08 Aug 2018

Mereo BioPharma Group plc

("Mereo" or the "Company" or the "Group")

Unaudited interim results for the six month period ended June 30, 2018

Continued strong progress across all programs

 

London, 8 August 2018 – Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare diseases, is pleased to announce its unaudited interim results for the six months ended June 30, 2018 which demonstrate that Mereo continues to make strong progress on all fronts.

Operational highlights

BPS-804 for Osteogenesis Imperfecta (OI)

  • Enrolment in Mereo’s adult Phase 2b study for Osteogenesis Imperfecta (OI) due to complete around the end of Q3 2018
  • The Adult Phase 2b study is currently being amended and this will result in 6-month efficacy data from an open-label high-dose arm to be available in mid H1 2019
  • In July 2018 Mereo’s Paediatric Investigation Plan (PIP) was recommended for approval by the European Medicine Agency’s (EMA’s) Paediatric Committee (PDCO) and this now clears the regulatory path for our planned registration study in this patient population in Europe
  • Further positive interactions with the EMA through the PRIority Medicines for Europe scheme (PRIME) and Adaptive Pathways providing valuable input into our regulatory, manufacturing and commercial roadmap for BPS-804

MPH-966 (Formerly known as AZD-9668) for severe Alpha-1 Antitrypsin Deficiency (AATD)

  • Mereo has initiated a Phase 2 proof of concept study in the US and EU with first patient expected to be enrolled by early Q4 2018 and with top-line data expected in H2 2019
  • In April 2018, the National Centre for Advancing Translational Sciences (NCATS) issued the first phase of a grant award expected to total $10 million to The University of Alabama at Birmingham (UAB) to study MPH-966 in AATD. Mereo plans to support this study by providing clinical trial materials and regulatory assistance. This substantial NCATS grant is a validation of the relevance of targeting neutrophil elastase in AATD and the data generated will be supportive to our eventual package. We look forward to working closely with UAB.

BGS-649 for Hypogonadotropic Hypogonadism (HH)

  • In March 2018 Mereo announced positive top-line data from the Phase 2b dose-ranging study of BGS-649 for the treatment of HH in Obese Men
  • The follow-on six-month Phase 2b safety extension study enrolled 143 patients with top-line 12-month data is expected in Q4 2018

BCT-197 for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

  • In May 2018 the top-line data from Mereo’s completed Phase 2 AECOPD study was presented at the American Thoracic Society (ATS) conference
  • In addition, following completion of the Clinical Study report (CSR) for this study, additional analyses completed including data on inflammatory biomarkers and outcomes of patients with more than two exacerbations per year, supporting the underlying mechanism of action and totality of the clinical outcomes data
  • Partnering discussions were initiated in the first half of the year and continue to progress

Corporate

  • In February 2018 Wills Hughes-Wilson was appointed as Head of Patient Access and Commercial Planning
  • Mereo continued to increase IP protection across the portfolio during the period with new patent applications being pursued for all four products
  • A potential offering and additional listing of American Depositary Shares (ADS’s) on the Nasdaq Global Market (NASDAQ) remains under consideration
  • Mereo continues to review a strong pipeline of additional new rare disease product opportunities in bone, respiratory and endocrine diseases from pharmaceutical and large biotechnology companies

Financial Highlights 

  • Loss after tax for the six month period of £17.0 million (H1 2017: £22.7 million) or 24 pence per ordinary share (2017: 34 pence per ordinary share)
  • Net cash resources1 of £36.9 million at June 30, 2018, after net operating and investing outflows of £15.8 million and before receipt of the FY 2017 R&D tax credit of £8.2m received in early August 2018
  • Total development costs significantly reduced to £10.9 million (H1 2017 £21.4 million) reflecting an overall reduction in development activity in the period compared to the same period last year. This reflected a reduction in spend on BGS-649 and BCT-197 as these Phase 2 studies neared completion offset somewhat by ongoing expenditure on the BPS-804 Adult Phase 2b study and planning for the start of the MPH-966 study
  • Non-material placing via the PrimaryBid retail platform completed in June 2018 expanding our non-institutional shareholder base

1 Net cash resources defined as cash and short-term deposits, and short-term investments

“We continue to make strong progress on all fronts, most recently with the initiation of a Phase 2 study for patients with severe alpha-1 anti-trypsin deficiency and the approval of our plans for children with severe Osteogenesis Imperfecta in Europe which includes our key pivotal study.  We are pleased with our continuing interaction with the European regulators which provides us with the opportunity to engage in an ongoing dialogue in OI and to receive tailored development support with the goal of providing patients with earlier access to BPS-804.  With enrolment in our adult OI study expected to complete shortly, we look forward to reporting our first set of data for BPS-804 early next year.  We are also on track to report the 12 month data on BGS-649 in Q4 2018 following the positive top-line 6 month data earlier this year.  Finally, we continue to actively evaluate a number of opportunities in rare respiratory, bone and endocrine diseases to expand our product portfolio and we remain focussed on building a leading commercial business in orphan drugs and rare disease therapies.”

Dr Denise Scots-Knight Chief Executive Officer

For Further Enquiries:

Mereo BioPharma Group plc
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
+44 (0)333 023 7319

Nominated Adviser and Joint Broker
Cantor Fitzgerald Europe
Phil Davies
Will Goode
+44 (0)20 7894 7000

Joint Broker
RBC Capital Markets
Rupert Walford
+44 (0)20 7653 4000

UK Public Relations Advisor to Mereo Biopharma
FTI Consulting
Ben Atwell
Simon Conway
Brett Pollard
+44 (0)20 3727 1000

US Public Relations Advisor to Mereo Biopharma
Burns McClellan
Lisa Burns
Steven Klass
+01 (0) 212 213 0006

About Mereo

Mereo is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for patients with rare diseases. The portfolio currently consists of four clinical-stage product candidates, each of which were acquired from large pharmaceutical companies: BPS-804 (setrusumab) for the treatment of osteogenesis imperfecta (OI); MPH-966 (alvelestat) for the treatment of severe alpha-1 antitrypsin deficiency (AATD); BGS-649 (leflutrozole) for the treatment of hypogonadotropic hypogonadism (HH) in obese men and BCT-197 (acumapimod) for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Each of the Company’s product candidates has generated positive clinical data for Mereo’s target indication or in a related indication. The Company’s strategy is to selectively acquire product candidates that have already received significant investment from pharmaceutical companies and that have substantial preclinical, clinical and manufacturing data packages. Since inception the Company has commenced large, randomised, placebo-controlled Phase 2 clinical trials for three of the product candidates and has previously announced positive top-line results from two of its clinical trials; a Phase 2 trial with BCT-197 in December 2017 and a Phase 2b dose-ranging study with BGS-649 in March 2018.

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