Mereo BioPharma Reports Full Year 2025 Financial Results and Provides Corporate Highlights
Rhea-AI Summary
Mereo (NASDAQ: MREO) reported full‑year 2025 results and clinical updates on March 19, 2026. Cash was $41.0 million as of December 31, 2025, with a stated runway into mid‑2027.
Phase 3 Orbit and Cosmic studies of setrusumab missed primary fracture endpoints but showed statistically significant BMD gains, reductions in vertebral fractures and improved pediatric PROs. Alvelestat Phase 3 planning completed site feasibility (≈220 patients). Vantictumab was outlicensed with a partner planning a Phase 2 in H2 2026.
Positive
- Secondary efficacy: setrusumab showed significant bone mineral density improvements
- Pediatric benefits: setrusumab demonstrated significant PRO and vertebral fracture reductions
- Alvelestat Phase 3 site feasibility completed; planned ~220‑patient pivotal trial
- Vantictumab outlicense: partner plans Phase 2 initiation in H2 2026
- Cash runway: $41.0M expected to fund operations into mid‑2027
Negative
- Primary endpoints missed: setrusumab did not achieve statistical significance on primary fracture endpoints
- Cash decline: cash fell from $69.8M to $41.0M (2024→2025)
- Net loss: $41.9M for 2025, reflecting operating losses and FX translation loss
- R&D mix shift: R&D decreased overall but increased spend for setrusumab
News Market Reaction – MREO
On the day this news was published, MREO gained 2.56%, reflecting a moderate positive market reaction. Argus tracked a peak move of +11.8% during that session. Argus tracked a trough of -4.8% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $58.35M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
MREO is down 6.21%, while biotech peers like LXEO (-9.51%), LCTX (-5.66%), ANNX (-3.29%) and others are also negative, suggesting broader sector pressure.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Q3 2025 earnings | Positive | +5.7% | Q3 2025 results, cash runway to 2027, Phase 3 setrusumab catalysts. |
| Aug 12 | Q2 2025 earnings | Positive | +9.2% | Q2 2025 results, $56.1M cash and ongoing Phase 3 setrusumab work. |
| May 13 | Q1 2025 earnings | Neutral | -7.2% | Q1 2025 results, $62.5M cash and progressing Orbit Phase 3 study. |
| Mar 26 | FY 2024 earnings | Neutral | +0.8% | Full year 2024 results, $69.8M cash and growing R&D and G&A. |
| Nov 12 | Q3 2024 earnings | Positive | -4.2% | Q3 2024 results, $80.5M cash and Breakthrough Therapy designation. |
Earnings updates have usually produced modest price moves, with positive reactions slightly more common when cash runway and late-stage pipeline progress were emphasized.
Over the past five earnings cycles (Nov 2024–Nov 2025), Mereo repeatedly highlighted cash runway into 2027 and advancing Phase 3 studies for setrusumab, alongside progress on alvelestat partnering and orphan designation. Cash declined from $80.5M in Q3 2024 to $48.7M by Q3 2025, while net losses remained significant. Market reactions to earnings were generally modest (average move about 0.86%). Today’s full-year 2025 report continues the themes of cost control, reduced R&D and G&A, and reiterates late-stage pipeline and partnering plans.
Historical Comparison
In the last 5 earnings releases, average move was about 0.86%. Today’s -6.21% reaction to FY 2025 results is notably larger and more negative than typical.
Earnings updates from late 2024 through 2025 traced cash trending from $80.5M to $48.7M, while setrusumab advanced from ongoing Phase 3 work toward topline results and alvelestat moved to Phase 3–ready status.
Market Pulse Summary
This announcement details full-year 2025 results with R&D and G&A expenses reduced to $17.8M and $23.0M, a net loss of $41.9M, and cash of $41.0M guiding runway into mid-2027. It reiterates that Phase 3 setrusumab studies missed primary fracture endpoints but showed strong bone mineral density and PRO signals, while alvelestat progresses toward a single global Phase 3. Investors may watch partnering progress, trial initiations, Nasdaq listing compliance, and cash trends against this runway guidance.
Key Terms
osteogenesis imperfecta medical
patient reported outcomes (PROs) medical
bisphosphonates medical
bone mineral density medical
St. George’s Respiratory Questionnaire (SGRQ) medical
bronchiectasis medical
autosomal dominant osteopetrosis Type 2 (ADO2) medical
AI-generated analysis. Not financial advice.
Additional data analyses from Orbit and Cosmic Phase 3 studies of setrusumab (UX143) in osteogenesis imperfecta ongoing
Cash of
LONDON, March 19, 2026 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced financial results for the full year ended December 31, 2025, and provided an update on recent corporate developments.
