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Mereo BioPharma Group plc (NASDAQ: MREO) is a United Kingdom-based biopharmaceutical company dedicated to developing innovative therapeutics for rare and specialty diseases. The company's primary focus is on acquiring and advancing mid-stage development programs from larger pharmaceutical firms, aiming to transform patient quality of life and improve human health. Mereo's strategy includes optimizing the commercial value of its programs through strategic partnerships or, for select opportunities, by commercializing products independently.
Mereo has a robust pipeline of late-stage clinical product candidates, particularly in rare disease areas. The company's flagship candidates include setrusumab for Osteogenesis Imperfecta (OI) and alvelestat for severe Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD). Setrusumab, developed in partnership with Ultragenyx Pharmaceutical Inc., has shown promising results in reducing the annualized fracture rate by 67% in OI patients. The Phase 2/3 Orbit study continues to enroll patients, aiming for regulatory approvals from both the FDA and EMA.
Alvelestat, another key candidate, has demonstrated significant effects in clinical trials, including the ATALANTa study. The data supports its use for AATD-LD, and the company is aligning with both the FDA and EMA on Phase 3 study designs, targeting a broader patient population. Mereo is actively seeking partners for further development and commercialization of alvelestat.
Additionally, Mereo is advancing its oncology pipeline with candidates such as etigilimab (anti-TIGIT) and navicixizumab. Etigilimab is in a Phase 1b/2 trial for recurrent/advanced solid tumors, while navicixizumab has completed a Phase 1 study and is under a global licensing agreement with OncXerna Therapeutics Inc.
Financially, Mereo reported cash and short-term deposits of £51.2 million as of September 30, 2023, with a cash runway extending into 2026. The company has also recently entered into a global license agreement with ReproNovo SA for leflutrozole, a non-steroidal aromatase inhibitor.
Mereo BioPharma's commitment to rare disease therapeutics positions it as a significant player in the biopharmaceutical landscape, with ongoing advancements in its clinical programs and strategic partnerships shaping its path forward.
Mereo BioPharma Group plc (NASDAQ: MREO) announced updated clinical results from its Phase 1b/2 Study of Etigilimab and Nivolumab in patients with advanced solid tumors (ACTIVATE). The data, to be presented at the ASCO Annual Meeting on June 5, 2022, shows 2 complete responses, 4 partial responses, and 10 stable diseases among 38 evaluable subjects, indicating a 15.8% overall response rate. The combination therapy was deemed safe with no new safety signals. Additionally, Mereo's capital allocation strategy has extended its cash runway to late 2024, positioning for further development in key programs.
Mereo BioPharma Group (NASDAQ: MREO) announced interim results from its Phase 1b/2 ACTIVATE study of Etigilimab and Nivolumab for solid tumors. As of February 10, 2022, results showed 1 Complete Response (CR), 2 Partial Responses (PR), and 9 Stable Diseases (SD) among 27 evaluated subjects, yielding an overall response rate (ORR) of 11% and a disease control rate (DCR) of 44%. The combination treatment was found safe with no new safety signals. Further data will be presented at ASCO 2022 on June 5, 2022.
Mereo BioPharma Group (NASDAQ: MREO) received a notification from Nasdaq on May 23, 2022, stating its American Depositary Shares (ADSs) did not meet the minimum bid price of $1.00 for 30 consecutive business days. This letter does not lead to immediate delisting, allowing trading to continue. Mereo has a 180-day compliance period, until November 21, 2022, to regain compliance. Failure to do so may result in a second grace period or delisting. The company intends to monitor its ADSs, and this notification does not affect its operations.
Mereo BioPharma Group plc (NASDAQ: MREO) announced the appointment of Dr. Abdul Mullick to its Board of Directors, effective immediately. Dr. Mullick brings over 20 years of pharmaceutical industry experience, including leadership roles in rare diseases. His expertise includes successfully launching two rare disease products in Europe. CEO Dr. Denise Scots-Knight expressed enthusiasm for Dr. Mullick's contributions during this pivotal phase for the company. Mereo focuses on developing innovative therapeutics for oncology and rare diseases, with several programs underway.
Mereo BioPharma (NASDAQ: MREO) announced positive results from the Phase 2 ASTRAEUS study of alvelestat, an oral neutrophil elastase inhibitor for severe alpha-1 antitrypsin deficiency-related emphysema. The study demonstrated statistically significant inhibition of blood neutrophil elastase activity by up to 90% across both high and low dose groups, alongside significant reductions in key biomarkers Aα-val360 and desmosine. Importantly, no safety signals were observed. Mereo plans further analysis and engagement with regulators for a pivotal trial design.
Mereo BioPharma Group plc (NASDAQ: MREO) will host a conference call on May 9, 2022, at 10:30 a.m. ET to discuss top-line clinical data from its ASTRAEUS Phase 2 Study of Alvelestat, targeting Alpha-1 Antitrypsin Deficiency-associated Emphysema. The call will be accessible via the Company's website and will remain archived for 14 days. Mereo's Alvelestat has received U.S. Orphan Drug Designation and is currently under investigation in a Phase 2 study with results expected in early Q2 2022.
Mereo BioPharma Group (NASDAQ: MREO) announced CEO Dr. Denise Scots-Knight will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on April 13, 2022, at 12:45 PM ET. A live audio webcast will be available on the company's website, with an archived replay accessible for two weeks post-event.
Focused on oncology and rare diseases, Mereo has six clinical product candidates, including etigilimab in a Phase 1b/2 study and alvelestat, which recently received U.S. Orphan Drug Designation.
Mereo BioPharma Group (NASDAQ: MREO) announced its 2021 financial results, revealing a revenue of £36.5 million from a licensing agreement with Ultragenyx. The company reported a net profit of £12.7 million, a significant improvement from the £163.6 million loss in 2020, driven by a £40 million gain from financial instruments. R&D expenses increased by 44% to £23.6 million, mainly due to advancements in the etigilimab program. Noteworthy clinical updates include promising interim results from the ACTIVATE study and FDA orphan drug designation for alvelestat.
Mereo BioPharma Group plc (NASDAQ: MREO) announced a virtual R&D Day on March 14, 2022, focusing on its alvelestat (MPH966) program. This session will detail ongoing Phase 2 studies for treating alpha-1 antitrypsin deficiency (AATD)-related lung disease and updates on the investigator-sponsored Phase 1b/2 studies for Bronchiolitis Obliterans post-hematopoietic stem cell transplantation and hospitalized COVID-19 patients. Key opinion leaders and company management will present during the two-hour event. The audio will be accessible live and archived on the company's website.
Mereo BioPharma Group plc (NASDAQ: MREO) has appointed Anne Hyland to its Board of Directors and the Audit and Risk Committee, effective immediately. With over 30 years of financial expertise in the biopharmaceutical sector, Hyland's experience includes her role as CFO at Kymab Group Limited, which was acquired by Sanofi for $1.1 billion in 2021. CEO Denise Scots-Knight expressed enthusiasm for Hyland's operational insight, citing the potential impact on Mereo's ongoing development in oncology and rare diseases.
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