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Mereo BioPharma Reports Full Year 2024 Financial Results and Provides Corporate Highlights

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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.

Mereo BioPharma (NASDAQ: MREO) ha riportato i risultati finanziari e gli aggiornamenti aziendali per l'intero anno 2024. Lo studio Orbit di Fase 3 sull'setrusumab per l'osteogenesi imperfetta sta avanzando verso una seconda analisi intermedia prevista per metà 2025. Alvelestat ha ricevuto la Designazione Orfana dalla Commissione Europea per il trattamento della malattia polmonare associata alla carenza di Alfa-1 Antitripsina.

I punti salienti finanziari includono una posizione di cassa di 69,8 milioni di dollari al 31 dicembre 2024, prevista per finanziare le operazioni fino al 2027. Le spese per R&S sono aumentate a 20,9 milioni di dollari rispetto ai 17,4 milioni del 2023, mentre le spese generali e amministrative sono salite a 26,4 milioni di dollari rispetto ai 18,4 milioni. L'azienda ha riportato una perdita netta di 43,3 milioni di dollari per il 2024, rispetto ai 29,5 milioni del 2023.

Due studi globali sono in corso: lo studio Orbit di Fase 3 e lo studio Cosmic, che valutano l'setrusumab nei pazienti con OI. Attività pre-commerciali sono in corso in Europa, con pareri scientifici ottenuti dalla GBA in Germania e dal NICE nel Regno Unito.

Mereo BioPharma (NASDAQ: MREO) informó sus resultados financieros y actualizaciones corporativas para todo el año 2024. El estudio Orbit de Fase 3 sobre setrusumab en osteogénesis imperfecta avanza hacia un segundo análisis intermedio que se espera para mediados de 2025. Alvelestat recibió la Designación de Medicamento Huérfano de la Comisión Europea para el tratamiento de la enfermedad pulmonar asociada a la deficiencia de Alfa-1 Antitripsina.

Los aspectos financieros destacados incluyen una posición de efectivo de 69,8 millones de dólares al 31 de diciembre de 2024, que se espera financie las operaciones hasta 2027. Los gastos en I+D aumentaron a 20,9 millones de dólares desde 17,4 millones en 2023, mientras que los gastos generales y administrativos subieron a 26,4 millones de dólares desde 18,4 millones. La empresa reportó una pérdida neta de 43,3 millones de dólares para 2024, en comparación con 29,5 millones en 2023.

Dos estudios globales están avanzando: el estudio Orbit de Fase 3 y el estudio Cosmic, que evalúan setrusumab en pacientes con OI. Las actividades precomerciales están en curso en Europa, con asesoramiento científico obtenido de la GBA en Alemania y NICE en el Reino Unido.

메레오 바이오파마 (NASDAQ: MREO)는 2024년 전체 재무 결과 및 기업 업데이트를 보고했습니다. 회사의 골형성 부전증에 대한 세트루수맙의 3상 오르빗 연구는 2025년 중반에 예상되는 두 번째 중간 분석을 향해 진행되고 있습니다. 알벨레스타트는 알파-1 항트립신 결핍 관련 폐 질환 치료를 위한 유럽연합 고아약 지정을 받았습니다.

재무 하이라이트에는 2024년 12월 31일 기준 6,980만 달러의 현금 보유액이 포함되어 있으며, 이는 2027년까지 운영 자금을 지원할 것으로 예상됩니다. 연구개발 비용은 2023년 1,740만 달러에서 2,090만 달러로 증가했으며, 일반 및 관리 비용은 1,840만 달러에서 2,640만 달러로 증가했습니다. 회사는 2024년에 4,330만 달러의 순손실을 보고했으며, 이는 2023년의 2,950만 달러와 비교됩니다.

두 개의 글로벌 연구가 진행 중입니다: 3상 오르빗 연구와 OI 환자에서 세트루수맙을 평가하는 코스믹 연구입니다. 유럽에서 상업화 전 활동이 진행 중이며, 독일의 GBA와 영국의 NICE로부터 과학적 조언을 받았습니다.

Mereo BioPharma (NASDAQ: MREO) a publié ses résultats financiers et ses mises à jour d'entreprise pour l'année complète 2024. L'étude Orbit de phase 3 sur le setrusumab dans l'ostéogenèse imparfaite avance vers une seconde analyse intermédiaire prévue pour mi-2025. Alvelestat a reçu la désignation de médicament orphelin de la Commission européenne pour le traitement de la maladie pulmonaire associée à la déficience en alpha-1-antitrypsine.

