Click here to close now.

Welcome!

.NET Authors: Pat Romanski, Elizabeth White, Liz McMillan, Jaynesh Shah, Carmen Gonzalez

News Feed Item

Synthetic Biologics Reports Third Quarter 2012 Financial Results

-- Accelerating Development of Product Candidates to Address Serious Infectious Diseases --

ROCKVILLE, Md., Nov. 14, 2012 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, today reported financial results for the three and nine months ended September 30, 2012 and summarized operational highlights.

Operational Highlights

Completed Successful Capital Raise

  • Increased cash position with net proceeds of $10.1 million from the sale of approximately 6.8 million shares of common stock to new and existing investors in a private placement financing. Existing investors and an affiliate of R.J. Kirk constituted a majority of the participating investors in this transaction.

Ramping Up Infectious Disease Programs

  • Entered into an agreement with Prev AbR LLC to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile (C. diff) infection, the leading cause of hospital acquired infections (HAI), that may occur secondary to treatment with antibiotics. CDI is a widespread and often drug resistant infectious disease, resulting in more than 337,000 hospitalizations, 30,000 deaths[1] and aggregate costs associated with stays in the hospital of $8.2 billion[2] in the U.S. during 2009.
  • Initiated efforts to develop a monoclonal antibody (mAb) therapy for the treatment of Acinetobacter, a multidrug-resistant pathogen that is a leading cause of hospital-acquired infections. Our Intrexon collaboration enables us to have access to a comprehensive suite of proprietary mAb technologies including the mAbLogix™ and LEAP™ platforms, to develop fully human mAbs to neutralize acinetobacter pathogens. In addition to Acinetobacter, we expect to utilize Intrexon's technologies to target two other infectious disease indications.
  • Engaged Lewis (Lew) Barrett, former Assistant Vice President, Established Products at Pfizer and Vice President Global Business Manager, Infectious Diseases at Wyeth Pharmaceuticals. As an advisor, Mr. Barrett will provide his expertise for the development and commercialization of infectious diseases.
  • Appointed Charles B. Shoemaker, Ph.D., to serve as a member of our Scientific Advisory Board to aid in the research process for our infectious disease program. Dr. Shoemaker has over 30 years of experience as a scientist in academia, government agencies and the biotechnology industry. He also serves as Professor of Biomedical Sciences at Tufts University's Cummings School of Veterinary Medicine, where he develops treatments for the prevention and cure of toxins from Clostridium difficile, E. coli, anthrax and ricin, among other microbial toxins.

Strengthened Management Team

  • Appointed Andrew Bristol, Ph.D. as Vice President of Research and Development, guiding the research development team in the mAbs drug development process. Dr. Bristol has over 20 years of experience in cancer research and drug development with a focus on monoclonal antibodies and cancer vaccines.
  • Promoted Michael Kaleko, M.D., Ph.D. to Senior Vice President of Research Development, to further expand the synthetic biologic and infectious disease programs.

"We are making considerable strides in our infectious disease programs, with our progress to develop mAbs for infectious diseases and through our efforts to acquire a C. diff program. Utilizing Intrexon's proprietary mAb technologies, we have successfully initiated development for the first mAb candidate, Acinetobacter, a debilitating multi-drug resistant disease with a multi-billion dollar market opportunity. We expect to hit milestones in the mAb discovery phase for this disease during 2013. In order to quickly advance our infectious disease platform, we've strengthened our R&D management team and Scientific Advisory board, which has enhanced our position in the biotech space," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

"Our recent private placement has increased our cash position, allowing us to further advance our clinical programs, as well as develop our preclinical and discovery projects. We look forward to announcing our additional infectious disease targets, as well as the progress of our C. diff program," concluded Mr. Riley.

Three and Nine Months Ended September 30, 2012 Financial Results

As part of management's plan to streamline our focus, we sold the clinical reference lab on March 8, 2012. Laboratory revenues for the three and nine months ended September 30, 2012 and September 30, 2011 were charged to discontinued operations, resulting in no revenues for these periods. In addition, the gain on the sale of the clinical reference lab of $677,000 was included in discontinued operations for the nine months ended September 30, 2012.

General and administrative expenses were $1.1 million and $3.7 million for the three and nine months ended September 30, 2012, respectively, compared to $582,000 and $2.3 million for the same periods in 2011. These increases of 84% and 59%, respectively, are primarily the result of additional employee costs, the expansion of our investor relation activities and legal fees. Charges related to stock-based compensation were $279,000 and $1.1 million for the three and nine months ended September 30, 2012, respectively, compared to $51,000 and $861,000 for the same periods in 2011.

