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Category: AWG Member News

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Qpex Biopharma Initiates Phase 1 Study of QPX9003 Targeting Antibiotic-Resistant Pathogens

SAN DIEGO, June 17, 2021 – Qpex Biopharma, Inc., (Qpex) a resistance-focused clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, announced initiation of a Phase 1 study of QPX9003, a next generation intravenous (IV)-administered synthetic polymyxin for infections caused by drug-resistant gram-negative pathoge

June 17, 2021June 23, 2021by Monica HeilIn AWG Member News

The Antimicrobials Working Group (AWG) is an industry-led, 501(c)(6) comprised of emerging antimicrobials and diagnostics companies. AWG is committed to improving the regulatory, investment, and commercial environment for antimicrobial drug and diagnostic device development.

Inquire About Membership

Pharmaceutical and biotechnology companies developing new antimicrobial therapeutics and diagnostic devices are eligible for consideration of membership in AWG. Learn More »

Vu L. Truong, Ph.D.

Founder, Chief Executive Officer and Director

Aridis Pharmaceuticals

Dr. Truong is a founder of Aridis and was elected CEO in 2014 after having served as the company’s Chief Scientific Officer since 2005. He has more than 20 years of experience in biopharmaceutical drug development, having held positions of increasing responsibilities in companies which were eventually acquired by larger entities, including Gene Medicine (sold to Megabios), Aviron (sold to MedImmune) and MedImmune (sold to Astra Zeneca). Having maintained a life-long interest in infectious diseases, he has focused on researching and developing innovative human monoclonal antibodies and vaccines designed to address life-threatening infections. His product development experience includes FluMist™, Synagis™ mAb and a number of other monoclonal antibody-based therapeutics. Dr. Truong is the principal architect of Aridis’ technologies, which includes a range of anti-infective products and pharmaceutical processing technologies. He received his Ph.D. in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.

René Russo, PharmD, BCPS

President and Chief Executive Officer

Arsanis, Inc.

René Russo, PharmD, BCPS, has spent more than 15 years in anti-infective R&D and has leadership experience across all phases of drug development, including global commercial launches for five novel antibacterial agents and clinical development and registration of several antiviral, antibacterial, and antifungal therapeutics. Her work has spanned the earliest phases of in vitro and animal work to clinical pharmacology, clinical development, and post-marketing clinical outcomes research. Prior to Arsanis, Dr. Russo served in various roles over an 11-year period at Cubist Pharmaceuticals (Cubist). As Vice President of an 80+ person global team, Dr. Russo oversaw the clinical microbiology program (including extensive in vitro and animal work to support dose selection and PK/PD analyses), contributed to the design of multiple Phase 1 to Phase 3 clinical studies, and directly managed the oversight of several global burden of disease programs, including urosepsis and nosocomial pneumonia, to understand the outcomes and unmet medical needs in these infectious diseases. In her role at Cubist, she was also responsible for the oversight of more than 140 studies designed to further understand Gram-positive and Gram-negative infections, including epidemiology, resistance patterns, and the study of various treatments (including combination therapies) across nonclinical and clinical studies. Dr. Russo directly oversaw investigator-initiated research for a broad portfolio of anti-infectives, including daptomycin, fidaxomicin, ceftolozane/tazobactam, and tedizolid. Prior to her time at Cubist, Dr. Russo held roles of increasing responsibility at Bristol-Myers Squibb where she started her industry career as a Postdoctoral Fellow in Industrial Pharmacy Infectious Diseases. She also held clinical positions at Robert Wood Johnson University Hospital and Princeton Hospital before joining the biotechnology industry. Dr. Russo received her PharmD and Bachelor of Science in Pharmacy from Rutgers University and holds a Board of Pharmacy Specialties Pharmacotherapy Certification (BCPS).

Roger J. Pomerantz, M.D., F.A.C.P.

Chief Executive Officer and Chairman of the Board

ContraFect Corporation

Dr. Pomerantz was appointed ContraFect’s Chief Executive Officer and Chairman of the board of directors in April of 2019, prior to which he served as Vice Chairman of the Company’s board of directors since May 2014. He currently serves as Chairman of the board of directors of Seres Therapeutics, and served as Chairman and CEO from June 2014 until January 2019. From 2011 to 2013, he was formerly Worldwide Head of Licensing & Acquisitions, Senior Vice President at Merck & Co., Inc. where he oversaw all licensing and acquisitions at Merck Research Laboratories. Previously, he served as Senior Vice President and Global Franchise Head of Infectious Diseases at Merck. Prior to joining Merck, Dr. Pomerantz was Global Head of Infectious Diseases for Johnson & Johnson Pharmaceuticals. He joined Johnson & Johnson in 2005 as President of Tibotec Pharmaceuticals, Inc. Dr. Pomerantz received his B.A. in Biochemistry at the Johns Hopkins University and his M.D. at the Johns Hopkins School of Medicine. He received post-graduate training at the Massachusetts General Hospital, Harvard Medical School and M.I.T. Dr. Pomerantz is Board Certified in both Internal Medicine and Infectious Diseases. He was Professor of Medicine, Biochemistry and Molecular Pharmacology, Chief of Infectious Diseases, and the Founding Director and Chair of the Institute for Human Virology and Biodefense at the Thomas Jefferson University and Medical School. He has developed 12 drugs approved world-wide in important diseases, including HIV, HCV, CMV, and tuberculosis.

