LoneStar Heart's Approach to Heart Disease Therapies (Chart)

Privately-held LoneStar Heart, Inc. was founded in June 2010 to develop a cluster of novel technologies and research projects aimed at transforming the treatment of Advanced Heart Failure, one of the most challenging, widespread, and expensive medical conditions affecting societies with ageing populations. From inception, the Company's focus was on understanding the full spectrum of biological, mechanical, and medical events that contribute to the evolution of heart failure in order to identify better mechanisms to prevent, stop, and reverse the disorder. Its scientific founders included James T. Willerson, MD, president and medical director of the Texas Heart Institute, and Eric N. Olson, Ph.D., Chairman of the Department of Molecular Biology at the University of Texas Southwestern Medical Center who is one of the world's leading experts in developmental biology of the heart.

Upon completion of its first round of financing, LoneStar Heart acquired CardioPolymers, Inc., a privately-held company involved in the development of Algisyl®, an implantable hydrogel for the treatment of heart failure patients who have a dilated left ventricle. Originally conceived in 2005 as a potential carrier to deliver cells, biologics, or drugs to the heart muscle, the hydrogel proved to have a profound effect on heart function by itself – without additional agents. Following exhaustive preclinical testing and validation, the first Algisyl® patient was treated successfully in Munich, Germany in 2009. In 2014, Algisyl® was approved for sale in the European Union (CE-Mark) based on the positive outcomes of two clinical studies. Recently, the 6- and 12-month data presented and published on AUGMENT-HF, a multicentric controlled randomized study, confirmed that patients treated with Algisyl® experienced significant cardiovascular improvements in comparison to patients treated with standard medical therapy.

Besides the acquisition and development of Algisyl®, in 2010 LoneStar Heart gained worldwide exclusive rights to various additional patented technologies aimed at regenerating heart muscle. They include a family of small molecules that interact with cardiac progenitor cells to enhance native stem cell-mediated repair, a gene therapy to reprogram cardiac fibroblasts into muscle cells, and a biologic sourced from stem cells for tissue repair. Additionally, the small molecule program led to the identification of a drug candidate for the treatment of diabetes. All of these programs are being developed in close collaboration with academic partners.

LoneStar Heart has gone through 3 series of equity financing to fund its operations in California, Texas, and Europe. It presently employs a small core of highly experienced senior managers who operate primarily through established collaborations with academic and private contract partners ranging from research labs to manufacturers and clinical networks.