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 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com&amp;esheet=51545104&amp;newsitemid=20170421005815&amp;lan=en-US&amp;anchor=Bristol-Myers+Squibb+Company&amp;index=1&amp;md5=055486dbe9f22b005c7dcd689f070766" rel="nofollow" rel="nofollow">Bristol-Myers 
 Squibb Company</a> BMY today announced data from a Phase 2 study 
 of BMS-986036, an investigational pegylated analogue of human fibroblast 
 growth factor 21 (FGF21), a key regulator of metabolism, in patients 
 with biopsy-confirmed nonalcoholic steatohepatitis (NASH) (F1-F3). The 
 study achieved its primary endpoint of significant reduction in liver 
 fat versus placebo. Statistically significant improvements were also 
 seen in prespecified exploratory endpoints including biomarkers of 
 fibrosis, metabolic parameters and markers of liver injury. These data 
 were presented at a late-breaking oral presentation at EASL: The 
 International Liver Congress on April 22 at 4:15 p.m. CET in Amsterdam.
 
 
 "These data suggest that BMS-986036 may be effective in patients with 
 NASH, many of whom will experience disease progression due to the lack 
 of available treatment options," said Arun Sanyal, MBBS, M.D., 
 professor, Departments of Medicine, Physiology, and Molecular Pathology, 
 Virginia Commonwealth University. "The results of this study show that 
 BMS-986036 had beneficial effects on three important components in the 
 treatment of NASH: liver fat, liver injury and fibrosis."
 
 
 "We are encouraged by the improvements these data showed across multiple 
 aspects of NASH, and that patients could be effectively evaluated 
 through imaging rather than through invasive liver biopsy," said Mike 
 Burgess, head of Cardiovascular, Fibrosis and Immunoscience Development, 
 Bristol-Myers Squibb. "These data, along with previously announced Phase 
 2 data in patients with type 2 diabetes, support further clinical 
 research of BMS-986036 as a potential treatment for NASH. We look 
 forward to sharing these data with health authorities to determine next 
 steps for further study of this asset."
 
 
 Bristol-Myers Squibb exclusively licensed the rights to research, 
 develop and commercialize BMS-986036 from Ambrx, Inc.
 
 
 About MB130-045: A Phase 2 Randomized, Double-Blind, 
 Placebo-Controlled, Parallel-Group, Multiple Dose Study to Evaluate the 
 Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in 
 Adults with Nonalcoholic Steatohepatitis
 
 
 This was a multicenter, randomized (1:1:1), double-blind, 
 placebo-controlled study in adults with body mass index ≥25 kg/m2, 
 biopsy-confirmed NASH (F1-F3), and hepatic fat fraction ≥10%, assessed 
 by magnetic resonance imaging-proton density fat fraction (MRI-PDFF), a 
 noninvasive measurement of liver fat. Randomization was stratified by 
 diabetes status. Patients received subcutaneous injections of BMS-986036 
 10 mg daily (n=25), BMS-986036 20 mg weekly (n=23), or placebo (n=26) 
 daily for 16 weeks. The primary efficacy endpoint was absolute change in 
 MRI-PDFF at Week 16. Exploratory endpoints included serum Pro-C3 
 (N-terminal type III collagen propeptide, a fibrosis biomarker), enzymes 
 alanine aminotransferase (ALT) and aspartate aminotransferase (AST), 
 and, in a subset of patients, liver stiffness, assessed by MR 
 elastography (MRE).
 
 
 Among the 74 patients treated, 68 were assessed by MRI-PDFF at both 
 Baseline and Week 16. Liver biopsy was conducted to confirm NASH at 
 Baseline. At Week 16, both dosing regimens of BMS-986036 (10 mg daily or 
 20 mg weekly) significantly reduced liver fat as measured by MRI-PDFF 
 versus placebo (6.8% and 5.2%, respectively, vs. 1.3%, p=0.0004 and 
 p=0.008). The 10 mg daily dose resulted in 57% of patients (13/23) 
 reaching ≥30% relative risk reduction. The 20 mg weekly dose resulted in 
 52% of patients (11/21) reaching ≥30% relative risk reduction. Both 
 dosing regimens also improved Pro-C3 (a serum biomarker of fibrosis), 
 magnetic resonance elastography (MRE, a measure of liver stiffness), as 
 well as adiponectin, ALT and AST (markers of liver injury). Improvements 
 in triglycerides, low density lipoprotein (LDL), and high density 
 lipoprotein (HDL) were also observed in the treatment groups.
 
