Full Press Release Details
Synthetic Biologics Reports Third Quarter
2019 Operational Highlights and Financial Results
-- Enrollment is Ongoing in Phase
2b Investigator-Sponsored Clinical Study of SYN-010,
for the Treatment of IBS-C --
-- Conference Call Today, November
4, 2019, at 4:30 p.m. (EST) --
MD, November 4, 2019 - Synthetic Biologics, Inc. (NYSE American: SYN),
a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal
(GI) diseases in areas of high unmet need, today provided an operational update and reported financial
results for the three and nine months ended September 30, 2019.
"During the third quarter, we remained
sharply focused on the advancement of our portfolio of GI-focused clinical programs which leverage the microbiome to improve the
health of patients," stated Steven A. Shallcross, Chief Executive and Financial Officer. "We were pleased to announce
our clinical trial collaboration with Washington University School of Medicine in St. Louis ("Washington University")
to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase). The announcement of this agreement is an important step in our
pursuit of a more cost-effective development strategy for our SYN-004 (ribaxamase) program aimed at improving clinical outcomes
of high-risk patients who undergo allogeneic hematopoietic cell transplantation (HCT) and receive long courses of intravenous (IV)
beta-lactam antibiotics. Looking ahead, we intend to hold a Type-C meeting with the U.S. Food & Drug Administration ("FDA")
during the fourth quarter to solidify the clinical protocol parameters for this program with the intention of initiating enrollment
during the first quarter of 2020."
Mr. Shallcross continued, "Enrollment
in our investigator-sponsored Phase 2b clinical study for SYN-010 in breath-methane positive irritable bowel syndrome with constipation
(IBS-C) patients remains ongoing. We anticipate a data readout sometime during the first half of 2020 which we believe will further
fortify the established clinical data set for SYN-010 and support regulatory discussions to potentially simplify future registration
studies. For our SYN-020 intestinal alkaline phosphatase (IAP) program, preclinical activities and toxicology studies remain on
track to support an Investigational New Drug Application (IND) application filing during the first quarter of 2020. We look forward
to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."
Clinical Development and Operational
Quarter Ended September 30, 2019
General and administrative expenses decreased
by approximately 26% to $1.1 million for the three months ended September 30, 2019, from $1.5 million for the three months ended
September 30, 2018. This decrease is primarily due to decreased stock-based compensation expense related to forfeitures and decreased
option grants, along with the reduction of investor relations and consulting costs. The charge related to stock-based compensation
expense was $68,000 for the three months ended September 30, 2019, compared to $186,000 the three months ended September 30, 2018.
Research and development expenses increased by approximately 46% to $4.1 million for the three months
ended September 30, 2019 from $2.8 million for the three months ended September 30, 2018. This increase is primarily the result
of higher manufacturing and pre-IND-enabling toxicology study costs for SYN-020 and the cost incurred to co-fund the investigator-sponsored
Phase 2b clinical study of SYN-010. Research and development expenses also include a charge relating to stock-based compensation
expense of $22,000 for the three months ended September 30, 2019, compared to $289,000 for the three months ended September 30,
Other income was $92,000 for the three
months ended September 30, 2019, compared to other income of $631,000 for the three months ended September 30, 2018. Other income
for the three months ended September 30, 2019 is primarily comprised of interest income while the three months ended September
30, 2018 is comprised of non-cash income of $626,000 from the change in fair value of warrants. The decrease in the fair value
of the warrants was due to the decrease in our stock price.
Cash and cash equivalents as of September
30, 2019 totaled $18.7 million, a decrease of $10.3 million from December 31, 2018.
Synthetic Biologics will hold a conference
call today, Monday, November 4,
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/1096/32094. An archive of the call will be available for replay at
the same URL, https://www.webcaster4.com/Webcast/Page/1096/32094, for 90 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American:
SYN) is a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal
(GI) diseases in areas of high unmet need. 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 is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline
phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website
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 includes statements regarding the intent to hold a Type-C meeting with the FDA during the fourth quarter to solidify the clinical
protocol parameters for the SYN-004 program, the anticipated filing of an IND for SYN-020 during in the first quarter of 2020;
enrollment for the Phase 1b/2a clinical trial of SYN-004 initiating during the first quarter of 2020, contingent upon agreement
with the FDA and approval of the clinical study protocol by the Washington University School of Medicine's Institutional
Review Board (IRB); the study design of the Phase 1b/2a clinical trial of SYN-004, a data readout for the Phase 2b investigator-sponsored
clinical study of SYN-010 for the treatment of IBS-C is anticipated in 1H 2020; the data readout further fortifying the clinical
data set for SYN -010 and enabling regulatory discussions to potentially simplify future registration. 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, the ability of Synthetic Biologics' product candidates
to demonstrate safety and effectiveness, as well as results that are consistent with prior results, a failure to receive the necessary
regulatory approvals for commercialization of Synthetic Biologics' therapeutics, including approval of proposed trial designs,
a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004, SYN-010 and SYN-020 to be
commenced or completed on time or to achieve desired results and benefits, a failure to file INDs when anticipated, 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, Synthetic Biologics'
ability to achieve acceptance of its product candidates in the marketplace and the successful development, marketing or sale of
Synthetic Biologics' products by competitors that render Synthetic Biologics' products obsolete or non-competitive, Synthetic Biologics'
ability to continue to comply with the continued listing requirements of the NYSE American, the continued maintenance and growth
of Synthetic Biologics' patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics' ability to obtain
or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics'
key scientists or management personnel and other factors described in Synthetic Biologics' Form 10-K and 10-K/A for the year ended
December 31, 2018 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
For further information, please contact:
Synthetic Biologics, Inc. (Corporate and
Vincent I. Perrone, Director Corporate Communication, (240)
660-2000, info@syntheticbiologics.com
Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@ogilvy.com