Excerpts of today's news:
STR’s Chairman, President and Chief Executive Officer, Robert S. Yorgensen commented, “This tax refund is material to the Company, bringing our cash balance, including $1.3 million of negotiable bank acceptance notes, to approximately $15.0 million, as of today.” Mr. Yorgensen continued, “Our current unaudited stockholders’ equity is over $40 million, or about $2.18 per share, with approximately $0.82 per share in cash and negotiable bank acceptance notes.”
“Having these funds available,” continued Mr. Yorgensen, “is an important development for the Company and significantly bolsters our liquidity.”
With the estimated $8M coming from the sale of the Malaysia plant STRI wil have about $23M in cash and no debt.
This is from a recent news regarding the Malaysia plant:
We've also engaged advisers to sell the Malaysia facility and its equipment. As a result of those actions, we expect to be able to convert approximately $8 million of PP&E value back to cash, less $1 million to $1.5 million in associated non-recurring costs. On a going-forward basis, we expect to generate approximately $2.4 million of annual pre-tax savings. The closure of this facility should improve utilization in our encapsulant business allowing us to operate our China facility more efficiently.
Yo do the Math, STRI should easily be trading well North of $1 per share
"Heart failure with preserved ejection fraction is a major public health problem that has no proven effective treatment, yet currently afflicts 2 to 3 million Americans," stated Dr. Borlaug. "One factor that complicates treatment is that the hemodynamic perturbations causing morbidity such as high filling pressures and low cardiac output are typically present only intermittently—being absent at rest but observed during stress such as exercise. As such, an ideal therapy would become more effective during stress, without untoward effects on resting cardiovascular function. The results observed with AIR001 in this study support our hypothesis that acute administration of nebulized inhaled sodium nitrite unloads the heart during exercise without excessive reduction in resting pressures or arterial blood pressure."
"These results are an important step in validating our second asset and establishing the potential clinical utility of AIR001 in HFpEF," stated Brian M. Culley, Chief Executive Officer of Mast Therapeutics. "Mayo Clinic is a well-known leader in the characterization and treatment of heart failure and we thank Dr. Borlaug for working with us and leading this study," continued Mr. Culley. "We look forward to advancing AIR001 in this area of high unmet medical need for which there is no FDA-approved therapy available. We also anticipate reporting interim data from a second investigator-sponsored Phase 2a study of AIR001 in HFpEF patients around the middle of this year."
Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, today reported that its product candidate AIR001, a sodium nitrite solution being developed for treatment of heart failure with preserved ejection fraction (HFpEF), has been selected by the Heart Failure Clinical Research Network (HFN) for evaluation in a 100-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study.
The HFN is made up of premier clinical centers located across North America and was established to expedite clinical research on treatments and strategies to improve the management of acute and chronic heart failure. The HFN is providing the platform to conduct the INDIE-HFpEF study. Mast Therapeutics will provide test materials, nebulizers, and regulatory, technical, and additional financial support. The Company expects to complete a contract with the HFN's Coordinating Center, which will be the sponsor of the study, in the coming weeks.
The collaborative scientific leadership for the study will include Dr. Barry Borlaug, the Principal Investigator, and the investigators from the HFN Regional Coordinating Centers.
"Given the results from prior clinical studies of AIR001, including decreases in right atrial and pulmonary capillary wedge pressures, as well as improvements observed in pulmonary vascular resistance and cardiac lusitrophy, AIR001 may further demonstrate its potential benefit to patients with heart failure and preserved ejection fraction in this study," stated Edwin L. Parsley, D.O., Chief Medical Officer of Mast Therapeutics, Inc. "We have assisted with the study development and will support training on AIR001 and nebulizer devices, as well as assist in the submission of an institutional Investigational New Drug application, which we anticipate will occur in the first quarter of this year."
"We appreciate the HFN's recognition of the study of AIR001 in heart failure as an appropriate area of investigation and the opportunity to work with them," stated Brian M. Culley, Chief Executive Officer of Mast Therapeutics, Inc. "With their help, we expect to accelerate efforts to define the potential efficacy of AIR001 and hopefully provide a viable and much-needed treatment option for patients who have heart failure with preserved ejection fraction, as currently there are no proven effective therapeutic agents available for this large patient population."
About the Heart Failure Clinical Research Network (HFN)
The primary goal of the HFN is to conduct multiple clinical trials to evaluate treatments and strategies to improve management of acute and chronic heart failure. The HFN provides a unique platform for collaborative research by bringing together many premier centers across North America. HFN is composed of nine Regional Coordinating Centers and their affiliated sites, whose investigators provide scientific leadership in the collaborative development of the HFN's scientific agenda. HFN is recognized for robust enrollment in heart failure clinical trials and high scientific productivity. The goal of partnering with HFN is to accelerate research and medical innovation, and provide early results that may improve public health
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulization. Nitrite is a direct vasodilator and can be recycled in vivo to form nitric oxide (NO) independent of the classical NO synthase (NOS) pathway. Nitrite mediated NO formation has several beneficial effects, including dilation of blood vessels and reduction of inflammation and undesirable cell growth. Generation of NO from sodium nitrite is not dependent upon endothelial function and is enhanced in the setting of tissue hypoxia and acidosis, conditions in which NOS activity typically is depressed. In early clinical studies, AIR001 demonstrated positive hemodynamic effects with reductions observed in right atrial pressure and pulmonary capillary wedge pressure, as well as improvements in mean pulmonary artery pressures, cardiac output, and exercise tolerance as measured by six minute walk distance. Mast Therapeutics obtained the AIR001 program through its acquisition of privately-held Aires Pharmaceuticals, Inc. in 2014.
