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Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2024

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Centessa Pharmaceuticals (Nasdaq: CNTA) reported its Q4 and full-year 2024 financial results, highlighting progress in its orexin receptor 2 (OX2R) agonist pipeline. The company's lead candidate, ORX750, showed positive Phase 1 results with significant wakefulness increases in sleep-deprived volunteers and is advancing in Phase 2a CRYSTAL-1 study for narcolepsy and idiopathic hypersomnia.

Financial highlights include:

  • Cash position of $482.2M as of December 31, 2024, expected to fund operations into mid-2027
  • Q4 2024 R&D expenses increased to $60.9M (vs $29.7M in Q4 2023)
  • Full-year 2024 net loss of $235.8M (vs $151.1M in 2023)

The company is advancing two additional compounds: ORX142 in IND-enabling studies with clinical data expected in 2025, and ORX489, their most potent OX2R agonist to date, also in IND-enabling studies.

Centessa Pharmaceuticals (Nasdaq: CNTA) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nel suo pipeline di agonisti del recettore dell'orexina 2 (OX2R). Il candidato principale dell'azienda, ORX750, ha mostrato risultati positivi nella Fase 1 con significativi aumenti di vigilanza in volontari privati del sonno e sta avanzando nello studio CRYSTAL-1 di Fase 2a per la narcolessia e l'ipersonnia idiopatica.

I punti salienti finanziari includono:

  • Posizione di cassa di 482,2 milioni di dollari al 31 dicembre 2024, prevista per finanziare le operazioni fino a metà 2027
  • Spese per R&S del quarto trimestre 2024 aumentate a 60,9 milioni di dollari (rispetto ai 29,7 milioni di dollari nel quarto trimestre 2023)
  • Perdita netta per l'intero anno 2024 di 235,8 milioni di dollari (rispetto ai 151,1 milioni di dollari nel 2023)

L'azienda sta facendo progressi con altri due composti: ORX142 in studi di abilitazione IND con dati clinici previsti per il 2025, e ORX489, il loro agonista OX2R più potente fino ad oggi, anch'esso in studi di abilitazione IND.

Centessa Pharmaceuticals (Nasdaq: CNTA) reportó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando el progreso en su pipeline de agonistas del receptor de orexina 2 (OX2R). El candidato principal de la compañía, ORX750, mostró resultados positivos en la Fase 1 con aumentos significativos en la vigilia en voluntarios privados de sueño y está avanzando en el estudio CRYSTAL-1 de Fase 2a para la narcolepsia y la hipersomnia idiopática.

Los aspectos financieros destacados incluyen:

  • Posición de efectivo de 482,2 millones de dólares al 31 de diciembre de 2024, que se espera financie las operaciones hasta mediados de 2027
  • Gastos de I+D del cuarto trimestre de 2024 aumentaron a 60,9 millones de dólares (frente a 29,7 millones de dólares en el cuarto trimestre de 2023)
  • Pérdida neta del año completo 2024 de 235,8 millones de dólares (frente a 151,1 millones de dólares en 2023)

La compañía está avanzando con otros dos compuestos: ORX142 en estudios de habilitación IND con datos clínicos esperados para 2025, y ORX489, su agonista OX2R más potente hasta la fecha, también en estudios de habilitación IND.

Centessa Pharmaceuticals (Nasdaq: CNTA)는 2024년 4분기 및 연간 재무 결과를 보고하며, 오렉신 수용체 2 (OX2R) 작용제 파이프라인의 진전을 강조했습니다. 회사의 주요 후보인 ORX750은 수면 부족 자원자에서 유의미한 각성 증가를 보이며 1상 긍정적인 결과를 나타냈고, 현재 기면증 및 특발성 과다수면증을 위한 2a 단계 CRYSTAL-1 연구에 진입하고 있습니다.

재무 하이라이트는 다음과 같습니다:

  • 2024년 12월 31일 기준 현금 보유액 4억 8,220만 달러로, 2027년 중반까지 운영 자금을 지원할 것으로 예상됨
  • 2024년 4분기 연구개발 비용이 6,090만 달러로 증가 (2023년 4분기 2,970만 달러 대비)
  • 2024년 전체 순손실 2억 3,580만 달러 (2023년 1억 5,110만 달러 대비)

회사는 두 가지 추가 화합물도 진행 중입니다: ORX142는 IND 승인 연구 중이며 2025년에 임상 데이터가 예상되고, ORX489는 현재까지 가장 강력한 OX2R 작용제이며, 역시 IND 승인 연구 중입니다.

