Leading BioSciences

Offering information

Name of Offering
Leading BioSciences
Sector
Health Care
Industry
Pharmaceuticals
Minimum Investment
$250,000
Amount Offered
$5,000,000
Amount Raised
$3,000,000
Is there internal liquidity ?
no
Open for New Investment ?
yes

Offering Executive Summary

Leading BioSciences Inc. (LBS) is a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock. Our pipeline includes a drug to treat gastrointestinal (GI) breakdown resulting from three common forms of shock: cardiogenic shock following heart surgery, septic shock and hemorrhagic/hypovolemic shock.

 

Severe, Acute Shock is a life-threatening medical condition with over 1,300,000 cases in the U.S. annually. Globally, severe shock and multi-organ failure kills over 2,000,000 people annually. The company’s lead product, LB1148, may be used for the treatment of cardiovascular surgeries which can result in systemic hypoperfusion and cardiogenic shock, septic shock in severe sepsis cases, and trauma or heavy blood loss, which can lead to extremely low blood pressure and hypovolemic or hemorrhagic shock. Each of these represents large patient populations with high unmet medical need due to long term morbidity and high mortality rates.

 

The development of LB1148 is the result of over 15 years of research and testing. This investigational drug is centered around a broad-acting protease inhibitor designed to preserve the intestine during physiologic shock. LB1148 is being investigated for use as a therapy for treating multi-organ failure brought on by cardiogenic shock following heart surgery, hypovolemic, hemorrhagic and septic shock. Additionally, this product is targeted as a therapy for treating gastrointestinal (GI) breakdown and multi-organ failure that often result from hypovolemic or hemorrhagic shock experienced by severe Ebola patients.

 

Extensive preclinical animal data has demonstrated the efficacy of LB1148 across multiple animal models of shock. In collaboration with investigators, a phase 1 safety study was completed in 2013. This study tested the active components of LB1148 vs. a nontreated control in 45 cardiovascular surgery patients. Based on these findings we are now proceeding to Phase 2 proof of concept clinical trials in two key indications, cardiogenic shock following heart surgery and septic shock. Following recent dialogue with the FDA, LBS will be submitting a conventional IND for LB1148 to treat multi-organ failure linked to hypovolemic, hemorrhagic or septic shock caused by Ebola. In the meantime, LBS will continue to support access to LB1148 when requested by clinicians on an individual basis, using expanded access mechanisms, also known as “compassionate use,” which may allow access to LB1148 outside of clinical trials.

 

The addressable market for the full LBS platform of therapies and diagnostics is over $100B. More specifically, GI breakdown contributes to disease in approximately 20 to 30 million people on a yearly basis. To develop that pipeline, LBS has established a world-class management team, as well as medical advisory panels, qualified to bring multiple blockbusters to the global marketplace to successfully address the adverse effects of this mechanism.

Background Information on Issuer

Management Team at Issuer

Robin Jackman - CEO

A 20-year biopharmaceutical industry veteran, Robin was most recently President and CEO of Zacharon Pharmaceuticals where he successfully led the venture-backed startup from financing through new orphan drug program development, multiple new partnerships, and on to a sale of the company last year to BioMarin Pharmaceuticals. Previously Dr. Jackman was Senior Vice President at Vical where he ran the oncology division, which included completing a first-in-human exploratory Phase 1 clinical study, as well as launching and enrolling a Phase 3 worldwide registration clinical trial encompassing over 120 clinical sites in 15 countries. Early in his career he was an investment banker with the life-science unit at BankAmerica Robertson Stephens where he provided strategic and financing services to companies ranging from small venture-backed startups to large multinational pharmaceuticals. Robin holds graduate degrees from Harvard Medical School and Harvard University, and an undergraduate degree from Stanford University.

Greg Doyle - COO

Mr. Doyle brings 20 years of professional and entrepreneurial experience, which includes senior level business leadership in both public and private companies, strategic management consulting, forming and incubating early to mid-stage companies, mergers & acquisitions, and company management. Prior to joining the Company, Mr. Doyle was the Managing Partner at InLab Ventures, an early-stage venture capital fund based in Southern California. Prior to InLab Ventures, he served as the Division President at UBICS Corporation, a publicly traded IT Consulting and Systems Integration company. Prior to UBICS, Mr. Doyle had a successful strategic management consulting career at both A.T. Kearney and Sapient Corporation. Mr. Doyle consulted for dozens of Fortune 500 companies, including Roche, Caterpillar, Time Warner, Nokia, Hewlett-Packard, Sun Microsystems, GEICO, Progressive, ADM, and General Motors. Mr. Doyle began his career as a member of EDS’s corporate finance and M&A organization. He has played key financial and due diligence roles for dozens of M&A transactions valued at over $3B. In addition to his professional career, Mr. Doyle is also a serial entrepreneur, having started and sold four different businesses from the ground up since 1990. He has successfully raised over $55 million in seed, Series A, and Series B funds for both private investor-held and VC-backed ventures and has raised and managed a $70 million company. Mr. Doyle has an MBA from USC’s Marshall School of Business and an undergraduate degree in Finance from Brigham Young University.

John Rodenrys - Co-Founder and Executive Director R&D

Mr. Rodenrys is the Executive Director of R&D of the corporation and was the CEO and co-Founder of the previous company, Leading Ventures LLC, from its inception in 2005. He has held extensive leadership positions in several significant companies. He has been CEO of SafetyMate Corporation and Chief Operating Officer of ForHealth Technologies. where he was responsible for R&D, manufacturing, quality assurance, customer service and field operations. Before ForHealth Technologies, Mr. Rodenrys served as president of Vistant Corporation, a subsidiary of Cardinal Health (NYSE:CAH), and a Fortune 40 Company. He previously served as Vice President R&D and IT for Pyxis Corporation, a subsidiary of Cardinal Health (NYSE:CAH) and as Vice President Development for MicroMRP, a LAN-based enterprise software company. Mr. Rodenrys is an active member of the San Diego Tech Coast Angels. Additionally, he serves on the review panels for CCAT (Center for the Commercialization of Advanced Technology) and for the von Liebig center at University of California, San Diego. He holds a BS in engineering from Rensselaer Polytechnic Institute (RPI), a master’s in Management Science from US International University (USIU) and an APICS CPIM (American Production & Inventory Control Society: Certified in Production & Inventory Management). He is the co-author of Production and Management Systems for Business, published by Prentice Hall and is the co-inventor on six patents.