ROCKVILLE, Md., Aug. 14, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of novel
anti-infective biologic and drug candidates targeting specific
pathogens that cause serious infections and diseases, today
reported financial results for the three and six months ended
June 30, 2014, and provided an
operational progress update.
Jeffrey Riley, CEO of Synthetic
Biologics, stated, "We have accomplished key goals in all of our
pipeline programs, further built infrastructure, including GMP
manufacturing resources to support these activities, and filed new
patent applications covering our C-IBS and Pertussis programs, as
well as in the Trimesta program for multiple sclerosis (MS).
"Of particular note, I am pleased to report that significant
progress has been made in further analysis of the clinical outcomes
in the Phase II MS study of Trimesta since topline results were
presented in April 2014. It is
important to emphasize that patients treated with Trimesta
benefited from the dual mode of action of the drug, including the
anti-inflammatory effects that improve relapse rate, as well as the
potential neuroprotective effects that improve disability and
cognition measures. Additional MRI analyses are ongoing to evaluate
changes in the brain that correlate with the improvements seen in
clinical outcome. The expanded data from the trial continues to
build our confidence in the high value of this program for patients
with MS.
"In addition, we have completed plans to file INDs and initiate
clinical trials this year for our C. difficile and C-IBS
programs, both of which are expected to report topline Phase II
data in mid-2015. We also have plans to file an IND and start Phase
I testing during the first half of next year of our novel
monoclonal antibody cocktail as a first-in-class candidate for the
prevention and treatment of Pertussis (whooping cough)."
Mr. Riley added that near-term calendar events include a planned
September 12th
presentation at the 2014 Joint Americas and European Committees for
Treatment and Research in Multiple Sclerosis Meeting
(ACTRIMS-ECTRIMS) in Boston of
additional Trimesta MS data, including important new findings in
cognitive function, and a Company-sponsored IBS Investor Day
planned for September 16th
in NYC which will include clinical presentations by Mark Pimentel, M.D., FRCP(C) of Cedars-Sinai
Medical Center, the lead investigator of our 505(b)(2) compound,
SYN-010 for constipation-predominant irritable bowel syndrome
(C-IBS).
Three and Six Months Ended June 30,
2014 Financial Results
General and administrative expenses were $1.8 million and $2.9
million for the three and six months ended June 30, 2014, respectively, compared to
$1.3 million and $2.4 million for the same periods in 2013. These
increases of 44% and 23%, respectively, are primarily the result of
supplemental compensation granted by the Board of Directors to
executive officers and increased stock-based compensation expense.
Non-cash charges related to stock-based compensation were
$645,000 and $899,000 for the three and six months ended
June 30, 2014, respectively, compared
to $298,000 and $652,000 for the same periods in 2013.
Research and development expenses increased to $2.8 million and $5.6
million for the three and six months ended June 30, 2014, respectively, compared to
$1.2 million and $2.3 million, for the same periods in 2013. These
increases of 136% and 139%, respectively, are primarily the result
of increased program costs associated with expanded research,
development and manufacturing activities within our anti-infective
pipeline, including the Company's C. diff, C-IBS and
Pertussis programs. Non-cash charges related to stock-based
compensation were $210,000 and
$318,000 for the three and six months
ended June 30, 2014, respectively,
compared to $109,000 and $212,000 for the same period in 2013.
Other income was $95,000 and
$96,000 for the three and six months
ended June 30, 2014, respectively,
compared to other expense of $36,000
and $24,000 for the same periods in
2013.
Conference Call
Synthetic Biologics will hold a conference call today,
Thursday, August 14, 2014, at
8:30 am EDT, during which Mr. Riley
will provide an operational update and C.
Evan Ballantyne, Synthetic Biologics' Chief Financial
Officer, will review the Company's financial results for the three
and six months ended June 30,
2014.
Interested parties should call 1-877-870-4263 (U.S. toll free),
1-855-669-9657 (Canada toll free),
or +1 412-317-0790 (International), fifteen minutes before the
start of the call to register. Registered callers on the toll free
line may ask to be placed in the queue for the Question &
Answer Session. The call will also be webcast over the Internet at
http://www.videonewswire.com/event.asp?id=100224. If you are unable
to participate during the live conference call, the webcast will be
available for replay at the same URL,
http://www.videonewswire.com/event.asp?id=100224, for 30 days after
the call.
