Metacrine to Present Rapid Efficacy of MET409 in a NASH Mouse Model at The Liver Meeting 2018

SAN DIEGO, November 5, 2018 – Metacrine, Inc., a clinical-stage biotechnology company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases, will present data showing rapid efficacy of MET409, a potent, systemic and sustained non-bile acid farnesoid X receptor (FXR) agonist in a biopsy confirmed nonalcoholic steatohepatitis (NASH) mouse model. The poster presentation will take place at The Liver Meeting (AASLD 2018) being held in San Francisco, California on November 11, 2018. The abstract can be found on the AASLD 2018 website at https://www.aasld.org/events-professional-development/liver-meeting/abstracts.

NASH is a liver disease that exists along a continuum of progressive liver deterioration and is characterized by fatty deposits, inflammation and cellular damage. NASH is expected to be the #1 reason for liver transplant by the year 2020. Targeting FXR, a nuclear hormone receptor, represents a clinically validated and effective approach to treating NASH with the added benefit of improving fibrosis. FXR is a ligand-activated transcription factor highly expressed in the liver and gastrointestinal tract. The abstract compares the efficacy of MET409, a sustained non-bile acid FXR agonist, in a pre-clinical mouse NASH model to the activity seen with a transient FXR agonist. This pre-clinical disease model is thought to be representative of human NASH.

MET409 demonstrated superior efficacy with 2 weeks of treatment as compared to 8 weeks of treatment with an equally potent transient FXR agonist. MET409 significantly improved fibrosis, while the transient FXR agonist showed no effect on fibrosis. The findings of this study suggest that MET409 is a promising drug candidate for the improvement of liver health by reducing NASH and fibrosis. MET409 is currently being evaluated in a phase 1 clinical study in healthy volunteers to assess safety, pharmacokinetic and pharmacodynamic properties.

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal (GI) diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. MET409, the lead product candidate, was purposefully designed to be an optimized, next-generation FXR agonist that is initially being developed as a potentially differentiated and best-in-class treatment for nonalcoholic steatohepatitis (NASH). In addition, Metacrine plans to evaluate MET409 as a potential first-in-class treatment for irritable bowel syndrome with diarrhea (IBS-D), and inflammatory bowel diseases (IBD), such as ulcerative
colitis and Crohn’s disease. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.

Contacts:

Investor Inquiries
Trisha Millican
Chief Financial Officer
858.369.7800
tmillican@metacrine.com

Metacrine Appoints Hubert Chen, M.D. as Chief Medical Officer and Andrew Guggenhime to the Board of Directors

SAN DIEGO, September 6, 2018 – Metacrine, Inc., a biotechnology company developing therapies to benefit patients with liver and gastrointestinal diseases (GI), today announced the appointment of Hubert C. Chen, M.D., as Chief Medical Officer, and Andrew Guggenhime as a director of the company. Dr. Chen most recently served as Chief Medical and Scientific Officer at Pfenex, Inc. Mr. Guggenhime currently serves as Chief Financial Officer of Dermira, Inc.

“We are delighted to have both Hubert and Andrew join Metacrine at this pivotal moment in our company growth,” said Ken Song, M.D., President and Chief Executive Officer of Metacrine. “Hubert’s demonstrated leadership in early and late stage clinical development and regulatory negotiations in several biotechnology companies positions him well to drive progress across our product pipeline. Andrew brings with him a wealth of financial, operational, and managerial experience in the life sciences industry and we look forward to benefiting from his expertise and counsel in the coming years.”

Dr. Chen is a board certified endocrinologist with expertise in both clinical medicine and basic science research. His biotechnology career has spanned early to late stage clinical development in multiple disease areas including hepatitis, fibrosis, and inflammatory disease. Most recently, he served as Pfenex’s Chief Medical and Scientific Officer where he oversaw the development of a biosimilar drug. Previously, he served as Vice President, Clinical Development of Aileron Therapeutics, where he designed and led the company’s first two IND submissions and early clinical development for a novel drug discovery platform. Dr. Chen also held clinical leadership roles at Regulus Therapeutics, Amylin Pharmaceuticals, and Amgen, Inc. Concurrent with his corporate career, Dr. Chen served as Assistant Clinical Professor of Medicine at the University of California, San Francisco. Dr. Chen received his medical residency training at Massachusetts General Hospital, his M.D. from Columbia University and his B.A.S. in political science and biological sciences from Stanford University.

“It is great to be joining the Metacrine team at such an important time in the development of its FXR program,” said Dr. Chen. “I look forward to bringing important therapies to patients with liver and GI diseases.”

