ROCKVILLE, Md., May 8, 2019 /PRNewswire/ -- 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 an
operational update and reported financial results for the three
months ended March 31, 2019.
"During the first quarter, we remained keenly focused on
executing our strategy to advance our portfolio of GI and
microbiome-focused clinical programs," stated Steven A. Shallcross, Chief Executive &
Financial Officer of Synthetic Biologics. "Enrollment into our
investigator-sponsored Phase 2b
clinical trial of SYN-010 in breath methane positive irritable
bowel syndrome with constipation (IBS-C) patients is ongoing and we
believe we are on track to announce a topline data-readout during
the second half of 2019. Importantly, we believe dose-response data
derived from this clinical study will further fortify the already
well-established clinical data set for SYN-010 and enable
regulatory discussions to potentially simplify future registration
studies."
Mr. Shallcross continued, "During the first quarter, we
continued to pursue our strategy for a potential secondary clinical
indication for SYN-004 (ribaxamase) in a specialized patient
population which may allow for more narrow and cost-efficient
clinical development opportunities. Discussions with key opinion
leaders are progressing to determine an optimal development pathway
for SYN-004 to reduce the incidence and/or severity of adverse
outcomes in allogeneic hematopoietic cell transplant (HCT)
recipients. These adverse outcomes include acute
graft-versus-host-disease (aGVHD) and colonization of opportunistic
pathogens such as vancomycin resistant Enterococci (VRE), each of
which are associated with poor outcomes and increased mortality in
allogeneic HCT recipients. We believe SYN-004 may provide a
distinct benefit to patient outcomes in allogeneic HCT recipients,
where gut microbiome damage resulting from prolonged beta-lactam
antibiotic use has been linked to the development of aGVHD and
colonization by VRE. We look forward to sharing important updates
and progress for this potential indication."
Clinical Development and Operational Update
- Commenced enrollment in 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,
- A topline data readout is anticipated in 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;
- Continued to evaluate a potential secondary indication for
SYN-004 (ribaxamase) to reduce the incidence and/or severity of
aGVHD and other adverse outcomes in allogeneic HCT recipients
-
- Identification of key investigators and establishment of
clinical protocols are ongoing,
- Anticipate initiation of a Phase 1/2 clinical study in
allogeneic HCT patients in 2H 2019, contingent upon the
identification of a research partner and subsequent Institutional
Review Board (IRB) approval;
- Evaluated regulatory strategies to advance SYN-020 (intestinal
alkaline phosphatase) to and through clinical trials targeting
areas of significant unmet medical need, including enterocolitis
associated with radiation therapy for cancer
-
- Submitted request for pre-IND meeting with FDA in Q1 2019,
- Anticipate filing a US IND application in Q4 2019,
- Plan to commence a Phase 1 clinical trial in Q1 2020;
- Continued to exercise prudent cash management and financial
stewardship
-
- Further reduced cash burn, extending projected cash runway to
fund operations through at least the end of Q2 2020;
Quarter Ended March 31, 2019
Financial Results
General and administrative expenses decreased by 30% to
$1.1 million for the three months
ended March 31, 2019, from
$1.6 million for the three months
ended March 31, 2018. This decrease
is primarily due to decreased stock-based compensation expense
related to forfeitures and decreased share price, along with the
reduction of investor relations, registration, and legal costs. The
charge related to stock-based compensation expense was $65,000 for the three months ended March 31, 2019, compared to $349,000 the three months ended March 31, 2018.
Research and development expenses decreased by 28% to
$2.4 million for the three months
ended March 31, 2019, from
$3.4 million for the three months
ended March 31, 2018. This decrease
is primarily the result of lower SYN-004 (ribaxamase) indirect
program costs for the three months ended March 31, 2019, including salary and related
expense reductions resulting from the 2018 restructuring and the
fact that no clinical trial activity for SYN-004 (ribaxamase) was
ongoing during the quarter, offset by an increase in manufacturing
costs for SYN-020. The research and development costs incurred
during the quarter were primarily related to the
investigator-sponsored Phase 2b
clinical study of SYN-010. We anticipate research and development
expense to increase in association with the ongoing Phase
2b investigator-sponsored clinical
study of SYN-010, a potential Phase 1/2 clinical trial of SYN-004
(ribaxamase) in allogeneic HCT recipients, and the continued
development of SYN-020. There was no charge related to stock-based
compensation expense for the three months ended March 31, 2019 resulting from the 2018
restructuring, compared to $326,000
for the three months ended March 31,
2018.