Les faits saillants financiers incluent une position de trésorerie de 69,8 millions de dollars au 31 décembre 2024, censée financer les opérations jusqu'en 2027. Les dépenses de R&D ont augmenté à 20,9 millions de dollars contre 17,4 millions en 2023, tandis que les dépenses générales et administratives ont augmenté à 26,4 millions de dollars contre 18,4 millions. L'entreprise a rapporté une perte nette de 43,3 millions de dollars pour 2024, contre 29,5 millions en 2023.

Deux études mondiales sont en cours : l'étude Orbit de phase 3 et l'étude Cosmic, qui évaluent le setrusumab chez les patients atteints d'OI. Des activités pré-commerciales sont en cours en Europe, avec des conseils scientifiques obtenus de la GBA en Allemagne et du NICE au Royaume-Uni.

Mereo BioPharma (NASDAQ: MREO) hat seine finanziellen Ergebnisse und Unternehmensaktualisierungen für das gesamte Jahr 2024 veröffentlicht. Die Phase-3-Studie Orbit zum Setrusumab bei Osteogenesis imperfecta schreitet auf eine zweite Zwischenanalyse zu, die für Mitte 2025 erwartet wird. Alvelestat erhielt die Orphan-Designation der Europäischen Kommission für die Behandlung der mit Alpha-1-Antitrypsinmangel assoziierten Lungenerkrankung.

Zu den finanziellen Höhepunkten gehört eine Barmittelposition von 69,8 Millionen Dollar zum 31. Dezember 2024, die voraussichtlich die Betriebe bis 2027 finanzieren wird. Die F&E-Ausgaben stiegen auf 20,9 Millionen Dollar von 17,4 Millionen im Jahr 2023, während die allgemeinen und administrativen Ausgaben auf 26,4 Millionen Dollar von 18,4 Millionen stiegen. Das Unternehmen meldete einen Nettoverlust von 43,3 Millionen Dollar für 2024, verglichen mit 29,5 Millionen Dollar im Jahr 2023.

Zwei globale Studien sind im Gange: die Phase-3-Studie Orbit und die Cosmic-Studie, die Setrusumab bei OI-Patienten bewerten. Vor-kommerzielle Aktivitäten laufen in Europa, mit wissenschaftlichem Rat von der GBA in Deutschland und NICE im Vereinigten Königreich.

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

Insights

Mereo BioPharma's year-end results reveal a company strategically positioning itself ahead of potential value-inflection points in 2025. The most significant near-term catalyst is the setrusumab Phase 3 Orbit study in osteogenesis imperfecta, with a second interim analysis expected mid-2025 and potential final analysis in Q4 2025. This represents a transformative opportunity as positive data could trigger regulatory submissions in both US and EU markets.

The European Commission's Orphan Designation for alvelestat in AATD-LD adds regulatory validation and potential commercial benefits including market exclusivity. This strengthens Mereo's position in ongoing partnership discussions, potentially bringing non-dilutive capital not reflected in current projections.

While the $43.3 million net loss represents a 46.8% increase year-over-year, this reflects strategic investments in pipeline advancement and pre-commercial infrastructure rather than operational inefficiency. The $69.8 million cash position, providing runway into 2027, offers substantial operational flexibility through multiple clinical readouts.

The company's strategic focus on European commercialization of setrusumab, including engagement with key HTA bodies like Germany's GBA and UK's NICE, demonstrates forward-thinking market access planning. This groundwork is critical for successful rare disease drug launches, where pricing and reimbursement negotiations significantly impact commercial potential.

Mereo's financial position presents a nuanced picture that requires careful interpretation. While the $43.3 million net loss exceeds 2023's $29.5 million, this increased spending reflects targeted investments in pipeline advancement. The $20.9 million R&D expense (20.1% YoY increase) shows disciplined capital allocation toward value-creating activities, primarily supporting alvelestat's Phase 3 preparations and setrusumab's European activities.

The $69.8 million cash position (21.6% increase from 2023) provides an extended runway into 2027, significantly de-risking near-term financing concerns. This runway calculation excludes potential partnership revenues from alvelestat, representing an unmodeled upside opportunity.

The $8 million increase in G&A expenses warrants monitoring, though $2.7 million is attributable to necessary pre-commercial activities for setrusumab. The remaining increase stems from corporate expenses including enhanced compliance costs as a US domestic issuer.