Christine Ann Miller

AWG Board Chair
President & CEO
Melinta Therapeutics

Christine Ann Miller has served as President and Chief Executive Officer and as a member of the board of Melinta Therapeutics since August 2020. Ms. Miller is a global pharmaceutical veteran with more than 20 years of experience in life sciences. Most recently, Ms. Miller led the global and U.S. product portfolio for Sandoz, a $10 billion division of Novartis, where she was accountable for transitioning the portfolio toward- rapid-growth and higher-margin segments, such as complex generics and value-added medicines, while continuing to build the branded generics business.

Among her various achievements, Ms. Miller directed more than 50 product launches that generated over $300 million of new annual revenue, closed numerous business development acquisitions, and built a robust five-year development and acquisition product pipeline. Before Sandoz, Ms. Miller spent over a decade at Actavis (now Allergan) and its predecessor Watson Pharmaceuticals where she led the preparation of numerous product launches and held leadership roles in both R&D operations and supply chain management. Ms. Miller started her career at Merck as a chemical engineer and procurement analyst and earned an MBA and a Master’s in Technology Management at Stevens Institute of Technology and a B.S. in Chemical Engineering from Rensselaer Polytechnic Institute.

Ms. Miller’s leadership focus combines her passion for building and leading high performing teams with goal-driven operational rigor. She articulates a clear mission, vision and strategy that engages people to cohesively work towards creative problem solving and innovative solutions.

She serves as an Advisory Board Member for the Healthcare Businesswomen’s Association and is a frequent panelist and speaker at industry events.

Graham G. Lumsden

Chief Executive Officer

Motif BioSciences Inc

Graham G. Lumsden, Chief Executive Officer of Motif, is responsible for all aspects of the strategy, management, and operations of the Company. Prior to joining Motif, Mr. Lumsden was a senior executive at Merck & Co., Inc. where he held commercial leadership positions in worldwide businesses including contraceptives and osteoporosis. Mr. Lumsden has a proven record of success leading change and delivering results in subsidiary and global leadership positions, including new product launches, pre-clinical/clinical development, regulatory strategy, cross-functional team leadership, IP strategy/litigation, and domestic/international sales and marketing. Mr. Lumsden is a member of the Royal College of Veterinary Surgeons (MRCVS), holds a postgraduate diploma from the Chartered Institute of Marketing (MCIM), and is a dual citizen of the U.S. and UK.

Marco Taglietti, M.D.

Chair, AWG Antifungal Subcommittee

President and Chief Executive Officer

SCYNEXIS, Inc.

Dr. Taglietti joined SCYNEXIS as Chief Executive Officer in April 2015 and has been a member of the board since November 2014. He became SCYNEXIS President in September 2015. He served as Executive Vice President, Research and Development, and Chief Medical Officer of Forest Laboratories, Inc. and as President of the Forest Research Institute until its acquisition by Actavis in 2014. Prior to joining Forest Laboratories, Inc. in 2007, Dr. Taglietti held the position of Senior Vice President, Head of Global Research and Development, at Stiefel Laboratories, Inc. for three years. He joined Stiefel Laboratories, Inc. after 12 years at Schering-Plough Corporation where he last held the position of Vice President, Worldwide Clinical Research for Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr. Taglietti began his pharmaceutical career at Marion Merrell Dow Research Institute. Over the course of his career, he has brought to market 35 different products in the U.S. and internationally. Dr. Taglietti currently serves on the Board of Directors of NephroGenex, Inc. (NASDAQ:NRX) and Delcath (NASDAQ:DCTH). He received his medical degree and board certifications from the University of Pavia in Italy.

Ankit Mahadevia

Chief Executive Officer

Spero Therapeutics

Ankit Mahadevia is the Chief Executive Officer of Spero Therapeutics and a member of the Board of Directors. He was formerly a Venture Partner in the life sciences group at Atlas Venture, located in Cambridge, MA. In that capacity he supported the formation of eight companies focused on novel drug discovery platforms and therapeutic products, three of which he led as Acting CEO. Prior to joining Atlas in 2008, Ankit worked on product and business development with the founding team at Arcion Therapeutics. He has also held positions in business development both at Genentech and at Vanda Pharmaceuticals. Previously, he worked in the health care groups of McKinsey & Company and Monitor Group. Ankit began his career in health care policy, with roles in the U.S. Senate Health, Education, Labor, and Pensions committees, the U.S. Government Accountability Office, and the Mexican Institute of Social Security (IMSS).

