New Risk • Aug 12
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$28m Forecast net loss in 3 years: US$42m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years). Market cap is less than US$100m (€42.3m market cap, or US$48.8m). Breakeven Date Change • Aug 11
Forecast to breakeven in 2027 The 4 analysts covering Mereo BioPharma Group expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 61% to 2026. The company is expected to make a profit of US$308.6k in 2027. Average annual earnings growth of 4.0% is required to achieve expected profit on schedule. New Risk • May 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m (US$500k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Market cap is less than US$100m (€45.8m market cap, or US$53.3m). Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 2 highly experienced directors. Independent Director Marc Yoskowitz was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Mar 30
Mereo BioPharma Group plc, Annual General Meeting, May 14, 2026 Mereo BioPharma Group plc, Annual General Meeting, May 14, 2026. Location: 5th floor, one cavendish place, london w1g 0qf, united kingdom, United Kingdom Announcement • Mar 27
Mereo Biopharma Group plc Announces Departure of Annalisa Jenkins as Director Mereo BioPharma Group plc announced that on March 26, 2026, Dr. Annalisa Jenkins informed the Company that she will not stand for re-election as a Director of the Board of Directors at the Company's 2026 annual general meeting of shareholders, scheduled for May 14, 2026. Dr. Jenkins will continue to serve out the remainder of her term, which will expire immediately prior to the 2026 AGM. Dr. Jenkins' decision not to stand for re-election did not result from any disagreement with the Company or the Board on any matter relating to the Company's operations, policies or practices. Announcement • Feb 18
Mereo BioPharma Group plc Receives Notice of Nasdaq Bid Price Non-Compliance On February 17, 2026, Mereo BioPharma Group plc (the Company") received a letter (the Notification Letter") from the Listings Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that its American Depositary Shares (ADSs") failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the Bid Price Requirement"). The Notification Letter does not result in the immediate delisting of the Company's ADSs, and the ADSs will continue to trade uninterrupted under the symbol MREO." Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until August 17, 2026 (the Compliance Period"), to regain compliance with the Bid Price Requirement. If at any time during the Compliance Period, the closing bid price per ADS of the Company's ADSs is at least $1.00 for a minimum of 10 consecutive business days (unless the Nasdaq staff exercises its discretion to extend this ten business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by August 17, 2026, the Company may be eligible for an additional 180 calendar day grace period. To qualify, the Company would be required to meet the applicable market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on the Nasdaq Capital Market, with the exception of the Bid Price Requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company does not regain compliance during the Compliance Period and is not eligible for an additional grace period, Nasdaq would provide written notice that the ADSs are subject to delisting from the Nasdaq Capital Market. In that event, the Company may appeal such determination to a hearing panel. However, there can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to monitor the closing bid price of its ADSs and its business operations are not affected by the receipt of the Notification Letter. However, there can be no assurance that the Company will be able to regain compliance for continued listing on Nasdaq or will otherwise be in compliance with other Nasdaq listing criteria and that the Company will be able to maintain its listing with Nasdaq. Announcement • Jan 13
Mereo BioPharma Group plc Provides Corporate Update Mereo BioPharma Group plc provided an update on its programs, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat, which is being studied for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), and revised its cash runway guidance. Data from the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta, including data on bone mineral density, vertebral fractures, and patient reported outcomes on pain and physical function, will be presented at the J.P. Morgan Healthcare Conference. The Company is also updating its previous cash runway guidance. As of December 31, 2025, cash and cash equivalents were approximately $41 million, which are expected to fund operations to mid-2027. Setrusumab (UX143): As announced on December 29, 2025, the Phase 3 Orbit and Cosmic studies