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Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Unaudited interim results for the period ended 30 June 2017
Strong progress across all programmes, top line data for Acumapimod and BGS 649 expected within the next 6 months
London, 8 August 2017 – Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare and specialty diseases, is pleased to announce its unaudited interim results for the six months ended 30 June 2017.
- Initiation of ASTEROID, a Phase 2b, potentially pivotal study of BPS-804 in 120 adult patients with the orphan disease osteogenesis imperfecta (OI), (brittle bone disease) in the US and Europe. Top-line data expected in mid-2018
- Accepted onto the Adaptive Pathway process by the EMA
- Initiation of the paediatric programme expected towards the end of 2017
- Expected completion of enrolment (268 patients) in the coming weeks, of a Phase 2b dose-confirmation study for the treatment of hypogonadotropic hypogonadism (HH) in obese men
- Top-line data expected Q1 2018
- Independent Data Monitoring Committee recommended in March the continuation of all three dosing arms following a blinded interim review of safety and efficacy data from 93 patients who had completed at least one month of treatment
- Follow-on six-month Phase 2b safety extension study recruiting well with approximately 65-70% of patients opting to continue treatment
- Successful completion of enrolment of 282 patients into AETHER, a Phase 2 dose-ranging study for treatment of patients with acute exacerbations of COPD (AECOPD)
- Top-line data expected Q4 2017
- Increased intellectual property protection across the portfolio, with new patent applications being pursued and allowance and grant of additional patents for all three products in the US, EU and elsewhere
- Further strengthened operational team
- Richard Jones appointed CFO and Executive Director in January 2017
- Jerome Dauvergne appointed Head of Pharmaceutical Development in May 2017
- Additional hires in clinical development bring total current headcount to 28
- Continued assessment of strong pipeline of additional new product opportunities in orphan and rare diseases from large pharmaceutical and large biotechnology companies
- Raised £15m (gross) via a placing of new shares.
- Subsequent conversion of £1.4 million of a loan note held by Novartis resulting in a balance of loan note as at 30 June 2017 of £2.3 million
- Loss after tax of £22.7 million (2016: £14.7 million) or 34 pence per ordinary share (2016: 59 pence per ordinary share)
- Net cash and investment balance of £56.6 million at 30 June 2017, includes a net cash movement of £3.0 million after net operating and investing outflows of £11.3 million and gross financing inflows of £14.3 million
- Total development spend of £21.4 million (2016 £11.1 million) reflecting increased clinical development activity in the period, including the commencement of the Phase 2b study for BPS-804
- New £20 million debt facility agreed with Silicon Valley Bank and Kreos Capital both having significant experience in the sector
- £10 million of this facility is expected to be drawn down shortly
- Funds received will increase operational and development flexibility
“During the period we continued to make strong progress in the development of our portfolio and look forward to delivering the top-line data on our two Phase 2 studies for AECOPD and hypogonadotropic hypogonadism within the next six months. Our orphan candidate for OI is one of a small number of programmes that has been selected by the EMA for the Adaptive Pathway process. Through this we hope to accelerate the access of BPS-804 for patients in Europe. The phase 2b study in adult patients is recruiting and the paediatric study is expected to start at the end of the year. We also continue to seek and actively evaluate a number of opportunities in rare and orphan diseases to expand and further diversify our product portfolio. We remain focussed on building a leading commercial business in rare and orphan diseases.”Denise Scots-Knight Chief Executive Officer
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
UK Public Relations Advisor to Mereo Biopharma
+44 (0)20 3727 1000
US Public Relations Advisor to Mereo Biopharma
+01 (0) 212 213 0006
Mereo BioPharma is an innovative biopharma company established to address the development and financial challenges faced by an increasing number of large pharma and biotech companies. Mereo focuses on developing and optimising the value of novel medicines acquired from large pharma and biotech designed to address significant unmet medical needs in rare and specialty disease areas.
Mereo is comprised of a strong team with broad operational capabilities and the financial resources to conduct comprehensive clinical studies. The Company plans to build a rare and orphan commercial business combined with plans to partner products where appropriate.
Mereo's initial portfolio consists of three mid-late stage clinical assets that were acquired from Novartis in July 2015 each with proof of concept data in the indication that Mereo is now developing. BPS-804 is being developed for the treatment of osteogenesis imperfecta (brittle bone disease); acumapimod (BCT-197), is being developed to treat inflammation in patients with an AECOPD; and BGS-649 is a once-weekly oral novel therapy that restores the patient's own testosterone in men with hypogonadotropic hypogonadism. In H1 2016 the Company initiated a Phase 2 study with acumapimod and a Phase 2b study with BGS-649. Mereo recently announced commencement of the first potentially pivotal trial for BPS-804 and completion of enrolment of the acumapimod Phase 2 study. Additional product opportunities, from a range of large pharmaceutical and biotechnology companies, are under active evaluation and these are focussed on orphan and rare diseases.