Table of Contents FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the quarterly period ended June 30, 2025 OR MEREO BIOPHARMA GROUP PLC (Exact name of Registrant as specified in its charter) | England and Wales | | Not Applicable | | --- | --- | --- | | (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) | | th One Cavendish Place ...

Exhibit 99.1 Mereo BioPharma Reports Second Quarter 2025 Financial Results and Provides Corporate Highlights Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta expected around year-end 2025 Cash of $56.1 million as of June 30, 2025, expected to support operations into 2027 London, August 12, 2025 – 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 ...

Core Viewpoint - Mereo BioPharma is advancing its clinical programs for setrusumab and alvelestat, with significant financial results and operational updates provided for the second quarter of 2025, indicating a focus on rare diseases and a strong cash position to support operations into 2027 [1][2][9]. Group 1: Clinical Development - Data from the Phase 3 Orbit and Cosmic studies for setrusumab in osteogenesis imperfecta (OI) is expected by the end of 2025, with ongoing patient dosing and a focus on reducing fractures and improving functional parameters [2][5]. - The Phase 3 studies are being conducted in partnership with Ultragenyx, which has confirmed an acceptable safety profile for setrusumab during an interim analysis [5]. - Pre-commercial efforts for setrusumab are ongoing in Europe, including the SATURN program to understand the natural history of OI and generate data for health economic models [5]. Group 2: Financial Performance - For the second quarter of 2025, total research and development expenses increased to $5.4 million, up from $4.9 million in the same period of 2024, primarily due to increased costs associated with setrusumab [4]. - General and administrative expenses decreased to $5.5 million from $7.9 million in the second quarter of 2024, attributed to reimbursements and lower professional fees [7]. - The net loss for the second quarter of 2025 was $14.6 million, compared to $12.3 million in the same period of 2024, influenced by a foreign currency transaction loss of $5.4 million [8]. Group 3: Cash Position and Guidance - As of June 30, 2025, the company had cash and cash equivalents of $56.1 million, down from $69.8 million at the end of 2024, but sufficient to fund operations into 2027 [9]. - The company maintains its guidance that existing cash will support committed clinical trials and operational expenses, excluding potential partnership payments for alvelestat [9]. Group 4: Shareholder Information - Total ordinary shares issued as of June 30, 2025, were 795,001,444, with total ADS equivalents of 159,000,288 [10].

NEW YORK, Aug. 6, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Mereo BioPharma Group plc ("Mereo" or the "Company") (NASDAQ: MREO).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.  The investigation concerns whether Mereo and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action]On July 9, 2025, Me ...

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Mereo BioPharma Group plc and its officers or directors [1] Group 1: Company Developments - On July 9, 2025, Mereo and Ultragenyx Pharmaceutical Inc. announced progress in the Phase 3 Orbit study for UX143 (setrusumab) in treating osteogenesis imperfecta, with a final analysis expected by the end of the year [3] - Following this announcement, Mereo's ADR price dropped by $1.25, or 42.52%, closing at $1.69 per share on July 10, 2025 [3] Group 2: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4] - The firm has successfully recovered numerous multimillion-dollar damages for class members over its 80-year history [4]

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Core Insights - Ultragenyx Pharmaceutical (RARE) and Mereo BioPharma (MREO) have provided an update on the mid-to-late-stage Orbit study for UX143 (setrusumab) aimed at treating osteogenesis imperfecta (OI) in pediatric and young adult patients, with final analysis expected by the end of 2025 [1][5] - The shares of both companies experienced a significant decline in premarket trading following the announcement of the delay in new data from the Orbit study [2][5] - UX143 is a fully human monoclonal antibody that inhibits sclerostin, and interim safety data has shown an acceptable safety profile, allowing the study to proceed as planned [2][5] Study Details - The Orbit study is assessing the impact of UX143 on fracture rates in patients aged 5 to 25 with OI, with a pivotal phase III portion enrolling 159 additional patients [7] - The primary efficacy endpoint of the Orbit study is to reduce the annualized clinical fracture rate, with participants moving into an open-label extension period after the primary analysis [7] - The Cosmic study targets a younger population aged two to under seven years, comparing UX143 to intravenous bisphosphonates for fracture reduction, with 69 patients enrolled [8] Partnership and Market Context - Ultragenyx Pharmaceuticals and Mereo BioPharma entered a licensing agreement in 2020 for the joint development of UX143, with RARE holding exclusive rights in several regions [9] - The partnership was expanded in 2024 through a manufacturing and supply agreement, with RARE responsible for supplying setrusumab to MREO [9] - OI affects approximately 60,000 individuals in commercially accessible geographies, and there are currently no approved treatments available [11]

