Mereo BioPharma Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Rhea-AI Summary
Mereo BioPharma (NASDAQ:MREO) reported first quarter 2026 results and rare disease pipeline updates. Net loss was $6.7 million versus $12.9 million a year earlier, with cash of $36.2 million and runway expected into mid‑2027.
Phase 3 setrusumab studies in osteogenesis imperfecta did not meet primary fracture endpoints but showed statistically significant gains in bone mineral density and vertebral fracture reductions. Mereo is engaging regulators on a pediatric path. Alvelestat Phase 3 is planned as a single ~220‑patient trial pending partnership, and vantictumab is slated to enter Phase 2 in ADO2 in 2H 2026 via partner āshibio.
Positive
- Net loss narrowed to $6.7 million from $12.9 million year over year
- General and administrative expenses decreased to $4.0 million from $7.3 million
- Cash and cash equivalents of $36.2 million with runway into mid‑2027
- Setrusumab Phase 3 showed statistically significant bone mineral density and vertebral fracture benefits
- Alvelestat has a defined single Phase 3 trial design for U.S. and Europe
- Vantictumab Phase 2 in ADO2 expected in 2H 2026, funded by partner āshibio
Negative
- Setrusumab Orbit and Cosmic Phase 3 studies did not achieve primary fracture endpoints
- R&D expenses increased to $4.7 million from $3.9 million, driven by setrusumab costs
- Cash and cash equivalents declined to $36.2 million from $41.0 million since year‑end 2025
- Setrusumab program incurred costs related to cancellation of manufacturing slots by partner Ultragenyx
News Market Reaction – MREO
In the May 12 session, MREO gained 1.44%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 19 | Full-year 2025 earnings | Positive | +2.6% | Reported FY 2025 results, cash $41.0M, reiterated mid-2027 runway and Phase 3 data. |
| Nov 10 | Q3 2025 earnings | Positive | +5.7% | Q3 2025 results with $48.7M cash, 2027 runway and upcoming Phase 3 readouts. |
| Aug 12 | Q2 2025 earnings | Positive | +9.2% | Q2 2025 update showing $56.1M cash and advancing Phase 3 setrusumab studies. |
| May 13 | Q1 2025 earnings | Positive | -7.2% | Q1 2025 results with $62.5M cash and progressing Orbit interim analysis. |
| Mar 26 | Full-year 2024 earnings | Positive | +0.8% | FY 2024 report showing $69.8M cash and continued Phase 3 setrusumab work. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings updates have usually been received constructively, with four of the last five tagged earnings releases followed by positive price moves.
Over the last year, Mereo’s earnings releases have consistently highlighted cash runway into 2027 and progression of late‑stage assets setrusumab and alvelestat. Cash has trended down from $69.8M at Dec 31, 2024 while management reiterated funding into 2027. Most earnings prints (e.g., Mar 19, 2026 and Nov 10, 2025) saw positive price reactions, suggesting investors often focus on clinical and partnering milestones as much as headline loss figures.
Key Terms
osteogenesis imperfecta medical
bone mineral density medical
patient reported outcomes (PROs) medical
St. George’s Respiratory Questionnaire (SGRQ) medical
CT scan medical
autosomal dominant osteopetrosis Type 2 (ADO2) medical
ADR program financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
LONDON, May 12, 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 first quarter ended March 31, 2026, and provided an update on recent corporate developments.
“Based on extensive analysis of data across the two global Phase 3 studies of setrusumab in osteogenesis imperfecta in collaboration with our partner Ultragenyx, we believe there is basis to engage with the regulatory agencies to determine if there is a path forward in pediatric patients. These interactions have been initiated, and we plan to provide updates once we have some definitive feedback. We continue to believe that setrusumab has the potential to provide meaningful benefit for people living with OI, a condition with no FDA or EMA approved therapies,” said Denise Scots-Knight, Chief Executive Officer of Mereo. “We are engaged with potential partners for alvelestat in AATD-LD and believe alvelestat can quickly enter Phase 3 development following closing of a partnership transaction. Our other partnered program, vantictumab, is continuing to move forward with āshibio, who plan to initiate a Phase 2 trial in osteopetrosis in the second half of 2026. We continue to expect that our cash position, which totaled
Recent Corporate Developments and Anticipated Milestones
Setrusumab (UX143)
- Further analyses of the data from the Orbit and Cosmic Phase 3 studies, including patient subgroups, have been completed.