 
 Overall, BMS-986036 had a favorable safety profile, with no deaths or 
 serious adverse events related to treatment, and no discontinuations due 
 to adverse events. The most frequent adverse events were diarrhea (13% 
 and 22%, respectively, vs. 8% in placebo), nausea (16% and 13%, 
 respectively, vs. 8%), and frequent bowel movements (20% and 0%, 
 respectively, vs. 0%), none of which were severe.
 
 
 About Fibrosis and NASH
 
 
 Fibrotic diseases are characterized by chronic inflammation that leads 
 to excess collagen deposition and scar formation in an organ or tissue. 
 This scarring response compromises function and ultimately leads to 
 organ failure. Nonalcoholic steatohepatitis (NASH) may progress to 
 cirrhosis, hepatocellular carcinoma (liver cancer) and liver failure, 
 and is expected to be the leading cause of liver transplant by 2020. The 
 severity of liver fibrosis (scar tissue in the liver) is measured on a 
 scale of F0 (normal) to F4 (cirrhosis) in a liver biopsy specimen. 
 Approximately 20 million patients in the U.S. have NASH, and there are 
 currently no approved pharmacological treatments.
 
 
 About Fibrosis at Bristol-Myers Squibb
 
 
 Bristol-Myers Squibb is committed to the discovery and development of 
 medicines for the treatment of fibrosis, the buildup of scar tissue that 
 impacts organ function. We are advancing a robust pipeline of 
 investigational compounds to address areas of high unmet need in 
 fibrosis, including nonalcoholic steatohepatitis (NASH), a condition 
 with no approved treatment options that may lead to liver fibrosis 
 and/or cirrhosis; and idiopathic pulmonary fibrosis (IPF), a progressive 
 lung disease with a high mortality rate. We are researching multiple 
 mechanisms and approaches to make the biggest impact on patients.
 
 
 About Bristol-Myers Squibb
 
 
 Bristol-Myers Squibb is a global biopharmaceutical company whose mission 
 is to discover, develop and deliver innovative medicines that help 
 patients prevail over serious diseases. For more information about 
 Bristol-Myers Squibb, visit us at <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2Fpages%2Fdefault.aspx&amp;esheet=51545104&amp;newsitemid=20170421005815&amp;lan=en-US&amp;anchor=BMS.com&amp;index=2&amp;md5=0fe66ec542eca6323485566fa7fcc2fa" rel="nofollow" rel="nofollow">BMS.com</a> 
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 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FBristolMyersSquibb&amp;esheet=51545104&amp;newsitemid=20170421005815&amp;lan=en-US&amp;anchor=Facebook&amp;index=6&amp;md5=de11af1b42f1446c04e1c1304ef51ef2" rel="nofollow" rel="nofollow">Facebook</a>.
 
 
 Bristol-Myers Squibb Forward Looking Statement
 
 
 This press release contains "forward-looking statements" as that term 
 is defined in the Private Securities Litigation Reform Act of 1995 
 regarding the research, development and commercialization of 
 pharmaceutical products. Such forward-looking statements are based on 
 current expectations and involve inherent risks and uncertainties, 
 including factors that could delay, divert or change any of them, and 
 could cause actual outcomes and results to differ materially from 
 current expectations. No forward-looking statement can be 
 guaranteed. Among other risks, there can be no guarantee that the 
 investigational compound discussed in this release will be successfully 
 developed or approved for any of the indications described in this 
 release. Forward-looking statements in this press release should be 
 evaluated together with the many uncertainties that affect Bristol-Myers 
 Squibb&#39;s business, particularly those identified in the cautionary 
 factors discussion in Bristol-Myers Squibb&#39;s Annual Report on Form 10-K 
 for the year ended December 31, 2016 in our Quarterly Reports on Form 
 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb 
 undertakes no obligation to publicly update any forward-looking 
 statement, whether as a result of new information, future events or 
 otherwise.
 
 
 
 
 
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