ROCKVILLE, Md., May 4, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: 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, 2017.
"During the first quarter of 2017, we announced several
important clinical milestones which continue to drive momentum for
Synthetic Biologics," said Jeffrey
Riley, President and Chief Executive Officer. "We announced
positive results from our Phase 2b proof-of-concept clinical trial
for ribaxamase demonstrating the achievement of the primary
endpoint of significantly reducing the incidence of primary
Clostridium difficile infection (CDI). In addition, data
from this study demonstrated that ribaxamase significantly lowered
the incidence of new colonization by vancomycin-resistant
enterococci (VRE), compared to placebo. Most recently, we shared
supportive data from exploratory endpoints in this trial with the
CDC demonstrating ribaxamase successfully protected and preserved
the naturally occurring composition of the gut microbiome from the
dysbiotic effects of IV ceftriaxone, compared to placebo. These
results position ribaxamase as a leader in clinical development for
microbiome-based interventions specifically designed to prevent the
incidence of primary CDI and antimicrobial resistance (AMR) amongst
at-risk patients. We continue to analyze data from this study and
expect to share results in the coming months from several
additional exploratory endpoints designed to evaluate ribaxamase's
ability to prevent the emergence and proliferation of AMR in the
gut microbiome."
Mr. Riley continued, "Since the beginning of the first quarter,
we also shared positive preclinical findings for SYN-005, our
orphan drug program designed to treat and prevent pertussis, which
if translated to humans may provide a much-needed approach to
protecting and treating the more than 50 million global at-risk
individuals, especially newborns in the developing world. Looking
ahead, we are focused on building upon the progress of the first
quarter during the remainder of 2017. With the foundation of our
Phase 2b/3 adaptive design pivotal trial in place for SYN-010,
intended to treat an underlying cause of IBS-C, we remain focused
on solidifying the infrastructure to support its continued
successful clinical advancement."
Microbiome-Focused Clinical Program
Progress
SYN-004 – Prevention of C. difficile infection (CDI),
antibiotic-associated diarrhea (AAD) and the emergence of
antimicrobial resistance (AMR):
- Reported positive topline data from global Phase 2b
proof-of-concept randomized, double-blind, placebo controlled
clinical trial of 412 patients (1Q 2017)
-
- Achieved primary endpoint, demonstrating a statistically
significant relative risk reduction of 71.4% (p=0.045) in CDI
rates, compared to placebo
- Demonstrated a significant reduction in new colonization by
vancomycin-resistant enterococci (VRE) for patients receiving
ribaxamase, compared to placebo (p=0.0002)
- Reported supportive data from several exploratory endpoints
from Phase 2b proof-of-concept clinical trial demonstrating
ribaxamase protected the gut microbiome from antibiotic-mediated
dysbiosis in patients receiving ribaxamase, compared to
placebo
-
- Patients receiving ribaxamase demonstrated significantly better
maintenance of and recovery of the composition of the gut
microbiome, compared to placebo
- Patients receiving ribaxamase demonstrated lower incidences of
new colonization by VRE and other opportunistic and potentially
pathogenic microorganisms, compared to placebo
- These results are consistent with protection of the gut
microbiome and with ribaxamase's mechanism of action during IV
administration of ceftriaxone
- Expect to share results from several additional exploratory
endpoints designed to evaluate ribaxamase's ability to protect the
gut microbiome from opportunistic bacteria and prevent the
emergence of antimicrobial resistance (AMR) in the gut microbiome
(2H 2017)
- Anticipate requesting end of Phase 2 meeting with FDA (2H
2017)
- Plan to initiate Phase 3 clinical trial(s) (1H 2018)
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Confirmed key elements of Pivotal Phase 2b/3 clinical trial
pursuant to consultations with the FDA (1Q 2017)
-
- A 12-week, multi-center, double-blind, placebo-controlled,
adaptive design clinical trial
- A study population of approximately 840 adult subjects
