SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
March 16, 2015
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in
its charter)
| Nevada |
|
1-12584 |
|
13-3808303 |
| (State or other jurisdiction of incorporation) |
|
(Commission File No.) |
|
(IRS Employer Identification No.) |
155 Gibbs Street, Ste. 412
Rockville, MD 20850
(Address of principal executive offices
and zip code)
617 Detroit Street, Ste. 100
Ann Arbor, MI 48104
(Mailing Address and zip code)
Registrant’s telephone number, including
area code: (734) 332-7800
N/A
(Former name or former address, if changed
since last report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 - Results of Operations and
Financial Condition.
On March 16, 2015, Synthetic Biologics,
Inc., a Nevada corporation, (the “Registrant") issued the attached press release that included financial information
for its fiscal year ended December 31, 2014. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K.
The information contained in the press release is being furnished to the Commission and shall not be deemed incorporated by reference
into any of the Registrant’s registration statements or other filings with the Commission.
Item 9.01 Financial Statements and Exhibits.
| (d) Exhibits. |
|
| |
|
| Exhibit 99.1 |
Press Release issued by Synthetic Biologics, Inc. dated March 16, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
SYNTHETIC BIOLOGICS, INC. |
| |
|
| Date: March 16, 2015 |
By: |
/s/ C. Evan Ballantyne |
| |
Name: |
C. Evan Ballantyne |
| |
Title: |
Chief Financial Officer |
EXHIBIT INDEX
| Exhibit No. |
Exhibits. |
| |
|
| 99.1 |
Press Release issued by Synthetic Biologics, Inc. dated March 16, 2015. |
Exhibit 99.1
Synthetic Biologics Reports Year End
2014 Financial Results and Operational Highlights
-- Steady Progress in All Programs;
Two Phase 2 Clinical Trials to Start in 2015 --
-- Conference Call Today, March 16,
2015, at 8:30 a.m. (ET) --
For Immediate Release
Rockville,
MD, March 16, 2015 – Synthetic Biologics, Inc.
(NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting
the microbiome, today reported financial results for the year ended December 31, 2014, and provided
an operational update.
“During the past year Synthetic
Biologics made important advances in furthering our goal of building a late-stage, pathogen-specific, microbiome-focused portfolio
with strong opinion leader support and a solid investor base,” said Jeffrey Riley, Chief Executive Officer of Synthetic
Biologics. “This year we plan to initiate Phase 2 clinical trials in two programs – SYN-004, a preventive therapeutic
for C. difficile infection, and SYN-010, a treatment for irritable bowel syndrome with constipation (IBS-C), with topline
data expected from both programs by year end. In addition, we are making good progress with previously reported partnering discussions
on our relapsing-remitting multiple sclerosis (RRMS) program.”
Clinical Programs Update
SYN-004 is a first-in-class oral
enzyme preventive therapy designed to protect the gut microbiome from the unintended harmful effects of intravenous (IV) antibiotics,
for the prevention of C. difficile infection.
| · | Established Clinical Advisory Board and strengthened intellectual property portfolio |
| · | Completed Phase 1a and 1b clinical trials; reported positive topline safety and tolerability data
from both studies |
| · | Plan to initiate a Phase 2a clinical trial to evaluate gastrointestinal
(GI) antibiotic-degrading effects and safety (1Q 2015); expect topline data (1H 2015) |
| · | Presenting poster of late-breaking preclinical data for protection of microbiome at Digestive Disease
Week® (May 2015) |
| · | Plan to initiate a Phase 2b proof-of-concept clinical trial (2H 2015); expect topline data (2H
2015) |
SYN-010 is a proprietary, modified-release
statin formulation optimal for reducing methane-production by certain microorganisms in the gut to treat the underlying cause of
pain, bloating, and constipation associated with IBS-C.
| · | Established Clinical Advisory Board and
strengthened intellectual property portfolio |
| · | A 505(b)(2) regulatory pathway is anticipated
for development |
| · | Poster presentation of preclinical data
by lead principal investigator of Cedars-Sinai Medical Center at Digestive Disease Week® (May 2015) |
| · | Expect to submit an Investigational New
Drug (IND) application to initiate clinical trials (1H 2015) |
| · | Plan to initiate Phase 2 clinical trials
(2Q 2015); expect topline data (2H 2015) |
SYN-005 is a novel combination of
two monoclonal antibodies designed to treat Pertussis (whooping cough) by targeting and neutralizing pertussis toxin.
| · | Strengthened intellectual property portfolio
|
| · | Reported positive preclinical research
findings from non-human primate studies |
| · | Granted U.S. Orphan Drug designation by
the FDA |
| · | Seeking non-dilutive funding to support
clinical development (ongoing) |
TrimestaTM (oral estriol)
may offer a differentiated mechanism of action in the treatment of RRMS, as demonstrated in clinical trials. Based on Phase
2 clinical findings, Trimesta may offer both anti-inflammatory (decrease in relapse rate) and neuroprotective (improvements in
disability and cognition) benefits for patients with MS when taken in combination with Copaxone®.