of setrusumab in OI did not achieve statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively. Both studies achieved strong statistical significance against the key secondary endpoint of improvement in bone mineral density versus comparator. The improvement in bone mineral density in the Cosmic study was associated with a decreased rate of fracture in this younger more highly fracturing patient population, although this was not statistically significant. The safety profile of setrusumab was consistent with that observed in prior studies. Further analyses of the data from both studies are ongoing to determine the path forward, including potential regulatory interactions. There is a high unmet medical need in OI, which is associated with a substantial clinical, humanistic and economic burden of illness due to the complexity of the condition and necessary medical care and support. As well as fractures, people living with OI present with a broad spectrum of skeletal features including bone deformity, scoliosis and growth impairment. Pain is the most common and impactful sign, symptom or clinical event reported in children and adolescents. There are no EMA or FDA approved treatments for OI (except for neridronate, which is approved nationally in Italy). Bisphosphonates are used off-label in children in Europe and the U.S., despite the lack of clinical evidence to support their effectiveness in reducing fractures. Alvelestat (MPH-966): The Company is continuing to advance key activities to support the planned initiation of the global Phase 3 pivotal study. Based on previous discussions with the FDA and EMA, Mereo anticipates a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients evaluating alvelestat over an 18-month treatment period will support regulatory submissions in both the U.S. and Europe. The primary efficacy endpoint for U.S. approval will be the St. George’s Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval. Mereo continues to be in active discussions with potential partners for the Phase 3 development and commercialization of alvelestat. Vantictumab (OMP18R5): The Company out-licensed vantictumab for autosomal dominant osteopetrosis Type 2 (ADO2) to ashibio Inc. whilst retaining European rights. ashibio Inc. is responsible for funding the global program and following regulatory discussions, plans to initiate a Phase 2 study in 2H 2026. Vantictumab was previously investigated in Phase 1a/b oncology trials in around 100 patients with biomarker evidence of potential impact on osteoclast function and high bone turnover which led to fragility fractures in some patients. ashibio Inc. reported promising pre-clinical data at ASBMR 2025 in ADO2 mouse model. Vantictumab significantly decreased areal bone mineral density and rescued the bone phenotype in the ADO2 mouse model. Announcement • Dec 31
Mereo Announces the Results from the Phase 3 Orbit and Cosmic Studies Evaluating Setrusumab (UX143) in Pediatric and Young Adult Patients with OI On December 29, 2025, the Mereo BioPharma Group plc announced the results from the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta (OI). All of Mereo's forward-looking statements involve known and unknown risks and uncertainties some of which are significant or beyond its control and assumptions that could cause actual results to differ materially from Mereo's historical experience and its present expectations or projections. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical development process; Mereo's reliance on third parties to conduct and provide funding for its clinical trials; Mereo's dependence on enrollment of patients in its clinical trials; and Mereo's dependence on its key executives. The foregoing factors and the other risks and uncertainties that affect Mereo's business, including those described in the Risk Factors" section of its latest Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Mereo's subsequent filings with the Securities and Exchange Commission. Mereo wishes to cause you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Mereo undertakes no obligation to publicly update or revise any of the company's forward-looking statements after the date they are made, whether as a result of new information, future events or otherwise, except to the extent required by law. Vantictumab for osteopetrosis partnered with shibio Leflutrozole for male infertility partnered with ReproNovo. About the Setrusumab Phase 3 Program: Ultragenyx is developing setrusumab in pediatric and young adult patients across OI sub-types I, III and IV with two late-stage studies: the pivotal Phase 2/3 Orbit study and Phase 3 Cosmic study is evaluating the effect of setrusumab on clinical fracture rate in patients aged 5 to 25 years. The pivotal Phase 3 portion of the study enrolled 159 patients at 45 sites across 11 countries, with subjects randomized 2:1 to receive setrusumab or placebo, and a primary efficacy endpoint of annualized clinical fracture rate. The global Phase 3 Cosmic study evaluated the effect of setusumab on reduction in annualized fracture rate in patients aged 2 to <7 years compared to bisphosphonates. The Cosmic study has enrolled 69 patients at 21 sites across 7 countries with patients randomized 1:1 to receive setrusUMab or intravenous bisphosphonates (IV-BP) therapy. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Setrusumab has received orphan designation for osteogenesis imperfecta from the European Commission (EC) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which, if successful, could enable full approval in both the U.S. and Europe. The Company's partner for vantictumab,shibio Inc., is funding the global development program. Announcement • Jul 10
Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc Announce UX143 Phase 3 Orbit Study for Osteogenesis Imperfecta Progressing to Final Analysis Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is progressing toward a final analysis consistent with the original plan, around the end of the year. The Data Monitoring Committee (DMC) met and informed the company that UX143 demonstrates an acceptable safety profile and the company should continue the study to the final analysis. Study conduct is going well and safety in this younger patient population is consistent with the safety profile in the other studies. Patients will continue dosing in the ongoing Phase 3 Orbit and Cosmic clinical studies with the final analyses to be conducted after patients have been on therapy for at least 18-months. The threshold for the Phase 3 Orbit final analysis is p. About the Setrusumab Phase 3 Program: Ultragenyx is developing setrusumab in pediatric and young adult patients across OI sub-types I, III and IV with two late-stage studies: the pivotal Phase 2/3 Orbit study and Phase 3 Cosmic study. The global, seamless Phase 2/3 Orbit study is evaluating the effect of setrusumab on clinical fracture rate in patients aged 5 to 25 years. All patients will transition to an extension period and receive open-label setrusumab after the Phase 3 primary analysis is complete. The global Phase 3 Cosmic study is an open-label, randomized, active-controlled study in patients aged 2 to 2 to 2. Osteogenesis Imperfecta (OI) includes a group of genetic disorders impacting bone metabolism. In 2019, Mereo BioPharma completed the Phase 2b dose-finding study (ASTEROID) for setrusumab in 112 adults with OI. The companies have developed a comprehensive late-stage program to continue development of setrusumab in pediatric & young adult patients across OIsub-types I, III andIV. About Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. Setrusumab has received orphan designation for osteogenesis from the European Commission ("EC") and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which, if successful, could enable full approval in both the U.S. and Europe. Such risks and uncertainties include, among others, the uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals, the ability of the company and Mereo BioPharma to successfully develop UX143, the risk that fast track or breakthrough designations by the FDA may not lead to faster development or regulatory review or approval process and does not increase the likelihood that UX143 will receive marketing approval, the company's ability to achieve its projected development goals in its expected timeframes, risks related to adverse side effects, risks related to reliance on third party partners to conduct certain activities on the company's behalf, the potential for any license or collaboration agreement, including the company's collaboration agreement with Mereo to be terminated, smaller than anticipated market opportunities for the company's products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company's future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx's products and drug candidates. Such risks and uncertainties include the uncertainties inherent in the clinical development process; the Company's products and drug candidates; the Company's reliance on third parties to conduct and provide funding for its clinical development process. Announcement • Apr 09
Mereo BioPharma Group plc, Annual General Meeting, May 13, 2025 Mereo BioPharma Group plc, Annual General Meeting, May 13, 2025. Location: at 5th floor, one cavendish place, w1g 0qf, united kingdom, london United Kingdom Announcement • Jan 13
