Family Office Insights “Peer Insights Report” Q&A interview with Brian Windsor PhD here.
Firm Overview: Company Overview:
Lung Therapeutics is developing revolutionary drugs for treating fibrosis – the cause of some of the most devastating diseases or our time and also one of the hottest areas in pharmaceutical research. Pulmonary (lung) Fibrosis alone has a 5-year mortality rate of 80% and is growing at a rate of 11% per year. The market for drugs to treat this condition is estimated to be $3.2B by 2025, with a CAGR of 24%. Lung Therapeutics has developed breakthrough technology for reversing established fibrosis in pulmonary fibrosis and many other fibrotic diseases. Lung Therapeutics scientists have demonstrated proof of concept in nine models of disease – an astonishing number – and these include proof in cardiac fibrosis (thought to be a leading cause of heart failure), psoriasis, and systemic scleroderma (a devastating skin condition). The total market value of the indications studied so far is a staggering $20B, and proof of concept studies are planned for even more conditions as well. In addition, Lung Therapeutics has developed a drug now in Phase I clinical trials for pneumonia-related fibrosis, a niche market with significant value for which there is currently no pharmaceutical treatment. Lung Therapeutics’ drugs already enjoy significant interest from potential pharmaceutical partners (including one of the top 50 pharma worldwide).
History
Lung Therapeutics was formed to take advantage of 30 years of leading research in the treatment of lung related fibrosis. Lung Therapeutics is developing two drugs: LTI-01 and LTI-03, entering Phase I trials and preclinical studies, respectively. Led by a core team with decades of experience in all aspects of pharmaceutical product development, and with additional outside funding from new investors, Lung Therapeutics will move LTI-01 through the Phase I clinical trial and will also complete all IND-enabling studies for LTI-03. Lung Therapeutics has seen strong interest in their assets and will pursue collaboration opportunities as appropriate. The company utilizes a capital efficient virtual model integrated with NIH translational grants to leverage investment and reduce risk. Cumulative non-dilutive to dilutive funding is 4:1 to date.
Strategy
Big pharma has an increasing appetite for companies with assets in fibrosis – even at an early stage – and this appetite is only growing. Current thinking related to diseases caused by fibrosis is to move to treating these in a way similar to how cancer is being treated today: multiple drugs hitting different targets. The target of Lung Therapeutics’ LTI-03 drug is unique, and it is likely the only drug specifically targeting a pathway that leads to survival of lung epithelial cells – critically important for restoring lung function. This should make for a major weapon in the arsenal of drugs targeting fibrosis. Lung Therapeutics’ strategy is guided by the examples of companies with acquisitions of early stage programs in fibrosis, as seen in the following deal comps. Bristol-Myers Squibb has optioned/acquired at least three companies in the past five years for assets in pulmonary fibrosis as early as preclinical stage and with values ranging from $325M to $1.25B. Biogen acquired Stromedix for a Phase I asset in pulmonary fibrosis for $562M. Boehringer Ingelheim last year acquired a Phase I fibrosis-related drug for $242M. This year Allergan acquired two fibrosis-related companies 24 hours apart. Lung Therapeutics plans to follow the lead of other companies and explore deal opportunities at an early stage. The company already has an offer to begin exclusive due diligence on its LTI-03 asset. Lung Therapeutics will maximize shareholder value in a timely fashion by exploiting big pharma’s aggressive desire for assets in fibrosis.
Company Highlights:
- Multi-billion-dollar market opportunity with multiple compounds, including one in Phase 1a/b clinical trial
- Exceptionally promising early results for drug programs
- Proprietary technology, built on 30 years of research in fibrosis
- Outstanding validation of science from NIH with $27 M in non-dilutive NIH grant funding
- Total non-dilutive to dilutive funding ratio = 4:1
- Strong core of committed repeat investors
- Ideal target for company acquisition by big pharma, already receiving opportunities for product deals
- Accomplished management and World-renowned Medical Advisory Board with knowledge and experience to execute plan and deliver successful exit
Management & Governance Team:
Brian Windsor, PhD
President and CEO
Dr. Windsor joined Lung Therapeutics in June of 2013, shortly after the company’s inception. Since that time, he has spearheaded the development of the company’s lead drug, LTI-01, culminating in its entry into clinical trials this year. LTI-01 is poised to be the first pharmaceutical agent ever approved for pneumonia-related fibrosis around the lungs. In addition, he launched a program for in-licensing assets complementary to the company’s mission, and this resulted in the exclusive license of LTI-03, a novel agent with blockbuster potential for treatment of pulmonary fibrosis and other fibrotic indications. He has spent the last 18 years in the formation and management of life science-based technology ventures and has led technology and pharmaceutical drug development and licensing to major pharmaceutical firms.
