Mereo BioPharma Reports Third Quarter 2025 Financial Results and Provides Corporate Highlights
Rhea-AI Summary
Mereo (NASDAQ: MREO) reported Q3 2025 results and corporate highlights on Nov 10, 2025. Key near-term catalysts include Phase 3 Orbit and Cosmic setrusumab readouts expected around the end of 2025 (Orbit final analysis threshold p<0.039; Cosmic p<0.05).
Financials: cash $48.7M as of Sep 30, 2025, expected to fund operations into 2027; Q3 R&D expense rose to $4.3M (vs $3.2M prior year); G&A was $6.0M; net loss was $7.0M in Q3 2025.
Corporate items: ongoing alvelestat partnering discussions, retained European commercial rights for vantictumab, and continued pre-commercial work in Europe for setrusumab.
Positive
- Setrusumab Phase 3 readouts expected around end of 2025
- $48.7M cash expected to fund operations into 2027
- Retained European commercial rights for vantictumab
Negative
- Cash down from $69.8M to $48.7M since Dec 31, 2024
- Total ordinary shares of 795,484,404 (ADS equivalents 159,096,880) outstanding
News Market Reaction 12 Alerts
On the day this news was published, MREO declined 1.67%, reflecting a mild negative market reaction. Argus tracked a peak move of +4.6% during that session. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $307M at that time.
Data tracked by StockTitan Argus on the day of publication.
Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta on-track for around the end of 2025
Cash of
LONDON, Nov. 10, 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 third quarter ended September 30, 2025, and provided recent corporate highlights.
“We are rapidly approaching a major transition period in our corporate evolution, with the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta on track to read out around the end of the year. Based on the data from prior studies, we remain confident in the potential of setrusumab to reduce fractures and improve quality of life for people with OI. We continue to invest in commercial readiness activities to ensure Mereo is well positioned for a potential launch in our European territories,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “Alongside the progress of the setrusumab program, we are continuing to advance partnering discussions for alvelestat. In addition, we are excited to have retained European commercial rights in our recent partnership deal with āshibio for vantictumab, which is being investigated in autosomal dominant osteopetrosis type 2, another rare bone disease for which promising preclinical data were presented at this year’s ASBMR Annual Meeting. With
Third Quarter 2025 Highlights, Recent Developments, and Anticipated Milestones
Setrusumab (UX143) for osteogenesis imperfecta (OI)
- The Phase 3 Orbit and Cosmic studies, led by our partner Ultragenyx, evaluating setrusumab in pediatric and young adult patients and young pediatric patients with OI, are progressing towards final analyses at which time patients will have been on therapy for at least 18 months.
- The data from both Orbit and Cosmic are expected around the end of 2025. The threshold for the Phase 3 Orbit final analysis is p<0.039 and the threshold for the Phase 3 Cosmic final analysis is p<0.05.
- Pre-commercial efforts continue in Europe where Mereo holds commercial rights. These include continuation of the SATURN program and an expansion of the activities to determine the potential addressable market and identify treatment centers beyond the five major countries in Europe to the Nordic and Benelux regions.
Alvelestat (MPH-966) for alpha-1-anti-trypsin deficiency lung disease (AATD-LD)
- Activities to support initiation of the planned single, global Phase 3 pivotal study are ongoing.
- The Company continues to be actively engaged with multiple potential partners regarding development and commercialization of alvelestat.
Vantictumab for autosomal dominant osteopetrosis type 2 (ADO2)
- Vantictumab is a fully-human monoclonal antibody that binds to certain frizzled receptors and inhibits Wnt signaling pathways, which was previously being developed in oncology settings.
- Mereo granted āshibio, Inc. an exclusive license to develop vantictumab in ADO2. Under the agreement, announced in August 2025, Mereo has retained European commercial rights, and has granted āshibio the right to commercialize in the U.S. and rest of the world.
Third Quarter 2025 Financial Results
Total research and development (“R&D”) expenses increased by
General and administrative (“G&A”) expenses decreased by
Net loss for the third quarter of 2025 was
As of September 30, 2025, the Company had cash and cash equivalents of
Total ordinary shares issued as of September 30, 2025, were 795,484,404. Total ADS equivalents as of September 30, 2025, were 159,096,880, 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’s partner for setrusumab, Ultragenyx Pharmaceutical, Inc., has completed enrollment in the Phase 3 portion of a pivotal Phase 2/3 study in pediatrics and young adults (5 to 25 years old) for setrusumab in OI and in the Phase 3 study in pediatric patients (2 to <7 years old). 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. 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 usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook” 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.
