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Aileron Acquires Lung Therapeutics

Acquisition of Lung Therapeutics and concurrent $18M private investment positions the company to advance first-in-class therapies for orphan pulmonary and fibrosis conditions.

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Developing novel medicines to provide better treatment options for patients with life-threatening pulmonary conditions

With its acquisition of Lung Therapeutics, Aileron is shifting its disease focus to advancing a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis diseases. Lung Therapeutics’ lead clinical programs include LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE).

LTI-03: A Pioneering Compound Treatment for IPF

IPF is a chronic lung disease characterized by progressive tissue scarring that prevents proper lung function.

LTI-03 operates through a novel mechanism of action by targeting healthy epithelial cells and profibrotic proteins. LTI-03 promotes the protection of lung epithelium while inhibiting fibroblast growth and expansion.

LTI-03 is currently being evaluated in a Phase 1b clinical trial in patients recently diagnosed with IPF.

LTI-01: First-in-Class Treatment for LPE

A pleural effusion is defined by the build-up of fluid in the pleural cavity, predominantly resulting from pneumonia. An LPE occurs when scar tissue forms in the pleural cavity, trapping the fluid and preventing drainage. LTI-01 is a proenzyme, or zymogen, designed to slowly activate in the pleural space and break up the scar tissue, allowing for drainage of the pleural effusion. The Company believes this unique mechanism can help efficacy and can provide dosing convenience and while avoiding significant bleeding side effects which can occur in off-label use of fibrinolytics for the treatment of LPE.

LTI-01 has been evaluated in Phase 1b and Phase 2 clinical trials in patients with infected, non-draining LPEs. LTI-01 has received Orphan Drug Designation in the US and EU for the treatment of empyemas and Fast Track Designation in the US.

Management Team

CEO

Manuel Aivado has served as our President and CEO since September 2018. Prior to this, he was our SVP, CMO & CSO since September 2014. From March 2012 until September 2014, Dr. Aivado served as vice president of clinical development and pharmacovigilance at Taiho Oncology, Inc. From October 2006 until March 2012, Dr. Aivado served as senior medical director in the clinical development group at GlaxoSmithKline, Inc. In addition, Dr. Aivado was an instructor in medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for ten years, during which time he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician for internal medicine, hematology and medical oncology, and he received an M.D. and Ph.D. from the Medical School of the University of Dusseldorf, in Germany.

Interim CFO
Susan Drexler headshot

Susan Drexler joined Aileron in June 2022 as Interim Chief Financial Officer (CFO). Susan is an accomplished executive with over 25 years of experience with development- and commercial-stage life science companies in financial management, M&A and licensing deals, financial planning & analysis, and business analytics.

Ms. Drexler was previously CFO with Harmony Biosciences Holdings, Inc., where she oversaw finance, accounting, and IP operations. She led the company’s S-1 process and oversubscribed IPO and managed the company’s transition from a private to a public entity. Previously, Ms. Drexler served as Acting CFO and Vice President, Business Development with Ocugen, Inc. At Ocugen, she established the Business Development function, building a strategy for partnering the company’s early- and late-stage assets, and generating awareness among 40 potential partners in a nine-month timeframe. Prior to that, she served as Senior Director, Strategy and Business Development at Amerisourcebergen Drug Corporation, and subsequently was promoted to Vice President, Business Development and Market Intelligence. Previously, Ms. Drexler served as Director, Corporate Finance with Shire Pharmaceuticals for eight years, responsible for providing financial advice relating to M&A, licensing deals and internal assets evaluation. Prior to Shire, Ms. Drexler held several roles of increasing responsibility over the course of 10 years with Duff & Phelps, LLC (formerly Standard & Poor’s Corporate Value Consulting). She began her career as an audit associate with Goldenberg Rosenthal Friedlander LLP in Jenkintown, PA.

Ms. Drexler received her B.S. in Accounting from Albright College and her M.B.A. in Finance from the Joseph M. Katz Graduate School of Business at the University of Pittsburgh. She is a certified public accountant and a member of the American Institute of Certified Public Accountants.