“In collaboration with our partner Ultragenyx, we have analysed a significant part of the data from the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta and continue to develop our understanding of the fracture data and the patient reported outcomes (PROs), especially in patients aged 2–18 years old. We believe that these data, which include pre-specified sub-groups and ad hoc analyses, may provide the basis for engagement with the regulatory agencies,” said Denise Scots-Knight, Chief Executive Officer of Mereo. “There are no FDA or EMA therapies approved specifically for OI and although bisphosphonates are used to improved bone mineral density, it remains a high unmet need. Setrusumab has demonstrated statistically significant improvements in bone mineral density as well as compelling reductions in vertebral fractures and statistically significant improvements in PROs of disease pain and daily activity in pediatric and teenage patients. We look forward to providing updates on these efforts as we progress with next steps. Alongside this, our partnering discussions around alvelestat in AATD-LD are continuing to advance on multiple fronts and our partner āshibio has indicated that it plans to initiate a Phase 2 trial of vantictumab in osteopetrosis in the second half of this year. Following our cost reductions and delays to investment in manufacturing and pre-commercial activities for setrusumab, our revised financial runway into mid-2027 enables us to potentially deliver on several key milestones during 2026.”
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 high statistical significance against the key secondary endpoint of improvement in bone mineral density versus a placebo or versus a bisphosphonate (standard of care) 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.
- Additionally, the studies demonstrated reductions in vertebral fractures, which are a key contributor to pain and disability in this patient population and are known to drive treatment decisions, as well as improvements in patient-reported outcomes of disease severity, pain / comfort and daily activities which were statistically significant in the Orbit study in pediatrics and teens.
- The safety profile of setrusumab was consistent with that observed in prior studies.
- Further analyses of the data from both studies, including patient subgroups, are ongoing ahead of any planned interactions with the regulatory agencies.
Alvelestat (MPH-966)
- The site feasibility work for initiation of the global Phase 3 pivotal study has been completed.
- 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 potential 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.
- Additionally, the Company has designed a potential Phase 2b study of alvelestat in bronchiectasis to further support the ongoing partnering discussions.
- The proposed study would enroll approximately 250 patients, randomized 1:1:1 to receive one of two alvelestat doses with standard of care or placebo with standard of care, with a primary efficacy endpoint of change in exacerbation rate at six months.
- The proposed trial design is intended to substantially de-risk potential Phase 3 development, as exacerbations are a required confirmatory endpoint in registrational trials.
Vantictumab (OMP18R5)
- The Company outlicensed vantictumab for autosomal dominant osteopetrosis Type 2 (ADO2) to āshibio, Inc. whilst retaining European rights.
- āshibio is responsible for funding the global program and, following regulatory discussions, plans to initiate a Phase 2 study in the second half of 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.
- āshibio reported promising pre-clinical data at ASBMR 2025 in an ADO2 mouse model, in which vantictumab significantly decreased areal bone mineral density and rescued the bone phenotype in this model.
- ADO2 is an inherited metabolic bone disorder characterized by impaired osteoclast function, with no currently approved therapies. This impaired osteoclast function results in the growth of dense, brittle bones leading to multiple fractures, osteomyelitis, bone pain, low blood counts and significant morbidity.
Full Year 2025 Financial Results
Total research and development (“R&D”) expenses decreased by
General and administrative expenses decreased by
Net loss for the full year ended December 31, 2025, was
As of December 31, 2025, the Company had cash and cash equivalents of
Total ordinary shares issued as of December 31, 2025 were 795,658,504. Total ADS equivalents as of December 31, 2025 were 159,131,700, with each ADS representing five ordinary shares of the Company.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. The Company has three rare disease product candidates: setrusumab for the treatment of osteogenesis imperfecta (OI); alvelestat for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD); and vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2). The Company and its partner for setrusumab, Ultragenyx Pharmaceutical Inc., have reported top-line results from the Phase 3 portion of a pivotal Phase 2/3 study in pediatrics and young adults (5 to 25 years old) and in the Phase 3 study in pediatric patients (2 to <7 years old) for setrusumab in OI. The partnership with Ultragenyx includes potential additional milestone payments of up to
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact contained herein are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements reflect our current expectations, beliefs and assumptions concerning future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Risks and uncertainties include, among other things, the uncertainties inherent in the clinical development process; the Company’s reliance on third parties to conduct and provide funding for its clinical trials; the sufficiency of existing cash to fund operations and/or the inability to raise additional funding on favorable terms or at all; the uncertainty inherent in regulatory review processes, including varying interpretations and analyses of data from clinical trials; the Company’s dependence on enrollment of patients in its clinical trials; potentially smaller than anticipated market opportunities for the Company's product candidates; the Company’s dependence on its key executives; and the Company’s ability to maintain compliance with Nasdaq continued listing requirements.
