ROCKVILLE, Md., Feb. 20, 2020 /PRNewswire/ -- 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 a
clinical programs update and reported financial results for the
year ended December 31, 2019.
"2019 was a highly eventful period marked by significant
progress as we continued to execute our strategy to advance and
demonstrate the significant value of our portfolio of GI and
microbiome-focused clinical programs," stated Steven A. Shallcross, Chief Executive and
Financial Officer. "Following the announcement of our clinical
trial collaboration with the Washington
University School of Medicine in St. Louis ("Washington
University") to advance SYN-004 in allogeneic hematopoietic
cell transplant (HCT) patients, we held an extremely productive
Type-C meeting with the U.S. Food and Drug Administration ("FDA")
to finalize the clinical program parameters of a Phase 1b/2a clinical trial expected to begin next
quarter. Allogeneic HCT recipients who receive broad-spectrum IV
beta-lactam antibiotics at onset of fever following conditioning
chemotherapy are at high risk for Clostridioides
difficile infection (CDI), colonization by
vancomycin-resistant Enterococci (VRE) and acute
graft-versus-host-disease (aGVHD). We believe 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
HCT, an area of significant unmet need."
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. Preclinical activities and
toxicology studies are ongoing and remain on track to support a
near-term Investigational New Drug Application (IND) filing for our
SYN-020 Intestinal Alkaline Phosphatase (IAP) program. 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
- Received official meeting minutes from FDA following a Type-C
meeting held on December 2, 2018 at
the Company's request to discuss the development of a Phase
1b/2a clinical trial of SYN-004
(ribaxamase) in allogeneic HCT recipients. Based on the final
meeting minutes,
-
- Enrollment is expected to begin during the second quarter of
2020 contingent upon approval of the clinical trial protocol by the
Washington University School of
Medicine's Institutional Review Board (IRB) and the FDA,
- The Phase 1b/2a clinical trial
will comprise a single center, randomized, double-blind,
placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in
up to 36 evaluable adult allogeneic HCT recipients,
- The goal of this clinical trial is to evaluate the safety,
tolerability and potential absorption into the systemic circulation
(if any) of 150 mg oral SYN-004 (ribaxamase) administered to
allogeneic HCT recipients who receive an IV beta-lactam antibiotic
to treat fever,
- Clinical trial participants will be enrolled into three
sequential cohorts and 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;
- Enrollment is ongoing in the Phase 2b investigator-sponsored clinical study of
SYN-010 for the treatment of IBS-C
-
- The Phase 2b clinical trial 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
up to 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;
- Completed Pre-IND meeting with FDA to discuss advancement of
SYN-020 (intestinal alkaline phosphatase) into clinical trials
targeting areas of significant unmet medical need, including
enterocolitis associated with radiation therapy for cancer
-
- Anticipate filing a US IND in Q2 2020;
- Continued to exercise prudent cash management and financial
stewardship to maintain cash runway through at least the fourth
quarter of 2020.
Year Ended December 31, 2019
Financial Results
General and administrative expenses decreased to $4.6 million for the year ended December 31, 2019, from $5.7 million for the year ended December 31, 2018. This decrease of 19% is due to
decreased stock-based compensation expense related to forfeitures
and decreased option grants, along with the reduction of investor
relations, consulting, registration, and legal costs. The
charge relating to stock-based compensation expense was
$0.3 million for the year ended
December 31, 2019, compared to
$1.0 million for the year ended
December 31, 2018.
Research and development expenses decreased to $11.1 million for the year ended December 31, 2019, from $11.8 million for the year ended December 31, 2018. This decrease of 6% is
primarily the result of lower SYN-004 (ribaxamase) indirect program
costs for the year ended December 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 year ended December 31, 2019,
offset by an increase in manufacturing and pre IND-enabling
toxicology study costs for SYN-020. Research and development
expenses also include a charge relating to non-cash stock-based
compensation expense of $75,000 for
the year ended December 31, 2019,
compared to $1.1 million for the year
ended December 31, 2018.
Total other income was $283,000
for the year ended December 31, 2019,
compared to other income of $4.2
million for the year ended December
31, 2018. Total other income for the year ended December 31, 2019 is primarily comprised of
interest income while total other income for the year ended
December 31, 2018 is comprised of
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 to December 31, 2018.
Cash and cash equivalents on December 31,
2019 were $15.0 million, a
decrease of $13.9 million from
December 31, 2018.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, February 20, 2020, 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/1096/32979. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/32979, for 90
days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a
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 clinical
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 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 anticipated initiation of a Phase 1b/2a investigator-sponsored clinical study in
allogeneic HCT patients in the second quarter of 2020, the
potential of SYN-004's unique mechanism of action designed
to degrade IV beta-lactam antibiotics and prevent dysbiosis of the
gut microbiome to significantly improve outcomes for patients who
undergo allogeneic HCT, an area of significant unmet
need, anticipated data readout for the
investigator-sponsored Phase 2b
clinical study for SYN-010 during the first half of 2020, the data
readout further fortifying the established clinical data set
for SYN-010 and supporting regulatory discussions to potentially
simplify future registration studies, anticipated IND filing for
SYN-020 in the first half of 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,
|
|
2019
|
|
2018
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
15,045
|
|
$
28,918
|
Prepaid
expenses and other current assets
|
1,381
|
|
593
|
Property
and equipment, net
|
367
|
|
607
|
Right of
Use Asset
|
419
|
|
-
|
Deposits
and other assets
|
23
|
|
23
|
Total
Assets
|
$
17,235
|
|
$
30,141
|
Liabilities and
Stockholder's Equity (Deficit)
|
|
|
|
Total
liabilities
|
$
5,748
|
|
$
3,686
|
Series A
Convertible Preferred Stock
|
12,544
|
|
12,296
|
Synthetic Biologics, Inc. and Subsidiaries Equity
(Deficit)
|
(1,057)
|
|
14,159
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
17,235
|
|
$
30,141
|
Condensed
Consolidated Statements of Operations
|
|
|
For the years
ended
December 31,
|
|
|
2019
|
|
2018
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
4,580
|
|
$
5,727
|
Research
and development
|
|
11,083
|
|
11,844
|
Total Operating
Costs and Expenses
|
|
15,663
|
|
17,571
|
Loss from
Operations
|
|
(15,663)
|
|
(17,571)
|
Other
Income
|
|
|
|
|
Change
in fair value of warrant liability
|
|
-
|
|
4,083
|
Interest
income
|
|
283
|
|
67
|
Total Other
Income
|
|
283
|
|
4,150
|
Net
Loss
|
|
(15,380)
|
|
(13,421)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(77)
|
|
(54)
|
Net Loss
Attributable to Synthetic Biologics, Inc.
and
Subsidiaries
|
|
$
(15,303)
|
|
$
(13,367)
|
Series A Preferred
Stock Dividends
|
|
(248)
|
|
(243)
|
Series B Preferred
Stock Dividends
|
|
(525)
|
|
(11,681)
|
Net Loss
Attributable to Common Stockholders
|
|
(16,076)
|
|
(25,291)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.98)
|
|
$
(4.06)
|
Weighted average
number of common shares
outstanding - Basic and Dilutive
|
|
16,438,201
|
|
6,232,442
|
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SOURCE Synthetic Biologics, Inc.