- While neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic), both studies achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density versus control as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study.
- The safety profile of setrusumab was consistent with that observed in prior studies.
- Based on the Phase 3 data analysis from both global Phase 3 studies and the safety profile of setrusumab, Mereo and its partner Ultragenyx believe there is a basis to engage regulatory agencies to determine if there is a path forward for setrusumab in pediatric patients. These interactions have been initiated.
Alvelestat (MPH-966)
- Mereo is actively engaged in discussions with potential partners for the Phase 3 development and commercialization of alvelestat.
- 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. These are independent primary endpoints.
- The Company believes initiation of the Phase 3 study could happen within 6 months of closing a potential partnership transaction.
Vantictumab (OMP18R5)
- The Company’s development partner for vantictumab, āshibio, Inc., is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2), which is expected to commence in the second half of 2026.
- āshibio is responsible for funding the global clinical program and holds the right to commercialize vantictumab outside of Europe, where Mereo has retained commercial rights.
First Quarter 2026 Financial Results
Total research and development (“R&D”) expenses increased by
General and administrative expenses decreased by
Net loss for the first quarter of 2026 was
As of March 31, 2026, the Company had cash and cash equivalents of
Total ordinary shares issued as of March 31, 2026 were 798,078,829. Total ADS equivalents as of March 31, 2026 were 159,615,765, 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 CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 36,223 | $ | 40,992 | ||||
| Prepaid expenses and other current assets | 2,249 | 2,531 | ||||||
| Research and development incentives receivables | 1,562 | 1,497 | ||||||
| Total current assets | 40,034 | 45,020 | ||||||
| Property and equipment, net | 91 | 137 | ||||||
| Operating lease right-of-use assets, net | 108 | 244 | ||||||
| Intangible assets, net | 381 | 516 | ||||||
| Total assets | $ | 40,614 | $ | 45,917 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,226 | $ | 1,333 | ||||
| Accrued expenses | 2,046 | 2,026 | ||||||
| Operating lease liabilities – current | — | 202 | ||||||
| Other current liabilities | 905 | 741 | ||||||
| Total current liabilities | 6,177 | 4,302 | ||||||
| Warrant liabilities – non-current | 21 | 38 | ||||||
| Other non-current liabilities | 362 | 661 | ||||||
| Total liabilities | $ | 6,560 | $ | 5,001 | ||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value | $ | 3,145 | $ | 3,135 | ||||
| Additional paid-in capital | 551,018 | 549,622 | ||||||
| Accumulated deficit | (507,538 | ) | (501,018 | ) | ||||
| Accumulated other comprehensive loss | (12,571 | ) | (10,823 | ) | ||||
| Total shareholders’ equity | 34,054 | 40,916 | ||||||
| Total liabilities and shareholders’ equity | $ | 40,614 | $ | 45,917 | ||||
| MEREO BIOPHARMA GROUP PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | (4,747 | ) | $ | (3,930 | ) | ||
| General and administrative | (4,019 | ) | (7,272 | ) | ||||
| Loss from operations | (8,766 | ) | (11,202 | ) | ||||
| Other income/(expenses) | ||||||||
| Interest income | 327 | 659 | ||||||
| Interest expense | (20 | ) | (180 | ) | ||||
| Changes in the fair value of warrants | 17 | 416 | ||||||
| Foreign currency transaction gain/(loss), net | 1,628 | (2,765 | ) | |||||
| Benefit from research and development tax credit | 95 | 185 | ||||||
| Net loss before income tax | (6,719 | ) | (12,887 | ) | ||||
| Income tax benefit | — | — | ||||||
| Net loss | $ | (6,719 | ) | $ | (12,887 | ) | ||
| Loss per share – basic and diluted | $ | (0.01 | ) | $ | (0.02 | ) | ||
| Weighted average shares outstanding – basic and diluted | 801,805,570 | 784,279,387 | ||||||
| Net loss | $ | (6,719 | ) | $ | (12,887 | ) | ||
| Other comprehensive (loss)/income – Foreign currency translation adjustments, net of tax | (1,748 | ) | 3,559 | |||||
| Total comprehensive loss | $ | (8,467 | ) | $ | (9,328 | ) | ||
