Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Mereo BioPharma Announces Preliminary Results for the Year Ended December 31, 2017
London, March 23, 2017 - Mereo BioPharma Group plc (AIM: MPH), a multi-asset biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics that aim to improve outcomes for patients with rare and specialty diseases, is pleased to announce its audited preliminary results for the year ended December 31, 2017.
Dr. Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma Group plc commented:
"This has been a pivotal period for Mereo. We announced positive top-line data with BCT-197 for AECOPD, our first significant clinical study read-out since the company's inception in mid-2015. Together with the positive BGS-649 data announced earlier this week, we have now successfully completed two substantial Phase 2 studies on our specialty pharma product candidates and initiated a Phase 2b study with BPS-804, our orphan disease product candidate for osteogenesis imperfecta in adults.
We also demonstrated the sustainability of our business model with the in-licensing of AZD-9668 from AstraZeneca for the rare disease Alpha-1 Antitrypsin Deficiency. We continue to review a large number of opportunities to further diversify our portfolio, and look forward to reporting further significant progress and initiating additional clinical studies in 2018."
Rare & Orphan Diseases
BPS-804 for Osteogenesis Imperfecta (OI)
- BPS-804 was accepted into the adaptive pathways program in the EU in February 2017 and admitted to the PRIME scheme of the EMA in November 2017.
- In May 2017, the Company initiated a randomized, double-blind, placebo-controlled Phase 2b clinical trial of BPS-804 in approximately 120 adults in the United States, Europe and Canada.
- Mereo also intends to commence a Phase 2b/3 clinical trial of BPS-804 in approximately 150 children with OI in the second half of 2018 in Europe and Canada with fracture rate as the primary endpoint.
AZD-9668 for Alpha-1 Antitrypsin Deficiency (AATD)
- In October 2017, the Company announced an exclusive license agreement, together with an option to acquire the IP, with AstraZeneca for AZD-9668.
- Mereo intends to initiate a Phase 2 proof-of-concept clinical trial in patients with severe AATD in the second half of 2018.
BCT-197 for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- In December 2017, the Company announced positive top-line data from the AETHER study, a Phase 2 double-blind, randomized, placebo-controlled trial investigating the use of BCT-197 on top of standard of care, for the treatment of patients with AECOPD.
- Mereo has initiated partnering discussions for future development and commercialization of BCT-197.
BGS-649 for Hypogonadotrophic Hypogonadism (HH)
- The Company recently announced positive top-line data from a dose-ranging Phase 2b double-blind, randomized, placebo controlled clinical trial with BGS-649 for the treatment of obese men with HH.
- Results of a 6-month safety extension study are expected in Q4 2018 and these, plus additional data analysis, will help guide the next stage of the Company’s clinical development strategy for BGS-649.
- In December 2017, the Company announced plans to conduct a registered initial public offering in the U.S. in the first half of 2018.
- Since the year end, the Company recently appointed “Wills” Alexandra Hughes-Wilson as Head of Patient Access and Commercial Planning.
Full Year 2017 Financial Highlights
- Loss after tax of £38.8 million (2016: £28.4 million) or 56 pence per ordinary share (2016: 63 pence per ordinary share)
- Net cash, short term deposits and short-term investment balance of £52.5 million at December 31, 2017 (2016: £53.6 million)
- Total development spend increased to £34.6 million (2016 £24.6 million) reflecting increased clinical development activity in the period, including the commencement of the adult Phase 2b study for BPS-804
- A total of £35m of cash proceeds from financing was raised during 2017 by way of (i) an equity placing in April which raised £15 million (gross) and (ii) a new loan facility of £20m agreed in August which was fully drawn by December 31, 2017
FOR FURTHER ENQUIRIES:
Mereo BioPharma Group plc
+44 (0)333 023 7319
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Nominated Adviser and Joint Broker
Cantor Fitzgerald Europe
+44 (0)20 7894 7000
RBC Capital Markets
+44 (0)20 7653 4000
Public Relations Adviser to Mereo
FTI Consulting +44 (0)20 3727 1000
US Public Relations Advisor to Mereo
+01 (0) 212 213 0006