Welcome!

News Feed Item

Mast Therapeutics Reports Fourth Quarter And Full Year 2013 Financial Results

SAN DIEGO, March 26, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today reported financial results for the fourth quarter and year ended December 31, 2013.

"2013 was a year of great progress for Mast as we delivered on our operational goal of opening 40 clinical sites in the U.S. for EPIC, our pivotal Phase 3 study of MST-188 in sickle cell disease," said Brian M. Culley, Chief Executive Officer. "Already in 2014, we've achieved numerous operational and strategic milestones.  First, we initiated ex-U.S. enrollment for EPIC.  Second, we initiated our Phase 2 study of MST-188 in combination with recombinant tissue plasminogen activator in patients with acute limb ischemia. Third, we announced positive nonclinical data in heart failure, which suggests MST-188 provides a new mechanistic approach in an area of significant unmet need and commercial opportunity.  Fourth, we added another clinical-stage asset in AIR001 as a result of our February acquisition of Aires Pharmaceuticals. We look forward to progressing our pipeline across all of our programs and building upon last year's achievements in 2014, including having a total of 70 EPIC study sites open globally by year-end and announcing our clinical development plans for MST-188 in heart failure."

Fourth Quarter 2013 Operating Results

The Company's net loss for the fourth quarter of 2013 was $5.7 million, or $0.06 per share (basic and diluted), compared to a net loss of $4.0 million, or $0.08 per share (basic and diluted), for the same period in 2012.

Research and development (R&D) expenses for the fourth quarter of 2013 were $3.5 million, an increase of $1.4 million, or 67%, compared to $2.1 million for the same period in 2012. The increase was primarily due to increases of $1.2 million in external clinical study fees and expenses related primarily to EPIC, the Company's phase 3 study of MST-188 in sickle cell disease, and $0.2 million in personnel expenses.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2013 were $2.1 million, an increase of $0.3 million, or 20%, compared to $1.8 million for the same period in 2012. The increase resulted primarily from an increase in personnel costs and consulting fees.

Year-to-Date Operating Results

The Company's net loss for the year ended December 31, 2013 was $21.5 million, or $0.28 per share (basic and diluted), compared to a net loss of $15.6 million, or $0.33 per share (basic and diluted), for the same period in 2012.

R&D expenses for the year ended December 31, 2013 were $12.9 million, an increase of $4.8 million, or 60%, compared to $8.1 million for the same period in 2012. The increase was primarily due to increases of $6.2 million in external clinical study fees and expenses, $0.4 million in personnel costs and $0.1 million in share-based compensation expense, offset by a $1.9 million decrease in external nonclinical study fees and expenses.  The increase in external clinical study fees and expenses was primarily related to EPIC and the thorough QT/QTc study of MST-188.  The decrease in external nonclinical study fees and expenses resulted primarily from a decrease in research-related manufacturing activities for ANX-514, which the Company discontinued in 2012.

SG&A expenses for the year ended December 31, 2013 were $8.5 million, an increase of $1.0 million, or 13%, compared to $7.5 million for the same period in 2012. The increase resulted primarily from an increase in consulting fees and legal expenses.

Balance Sheet Highlights

As of December 31, 2013, the Company had cash, cash equivalents and investment securities totaling $44.4 million. Stockholders' equity amounted to $47.8 million as of December 31, 2013. 

About Mast Therapeutics

Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California.  The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop MST-188, its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. 

The Company is enrolling subjects in EPIC, a pivotal phase 3 study of MST-188 in sickle cell disease, and has initiated a phase 2, clinical proof-of-concept study to evaluate whether MST-188 improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia.  The Company also is developing MST-188 in heart failure and plans to announce its clinical development plans in this indication in the second half of 2014.  More information can be found on the Company's web site at www.masttherapeutics.com. (Twitter: @MastThera)  

Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.

Forward Looking Statements

Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to progress with the EPIC study, including the total number of study sites expected to be open at year-end, and the Company's clinical development plans for MST-188 in heart failure.  Among the factors that could cause or contribute to material differences between the Company's actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the uncertainty of outcomes in ongoing and future studies of the Company's product candidates and the risk that its product candidates, including MST-188, may not demonstrate adequate safety, efficacy or tolerability in one or more such studies, including EPIC; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a "clinical hold," and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of a phase 2 clinical study of MST-188 in heart failure or other indications; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company's reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of its product candidates, including clinical studies, and regulatory activities for its product candidates and that such third parties may fail to perform as expected; the Company's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success with its products and may never generate revenue sufficient to achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and MST-188 or AIR001 and prevent competitors from duplicating or developing equivalent versions of its product candidates; and other risks and uncertainties more fully described in the Company's press releases and periodic filings with the Securities and Exchange Commission. The Company's public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law. 

[Tables to Follow]

 

Mast Therapeutics, Inc

(A Development Stage Enterprise)

Condensed Consolidated Statements of Operations

(In thousands except per share data)



Three months ended

December 31,

(Unaudited)

Year ended

December 31,(1)



2013

2012

2013

2012








Total net revenue

$              —

$              —

$               —

$               —






Operating expenses:





     Research and development

3,520

2,112

12,902

8,088

     Selling, general and administrative

2,147

1,787

8,518

7,519

     Transaction-related expenses

44

105

79

(69)

     Depreciation and amortization

11

12

40

90

     Total operating expenses

5,722

4,016

21,539

15,628






Loss from operations

(5,722)

(4,016)

(21,539)

(15,628)






Interest and other income, net

17

19

59

69






Net loss

$         (5,705)

$         (3,997)

$           (21,480)

$          (15,559)






Net loss per share – basic and diluted

$            (0.06)

$            (0.08)

$               (0.28)

$              (0.33)






Weighted average shares – basic and diluted

102,710

47,419

76,586

47,641






(1)

The condensed consolidated statements of operations for the years ended December 31, 2013 and 2012 have been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for the complete financial statements.

 


Mast Therapeutics, Inc

(A Development Stage Enterprise)

Balance Sheet Data

(In thousands)



December 31,

2013


December 31,

2012





Cash, cash equivalents and investment securities

$         44,393


$         36,511





Working capital

40,695


34,603





Total assets

55,250


46,972





Total liabilities

7,442


5,179





Stockholders' equity

47,808


41,792

Mast Therapeutics, Inc. logo

Photo - http://photos.prnewswire.com/prnh/20120612/LA22456LOGO-a

SOURCE Mast Therapeutics, 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.

Latest Stories
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
"Infoblox does DNS, DHCP and IP address management for not only enterprise networks but cloud networks as well. Customers are looking for a single platform that can extend not only in their private enterprise environment but private cloud, public cloud, tracking all the IP space and everything that is going on in that environment," explained Steve Salo, Principal Systems Engineer at Infoblox, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventio...