investigator-sponsored clinical study in HCT patients in 2H 2019, anticipated
increase in research and development expense due to the ongoing Phase 2b investigator-sponsored clinical trial for SYN-010 and
development activities associated with the potential initiation of a Phase 1/2 investigator-sponsored clinical trial for the prevention
of aGVHD in HCT recipients for SYN-004, anticipated filing of a US IND application for SYN-020 in Q4 2019 and plans to commence
a Phase 1 clinical trial for SYN-020 in Q1 2020. 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
Last updated: Feb 27, 2019