Curis Provides Third Quarter 2024 Business Update
Curis Inc (NASDAQ: CRIS) reported Q3 2024 financial results with a net loss of $10.1 million ($1.70 per share), compared to $12.2 million in Q3 2023. Revenues were $2.9 million, primarily from Erivedge® royalties. The company completed a registered direct offering with net proceeds of $10.8 million. Clinical progress includes promising data from the TakeAim Lymphoma study, showing 3 complete responses and 1 unconfirmed complete response in PCNSL patients. Cash position stands at $31.6 million, expected to fund operations into mid-2025.
Curis Inc (NASDAQ: CRIS) ha riportato i risultati finanziari per il terzo trimestre del 2024, evidenziando una perdita netta di 10,1 milioni di dollari (1,70 dollari per azione), rispetto ai 12,2 milioni di dollari del terzo trimestre del 2023. I ricavi ammontano a 2,9 milioni di dollari, principalmente provenienti da royalties di Erivedge®. L'azienda ha completato un'offerta diretta registrata con un provento netto di 10,8 milioni di dollari. I progressi clinici includono dati promettenti dallo studio TakeAim Lymphoma, che mostrano 3 risposte complete e 1 risposta completa non confermata nei pazienti affetti da PCNSL. La posizione di cassa ammonta a 31,6 milioni di dollari, prevista per finanziare le operazioni fino a metà 2025.
Curis Inc (NASDAQ: CRIS) informó los resultados financieros del tercer trimestre de 2024, destacando una pérdida neta de 10,1 millones de dólares (1,70 dólares por acción), en comparación con los 12,2 millones de dólares en el tercer trimestre de 2023. Los ingresos fueron de 2,9 millones de dólares, procedentes principalmente de regalías de Erivedge®. La compañía completó una oferta directa registrada con un ingreso neto de 10,8 millones de dólares. El progreso clínico incluye datos prometedores del estudio TakeAim Lymphoma, mostrando 3 respuestas completas y 1 respuesta completa no confirmada en pacientes con PCNSL. La posición de efectivo se sitúa en 31,6 millones de dólares, que se espera financie las operaciones hasta mediados de 2025.
Curis Inc (NASDAQ: CRIS)는 2024년 3분기 재무 결과를 발표하며 net loss 10.1 million 달러 (주당 1.70 달러)의 손실을 기록했다고 밝혔으며 이는 2023년 3분기 12.2 million 달러와 비교된다. 수익은 2.9 million 달러로, 주로 Erivedge®의 로열티로부터 발생했다. 회사는 순수익 10.8 million 달러의 등록된 직접 제공을 완료했다. 임상적 진행 상황으로는 TakeAim 림프종 연구의 유망한 데이터가 포함되어 있으며, 이는 PCNSL 환자에서 3개의 완전 반응과 1개의 확인되지 않은 완전 반응을 보여준다. 현금 보유액은 31.6 million 달러로, 2025년 중반까지 운영을 지원할 것으로 예상된다.
Curis Inc (NASDAQ: CRIS) a rapporté les résultats financiers du troisième trimestre 2024, faisant état d'une perte nette de 10,1 millions de dollars (1,70 dollar par action), contre 12,2 millions de dollars au troisième trimestre 2023. Les revenus s'élevaient à 2,9 millions de dollars, principalement issus des redevances d'Erivedge®. La société a complété une offre directe enregistrée avec un produit net de 10,8 millions de dollars. Les progrès cliniques incluent des données prometteuses de l'étude TakeAim sur le lymphome, montrant 3 réponses complètes et 1 réponse complète non confirmée chez des patients atteints de PCNSL. La position de trésorerie s'élève à 31,6 millions de dollars, prévue pour financer les opérations jusqu'à la mi-2025.
Curis Inc (NASDAQ: CRIS) veröffentlichte die finanziellen Ergebnisse für das dritte Quartal 2024 und berichtete von einem Nettoverlust von 10,1 Millionen Dollar (1,70 Dollar pro Aktie), verglichen mit 12,2 Millionen Dollar im dritten Quartal 2023. Die Einnahmen betrugen 2,9 Millionen Dollar, hauptsächlich aus Lizenzgebühren für Erivedge®. Das Unternehmen schloss eine registrierte Direktplatzierung mit Nettoeinnahmen von 10,8 Millionen Dollar ab. Der klinische Fortschritt umfasst vielversprechende Daten aus der TakeAim-Lymphom-Studie, die 3 vollständige Antworten und 1 unbestätigte vollständige Antwort bei PCNSL-Patienten zeigt. Die Liquiditätslage beträgt 31,6 Millionen Dollar, und soll die Betriebstätigkeiten bis Mitte 2025 finanzieren.
- Reduced net loss from $12.2M in Q3 2023 to $10.1M in Q3 2024
- Raised $10.8M through registered direct offering
- Strong clinical results with 4 complete/unconfirmed complete responses in PCNSL patients
- Slight revenue increase to $2.9M from $2.8M year-over-year
- Continuing net losses ($10.1M in Q3 2024)
- Cash runway only extends to mid-2025
- Dependence on external funding as evidenced by recent offering
Insights
The Q3 update reveals noteworthy clinical progress for emavusertib in R/R PCNSL, showing 3 complete responses (CR), 1 unconfirmed CR and 2 partial responses among 10 evaluable patients who previously failed BTK inhibitor therapy. Importantly, 75% of CR/CRu patients maintained responses beyond 6 months, suggesting durability. The upcoming ASH presentations for both AML and MDS indications will be important for understanding the drug's broader potential in blood cancers.
