On September 29, 2020 Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or "the Company", a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported unaudited interim financial results for the six months ended June 30, 2020 and provides a corporate update (Press release, Mereo BioPharma, SEP 29, 2020, View Source [SID1234568616]).

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Denise Scots-Knight, Chief Executive of Mereo, said: "Following the closing of our $70 million financing in the first half of 2020 we have focussed on executing our strategy, advancing etigilimab ("Anti-TIGIT") for the treatment of solid tumors alongside developing our rare disease portfolio. We remain on track to initiate a Phase 1b/2 study of etigilimab (Anti-TIGIT) in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020. Our rare disease portfolio includes setrusumab for osteogenesis imperfecta which we plan to partner prior to the initiation of a pivotal Phase 3 study, and alvelestat which is being investigated in an ongoing Phase 2 proof-of-concept study for alpha-1 anti-trypsin deficiency. We were also pleased to have recently announced the initiation of a Phase 1b/2 placebo-controlled study of alvelestat in COVID-19 infected patients following the scientific publications demonstrating the involvement of neutrophil elastase in COVID-19 infection pathways. We also continue to advance other discussions with potential partners to optimize the value of our broader product portfolio."

Recent Highlights and Upcoming Milestones

Etigilimab (Anti-TIGIT) for Solid Tumors

On track to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020.

Setrusumab for Osteogenesis Imperfecta (OI)

Receipt of FDA Rare Pediatric Disease Designation on September 23, 2020.
Following regulatory discussions in 1H 2020, both the FDA and EMA have agreed on the principles of a design of a single Phase 3 pediatric pivotal study in OI.
Intend to partner setrusumab prior to conducting a pivotal trial of setrusumab in children with severe OI. Partnering discussions are well underway with a range of potential structures including options for Mereo to retain commercial rights in certain regions.

Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD)

Topline data from an ongoing Phase 2 proof of concept study remains on track for 2H 2021.
Announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease.
Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome (BOS).

Partnering Discussions Continue for Portfolio of Other Clinical-Stage Programs

Leflutrozole for hypogonadotropic hypogonadism (HH)
º Partnering discussions continuing based on development in male infertility.
Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
º Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA.
Corporate

Appointment of Dr. Brian Schwartz and Dr. Jeremy Bender as Non-Executive Directors and departure of Mr Paul Blackburn as Non-Executive Director effective October 1, 2020
Dr. John Lewicki appointed as Chief Scientific Officer and Dr. Ann Kapoun appointed as Head Translational R&D in July 2020.
Financial Highlights

Cash resources of £56.8 million as at June 30, 2020 (June 30, 2019 £36.1 million).
£11.8 million raised in equity and debt in Q1 2020.
Additional $70 million (£56 million) raised in PIPE in Q2 2020.
Cash runway to early 2022.

Conference Call Information
Mereo will host a live conference call and webcast today at 8:00 a.m. EDT / 1:00 p.m. BST to discuss the Company’s financial results and provide a corporate update.

Dial-in numbers: (866) 688-2942 (U.S.) or +1 (561) 569-9224 (U.K./International)

Conference ID number: 9572439

A live and archived webcast may be accessed by visiting the Investors sections of the Company’s website at View Source The archived webcast will remain available on the Company’s website following the live call.