Prior to Lung Therapeutics, Dr. Windsor served as President of Enavail, LLC, a specialty pharmaceutical manufacturing company developing unique formulations for superior drug performance. Dr. Windsor directed portfolio company management for Emergent Technologies Inc. (ETI), an early stage technology venture creation and management company. During his tenure at ETI, Dr. Windsor has served as Managing Director or President for ten of ETI’s portfolio companies and has been involved in the conception, technology licensing, corporate and technical strategic planning, launch, and business development of all of these ventures. Applications areas of these companies span diverse segments within life and material sciences and include pharmaceutical development and manufacturing, drug delivery, and biotechnology. Previously, Dr. Windsor was Founder and Vice President of R&D for Texagen, Inc., a startup focused on genetic and chemical methods for overcoming mechanisms of drug resistance important to medicine and agriculture. He holds a Ph.D. in Molecular Biology from The University of Texas at Austin, is a frequent invited speaker for both scientific and technology transfer events, and is an inventor on multiple patents and patent applications.
Steve Idell, MD, PhD
Founder and CSO
Dr. Idell is a clinical investigator who has been continuously funded over the past 25 years by the National Institutes of Health for his work in the areas of acute lung injury and pleural diseases. He is a board-certified internist and pulmonologist who has also directed the Intensive Care Units at Temple University Hospital in Philadelphia and at The University of Texas Health Science Center at Tyler, Texas. He is now Vice President for Research, a Professor of Medicine and Temple Chair of Pulmonary Fibrosis at UTHSCT and Director of an NIH-sponsored Program Project Grant to study the role of the fibrinolytic system in the pathogenesis of lung and pleural disease. Work from that project led to the development of scuPA as a treatment for pleural loculation and of a peptide-based approach to treat acute lung injury and pulmonary fibrosis.
Dr. Idell also continues to manage patients in the UTHSCT Pulmonary Clinic. He has successfully obtained over $27 million in grant support from agencies including the NIH, The American Heart Association, The American Lung Association and various foundations. He is the Director of the Texas Lung Injury Institute of UTHCT and has raised nearly $1 million of philanthropic support for lung injury research to develop novel experimental therapeutics from the community, grateful patients and various foundations in East Texas and has received commitment from the NIH RAID and SMARTT programs to perform IND-enabling studies with his lead therapeutic, LTI-01. In addition to his role as CSO, Dr. Idell also serves as Chair of the Scientific Advisory Board and a Member of the Board of Directors.
Andrew Mazar, PhD
Consulting Head of Drug Development
Dr. Mazar serves as Consulting Head of Product Development in addition to his current position as Adjunct Professor in Pharmacology at the Feinberg School of Medicine at Northwestern University and Founder, Director, Chief Scientific Officer at Monopar Therapeutics, Inc., Clinical stage orphan oncology drug development company. Prior to this, Dr. Mazar was most recently Director, Center for Developmental Therapeutics, Entrepeneur-in-Residence, AND Research Professor at Northwestern University. Before Northwestern, Dr. Mazar was the Chief Scientific Officer at Attenuon, LLC and led three projects at Attenuon through IND and into phase II trials. Prior to Attenuon, Dr. Mazar had significant input in three projects that led two successful INDs, two of which made it through phase II trials and one of which is currently in phase II trials. One of these projects was the original development of scuPA for the treatment of myocardial infarction. Thus, Dr. Mazar has extensive expertise in translating early stage science into clinical projects through phase II clinical development and managing this entire process. He also has direct experience in the development of LTI-01 (scuPA) as a clinical therapeutic agent. During his tenure in biotechnology, Dr. Mazar led several projects that culminated in several out-license deals as well as funded collaborations. A new partnership deal with a large European venture group on all of Attenuon’s projects has closed. During the partnership process, Dr. Mazar led early and late stage discussion with most every large and mid-size biotechnology company interested in cancer therapeutics. During these discussions, terms sheets were obtained from five different suitors, all of them public companies. While at Attenuon, Dr. Mazar managed $63M of investment capital, the majority of this raised through a single investor, during his nine-year tenure and led a road show managed by Bank of America.
John Koleng, PhD
Director CMC
John J. Koleng co-founded AlphaVektor, LLC, a life sciences development and industrialization consultancy focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 17 years of experience in the pharmaceutical industry, including over 8 years as a consultant. He specializes in product development, drug delivery technology, current Good Manufacturing Practice (cGMP) for clinical trial supplies and commercial products, facilities, project management, contractor engagement, Quality System requirements, and developing and directing corrective and preventive action (CAPA) initiatives.
During his career, he has guided and assisted numerous life-science client companies in the development of their technology enriched/enabled products, delivery systems, and processes for various clinical indications and commercial opportunities. John’s drug product development experience ranges from nasal/pulmonary products, trandermals, and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and nano-dose tablets. He has published numerous scientific research articles on topics including hot melt extrusion, pressurized meter dose inhalation, and aqueous film coating. He is an inventor on 6 issued US patents and numerous pending patent applications.
Prior to his consulting career, Dr. Koleng was Vice President of Industrial Operations at PharmaForm, a contract development and manufacturing organization (CDMO). John was part of the team that started the company in 1996. Over the next 11 years, his roles increased from Vice President of Pharmaceutical Research to Chief Operating Officer before selling the company to Akela Pharma, Inc. in 2007. At the time of the sale, he was responsible for ~ 120 individuals operating over a variety of disciplines in an FDA qualified 40,000 ft2 facility that he helped design and validate. Under his leadership, PharmaForm successfully navigated an FDA preapproval inspection (PAI) ~ 12 months after construction was complete.