As Chief Financial Officer of Dermira, Mr. Guggenhime oversees the finance, corporate communications, corporate development, facilities, information technology, investor relations and legal functions. During his tenure he has helped Demira raise more than $850 million in equity and debt financing. Previously, Andrew was the Chief Financial Officer for CardioDx, Inc., where he also served as a director. He has also served as Chief Financial Officer for Calistoga Pharmaceuticals, Inc. until its acquisition by Gilead, Inc., Facet Biotech Corporation until its acquisition by Abbott Laboratories, PDL BioPharma, Inc., and Neoforma, Inc. Andrew began his career in financial services at Merrill Lynch & Co. and Wells Fargo & Company. He holds a B.A. in international politics and economics from Middlebury College and an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University.

“I am pleased to be joining the Metacrine board at an exciting time for the company as it looks to advance several development programs to address underserved liver and GI diseases,” said Andrew Guggenhime. “I look forward to working closely with the Metacrine leadership team and the other directors as they prepare the company for the next phase of the company’s future.”

About Metacrine

Metacrine is a clinical-stage biopharmaceutical company focused on building an innovative pipeline of best-in-class drugs to treat liver and gastrointestinal, or GI, diseases. The most advanced program is focused on the farnesoid X receptor (FXR) an important drug target in multiple liver and GI diseases. MET409, the lead product candidate, was purposefully designed to be an optimized, next-generation FXR agonist that is initially being developed as a potentially differentiated and best-in-class treatment for nonalcoholic steatohepatitis (NASH). In addition, Metacrine plans to evaluate MET409 as a potential first-in-class treatment for irritable bowel syndrome with diarrhea (IBS-D), and inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease. Beyond the FXR program, a pipeline of novel drug candidates against other drug targets is being explored by taking advantage of internal drug discovery and development capabilities. Privately held Metacrine is headquartered in San Diego, California. For additional information, please visit www.metacrine.com.

Contacts:

Investor Inquiries
Trisha Millican
Chief Financial Officer
858.369.7837
tmillican@metacrine.com

Metacrine Completes Dosing of First Cohort in Phase 1 Trial of MET409, a Novel Non-Bile Acid FXR Agonist

San Diego, CA – Metacrine, Inc., an innovative biotechnology company developing therapies to benefit patients with liver, gastrointestinal and metabolic diseases, today announced dosing of the first subjects in a Phase 1 randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) trial of its lead product candidate MET409. The trial is a single and multiple ascending oral dose administration design that will be conducted in healthy male subjects. The trial is being conducted in the Netherlands.

MET409 is a potent oral non-bile acid small molecule farnesoid X receptor (FXR) agonist. Leveraging its highly experienced internal team in biology and chemistry, Metacrine believes it has identified key factors in regards to FXR engagement that are important for efficacy as well as safety. Developed as a best-in-class FXR agonist, MET409 has the potential to treat patients with non-alcoholic steatohepatitis (NASH), irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD).

“The completion of the first dosing cohort with MET409 is a great milestone for the company as we continue clinical development of MET409,” said Ken Song, M.D., President and Chief Executive Officer of Metacrine.

Following the completion of the Phase 1 study in healthy male subjects, Metacrine plans to evaluate MET409 in several parallel Phase 2 clinical trials in patients with NASH, IBS-D and IBD. Metacrine recently completed a $65 million Series C financing to help fund these studies.

About Metacrine

Metacrine is developing best-in-class and first-in-class therapies to benefit patients with liver, gastrointestinal, and metabolic diseases. Metacrine’s lead program for non-alcoholic steatohepatitis (NASH), MET409, focuses on the farnesoid X receptor (FXR) and is based on a novel non-bile acid chemical scaffold. Additional programs are underway in irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD) and the company has a research collaboration with Novo Nordisk in type 2 diabetes. Privately held Metacrine is headquartered in San Diego. For additional information, please visit www.metacrine.com.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine Completes $65 Million Series C Financing

Proceeds will support clinical development of FXR program in NASH and GI diseases

San Diego, CA – Metacrine, Inc., an innovative biotechnology company developing therapies to benefit patients with liver, gastrointestinal and metabolic diseases, today announced it has completed a Series C financing which raised $65 million in new funds. The investment was led by Venrock Healthcare Partners and includes new investors Franklin Templeton Investments, Deerfield Management, Arrowmark Partners, Invus, Lilly Asia Ventures, Vivo Capital, and other undisclosed investors. Existing investors Arch Venture Partners, venBio, Polaris Partners, NEA, and Alexandria Venture Investments participated in the financing as well.