Mereo Biopharma Provides Update on Lead Clinical Programs Mereo BioPharma Group plc provided an update on its lead clinical programs, setrusumab, a monoclonal antibody in Phase 3 clinical development for the treatment of Osteogenesis Imperfecta (OI) through a partnership with Ultragenyx Pharmaceutical Inc. (Ultragenyx) and alvelestat, an oral neutrophil elastase inhibitor being studied for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). The Company also reiterated its previous cash runway guidance that its current cash and cash equivalents are expected to fund operations into 2027, through multiple key inflection points. Setrusumab (UX143), As announced by the Company’s partner, Ultragenyx, the Phase 3 Orbit Study of setrusumab in OI is continuing to dose patients and 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 Cosmic, an open-label Phase 3 study 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. Alvelestat (MPH-966), The European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products has issued a positive opinion on the Company’s application for Orphan Designation for alvelestat. The COMP recommendation has been provided to the European Commission, which is expected to issue a final decision on the Orphan Designation in the first quarter of 2025. Alvelestat previously received Orphan Drug Designation and Fast Track Designation from the U.S. FDA in 2021 and 2022, respectively. European Orphan Designation is awarded to therapeutic candidates targeting the treatment, prevention or diagnosis of life-threatening or chronically debilitating diseases with a prevalence of fewer than 5 in 10,000 people in the European Union which provide a significant benefit over available therapies, or for which no approved therapies exist. Therapeutics receiving EU Orphan Designation are eligible for ten years of marketing exclusivity upon approval, as well as fee reductions for various centralized activities including the Marketing Authorization Application, inspections and protocol assistance. Individual EU Member States also provide specific incentives to support the development, review and availability of Orphan Medicinal Products at the time of HTA evaluations and Pricing and Reimbursement negotiations. Announcement • Jun 15
Mereo BioPharma Group plc has filed a Follow-on Equity Offering in the amount of $49.999887 million. Mereo BioPharma Group plc has filed a Follow-on Equity Offering in the amount of $49.999887 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 12,531,300
Price\Range: $3.99
Discount Per Security: $0.2394
Transaction Features: Registered Direct Offering Announcement • Jun 13
Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc Announce Positive 14-Month Results from the Phase 2 Portion of the Ongoing Phase 2/3 Orbit Study On June 11, 2024, Ultragenyx Pharmaceutical Inc. (the Company), together with its collaboration partner, Mereo BioPharma Group plc, announced positive 14-month results from the Phase 2 portion of the ongoing Phase 2/3 Orbit study (NCT05125809) demonstrating that, as of a May 24, 2024 data cut-off date, treatment with setrusumab (UX143) continued to significantly reduce incidence of fractures in patients with osteogenesis imperfecta (OI") with at least 14 months of follow-up. Treatment with setrusumab also resulted in ongoing and meaningful improvements in lumbar spine bone mineral density at month 12 without evidence of plateau. The large reduction in annualized radiologically confirmed fracture rate previously reported in patients treated for a minimum of six months was sustained in patients treated for at least 14 months with a high degree of significance. The median annualized rate of radiologically confirmed fractures across all 24 patients in the two years prior to treatment was 0.72. Following a mean treatment duration period of 16 months, the median annualized fracture rate was reduced 67% to 0.00 (p=0.0014; n=24). As of the data cut-off, there were no treatment-related serious adverse events observed in the study. Reported adverse events were generally consistent with those observed in the Asteroid study with infusion-related events and headache determined to be the most common adverse events related to the study drug. As of the data cut- off, there were no reported hypersensitivity reactions related to setrusumab. More detailed 14-month data will be presented at a future scientific meeting. The Company is developing setrusumab in pediatric and young adult patients across OI sub-types I, III and IV with two late-stage trials: the pivotal Phase 2/3 Orbit study and Phase 3 Cosmic study. The global, seamless Phase 2/3 Orbit study is evaluating the effect of setrusumab on clinical fracture rate in patients aged five to 25 years. In the Phase 2 portion, 24 patients were randomized 1:1 to receive setrusumab at one of two doses to determine the optimal dosing strategy for Phase 3. All patients from the 40 mg/kg dosing cohort have been transitioned to 20 mg/kg of setrusumab. The pivotal Phase 3 portion of the study has enrolled an additional 158 patients at 45 sites across 11 countries, with subjects randomized 2:1 to received setrusumab or placebo, and a primary efficacy endpoint of annualized clinical fracture rate. All patients will transition to an extension period and receive open-label setrusumab after the Phase 3 primary analysis is complete. The global Phase 3 Cosmic study is an open-label, randomized, active-controlled study in patients aged 2 to <7 years. Patients are randomized 1:1 to receive settingrusumab or intravenous bisphosphonates (IV-BP) therapy to evaluate reduction in total fracture rate. The Cosmic study has enrolled 69 patients at 21 sites across seven countries. Announcement • Apr 26
