Mereo BioPharma Group plc 2019 Interim Financial Results Conference Call Summary Company Overview - Company: Mereo BioPharma Group plc (NASDAQ:MREO) - Date of Call: September 17, 2019 - Participants: - Richard Jones – Chief Financial Officer - Denise Scots-Knight – Chief Executive Officer Key Industry and Company Insights Core Strategy and Developments - Mereo BioPharma has made significant progress in the first half of 2019, focusing on rare diseases, particularly osteogenesis imperfecta (OI) and severe alpha-1 antitrypsin deficiency (AATD) [6][7] - The company has a diversified portfolio of therapeutic candidates, with significant investments from major pharmaceutical companies [7] - Completed two large Phase 2 studies in COPD and hypogonadotropic hypogonadism, both meeting primary endpoints [7] Lead Product Candidates - Setrusumab: A human monoclonal antibody targeting sclerostin, aimed at treating OI. It has shown a dual-action anabolic effect to build bone density [8][9] - OI is a rare genetic disorder with no FDA or EMA approved therapies [9] - Setrusumab has received prime designation from the EMA and orphan status from both EMA and FDA [9] - Interim data from the ASTEROID study showed a mean increase in trabecular volumetric bone mineral density (Tr vBMD) of 1.4% at three months and 3.2% at six months [10] - The study is the largest investigational clinical study in adult OI patients in the U.S. and EU [13] - Alvelestat: A small molecule inhibiting neutrophil elastase, currently in a Phase 2 proof-of-concept study for AATD [16][17] - AATD patients suffer from progressive lung deterioration, with the only approved therapy being plasma-derived protein, which is not widely available [18] - Top line data from the study is expected in mid-2020 due to slower than anticipated patient enrollment [18] Financial Highlights - R&D expenditure increased to £11.9 million in H1 2019 from £10.9 million in H1 2018 [25] - Administrative expenses decreased to £6.5 million from £7.1 million in the same period [26] - Total cash resources increased to £36.1 million following the merger with OncoMed Pharmaceuticals [27] Upcoming Milestones - Anticipated data readouts from lead programs in H2 2019 and into 2020 [6] - Completion of the ASTEROID study and initiation of a pivotal pediatric study for setrusumab [14][44] - Continued discussions for potential partnerships, particularly for leflutrozole and navicixizumab [42] Additional Important Insights - The company is focused on building relationships with key opinion leaders (KOLs) and patient representative organizations in both the EU and North America [19] - Regulatory interactions are ongoing, including discussions with the EMA regarding the use of HRpQCT as a biomarker [15] - The company aims to position itself as a leading integrated rare disease company, with a focus on significant value inflection points for its lead assets [8] This summary encapsulates the key points from the Mereo BioPharma conference call, highlighting the company's strategic focus, product development, financial performance, and future milestones.
Mereo BioPharma's (MREO) CEO Denise Scots-Knight on 2019 Interim Financial Results and Corporate Update Conference Call