Mereo BioPharma: A Promising Biotech with Strong Pipeline Progress and Cash Runway

Mereo BioPharma Group plc (NASDAQ: MREO), a clinical-stage biopharmaceutical company focused on rare diseases, has provided an update on its lead clinical programs, highlighting significant progress and a strong cash runway. The company's pipeline consists of six clinical-stage product candidates, with two key programs, setrusumab and alvelestat, showing promising results.

Setrusumab, a monoclonal antibody in Phase 3 clinical development for the treatment of Osteogenesis Imperfecta (OI), is being developed through a partnership with Ultragenyx Pharmaceutical, Inc. The Phase 3 Orbit Study is continuing to dose patients and is progressing towards the planned second interim analysis expected in mid-2025, with a potential final analysis in the fourth quarter of 2025. Additionally, treatment is continuing in the Cosmic Study, which is evaluating setrusumab against intravenous bisphosphonate therapy in patients aged 2 to <7 years. Data from the Cosmic Study will be evaluated in parallel with the Orbit interim and final analyses.

The Phase 2 portion of the Orbit Study has already shown encouraging results, with treatment with setrusumab reducing the annualized fracture rate by 67% in patients with OI. This reduction was associated with continuing large and meaningful improvements in bone mineral density (BMD). Setrusumab was well tolerated with no drug-related serious adverse events (SAEs) reported and no reports of drug-related hypersensitivity. Additional data from the Phase 2 portion of the Orbit Study are expected during 2024.

Alvelestat, an oral neutrophil elastase inhibitor being studied for the treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), has received positive opinions from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Orphan Drug Designation. The Company has aligned on the design for a single, global Phase 3 study of alvelestat in AATD-LD following additional interactions with the U.S. FDA in the second half of 2023. If the proposed Phase 3 study is successful, it could support submissions for full regulatory approvals for this first-in-class therapy addressing a major unmet medical need in AATD-LD.

Mereo has also signed a global licensing deal for the development and commercialization of leflutrozole, a novel once-weekly oral aromatase inhibitor. The company reiterates its previous cash runway guidance, with current cash expected to fund operations into 2027, through multiple key inflection points.



Mereo's cash runway into 2027 indicates that the company has sufficient financial resources to fund its operations and execute on key milestones through 2025. This includes the completion of the Phase 3 portion of the Orbit Study and the Phase 3 Cosmic Study of setrusumab for the treatment of Osteogenesis Imperfecta (OI) by the end of the first quarter of 2024 and the first half of 2024, respectively. Additionally, Mereo has aligned on the design for a single, global Phase 3 study of alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) following additional interactions with the U.S. FDA in the second half of 2023. The company has also signed a global licensing deal for the development and commercialization of leflutrozole. With this cash runway, Mereo is well-positioned to execute on these key milestones and maintain long-term growth.

In conclusion, Mereo BioPharma's strong pipeline progress and cash runway position the company for long-term growth and success. The company's lead clinical programs, setrusumab and alvelestat, have shown promising results, and Mereo is well-funded to execute on key milestones through 2025. Investors should consider Mereo as a promising biotech with a strong pipeline and a solid financial foundation.