Mereo BioPharma Group plc
Interim Financial Results for the Six Months Ended June 30, 2019 and Corporate Update
12-Month Topline Results from Phase 2b ASTEROID Study with Setrusumab for Osteogenesis Imperfecta (OI) Expected in Q4 2019; Positive 6-Month Data to be Featured in Late-Breaking Oral Presentation at ASBMR 2019
London and Redwood City, Calif., September 17, 2019 - Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), a clinical stage biopharmaceutical company focused on rare diseases, today announces unaudited interim financial results for the six months ended June 30, 2019 and provides a corporate update.
Denise Scots-Knight, Chief Executive of Mereo, said: “The first half of 2019 has been notable for the announcement of positive six-month data for our Phase 2b ASTEROID trial which is evaluating setrusumab as a treatment for OI. We are entering another exciting period with the 12-month data from this study expected in Q4 2019 and proof-of-concept data from our Phase 2 study for alvelestat in severe alpha-1 antitrypsin deficiency expected in mid-2020. While our mission remains to provide new therapies for undertreated, chronically debilitating and life-limiting rare diseases, the proposed evaluation of alvelestat in the orphan disease bronchiolitis obliterans syndrome also strengthens our respiratory focus. We continue to advance discussions with potential partners to optimize the value of our broader product portfolio.”
Recent Highlights and Upcoming Milestones
Setrusumab for Osteogenesis Imperfecta (OI)
- Reported positive 6-month interim data from the fully-enrolled Phase 2b ASTEROID study.
- ASTEROID data accepted for late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2019 Annual Meeting, September 20-23 in Orlando, FL.
- 12-month topline data from the blinded portion of the study expected in Q4 2019.
- In addition to evaluating setrusumab in adult OI patients, pivotal pediatric study ready to go in the EU and Canada. Mereo is also exploring an extension of this study into the U.S.
Alvelestat for severe Alpha-1 Antitrypsin Deficiency (AATD)
- Patient enrolment continues in Phase 2 proof of concept study; topline data expected mid-2020.
- Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome (BOS).
Partnering Discussions Continue for Broad Portfolio of Clinical-Stage Programs
- Leflutrozole for hypogonadotropic hypogonadism (HH)
- Following positive Phase 2b and six-month extension data reported in 2018, Mereo convened an advisory board meeting and concluded that future product development should focus on male fertility.
- Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- Phase 3-ready following a successful Type B End of Phase 2 meeting with the FDA and agreed outline for a pivotal Phase 3 clinical trial program.
- Recent positive Scientific Advice Working Party (SAWP) meeting with the EMA
- Navicixizumab (OMP-305B83) for Advanced Platinum-Resistant Ovarian Cancer.
- Type B, End of Phase 1 meeting with the FDA in July 2019 has resulted in agreement in principle for design of a Phase 2 clinical trial to potentially support the accelerated approval of navicixizumab in patients with ovarian cancer (including peritoneal or fallopian tube cancer) who have become resistant to prior therapies.
- Etigilimab (anti-TIGIT, OMP-313M32) for Advanced Solid Tumors
- Completed a Phase 1a/b trial of etigilimab, administered as either a single-agent or in combination with nivolumab, in patients with advanced or metastatic solid tumors.
- In April 2019, Mereo completed a merger with OncoMed Pharmaceuticals, Inc. (“OncoMed”), acquiring two clinical stage oncology programs -- navicixizumab and etigilimab.
- Following completion of the acquisition of OncoMed, Michael Wyzga and Deepa Pakianathan, Ph.D. were appointed as Non-Executive Directors to the Mereo Board.
- In August 2019, Mereo appointed Richard Francis as Head of Pharmaceutical Development.
- In September 2019, Dr Arun Mistry appointed as Therapeutic Area Head, Setrusumab.
- Cash resources ¹ of £36.1m as at June 30, 2019 (June 30, 2018 £36.9m)
- Loss after tax for the six-month period of £16.2m (2018: £17.0m) or 22 pence per ordinary share (2018: 24 pence per ordinary share)
- American Depositary Receipts (“ADRs”) commenced trading on the NASDAQ Global Market on April 24, 2019 with the issue of 4.9m ADR’s each represented by 5 ordinary shares
1 Cash resources is defined as the aggregate of cash and short-term deposits and short-term investments
Conference Call Information
Mereo will host a live conference call and webcast today at 8:30 a.m. EDT / 1:30 p.m. BST to discuss the Company’s financial results and provide a corporate update. To participate in the conference call, please dial (866) 688-2942 (U.S.) or (561) 569-9224 (U.K./International). The conference ID number is 4572478.
A live and archived webcast may be accessed by visiting the Investors sections of the Company’s website at https://www.mereobiopharma.com/investors/results-reports-and-presentations/. The archived webcast will remain available on the Company's website for fourteen (14) days following the live call.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for patients with rare diseases. Mereo's strategy is to selectively acquire product candidates for rare diseases that have already received significant investment from pharmaceutical and large biotechnology companies and that have substantial preclinical, clinical and manufacturing data packages. Mereo’s lead rare disease product candidate, setrusumab, is being developed for the treatment of osteogenesis imperfecta (OI) with topline 12-month results from a Phase 2b dose ranging study expected in Q4 2019. Mereo’s second lead product candidate, alvelestat, is being investigated in a Phase 2 proof-of-concept clinical trial in patients with alpha-1 antitrypsin deficiency (AATD) with topline data expected in mid-2020.
Mereo’s broader pipeline consists of four additional clinical-stage product candidates; acumapimod for the treatment of acute exacerbations of chronic obstructive pulmonary disease (“AECOPD”), leflutrozole for the treatment of hypogonadotropic hypogonadism (“HH”) in obese men, navicixizumab for the treatment of platinum-resistant ovarian cancer, and etigilimab for patients with advanced or metastatic solid tumors.
FOR FURTHER ENQUIRIES
+44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser and Broker to Mereo)
+44 (0)20 7894 7000
FTI Consulting (Public Relations Adviser to Mereo)
+44 (0)20 3727 1000
Burns McClellan (US Public Relations Adviser to Mereo)
+01 (0) 212 213 0006