John has a B.S. degree in Pharmacy (1994), and a Ph.D. in Pharmaceutics (2002), both from the University of Texas at Austin where he currently holds an Adjunct Assistant Professor of Pharmaceutics appointment and serves on the UT College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist.
Gina Lento, PhD
VP Operations
Dr. Lento is a former bench scientist and university lecturer now with a career in the commercialization of biotechnology and life science opportunities. She has spent 14 years in executive roles in business development and operations for life science ventures covering pharmaceuticals, medical devices, diagnostics and platform technologies. Medical areas these products have addressed range from diabetes, cardiology, immuno-oncology, infectious diseases, transplant medicine and pulmonary diseases. Beginning in 2010, Dr. Lento directed business development and operations efforts for several portfolio companies of Emergent Technologies Inc., an early stage technology venture creation and management company in Austin, Texas. Prior to moving to Austin, Dr. Lento served as Director of Economic Development in the Americas region for the Government of New Zealand’s Trade & Enterprise, a national economic development agency. Based in New York City, she oversaw US market entry activities for New Zealand companies in seven industry areas while also serving as New Zealand’s Consul General Designate to New York and New Jersey. During a 15-year tenure living in New Zealand, Dr. Lento was VP of Discovery, for Protemix Corp, a spin-out of The University of Auckland, developing novel therapies for the treatment of Type 2 Diabetes and served the New Zealand Government’s Ministry of Foreign Affairs and Trade as a Scientific Consultant on the New Zealand Delegation to the International Whaling Commission. Dr. Lento was a Rotary International Ambassadorial Graduate Scholar in New Zealand where she completed three degrees in biochemistry at universities in New Zealand and Australia including a PhD in Molecular Evolution from Victoria University of Wellington. Dr. Lento maintained an Honorary Faculty Fellowship at The University of Auckland until 2008 and remains a dual citizen of the US and New Zealand.
Robert S. Mills Jr.
Board Chair
Robert S. Mills, Bob is a 41-year veteran in the pharmaceutical industry. Bob’s expertise ranges across GMP Operations, Clinical Research, Regulatory Affairs and Commercial Operations as well as R&D, IT, Product Development, Technical Services, Manufacturing, Engineering and Quality Assurance. Bob has a large network of industry relationships, as well as a very strong track record successfully managing businesses, delivering quality products, successfully interacting with the FDA, and generating attractive growth through expanding market share and launching exciting new products. Most recently, he was the President and CEO of Scientific Protein Labs (SPL), the US’s leading manufacturer of heparin and pancreatin. Recently, Bob sold SPL to a Chinese pharmaceutical company for 3 times the original purchase price and with milestone payments over the next several years could be as high as 5 times the original purchase price. Prior to SPL, Bob was President of Qualitest Pharmaceuticals, a leading manufacturer and distributor of generic pharmaceuticals. He joined Qualitest in early 2010 with the specific charge to grow the business at a quicker pace. In less than one year, monthly net sales increased by over 50 percent. In late 2010, Qualitest was acquired by Endo Pharmaceuticals for $1.2 billion or 15 times EBITDA. Prior to Qualitest, Bob was recruited to Columbia Laboratories, Inc. in 2001 to solve a worldwide recall issue for the principal product and re-launched the product to the marketing partner within 4 months. He was also responsible for a product with a completely new delivery system being approved on its PDUFA date and after becoming CEO in 2006 more than doubled sales to $36 million in two years. As Vice President and General Manager of Watson/Schein’s solid dose division, after correcting a number of quality and regulatory issues through a voluntary corrective action plan with FDA, the Company received 5 new product approvals. The launch of these products coupled with operational efficiencies resulted in an improvement of profitability in one year by $60 million, which was instrumental in Schein being acquired by Watson. Bob served as Vice President of Operations at Alpharma, Inc. from 1993 to 1996. Prior to Alpharma, Bob held various positions with Sanofi including Director-Plant Operations, Rhone-Poulenc Rorer. His business development experience has led to multiple product acquisitions, joint ventures and product divestitures. He was recognized as a finalist for Entrepreneur of the Year for New Jersey in 2009 by Ernst and Young. Bob holds a B.S. Degree from Grove City College and numerous graduate business credits from Temple University.
Aaron Fletcher, PhD
Board Member, Representing Bios Partners
Dr. Fletcher founded and serves as President of Bios Research, a financial services firm that provides public equity research in the healthcare space tailored to institutional firms and large family offices. Bios Research provides fundamental healthcare industry research focused in the biotech and med-tech sub-sectors and through this research Dr. Fletcher has a strong understanding of commercial viability in the marketplace. Dr. Fletcher holds a Ph.D. in Biochemistry from Colorado State University, and serves as a professor at Dallas Baptist University where he teaches Biochemistry, Bioethics, and Cell Biology. Dr. Fletcher has worked as an independent consultant for the biotech/healthcare equity industry for over 10 years.
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