John McDonough

Chief Executive Officer

T2 Biosystems

John McDonough has served as President and Chief Executive Officer and a member of T2’s Board of Directors since November 2007. From 2003 to 2007, John held various positions at Cytyc Corporation, a company engaged in the design, development, manufacturing and marketing of clinical products that focus on women’s health, and ultimately served as President at Cytyc Development Corporation. John had the responsibility of designing and executing Cytyc Corporation’s growth strategy for expanding the company from a single product company with revenue of approximately $300 million to a diverse women’s health company with revenue of approximately $750 million. He led the efforts that resulted in Cytyc’s acquisition by Hologic, Inc. in October, 2007, for over $6 billion. John has served in senior executive management and CEO roles in several private and public companies. He is currently a member of the Board of Directors at Solace Therapeutics and Cytrellis Biosystems. John earned his B.S.B.A. from Stonehill College.

Frank Pasqualone

Senior Vice President and Global Head, Acute Care Business

Theravance Biopharma

Frank Pasqualone joined Theravance Biopharma as Senior Vice President, Operations in June 2014 in connection with the spin-off from Theravance, Inc. Prior to the Spin-Off, Mr. Pasqualone held the position of Senior Vice President, Operations at Theravance, Inc. since January 2014. From 2010 to 2012, he served as President of Intercontinental Region: Latin America, Middle East and Africa and also as President of Southern Europe from 2009 to 2010, at Bristol-Myers Squibb (“BMS”). Over a 25-year period with BMS, Mr. Pasqualone held senior management positions in the U.S. and globally. In the U.S., he was responsible for the Oncology/Virology business and led the marketing group in the Diabetes business. Since leaving BMS and prior to joining Theravance, Mr. Pasqualone was self-employed as a part-time consultant. Mr. Pasqualone holds an M.B.A. from University of Dayton and a B.S. in Marketing from Bowling Green State University in Ohio.

Ed Garvey

Vice President, Biology

Viamet

Edward Garvey, Ph.D, has spent his entire academic and professional career within the field of infectious disease drug discovery and development. He is the Vice President of Biology at Viamet Pharmaceticals and has led Viamet’s antifungal drug discovery and development program since 2010, playing leading roles in the development of VT-1161 (now in Phase 3) and VT-1598 (now in Phase 1). He has been the PI on numerous grant and contract research programs funded by the NIH and DOD while at Viamet, and is author or co-author on 19 peer-reviewed articles since 2014. Beginning in 1989, he had previously focused on antiviral drug discovery his entire career at Burroughs Welcome/Glaxo Welcome/GlaxoSmithKline. The highlight of that work was the discovery program he initiated and led that resulted in the approval of the best-in-class HIV integrase inhibitor Dolutegravir and also the late-stage clinical asset Cabotegravir. His Ph.D. research in the department of Pharmaceutical Chemistry at UCSF described various mechanisms of drug resistance in the protozoal parasite Leishmania.

Vijay B. Samant

President and Chief Executive Officer

Vical, Inc.

Vijay B. Samant joined Vical as President and Chief Executive Officer in November 2000. Mr. Samant has 23 years of diverse U.S. and international sales, marketing, operations, and business development experience with Merck. From 1998 to mid-2000, he was Chief Operating Officer of the Merck Vaccine Division. From 1990 to 1998, he served in the Merck Manufacturing Division as Vice President of Vaccine Operations, Vice President of Business Affairs, and Executive Director of Materials Management. Mr. Samant earned a master's degree in management studies from the Sloan School of Management at the Massachusetts Institute of Technology in 1983. He received a master's degree in chemical engineering from Columbia University in 1977 and a bachelor's degree in chemical engineering from the University of Bombay, University Department of Chemical Technology, in 1975. Mr. Samant presently serves as a member of the board of directors of AmpliPhi Biosciences Corporation. Mr. Samant was a member of the Board of Directors for Raptor Pharmaceutical from 2011 to 2014, and was a member of the Board of Directors for BioMarin Pharmaceutical from 2002 to 2004. Mr. Samant was a Director of the Aeras Global TB Vaccine Foundation (Rockville, MD) from 2001 to 2010; a member of the Board of Trustees for the National Foundation for Infectious Diseases (NFID, Bethesda, MD) from 2003 to 2012; and a member of the Board of Trustees for the International Vaccine Institute (IVI, Seoul, Korea) from 2008 to 2012.

Jeffrey Stein, Ph.D.