Founded in 2015, Metacrine has now raised a total of $125M million in equity financing. Since inception, Metacrine has leveraged its highly experienced internal team in biology, chemistry, and protein engineering to discover and develop novel therapies. The company has judiciously expanded its capabilities to include early development, clinical, and regulatory expertise. With these capabilities, Metacrine has built the infrastructure to advance potential best-in-class novel medicines from discovery through full clinical development.

“The team at Metacrine has repeatedly proven to be scientifically driven, highly productive and very creative,” said Rich Heyman, Ph.D., Chairman of the Board at Metacrine. “We are very pleased to have a leading syndicate of investors to partner with the company to build a lasting enterprise that aims to develop drugs than can materially benefit patients.”

Metacrine’s lead program is focused on the farnesoid X receptor (FXR). FXR represents a promising target to treat non-alcoholic steatohepatitis (NASH), a debilitating condition that is becoming a leading cause for liver transplant and for which no approved therapies exist today. In addition to NASH, Metacrine has identified a potential role for FXR in diarrhea-predominant irritable bowel syndrome (IBS-D) and inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. Through Metacrine’s discovery efforts and extensive characterization of a broad set of FXR agonists, MET409 has been selected as the lead clinical candidate. MET409 is a non-bile acid FXR agonist and has demonstrated robust preclinical efficacy with a predicted favorable safety profile. While there are a number of FXR agonists in development, Metacrine believes it has identified key factors in regards to FXR engagement that are important for efficacy as well as safety.

“The strong interest from high-quality investors further validates the potential of MET409 for treating liver and gastrointestinal diseases,” said Ken Song, M.D., President and Chief Executive

Officer of Metacrine. “We have purposefully designed an industry leading FXR agonist portfolio with the potential for best-in-class therapy in NASH and first-in-class therapies for IBS-D and IBD.”

Metacrine plans to use proceeds from the Series C financing to advance its clinical development pipeline, including its lead candidate MET409 for the potential treatment of NASH, IBS-D, and inflammatory bowel disease, and to expand its pipeline through continued internal discovery efforts. A Phase 1 clinical study of MET409 is planned to begin later this month.

About Metacrine

Metacrine is developing best-in-class and first-in-class therapies to benefit patients with liver, gastrointestinal, and metabolic diseases. Metacrine’s lead program for non-alcoholic steatohepatitis (NASH), MET409, focuses on the farnesoid X receptor (FXR) and is based on a novel non-bile acid chemical scaffold. Additional programs are underway in irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD) and the company has a research collaboration with Novo Nordisk in type 2 diabetes. Privately held Metacrine is headquartered in San Diego.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine to Present at Jefferies 2018 Global Healthcare Conference

San Diego, CA – Metacrine, Inc., an innovative biotechnology company developing therapies to benefit patients with liver, gastrointestinal and metabolic diseases, today announced that Ken Song, M.D., President and CEO, will present at the Jefferies 2018 Global Healthcare Conference on Thursday, June 7, 2018 at 3:30 p.m. EDT (12:30 p.m. PDT) in New York City.

About Metacrine

Metacrine is developing best-in-class and first-in-class therapies to benefit patients with liver, gastrointestinal, and metabolic diseases. Metacrine’s lead program for non-alcoholic steatohepatitis (NASH), MET409, focuses on the farnesoid X receptor (FXR) and is based on a novel non-bile acid chemical scaffold. Additional programs are underway in irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD) and the company has a research collaboration with Novo Nordisk in type 2 diabetes. Privately held Metacrine is headquartered in San Diego.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine to Present Role of FXR in Treating Inflammatory Bowel Disease at Digestive Disease Week 2018

San Diego, CA – Metacrine, Inc., an innovative biotechnology company developing therapies to benefit patients with liver, gastrointestinal and metabolic diseases, today presented data showing equivalent efficacy of M480, a potent oral non-bile acid farnesoid X receptor (FXR) agonist for the potential treatment of inflammatory bowel disease (IBD), to anti-IL-12/23, a biologic agent. The oral presentation will take place at the Digestive Disease Week 2018 Annual Meeting (DDW 2018) being held in Washington, D.C. on June 5, 2018 at 4:45pm EDT and presented by Xueqing Liu, PhD, a scientist from Metacrine. The abstract can be found on the DDW 2018 website here

IBD is a debilitating disease in which most existing therapies are injectable biologics with immunosuppressive side effects. Targeting FXR, a nuclear hormone receptor activated by bile acids, represents a novel approach to treating IBD. FXR is a ligand-activated transcription factor highly expressed in the liver and gastrointestinal tract. Metacrine has developed an extensive portfolio of oral FXR agonists that are taken once a day. The abstract compares the efficacy of M480 (a Metacrine developed oral FXR agonist), anti-IL-12/23, and Cyclosporine A (CsA) in the mouse adoptive T-cell transfer model of colitis. This pre-clinical disease model is thought to be more representative of human IBD.

