Mereo BioPharma Q1 2024 Financial Results and Corporate Update

LONDON, May 15, 2024 – Mereo BioPharma Group plc (NASDAQ: MREO), a clinical-stage biopharmaceutical company specializing in rare diseases, disclosed its financial results for the first quarter of 2024, ending March 31. The company reported cash and cash equivalents totaling $48.7 million as of March 31, 2024, which is expected to support operations through 2026.

CEO Dr. Denise Scots-Knight remarked on the year’s dynamic beginning, highlighted by the completion of patient enrollment by Ultragenyx for the Orbit and Cosmic trials of setrusumab in Osteogenesis Imperfecta (OI). Mereo is advancing pre-launch activities in Europe, which include identifying potential patients, engaging with European HTAs and Payors to facilitate quick adoption and reimbursement upon setrusumab’s potential approval. Additionally, the SATURN initiative aims to gather coordinated data across European treatment centers to support pricing and reimbursement decisions.

Key Developments and Future Milestones in Q1 2024

Setrusumab (UX143)
- Enrollment was finalized in the Phase 3 Orbit and Cosmic studies for setrusumab in OI, led by Ultragenyx.
- The Orbit Phase 2/3 trial enrolled 158 patients aged 5-25 years and aims to measure efficacy through the annualized clinical fracture rate. Longer-term data from the Phase 2 portion are anticipated in the latter half of 2024.
- The Cosmic study, initiated in late 2023, enrolled 69 patients aged 2-7 years, comparing setrusumab to bisphosphonates in reducing clinical fractures.
- The IMPACT Survey, the largest of its kind, detailing the burden of OI, was conducted in collaboration with Mereo and OI-related organizations, providing significant insights into the disease's impact on various stakeholders.

Alvelestat (MPH-966)
- Mereo plans to submit initial validation work for the St. George’s Respiratory Questionnaire (SGRQ), a key efficacy measure, to the FDA along with the Phase 3 study protocol by mid-2024.
- Validation based on interviews with AATD-LD patients confirmed the SGRQ’s suitability for clinical outcomes.
- A global Phase 3 study will enroll around 220 patients with severe Pi*ZZ genotype emphysema, scheduled for an 18-month treatment period. Success in this trial could lead to full approvals in the U.S. and Europe.
- Mereo is in discussions with potential partners to support alvelestat’s Phase 3 study, expected to commence by late 2024.

Etigilimab (MPH-313)
- Etigilimab, combined with nivolumab, is under investigation in a Phase 1b/2 trial for clear cell ovarian cancer at MD Anderson Cancer Center, funded by the Cancer Focus Fund. The trial has been expanded based on interim results, with potential updates by late 2024 or early 2025.

Financial Overview of Q1 2024

- R&D expenses fell by $1.3 million (25%) compared to Q1 2023, primarily due to reduced expenditures on etigilimab, while expenses for setrusumab and alvelestat saw slight increases.
- General and administrative expenses decreased by $0.5 million (8%), mainly due to recognized reimbursements for ADR program expenses, offset by higher employee-related costs and professional fees.
- Net loss for Q1 2024 was $9.0 million, reduced from $12.1 million in Q1 2023, mainly due to an operating loss of $9.9 million.
- As of March 31, 2024, cash and cash equivalents totaled $48.7 million, compared to $57.4 million at the end of 2023. Mereo’s financial outlook remains unchanged, anticipating adequate funding for operations, clinical trials, and capital expenditures into 2026.

Shareholder Information

- Total ordinary shares issued as of March 31, 2024, were 701,349,434, equivalent to 140,269,886 ADSs, with each ADS representing five ordinary shares.

About Mereo BioPharma

Mereo BioPharma focuses on developing innovative treatments for rare diseases. It has two primary product candidates: setrusumab for OI and alvelestat for severe AATD-LD. The company collaborates with Ultragenyx on setrusumab, which is in Phase 3 trials, and plans to engage partners for alvelestat’s Phase 3 study. Mereo also has oncology candidates in development and has entered a global license agreement for leflutrozole with ReproNovo SA for reproductive medicine.

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