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]

Financial Performance - As of March 31, 2025, Mereo BioPharma had cash and cash equivalents of $62.5 million, down from $69.8 million as of December 31, 2024, with expectations to fund operations into 2027[9] - The net loss for Q1 2025 was $12.9 million, compared to a net loss of $9.0 million in Q1 2024, reflecting an operating loss of $11.2 million[8] - General and administrative expenses increased by $1.4 million to $7.3 million in Q1 2025, compared to $5.9 million in Q1 2024[7] - Total research and development (R&D) expenses decreased by $0.1 million to $3.9 million in Q1 2025, compared to $4.0 million in Q1 2024, primarily due to reduced expenses for alvelestat[6] Clinical Development - The Phase 3 Orbit study of setrusumab is on track for interim analysis in mid-2025 or final analysis in Q4 2025[2] - Alvelestat has received Orphan Designation from the European Commission for the treatment of alpha-1 antitrypsin deficiency-associated lung disease[5] - The company is finalizing trial start-up activities for alvelestat, which is now Phase 3 ready[2] Strategic Partnerships - Mereo is in discussions with multiple potential development and commercialization partners for its product candidates[5] Shareholder Information - Total ordinary shares issued as of March 31, 2025, were 795,001,444, with total ADS equivalents of 159,000,288[10] Cash Management - The company anticipates continued close management of its cash balance to support operations and clinical trials[2]

Progress continues in Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) Cash of $62.5 million as of March 31, 2025, expected to fund operations into 2027 LONDON, May 13, 2025 (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, 2025, and provided recent corporate highlights. “As we close out the first quarter of 2 ...

Financial Performance - The company reported no revenue for the year ended December 31, 2024, a decrease of $10 million compared to $10 million in 2023[512][534] - Revenue for the year ended December 31, 2024 was $0, compared to $10.0 million in 2023, which included a one-time milestone payment of $9.0 million for setrusumab[535] - The net loss for the year ended December 31, 2024, was $43.25 million, compared to a net loss of $29.47 million in 2023, reflecting an increase of $13.79 million[534] - The accumulated deficit as of December 31, 2024 was $462.9 million, with expectations of continued significant operating losses due to ongoing R&D efforts[565] Research and Development - Research and development expenses increased by $3.5 million, totaling $20.93 million in 2024 compared to $17.42 million in 2023[534] - Total R&D expenses increased by $3.5 million, from $17.4 million in 2023 to $20.9 million in 2024, driven by increases in expenses for alvelestat and setrusumab[538] - The benefit from research and development tax credit increased to $1.6 million in 2024 from $1.3 million in 2023, due to higher eligible R&D activities[548] - The company is preparing for potential commercialization of setrusumab in Europe and the U.K., with associated costs for clinical trials and manufacturing supplies[568] - Future revenues will depend on successful development and commercialization of product candidates, necessitating substantial additional funding[569] Expenses - General and administrative expenses rose by $8.01 million, reaching $26.43 million in 2024, up from $18.42 million in 2023[534] - General and administrative expenses rose by $8.0 million, from $18.4 million in 2023 to $26.4 million in 2024, primarily due to pre-commercial activities for setrusumab and other operational costs[542] - Net cash used in operating activities for 2024 was $32.8 million, an increase of $11.7 million from $21.1 million in 2023, largely due to milestone payments received in 2023[559] Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of $69.8 million, with fixed interest payable on convertible loan notes[581] - Net cash provided by financing activities increased significantly to $46.1 million in 2024, up from $8.0 million in 2023, primarily due to proceeds from a registered direct offering[564] - The Novartis Loan Note was amended to extend the maturity date to February 10, 2025, with an increased interest rate of 9%[576] - The company issued 17,105,450 ordinary shares on the non-cash conversion of the Novartis Loan Note principal and accrued interest[577] Tax and Regulatory - The company had cumulative carry-forward U.K. tax losses of $36.6 million as of December 31, 2024, up from $30.6 million in 2023[526][532] - The U.K. corporation tax rate applied for 2024 was 25%, up from 23.5% in 2023[531] - The company has not generated any commercial sales revenue and expects to do so only upon obtaining regulatory approval for its product candidates[513] Foreign Exchange and Interest - Interest income increased to $3.04 million in 2024, compared to $2.13 million in 2023, an increase of $0.91 million[534] - The company recognized a foreign currency transaction gain of $1.21 million in 2024, compared to a loss of $2.35 million in 2023, resulting in a positive change of $3.56 million[534] - The net foreign exchange gain for 2024 was $1.2 million, compared to a loss of $2.3 million in 2023, reflecting changes in currency valuation[547] - For the year ended December 31, 2024, the company reported an unrealized loss of $1.4 million on foreign currency translation, compared to a gain of $4.2 million in 2023[582] Risks and Challenges - The company is subject to various risks and uncertainties in the development of its product candidates, which could significantly impact costs and timelines[520] - The company may face challenges in obtaining additional funds on acceptable terms, which could impact technology rights and revenue streams[570] - Inflation has led to increased operating expenses, although it has not materially affected the company's financial condition in 2024[584] Warrants and Contracts - The company has outstanding warrants for 1,243,908 ordinary shares at an exercise price of £2.95, expiring in August 2027[573] - The total change in fair value of warrants for 2024 was an unrealized loss of $0.4 million, contrasting with an unrealized gain of $0.2 million in 2023[546] - The company has not entered into foreign exchange contracts to hedge against fluctuations but maintains cash in U.S. dollars for anticipated commitments[583]