M480 was shown to be efficacious in reducing colitis in the adoptive T-cell transfer model with efficacy superior to CsA and comparable to anti-IL-12/23 treatment. The findings of this study suggest that FXR agonists being developed by Metacrine represent a novel class of oral agents that may offer an alternative treatment for IBD. M480 is a predecessor compound to Metacrine’s lead product candidate MET409 which is entering clinical development this summer.

About Metacrine

Metacrine is developing best-in-class and first-in-class therapies to benefit patients with liver, gastrointestinal, and metabolic diseases. Metacrine’s lead program for non-alcoholic steatohepatitis (NASH), MET409, focuses on the farnesoid X receptor (FXR) and is based on a novel non-bile acid chemical scaffold. Additional programs are underway in irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD) and the company has a research collaboration with Novo Nordisk in type 2 diabetes. Privately held Metacrine is headquartered in San Diego.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine Broadens Management Team with Two Key Hires

San Diego, CA – Metacrine, Inc., an innovative biotechnology company developing therapies to benefit patients with liver, gastrointestinal and metabolic diseases, today announced two new key management appointments. Trisha M. Millican has joined the company as Chief Financial Officer, while Karl F. Cremer, Pharm.D., has been appointed Vice President, Clinical Operations.

“I am delighted to welcome Trisha and Karl to Metacrine’s growing leadership team,” said Ken Song, M.D., President and Chief Executive Officer of Metacrine. “Trisha brings with her a wealth of operational, strategic and financial expertise in the biotechnology sector. Karl’s successful track record in clinical operations across multiple products, ultimately leading to approvals, significantly strengthens our development team to advance innovative best-in-class and first-in-class therapeutics. As we prepare to enter the clinic by mid-2018 with our lead candidate, MET409, a non-bile acid best-in-class farnesoid X receptor agonist (FXR) for non-alcoholic steatohepatitis (NASH), I am confident we have the right team in place to advance our programs.”

Trisha Millican joins as the Chief Financial Officer of Metacrine. Her broad experience includes corporate finance, corporate and business development and business operations. Prior to Metacrine, she was Senior Vice President of Finance at Seragon Pharmaceuticals where she led corporate finance and was a key player in the sale of the company to Genentech/Roche in August 2014. Prior to joining Seragon, she served as Vice President of Finance at Aragon Pharmaceuticals until its sale in August 2013 to Johnson & Johnson. She has over 17 years of finance experience in healthcare, having also served in various senior financial management roles at Zogenix, Inc., from 2009 to 2012, and Metabasis Therapeutics, Inc. from 2006 to 2009. Trisha spent five years with the public accounting firm Deloitte, is a certified public accountant in the state of California, and holds a B.S. in accounting from the University of San Diego.

Karl Cremer joins Metacrine as Vice President of Clinical Operations. He has more than 30 years of experience building clinical departments and managing clinical programs, and was a key leader in five product approvals. Previously he was Executive Director of Clinical Operations at Triphase Accelerator, where he was responsible for conducting clinical studies in patients with multiple myeloma and glioblastoma, leading to Celgene’s acquisition of assets related to marizomib in 2016. He has experience in a broad base of therapeutic areas. He received his Pharm.D. at the University of the Pacific, completed a Clinical Residency in ICU Medicine at Veterans Association Medical Center in La Jolla, California, completed a Research Fellowship in Cardiology and Pharmacokinetics at University of Florida, and started his academic career at the University of Texas Health Science Center at San Antonio.

