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altimmune Altimmune Announces Third Quarter 2021 Financial Results and Provides a Corporate Update November 9 , 2021 Exploratory MRI - PDFF analysis of subjects with hepatic steatosis in recently completed Phase 1 study of pemvidutide shows reduction of liver fat to undetectable levels after 6 weeks of treatment Approximately $ 200 Million in cash and short - term investments to advance pipeline GAITHERSBURG , Md . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- Altimmune , Inc. ( Nasdaq : ALT ) , a clinical - stage biopharmaceutical company , today announced financial results for the three- and nine - months ending September 30 , 2021 and provided a corporate update . " The third quarter was a momentous time for our pemvidutide ( ALT - 801 ) program , as we delivered on positive topline data for the 12 - week Phase 1 trial , cleared an IND in non - alcoholic steatohepatitis ( NASH ) with the FDA and initiated a 12 - week Phase 1b study in non - alcoholic fatty liver disease ( NAFLD ) , " remarked Vipin K. Garg , Ph.D. , President and Chief Executive Officer at Altimmune . " In addition to the previously announced 12 - week data showing double - digit weight loss in the 1.8 mg arm without the need for dose titration , we now have MRI - PDFF data in a subset of subjects with hepatic steatosis , or fatty liver , from that study demonstrating a remarkable reduction in liver fat to undetectable levels after only 6 weeks of pemvidutide treatment . These findings show the potential of pemvidutide in the treatment of both obesity and NASH , and we look forward to sharing the data from our ongoing Phase 1b trial in NAFLD and initiating Phase 2 trials for obesity and NASH in 2022. " Program Highlights : Pemvidutide¹ ( ALT - 801 ) • Announced weight loss data from 12 - week Phase 1 clinical trial of pemvidutide in overweight and obese subjects o Subjects achieved mean weight losses of 4.9 % , 10.3 % , and 9.0 % at 1.2 mg , 1.8 mg , and 2.4 mg doses , respectively o Once - weekly dosing regimen was well - tolerated without dose titration o Clinically meaningful reductions in serum lipids and blood pressure o No discontinuations due to adverse events • Obesity program advancing towards 48 - week Phase 2 trial in the first half of 2022 1 o Investigational New Drug application ( IND ) for obesity expected to be submitted by year end 2021 o 48 - week Phase 2 obesity study expected to commence in the first half of 2022 proposed INN • Reduction in liver fat by MRI - PDFF exploratory analysis in recently completed Phase 1 study o MRI - PDFF data on liver fat content have now been analyzed through 6 weeks of treatment . While the trial inclusion criteria did not pre - specify a minimum liver fat content , the study did enroll a number of subjects with hepatic steatosis or fatty liver , defined as liver fat content greater than or equal to 5 % . Five subjects had baseline hepatic steatosis ( liver fat content ranging from 5.5 to 19.5 % ) and received pemvidutide at 1.8 mg or 2.4 mg dose levels . In each of these subjects , liver fat levels fell to undetectable levels within weeks of treatment , representing a greater than 90 % reduction in the liver fat content . These findings reinforce the results from preclinical studies of pemvidutide , which demonstrated statistically greater reductions in liver fat than an equivalent dose of semaglutide and confirm the combined beneficial effects of weight loss and glucagon on liver fat metabolism . • Pemvidutide IND application for NASH cleared and enrollment initiated in Phase 1b clinical trial in NAFLD , with topline data expected in the first half of 2022 o The Phase 1b , 12 - week NAFLD trial is being conducted in the US , with Dr. Stephen A. Harrison serving as Principal Investigator o The study will include diabetic and non - diabetic subjects , with a primary efficacy end point of the change in liver fat as measured by MRI - PDFF , and a key secondary endpoint of weight loss at Week 12 o A 52 - week biopsy driven Phase 2 NASH trial is expected to follow the conclusion of the NAFLD trial • Additional activities for continued development of pemvidutide o Drug - drug interaction trial of pemvidutide has been initiated in Australia , with results expected in the first half of