Other income was $44,000 for the
three months ended March 31, 2019,
compared to other income of $2.7
million for the three months ended March 31, 2018. Other income for the three months
ended March 31, 2019 is primarily
comprised of interest income while the three months ended
March 31, 3018 is comprised of
non-cash income of $2.7 million 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 March 31,
2019 was $24.7 million, a
decrease of $4.2 million from
December 31, 2018.
Conference Call
Synthetic Biologics will hold a conference call today,
Wednesday, May 8, 2019, at
4:30 p.m. (ET). 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/1096/30393. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/30393, 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 is also advancing SYN-020, an oral formulation
of the enzyme intestinal alkaline phosphatase (IAP) to treat both
local GI and systemic diseases, and has completed proof-of-concept
studies with 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 includes statements
regarding being on track to announce a topline data-readout
during the second half of 2019, dose-response data derived
from the investigator-sponsored Phase 2b clinical trial of SYN-010 further fortifying
the already well-established clinical data set for SYN-010 and
enabling regulatory discussions to potentially simplify future
registration studies, a potential secondary clinical indication for
SYN-004 (ribaxamase) in a specialized patient population which may
allow for more narrow and cost-efficient clinical development
opportunities, SYN-004 providing a distinct benefit to patient
outcomes in allogeneic HCT recipients, initiation of a Phase
1/2 clinical study in allogeneic HCT patients in 2H 2019, filing of
a US IND application in Q4 2019 for SYN-020,
commencing a Phase 1 clinical trial for SYN-020 in Q1
2020, and extending Synthetic Biologics' projected cash runway
through at least the end of Q2 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, the ability of Synthetic Biologics'
product candidates to demonstrate safety and effectiveness, as well
as results that are consistent with prior results, Synthetic
Biologics' clinical trials continuing enrollment as expected, 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 regain
compliance with the continued listing standards of the NYSE
American by September 2, 2019,
Synthetic Biologics' ability to comply with other 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 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 by law.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Balance Sheets
|
|
March 31,
2019
|
|
December 31,
2018
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
24,694
|
|
$
28,918
|
Prepaid
expenses and other current assets
|
860
|
|
593
|
Property
and equipment, net
|
545
|
|
607
|
Right of use
asset
|
510
|
|
-
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
26,632
|
|
$
30,141
|
Liabilities and
Stockholder's Equity
|
|
|
|
Total
liabilities
|
$
3,624
|
|
$
3,686
|
Series A
Convertible Preferred Stock
|
12,357
|
|
12,296
|
Total
stockholder's equity
|
10,651
|
|
14,159
|
Total Liabilities
and Stockholders' Equity
|
$
26,632
|
|
$
30,141
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
For the three
months ended March 31,
|
|
2019
|
|
2018
|
Operating Costs
and Expenses
|
|
|
|
General
and administrative
|
$
1,154
|
|
$
1,620
|
Research
and development
|
2,418
|
|
3,370
|
Total Operating
Costs and Expenses
|
3,572
|
|
4,990
|
Loss from
Operations
|
(3,572)
|
|
(4,990)
|
Other
Income
|
|
|
|
Change
in fair value of warrant liability
|
-
|
|
2,655
|
Interest
income
|
44
|
|
9
|
Total Other
Income
|
44
|
|
2,664
|
Net
Loss
|
(3,528)
|
|
(2,326)
|
Net Loss
Attributable to Non-controlling Interest
|
(16)
|
|
(10)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
$
(3,512)
|
|
$
(2,316)
|
Series A Preferred
Stock Dividends
|
(61)
|
|
(59)
|
Series B Preferred
Stock Dividends
|
(398)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
(3,971)
|
|
(2,375)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.25)
|
|
$
(0.65)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
15,656,784
|
|
3,673,340
|
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SOURCE Synthetic Biologics, Inc.