You should carefully consider the foregoing factors and the other risks and uncertainties that affect the Company’s business, including those described in the “Risk Factors” section of its Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook,” “will,” “continue” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company’s current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates. The Company wishes to caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any of our 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.
| Mereo BioPharma Contacts: | |
| Mereo | +44 (0)333 023 7300 |
| Denise Scots-Knight, Chief Executive Officer | |
| Christine Fox, Chief Financial Officer | |
| Burns McClellan (Investor Relations Adviser to Mereo) | +01 646 930 4406 |
| Lee Roth | |
| Investors | investors@mereobiopharma.com |
| MEREO BIOPHARMA GROUP PLC CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) | |||||||
| December 31, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 40,992 | $ | 69,802 | |||
| Prepaid expenses and other current assets | 2,531 | 2,175 | |||||
| Research and development incentives receivables | 1,497 | 2,786 | |||||
| Total current assets | 45,020 | 74,763 | |||||
| Property and equipment, net | 137 | 257 | |||||
| Operating lease right-of-use assets, net | 244 | 727 | |||||
| Intangible assets, net | 516 | 643 | |||||
| Total assets | $ | 45,917 | $ | 76,390 | |||
| Liabilities | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,333 | $ | 2,440 | |||
| Accrued expenses | 2,026 | 4,071 | |||||
| Convertible loan notes – current | — | 5,535 | |||||
| Operating lease liabilities – current | 202 | 707 | |||||
| Other current liabilities | 741 | 1,095 | |||||
| Total current liabilities | 4,302 | 13,848 | |||||
| Warrant liabilities – non-current | 38 | 821 | |||||
| Operating lease liabilities – non-current | — | 187 | |||||
| Other non-current liabilities | 661 | 565 | |||||
| Total liabilities | $ | 5,001 | $ | 15,421 | |||
| Commitments and contingencies | |||||||
| Shareholders’ Equity | |||||||
| Ordinary shares, par value | $ | 3,135 | $ | 3,059 | |||
| Additional paid-in capital | 549,622 | 539,642 | |||||
| Accumulated deficit | (501,018 | ) | (462,883 | ) | |||
| Accumulated other comprehensive loss | (10,823 | ) | (18,849 | ) | |||
| Total shareholders’ equity | 40,916 | 60,969 | |||||
| Total liabilities and shareholders’ equity | $ | 45,917 | $ | 76,390 | |||
| MEREO BIOPHARMA GROUP PLC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share amounts) | |||||||
| Year Ended December 31, | |||||||
| 2025 | 2024 | ||||||
| Revenue | $ | 500 | $ | — | |||
| Operating expenses | |||||||
| Cost of revenue | (133 | ) | — | ||||
| Research and development | (17,766 | ) | (20,930 | ) | |||
| General and administrative | (23,008 | ) | (26,434 | ) | |||
| Other income | 300 | — | |||||
| Loss from operations | (40,107 | ) | (47,364 | ) | |||
| Other income/(expenses) | |||||||
| Interest income | 2,173 | 3,041 | |||||
| Interest expense | (255 | ) | (1,370 | ) | |||
| Changes in the fair value of warrants | 805 | (419 | ) | ||||
| Foreign currency transaction (loss)/gain, net | (6,344 | ) | 1,210 | ||||
| Benefit from research and development tax credit | 1,850 | 1,649 | |||||
| Net loss before income tax | (41,878 | ) | (43,253 | ) | |||
| Income tax benefit | — | — | |||||
| Net loss | $ | (41,878 | ) | $ | (43,253 | ) | |
| Loss per share – basic and diluted | $ | (0.05 | ) | $ | (0.06 | ) | |
| Weighted average shares outstanding – basic and diluted | 797,119,632 | 739,624,264 | |||||
| Net loss | $ | (41,878 | ) | $ | (43,253 | ) | |
| Other comprehensive income/(loss) – Foreign currency translation adjustments, net of tax | 8,026 | (1,364 | ) | ||||
| Total comprehensive loss | $ | (33,852 | ) | $ | (44,617 | ) | |
FAQ
What were the key Phase 3 results for Mereo's setrusumab (MREO) reported March 19, 2026?
How does the setrusumab Phase 3 outcome affect Mereo (MREO) regulatory plans?
What is Mereo's cash position and runway as of December 31, 2025 (MREO)?
What is the planned Phase 3 design for alvelestat in AATD‑LD by Mereo (MREO)?
What did Mereo (MREO) announce about vantictumab and partner plans on March 19, 2026?
How did Mereo's 2025 operating expenses change and what does this mean for investors (MREO)?
