Mereo BioPharma Reports First Quarter 2025 Financial Results and Provides Corporate Highlights
- Strong cash position of $62.5 million expected to fund operations into 2027
- European Commission granted Orphan Designation to alvelestat for AATD-LD treatment
- Phase 3 Orbit study progressing well with all patients on therapy for at least 12 months
- Slight decrease in R&D expenses from $4.0M to $3.9M year-over-year
- Net loss increased to $12.9M from $9.0M year-over-year
- G&A expenses increased by $1.4M to $7.3M compared to Q1 2024
- Cash position decreased from $69.8M to $62.5M since December 2024
Insights
Mereo reports stable Q1 with sufficient cash runway while progressing two Phase 3 trials with potential catalysts in mid-to-late 2025.
Mereo BioPharma's Q1 2025 financial results indicate a stable cash position of
The company's lead asset setrusumab (UX143) for osteogenesis imperfecta (OI) - a rare genetic bone disorder - continues advancing in two global Phase 3 studies. The Orbit study in patients aged 5-25 years is approaching critical inflection points with a second interim analysis expected mid-2025 or final analysis in Q4 2025. All patients have now completed at least 12 months of therapy, with safety profiles consistent with Phase 2 observations - a positive sign for the drug's tolerability.
Meanwhile, the Cosmic study in younger patients (ages 2-<7) is progressing alongside Orbit, with timing aligned to maintain statistical integrity. Mereo is prudently investing in European pre-commercial activities for setrusumab, suggesting confidence in eventual regulatory approval.
For alvelestat, Mereo's second clinical asset for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), the company secured European Commission Orphan Designation in Q1, complementing existing FDA Orphan Drug and Fast Track designations. These designations provide regulatory benefits that could accelerate approval pathways. Importantly, ongoing partnership discussions for alvelestat could potentially bring non-dilutive capital not factored into the current cash runway projections.
R&D expenses remained essentially flat at
The net loss widened to
Progress continues in Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI)
Cash of
LONDON, May 13, 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 first quarter ended March 31, 2025, and provided recent corporate highlights.
“As we close out the first quarter of 2025, we continue to anticipate that this will be an important, milestone-rich year for Mereo. The Phase 3 Orbit study of setrusumab in osteogenesis imperfecta remains on track to read-out either at the second interim analysis in mid-2025 or at the final analysis in the fourth quarter. We are continuing to invest in the pre-commercial activities for setrusumab to enable a successful launch in our European territory, following potential regulatory approvals,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "Further, alvelestat is now Phase 3 ready and we are finalizing the trial start-up activities to support our ongoing partnering process. Along with our late-stage pipeline, we believe that continued close management of our cash balance will enable us to support our operations into 2027.”
First Quarter 2025 Highlights, Recent Developments, and Anticipated Milestones
Setrusumab (UX143)
- Continued progress in the two global Phase 3 studies led by our partner Ultragenyx:
- The randomized, placebo-controlled Phase 3 portion of the Orbit study (in patients aged 5 to 25 years) is progressing toward the second interim analysis (IA2) in mid-2025 or a final analysis in the fourth quarter of 2025. All patients have now been on therapy for at least 12 months, conduct of the study is going well and patient safety in the Phase 3 portion of the study is consistent with safety observed in the Phase 2.
- Patients in the Cosmic study (aged 2 to <7 years) are being treated with either setrusumab or intravenous bisphosphonates (IV-BP) therapy and will be evaluated in parallel with the Orbit interim analysis. If Orbit progresses to full study completion in the fourth quarter of 2025, Cosmic will also continue to a data readout, to align with the Orbit readout without spending alpha at the mid-year interim assessment.
- Continued pre-commercial activities in Europe to support potential launch, including engagement with regulatory/HTA bodies and real-world data collection efforts through the SATURN program.
Alvelestat (MPH-966)
- In the first quarter of 2025, the European Commission granted Orphan Designation to alvelestat for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). This adds to existing US FDA Orphan Drug and Fast Track designations.