Mast Therapeutics (MSTX) is a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure today announced that it has completed patient enrollment in its Phase 3 clinical study of vepoloxamer for the treatment of patients with sickle cell disease experiencing vaso-occlusive crisis, known as the EPIC study. Consistent with prior guidance, the Company expects to report top-line results in the second quarter of 2016.
The EPIC study was conducted under the direction of Principal Investigator James F. Casella, M.D., Rainey Professor and Chief, Division of Pediatric Hematology, Vice Chair for Research, Pediatrics and Director of the Basic and Translational Research Program in Sickle Cell Disease, Comprehensive Sickle Cell Center at Johns Hopkins University School of Medicine.
"The full enrollment of EPIC is an important achievement in the history of sickle cell disease clinical development, as it represents the largest placebo-controlled clinical trial conducted to date for our patients with this disease," stated Mark T. Gladwin, M.D., Jack D. Myers Professor and Chair, Chairman of the Department of Medicine, Director, Pittsburgh Heart, Lung, Blood and Vascular Medicine Institute, UPMC and the University of Pittsburgh School of Medicine, and member of the Executive Steering Committee for EPIC. "Interventional treatment of acute painful crisis represents an important unmet medical need, and has remained elusive to large, multicenter randomized trials necessary to support registration of a new drug. EPIC has set a new standard for the field, and the learnings from this study will have an important impact on the design of future studies. The patients and their families, our committed clinical investigators, and Mast Therapeutics should be applauded for this important achievement."
"As physicians, we are frustrated by our inability to offer patients a disease-modifying treatment for an ongoing crisis," stated Gregory J. Kato, M.D., Professor of Medicine, Division of Hematology/Oncology, Director, Sickle Cell Center of Excellence, UPMC and the University of Pittsburgh School of Medicine, and member of the Executive Steering Committee for EPIC. "This is a challenging condition for which multiple underlying pathologies may need to be addressed simultaneously to achieve clinical outcomes. In non-clinical studies, vepoloxamer has demonstrated multiple activities that may improve the complex pathologies occurring during sickle cell crisis. We are anxious to review the data from the trial, once unblinded, to determine how vepoloxamer's pharmacodynamic activity translates to clinical benefit for sickle cell patients."
"We are proud to have completed enrollment in the EPIC study," stated Brian M. Culley, Chief Executive Officer. "We wish to express our deep gratitude to the courageous patients and their family members and the committed investigators and study coordinators around the globe who have helped us achieve this goal."
"Following the last patient's discharge from the hospital and 30-day safety observation period, there will be an extensive and rigorous review of the blinded data for quality control, ultimately leading to database lock. Study unblinding then will be performed by the study biostatistician. After the biostatistician's work is complete, Mast will learn the top-line outcome of the study from the biostatistician and will be able to report top-line results to the public," continued Mr. Culley.
About the EPIC Study
The EPIC study is a randomized, double-blind, two-arm, placebo-controlled, Phase 3 clinical trial of vepoloxamer in patients with sickle cell disease hospitalized for treatment of vaso-occlusive crisis. The primary objective of the study is to demonstrate that vepoloxamer reduces the duration of vaso-occlusive crisis, with the duration of crisis measured from the time a patient is randomized to the time at which the patient receives the last dose of parenteral opioid analgesic for the treatment of vaso-occlusive crisis prior to hospital discharge. A total of 388 patients, ages four to 46 were enrolled in EPIC. Secondary efficacy endpoints are to compare the rates of re-hospitalization for vaso-occlusive crisis within 14 days of initial hospital discharge and the occurrence of acute chest syndrome within 120 hours of randomization between the treatment and control groups.
About Sickle Cell Disease and Vaso-Occlusive Crisis
Sickle cell disease is a chronic, genetic blood disorder that affects millions worldwide and an estimated 90,000 to 100,000 people in the United States, where it is classified as a rare, or orphan, disease. The hallmark of sickle cell disease is recurring episodes of severe, debilitating pain commonly known as sickle cell crisis or vaso-occlusive crisis. The intense pain experienced by patients is the result of obstruction of blood vessels by "sickled" red blood cells, which are rigid and highly adherent to the vessel walls and to each other. This obstruction leads to reduced blood flow to organs, including the bone marrow, not only causing severe pain, but also cumulative tissue damage and, ultimately, loss of vital organ function and significantly reduced lifespan. There are between 80,000 to 100,000 hospitalizations annually in the U.S. related to vaso-occlusive crisis and no approved treatment option to shorten the duration or reduce the severity of a crisis once underway.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging its 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 vepoloxamer (also known as 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 also developing AIR001, a sodium nitrite solution for inhalation via nebulization, for the treatment of heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational new drug being evaluated in a pivotal Phase 3 study called EPICfor the treatment of vaso-occlusive crisis in patients with sickle cell disease and in a Phase 2 study for the treatment of patients with chronic heart failure. AIR001 is in Phase 2 clinical development for the treatment of patients with HFpEF. More information can be found on the Company's web site
Revenue for the fourth quarter of 2015 increased 13% to $5.5 million from $4.8 million in the same year-ago quarter. During the quarter, the Company had strong performance in both printed products revenues, which increased 14% and technology sales, services and licensing revenue, which increased 11%.
"During the fourth quarter of 2015, we continued to benefit from the performance of our core operating groups, which delivered strong revenue results while constraining costs. While a goodwill impairment taken by our technology management group hurt overall results for the quarter, our near positive adjusted EBITDA results for the quarter reiterates the strength of our business," said Jeff Ronaldi, CEO of Document Security Systems (DSS).
Mr. Ronaldi continued: "Our business is benefiting from our strategy to intensify our focus on high growth, higher margin products and services. I am excited by our momentum as we enter 2016 and believe that we will continue to gain a wider audience as companies more earnestly address their counterfeiting and brand protection issues."