Mereo BioPharma Group plc, Annual General Meeting, May 23, 2024 Mereo BioPharma Group plc, Annual General Meeting, May 23, 2024, at 09:00 US Eastern Standard Time. Location: at 5th Floor, One Cavendish Place, London W1G 0QF, United Kingdom London United Kingdom Agenda: To approve the annual report and accounts for the year ended December 31, 2023, together with the directors’ report and independent auditor’s report thereon, be received and adopted; To approve the PricewaterhouseCoopers LLP (“PwC”) be re-appointed as auditors to hold office from the conclusion of the annual general meeting until the conclusion of the next annual general meeting at which the Company’s annual report and accounts are presented; to approve the Audit and Risk Committee be authorized to determine PwC’s remuneration; to approve the directors’ remuneration report (excluding the directors’ remuneration policy), as set out in the Company’s annual report and accounts for the year ended December 31, 2023, be approved; and to consider other matters if any. Announcement • Oct 16
Ultragenyx and Mereo BioPharma Announce Interim Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Setrusumab (UX143) Significantly Reduced Fracture Rates in Patients with Osteogenesis Imperfecta (OI) Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc announced interim data from the Phase 2 portion of the Phase 2/3 Orbit study demonstrating that treatment with setrusumab (UX143) significantly reduced incidence of fractures in patients with OI with at least 6 months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD). The data were presented in a late-breaker presentation at the American Society for Bone and Mineral Research 2023 Annual Meeting (ASBMR). As of the cut-off date and following at least 6 months of treatment with setrusumab, the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%. In the 2 years prior to treatment with setrusumab all patients experienced at least 1 fracture. The median annualized fracture rate of 0.72 in the 2 years prior to treatment was reduced to 0.00 (n=24, p=0.042) during the mean treatment duration period of 9 months. Following initiation of treatment with setrusumab, 20 patients experienced no radiographic-confirmed fractures, and 4 patients experienced 7 radiographic-confirmed fractures in 5 separate events. These fractures exclude fractures of the fingers, toes, skull, and face consistent with the Phase 3 study design. The reduction in annualized fracture rates was associated with a clinically meaningful increase in BMD. At the 6-month timepoint, treatment with setrusumab resulted in a mean increase in lumbar spine BMD from baseline of 13% at 20 mg/kg (n=11) and 16% at 40 mg/kg (n=8), which represents the same substantial mean improvement in Z-score of +0.85 for both dose groups at 6 months compared to a combined mean baseline Z-score of –1.68. The small apparent difference in BMD change from baseline is likely related to differences in patients assigned to the two treated groups. There was no statistically significant difference in BMD percent change or Z-score change from baseline between the 20 and 40 mg/kg dosing cohorts. As of the data cut-off, there were no treatment-related serious adverse events observed in the study. Reported adverse events were generally consistent with those observed in the ASTEROID study with infusion-related events and headache determined to be the most common adverse events related to the study drug. There have been no reported hypersensitivity reactions related to setrusumab. There were no notable safety-related differences observed between dosing groups or age groups. The Phase 3 portion of the study is currently enrolling approximately 195 patients at 50 sites across 12 countries. Announcement • Jun 07