- The start-up activities for the planned single, global Phase 3 pivotal study are ongoing.
- The Company remains in discussion with multiple potential development and commercialization partners.
First Quarter 2025 Financial Results
Total research and development (“R&D”) expenses decreased by
General and administrative expenses increased by
Net loss for the first quarter of 2025 was
As of March 31, 2025, the Company had cash and cash equivalents of
Total ordinary shares issued as of March 31, 2025 were 795,001,444. Total ADS equivalents as of March 31, 2025 were 159,000,288, 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 two rare disease product candidates: setrusumab for the treatment of osteogenesis imperfecta (OI); and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). The Company’s partner, 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) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 62,483 | $ | 69,802 | ||||
| Prepaid expenses and other current assets | 2,519 | 2,175 | ||||||
| Research and development incentives receivables | 1,897 | 2,786 | ||||||
| Total current assets | 66,899 | 74,763 | ||||||
| Property and equipment, net | 247 | 257 | ||||||
| Operating lease right-of-use assets, net | 622 | 727 | ||||||
| Intangible assets, net | 554 | 643 | ||||||
| Total assets | $ | 68,322 | $ | 76,390 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,924 | $ | 2,440 | ||||
| Accrued expenses | 2,932 | 4,071 | ||||||
| Convertible loan notes – current | — | 5,535 | ||||||
| Operating lease liabilities – current | 747 | 707 | ||||||
| Other current liabilities | 894 | 1,095 | ||||||
| Total current liabilities | 7,497 | 13,848 | ||||||
| Warrant liabilities – non-current | 419 | 821 | ||||||
| Operating lease liabilities – non-current | — | 187 | ||||||
| Other non-current liabilities | 325 | 565 | ||||||
| Total liabilities | $ | 8,241 | $ | 15,421 | ||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value | $ | 3,132 | $ | 3,059 | ||||
| Additional paid-in capital | 544,266 | 539,642 | ||||||
| Accumulated deficit | (472,027 | ) | (462,883 | ) | ||||
| Accumulated other comprehensive loss | (15,290 | ) | (18,849 | ) | ||||
| Total shareholders’ equity | 60,081 | 60,969 | ||||||
| Total liabilities and shareholders’ equity | $ | 68,322 | $ | 76,390 | ||||
| MEREO BIOPHARMA GROUP PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share amounts) (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | (3,930 | ) | $ | (3,994 | ) | ||
| General and administrative | (7,272 | ) | (5,906 | ) | ||||
| Loss from operations | (11,202 | ) | (9,900 | ) | ||||
| Other income/(expenses) | ||||||||
| Interest income | 659 | 617 | ||||||
| Interest expense | (180 | ) | (310 | ) | ||||
| Changes in the fair value of warrants | 416 | (448 | ) | |||||
| Foreign currency transaction (loss)/gain, net | (2,765 | ) | 613 | |||||
| Benefit from research and development tax credit | 185 | 477 | ||||||
| Net loss before income tax | (12,887 | ) | (8,951 | ) | ||||
| Income tax benefit | — | — | ||||||
| Net loss | $ | (12,887 | ) | $ | (8,951 | ) | ||
| Loss per share – basic and diluted | $ | (0.02 | ) | $ | (0.01 | ) | ||
| Weighted average shares outstanding – basic and diluted | 784,279,387 | 700,263,490 | ||||||
| Net loss | $ | (12,887 | ) | $ | (8,951 | ) | ||
| Other comprehensive income/(loss) – Foreign currency translation adjustments, net of tax | 3,559 | (798 | ) | |||||
| Total comprehensive loss | $ | (9,328 | ) | $ | (9,749 | ) | ||
FAQ
What were Mereo BioPharma's (MREO) key financial results for Q1 2025?
What is the status of MREO's Phase 3 Orbit study for setrusumab?
How long will Mereo BioPharma's current cash position last?
What regulatory designation did MREO's alvelestat receive in Q1 2025?
How many shares does Mereo BioPharma (MREO) have outstanding as of Q1 2025?