| · | Expanded efficacy and safety results from
the investigator-initiated Phase 2 trial evaluating adjunctive Trimesta in women with RRMS including positive results on cognitive
and disability scores at 12 months, attesting to Trimesta's unique neuroprotective properties, were presented at the ACTRIMS-ECTRIMS
meeting in Boston in September 2014 by the trial's lead investigator. |
| · | Strengthened intellectual property portfolio
|
| · | As previously disclosed, active discussions
with a number of potential strategic partners may accelerate development of Trimesta (ongoing) |
| · | MRI brain scan analyses underway to evaluate changes in the brain that correlate with improvements
seen in clinical outcomes; topline data expected from the principal investigator during the first half of 2015 |
| · | A separate multi-center U.S. Phase 2 trial
is underway focused exclusively on cognition utilizing Trimesta with a variety of currently marketed MS drugs, including Copaxone®,
Avonex®, Betaseron®, Extavia®, Rebif®, Gilenya®, Aubagio® and Tecfidera® |
Year Ended December 31, 2014 Financial
Results
General and administrative expenses were
$6.0 million for the year ended December 31, 2014, compared to $5.8 million for the same period in 2013. This increase is primarily
the result of supplemental compensation granted by the Board of Directors to executive officers and increased stock-based compensation
expense during the year ended December 31, 2014, which was offset by the decrease of bad debt expense of $763,000 associated with
the note and interest receivables from the sale of Adeona Clinical Laboratory that were determined uncollectible during the year
ended December 31, 2013. Non-cash charges related to stock-based compensation were $1.6 million for the year ended December 31,
2014, compared to $1.3 million for the same period in 2013.
Research and development expenses increased
to $14.5 million for the year ended December 31, 2014, compared to $6.5 million for the same period in 2013. This increase of 123%
is primarily the result of increased program costs associated with expanded clinical development, manufacturing and research activities
within our pathogen-specific, microbiome-focused pipeline, including the Company’s C. difficile, IBS-C and Pertussis
programs. Non-cash charges related to stock-based compensation were $803,000 for the year ended December 31, 2014, compared to
$375,000 for the same period in 2013.
Other income was $718,000 for the year
ended December 31, 2014, compared to other income of $21,000 for the same period in 2013. The increase in other income is primarily
due to non-cash income of $620,000 from the change in fair value of warrants for the year ended December 31, 2014. The decrease
in fair value of the warrants was due to the decline in our stock price and the reduction in the time to maturity. There was no
non-cash income or expense relating to fair value warrants for the year ended December 31, 2013.
Cash at December 31, 2014 was $17.5 million
compared to $14.6 million at December 31, 2013.
Conference Call
Synthetic Biologics will hold a conference
call today, Monday, March 16, 2015, at 8:30 a.m. (ET), 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 year ended December
31, 2014.
Interested parties should call 1-888-347-5280
(U.S. toll free), 1-855-669-9657 (Canada toll free), or +1 412-902-4280 (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=101639.
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=101639,
for 30 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN)
is a clinical-stage biotechnology company developing pathogen-specific therapies for serious infections and diseases, with a focus
on protecting the microbiome. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics
for the prevention of C. difficile infection, an oral statin treatment to reduce the impact of methane producing organisms
on irritable bowel syndrome with constipation (IBS-C), and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal
antibody combination for the treatment of Pertussis. In addition, the Company is developing a Phase 2 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.
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 the planned Phase 2 clinical
trials, expected date of topline data from clinical trials, the expected date of submission of IND application for SYN-010, and
the 505 (b)(2) regulatory pathway anticipated for development of SYN-010. 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 prevention and treatment of diseases to be successfully developed
or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics
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.
For further information, please contact:
Synthetic Biologics: Kris Maly, VP, Corporate
Communication, (734) 332-7800, info@syntheticbiologics.com
Media: Wendy Emanuel, Wellspring Communications,
Inc., (773) 255-9580, wendy@wellspringcom.com
- Financial Tables Follow -
Synthetic Biologics, Inc. and Subsidiaries
(in thousands, except share and per
share amounts)
| Condensed Consolidated Balance Sheets |
| | |
December 31, | |
| | |
2014 | | |
2013 | |
| Assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 17,525 | | |
$ | 14,625 | |
| Prepaid expenses and other current assets | |
| 1,548 | | |
| 1,591 | |
| Property and equipment, net | |
| 65 | | |
| 37 | |
| Deposits and other assets | |
| 6 | | |
| 4 | |
| Total Assets | |
$ | 19,144 | | |
$ | 16,257 | |
| Liabilities and Equity | |
| | | |
| | |
| Current liabilities | |
$ | 9,588 | | |
$ | 1,027 | |
| Synthetic Biologics, Inc. and subsidiaries equity | |
| 9,556 | | |
| 15,230 | |
| Total Liabilities and Equity | |
$ | 19,144 | | |
$ | 16,257 | |
| Condensed Consolidated Statements of Operations | |
| |
| | |
For the years ended
December 31, | |
| | |
2014 | | |
2013 | |
| Operating Costs and Expenses | |
| | | |
| | |
| General and administrative | |
$ | 6,013 | | |
$ | 5,832 | |
| Research and development | |
| 14,489 | | |
| 6,507 | |
| Total Operating Costs and Expenses | |
| 20,502 | | |
| 12,339 | |
| Loss from Operations | |
| (20,502 | ) | |
| (12,339 | ) |
| Other Income (Expense) | |
| | | |
| | |
| Change in fair value of warrant liability | |
| 620 | | |
| - | |
| Interest income | |
| 3 | | |
| 33 | |
| Other income (expense) | |
| 95 | | |
| (12 | ) |
| Total Other Income, net | |
| 718 | | |
| 21 | |
Net Loss | |
| (19,784 | ) | |
| (12,318 | ) |
| Net Loss Attributable to Non-controlling Interest | |
| - | | |
| (1 | ) |
| Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries | |
$ | (19,784 | ) | |
$ | (12,317 | ) |
| Net Loss Per Share - Basic and Dilutive | |
$ | (0.32 | ) | |
$ | (0.27 | ) |
| Net Loss Per Share Attributable to Synthetic Biologics, Inc. and Subsidiaries | |
$ | (0.32 | ) | |
$ | (0.27 | ) |
| Weighted average number of common shares outstanding - Basic and Dilutive | |
| 61,945,356 | | |
| 45,667,813 | |
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