Mereo BioPharma Reports Second Quarter 2025 Financial Results and Provides Corporate Highlights
Mereo BioPharma (NASDAQ: MREO) has reported its Q2 2025 financial results and provided corporate updates. The company maintains a strong financial position with $56.1 million in cash as of June 30, 2025, expected to fund operations into 2027. Key highlights include the progression of two Phase 3 studies for setrusumab in osteogenesis imperfecta, with final analyses expected around year-end 2025.
Financial results show R&D expenses increased to $5.4 million in Q2 2025 from $4.9 million in Q2 2024, while G&A expenses decreased to $5.5 million from $7.9 million. The company reported a net loss of $14.6 million for Q2 2025, compared to $12.3 million in Q2 2024. The Orbit study's Data Monitoring Committee confirmed setrusumab's acceptable safety profile, allowing the study to proceed to final analysis.
Mereo BioPharma (NASDAQ: MREO) ha reso noti i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti societari. L'azienda mantiene una solida posizione finanziaria con $56.1 million in cash al 30 giugno 2025, che si prevede finanzierà le operazioni fino al 2027. Tra i punti salienti c'è il progresso di due studi di Fase 3 su setrusumab per l'osteogenesi imperfetta, con le analisi finali attese verso la fine del 2025.
I risultati finanziari mostrano che le spese di R&S sono aumentate a $5.4 million nel secondo trimestre 2025 rispetto a $4.9 million nel Q2 2024, mentre le spese amministrative e generali sono calate a $5.5 million da $7.9 million. La società ha registrato una perdita netta di $14.6 million per il Q2 2025, rispetto a $12.3 million nel Q2 2024. Il comitato di monitoraggio dei dati dello studio Orbit ha confermato un profilo di sicurezza accettabile per setrusumab, consentendo allo studio di procedere all'analisi finale.
Mereo BioPharma (NASDAQ: MREO) ha informado sus resultados financieros del segundo trimestre de 2025 y ofrecido actualizaciones corporativas. La compañía mantiene una posición financiera sólida con $56.1 million in cash al 30 de junio de 2025, que se espera financie las operaciones hasta 2027. Entre los aspectos destacados está el avance de dos ensayos de fase 3 de setrusumab en osteogénesis imperfecta, con los análisis finales previstos hacia finales de 2025.
Los resultados financieros muestran que los gastos de I+D aumentaron a $5.4 million en el Q2 2025 desde $4.9 million en el Q2 2024, mientras que los gastos generales y administrativos disminuyeron a $5.5 million desde $7.9 million. La compañía reportó una pérdida neta de $14.6 million en el Q2 2025, frente a $12.3 million en el Q2 2024. El Comité de Supervisión de Datos del estudio Orbit confirmó un perfil de seguridad aceptable de setrusumab, permitiendo que el estudio avance hacia el análisis final.
Mereo BioPharma (NASDAQ: MREO)는 2025년 2분기 재무실적과 회사 최신 정보를 발표했습니다. 회사는 2025년 6월 30일 기준 $56.1 million in cash의 강한 재무 상태를 유지하고 있으며, 이는 2027년까지 운영자금으로 충분할 것으로 예상됩니다. 주요 내용으로는 골형성부전(osteogenesis imperfecta) 치료제 세트루수맙(setrusumab)의 2건의 3상 시험이 진행 중이며, 최종 분석은 2025년 연말경으로 예상된다는 점이 포함됩니다.
재무 결과에서 연구개발비(R&D)는 2024년 2분기 $4.9 million에서 2025년 2분기 $5.4 million으로 증가했고, 관리비 및 일반비는 $7.9 million에서 $5.5 million으로 감소했습니다. 회사는 2025년 2분기에 $14.6 million의 순손실을 기록했으며, 이는 2024년 2분기의 $12.3 million과 비교됩니다. Orbit 연구의 데이터 모니터링 위원회(DMC)는 세트루수맙의 허용 가능한 안전성 프로필을 확인해 해당 연구가 최종 분석 단계로 진행될 수 있도록 했습니다.
Mereo BioPharma (NASDAQ: MREO) a publié ses résultats financiers du deuxième trimestre 2025 et fourni des mises à jour d'entreprise. La société dispose d'une solide position financière avec $56.1 million in cash au 30 juin 2025, qui devrait financer ses opérations jusqu'en 2027. Parmi les points clés figure la progression de deux essais de phase 3 pour le setrusumab dans l'ostéogenèse imparfaite, avec des analyses finales attendues vers la fin de 2025.
