— Commercial preparations advancing, with topline PEDFIC 1 results expected mid-2020  —
— First sites initiated for second pivotal trial in biliary atresia —
— Management to host conference call and webcast today at 10:00 a.m. ET —BOSTON, May 07, 2020 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the first quarter ended March 31, 2020.“Despite the unprecedented challenges of COVID-19, our fundamentals remain unchanged, and we continue to make significant progress across our development programs, while accelerating preparations for commercialization,” said Ron Cooper, President and Chief Executive Officer of Albireo. “In PFIC, we are now months away from our Phase 3 data readout, and we are advancing our preparations in manufacturing, market development, market access, patient support and other areas. Meanwhile, we are advancing pivotal trials in biliary atresia and Alagille syndrome, and our NASH program is making excellent progress, with data readout from our Phase 2 trial also a few months away.“COVID-19 has had a sweeping impact across the industry and society as a whole. We have successfully adapted our business operations, with the safety of our employees and the patient communities as our top priority. We are fortunate that our clinical trials in PFIC and NASH have completed enrollment this quarter, and we have sufficient clinical trial supply to support those programs. As of now, our prior guidance regarding our clinical trials remains unchanged.”More information on the impact of COVID-19 on Albireo is available at albireopharma.com.Recent HighlightsOdevixibatWith the PEDFIC 1 trial fully randomized, have accelerated preparations for commercialization. More than three-quarters of patients have completed the trial, and we continue to expect topline results mid-2020 and anticipate potential first regulatory approval H2 2021.
 We have initiated the first clinical trial sites for the BOLD pivotal study, Biliary Atresia and the Use of Odevixibat in Treating Liver Disease. Biliary atresia is a rare pediatric liver disease that is the leading cause of liver transplants among children, and for which there is no approved pharmacological therapy. Biliary atresia is the most common rare pediatric cholestatic liver disease and the largest market opportunity in that therapeutic category. The U.S. Food and Drug Administration (FDA) and European Commission have granted orphan designations for odevixibat in the treatment of biliary atresia.     Received FDA feedback and are finalizing pivotal trial design in Alagille syndrome. Anticipate initiating trial by the end of this year. The FDA and the European Commission have granted orphan designations for odevixibat in the treatment of Alagille syndrome.PipelineAchieved full enrollment in elobixibat Phase 2 trial in NAFLD and NASH. Proof-of-concept study is the first study ever conducted in both NAFLD and NASH patients with an IBAT inhibitor. Expect topline data by mid 2020. Additionally, expect topline data from another Phase 2 trial being conducted through our partner EA Pharma in Japan by the end of the year or early next year.
 Continued as planned IND-enabling studies of lead preclinical candidate with novel mechanism of action.       CorporateCompleted equity capital raise of net $43.0 million.First Quarter 2020 Financial ResultsRevenues were $1.5 million for the first quarter of 2020, compared with $0.6 million for the first quarter of 2019. The higher revenue  was due to the estimated royalty revenue received from EA Pharma for elobixibat for the treatment of chronic constipation. The royalty revenue is passed on to HealthCare Royalty Partners.
 R&D expenses were $16.1 million for the first quarter of 2020, compared with $8.3 million for the first quarter of 2019. The higher expenses were primarily due to program expenses for odevixibat and elobixibat, as well as personnel costs, as we continue to increase our program activities and headcount.
 G&A expenses were $8.2 million for the first quarter of 2020, compared with $5.3 million for the first quarter of 2019. The increase was attributable to personnel and related expenses, as we continue to increase our headcount, and commercialization readiness expenses.
 Net loss for the first quarter of 2020 was $31.5 million, or $(2.23) per share, compared with $16.7 million, or $(1.39) per share for the first quarter of 2019.
 The company had cash and cash equivalents at March 31, 2020, of $150.5 million, which compares with $150.3 million at March 31, 2019. During the first quarter of 2020, an additional $43.0 million of net cash was raised through an underwritten public offering of our common stock. As a result, cash and cash equivalents are anticipated to be sufficient into the second half of 2021.Conference Call
As previously announced, Albireo will host a conference call and webcast today, May 7, 2020, at 10:00 a.m. ET. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263  (international), and provide the access code 13699920. A live audio webcast will be accessible from the Media & Investors page of Albireo’s website, http://ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo’s website for 3 months following the event.
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