Ultragenyx Pharmaceutical Inc. Announces Data from the Dose- Selection Phase 2/3 Orbit Study Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc announced data from the dose-selection Phase 2 portion of the Phase 2/3 Orbit study showing that setrusumab rapidly induced bone production in OI-affected patients. Across all patients evaluated setrusumab demonstrated statistically significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months. The rate of increasing bone mineralization we're observing on DXA scans is striking, unlike anything I have typically seen with bisphosphonate therapy. This increase in bone mass underscores the potential to make denser and stronger bone, said Gary Gottesman, M.D., Professor of Pediatrics and Medicine, Washington University School of Medicine. As of the data cut off, serum P1NP levels through at least 1 month of treatment were available from all 24 patients enrolled in Orbit and demonstrated that treatment with setrusumab significantly increased serum P1NP in both dosing cohorts, peaking at one to two weeks and again, as expected, after the 2-month dosing timepoint. In the 20 mg/kg cohort, there was a mean serum P1NP increase of 57% from baseline over the first month. Because of the higher baseline P1NP level in younger patients, this represents an approximate 8-fold greater increase in serum P1NP over 1 month in pediatric and adolescent patients when compared to adult OI patients. The absolute effect of setrusumab on increasing serum P1NP over the 1-month period with the 20 mg/kg dose, was approximately 80% of the effect achieved with the 40 mg/kg dose, demonstrating a dose response. Patients on placebo at the 1-month timepoint (n=4) showed no significant change in mean serum P1NP from baseline. The large increase in BMD observed in the Orbit patient population over the first 3 months was consistent with the rapid increase in serum P1NP levels and was similar to results that took 1 year to achieve in the ASTEROID study in adult OI patients. Lumbar spine BMD data were available in 17 of 24 Orbit patients at the 3-month timepoint. Treatment with setrusumab for 3 months resulted in an increase in lumbar spine BMD from baseline of 9.4% at 20 mg/kg (n=10), which represents a substantial mean change in Z-score of +0.65. Treatment with 40 mg/kg (n=7) resulted in a 9.8% BMD increase. Patients on placebo at the 3-month timepoint (n=2) showed no significant change in BMD or change in lumbar spine Z-score. Announcement • May 24
Mereo BioPharma Group plc Presents Phase 2 Data from “ASTRAEUS” Trial of Its Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease at the 2023 American Thoracic Society International Conference Mereo BioPharma Group plc announced that data from the Phase 2 “ASTRAEUS” trial of alvelestat for the treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), as well as post-hoc analyses demonstrating the association between biomarker reductions with alvelestat and improvements in SGRQ, a key Patient-Reported Outcome (PRO) measure, were presented for the first time to the scientific community at the 2023 American Thoracic Society International Conference. The ASTRAEUS data were presented during an oral abstract session on novel treatments and targets by Prof. Robert Stockley, Lung Investigation Unit, University of Birmingham (United Kingdom) and Chief Investigator of the ASTRAEUS trial, while the post-hoc analyses were presented in a poster session by Dr. Jackie Parkin, Senior Vice President and Therapeutic Head at Mereo. Consistent with previously reported biomarker analyses, alvelestat demonstrated significant and consistent reductions in all three biomarkers related to AATD-LD disease activity: blood neutrophil elastase (NE), Aa-val360 and the elastin breakdown product, desmosine. Low - and high-dose alvelestat significantly suppressed NE activity compared to baseline (-83.5% and -93.3%, p=0.023 and p<0.001 respectively) and versus placebo (p=0.001 and p<0.001). In the high dose arm, Aa-val360 and desmosine progressively decreased from baseline, -22.7% (p=0.004) and -13.2% (p=0.045) respectively, with significant reductions compared to placebo as well (p=0.001 and p=0.041). The low dose did not generate consistent changes in Aa-val360 or desmosine. Based on these data, Mereo is completing preparatory work for a single pivotal Phase 3 study evaluating the high dose of alvelestat (240mg), which, if successful, is expected to support submissions for full regulatory approvals in both the U.S. and EU. The planned study will have two independent primary endpoints, based on the recommendations of the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA): i) a Patient-Reported Outcome (PRO) expected to be change from baseline in the SGRQ-Activity Domain score, as guided by the FDA, and ii) lung density measured by CT scan, as guided by the EMA. In line with previous guidance, Mereo is continuing to explore potential partnerships to fund the Phase 3 development of alvelestat. Findings from the biomarker-SGRQ post-hoc analysis showed an association between the extent of reduction in biomarkers and degree