diagnosed with IBS-C
- Evaluation of efficacy and safety of two dose strengths of
SYN-010 (21 mg and 42 mg) compared to placebo
- Conducted in approximately 150 clinical sites in North America
- Study subjects will be randomized in a 1:1:1 ratio, receiving
either 21 mg of SYN-010, 42 mg of SYN-010, or placebo
- Enrollment is open to all IBS-C patients; breath-methane will
be measured at baseline to ensure a comparable ratio of high-to-low
breath methane IBS-C patients in each treatment arm
- An interim futility analysis may be conducted when
approximately 50% of patients in each dosing arm have completed
treatment
SYN-005 – Treatment and Prevention of Pertussis (whooping
cough)
- Reported positive preclinical research findings from neonatal
non-human primate study designed to determine if administration of
hu1B7, one component of SYN-005, at two days of age could protect
study animals from a subsequent pertussis infection
-
- Control animals (n=6), challenged with Bordetella
pertussis (B. pertussis) at five weeks of age,
demonstrated marked elevations in white blood cell counts and most
exhibited behavioral signs of pertussis including coughing and
diminished activity
- Treatment animals (n=7), treated with hu1B7 at two days of age
and then infected five weeks later, had significantly lower peak
white blood cell counts (p=0.004) that remained within the normal
range or were only slightly elevated
- All seven treatment animals that received prophylactic hu1B7
appeared healthy and none exhibited any behavioral signs of
pertussis
Synthetic Biologics also announced that four abstracts have been
accepted for presentation at Digestive Disease Week ® 2017. Members
of the Synthetic Biologics team will present two posters on SYN-010
and two talks on ribaxamase at DDW ®.
Digestive Disease Week ® (DDW)
May 7, 2017
- Poster Su2012: Poster Su2012: Increased pulmonary
CO2 Excretion in Patients with Small Intestinal Bacterial
Overgrowth (SIBO): Possible Implications for COPD
-
- Session Number 7245 from 12:00
p.m. – 2:00 p.m. CDT
- Venue: McCormick Place, South Hall
- Poster Su1562: Initial Paradoxical Peaks on Breath
Testing (first sample high) do not Affect the Diagnostic Utility of
the Spot-methane Breath Test
-
- Session Number 7130 from 12:00
p.m. – 2:00 p.m. CDT
- Venue: McCormick Place, South Hall
- Lecture 332g: An Orally Delivered Beta-Lactamase
Protects the Gut Microbiome from Antibiotic-Mediated Damage and
Mitigates the Propagation of Antibiotic-Resistance Genes in a
Porcine Dysbiosis Model.
-
- Session Number 3505 from 2:15
p.m. – 2:30 p.m. CDT
- Venue: McCormick Place, room S503
May 9, 2017
- Lecture 874j: SYN-004 (ribaxamase), an Oral
β-Lactamase, Prevented Clostridium difficile Infection and
Protected Patients from Colonization by Antimicrobial Resistant
Pathogens by Preserving Gut Microbiome Diversity in a Phase 2b
Clinical Trial
-
- Session Number 5235 from 10:30
a.m. – 10:45 a.m. CDT
- Venue: McCormick Place, room S103
Quarter Ended March 31, 2017
Financial Results
General and administrative expenses were $2.1 million for the three months ended
March 31, 2017, compared to
$2.4 million for the same period in
2016. This decrease is primarily the result of lower employee
salary expense and related benefits costs along with reduced travel
and legal expenses. The charge related to stock-based compensation
expense was $698,000 for the three
months ended March 31, 2017, compared
to $643,000 the same period in
2016.
Research and development expenses were $6.0 million for the three months ended
March 31, 2017, compared to
$8.1 million for the same period in
2016. This decrease is primarily the result of lower ribaxamase
program costs associated with its clinical development program, as
well as manufacturing and research activities within our other
microbiome-focused research and development activities. The charge
related to non-cash stock-based compensation expense was
$437,000 for the three months ended
March 31, 2017, compared to
$409,000 for the same period in
2016.
Other income was $5.1 million for
the three months ended March 31,
2017, compared to other expense of $0.5 million for the same period in 2016. Other
income for the three months ended March 31,
2017 is due to non-cash income of $5.1 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 from the prior quarter.