President and Chief Executive Officer
Cidara Therapeutics

Dr. Stein has been President, CEO and Director of Cidara since January 2014. Previously he was CEO of Trius Therapeutics, Inc. from 2007 until its acquisition by Cubist Pharmaceuticals, Inc. in September 2013. During his tenure, Trius developed the antibacterial drug tedizolid, which received marketing approval from the U.S. Food and Drug Administration in June 2014. Tedizolid is now marketed by Merck under the name Sivextro. Dr. Stein currently serves as a Director of Paratek Pharmaceuticals (NASDAQ: PRTK) and Ideaya Biosciences. He is also founding Chairman and President of the Antimicrobials Working Group, an industry leading 501(c)(6) organization. Previously, Dr. Stein was a Venture Partner and Kauffman Fellow with Sofinnova Ventures and opened the firm’s San Diego office in 2005. Prior to joining Sofinnova Ventures, Dr. Stein was co-founder and Chief Scientific Officer of Quorex Pharmaceuticals, which was acquired by Pfizer Pharmaceuticals in 2005. He has also served as a Principal Scientist with Diversa Corporation and the Agouron Institute. Dr. Stein conducted his postdoctoral research as an Alexander Hollaender Distinguished Postdoctoral Fellow at the California Institute of Technology and his graduate work as a NASA Graduate Student Researcher Fellow at the University of California, San Diego.

Evan Loh, M.D.

Chair, AWG Chemistry, Manufacturing
and Controls(CMC) Subcommittee
Chief Executive Officer
Paratek Pharmaceuticals, Inc

Evan Loh, M.D. is the Chief Executive Officer of Paratek Pharmaceutical since June 2019. Prior to that, Dr. Loh served as Chief Operating Officer from January 2017 to June 2019 and as President and Chief Medical Officer from July 2014, in each case until June 2019. He is a member of the Board of Directors since July 2014. Prior to the merger with Transcept Pharmaceuticals, Dr. Loh was appointed President in June 2014 and served as Chief Medical Officer and Chairman of the Board of Directors from June 2012 to June 2014. Previously, Dr. Loh served as Senior Vice President, Development and Strategic Operations, Worldwide Research and Development, at Pfizer. While at Pfizer, Dr. Loh’s responsibilities included scientific, operational, and strategic drug development oversight for all pre-proof of concept development phase programs and leading portfolio prioritization. Dr. Loh joined Pfizer from Wyeth Pharmaceuticals, where he was Vice President, Multiple Therapeutic Areas where he was responsible for global development strategy and clinical operational deliverables. At Wyeth, he led the successful global registration programs for Torisel and Tygacil. He currently serves on the Board of Directors of Eiger Biopharmaceuticals, Inc. and as Chair of the Antimicrobials Working Group, an industry leading organization of biotech companies focused on antimicrobial development. Dr. Loh served as a director on the Board of Nivalis from 2012 until the completion of its sale to Alpine Immunotherapeutics in 2017. Dr. Loh served as a faculty member at both Harvard Medical School and the University of Pennsylvania School of Medicine. Dr. Loh received his A.B. from Harvard College and his M.D. from Harvard Medical School. He completed his Internal Medicine and Cardiovascular fellowship training at Brigham and Women’s Hospital.

Michael Dunne, M.D

AWG Vice Chair

Chief Scientific Officer

Iterum Therapeutics

Michael Dunne, M.D. has served as Chief Scientific Officer of Iterum Therapeutics since late 2015 when the company was formed. Prior to that, Dr. Dunne was the Chief Medical Officer of Durata Therapeutics, Inc. from 2009 until its acquisition by Actavis plc in 2014 and remained in a leadership role as part of the Actavis integration efforts to ensure successful transition of all priority development activities until 2015. From 1992 to 2009, Dr. Dunne served in a variety of roles in connection with the clinical development of numerous infectious disease compounds at Pfizer Inc., including as the Vice President, Therapeutic Head of Development for Infectious Disease from 2001 to 2009. Dr. Dunne holds a BA in Economics from Northwestern University and an MD from the State University of New York Health Sciences Center. He completed his internal medicine residency and fellowships in infectious diseases and pulmonary medicine at Yale University School of Medicine.

Ciara Kennedy, Ph.D.

AWG Chairperson of the Board

President and Chief Executive Officer

Amplyx Pharmaceuticals, Inc.

Ciara Kennedy, Ph.D., is President and CEO of Amplyx Pharmaceuticals, Inc. Initially, Ciara Kennedy was appointed Chief Operating Officer of Amplyx in October 2015, following a successful, $50 million Series B financing. Prior to joining Amplyx, Dr. Kennedy served as Chief Operating Officer at Lumena Pharmaceuticals until the company was acquired by Shire Pharmaceuticals in June 2014; she remained with Shire for one year post-acquisition as Vice President and Head of the Cholestatic Liver Disease Program. As COO of Lumena, Dr. Kennedy played a critical role in the development of assets licensed from Pfizer and Sanofi, raising $78M from venture capital to fund operations and preparing to take the company public. Ciara has a proven track record of delivering significant results and advancing therapeutic and diagnostic programs across multiple therapeutic areas and stages of development in the biotechnology industry. Prior to Lumena, she was Vice President of Operations and Senior Director of Strategy and Corporate Development at Cypress Bioscience Inc., where she played a key role in obtaining FDA approval for Savella, a therapy for fibromyalgia, and also oversaw corporate acquisitions and in-licensing of several clinical assets. Previously, Dr. Kennedy held several positions in the Program and Alliance department of Biogen Idec, managing projects spanning the drug discovery and development continuum. Dr. Kennedy received her doctorate at the Queen’s University of Belfast, Northern Ireland, and continued her research in the field of apoptotic proteases at the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, California. In 2004, she became a member of the inaugural class of the Rady School of Management at University of California, San Diego. She graduated with a Masters of Business Administration in 2006.