of improvement in the SGRQ-Activity domain in alvelestat-treated subjects. By week 12, there was an observed difference in improvement in SGRQ-Activity in biomarker responders compared to non-responders, with a mean improvement of 4.4 in those showing a >0% biomarker decrease and 6.1 in those with >5% biomarker decrease (P=0.05 and p=0.02 respectively), compared to those on alvelestat without biomarker decrease. This association was not observed in the patients who received placebo. These data support a potential association between the effect of alvelestat on the NE pathway and improvement in how a patient feels and functions based on SGRQ score. Data from ASTRAEUS and other research support the hypothesis that longer term treatment is expected to lead to a deepening of the biomarker and associated clinical response. Alvelestat has been generally safe, with no safety signals of concern observed to date. Adverse events leading to study drug discontinuation (one liver function and one prolonged QTc) resolved on study drug cessation. Three treatment-related SAEs of headache were reported in the alvelestat arms. Headache is a known adverse event associated with alvelestat and is being addressed through dose-escalation during initiation of alvelestat treatment. Announcement • May 09
Mereo BioPharma Regains Compliance with Nasdaq Minimum Bid Price Requirement Mereo BioPharma Group plc (“Mereo” or the “Company”) announced that it received written confirmation from the Nasdaq Stock Market LLC ("Nasdaq") that it had regained compliance with the minimum bid price requirement under the Nasdaq Listing Rules for continued Nasdaq listing, and is now compliant with applicable listing standards for continued Nasdaq listing. To regain compliance with the applicable Nasdaq Listing Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved on May 5, 2023. As previously announced, on November 2, 2022, the Company reported that it had received notification from Nasdaq on November 1, 2022, that, for the previous thirty consecutive business days, the bid price for the Company’s American Depositary Shares (the "ADSs") had closed below the minimum $1.00 per share requirement for continued listing. On May 8, 2023, the Company received written notification from the Nasdaq Listings Qualifications Department that the ADSs had, for the last 10 consecutive business days, a closing bid price at $1.00 per share or greater, and accordingly had regained compliance with the applicable Nasdaq Listing Rule. Announcement • May 08
Mereo BioPharma Announces Listing Transfer to Nasdaq Capital Market Mereo BioPharma Group plc announced that it has received approval from Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) to transfer the listing of its American Depositary Shares (“ADSs”) from the Nasdaq Global Market to the Nasdaq Capital Market. This transfer became effective at the opening of business on May 3, 2023. The Nasdaq Global Market and the Nasdaq Capital Market are each market tiers of Nasdaq and the Nasdaq Capital Market is a continuous trading market that operates in the same manner as the Nasdaq Global Market. Therefore, the Company’s ADSs continue to trade under the ticker symbol “MREO” and are not affected by this change to the listing. The approval by Nasdaq was based upon the Company meeting the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing on the Capital Market, except for the bid price requirement. In connection with the transfer to the Nasdaq Capital Market, the Company became eligible for an additional 180-day period (or until October 30, 2023) to regain compliance with the requirement set forth in Nasdaq Listing Rule 5450(a)(1) that the bid price of the Company’s ADSs meet or exceed $1.00 per ADS for at least ten consecutive business days. As of May 5, 2023, the closing bid price of the Company’s ADSs had exceeded the $1.00 minimum per ADS for 10 consecutive business days and as a result, the Company believes that it has regained compliance with the relevant listing rule. The Company will provide a further update on its compliance upon receipt of a formal written notification from Nasdaq. Board Change • Nov 16
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (5 non-independent directors). Co-Founder, CEO & Executive Director Denise Scots-Knight is the most experienced director on the board, commencing their role in 2015. Independent Director Pierre Jacquet was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Board Change • Nov 11
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (5 non-independent directors). Co-Founder, CEO & Executive Director Denise Scots-Knight is the most experienced director on the board, commencing their role in 2015. Independent Director Pierre Jacquet was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. 