Les résultats financiers montrent que les dépenses de R&D sont passées à $5.4 million au T2 2025 contre $4.9 million au T2 2024, tandis que les frais généraux et administratifs ont diminué à $5.5 million contre $7.9 million. La société a enregistré une perte nette de $14.6 million pour le T2 2025, contre $12.3 million au T2 2024. Le comité de surveillance des données (Data Monitoring Committee) de l'étude Orbit a confirmé un profil de sécurité acceptable pour le setrusumab, permettant à l'étude d'aller à l'analyse finale.
Mereo BioPharma (NASDAQ: MREO) hat seine Finanzergebnisse für Q2 2025 veröffentlicht und Unternehmensupdates bereitgestellt. Das Unternehmen verfügt über eine starke finanzielle Lage mit $56.1 million in cash zum 30. Juni 2025, die voraussichtlich die Geschäftstätigkeit bis ins Jahr 2027 finanzieren wird. Zu den wichtigsten Punkten gehört der Fortschritt von zwei Phase‑3‑Studien zu setrusumab bei Osteogenesis imperfecta; die Abschlussanalysen werden gegen Ende 2025 erwartet.
Die Finanzergebnisse zeigen, dass die F&E‑Aufwendungen im Q2 2025 auf $5.4 million gestiegen sind (vorher $4.9 million im Q2 2024), während Verwaltungs‑ und Allgemeinkosten auf $5.5 million gesunken sind (vorher $7.9 million). Das Unternehmen verzeichnete im Q2 2025 einen Nettoverlust von $14.6 million gegenüber $12.3 million im Q2 2024. Das Data Monitoring Committee der Orbit‑Studie bestätigte ein akzeptables Sicherheitsprofil von setrusumab, sodass die Studie zur Abschlussanalyse übergehen kann.
- None.
- Net loss increased to $14.6M from $12.3M year-over-year
- R&D expenses increased by $0.4M compared to Q2 2024
- Significant foreign currency transaction loss of $5.4M
Insights
Mereo's Phase 3 setrusumab trials continue with positive safety profile and final readouts expected by year-end, with $56.1M cash runway into 2027.
Mereo BioPharma's second quarter results highlight continued progress in their rare disease pipeline with two critical Phase 3 readouts approaching. The company's lead asset setrusumab for osteogenesis imperfecta (OI) – a rare genetic bone disorder – recently passed a key safety review by the Data Monitoring Committee for the Phase 3 Orbit study, allowing the trial to proceed to final analysis. This positive safety signal is encouraging, though efficacy data remains pending.
Both the Orbit trial (in pediatric/young adult patients) and the Cosmic trial (in young pediatric patients) are approaching final analyses around year-end 2025, representing potential inflection points for Mereo. The statistical threshold for success has been set at p<0.04 for Orbit and p<0.05 for Cosmic, standard benchmarks that suggest the company is pursuing robust efficacy demonstrations.
While Ultragenyx leads global development, Mereo retains European commercial rights and is wisely laying groundwork through the SATURN program to collect natural history data and build health economic models – essential components for European regulatory approval and reimbursement discussions.
For alvelestat, their AATD-lung disease candidate, Mereo continues partnership discussions while preparing for Phase 3. The company has strategically reduced spending on this program (
With
Mereo shows disciplined financial management with $56.1M runway into 2027, though Q2 net loss widened to $14.6M despite reduced G&A expenses.
Mereo's financial position demonstrates careful capital stewardship with
The quarter's financial results show mixed signals. R&D expenses increased moderately by
Notably, the company achieved significant G&A expense reduction of
Cash burn appears manageable, with a
Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta expected around year-end 2025
Cash of
LONDON, Aug. 12, 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 second quarter ended June 30, 2025, and provided recent corporate highlights.
“We look forward to the final analysis for the two ongoing Phase 3 studies for setrusumab in osteogenesis imperfecta, the Phase 3 Orbit study in pediatric and young adult patients, and the Phase 3 Cosmic study in young pediatric patients, around the end of the year. We continue to be excited about the potential of setrusumab to reduce fractures and improve other functional parameters for individuals living with osteogenesis imperfecta,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “In parallel with the advancement of setrusumab, we are continuing to advance partnering discussions around alvelestat, our first-in-class oral small molecule for AATD-lung disease, and to ready the program for Phase 3 initiation. Our prudent management of our cash and resources means we are well positioned through these key milestones to support our operations into 2027.”
Second 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 their final analyses around the end of 2025. The randomized, placebo-controlled Phase 3 portion of the Orbit study was evaluated by the Data Monitoring Committee at an interim analysis in July 2025 and they informed Ultragenyx that setrusumab demonstrated an acceptable safety profile and that the study should continue to the final analysis. Data from the Cosmic study were not analyzed at the interim timepoint, consistent with the statistical analysis plan.
