ROCKVILLE, Md., Aug. 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 June 30, 2019. The
Company also announced today a clinical trial agreement with
Washington University School of
Medicine in St. Louis
("Washington University") to conduct a
Phase 1b/2a clinical trial of SYN-004
(ribaxamase), with enrollment expected to begin in the first
quarter of 2020.
"Our clinical trial collaboration with Washington University is an important step in our
pursuit of a more cost-effective development strategy for SYN-004
targeting a more specialized patient population," stated
Steven A. Shallcross, Chief
Executive and Financial Officer. "SYN-004's unique mechanism of
action designed to degrade intravenous (IV) beta-lactam antibiotics
and prevent dysbiosis of the gut microbiome has the potential to
significantly improve outcomes for patients who undergo allogeneic
hematopoietic cell transplantation (HCT), an area of significant
unmet medical need."
"Prompt initiation of broad-spectrum IV beta-lactam antibiotics
at onset of fever after conditioning chemotherapy for allogenic HCT
is a life-saving intervention. However, this causes significant
disruption of the microbiome, which places these patients at very
high risk for infection due to some of our greatest antibiotic
resistant threats, such as Clostridioides difficile,
vancomycin-resistant Enterococci (VRE), and
multidrug-resistant Gram-negative bacteria. We are seeking to
determine if coadministration of SYN-004 while the patient is
receiving IV beta-lactam antibiotics will preserve the microbiome
and thus mitigate the risk from these threats," said Dr. Erik R.
Dubberke Professor of Medicine and Clinical Director, Transplant
Infectious Diseases at Washington
University. "There are data to suggest preservation of the
microbiome in allogeneic HCT recipients results in improved immune
function after HCT as well. This would further enhance these
patients' outcomes and quality of life."
Mr. Shallcross continued, "During the second quarter, we
remained focused on executing our strategy to advance our portfolio
of gastrointestinal (GI) and microbiome-focused clinical programs.
We held a highly informative pre-IND meeting with the U.S. Food and
Drug Administration (FDA) for our SYN-020 intestinal alkaline
phosphatase (IAP) program and clarified the parameters for
IND-enabling toxicology studies. These activities are ongoing and
will support our anticipated Investigational New Drug (IND)
application which we intend to file promptly during the first
quarter of 2020." Mr. Shallcross concluded, "Interest from
prospective patients in our investigator-sponsored Phase
2b clinical trial of SYN-010 in
breath-methane positive irritable bowel syndrome with constipation
(IBS-C) patients remains strong. However, after consulting with the
investigators at Cedars-Sinai Medical Center, the study sponsor,
enrollment has been extended to accommodate higher than anticipated
screen-fail rates. This is, in part, due to errant laxative use
during the screening period that adversely impacts baseline
measurements of IBS-C symptoms and breath-methane levels. Rigorous
screening and reliable baseline parameters are critical to all
IBS-C clinical trials in order to ensure the possibility of
generating a meaningful data set of the highest quality. At this
time, we are discussing with Cedars-Sinai the opportunity for a
data read out in the first half of 2020, extending our previous
guidance from the fourth quarter of 2019. We look forward to
sharing important updates and progress for this and all our GI and
microbiome-focused clinical programs."
Clinical Development and Operational Update
- Entered into a Clinical Trial Agreement with Washington University School of Medicine in
St. Louis to conduct a Phase
1b/2a clinical trial of SYN-004
(ribaxamase)
-
- Under the terms of this agreement, Synthetic Biologics will
serve as the sponsor of the study and supply SYN-004 (ribaxamase)
and Dr. Dubberke will serve as the principal investigator along
with his Washington University
colleague Dr. Mark A. Schroeder,
Associate Professor of Medicine, Division of Oncology, Bone Marrow
Transplantation and Leukemia,
- Enrollment is expected to begin during the first quarter of
2020, contingent upon review by the FDA and approval of the
clinical study protocol by Washington
University's Institutional Review Board (IRB),
- The proposed study is a Phase 1b/2a single-center, randomized, double-blinded,
placebo-controlled clinical trial designed to evaluate the safety,
tolerability and pharmacokinetics of oral SYN-004 (ribaxamase) in
up to 36 adult allogeneic HCT recipients,
- Study participants will be enrolled into three sequential
cohorts that will be administered a different study-assigned IV
beta-lactam antibiotic. Eight participants in each cohort will
receive SYN-004 (ribaxamase) and four will receive placebo,
- Safety and pharmacokinetic data for each cohort will be
reviewed by an independent Data and Safety Monitoring Committee,
which will make a recommendation on whether to proceed to the next
IV beta-lactam antibiotic,
- The proposed study will also evaluate potential protective
effects of SYN-004 (ribaxamase) on the gut microbiome as well as
generate preliminary information on potential therapeutic benefits
and patient outcomes of SYN-004 (ribaxamase) in allogeneic HCT
recipients;
- Enrollment is ongoing in the 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 data readout is anticipated in 1H 2020,
- 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;
- Evaluated potential clinical development 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
-
- Held Pre-IND meeting with FDA and clarified the requirements
for IND-enabling toxicology studies
- Exploratory study found SYN-020 enhanced 5-FU tumor treatment
in a mouse ectopic colon cancer tumor model. A confirmatory study
is ongoing with larger cohort sizes and additional mechanistic
endpoints which, if repeated, may allow for further broadening of
the clinical development strategy for this program,
- Anticipate filing a US IND application 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 Q3 2020;
Quarter Ended June 30, 2019
Financial Results
General and administrative expenses decreased by 27% to
$1.0 million for the three months
ended June 30, 2019, from
$1.4 million for the three months
ended June 30, 2018. This decrease is
primarily due to decreased stock-based compensation expense related
to forfeitures and decreased options grants, along with the
reduction of investor relations and consulting costs. The charge
related to stock-based compensation expense was $59,000 for the three months ended June 30, 2019, compared to $264,000 the three months ended June 30, 2018.
