Mereo BioPharma Reports Full Year 2024 Financial Results and Provides Corporate Highlights
Rhea-AI Summary
Mereo BioPharma (NASDAQ: MREO) reported its full year 2024 financial results and corporate updates. The company's Phase 3 Orbit study of setrusumab in osteogenesis imperfecta is advancing toward a second interim analysis expected mid-2025. Alvelestat received European Commission Orphan Designation for Alpha-1 Antitrypsin Deficiency-associated Lung Disease treatment.
Financial highlights include cash position of $69.8 million as of December 31, 2024, expected to fund operations into 2027. R&D expenses increased to $20.9 million from $17.4 million in 2023, while general and administrative expenses rose to $26.4 million from $18.4 million. The company reported a net loss of $43.3 million for 2024, compared to $29.5 million in 2023.
Two global studies are progressing: the Phase 3 Orbit study and Cosmic study, evaluating setrusumab in OI patients. Pre-commercial activities are ongoing in Europe, with scientific advice obtained from GBA in Germany and NICE in the U.K.
Positive
- Strong cash position of $69.8M expected to fund operations into 2027
- Alvelestat received European Commission Orphan Designation
- Phase 3 Orbit study progressing with key readouts expected in 2025
- Pre-commercial activities advancing in Europe for potential setrusumab launch
Negative
- Net loss increased to $43.3M from $29.5M in 2023
- R&D expenses increased by $3.5M to $20.9M
- General and administrative expenses rose by $8.0M to $26.4M
News Market Reaction
On the day this news was published, MREO gained 0.85%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Orbit Phase 3 study of setrusumab in osteogenesis imperfecta progressing toward second interim analysis, expected mid-2025
Alvelestat granted Orphan Designation by the European Commission for treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD)
Cash of
LONDON, March 26, 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 full year ended December 31, 2024, and provided recent corporate highlights.
“2024 was a year of focused execution and strategic advancement at Mereo, driving our lead programs closer to key milestones," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "The Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) is set to read out at the upcoming second interim analysis mid-year or at the final analysis during the fourth quarter of 2025. This could set the stage for us, alongside our partner Ultragenyx, to file for regulatory approvals in the U.S. and EU. Our European pre-commercial activities are ongoing, where we are focused on laying the foundation for a successful and efficient commercial launch, following potential regulatory approval. On alvelestat, the recent receipt of European Orphan Designation and the Phase 3 readiness activities have been highly supportive for our ongoing partnering process. With a strong financial position, we look forward to a transformative 2025, focused on bringing life-changing therapies to patients with rare diseases.”
2024 Highlights, Recent Developments, and 2025 Anticipated Milestones
Setrusumab (UX143)
- Continued progress in two global studies, the Phase 3 portion of Orbit (Phase 2/3) and Cosmic (Phase 3), of setrusumab in OI patients, led by our partner Ultragenyx.
- The Phase 3 portion of the Orbit Study is continuing to dose pediatric and young adult patients, with the second interim analysis expected mid-2025 and potential final analysis in the fourth quarter of 2025.
- Treatment is ongoing in the open-label Phase 3 Cosmic study evaluating setrusumab against intravenous bisphosphonate therapy in patients aged 2 to <7 years. Data from this study will be evaluated in parallel with the interim or final analysis from the Orbit study.
- Pre-commercial activities to lay the foundation for launch ongoing.
- Scientific advice obtained from GBA in Germany and NICE in the U.K.
- Progress on project SATURN with existing registries that are appropriate sources of data on the natural history of OI and longitudinal data with the standard-of-care.
Alvelestat (MPH-966)
- In the first quarter of 2025, the European Commission granted Orphan Designation to alvelestat for the treatment of AATD-LD. This designation followed a positive recommendation from the EMA Committee for Orphan Medicinal Products in January 2025.
- Alvelestat previously received Orphan Drug Designation and Fast Track Designation from the U.S. FDA in 2021 and 2022, respectively.
- The Company remains in discussion with multiple potential partners for the development and commercialization of alvelestat.