Ted Schroeder

Chief Executive Officer
Nabriva Therapeutics

Ted Schroeder joined Nabriva Therapeutics plc in July 2018. During the last 30 years, he has been focused on drug development and commercialization in both large and small pharmaceutical companies. Most recently, Ted served as president, chief executive officer and director of Zavante Therapeutics until its acquisition by Nabriva Therapeutics in 2018. Ted co-founded Cadence Pharmaceuticals in 2004 and previously held leadership roles at Elan Pharmaceuticals, Dura Pharmaceuticals and earlier in his career, Bristol-Myers Squibb. He currently serves on the board of Cidara Therapeutics (Nasdaq: CDTX), Otonomy (Nasdaq: OTIC) and Collegium Pharmaceutical (Nasdaq: COLL). He is a former chair of BIOCOM, the Southern California life sciences trade association and in 2014, he was named the EY Entrepreneur of the Year for the San Diego region and was listed as a national finalist. He received a bachelor’s degree in management from Rutgers University.

Kevin Finney

Chief Operating Officer

Zavante Therapeutics

Kevin P. Finney currently serves as Chief Operating Officer of Zavante Therapeutics. Finney has over 20 years of healthcare leadership experience spanning early stages of development and commercialized brands for pharmaceutical, medical device and diagnostic segments. Finney recently served as Vice President and Head of Corporate Development at Allergan, with responsibility for world-wide corporate development strategy, licensing, acquisitions and alliances. Finney held this position through the successful $71 billion acquisition of Allergan by Actavis in March 2015. In his previous tenure at Allergan, the company grew from less than $3 billion in annual revenue to more than $7 billion through a combination of acquisitions and organic growth. Before this, Finney held commercial executive management roles at Prometheus Laboratories, Inc. (now NestleHealthScience), Amylin Pharmaceuticals, Inc. (now Bristol-Meyers Squibb) and Parke-Davis division of Warner-Lambert (now Pfizer). Mr. Finney currently serves on the board of Taris Biomedical and Eirion Therapeutics. Finney received master’s degree in business from Pepperdine University and a bachelor’s degree in exercise physiology from California State University, Long Beach.

info@vical.com

http://www.vical.com

@Vical

VICAL

About Vical Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented vaccine technologies and other therapeutic approaches. Vical has three active clinical development programs:

1. ASP0113 vaccine for prevention of cytomegalovirus (CMV) reactivation in hematopoietic cell transplant recipients. Partnered with Astellas. Data from a pivotal Phase 3 trial expected in 1Q 2018. 2. VCL-HB01 vaccine for reduction of genital lesion recurrences caused by herpes simplex virus type 2 (HSV-2) infection. Data from a Phase 2 trial expected in 2Q 2018. 3. VL-2397 antifungal drug with novel mechanism of action for the treatment of invasive fungal infections. Phase 2 trial in invasive aspergillosis (IA) expected to initiate in 1Q 2018. Eligible for limited use indication approval by FDA. Target Indications CMV HSV-2 IA and other invasive fungal infections Hepatitis B virus (HBV) - treatment of chronic infections Leadership Vijay B. Samant - President and Chief Executive Officer Mammen P. "Anza" Mammen, Jr., M.D. - SVP, Clinical Development Larry R. Smith, Ph.D. - SVP, Research Anthony A. Ramos - Chief Financial Officer Keith D. Hall - VP, Operations

info@viamet.com

http://www.viamet.com

VIAMET

Discovering and Developing Breakthrough Therapies Based on Leadership and expertise in Metalloenzyme Chemistry & Biology About Viamet Viamet discovers and develops breakthrough therapies based on their leadership in metalloenzyme chemistry and biology. Viamet's promising clinical and preclinical candidates include potential therapies to treat invasive and hospital-based fungal infections, cancer, cardiovascular and orphan diseases. Viamet utilizes its MIDAS technology to design novel drugs that we expect to have improved potency, greater selectivity and superior therapeutic index. Our initial drug discovery and development efforts have been focused on a clinically validated metalloenzyme target, fungal CYP51, with broad applications in the treatment of human fungal infections. This approach includes VT-1598, an orally available inhibitor of fungal CYP51 that has shown high potency and selectivity in in vitro studies. An IND has been approved for VT-1598 and the molecule is ready to enter clinical testing for a range of invasive fungal infections, including cryptococcal meningitis. The Company’s pipeline also includes promising preclinical product candidates which target other validated metalloenzymes in the areas of cardiovascular disease and oncology. Viamet believes that their MIDAS technology is applicable to a broad range of metalloenzyme targets across many therapeutic indications. Target Indications Invasive fungal infections Leadership Robert Schotzinger, M.D., Ph.D. – President & Chief Executive Officer and Director Ed Garvey, Ph.D. – VP Biology

