Mereo BioPharma Reports First Quarter 2024 Financial Results and Provides Corporate Update

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LONDON, May 15, 2024 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the first quarter ended March 31, 2024, and provided an update on recent corporate highlights. The Company reported cash and cash equivalents of $48.7 million as of March 31, 2024 and continues to expect this to fund its operations into 2026.

“2024 is off to an exciting start following the completion of enrollment by our partner Ultragenyx in both the Orbit and Cosmic studies of setrusumab in Osteogenesis Imperfecta (OI) along with the continued advancement of the pre-launch activities in Mereo’s European territories. These include further identification of patients who could potentially benefit from setrusumab treatment, the ongoing dialogues with the HTA’s and Payors in Europe to support both rapid adoption and efficient reimbursement following a potential European approval, and SATURN,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “Further, in parallel with the ongoing partnering discussions for alvelestat, we have completed the initial validation work for the St. George’s Respiratory Questionnaire (SGRQ) instrument in the Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) population.”

First Quarter 2024 Highlights, Recent Developments and Anticipated Milestones

Setrusumab (UX143)

  • Enrollment completed in the Phase 3 Orbit and Cosmic studies of setrusumab in OI, conducted by our partner Ultragenyx.
    • The Phase 3 portion of the Orbit Phase 2/3 trial completed enrollment with 158 patients aged 5 to 25 years old. Patients were randomized 2:1 to receive setrusumab or placebo, and the study has a primary efficacy endpoint of annualized clinical fracture rate. Additional longer-term safety and efficacy data from the Phase 2 portion of the Orbit study are expected in the second half of 2024.
    • The Cosmic study was initiated in the second half of 2023 and completed enrollment with 69 patients. Cosmic is a Phase 3 open-label, randomized study in patients aged 2 to

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