Research and development expenses decreased by 27% to
$2.6 million for the three months
ended June 30, 2019, from
$3.6 million for the three months
ended June 30, 2018. This decrease is
primarily the result of lower SYN-004 (ribaxamase) indirect program
costs for the three months ended June 30,
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, a potential Phase
1b/2a clinical trial of SYN-004
(ribaxamase) in allogeneic HCT recipients, and the continued
development of SYN-020. Research and development expenses also
include a charge relating to stock-based compensation expense of
$31,000 for the three months ended
June 30, 2019, compared to
$293,000 for the three months ended
June 30, 2018.
Other income was $80,000 for the
three months ended June 30, 2019,
compared to other income of $789,000
for the three months ended June 30,
2018. Other income for the three months ended June 30, 2019 is primarily comprised of interest
income while the three months ended June 30,
2018 is comprised of non-cash income of $783,000 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 June 30,
2019 was $21.7 million, a
decrease of $7.2 million from
December 31, 2018.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, August 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/1096/31274. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/31274, 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 early-stage 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 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
that SYN-004's unique mechanism of action designed to
degrade IV beta-lactam antibiotics and prevent dysbiosis of the gut
microbiome has the potential to significantly improve outcomes for
patients who undergo allogeneic hematopoietic cell transplantation
(HCT); data to suggest preservation of the microbiome in allogeneic
HCT recipients results in improved immune function after HCT as
well and this further enhancing these patients' outcomes and
quality of life; an IND for SYN-020 will be filed during the
first quarter of 2020; enrollment for the Phase 1b/2a clinical trial of SYN-004 is expected
to begin during the first quarter of 2020, contingent upon approval
of the clinical study protocol by the Washington University School of Medicine's
Institutional Review Board (IRB) and the FDA; 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; and extending Synthetic Biologics' projected
cash runway through at least the end of Q3 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 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 by
law.
- Financial Tables Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
Consolidated
Balance Sheets
|
|
June 30,
2019
|
|
December 31,
2018
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
21,712
|
|
$
28,918
|
Prepaid
expenses and other current assets
|
1,298
|
|
593
|
Property
and equipment, net
|
485
|
|
607
|
Right of use
asset
|
481
|
|
-
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
23,999
|
|
$
30,141
|
Liabilities and
Stockholder's Equity
|
|
|
|
Total
liabilities
|
$
4,412
|
|
$
3,686
|
Series A
Convertible Preferred Stock
|
12,419
|
|
12,296
|
Total
stockholder's equity
|
7,168
|
|
14,159
|
Total Liabilities
and Stockholders' Equity
|
$
23,999
|
|
$
30,141
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
For the three
months ended June 30
|
|
2019
|
|
2018
|
Operating Costs
and Expenses
|
|
|
|
General
and administrative
|
$
1,044
|
|
$
1,431
|
Research
and development
|
2,594
|
|
3,572
|
Total Operating
Costs and Expenses
|
3,638
|
|
5,003
|
Loss from
Operations
|
(3,638)
|
|
(5,003)
|
Other
Income
|
|
|
|
Change
in fair value of warrant liability
|
-
|
|
783
|
Interest
income
|
80
|
|
6
|
Total Other
Income
|
80
|
|
789
|
Net
Loss
|
(3,558)
|
|
(4,214)
|
Net Loss
Attributable to Non-controlling Interest
|
(27)
|
|
(17)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
$
(3,531)
|
|
$
(4,197)
|
Series A Preferred
Stock Dividends
|
(61)
|
|
(61)
|
Series B Preferred
Stock Dividends
|
(117)
|
|
-
|
Net Loss
Attributable to Common Stockholders
|
(3,709)
|
|
(4,258)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.23)
|
|
$
(1.16)
|
Weighted average
number of common shares outstanding - Basic
and
Dilutive
|
16,465,314
|
|
3,683,383
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-second-quarter-2019-operational-highlights-and-financial-results-300899086.html
SOURCE Synthetic Biologics, Inc.