info@theravance.com

http://www.theravance.com

THERAVANCE BIOPHARMA

Medicines That Make a Difference

About Theravance Theravance’s pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), the Company’s first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Theravance’s neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Theravance’s research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop intestinally restricted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases. Target Indications cSSSI, HABP/VABP, Concurrent Bacteremia - Approved Primary Bacteremia Gram+ MRSA HCV COPD OIC Opioid FDC: Pain Gastroparesis ICU IV Prokinetic Ulcerative Colitis Heart Failure, Chronic Kidney Disease nOH Leadership Rick E Winningham - Chairman and Chief Executive Officer Renée D. Galá - Senior VP and Chief Financial Officer Brett K. Haumann, M.D., M.B.A. - Senior VP, Clinical Development and Chief Medical Officer Frank Pasqualone - Senior VP and Global Head, Acute Care Business

info@t2biosystems.com

http://www.t2biosystems.com

@T2Bio

T2 BIOSYSTEMS

Enabling patients to receive the best treatment faster than ever before, by transforming diagnostics – radically improving patient care and hospital economics.

About T2 Biosystems: T2 Biosystems is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx Instrument and T2Candida Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance technology, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. Antimicrobial Resistance The rapid and accurate T2 results are critical weapons in the hospital’s fight against antimicrobial resistance. T2 results reduce the overuse of antimicrobial therapies by getting doctors and hospitals specific pathogen information faster than ever before. Positive results enable targeted treatment, and negative results may allow physicians to limit or eliminate the use of unnecessary drugs. Technology & Solutions T2MR Technology - The technology platform for next-generation diagnostics T2Sepsis Solution T2Bacteria Panel T2Candida Panel T2Dx Instrument Leadership John McDonough - Chief Executive Officer Tom Lowery, Ph.D. - Chief Scientific Officer Rahul Dhanda - Senior Vice President, Corporate Development & Marketing

sperotherapeutics.com

@Spero_Tx

SPERO THERAPEUTICS

Developing MDR Bacterial Infection Treatments

About Spero
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections. Spero is advancing SPR994, which is designed to be the first broad-spectrum oral antibiotic for use in adults to treat MDR Gram-negative infections. Spero is also advancing its Potentiator Platform, which it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. The product candidates are two IV-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting. Spero is also developing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.

Target Indications
Complicated urinary tract infections MDR gram-negative infections Pulmonary non-tuberculous mycobacterial (NTM) infections

Leadership
Ankit Mahadevia, MD - President and CEO
Thomas Parr, PhD - Chief Scientific Officer
Joel Sendek - Chief Financial Officer
Cristina Larkin - Chief Operating Officer
David Melnick, MD - Chief Medical Officer

scynexis.com

info@scynexis.com

SCYNEXIS

Developing novel anti-infectives to address significant unmet therapeutic needs

About SCYNEXIS
SCYNEXIS, Inc. is a biotechnology company committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections by delivering innovative anti-infective therapies. The SCYNEXIS team has extensive experience in the life sciences industry discovering and developing more than 30 innovative medicines over of therapeutic areas.

The company's lead product candidate, SCY-078, is the first representative of a novel intravenous and oral triterpenoid antifungal family. SCY-078 is in Phase 2 clinical development for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections caused by Candida and Aspergillus species. The FDA granted Fast Track, Qualified Infectious Disease Product and Orphan Drug Designations for the formulations of SCY-078 for the indications of invasive candidiasis (including candidemia) and invasive aspergillosis.

Target Indications
Invasive candidiasis (including candidemia)
Invasive aspergillosis
Vulvovaginal candidiasis (VVC)

Leadership
Marco Taglietti, M.D. - President and Chief Executive Officer
David Angulo, M.D. - Chief Medical Officer

scynexis.com

info@paratekpharma.com

617-807-6600

@ParatekPharma

ParatekPharma

PARATEK

Positive Outcomes. Positive patient stories

About Paratek
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections.. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the target indications of ABSSSI, CABP, uUTI and cUTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI and has completed its New Drug Applications to the U.S. FDA and is preparing a marketing authorization in the European Union. Paratek has licensed rights for omadacycline to Zai Lab for the greater China region and retains all remaining global rights. Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

Paratek's second Phase 3 product candidate, Seysara™ (sarecycline), is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline. Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

Target Indications
Acute bacterial skin and skin structure infections (ABSSSI)
Community-acquired bacterial pneumonia (CABP)
Urinary tract infections (UTI)
Biodefense pathogens
Moderate to severe acne vulgaris

Leadership
Michael F. Bigham - Chief Executive Officer and Chairman of the Board
Evan Loh, M.D., - President, Chief Operating Officer & Chief Medical Officer

nabriva.com

office@nabriva.com

NABRIVA

Driven to Deliver Innovative Treatments for Patients with Infectious Diseases

About Nabriva
Nabriva is a clinical-stage biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva's medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva's lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The comany believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP).. Nabriva believes that lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of treatment-emergent adverse events comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications and is developing a formulation of lefamulin appropriate for pediatric use.