Clinical Programs Update
Relapsing-Remitting Multiple Sclerosis (RRMS) – Trimesta™
(oral estriol)
Trimesta's differentiated dual mechanism of action, combined
with the convenience of once-daily oral dosing, potentially make it
an ideal therapy to address this underserved $14.1 billion worldwide market[i].
Based on previous research findings,[ii] Trimesta may
offer both anti-inflammatory and neuro-protective benefits for
patients with MS. Available MS therapies demonstrate
anti-inflammatory or immunomodulatory effects, but in general are
not considered neuro-protective agents.
MS Operational Highlights and Upcoming Milestones:
- At the American Academy of Neurology annual meeting in April,
lead investigator Rhonda Voskuhl,
M.D. from the University of California, Los
Angeles (UCLA) David Geffen School of Medicine, presented
positive initial topline efficacy and safety results from the
investigator-initiated Phase II trial evaluating adjunctive
Trimesta in women with RRMS.
- The study was a Phase II comparing Trimesta plus Copaxone® to
Copaxone® alone as the active control arm in total of 158 women
with RRMS.
- Efficacy results far surpassed the investigator's expectations,
meeting the pre-specified endpoint of the study protocol by
demonstrating a statistically significant decrease in relapse rate
after 12 months of therapy, for which the study was powered to
achieve statistical significance, and a clinically meaningful
reduction in relapse rate after 24 months of therapy, powered for
trend as a pre-specified goal of the trial.
- Trimesta in combination was also safe and well tolerated by
women in the study.
- The study also demonstrated statistically significant and
clinically relevant improvement in cognitive scores at 12 months of
therapy, which is of high importance for MS specialists and
patients and is believed to be the result of Trimesta's unique
neuroprotective effect.
- Since the presentation of the initial topline results from the
trial, significant additional analyses have been performed on
various clinical outcome measures, as well as important parameters
from ongoing analysis of MRI brain scans.
- Dr. Voskuhl is scheduled to present some of the expanded data
from this additional clinical outcome analyses, including more
detailed results on cognitive and disability measures, at the
ACTRIMS-ECTRIMS meeting in Boston
on September 12, 2014.
- A separate Phase II trial focused exclusively on cognition
utilizing Trimesta with a variety of currently marketed MS drugs,
including Copaxone®, Avonex®, Betaseron®, Extavia®, Rebif®,
Gilenya®, Aubagio® and Tecfidera®, is currently enrolling patients
at four sites in the United
States.
- Synthetic Biologics continues discussions to attract a
strategic partner to accelerate development of this innovative
therapy for relapsing-remitting MS in women.
Prevention of C. difficile (C. diff.) Infections –
SYN-004 Oral Enzyme
SYN-004, Synthetic Biologics' lead
anti-infective product candidate, is believed to be the first and
only therapy designed to neutralize intravenous (IV) antibiotics in
the gut. It is intended to protect and maintain the balance of
bacterial flora in the gastrointestinal tract, to potentially
prevent the devastating effects of C. diff. The U.S.
Centers for Disease Control and Prevention (CDC) has classified
C. diff as an "urgent public health threat", surpassing
Methicillin-resistant Staphylococcus aureus (MRSA) as the
number one hospital-acquired infection in the United States. C. diff is a
multidrug-resistant bacterium that infects 1.1 million U.S.
patients annually,[iii] and 30,000 patients die with a
C. diff infection annually[iv].
C. diff Operational Highlights and Upcoming
Milestones:
- Completion of final preclinical toxicology study and subsequent
filing of an Investigational New Drug (IND) application in
anticipation of human clinical development expected in the upcoming
quarter.
- Initiation of Phase Ia and Ib clinical trials expected in the
fourth quarter of 2014, with preliminary topline data expected by
year-end 2014. A Phase II efficacy study is expected to begin
in the first half of 2015.
- Clinical drug manufacturing of SYN-004 in accordance with GMP
guidelines is currently underway pursuant to execution of an
agreement with Evonik.
- C. diff Clinical Advisory Board (CAB) comprised of
industry leaders Mark Wilcox, M.D.,
(Chairman), Curtis Donskey, M.D.,
Ciaran Kelly, M.D. and Tom Louie, M.D., formed to support clinical
development of SYN-004.
- Clinical microbiome study in collaboration with Enterome
Bioscience expected to begin in second half of 2014.
