ROCKVILLE, Md., Feb. 27, 2019 /PRNewswire/ -- 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
Update
- Commenced enrollment of Phase 2b
investigator-sponsored clinical study of SYN-010, for the treatment
of IBS-C,
-
- The Phase 2b clinical study is
being conducted by the Medically Associated Science and Technology
(MAST) Program at Cedars-Sinai Medical Center and is a 12-week,
placebo-controlled, double-blind, randomized clinical trial
evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in
approximately 150 patients diagnosed with IBS-C,
- The primary objective for the study will be to determine the
efficacy of SYN-010, measured as an improvement from baseline in
the weekly average number of complete spontaneous bowel movements
(CSBMs) during the 12-week treatment period for SYN-010 21 mg and
42 mg daily doses relative to placebo,
- Secondary efficacy endpoints for both dose strengths of SYN-010
will measure changes from baseline in abdominal pain, bloating,
stool frequency as well as the use of rescue medication relative to
placebo,
- Topline data readout anticipated for 2H 2019,
- Cedars-Sinai Medical Center and Synthetic Biologics are
co-funding the study. The patent rights covering the use of SYN-010
are owned by Cedars-Sinai Medical Center and are exclusively
licensed by Cedars-Sinai Medical Center to Synthetic
Biologics;
- Held an End-of-Phase 2 meeting with FDA and confirmed key
elements of the Phase 3 clinical program to support a marketing
application for SYN-004 (ribaxamase),
-
- A single Phase 3 clinical trial may be sufficient for marketing
approval for the prevention of antibiotic-mediated CDI,
- The Phase 3 clinical program will entail a single, global,
event-driven clinical trial with a fixed maximum number of patients
for total enrollment,
- The primary efficacy endpoint will be the reduction in the
incidence of CDI at one month after the last drug dose in the
ribaxamase treatment group versus placebo,
- A separate co-primary safety endpoint is non-inferiority in
mortality rates between the SYN-004 treatment group and placebo at
3 months post-randomization;
- Continued to evaluate a potential secondary indication for
SYN-004 (ribaxamase) for the prevention of acute
graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell
transplantation (HCT) recipients,
-
- Identification of key investigators and the development of
clinical protocols and a pre-IND package is ongoing,
- Anticipate initiation of a Phase 1/2 investigator-sponsored
clinical study in HCT patients in 2H 2019, contingent upon the
identification of a research partner and subsequent Institutional
Review Board (IRB) approval;
- Identified potential clinical indications for SYN-020
(intestinal alkaline phosphatase) in areas of unmet medical need
including, enterocolitis associated with radiation therapy for
cancer and autoimmune enterocolitis associated with checkpoint
inhibitor therapy for cancer,
-
- Preclinical efficacy studies are ongoing,
- Anticipate filing a US IND application in Q4 2019,
- Plan to commence a Phase 1 clinical trial in Q1 2020;
- Strengthened balance sheet by raising gross proceeds of
approximately $18.6 million from the
closing of a public offering of common stock and Series B
Convertible Preferred Stock in support of our lead clinical
development activities
-
- Raised additional net proceeds of approximately $12.2 million from the utilization of the
Company's "at-the-market" facility through the end of 2018.
Year Ended December 31, 2018
Financial Results
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.
Conference Call
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 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.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Balance Sheets
|
|
December
31,
|
|
2018
|
|
2017
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
|
28,918
|
|
$
|
17,116
|
Prepaid
expenses and other current assets
|
593
|
|
827
|
Property
and equipment, net
|
607
|
|
872
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
|
30,141
|
|
$
|
18,838
|
Liabilities and
Stockholder's Equity (Deficit)
|
|
|
|
Total
liabilities
|
$
|
3,686
|
|
$
|
10,195
|
Series A
Convertible Preferred Stock
|
12,296
|
|
12,053
|
Synthetic Biologics, Inc. and Subsidiaries Equity
(deficit)
|
14,159
|
|
(3,410)
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
|
30,141
|
|
$
|
18,838
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
For the years
ended
December 31,
|
|
2018
|
|
2017
|
Operating Costs
and Expenses
|
|
|
|
General
and administrative
|
$
|
5,727
|
|
$
|
7,467
|
Research
and development
|
11,844
|
|
18,784
|
Total Operating
Costs and Expenses
|
17,571
|
|
26,251
|
Loss from
Operations
|
(17,571)
|
|
(26,251)
|
Other
Income
|
|
|
|
Change
in fair value of warrant liability
|
4,083
|
|
10,738
|
Interest
income
|
67
|
|
21
|
Total Other
Income
|
4,150
|
|
10,759
|
Net
Loss
|
(13,421)
|
|
(15,492)
|
Net Loss
Attributable to Non-controlling Interest
|
(54)
|
|
(318)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
$
|
(13,367)
|
|
$
|
(15,174)
|
Series A Preferred
Stock Dividends
|
(243)
|
|
(6,962)
|
Series B Preferred
Stock Dividends
|
(11,681)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
(25,291)
|
|
(22,136)
|
Net Loss Per Share
- Basic and Dilutive
|
$
|
(4.06)
|
|
$
|
(6.23)
|
Weighted average
number of common shares outstanding - Basic
and Dilutive
|
6,232,442
|
|
3,553,316
|
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SOURCE Synthetic Biologics, Inc.