Through research and development efforts, Nabriva has also identified a topical pleuromutilin product candidate, BC-7013, for which the Company completed a Phase 1 clinical trial. Nabriva believes that this pleuromutilin compound is well suited for the topical treatment of a variety of Gram-positive infections, including uncomplicated skin and skin structure infections.

Target Indications
CABP - Community Acquired Bacterial Pneumonia
ABSSSI - Acute Bacterial Skin and Skin Structure Infections
STI - Sexually Transmitted Infections
HABP- Hospital Acquired Bacterial Pneumonia
VABP -Ventilator Acquired Bacterial Pneumonia
uSSI - uncomplicated skin and skin structure infections
osteomyelitis
Prosthetic joint infections

Leadership
Colin Broom - Chief Executive Officer
Francesco Maria Lavino - Chief Commercial Officer
Steven Gelone - Chief Scientific Officer and Head of Business Development
Gary Sender - Chief Financial Officer

Manos Perros, Ph.D.

AWG Vice Chair
Chief Executive Officer, co-Founder and Director
Entasis Therapeutics

Manos Perros, Ph.D., has served as Chief Executive Officer, co-founder and Director of Entasis Therapeutics since May 2015. Prior to this, Dr. Perros worked for AstraZeneca AB as Vice President and head of its infection research and early development organization from 2010 to 2015 and as site head for its research center in Waltham, Massachusetts from 2012 to 2015. Prior to joining AstraZeneca, Dr. Perros served as Director of the Novartis Institute for Tropical Diseases in Singapore, and prior to that, as Vice-President and Chief Scientific Officer, Antivirals, at Pfizer, Inc. A chemist by training, Dr. Perros conducted his Ph.D. work in Belgium, France and Germany, and was an Associate in the Biophysics department at Yale from 1993 to 1995. Dr. Perros received the PhRMA Discoverer’s Award in 2010.

David Roblin

Chief Operating Officer, Chief Medical Officer & President of R&D
Summit Therapeutics plc

David Roblin has served as Summit’s Chief Operating Officer, Chief Medical Officer and President of Research and Development since May 2017. Dr. Roblin acted as a research and development adviser to Summit from 2014. Dr. Roblin has served as the Chief Operating Officer and Director of Scientific Translation at the Francis Crick Institute in London from 2014 to 2017. Prior to that, Dr. Roblin was Head of Research, Site Director and Chief Medical Officer for Europe R&D at Pfizer Inc. from 2008 to 2011 and was Head of Therapy Area for Anti-infectives at Bayer AG from 1997 to 1999. After Dr. Roblin left Pfizer Inc. in 2011, he held a variety of board and advisory positions as well as Chief Medical Officer to biotechnology companies including Creabilis SA until 2014. Dr Roblin has a degree in biochemistry from University College London and later qualified in medicine from St George’s Hospital. He is a Fellow of the Royal College of Physicians, a Fellow of the Faculty of Pharmaceutical Medicine and a Fellow of the Academy of Medical Sciences. He is an honorary Professor of Medicine at Swansea University and Professor of Translational Medicine at St George’s. He remains as Chair of the Crick Translation Advisory Group and also serves on the BioMedical Catalyst Board Major Awards Committee, the Wellcome’s Science Innovation Translation Advisory Group and the scientific advisory groups for the LEO Foundation and Destiny Pharma PLC. He is also a member of the board of directors of Sosei. Before entering the life sciences industry, Dr Roblin practiced medicine for five years.

Stephen Conafay

AWG Washington Counsel

Steve Conafay has 35 years of leadership and management experience in government relations, public policy and communications. As the sole principal at The Conafay Group, he oversees all client servicing. While leader of the bio-life science practice at Fabiani & Company, he oversaw more than $810 million in non-dilutive financing awarded to the team’s clients. For 12 years, Mr. Conafay was vice president of government relations for Pfizer, where he was elected as a corporate officer in 1984. He served as senior vice president of corporate affairs for Glaxo Inc., where he was also a member of the Board of Directors. After heading the legislative practice for Jones, Day, Reavis and Pogue, the world’s second largest law firm, he was tapped by the Pharmaceutical Research and Manufacturers of America (PhRMA) to assume the No. 2 position of executive vice president of strategic and legislative affairs. He also served as an executive fellow at the American Enterprise Institute, the leading free market think tank in the U.S. After moving to the New York area, Mr. Conafay joined Shandwick, where he assumed several positions of increasing responsibility, culminating with his appointment as chief executive officer for The Americas-East in 2000.