Constipation-Predominant Irritable Bowel Syndrome (C-IBS) –
SYN-010 Oral Compound
Dr. Mark
Pimentel of Cedars-Sinai Medical Center (CSMC), led the
investigational team whose critical discoveries into the underlying
cause of gas, pain and constipation associated with C-IBS
established the foundation of Synthetic Biologics' C-IBS program,
and are the basis for developing an oral treatment to reduce the
impact of methane-producing organisms on conditions such as C-IBS.
Of the 40 million IBS patients in the
United States[v], approximately 13.2 million have
C-IBS[vi].
C-IBS Operational Highlights and Upcoming Milestones:
- Initiation of a Phase II dose-discovery and proof-of-mechanism
clinical trial of SYN-010 in C-IBS expected during the second half
of 2014 under a corporate IND, with topline data expected
mid-2015.
- C-IBS CAB formed with Dr. Mark
Pimentel as Chairman; in process of adding other prominent
thought leaders and researchers in the field of C-IBS.
- Synthetic Biologics to host an IBS investor day in New York on September
16, 2014, to provide an overview of the clinical development
strategy for SYN-010, with Dr. Pimentel as keynote speaker.
Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody
(mAb) Combination
SYN-005, a unique combination of two
humanized antibodies designed to target and neutralize pertussis
toxin, a major cause of Pertussis-mediated infant morbidity and
mortality, is being developed under an exclusive channel
collaboration with Intrexon Corporation (NYSE: XON), and Synthetic
Biologics' academic collaborator, The University of Texas at Austin. Despite widespread
vaccination, Pertussis rates in the
United States continue to rise steadily, and according to
the World Health Organization, B. pertussis infection causes
an estimated 300,000 deaths worldwide each year, primarily among
young, unvaccinated infants.
Pertussis Operational Highlights and Upcoming
Milestones:
- Positive preclinical data reported from two non-human primate
studies, supporting the association of SYN-005 with favorable
decreases in white blood cell counts within two days and
achievement of nearly normal levels within one week of treatment
with SYN-005.
- Research was highlighted last month at a Gordon Research
Conference on Microbial Toxins and Pathogenicity by Synthetic
Biologics' academic collaborator at The University of Texas at Austin, Jennifer Maynard, Ph.D.
- Dr. Maynard to present Synthetic Biologics' SYN-005 mAb
combination for the treatment of Pertussis in an oral presentation
at the 54th Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC) on September
7th in Washington
D.C.
- Filing of IND and initiation of a Phase I clinical trial is
expected during the first half of 2015. Topline data is expected
within approximately 90 days of the start of the trial, after
which a Phase II trial is planned, with topline results expected in
the second half of 2015.
- Orphan Drug designation request submitted for SYN-005 for the
treatment of Pertussis.
- Intend to initiate cGMP manufacturing of SYN-005 to support
clinical studies.
Mr. Riley concluded, "We look forward to Dr. Voskuhl's
presentation at the ACTRIMS-ECTRIMS meeting in September. Dr.
Voskuhl is expected to provide details about the significant
clinical outcome measures including relapse rate, disability, and
cognition measures evaluated in this compelling Phase II trial. We
believe the unique and differentiated anti-inflammatory, as well as
neuroprotective benefits of Trimesta, have the potential to provide
a new opportunity to be an ideal added or standalone oral therapy
to address significant unmet needs for women affected by this
progressive, debilitating condition."
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of novel anti-infective biologic
and drug candidates targeting specific pathogens that cause serious
infections and diseases. The Company is developing an oral biologic
to protect the gastrointestinal microflora from the effects of IV
antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS), a series of monoclonal antibodies for the
treatment of Pertussis and Acinetobacter infections, and a
biologic targeted at the prevention and treatment of a root cause
of a subset of IBS. In addition, the Company is developing an oral
estriol drug for the treatment of relapsing-remitting multiple
sclerosis (MS) and cognitive dysfunction in MS. For more
information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
Copaxone® is a registered trademark of Teva Pharmaceutical
Industries Ltd. Avonex® is a registered trademark of Biogen Idec.
Rebif® is a registered trademark of EMD Serono, Inc. or its
affiliates. Betaseron® is a registered trademark of
Bayer HealthCare Pharmaceuticals. Extavia® is a
registered trademark of Novartis AG. Gilenya® is a
registered trademark of Novartis AG. Aubagio® is a registered
trademark of Genzyme Corporation. Tecfidera® is a registered
trademark of Biogen Idec.