The financial position shows
Management to host conference call today at 8:30 a.m. ET
"We continue to make excellent progress across our clinical programs. We are especially excited about the recent R/R PCNSL data released in September which continue to demonstrate the activity of emavusertib in combination with ibrutinib in salvage-line patients and that the CR/CRu responses appear to be durable," said James Dentzer, Curis Chief Executive Officer. "We are also excited to present additional clinical data in our TakeAim Leukemia study next month at ASH. We believe the positive momentum as we finish the year sets us up well for 2025."
Third Quarter 2024 and Recent Operational Highlights
Emavusertib (IRAK4 Inhibitor)
TakeAim Lymphoma
- In September, at the 3rd Annual IRAK4 Symposium in Cancer, the Company released preliminary efficacy data in 10 response-evaluable patients who had progressed on treatment with a BTKi. The data showed 3 complete responses (CR), 1 unconfirmed complete response (CRu) and 2 partial responses (PR). The duration of response for 3 of the 4 patients with a CR/CRu was greater than 6 months.
- The Company is actively engaged in discussions with regulatory authorities to gain alignment on the registrational path in PCNSL.
TakeAim Leukemia
The Company will have both an oral presentation and a poster presentation at the 66th American Society of Hematology (ASH) annual meeting in December.
- Oral Presentation:
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: New Treatment Approaches for AML
Session Date: Monday, December 9, 2024
Presentation Time: 11:30 AM
Room: Manchester Grand Hyatt San Diego, Grand Hall B
Publication Number: 737
Title: Preliminary Safety, Efficacy, and Molecular Characterization of Emavusertib (CA-4948) in Relapsed/Refractory Acute Myeloid Leukemia Patients
- Poster:
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 8, 2024
Presentation Time: 6:00 PM - 8:00 PM
Location:
Publication Number: 3225
Title: Preliminary Safety, Efficacy and Molecular Characterization in Patients with Higher-Risk Myelodysplastic Syndrome Treated with Single Agent Emavusertib (CA-4948)
Corporate
In October 2024, Curis completed a registered direct offering and concurrent private placement of unregistered warrants ("October 2024 Offerings") with net proceeds of approximately
Third Quarter 2024 Financial Results
For the third quarter of 2024, Curis reported a net loss of
Revenues for the third quarter of 2024 were
Research and development expenses were
General and administrative expenses were
Other income, net was
Including the impact of the October 2024 Offerings, Curis's cash and cash equivalents totaled
Conference Call Information
Curis management will host a conference call today, November 14, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.
To access the live conference call, please dial 800-836-8184 from
About Curis, Inc.
Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the Phase 1/2 TakeAim Leukemia study (CA-4948-102) in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS) with either a FLT3 mutation or a splicing factor mutation (U2AF1 or SF3B2), and as a frontline combination therapy with azacitidine and venetoclax in patents with AML (CA-4948-104). Emavusertib has received Orphan Drug Designation from the
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the
CURIS, INC. | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
(UNAUDITED) | |||||||||||
(In thousands, except share and per share data) | |||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||
Revenues, net | $ | 2,931 | $ | 2,833 | $ | 7,563 | $ | 7,327 | |||
Operating expenses: | |||||||||||
Cost of royalties | 22 | 60 | 81 | 158 | |||||||
Research and development | 9,723 | 10,380 | 29,594 | 29,532 | |||||||
General and administrative | 3,753 | 4,761 | 13,436 | 13,770 | |||||||
Total operating expenses | 13,498 | 15,201 | 43,111 | 43,460 | |||||||
Loss from operations | (10,567) | (12,368) | (35,548) | (36,133) | |||||||
Total other income | 475 | 187 | 1,777 | 432 | |||||||
Net loss | $ | (10,092) | $ | (12,181) | $ | (33,771) | $ | (35,701) | |||
Net loss per common share (basic and diluted) | $ | (1.70) | $ | (2.13) | $ | (5.77) | $ | (6.96) | |||
Weighted average common shares (basic and diluted) | 5,940,924 | 5,720,789 | 5,847,982 | 5,131,904 |
CURIS, INC. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(UNAUDITED) | ||||||||
(In thousands) | ||||||||
September 30, 2024 | December 31, 2023 | |||||||
ASSETS | ||||||||
Cash, cash equivalents and investments | $ | 20,854 | $ | 56,334 | ||||
Restricted cash | 544 | 544 | ||||||
Accounts receivable | 2,978 | 2,794 | ||||||
Prepaid expenses and other assets | 5,408 | 5,138 | ||||||
Property and equipment, net | 246 | 434 | ||||||
Operating lease right-of-use asset | 3,461 | 3,056 | ||||||
Goodwill | 8,982 | 8,982 | ||||||
Total assets | $ | 42,473 | $ | 77,282 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Accounts payable and accrued liabilities | $ | 11,959 | $ | 12,212 | ||||
Operating lease liability | 3,260 | 2,794 | ||||||
Liability related to the sale of future royalties, net | 35,989 | 42,606 | ||||||
Total liabilities | 51,208 | 57,612 | ||||||
Total stockholders' equity (deficit) | (8,735) | 19,670 | ||||||
Total liabilities and stockholders' equity (deficit) | $ | 42,473 | $ | 77,282 |
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SOURCE Curis, Inc.
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