Cash and cash equivalents as of March 31,
2017 was $13.5 million, a
decrease of $5.6 million from
December 31, 2017.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, May 4, 2017, at
4:30 p.m. (EDT). 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/1096/20882. An archive of
the call will be available for replay at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/20882, for 90 days
after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics designed to preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development are: (1)
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), and (2) SYN-004
(ribaxamase) which is designed to protect the gut microbiome from
the effects of certain commonly used intravenous (IV) beta-lactam
antibiotics for the prevention of C. difficile infection
(CDI), antibiotic-associated diarrhea (AAD) and the emergence of
antimicrobial resistance (AMR). The Company is also developing
preclinical stage monoclonal antibody therapies for the prevention
and treatment of pertussis and novel discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This press 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 results of Synthetic Biologics' Phase 2b
proof-of-concept clinical trial for ribaxamase positioning
ribaxamase as a leader in clinical development for microbiome-based
interventions specifically designed to prevent the incidence of
primary CDI and antimicrobial resistance (AMR) amongst at-risk
patients, the continued analysis of data from
this study, the expected sharing of results in the coming
months from several additional exploratory endpoints designed to
evaluate ribaxamase's ability to prevent the emergence and
proliferation of AMR in the gut microbiome, the ability of SYN-005
to provide an approach to protecting and treating the more than 50
million global at-risk individuals for pertussis, the size of the
pertussis market, the continued clinical advancement of SYN-010 for
the treatment of IBS-C, the anticipated requesting end of
Phase 2 meeting with FDA , expected initiation of
Phase 3 clinical trials for SYN-004 and Phase2b/3 clinical trial
for SYN-010 and the timing of the initiation, and the
potential benefits of SYN-004 and SYN-010. 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, Synthetic
Biologics' product candidates demonstrating safety and
effectiveness, as well as results that are consistent with prior
results, Synthetic Biologics' ability to initiate clinical trials
and if initiated, to complete them on time and achieve desired
results and benefits, Synthetic Biologics' ability to successfully
design a protocol and a corresponding statistical analysis plan to
support the execution of its pivotal clinical trials, Synthetic
Biologics' clinical trials continuing enrollment as expected,
Synthetic Biologics' ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to
Synthetic Biologics' ability to promote or commercialize its
product candidates for specific indications, 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 maintain its
license agreements, the continued maintenance and growth of
Synthetic Biologics' patent estate, Synthetic Biologics
becoming and remaining profitable, Synthetic
Biologics' ability to establish and maintain collaborations,
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' Annual Report on Form 10-K for
the year ended December 31, 2016 and
its other filings with the SEC. 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)
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
|
Cash and
cash equivalents
|
|
$
13,471
|
|
$
19,055
|
Prepaid
expenses and other current assets
|
|
3,366
|
|
2,515
|
Property
and equipment, net
|
|
859
|
|
905
|
Deposits
and other assets
|
|
23
|
|
23
|
Total
Assets
|
|
$
17,719
|
|
$
22,498
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
$
16,488
|
|
$
19,757
|
Long-term deferred rent
|
|
470
|
|
492
|
Total
stockholders' equity
|
|
761
|
|
2,249
|
Total Liabilities
and Stockholders' Equity
|
|
$
17,719
|
|
$
22,498
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the three
months ended
March 31,
|
|
|
2017
|
|
2016
|
|
|
(unaudited)
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
2,090
|
|
$
2,426
|
Research
and development
|
|
6,059
|
|
8,155
|
Total Operating
Costs and Expenses
|
|
8,149
|
|
10,581
|
Loss from
Operations
|
|
(8,149)
|
|
(10,581)
|
Other Income
(Expense)
|
|
|
|
|
Change
in fair value of warrant liability
|
|
5,090
|
|
(498)
|
Interest income
|
|
1
|
|
1
|
Total Other
Expense, net
|
|
5,091
|
|
(497)
|
Net
Loss
|
|
(3,058)
|
|
(11,078)
|
Net Loss
Attributable to Non-controlling Interest
|
|
(212)
|
|
(233)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(2,846)
|
|
$
(10,845)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.02)
|
|
$
(0.12)
|
Weighted average
number of common shares outstanding during the period - Basic and
Dilutive
|
|
117,447,260
|
|
90,826,752
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-first-quarter-2017-operational-highlights-and-financial-results-300451867.html
SOURCE Synthetic Biologics, Inc.