COO and President
Brian Windsor headshot

Prior to becoming President and Chief Operating Officer, Dr. Windsor served, since July 2013, as President, Chief Executive Officer and a director of Lung. From September 2019 to March 2022, Dr. Windsor served as a director and the Chief Science Officer of TFF Pharmaceuticals, Inc. (Nasdaq: TFFP), a public biopharmaceutical company that Lung spun out into an independent company. From January 2018 to March 2022, Dr. Windsor provided consulting services to TFF Pharmaceuticals, Inc. in the areas of science and technology. From November 2009 to March 2013, Dr. Windsor served as President of Enavail, LLC, a specialty pharmaceutical manufacturing company, where he oversaw all aspects of the company’s pharmaceutical drug development. Before joining Enavail, Dr. Windsor directed portfolio company management for Emergent Technologies, Inc., an early stage technology venture creation and management company, where he served as Managing Director or President for ten portfolio companies. Dr. Windsor holds a B.S. and a Ph.D. in Molecular Biology from The University of Texas at Austin.

Board of Directors

Former Chairman and Chief Executive Officer, PAREXEL

Mr. von Rickenbach joined Aileron’s board of directors in June 2019. He has built a long and successful career in the drug development industry. Last year, he retired after 35 years as the Chairman and Chief Executive Officer of PAREXEL, one of the world’s largest biopharmaceutical service providers with about 19,000 employees and operations in more than 50 countries. Mr. von Rickenbach co-founded PAREXEL in 1982, led the company through its IPO in late 1995 and more than 40 mergers and acquisitions. Pamplona Capital Management, a private equity firm, took PAREXEL private for approximately $5 billion in September 2017. Mr. von Rickenbach started his career at Schering-Plough, Inc., and held positions at 3M (East), a division of 3M Company, and ERCO (later ENSECO), Inc. Currently the Managing Director of stet vision LLC, Mr. von Rickenbach recently was co-Founder, President & CEO of Helio Vision, Inc., a Boston-based ophthalmic biopharma company developing a therapy for proliferative vitreoretinopathy (PVR), that merged into Aldeyra, Inc. (NASDAQ: ALDX) in early 2019. Mr. von Rickenbach serves on the Board of Trustees of McLean Hospital and on the Board of Directors of NEHI (Network for Excellence in Health Innovation). Mr. von Rickenbach received an M.B.A. from Harvard Business School and a B.A. in Business Economics from Lucerne University in Switzerland.

Former Global Head, Novartis Venture Funds

Reinhard Ambros has served as a member of our board of directors since June 2013. Dr. Ambros retired from Novartis Venture Funds after serving as global head from August 2005 until September 2017. He previously served as head of group strategic planning for Novartis AG, a multinational pharmaceutical company, from 2001 until 2005, and as global head of business development and licensing for cardiovascular and metabolic diseases at Novartis Pharma AG. Dr. Ambros received an M.S. from the University of Regensburg, Germany, and a Ph.D. in medicinal chemistry and pharmacology from the University of Regensburg, Germany.

CEO, Aileron Therapeutics

Manuel Aivado has served as our President and CEO since September 2018. Prior to this, he was our SVP, CMO & CSO since September 2014. From March 2012 until September 2014, Dr. Aivado served as vice president of clinical development and pharmacovigilance at Taiho Oncology, Inc. From October 2006 until March 2012, Dr. Aivado served as senior medical director in the clinical development group at GlaxoSmithKline, Inc. In addition, Dr. Aivado was an instructor in medicine at Beth Israel Deaconess Medical Center/Harvard Medical School. Prior to his industry experience, Dr. Aivado practiced clinical medicine in Germany for ten years, during which time he was awarded the Dr. Mildred Scheel cancer research scholarship award in 2002. Dr. Aivado is a German board-certified physician for internal medicine, hematology and medical oncology, and he received an M.D. and Ph.D. from the Medical School of the University of Dusseldorf, in Germany.