Mr. Conafay is a lawyer and a decorated Vietnam veteran. He served as an infantry platoon leader and was awarded the Silver Star, Bronze Star with Oak Leaf Cluster, the Air Medal and the Army Commendation Medal, among others. He is also an avid golfer and has been a member of Congressional Country Club for more than 30 years. Mr. Conafay is a lifelong fan of the New York and San Francisco Giants. In his 60s, he ran and completed four Army 10-miler races, and plans to continue competing in his 70s.

Christopher J. Burns, Ph.D.

Founder, President and Chief Executive Officer
Venatorx Pharmaceuticals, Inc.

Dr. Burns has more than 25 years of corporate and research and development experience within both major and specialty pharmaceutical companies. At VenatoRx Pharmaceuticals, Dr. Burns has developed a comprehensive USG/NGO financing strategy that has enabled the Company to build out a world-class antibacterials portfolio. Prior to VenatoRx, Dr. Burns served as a member of the Executive Management Team and as Vice President of Research at Protez Pharmaceuticals through its acquisition by Novartis in 2008. Prior to Protez/Novartis, Dr. Burns served as Director of Chemistry at ViroPharma, producing clinical candidates for Hepatitis C (HCV-796) and smallpox infections (Tecovirimat, licensed to and developed by Siga Technologies). Prior to this, Dr. Burns served as a core member of the Global Lead Optimization Counsel at Rhone-Poulenc Rorer/Aventis. During his 12 years at RPR/Aventis, Dr. Burns led multidisciplinary teams in bone metabolism, cardiovascular disease (in the U.S.), and oncology (in France). Dr. Burns has appeared as co-author or co-inventor on more than 60 patents and publications and has served as Principal Investigator on more than 10 awarded U.S. National Institute of Health (NIH) grants. He received his Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology (MIT) under Nobel-laureate Professor K. Barry Sharpless. He currently serves on the Board of Directors at Life Sciences Pennsylvania (LSPA) and the Antimicrobials Working Group (AWG). .

Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

Ramani Varanasi

Co-Founder, President & Chief Executive Officer
X-Biotix Therapeutics, Inc.

Ms. Varanasi is a co-founder, President and CEO of X-Biotix. She is an accomplished business executive, with 24 years of biopharmaceutical industry experience and a distinguished track record in structuring, negotiating and executing successful strategic alliances, licensing agreements and M&A transactions as well as providing business development, management and strategic leadership to organizations. She has held Research and senior level positions in Business & Corporate Development including at Merck, Millennium (now Takeda), Momenta, and Checkmate Pharmaceuticals, to name a few. Over the course of her career, Ramani has been involved in the formation of strategic partnerships with companies and research organizations globally, including in emerging markets such as Asia - and continues to have a keen interest in bridging the research and business gap and fostering collaboration between enterprises in this global marketplace. Her broad experience in the areas of early stage company formation and financing, including dilutive and non-diluting funding initiatives, has enabled her to execute deals with total value in excess of several billion dollars. Ramani holds a B.Sc. and a M.Sc. from McGill University in Microbiology & Immunology and Biochemistry, respectfully, and an MBA in General Strategy from Northeastern University. She volunteers as a mentor to start-up companies in the biopharma area and also has an avid interest in the area of international healthcare, a sector in which she has been involved as a board member for two non-profit organizations.

Corey Fishman

Chief Executive Officer
Iterum Therapeutics

Corey Fishman is a founder of and has served as Chief Executive Officer of Iterum Therapeutics since its formation in late 2015. From 2010 to 2015, Mr. Fishman served as Chief Financial and Chief Operating Officer of Durata Therapeutics, Inc. overseeing all aspects of finance and administration, manufacturing, business development, strategy, international operations and portfolio optimization. While at Durata, he raised substantial capital, including a successful IPO and secondary public offering. Mr. Fishman also led the negotiation and sale of the company to Actavis plc. Prior to Durata, Mr. Fishman served as Chief Financial Officer of Ganic Pharmaceuticals, Inc., a Warburg Pincus company from 2008 to 2010. From 2002 to 2008, Mr. Fishman served in a leadership role at MedPointe Healthcare, Inc., a private equity backed specialty pharmaceutical company and became the Chief Financial Officer in 2006. Mr. Fishman had responsibility for finance and administration, portfolio optimization, manufacturing, strategy and business development. He led the development and implementation of a new strategic plan, which involved raising capital, restructuring debt, accelerating the growth of existing commercial assets and developing multiple line extensions to enhance future value, culminating in the successful sale of the company to Meda AB. From 1994 to 2002, Mr. Fishman held roles of increasing responsibility in both mid-size and large pharma.

Mr. Fishman was a Director of Momenta Pharmaceuticals (MNTA) and BioSpecifics Technology Corporation (Nasdaq: BSTC), until both companies were acquired late in 2020.

Mr. Fishman holds a BA in Economics from the University of Illinois at Urbana-Champaign and an MSM in Finance from the Krannert School of Management at Purdue University.