Full Press Release Details
Synthetic Biologics Reports Second Quarter
2014 Financial Results and Operational Highlights
-- Expanded Data from Phase II MS
Trial to be Released Next Month; Plans on Course to Advance
C-IBS Programs into the Clinic During 2014 --
-- Conference Call Today, August 14,
2014, at 8:30 a.m. (EDT); U.S. Participants Call (877) 870-4263 or Join Webcast at http://www.videonewswire.com/event.asp?id=100224
MD, August 14, 2014 - 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
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
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
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 marketi. 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.
Highlights and Upcoming Milestones:
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 annuallyiv.
Highlights and Upcoming Milestones:
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 Statesv, approximately 13.2 million have C-IBSvi.
Operational Highlights and Upcoming Milestones:
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:
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.