Centessa Pharmaceuticals (Nasdaq: CNTA) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en avant les progrès de son pipeline d'agonistes du récepteur d'orexine 2 (OX2R). Le candidat principal de l'entreprise, ORX750, a montré des résultats positifs lors de la phase 1 avec des augmentations significatives de l'éveil chez des volontaires privés de sommeil et avance dans l'étude CRYSTAL-1 de phase 2a pour la narcolepsie et l'hypersomnie idiopathique.

Les points forts financiers comprennent :

  • Position de trésorerie de 482,2 millions de dollars au 31 décembre 2024, prévue pour financer les opérations jusqu'à mi-2027
  • Dépenses de R&D pour le quatrième trimestre 2024 augmentées à 60,9 millions de dollars (contre 29,7 millions de dollars au quatrième trimestre 2023)
  • Perte nette pour l'année entière 2024 de 235,8 millions de dollars (contre 151,1 millions de dollars en 2023)

L'entreprise fait progresser deux composés supplémentaires : ORX142 dans des études de validation IND avec des données cliniques attendues pour 2025, et ORX489, leur agoniste OX2R le plus puissant à ce jour, également dans des études de validation IND.

Centessa Pharmaceuticals (Nasdaq: CNTA) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seiner Pipeline von Agonisten des Orexin-Rezeptors 2 (OX2R) hervorgehoben. Der Hauptkandidat des Unternehmens, ORX750, zeigte positive Ergebnisse der Phase 1 mit signifikanten Wachsamkeitssteigerungen bei schlafentzugenden Freiwilligen und schreitet im Phase 2a CRYSTAL-1-Studie für Narkolepsie und idiopathische Hypersomnie voran.

Finanzielle Höhepunkte umfassen:

  • Barmittel von 482,2 Millionen USD zum 31. Dezember 2024, die voraussichtlich die Betriebskosten bis Mitte 2027 decken werden
  • Forschung- und Entwicklungskosten im vierten Quartal 2024 stiegen auf 60,9 Millionen USD (im Vergleich zu 29,7 Millionen USD im vierten Quartal 2023)
  • Nettoverlust für das gesamte Jahr 2024 von 235,8 Millionen USD (im Vergleich zu 151,1 Millionen USD im Jahr 2023)

Das Unternehmen entwickelt zwei weitere Verbindungen: ORX142 in IND-fähigen Studien mit klinischen Daten, die für 2025 erwartet werden, und ORX489, deren bisher stärkster OX2R-Agonist ebenfalls in IND-fähigen Studien ist.

Positive
  • Strong cash position of $482.2M providing runway into mid-2027
  • Positive Phase 1 results for ORX750 showing significant efficacy in sleep-deprived volunteers
  • Advancing three potential best-in-class OX2R agonists with multiple data readouts expected in 2025
Negative
  • Net loss increased to $235.8M in 2024 from $151.1M in 2023
  • R&D expenses increased to $150.2M in 2024 from $124.4M in 2023
  • Discontinuation of SerpinPC development program resulting in $31.5M charge

Insights

Centessa's Q4 2024 results reveal a significantly expanded net loss of $111.3 million compared to $36.8 million in Q4 2023, with full-year losses increasing to $235.8 million versus $151.1 million in 2023. This substantial 56% year-over-year deterioration stems largely from two non-recurring items: a $34.1 million loss on debt extinguishment and a $31.5 million charge for discontinuing the SerpinPC hemophilia program.

The company maintains a strong cash position of $482.2 million, providing runway into mid-2027, which offers significant operational flexibility during a period of expanding R&D activities. Quarterly R&D expenses more than doubled to $60.9 million versus $29.7 million in Q4 2023, reflecting increased investment in their orexin receptor agonist platform.

Looking beyond the financial setbacks, Centessa is strategically pivoting toward its OX2R agonist franchise, with three compounds in development. ORX750 is advancing in Phase 2a trials with data expected this year—potentially significant given its reported performance in restoring wakefulness in sleep-deprived volunteers. Early data shows promise at the 5.0 mg dose with 38-minute mean sleep latency versus 15 minutes for placebo, suggesting potential best-in-class efficacy.

The pipeline expansion with ORX142 and ORX489 targeting broader neurological and neuropsychiatric applications represents a calculated expansion beyond sleep disorders. However, investors should note the company's complete pivot away from hemophilia, suggesting a narrowing strategic focus that increases dependency on success in the competitive orexin space.