For a clinical-stage biotech approaching potential regulatory filings, Mereo demonstrates prudent financial management by maintaining sufficient capital through key inflection points without immediate dilution pressure. The company's strategic retention of European commercialization rights for setrusumab while partnering with Ultragenyx globally balances risk and upside potential, creating a hybrid business model that could deliver significant shareholder value upon successful clinical execution.

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 $69.8 million as of December 31, 2024, expected to fund operations into 2027

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 $3.5 million from $17.4 million in 2023 to $20.9 million in 2024. The increase was primarily due to increases of $6.2 million and $2.6 million in R&D expenses for alvelestat and setrusumab, respectively, partially offset by a $5.5 million decrease in R&D expenses for etigilimab. The increase in program expenses for alvelestat is due to the preparatory work for the Phase 3 study. This principally comprised drug formulation and manufacturing activities, SGRQ validation activities and regulatory interactions. The increase in program expenses for setrusumab was primarily due to higher levels of ongoing activities in Europe, including real-world evidence programs and medical affairs activities, and amounts under the manufacturing and supply agreement with our partner, Ultragenyx, along with input into development, regulatory and manufacturing plans with Ultragenyx, who fund the global development of the program pursuant to our license and collaboration agreement. The reduction in program expenses for etigilimab was primarily due to the winding down and completion of the open label Phase 1b/2 basket study in combination with an anti-PD-1 in a range of tumor types.

General and administrative expenses increased by $8.0 million from $18.4 million in 2023 to $26.4 million in 2024. The increase primarily reflects $2.7 million higher pre-commercial activities to lay the foundation for the commercial launch of setrusumab in Europe, including activities to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe. The remaining increase is driven by additional corporate expenses, including employee-related costs and legal and professional fees in respect of compliance with the U.S. domestic reporting regime, and reductions in reimbursements of certain expenses from our depository in respect of our ADR program and settlement of a claim under our D&O insurance policy in the prior year.

Net loss for the full year ended December 31, 2024 was $43.3 million, compared to $29.5 million during the comparable period in 2023, primarily reflecting an operating loss of $47.4 million, partially offset by interest income and the benefit from R&D tax credits.

As of December 31, 2024, the Company had cash and cash equivalents of $69.8 million, compared to $57.4 million as of December 31, 2023. The Company’s guidance remains unchanged, and it continues to expect, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into 2027. This guidance does not include any potential upfront payments associated with a partnership for alvelestat or business development activity around any of the Company’s non-core programs.

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 $245 million and royalties to Mereo on commercial sales in Ultragenyx territories. Mereo has retained EU and UK commercial rights and will pay Ultragenyx royalties on commercial sales in those territories. Setrusumab has received orphan designation for osteogenesis imperfecta from the European Commission (“EC”) and the FDA, PRIME designation from the EMA, and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received Orphan Designation for AATD from the EC and the FDA, and Fast Track designation from the FDA for AATD-LD. Following results from ASTRAEUS and ATALANTa in AATD-lung disease, the Company has aligned with the FDA and the EMA on the primary endpoints for a Phase 3 pivotal study which, if successful, could enable full approval in both the U.S. and Europe. In addition to the rare disease programs, Mereo has two oncology product candidates, etigilimab, an anti-TIGIT; and navicixizumab for the potential treatment of late-line ovarian cancer. Navicixizumab has been partnered with Feng Biosciences, Inc. in a global licensing agreement that includes milestone payments and royalties. Mereo has also entered into an exclusive global license agreement with ReproNovo SA, a reproductive medicine company, for the development and commercialization of leflutrozole, a non-steroidal aromatase inhibitor.  

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 £0.003 per share; 775,728,034 shares issued at December 31, 2024 (December 31, 2023: 701,217,089).  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?

The second interim analysis is expected mid-2025, with potential final analysis in Q4 2025.

What is MREO's current cash runway based on their 2024 financial results?

The company's $69.8M cash position is expected to fund operations into 2027.

How much did Mereo BioPharma's (MREO) R&D expenses increase in 2024?

R&D expenses increased by $3.5M from $17.4M in 2023 to $20.9M in 2024.

What regulatory designation did MREO's alvelestat receive in Q1 2025?

Alvelestat received Orphan Designation from the European Commission for AATD-LD treatment.

What was Mereo BioPharma's (MREO) net loss for full year 2024?

The company reported a net loss of $43.3M, compared to $29.5M in 2023.
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