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Share Name | Share Symbol | Market | Type |
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Synthetic Biologics Inc | AMEX:SYN | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 1.02 | 0 | 01:00:00 |
ROCKVILLE, Md., May 15, 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 months ended March 31, 2014, and provided an operational progress update.
Recent Operational Highlights
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"[i], 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[ii].
Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody (mAb) Combination
SYN-005, a unique combination of two humanized antibodies designed to 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.
Constipation-Predominant Irritable Bowel Syndrome (C-IBS) – SYN-010 Oral Compound
Dr. Mark Pimentel, M.D., 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[iii], approximately 13.2 million have C-IBS[iv].
Relapsing-Remitting Multiple Sclerosis (RRMS) – Trimesta™ (oral estriol)
Trimesta's differentiated mechanism of action, combined with the convenience of once-daily oral dosing, potentially make it an ideal added therapy to address this underserved $14.1 billion worldwide market[v]. Based on previous research findings,[vi] Trimesta may offer both inflammatory and neuroprotective benefits for patients with MS when taken in combination with Copaxone®. Available MS therapies demonstrate anti-inflammatory and/or immunomodulatory responses but they are not considered neuroprotective.
"Synthetic Biologics' fundamental business mission is to develop novel anti-infectives to address significant unmet medical needs. We have built a strong pipeline of innovative anti-infective biologic and drug candidates, and we are committed to advancing these programs through preclinical studies, toward human clinical development," stated Jeffrey Riley, CEO of Synthetic Biologics. "We are on track to meet our goal of moving three anti-infective programs into the clinic during the coming 12 months. We look forward to reporting the progress of our anti-infective programs, and updating shareholders on our discussions with potential MS partners."
Three Months Ended March 31, 2014 Financial Results
General and administrative expenses were $1.1 million for both the three months ended March 31, 2014 and March 31, 2013. Charges related to stock-based compensation were $255,000 for the three months ended March 31, 2014, compared to $353,000 for the same period in 2013.
Research and development expenses increased to $2.7 million for the three months ended March 31, 2014, compared to $1.1 million for the same period in 2013. The increase of 143% is 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. Charges related to stock-based compensation were $107,000 for the three months ended March 31, 2014, compared to $104,000 for the same period in 2013.
Other income was $1,000 for the three months ended March 31, 2014, compared to $12,000 for the same period in 2013.
Conference Call
Synthetic Biologics will hold a conference call today, Thursday, May 15, 2014, at 8:30 am EDT. During the call, Jeffrey Riley, Synthetic Biologics' Chief Executive Officer, will provide an update of the Company's anti-infective drug pipeline for serious infections and diseases, including the prevention of C. difficile infections, reducing the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS) and the treatment of Pertussis, as well as its multiple sclerosis program. C. Evan Ballantyne, Synthetic Biologics' Chief Financial Officer, will review the Company's financial results for the three months ended March 31, 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=99332. 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=99332, for 30 days after the call.
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 treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, 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.
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 anticipated timing and results of the Synthetic Biologics' clinical trials and development efforts 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' monoclonal antibodies 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.
Synthetic Biologics, Inc. and Subsidiaries | |||||
(in thousands, except share and per share amounts) | |||||
Condensed Consolidated Balance Sheets |
|||||
March 31, |
December 31, | ||||
2014 |
2013 | ||||
(Unaudited) |
(Audited) | ||||
Assets |
|||||
Cash and cash equivalents |
$ 11,155 |
$ 14,625 | |||
Prepaid expenses and other current assets |
1,332 |
1,591 | |||
Property and equipment, net |
38 |
37 | |||
Deposits and other assets |
6 |
4 | |||
Total Assets |
$ 12,531 |
$ 16,257 | |||
Liabilities and Equity |
|||||
Current liabilities |
$ 773 |
$ 1,027 | |||
Synthetic Biologics, Inc. and subsidiaries equity |
11,758 |
15,230 | |||
Total Liabilities and Equity |
$ 12,531 |
$ 16,257 | |||
Condensed Consolidated Statements of Operations |
|||||
For the three months ended | |||||
2014 |
2013 | ||||
Operating Costs and Expenses |
|||||
General and administrative |
$ 1,122 |
$ 1,122 | |||
Research and development |
2,717 |
1,118 | |||
Total Operating Costs and Expenses |
3,839 |
2,240 | |||
Loss from Operations |
(3,839) |
(2,240) | |||
Other Income |
|||||
Interest income |
1 |
11 | |||
Other income |
- |
1 | |||
Total Other Income, net |
1 |
12 | |||
Net Loss |
(3,838) |
(2,228) | |||
Net Loss Attributable to Non-controlling Interest |
- |
- | |||
Net Loss Attributable to Synthetic Biologics, Inc. and |
$ (3,838) |
$ (2,228) | |||
Net Loss Per Share - Basic and Dilutive |
$ (0.07) |
$ (0.05) | |||
Net Loss Per Share Attributable to Synthetic Biologics, Inc. |
$ (0.07) |
$ (0.05) | |||
Weighted average number of common shares |
58,324,260 |
44,601,396 |
[i] U.S. Centers for Disease Control Web site: http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=51 Accessed: March 26, 2014.
[ii] 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.
[iii] GlobalData EPI Database Report – Prevalent Cases, March 2014.
[iv] American College of Gastroenterology website: http://patients.gi.org/topics/irritable-bowel-syndrome/#tabs3
Accessed: May 14, 2014.
[v] Credit Suisse. Multiple Sclerosis-Evolution or Revolution Report. March 18, 2013.
[vi] Sicotte, NL, et al. Treatment of Multiple Sclerosis with the Pregnancy Hormone Estriol. Ann Neurol 2002; 52:421–428.
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SOURCE Synthetic Biologics, Inc.
Copyright 2014 PR Newswire
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