Financial Performance - Net loss for the full year ended December 31, 2024, was $43.3 million, compared to $29.5 million in 2023, indicating a significant increase in operating loss[8]. - Cash and cash equivalents as of December 31, 2024, were $69.8 million, up from $57.4 million as of December 31, 2023, expected to fund operations into 2027[9]. - General and administrative expenses rose by $8.0 million from $18.4 million in 2023 to $26.4 million in 2024, reflecting higher pre-commercial activities and corporate expenses[7]. - Total research and development (R&D) expenses increased by $3.5 million from $17.4 million in 2023 to $20.9 million in 2024, primarily due to increases in expenses for alvelestat and setrusumab[6]. Clinical Development - The Phase 3 Orbit study of setrusumab is set to read out at the second interim analysis mid-2025, with potential regulatory filings in the U.S. and EU thereafter[2]. - Alvelestat received European Orphan Designation in early 2025, following a positive recommendation from the EMA Committee for Orphan Medicinal Products[5]. Strategic Partnerships - The partnership with Ultragenyx includes potential additional milestone payments of up to $245 million and royalties on commercial sales in Ultragenyx territories[11]. - The company remains in discussions with multiple potential partners for the development and commercialization of alvelestat[5]. Future Outlook - The company anticipates a transformative 2025 focused on bringing life-changing therapies to patients with rare diseases[2]. Shareholder Information - Total ordinary shares issued as of December 31, 2024, were 775,728,034, with total ADS equivalents of 155,145,606[10].

Core Insights - Mereo BioPharma is advancing its lead programs, particularly the Phase 3 Orbit study of setrusumab for osteogenesis imperfecta, with key milestones expected in mid-2025 and late 2025 [2][6] - The company received European Orphan Designation for alvelestat, enhancing its positioning for treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease [2][6] - Mereo reported a cash balance of $69.8 million as of December 31, 2024, which is expected to fund operations into 2027 [10] Financial Performance - Total R&D expenses increased by $3.5 million from $17.4 million in 2023 to $20.9 million in 2024, driven by higher costs for alvelestat and setrusumab [5][8] - General and administrative expenses rose by $8.0 million from $18.4 million in 2023 to $26.4 million in 2024, primarily due to pre-commercial activities for setrusumab [8] - The net loss for the full year ended December 31, 2024, was $43.3 million, compared to $29.5 million in 2023, reflecting increased operating expenses [9][19] Operational Highlights - The Phase 3 Orbit study is ongoing, with a second interim analysis expected mid-2025 and a final analysis in Q4 2025 [2][6] - Pre-commercial activities for setrusumab are in progress to prepare for a potential launch following regulatory approval [2][6] - Alvelestat has received multiple designations, including Orphan Drug Designation and Fast Track Designation from the FDA, supporting its development and commercialization efforts [6][12] Shareholder Information - As of December 31, 2024, the company had 775,728,034 ordinary shares issued, with total ADS equivalents of 155,145,606 [11] - The company’s accumulated deficit increased to $462.9 million as of December 31, 2024, from $419.6 million in the previous year [17][19]

Core Viewpoint - Mereo BioPharma Group plc (MREO) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Mereo BioPharma for the fiscal year ending December 2024 is projected at -$0.06 per share, reflecting a 70% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Mereo BioPharma has increased by 83.3%, indicating a strong upward trend in earnings estimates [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) to Zacks Rank 5 (Strong Sell), and has shown an impressive track record, with Rank 1 stocks averaging a +25% annual return since 1988 [7]. - The upgrade of Mereo BioPharma to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10]. Market Impact - Changes in earnings estimates are strongly correlated with near-term stock price movements, as institutional investors adjust their valuations based on these estimates, leading to significant stock price fluctuations [4][6]. - The positive earnings outlook for Mereo BioPharma is expected to encourage investor interest, potentially driving the stock price higher [5].