About Metacrine

Metacrine is developing best-in-class and first-in-class therapies to benefit patients with liver, gastrointestinal, and metabolic diseases. Metacrine’s lead program for non-alcoholic steatohepatitis (NASH), MET409, focuses on the farnesoid X receptor (FXR) and is based on a novel non-bile acid chemical scaffold. Additional programs are underway in irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD) and the company has a research collaboration with Novo Nordisk in type 2 diabetes. Privately held Metacrine is headquartered in San Diego.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine to Present Two Abstracts on its Novel FXR Non-Bile Acid Agonist Program at the EASL International Liver Congress 2017

San Diego, CA – Metacrine, Inc., a leading and innovative biotechnology company focused on drug development for metabolic diseases, announced it will present two abstracts on its novel FXR agonist program at the upcoming International Liver Congress Meeting of the European Association for the Study of Liver Disease (EASL) in Amsterdam, Netherlands. Metacrine has developed a leading and comprehensive FXR agonist program based on a unique non-bile acid chemical scaffold.

The first abstract (PS-027), titled “FXR agonists with sustained systemic rather than transient intestinal exposure are more efficacious in a diet-induced obese non-alcoholic steatohepatitis mouse model” will be presented as an oral platform presentation on Thursday, April 20th, 2017 at 5pm.

The second abstract (FRI-361), titled “M480, a novel non-bile acid FXR agonist, shows improvement across multiple parameters in a diet-induced obese mouse model with biopsy-confirmed NASH” will be part of the poster session on Friday, April 21st, 2017.

“FXR represents a foundational and clinically validated target for non-alcoholic steatohepatitis,” said Ken Song, MD, President and CEO of Metacrine. “Metacrine’s differentiated FXR agonist program can position us with the best-in-class molecule.”

About Metacrine

Metacrine is a privately held biotechnology company headquartered in San Diego, CA. The company is focused on efficiently developing innovative drugs that materially benefit patients with metabolic disease.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine to Present at 30th Annual ROTH Conference

Corporate and panel presentations as part of NASH program

San Diego, CA – Metacrine, Inc., an innovative biotechnology company focused on drug development, today announced that Ken Song, MD, President and CEO, will give a corporate presentation and participate in a NASH panel discussion at the 30th Annual ROTH Conference taking place at the Ritz-Carlton in Dana Point, CA. The corporate presentation will take place Monday, March 12, 2018 at 3:30 p.m. Pacific in Green Salon-3. The panel presentation “Not All Fruits are the Same, But What about FXR Agonists?” will take place earlier that same day at 10 a.m. Pacific in Green Salon-3. The presentation is part of a two-day panel program on the latest topics and developments in NASH/PBC drug development.

About Metacrine

Metacrine is a privately held biotechnology company headquartered in San Diego, CA. The company is focused on efficiently developing innovative drugs that materially benefit patients with metabolic disease.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Metacrine Completes Series B Financing to Advance Best-in-Class FXR Program into Clinical Development

San Diego, CA – Metacrine, Inc., an innovative biotechnology company focused on drug development, today announced it has closed a $22M Series B financing led by new investor New Enterprise Associates (NEA), along with participation from existing investors ARCH, Polaris, venBio, and Alexandria Venture Investments. As part of the new financing, Carol Gallagher, Pharm D, Partner at NEA, will join the company’s board of directors. With the new financing, Metacrine has raised approximately $60M since it began operations in early 2015.

Over the course of the past year, Metacrine has advanced its lead asset, MET409, an oral non-bile acid FXR agonist, into late stage IND-enabling studies. First-in-human studies of MET409 are planned to be initiated in the first half of 2018 and completed by year end. Based on extensive profiling and benchmarking against other FXR agonists in development, MET409 has been purposefully designed to have a differentiated profile to position it as best-in-class for efficacy and safety. FXR has been clinically validated to be a key target in hepatobiliary diseases such as primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH).

“We have had a keen interest in new therapeutics for patients with NASH. We look forward to working with the experienced management team at Metacrine to support their mission to discover and development innovative medicines,” said Dr. Gallagher.

In addition to advancing MET409 into clinical development, the Series B proceeds will also be used to fund drug discovery efforts against novel targets in liver inflammation and fibrosis. Metacrine is also advancing a FGF1 program, a first-in-class insulin sensitizer, in collaboration with Novo Nordisk.

We are thrilled to have NEA as a new investor along with the addition of Dr. Gallagher to our board,” said Ken Song, MD, President and CEO of Metacrine. “NASH represents one of the largest unmet medical needs in medicine today. We believe FXR is a compelling NASH target and that our program addresses the gaps in delivering a best-in-class molecule. In addition to NASH, we have outlined a strategy to pursue FXR in other clinical indications.”

About Metacrine

Metacrine is a privately held biotechnology company headquartered in San Diego, CA. The company is focused on efficiently developing innovative drugs that materially benefit patients with metabolic disease.

Contacts:
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com