Full Year 2024 Financial Results
Total research and development (“R&D”) expenses increased by
General and administrative expenses increased by
Net loss for the full year ended December 31, 2024 was
As of December 31, 2024, the Company had cash and cash equivalents of
Total ordinary shares issued as of December 31, 2024 were 775,728,034. Total ADS equivalents as of December 31, 2024 were 155,145,606, 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 | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except per share amounts) | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,802 | $ | 57,421 | ||||
| Prepaid expenses and other current assets | 2,175 | 5,156 | ||||||
| Research and development incentives receivables | 2,786 | 1,183 | ||||||
| Total current assets | 74,763 | 63,760 | ||||||
| Property and equipment, net | 257 | 405 | ||||||
| Operating lease right-of-use assets, net | 727 | 1,245 | ||||||
| Intangible assets, net | 643 | 1,089 | ||||||
| Total assets | $ | 76,390 | $ | 66,499 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,440 | $ | 2,346 | ||||
| Accrued expenses | 4,071 | 5,467 | ||||||
| Convertible loan notes – current | 5,535 | — | ||||||
| Operating lease liabilities – current | 707 | 652 | ||||||
| Other current liabilities | 1,095 | 1,021 | ||||||
| Total current liabilities | 13,848 | 9,486 | ||||||
| Convertible loan notes – non-current | — | 4,394 | ||||||
| Warrant liabilities – non-current | 821 | 412 | ||||||
| Operating lease liabilities – non-current | 187 | 906 | ||||||
| Other non-current liabilities | 565 | 764 | ||||||
| Total liabilities | $ | 15,421 | $ | 15,962 | ||||
| Commitments and contingencies (Note 17) | ||||||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value | 3,059 | 2,775 | ||||||
| Treasury shares | — | (1,230 | ) | |||||
| Additional paid-in capital | 539,642 | 486,107 | ||||||
| Accumulated deficit | (462,883 | ) | (419,630 | ) | ||||
| Accumulated other comprehensive loss | (18,849 | ) | (17,485 | ) | ||||
| Total shareholders’ equity | 60,969 | 50,537 | ||||||
| Total liabilities and shareholders’ equity | $ | 76,390 | $ | 66,499 | ||||
| MEREO BIOPHARMA GROUP PLC | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands, except per share amounts) | ||||||||
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | $ | — | $ | 10,000 | ||||
| Operating expenses: | ||||||||
| Cost of revenue | — | (2,574 | ) | |||||
| Research and development | (20,930 | ) | (17,418 | ) | ||||
| General and administrative | (26,434 | ) | (18,424 | ) | ||||
| Loss from operations | (47,364 | ) | (28,416 | ) | ||||
| Other income/(expenses) | ||||||||
| Interest income | 3,041 | 2,131 | ||||||
| Interest expense | (1,370 | ) | (2,881 | ) | ||||
| Changes in the fair value of warrants | (419 | ) | 245 | |||||
| Foreign currency transaction gain/(loss), net | 1,210 | (2,347 | ) | |||||
| Other expenses, net | — | (10 | ) | |||||
| Benefit from research and development tax credit | 1,649 | 1,280 | ||||||
| Net loss before income tax | (43,253 | ) | (29,998 | ) | ||||
| Income tax benefit | — | 532 | ||||||
| Net loss | $ | (43,253 | ) | $ | (29,466 | ) | ||
| Loss per share – basic and diluted | $ | (0.06 | ) | $ | (0.04 | ) | ||
| Weighted average shares outstanding – basic and diluted | 739,624,264 | 659,453,921 | ||||||
| Net loss | $ | (43,253 | ) | $ | (29,466 | ) | ||
| Other comprehensive (loss)/income – Foreign currency translation adjustments, net of tax | (1,364 | ) | 4,202 | |||||
| Total comprehensive loss | $ | (44,617 | ) | $ | (25,264 | ) | ||
FAQ
When is Mereo BioPharma's (MREO) setrusumab Phase 3 Orbit study expected to report results?
What is MREO's current cash runway based on their 2024 financial results?
How much did Mereo BioPharma's (MREO) R&D expenses increase in 2024?
What regulatory designation did MREO's alvelestat receive in Q1 2025?
What was Mereo BioPharma's (MREO) net loss for full year 2024?