Partner, Satter Management Co., L.P.

Dr. Nolan Sigal has served as a member of our board of directors since April 2019. Dr. Sigal currently serves as a partner at Satter Management Co., L.P., a private investment firm, a position he has held since January 2018. From March 2008 to December 2017, Dr. Sigal was Founder and CEO at Tunitas Therapeutics, Inc. Prior to Tunitas, Dr. Sigal’s biotechnology experience included President of Trellis Bioscience, Inc., EVP of Research and Development and Chief Science Officer at Cytokinetics, Inc., and SVP, Research at Pharmacopeia, Inc., where he was one of Pharmacopeia’s founders. He served at Merck & Company Inc. as Executive Director of the Department of Immunology Research. Prior to Merck, he was an assistant professor at University of Toronto. Dr. Sigal graduated from Princeton University with an A.B. in Chemistry, and he completed an M.D./Ph.D. program at the University of Pennsylvania.

Prior to his election to the Board, Mr. Fairey had, since August 2021, been a member of the board of directors of Lung. Mr. Fairey has served on the board of directors of Mirum Pharmaceuticals (Nasdaq: MIRM), a public biopharmaceutical company focused on the identification, acquisition, development and commercialization of novel therapies for debilitating rare and orphan diseases, since August 2021 and on the board of directors of Ascendis Pharma A/S (Nasdaq: ASND), a public biopharmaceutical company organized under the laws of the Kingdom of Denmark, since August 2022. Mr. Fairey served as Executive Vice President and Chief Commercial Officer of MyoKardia, Inc., a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases, from January 2019 to November 2020 prior to its acquisition by Bristol Myers Squibb (NYSE: BMY) in October 2020. Prior to MyoKardia, from January 2018 to January 2019, Mr. Fairey served as Executive Vice President and Chief Operating Officer of ChemoCentryx, Inc., (Nasdaq: CCXI), a public biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer. During that time, Mr. Fairey was responsible for the sales, marketing, medical affairs and market access functions, including commercialization of late stages compounds. Prior to ChemoCentryx, Mr. Fairey served in various roles at Actelion Pharmaceuticals Ltd., a pharmaceutical company, and its subsidiaries, from January 2001 to December 2017. Actelion was acquired by Johnson & Johnson (NYSE: JNJ) in 2017. Mr. Fairey holds a B.S. in biology from the University of Oregon and an M.B.A. from Saint Mary’s College of California.

Prior to his election to the Board, Mr. Musso had, since April 2022, been a member of the board of directors of Lung. Since August 2023, Mr. Musso has served as the Chief Financial Officer of Fulcrum Therapeutics (Nasdaq: FULC), a public clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Previously, he served as the Chief Financial Officer of ReViral Ltd., a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV), that was acquired by Pfizer Inc. in June 2022, from October 2019 until September 2022. Prior to ReViral, from September 2018 to September 2019, Mr. Musso was the Chief Financial Officer and Treasurer at Peloton Therapeutics Inc., a company focused on the development of novel small molecule therapeutic candidates for the treatment of cancer. While at Peloton, Mr. Musso helped to prepare the company for an initial public offering until the company was acquired by Merck & Co. in July 2019. Prior to Peloton, from November 2014 to August 2018, Mr. Musso served as the Chief Financial Officer and Treasurer at Bellicum Pharmaceuticals, Inc., a public biotechnology company focused on discovering and developing novel, controllable cellular immunotherapies for various forms of cancer. Prior to Bellicum, from February 2002 to November 2014, Mr. Musso served in various positions at Targacept, Inc., a public biopharmaceutical company. Mr. Musso spent the early part of his career as a Senior Internal Auditor for Pfizer as well as a Certified Public Accountant for KPMG International. Mr. Musso holds a B.S. in Accounting from Saint Mary’s College of California and a Master’s Degree from the Thunderbird School of Global Management.