ROCKVILLE, Md., Aug. 3, 2017 /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, 2017.
"During the second quarter, we achieved additional and exciting
progress for our lead microbiome-focused programs," said
Jeff Riley, President and Chief
Executive Officer of Synthetic Biologics. "The important momentum
generated during the quarter is perhaps best illustrated by the
FDA's granting of a Breakthrough Therapy Designation to ribaxamase,
the first ever such designation of a drug candidate for the
prevention of Clostridium difficile infection (CDI). We have
submitted a request for a Type-B multidisciplinary meeting with the
FDA to discuss potential options to expedite the development and
review timelines for ribaxamase's clinical advancement and path
towards marketing approval. We look forward to working closely with
the FDA on how to best move forward with this novel, complimentary
and potentially paradigm-shifting approach which may directly lead
to more effective and efficient antibiotic therapy."
Mr. Riley continued, "We also continued to be keenly focused on
ensuring we have in place the optimal timing and path forward for
the clinical advancement of SYN-010, our promising candidate for
the treatment of irritable bowel syndrome with constipation
(IBS-C). In June, we were pleased to announce that the U.S. Patent
and Trademark Office (USPTO) issued a Notice of Allowance for a
patent which covers the use of the active agent of SYN-010 to treat
constipation until at least 2034, significantly strengthening the
opportunity to build long-term value for our shareholders."
Microbiome-Focused Clinical Program Progress
SYN-004 – Prevention of C. difficile infection (CDI),
overgrowth of pathogenic organisms and the emergence of
antimicrobial resistance (AMR):
- Announced that the U.S. Food and Drug Administration (FDA)
granted the first-ever Breakthrough Therapy Designation to SYN-004
(ribaxamase) for the prevention of Clostridium difficile
infection
- Announced additional results from several exploratory endpoints
from Phase 2b proof-of-concept clinical trial funded under a
contract awarded to the Company from the Centers for Disease
Control and Prevention (CDC), demonstrating that SYN-004
(ribaxamase) prevented significant change to the presence of
certain AMR genes in the gut resistome of patients receiving
SYN-004 (ribaxamase) compared to placebo (Q3 2017)
-
- Expect to share additional results from several exploratory
endpoints from Phase 2b proof-of-concept clinical trial designed to
evaluate SYN-004's (ribaxamase) ability to protect the gut
microbiome from opportunistic bacteria and prevent the emergence of
antimicrobial resistance (AMR) in the gut microbiome (2H 2017)
- Submitted a request for a Type-B multidisciplinary meeting with
the FDA to discuss the overarching, high-level drug development
plan and pathway towards marketing approval for SYN-004
(ribaxamase) (2H 2017)
- Plan to initiate Phase 3 clinical trial(s) (1H 2018)
SYN-010 – Treatment of irritable bowel syndrome with
constipation (IBS-C):
- Announced that the U.S. Patent and Trademark Office (USPTO)
issued a Notice of Allowance for a patent which covers the use of
the active agent of SYN-010 for the treatment of constipation until
at least 2034
- Continue to solidify infrastructure to support successful
clinical advancement of SYN-010
Synthetic Biologics also announced that five abstracts have been
accepted for presentation at Infectious Disease Week 2017™ taking
place at the San Diego Convention
Center in San Diego, CA from
October 4 - 8, 2017. Members of the
Synthetic Biologics team will present three posters on SYN-004, and
one poster on SYN-006 and SYN-005 at ID Week™.
Infectious Disease Week™ (ID Week)
October 5, 2017
- Presentation 136: SYN-004 (ribaxamase) Prevents New
Onset Clostridium difficile Infection by Protecting the
Integrity of the Gut Microbiome in a Phase 2b Study
-
- Session 42: The Cutting Edge in Antimicrobial Resistance
Emergence Therapy from 10:30 a.m. –
10:45 a.m. CDT
- Venue: San Diego Convention
Center
- Presentation 86: Passive Immunization with
Anti-Pertussis Toxin Humanized Monoclonal Antibody Mitigates
Clinical Signs of Pertussis Infection in Newborn Baboons
-
- Session 29: Identification, Treatment, and Prevention of
Pediatric Bacterial Pathogens from 9:30
a.m. – 9:45 a.m. CDT
- Venue: San Diego Convention
Center
- Poster 630: SYN-006, a Novel Carbapenemase, Intended to
Protect the Gut Microbiome from Antibiotic-Mediated Damage May Also
Reduce Propagation of Carbapenem-Resistant Pathogens
-
- Session: Microbiome from 12:30
p.m. – 2:00 p.m. CDT
- Venue: San Diego Convention
Center Halls CD
- Poster 633: Gut Antibiotic Inactivation by
Beta-Lactamases Is Intended to Prevent Microbiome Damage and
Attenuate Antibiotic Resistance in Large Animal Models
-
- Session: Microbiome from 12:30
p.m. – 2:00 p.m. CDT
- Venue: San Diego Convention
Center Halls CD
October 7, 2017
- Poster 1843: SYN-004 (ribaxamase) Protects the Diversity
of the Gut Microbiome in Patients Receiving Intravenous Ceftriaxone
Treatment
-
- Session: Clinical Study with New Antibiotics and Antifungals
from 12:30 p.m. – 2:00 p.m. CDT
- Venue: San Diego Convention
Center Halls CD
Second Quarter 2017 Financial Results
General and administrative expenses decreased by 23% to
$1.6 million for the second quarter
of 2017, from $2.1 million for the
second quarter of 2016. This decrease is primarily the result of
higher salary expense and related benefits costs incurred in 2016
in connection with the transition of the administrative and
financial office to our Maryland
headquarters, along with a reduction of travel and legal expenses
in 2017. The charge related to stock-based compensation expense was
$539,000 for the second quarter of
2017, compared to $507,000 for the
second quarter of 2016.