Core Viewpoint - Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc stocks are experiencing significant declines following the update on the Phase 3 Orbit study for UX143 (setrusumab) in patients with osteogenesis imperfecta (OI) [1][2]. Group 1: Study Progress and Analysis - The Phase 3 portion of the Orbit study is progressing towards a final analysis expected by the end of the year, in line with the original plan [2]. - The second interim analysis did not meet the minimal p-value threshold of p<0.01, which would have allowed the study to conclude early [3]. - The Data Monitoring Committee confirmed that UX143 has an acceptable safety profile, recommending the continuation of the study [3][4]. Group 2: Future Expectations - The final analyses for the Orbit and Cosmic studies will occur after patients have been on therapy for at least 18 months, with thresholds set at p<0.04 for Orbit and p<0.05 for Cosmic [5]. - Analysts express optimism regarding the final analysis, anticipating a positive outcome due to longer follow-up duration and a lower statistical significance threshold [6]. Group 3: Market Reaction - Following the update, RARE stock has dropped by 26.2% to $30.60, while MREO stock has decreased by 34.7% to $1.919 [7].

Core Insights - The Phase 3 Orbit study for UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is on track for final analysis by the end of the year [1][3] - The Data Monitoring Committee has confirmed an acceptable safety profile for UX143, allowing the study to proceed [2] - Ultragenyx and Mereo BioPharma are collaborating on the development of setrusumab, targeting OI sub-types I, III, and IV [5][12] Study Details - The Phase 3 Orbit study has enrolled 159 patients across 45 sites in 11 countries, with a primary efficacy endpoint focused on annualized clinical fracture rate [7] - The Cosmic study, which is also in Phase 3, has enrolled 69 patients aged 2 to <7 years, comparing setrusumab to intravenous bisphosphonates [8] - Both studies will conduct final analyses after patients have been on therapy for at least 18 months, with specific statistical thresholds set for each study [4] Background on Osteogenesis Imperfecta - OI is a genetic disorder affecting bone metabolism, primarily caused by mutations in the COL1A1 or COL1A2 genes, leading to increased bone brittleness and a high rate of fractures [9] - Approximately 60,000 individuals are affected by OI in commercially accessible regions, with no globally approved treatments available [9] Mechanism of Setrusumab - Setrusumab is a fully human monoclonal antibody that inhibits sclerostin, which negatively regulates bone formation, potentially increasing bone mass and strength [10] - Previous studies have shown that anti-sclerostin antibodies can significantly improve bone formation and density in OI models [11] Company Profiles - Ultragenyx is focused on developing therapies for rare genetic diseases, with a portfolio aimed at addressing high unmet medical needs [13] - Mereo BioPharma is also dedicated to innovative therapeutics for rare diseases, with setrusumab as one of its key candidates [15]

Financial Performance - Total operating expenses for Q1 2025 were $11.2 million, an increase of $1.3 million from $9.9 million in Q1 2024[104] - Net loss before income tax for Q1 2025 was $12.9 million, compared to $9.0 million in Q1 2024, reflecting a $4.2 million increase[104] - The accumulated deficit as of March 31, 2025, was $472.0 million, with expectations of continued significant operating losses[128] - Cash used in operating activities increased to $8.3 million in Q1 2025 from $8.0 million in Q1 2024[123] - The net foreign exchange loss for Q1 2025 was $2.8 million, compared to a gain of $0.6 million in Q1 2024, due to currency fluctuations[113] Expenses - Research and development (R&D) expenses decreased by $0.1 million to $3.9 million in Q1 2025, primarily due to a $1.2 million decrease in expenses for alvelestat[106][107] - General and administrative expenses increased by $1.4 million to $7.3 million in Q1 2025, mainly due to a prior reimbursement reduction[109] Funding and Capital Requirements - The company anticipates needing additional external funding to complete development plans and potentially commercialize selected rare disease products[116][117] - The company expects existing cash and cash equivalents to fund clinical trials, operating expenses, and capital expenditures into 2027[130] - Future capital requirements will depend on factors such as developing additional product candidates and seeking regulatory approvals[131] - The company may need to obtain substantial additional funds to achieve business objectives, which may not be available on acceptable terms[133] - Future debt or preferred equity financing may involve agreements that limit the company's actions and could dilute shareholder ownership[134] Revenue and Business Objectives - Revenues will be derived from development milestones or sales of successfully developed and approved product candidates[132] Regulatory and Accounting Considerations - The costs and timing of regulatory reviews and potential commercialization activities are uncertain and could impact financial performance[138] - The company currently has no commitments or agreements for acquiring new product candidates or entering into licensing arrangements[138] - The company has no critical accounting estimates that significantly affect its financial statements[137] - There have been no significant changes to critical accounting estimates from the previous annual report[139] - The company is classified as a "smaller reporting company" and is not required to provide certain market risk information[141] Interest and Other Income - Interest income increased to $0.7 million in Q1 2025 from $0.6 million in Q1 2024, attributed to a higher cash balance[110] - Net cash provided by financing activities was $0.4 million in Q1 2025, compared to less than $0.1 million in Q1 2024, mainly from warrant exercises[127]