  • Advancing a broad, potential best-in-class orexin receptor 2 (OX2R) agonist franchise with key data readouts expected in 2025
    • ORX750 Phase 2a CRYSTAL-1 study for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) well underway and on track with data expected across all three indications in 2025 with first-in-class potential in NT2 and IH
    • ORX142 in IND-enabling studies for the treatment of neurological and neurodegenerative disorders; Clinical data in acutely sleep-deprived healthy volunteers planned for 2025
    • ORX489 in IND-enabling studies for the treatment of neuropsychiatric disorders

BOSTON and LONDON, March 24, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and full-year ended December 31, 2024.

“Centessa is proud to be at the forefront of developing OX2R agonists, a groundbreaking new drug class with the potential to transform the standard of care for patients across multiple therapeutic areas,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “Our team’s drug optimization techniques have enabled a growing pipeline of novel, potential best-in-class OX2R agonists aimed at restoring normative wakefulness for individuals living with excessive daytime sleepiness (EDS) in neurological, neurodegenerative and neuropsychiatric disorders, and potentially addressing other key symptoms such as impaired attention, cognitive deficits and fatigue.”

Dr. Saha continued, “Our most advanced OX2R agonist, ORX750, is progressing in the Phase 2a CRYSTAL-1 study for the treatment of NT1, NT2 and IH, and is on track with data expected across all three indications this year. Data from the Phase 1 study of ORX750 showed compelling activity in acutely sleep-deprived healthy volunteers at low doses with a favorable initial safety and tolerability profile. Based on the strength of these data, we believe ORX750 has the potential to be best-in-class and to enable the full range of doses required to meet the needs of patients living with NT1, NT2 and IH. We look forward to sharing data this year and expect the Phase 2a study to enable dose selection for future registrational studies of ORX750.”

Dr. Saha concluded, “In addition to the transformational potential of ORX750 for individuals living with sleep-wake disorders, we see tremendous opportunity with our follow-up OX2R agonists that are being advanced for the treatment of EDS, impaired attention, cognitive deficits and fatigue in neurological, neurodegenerative and neuropsychiatric disorders. ORX142 is progressing in IND-enabling studies, and subject to IND clearance, we expect to initiate clinical development and share clinical data in acutely sleep-deprived healthy volunteers this year. We are also pleased to have ORX489, our most potent OX2R agonist to date based on preclinical data, advancing in IND-enabling studies. With this ongoing momentum across our pipeline, we expect 2025 to be an exciting, data-rich year for Centessa.”

Recent Highlights

  • In January 2025, the Company shared positive data from the Phase 1 clinical study of ORX750, a highly potent and selective OX2R agonist, in healthy volunteers as of December 5, 2024, the most recent data cutoff date. These data showed ORX750 significantly increased wakefulness in acutely sleep-deprived healthy volunteers compared to placebo at all doses tested, with a clear dose response. More specifically, in the 2.5 mg (n=8), 3.5 mg (n=10) and 5.0 mg (n=8) dose cohorts, ORX750 was shown to restore normative wakefulness with mean sleep latencies (MSL) >30 minutes (out of a score of 40 minutes) as measured by the Maintenance of Wakefulness Test (MWT); the 5.0 mg dose cohort achieved an MSL of 38 minutes, compared to 15 minutes for placebo. A favorable safety and tolerability profile was observed with all treatment-emergent adverse events (AEs) being transient with none leading to treatment discontinuation. There were no cases of hepatotoxicity or visual disturbances observed. Additionally, there were no clinically significant treatment-emergent changes in hepatic and renal parameters, vital signs or ECG parameters. These data also showed linear pharmacokinetics (PK) with a profile that supports the use of ORX750 as a once-daily oral dosing regimen with rapid absorption. The Company believes these data continue to support ORX750’s profile as a potential best-in-class OX2R agonist for the treatment of NT1, NT2 and IH, with first-in-class potential in NT2 and IH. Data from the Phase 1 study of ORX750 will be presented in a poster session at the American Academy of Neurology (AAN) Annual Meeting on April 5, 2025.
  • In November 2024, the Company announced the initiation of the Phase 2a CRYSTAL-1 study of ORX750 in participants with NT1, NT2 and IH.