Research and development expenses decreased by 33% to
$4.8 million for the second quarter
of 2017, from $7.2 million for the
second quarter of 2016. This decrease is primarily the result of
lower SYN-004 (ribaxamase) program costs. In addition, there were
reductions in our other research and development activities,
including our SYN-010 program, offset by an increase in indirect
costs for medical affairs. Research and development expenses
also include a charge related to stock-based compensation expense
of $331,000 for the second quarter of
2017, compared to $400,000 for the
second quarter of 2016.
Other income was $2.2 million for
the second quarter of 2017, compared to other income of
$3.5 million for the second quarter
of 2016. Other income for the second quarter of 2017 is due to
non-cash income of $2.2 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 June 30,
2017 remained relatively unchanged at $13.4 million, a small decrease from the prior
quarter.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, August 3, 2017, at
8:30 a.m. EDT. The dial-in
information for the call is as follows: U.S. toll free:
1-888-347-5280 and 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/1096/21899. An
archive of the conference call will be available for approximately
90 days at the same URL,
https://www.webcaster4.com/Webcast/Page/1096/21899, beginning
approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a late-stage
clinical company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development are: (1)
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), overgrowth of pathogenic organisms
and the emergence of antimicrobial resistance (AMR), 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 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 includes forward-looking statements on
Synthetic Biologics' current expectations and projections about
future events. 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. These statements
are based upon current beliefs, expectations and assumptions and
are subject to a number of risks and uncertainties, many of which
are difficult to predict and include statements regarding the
potentially paradigm shifting approach which may directly lead to
more effective and efficient antibiotic therapy, the expected
sharing of additional results from several exploratory endpoints
from Phase 2b proof-of-concept clinical trial 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, plans to initiate a Phase 3
clinical trial of SYN-004 and the potential and results to be
achieved from the products. 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 substantial
risks and uncertainties, many of which are difficult to predict and
could cause actual results to differ materially and adversely from
current expectations and assumptions from those set forth,
projected 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' 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, 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 revise or 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
|
|
|
June
30,
|
|
December
31,
|
|
2017
|
|
2016
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
13,376
|
|
$
19,055
|
Prepaid
expenses and other current assets
|
1,540
|
|
2,515
|
Property
and equipment, net
|
800
|
|
905
|
Deposits
and other assets
|
24
|
|
23
|
Total
Assets
|
$
15,740
|
|
$
22,498
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
Totla
liabilities
|
$
12,778
|
|
$
20,249
|
Synthetic Biologics, Inc. and subsidiaries equity
(deficit)
|
2,962
|
|
2,249
|
Total Liabilities
and Stockholders' Equity (Deficit)
|
$
15,740
|
|
$
22,498
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
June 30,
|
|
For the six months
ended
June 30,
|
|
(Unaudited)
|
|
(Unaudited)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,644
|
|
$
2,147
|
|
$
3,734
|
|
$
4,573
|
Research
and development
|
4,831
|
|
7,164
|
|
10,891
|
|
15,319
|
Total Operating
Costs and Expenses
|
6,475
|
|
9,311
|
|
14,625
|
|
19,892
|
Loss from
Operations
|
(6,475)
|
|
(9,311)
|
|
(14,625)
|
|
(19,892)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Change
in fair value of warrant
liability
|
2,159
|
|
3,153
|
|
7,249
|
|
3,015
|
Interest
income
|
1
|
|
34
|
|
3
|
|
35
|
Total Other Income
(Expense), net
|
2,160
|
|
3,547
|
|
7,252
|
|
3,050
|
Net
Loss
|
(4,315)
|
|
(5,764)
|
|
(7,373)
|
|
(16,842)
|
Net Loss
Attributable to Non-controlling Interest
|
(60)
|
|
(82)
|
|
(272)
|
|
(315)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(4,255)
|
|
$
(5,682)
|
|
$
(7,101)
|
|
$
(16,527)
|
Net Loss Per Share
- Basic
|
$
(0.03)
|
|
$
(0.06)
|
|
$
(0.06)
|
|
$
(0.18)
|
Net Loss Per Share
- Dilutive
|
$
(0.03)
|
|
$
(0.10)
|
|
$
(0.06)
|
|
$
(0.21)
|
Weighted average
number of common shares outstanding - Basic
|
123,005,220
|
|
91,015,733
|
|
120,241,593
|
|
90,921,243
|
Weighted average
number of common shares outstanding - Dilutive
|
123,005,220
|
|
93,930,540
|
|
120,241,593
|
|
92,651,215
|
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SOURCE Synthetic Biologics, Inc.