Research and development expenses were $763,000 and $1.7 million for the three and nine months ended September 30, 2012, respectively, compared to $289,000 and $801,000 for the same periods in 2011. These increases of 164% and 112%, respectively, are primarily the result of additional employee costs and increased program costs associated with our expanded pipeline, including the initiation of development efforts for a monoclonal antibody (mAb) therapy for the treatment of Acinetobacter infections and of our preclinical program for the development of a DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH). Charges related to stock-based compensation were $116,000 and $238,000 for the three and nine months ended September 30, 2012, respectively, compared to $6,000 and $20,000 for the same periods in 2011.

Other income was $10,000 for the three months ended September 30, 2012, compared to other expense of $159,000 for the same period in 2011. Other income was $22,000 for the nine months ended September 30, 2012, compared to other expense of $1.7 million for the same period in 2011. Other expense for the nine months ended September 30, 2011 related to the estimated fair value of the warrants associated with the January 2011 and April 2011 financings, adjusted for the change in their fair value at September 30, 2012.

Cash at September 30, 2012 was $4.6 million compared to $6.7 million at December 31, 2011. As of October 31, 2012, we had approximately $14.2 million in cash.

About Synthetic Biologics, Inc.

Synthetic Biologics is a biotechnology company focused on the development of product candidates for serious infections and diseases. Synthetic Biologics is developing a biologic for the prevention of C. diff infection, and a series of monoclonal antibodies (mAbs) for the treatment of serious infectious diseases, including Acinetobacter. The Company is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension (PAH). In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and designing a clinical development pathway for the treatment of amyotrophic lateral sclerosis (ALS). For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.

mAbLogix™ and LEAP™ are registered trademarks of Intrexon Corporation.

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 our continued focus of our efforts in the field of synthetic biology and advancing our clinical programs and the expected size of the future market for sales of therapies for CDI and Acinetobacter. 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 our therapeutics, a failure of our clinical trials to be commenced or completed on time or to achieve desired results, a failure of our clinical trials to receive anticipated funding, a failure of gene therapy to receive market acceptance, a failure of our monoclonal antibodies for the treatment of infectious diseases to be successfully developed or commercialized, our inability to maintain our licensing agreements, including our agreement with Intrexon, our inability to successfully integrate new management, or a failure by us or our strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' report on Form 10-K/A for the year ended December 31, 2011 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 data)


Condensed Consolidated Balance Sheets


September 30,


December 31,


2012


2011


(Unaudited)


(Audited)

Assets




   Cash

$          4,577


$         6,678

   Accounts receivable, net

122


405

   Other

151


16

   Assets of discontinued operations

-


23

   Property and equipment, net

249


323

   Long-term note receivable

700


-

   Deposits and other assets

27


31

Total assets

$          5,826


$         7,476

Liabilities and Stockholders' Equity




   Current liabilities

$             417


$            417

   Stockholders' equity

5,409


7,059

Total liabilities and stockholders' equity

$          5,826


$         7,476

 


Condensed Consolidated Statements of Operations (Unaudited)


For the three months ended
September 30,


For the nine months ended
September 30,


2012


2011


2012


2011

Operating Costs and Expenses








   General and administrative

$      1,073


$          582


$       3,717


$       2,339

   Research and development

763


289


1,696


801

Total operating costs and expenses

1,836


871


5,413


3,140

Loss from Continuing Operations

(1,836)


(871)


(5,413)


(3,140)

Other Income (Expense)








   Warrant expense  

-


-


-


(1,492)

   Change in fair value of warrant liability

-


(165)


-


(242)

   Other income (expense)

10


6


22


55

Total other income (expense), net

10


(159)


22


(1,679)

Loss from Continuing Operations

(1,826)


(1,030)


(5,391)


(4,819)

Income (Loss) from Discontinued Operations

(104)


(68)


389


(145)

Net Loss and Comprehensive Loss

$    (1,930)


$     (1,098)


$    (5,002)


$    (4,964)

Net Income (Loss) Per Share - Basic and Dilutive








   Continuing Operations

$      (0.05)


$       (0.04)


$      (0.16)


$      (0.18)

   Discontinued Operations

-


-


0.01


-

Net Loss Per Share

$      (0.05)


$       (0.04)


$      (0.15)


$      (0.18)

Weighted average number of common shares outstanding - Basic and Dilutive

33,383,226


28,089,492


32,801,415


27,075,730

 


[1] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. Available at http://www.ahrq.gov/news/nn/nn012512.htm. Accessed November 5, 2012.
[2] Agency for Healthcare Research and Quality. Healthcare and Cost Utilization Project. Statistical Brief #124. Clostridium difficile Infections (CDI) in Hospital Stays, 2009. January 2012. Available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf.