This 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 advancing Synthetic
Biologics' clinical programs, Synthetic Biologics' opportunities
and its position in the infectious disease market, the intended
benefits of the products being developed, the anticipated timing
and results of the Synthetic Biologics' clinical trials, including
the expected initiation date of the Phase Ia and Ib clinical trial
for SYN-004, the date of release of topline data from the
trial, the Phase II efficacy trial for SYN -004 and the microbiome
study commencement date, expected date of the initiation of the
Phase II clinical trial for SYN-010 and release of topline data,
expected filing date of an IND, initiation of a Phase I clinical
trial and release of topline data for SYN-005, and the expected
size of the future market for sales of Synthetic Biologics'
therapies. The forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ
materially from those reflected in Synthetic Biologics'
forward-looking statements 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,
to be commenced or completed on time or to achieve desired results,
a failure of Synthetic Biologics' clinical trials to receive
anticipated funding, a failure of Synthetic Biologics' products for
the treatment of infectious diseases to be successfully developed
or commercialized, Synthetic Biologics' inability to maintain its
licensing agreements, or a failure by Synthetic Biologics or its
strategic partners to successfully commercialize products and other
factors described in Synthetic Biologics' report on Form 10-K for
the year ended December 31, 2013 and
any 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
|
|
|
June
30,
|
|
December
31,
|
|
2014
|
|
2013
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$ 7,843
|
|
$
14,625
|
Prepaid
expenses and other current assets
|
1,389
|
|
1,591
|
Property
and equipment, net
|
51
|
|
37
|
Deposits
and other assets
|
6
|
|
4
|
Total
Assets
|
$ 9,289
|
|
$
16,257
|
Liabilities and
Equity
|
|
|
|
Current
liabilities
|
$ 1,232
|
|
$
1,027
|
Synthetic Biologics, Inc. and subsidiaries equity
|
8,057
|
|
15,230
|
Total Liabilities
and Equity
|
$ 9,289
|
|
$
16,257
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
June 30,
|
|
For the six months
ended
June 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,814
|
|
$
1,258
|
|
$
2,936
|
|
$
2,380
|
Research
and development
|
2,837
|
|
1,203
|
|
5,554
|
|
2,321
|
Total Operating
Costs and Expenses
|
4,651
|
|
2,461
|
|
8,490
|
|
4,701
|
Loss from
Operations
|
(4,651)
|
|
(2,461)
|
|
(8,490)
|
|
(4,701)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Interest
income
|
-
|
|
10
|
|
1
|
|
21
|
Other
income (expense)
|
95
|
|
(46)
|
|
95
|
|
(45)
|
Total Other Income
(Expense), net
|
95
|
|
(36)
|
|
96
|
|
(24)
|
Net
Loss
|
(4,556)
|
|
(2,497)
|
|
(8,394)
|
|
(4,725)
|
Net Loss
Attributable to
Non-controlling
Interest
|
-
|
|
-
|
|
-
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(4,556)
|
|
$
(2,497)
|
|
$
(8,394)
|
|
$
(4,725)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.08)
|
|
$
(0.06)
|
|
$
(0.14)
|
|
$
(0.11)
|
Net Loss Per Share
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(0.08)
|
|
$
(0.06)
|
|
$
(0.14)
|
|
$
(0.11)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
58,453,528
|
|
44,654,414
|
|
58,348,153
|
|
44,628,051
|
[i] Credit Suisse. Multiple Sclerosis-Evolution or Revolution
Report. March 18, 2013.
[ii] Sicotte, NL, et al. Treatment of Multiple Sclerosis with
the Pregnancy Hormone Estriol. Ann Neurol 2002; 52:421–428.
[iii] This information is an estimate derived from the use of
information under license from the following IMS Health
Incorporated information service: CDM Hospital database for full
year 2012. IMS expressly reserves all rights, including rights of
copying, distribution and republication.
[iv] U.S. Department of Health & Human Services. Agency for
Healthcare Research and Quality. January 25,
2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed:
September 30, 2013.
[v] GlobalData EPI Database Report – Prevalent Cases,
March 2014.
[vi] American College of Gastroenterology website:
http://patients.gi.org/topics/irritable-bowel-syndrome/#tabs3
Accessed: May 14, 2014.
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SOURCE Synthetic Biologics, Inc.