Pipeline and Anticipated Upcoming Milestones

  • ORX750: Phase 2a CRYSTAL-1 study ongoing in participants with NT1, NT2 and IH. The Company expects to share Phase 2a data across all three indications in 2025. In addition, data from the Phase 1 study will be presented in a poster session at the AAN Annual Meeting on April 5, 2025.
  • ORX142: Advancing through IND-enabling studies. The Company is focused on obtaining IND clearance and initiating clinical development with the goal of sharing clinical data in acutely sleep-deprived healthy volunteers in 2025.
  • ORX489: Advancing in IND-enabling studies.

Fourth Quarter and Full-Year 2024 Financial Results

  • Cash, Cash Equivalents and Short-term Investments: Cash, cash equivalents and short-term investments totaled $482.2 million as of December 31, 2024. The Company expects its cash, cash equivalents and short-term investments as of December 31, 2024 will fund operations into mid-2027.
  • Research & Development (R&D) Expenses: R&D expenses were $60.9 million for the fourth quarter ended December 31, 2024, compared to $29.7 million for the fourth quarter ended December 31, 2023, and $150.2 million for the full-year 2024 compared to $124.4 million for the full-year 2023. R&D expenses for the quarter and full-year 2024 included a one-time charge of $31.5 million related to the discontinuation of the global clinical development program for SerpinPC that was being progressed for the treatment of hemophilia B.
  • General & Administrative Expenses: General and administrative expenses were $13.7 million for the fourth quarter ended December 31, 2024, compared to $12.3 million the fourth quarter ended December 31, 2023, and $50.8 million for the full-year 2024 compared to $53.7 million for the full-year 2023.
  • Net Loss Attributable to Ordinary Shareholders (Net loss): Net loss was $111.3 million for the fourth quarter ended December 31, 2024, compared to $36.8 million for the fourth quarter ended December 31, 2023, and $235.8 million for the full-year 2024 compared to $151.1 million for the full-year 2023. Net loss for the quarter and full-year 2024 reflects non-recurring items including a $34.1 million loss on debt extinguishment and a charge of $31.5 million related to the discontinuation of the global clinical development program for SerpinPC which was included in R&D expenses. In addition, net loss for full-year 2023 included a non-recurring non-cash tax benefit of $24.2 million.

About the Phase 2a CRYSTAL-1 Clinical Study of ORX750
The Phase 2a CRYSTAL-1 study is a randomized, double-blind, placebo-controlled, cross-over basket study to evaluate the safety, tolerability, and PK of ORX750 in participants with NT1, NT2 and IH. There are separate cohorts for each indication. Initial dosing is 1.0 mg for NT1 and 2.0 mg for NT2 and IH with sequential dose escalation/de-escalation between cohorts. Each dosing cohort consists of a 6-week treatment duration with crossover study design. During the 6 weeks of treatment, each participant will be randomized to one of two blinded treatment sequences and receive a total of 4 weeks of treatment with ORX750 and 2 weeks of treatment with placebo. Efficacy assessments will evaluate the effect of ORX750 on excessive daytime sleepiness (using the MWT and Epworth Sleepiness Scale (ESS)), cataplexy (NT1 only) and overall symptom improvement (measured by Narcolepsy Severity Scale (NSS) and Idiopathic Hypersomnia Severity Scale (IHSS)). Other exploratory assessments include measures of sleep, cognition, attention, memory and general health.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals, plc is a clinical-stage pharmaceutical company with a mission to discover, develop and ultimately deliver medicines that are transformational for patients. We are pioneering a new class of potential therapies within our orexin receptor 2 (OX2R) agonist program for the treatment of excessive daytime sleepiness (EDS), impaired attention, cognitive deficits and fatigue across neurological, neurodegenerative and neuropsychiatric disorders. We also have an early-stage immuno-oncology program focused on our novel LockBody® technology platform. For more information, visit www.centessa.com, which does not form part of this release.

Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; its expectations for executing on the Company's pipeline; its expectations on its anticipated cash runway; the timing of commencement of new studies or clinical trials or clinical and preclinical data related to ORX750, ORX142, ORX489 and other OX2R agonist molecules, and the LockBody technology platform; its ability to identify, screen, recruit and maintain a sufficient number of or any subjects in its existing and anticipated studies or clinical trials of ORX750, ORX142, ORX489 and other OX2R agonist molecules, and any LockBody candidates; its expectations on executing its research and clinical development plans and the timing thereof; its expectations as to the potential results and impact of each of its clinical programs and trials; the Company’s ability to differentiate ORX750, ORX142, ORX489 and other OX2R agonist molecules, any LockBody candidates from other treatment options; the development, design and therapeutic potential of ORX750, ORX142, ORX489 and other OX2R agonist molecules, and the LockBody technology platform; the anticipated net savings associated with the discontinuation of the SerpinPC program; and regulatory matters, including the timing and likelihood of success of obtaining regulatory clearance, obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates, assumptions and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of our product candidates; our ability to identify, screen and recruit a sufficient number of or any subjects in our existing and anticipated new studies or clinical trials of ORX750, ORX142, ORX489 or within anticipated timelines; our expectations relating to the clinical trials of ORX750, including the predicted timing of enrollment, the predicted efficacious doses of ORX750 and our ability to successfully conduct our clinical development of ORX750, our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oxford Finance, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; our operating costs and use of cash, including cash runway, cost of development activities and conducting clinical trials, future expenditures risks; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the historical results of preclinical studies or clinical studies will not be predictive of future results in ongoing or future studies; economic risks to the United States and United Kingdom banking systems; and geo-political risks such as the Russia-Ukraine war or the Middle East conflicts. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com



Centessa Pharmaceuticals plc
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(amounts in thousands except share and per share data)
         
  Quarter Ended
December 31, 2024
 Quarter Ended
December 31, 2023
 Year Ended
December 31, 2024
 Year Ended
December 31, 2023
License and other revenue $  $6,853  $  $6,853 
Operating expenses:        
Research and development  60,874   29,716   150,244   124,405 
General and administrative  13,706   12,315   50,811   53,731 
Loss from operations  (74,580)  (35,178)  (201,055)  (171,283)
Interest income  4,845   2,933   14,016   10,476 
Interest expense  (2,479)  (2,570)  (10,090)  (9,906)
Loss on extinguishment of debt  (34,097)     (34,097)   
Other non-operating expenses, net  (3,968)  (878)  (1,687)  (5,428)
Loss before income taxes  (110,279)  (35,693)  (232,913)  (176,141)
Income tax expense (benefit)  1,050   1,144   2,844   (25,056)
Net loss  (111,329)  (36,837)  (235,757)  (151,085)
         
Other comprehensive income:        
Foreign currency translation adjustment  1,721   459   1,223   1,700 
Unrealized gain on available for sale securities, net of tax  397   255   1,497   1,290 
Other comprehensive income  2,118   714   2,720   2,990 
         
Total comprehensive loss $(109,211) $(36,123) $(233,037) $(148,095)
         
Net loss per ordinary share - basic and diluted $(0.84) $(0.38) $(2.06) $(1.57)
Weighted average ordinary shares outstanding - basic and diluted  132,050,271   97,923,585   114,473,449   96,177,578 
                 



Centessa Pharmaceuticals plc
Condensed Consolidated Balance Sheets
(unaudited)
(amounts in thousands)
    
 December 31, 2024 December 31, 2023
Total assets:   
Cash and cash equivalents$383,221 $128,030
Short-term investments 98,956  128,519
Other assets 94,621  103,697
Total assets$576,798 $360,246
    
Total liabilities   
Other liabilities$66,313 $48,302
Long term debt 108,940  75,700
Total liabilities 175,253  124,002
    
Total shareholders’ equity 401,545  236,244
Total liabilities and shareholders' equity$576,798 $360,246

FAQ

What were the key Phase 1 results for Centessa's (CNTA) ORX750 drug candidate?

ORX750 showed significant wakefulness increases at all doses tested (2.5mg, 3.5mg, 5.0mg), with mean sleep latencies >30 minutes. The 5.0mg dose achieved 38 minutes vs 15 minutes for placebo, with favorable safety and no hepatotoxicity.

How much cash does Centessa (CNTA) have and how long will it last?

Centessa has $482.2M in cash, cash equivalents, and short-term investments as of December 31, 2024, expected to fund operations into mid-2027.

What caused Centessa's (CNTA) increased net loss in 2024?

The $235.8M net loss included a $34.1M loss on debt extinguishment and a $31.5M charge from discontinuing SerpinPC development program.

When will Centessa (CNTA) report Phase 2a CRYSTAL-1 study results for ORX750?

Centessa expects to share Phase 2a data for ORX750 across all three indications (NT1, NT2, and IH) in 2025.
Centessa Pharmaceuticals Plc

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