SOURCE Synthetic Biologics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, including what it is today, what it might ultimately be, the role of wearable tech, and technology gaps stil...
From telemedicine to smart cars, digital homes and industrial monitoring, the explosive growth of IoT has created exciting new business opportunities for real time calls and messaging. In his session at @ThingsExpo, Ivelin Ivanov, CEO and Co-Founder of Telestax, shared some of the new revenue sources that IoT created for Restcomm – the open source telephony platform from Telestax. Ivelin Ivanov is a technology entrepreneur who founded Mobicents, an Open Source VoIP Platform, to help create, deploy, and manage applications integrating voice, video and data. He is the co-founder of TeleStax, a...
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. He discussed opportunities and challenges ahead for the IoT from a market and technical point of vie...
Grow your business with enterprise wearable apps using SAP Platforms and Google Glass. SAP and Google just launched the SAP and Google Glass Challenge, an opportunity for you to innovate and develop the best Enterprise Wearable App using SAP Platforms and Google Glass and gain valuable market exposure. In his session at @ThingsExpo, Brian McPhail, Senior Director of Business Development, ISVs & Digital Commerce at SAP, outlined the timeline of the SAP Google Glass Challenge and the opportunity for developers, start-ups, and companies of all sizes to engage with SAP today.
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo – to be held June 9-11, 2015, at the Javits Center in New York City, NY – is now accepting Hackathon proposals. Hackathon sponsorship benefits include general brand exposure and increasing engagement with the developer ecosystem. At Cloud Expo 2014 Silicon Valley, IBM held the Bluemix Developer Playground on November 5 and ElasticBox held the DevOps Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of...
We’re no longer looking to the future for the IoT wave. It’s no longer a distant dream but a reality that has arrived. It’s now time to make sure the industry is in alignment to meet the IoT growing pains – cooperate and collaborate as well as innovate. In his session at @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, will examine the key ingredients to IoT success and identify solutions to challenges the industry is facing. The deep industry expertise behind this presentation will provide attendees with a leading edge view of rapidly emerging IoT oppor...
For years, we’ve relied too heavily on individual network functions or simplistic cloud controllers. However, they are no longer enough for today’s modern cloud data center. Businesses need a comprehensive platform architecture in order to deliver a complete networking suite for IoT environment based on OpenStack. In his session at @ThingsExpo, Dhiraj Sehgal from PLUMgrid will discuss what a holistic networking solution should really entail, and how to build a complete platform that is scalable, secure, agile and automated.
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focused on understanding how industrial data can create intelligence for industrial operations. Imagine ...
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS solutions that provide a Hadoop flavor either make choices for customers very flexible in the name of opti...
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon, will discuss how as enterprise IT embraces other IoT-related technology trends, enterprises with i...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water, are pursuing SmartGrid initiatives that represent one of the more mature examples of SAE. We have s...
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, June 9-11, 2015, at the Javits Center in New York City. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be
The Internet of Things will put IT to its ultimate test by creating infinite new opportunities to digitize products and services, generate and analyze new data to improve customer satisfaction, and discover new ways to gain a competitive advantage across nearly every industry. In order to help corporate business units to capitalize on the rapidly evolving IoT opportunities, IT must stand up to a new set of challenges. In his session at @ThingsExpo, Jeff Kaplan, Managing Director of THINKstrategies, will examine why IT must finally fulfill its role in support of its SBUs or face a new round of...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impact.
Can call centers hang up the phones for good? Intuitive Solutions did. WebRTC enabled this contact center provider to eliminate antiquated telephony and desktop phone infrastructure with a pure web-based solution, allowing them to expand beyond brick-and-mortar confines to a home-based agent model. It also ensured scalability and better service for customers, including MUY! Companies, one of the country's largest franchise restaurant companies with 232 Pizza Hut locations. This is one example of WebRTC adoption today, but the potential is limitless when powered by IoT.
One of the biggest challenges when developing connected devices is identifying user value and delivering it through successful user experiences. In his session at Internet of @ThingsExpo, Mike Kuniavsky, Principal Scientist, Innovation Services at PARC, described an IoT-specific approach to user experience design that combines approaches from interaction design, industrial design and service design to create experiences that go beyond simple connected gadgets to create lasting, multi-device experiences grounded in people's real needs and desires.
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of presentation. In her session at @ThingsExpo, Jocelyn Scheirer, CEO & Founder of Bionolux, will discuss ho...