Core Viewpoint - Mereo BioPharma Group plc is actively engaged in the development of innovative therapeutics for rare diseases and will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on March 12, 2025 [1][2]. Company Overview - Mereo BioPharma focuses on rare diseases with two main product candidates: setrusumab for osteogenesis imperfecta (OI) and alvelestat for severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD) [3]. - The partnership with Ultragenyx Pharmaceutical includes potential milestone payments of up to $245 million and royalties on commercial sales in Ultragenyx territories, while Mereo retains EU and UK commercial rights [3]. - Setrusumab has received multiple designations from regulatory bodies, including orphan designation from the EMA and FDA, and Breakthrough Therapy designation from the FDA [3]. - Alvelestat has also received U.S. Orphan Drug Designation and Fast Track designation from the FDA, along with Orphan Designation from the European Commission [3]. - Mereo has oncology product candidates, including etigilimab and navicixizumab, with navicixizumab partnered with Feng Biosciences in a global licensing agreement [3]. Upcoming Events - Dr. Denise Scots-Knight, CEO of Mereo, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on March 12, 2025, at 8:40 am ET [1]. - A live audio webcast of the event will be available on the company's website, with an archived replay accessible for two weeks post-event [2].

Clinical Programs Update - Setrusumab, a monoclonal antibody for Osteogenesis Imperfecta (OI), is progressing in its Phase 3 Orbit Study with the second interim analysis expected in mid-2025 and a potential final analysis in Q4 2025 [1][2] - The Cosmic study, an open-label Phase 3 trial comparing setrusumab to intravenous bisphosphonate therapy in patients aged 2 to <7 years, is ongoing with data to be evaluated alongside Orbit results [2] - Alvelestat, an oral neutrophil elastase inhibitor for Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), received a positive opinion from EMA's Committee for Orphan Medicinal Products (COMP) for Orphan Designation, with a final decision expected in Q1 2025 [1][3] Regulatory Milestones and Designations - Setrusumab has received Orphan Designation from both EMA and FDA, PRIME designation from EMA, and Breakthrough Therapy and rare pediatric disease designations from FDA [6] - Alvelestat previously received Orphan Drug Designation and Fast Track Designation from FDA in 2021 and 2022, respectively [3][6] - The company has aligned with FDA and EMA on primary endpoints for a Phase 3 pivotal study of alvelestat, which could enable full approval in both US and Europe if successful [6] Financial and Partnership Updates - The company's current cash and cash equivalents are expected to fund operations into 2027, supporting multiple key inflection points [1] - The partnership with Ultragenyx includes potential additional milestone payments of up to $245 million and royalties on commercial sales in Ultragenyx territories [6] - Mereo has retained EU and UK commercial rights for setrusumab and will pay Ultragenyx royalties on commercial sales in those territories [6] Market Potential and Development Strategy - Setrusumab has the potential to become the standard-of-care in OI based on promising data from completed studies, including the Phase 2 portion of the Orbit Study [1] - Alvelestat's Orphan Designation in Europe could benefit earlier stage patients who are not currently eligible for augmentation therapy in many countries [1] - The company is preparing for launch readiness activities in key European markets for setrusumab [1] Additional Pipeline Information - The company has two oncology product candidates: etigilimab (anti-TIGIT) and navicixizumab for late-line ovarian cancer, with navicixizumab partnered with Feng Biosciences [6] - Mereo has entered into an exclusive global license agreement with ReproNovo SA for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor [6]

Core Viewpoint - Mereo BioPharma Group plc is set to present at the 43rd Annual J.P. Morgan Healthcare Conference, highlighting its focus on rare diseases and ongoing clinical developments [1]. Company Overview - Mereo BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases [3]. - The company has two primary product candidates: setrusumab for osteogenesis imperfecta (OI) and alvelestat for severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD) [3]. - Mereo has partnered with Ultragenyx Pharmaceutical, which has completed enrollment in the Phase 3 portion of a pivotal Phase 2/3 study for setrusumab in pediatric and young adult patients [3]. - The partnership includes potential milestone payments of up to $245 million and royalties on commercial sales in Ultragenyx territories, while Mereo retains EU and UK commercial rights [3]. - Setrusumab has received multiple designations from regulatory bodies, including orphan designation from the EMA and FDA, and Breakthrough Therapy designation from the FDA [3]. - Alvelestat has also received U.S. Orphan Drug Designation and Fast Track designation from the FDA [3]. Clinical Development - Mereo has aligned with the FDA and EMA on primary endpoints for a Phase 3 pivotal study for alvelestat, which could lead to full approval in both the U.S. and Europe if successful [3]. - In addition to rare disease programs, Mereo is developing two oncology product candidates: etigilimab and navicixizumab, with navicixizumab partnered with Feng Biosciences Inc. [3]. - Mereo has entered into a global license agreement with ReproNovo SA for the development of leflutrozole, a non-steroidal aromatase inhibitor [3].