- Patients will continue dosing in both the Phase 3 Orbit and Cosmic studies, with the final analyses to be conducted after patients have been on therapy for at least 18-months. The threshold for the Phase 3 Orbit final analysis is p<0.04 and 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, working with existing OI datasets to better understand the natural history and the unmet medical need in pediatrics and adults and to generate data to support the health economic model, both important to support the assessment by Regulatory and Health Technology Assessment (HTA) bodies and payors. In addition, the activities to define the treatment landscape, including the number of treatment centers and the patient journey from childhood to adulthood, are being extended beyond the five major countries in Europe.
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.
Second 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 second quarter ended June 30, 2025 was
As of June 30, 2025, the Company had cash and cash equivalents of
Total ordinary shares issued as of June 30, 2025, were 795,001,444. Total ADS equivalents as of June 30, 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 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) (Unaudited) | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 56,125 | $ | 69,802 | ||||
| Prepaid expenses and other current assets | 2,545 | 2,175 | ||||||
| Research and development incentives receivables | 2,751 | 2,786 | ||||||
| Total current assets | 61,421 | 74,763 | ||||||
| Property and equipment, net | 218 | 257 | ||||||
| Operating lease right-of-use assets, net | 522 | 727 | ||||||
| Intangible assets, net | 470 | 643 | ||||||
| Total assets | $ | 62,631 | $ | 76,390 | ||||
| Liabilities | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,138 | $ | 2,440 | ||||
| Accrued expenses | 5,041 | 4,071 | ||||||
| Convertible loan notes – current | — | 5,535 | ||||||
| Operating lease liabilities – current | 601 | 707 | ||||||
| Other current liabilities | 777 | 1,095 | ||||||
| Total current liabilities | 7,557 | 13,848 | ||||||
| Warrant liabilities – non-current | 545 | 821 | ||||||
| Operating lease liabilities – non-current | — | 187 | ||||||
| Other non-current liabilities | 352 | 565 | ||||||
| Total liabilities | $ | 8,454 | $ | 15,421 | ||||
| Shareholders’ Equity | ||||||||
| Ordinary shares, par value | $ | 3,132 | $ | 3,059 | ||||
| Additional paid-in capital | 546,331 | 539,642 | ||||||
| Accumulated deficit | (486,643 | ) | (462,883 | ) | ||||
| Accumulated other comprehensive loss | (8,643 | ) | (18,849 | ) | ||||
| Total shareholders’ equity | 54,177 | 60,969 | ||||||
| Total liabilities and shareholders’ equity | $ | 62,631 | $ | 76,390 | ||||
| MEREO BIOPHARMA GROUP PLC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | 500 | $ | — | $ | 500 | $ | — | ||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenue | (132 | ) | — | (132 | ) | — | ||||||||||
| Research and development | (5,373 | ) | (4,946 | ) | (9,303 | ) | (8,939 | ) | ||||||||
| General and administrative | (5,494 | ) | (7,868 | ) | (12,766 | ) | (13,777 | ) | ||||||||
| Loss from operations | (10,499 | ) | (12,814 | ) | (21,701 | ) | (22,716 | ) | ||||||||
| Other income/(expenses) | ||||||||||||||||
| Interest income | 589 | 559 | 1,248 | 1,175 | ||||||||||||
| Interest expense | (24 | ) | (331 | ) | (204 | ) | (641 | ) | ||||||||
| Changes in the fair value of warrants | (101 | ) | (69 | ) | 315 | (517 | ) | |||||||||
| Foreign currency transaction (loss)/gain, net | (5,326 | ) | 31 | (8,091 | ) | 644 | ||||||||||
| Benefit from research and development tax credit | 745 | 369 | 930 | 847 | ||||||||||||
| Net loss before income tax | (14,616 | ) | (12,255 | ) | (27,503 | ) | (21,208 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net loss | $ | (14,616 | ) | $ | (12,255 | ) | $ | (27,503 | ) | $ | (21,208 | ) | ||||
| Loss per share – basic and diluted | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.03 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 799,435,329 | 711,770,804 | 794,022,295 | 706,407,371 | ||||||||||||
| Net loss | $ | (14,616 | ) | $ | (12,255 | ) | $ | (27,503 | ) | $ | (21,208 | ) | ||||
| Other comprehensive income/(loss) – Foreign currency translation adjustments, net of tax | 6,647 | 5 | 10,206 | (793 | ) | |||||||||||
| Total comprehensive loss | $ | (7,969 | ) | $ | (12,250 | ) | $ | (17,297 | ) | $ | (22,001 | ) | ||||
FAQ
What were Mereo BioPharma's (MREO) key financial results for Q2 2025?
When will Mereo BioPharma's Phase 3 setrusumab trial results be available?
How long can Mereo BioPharma fund its operations with current cash?
What was the outcome of the interim analysis for MREO's Orbit study?
What are Mereo BioPharma's plans for alvelestat?