All of the Company’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 the Company’s historical experience and its present expectations or projections. Such risks and uncertainties include, among others, 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 Company’s dependence on enrollment of patients in its clinical trials; and the Company’s dependence on its key executives. 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. 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 per share amounts) (Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 48,698 | $ | 69,802 | ||||
| Prepaid expenses and other current assets | 2,694 | 2,175 | ||||||
| Research and development incentives receivables | 1,015 | 2,786 | ||||||
| Total current assets | 52,407 | 74,763 | ||||||
| Property and equipment, net | 174 | 257 | ||||||
| Operating lease right-of-use assets, net | 378 | 727 | ||||||
| Intangible assets, net | 643 | 643 | ||||||
| Total assets | $ | 53,602 | $ | 76,390 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 879 | $ | 2,440 | ||||
| Accrued expenses | 4,118 | 4,071 | ||||||
| Convertible loan notes – current | — | 5,535 | ||||||
| Operating lease liabilities – current | 397 | 707 | ||||||
| Other current liabilities | 622 | 1,095 | ||||||
| Total current liabilities | 6,016 | 13,848 | ||||||
| Warrant liabilities – non-current | 336 | 821 | ||||||
| Operating lease liabilities – non-current | — | 187 | ||||||
| Other non-current liabilities | 652 | 565 | ||||||
| Total liabilities | $ | 7,004 | $ | 15,421 | ||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value | $ | 3,134 | $ | 3,059 | ||||
| Additional paid-in capital | 548,041 | 539,642 | ||||||
| Accumulated deficit | (493,667 | ) | (462,883 | ) | ||||
| Accumulated other comprehensive loss | (10,910 | ) | (18,849 | ) | ||||
| Total shareholders’ equity | 46,598 | 60,969 | ||||||
| Total liabilities and shareholders’ equity | $ | 53,602 | $ | 76,390 | ||||
| MEREO BIOPHARMA GROUP PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | — | $ | — | $ | 500 | $ | — | ||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenue | — | — | (133 | ) | — | |||||||||||
| Research and development | (4,270 | ) | (3,170 | ) | (13,573 | ) | (12,109 | ) | ||||||||
| General and administrative | (6,045 | ) | (6,203 | ) | (18,811 | ) | (19,980 | ) | ||||||||
| Other income | 300 | — | 300 | — | ||||||||||||
| Loss from operations | (10,015 | ) | (9,373 | ) | (31,717 | ) | (32,089 | ) | ||||||||
| Other income/(expenses) | ||||||||||||||||
| Interest income | 504 | 983 | 1,752 | 2,160 | ||||||||||||
| Interest expense | (28 | ) | (353 | ) | (232 | ) | (995 | ) | ||||||||
| Changes in the fair value of warrants | 196 | (59 | ) | 511 | (576 | ) | ||||||||||
| Foreign currency transaction gain/(loss), net | 1,873 | (6,425 | ) | (6,218 | ) | (5,780 | ) | |||||||||
| Benefit from research and development tax credit | 446 | 226 | 1,377 | 1,073 | ||||||||||||
| Net loss before income tax | (7,024 | ) | (15,001 | ) | (34,527 | ) | (36,207 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net loss | $ | (7,024 | ) | $ | (15,001 | ) | $ | (34,527 | ) | $ | (36,207 | ) | ||||
| Loss per share – basic and diluted | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.05 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 799,947,013 | 770,146,589 | 796,018,903 | 727,808,860 | ||||||||||||
| Net loss | $ | (7,024 | ) | $ | (15,001 | ) | $ | (34,527 | ) | $ | (36,207 | ) | ||||
| Other comprehensive (loss)/income – Foreign currency translation adjustments, net of tax | (2,267 | ) | 7,174 | 7,939 | 6,381 | |||||||||||
| Total comprehensive loss | $ | (9,291 | ) | $ | (7,827 | ) | $ | (26,588 | ) | $ | (29,826 | ) | ||||
FAQ
When will Mereo (MREO) report Phase 3 setrusumab (Orbit and Cosmic) results?
How much cash did Mereo (MREO) have at Sept 30, 2025 and how long is the runway?
What were Mereo's (MREO) Q3 2025 R&D and net loss figures?
What commercial rights did Mereo (MREO) retain in the vantictumab deal announced in 2025?
What are Mereo's (MREO) next steps for alvelestat development?
What statistical thresholds apply to Mereo's (MREO) Phase 3 analyses for setrusumab?
