Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results
Corvus Pharmaceuticals provided Q3 2024 updates on its clinical programs. The company is advancing two clinical trials for soquelitinib: a Phase 3 trial in Peripheral T Cell Lymphoma (PTCL) and a Phase 1 trial in atopic dermatitis, with interim data expected in December 2024. Financial highlights include cash position of $41.7M as of September 30, 2024, with an additional $5.9M from warrant exercises in October. Q3 net loss was $40.2M, including a $32.8M non-cash warrant liability loss. R&D expenses increased to $5.2M from $4.0M year-over-year. The company expects current cash to fund operations into 2026.
Corvus Pharmaceuticals ha fornito aggiornamenti sul terzo trimestre del 2024 riguardanti i suoi programmi clinici. L'azienda sta avanzando in due trial clinici per soquelitinib: uno studio di Fase 3 nel Linfoma T Periferico (PTCL) e uno studio di Fase 1 nella dermatite atopica, con dati provvisori attesi per dicembre 2024. I risultati finanziari includono una posizione di cassa di $41,7 milioni al 30 settembre 2024, con ulteriori $5,9 milioni derivanti dall'esercizio di warrant in ottobre. La perdita netta del terzo trimestre è stata di $40,2 milioni, inclusa una perdita di $32,8 milioni legata a passività di warrant non monetarie. Le spese per Ricerca e Sviluppo sono aumentate a $5,2 milioni rispetto ai $4,0 milioni dell'anno precedente. L'azienda prevede che l'attuale liquidità finanzierà le operazioni fino al 2026.
Corvus Pharmaceuticals proporcionó actualizaciones del tercer trimestre de 2024 sobre sus programas clínicos. La compañía está avanzando en dos ensayos clínicos para soquelitinib: un ensayo de Fase 3 en Linfoma T Periférico (PTCL) y un ensayo de Fase 1 en dermatitis atópica, con datos provisionales esperados para diciembre de 2024. Los destacados financieros incluyen una posición de efectivo de $41,7 millones al 30 de septiembre de 2024, con $5,9 millones adicionales provenientes del ejercicio de garantías en octubre. La pérdida neta del tercer trimestre fue de $40,2 millones, incluyendo una pérdida de pasivo de garantía no monetaria de $32,8 millones. Los gastos de I+D aumentaron a $5,2 millones en comparación con $4,0 millones del año anterior. La compañía espera que el efectivo actual financie las operaciones hasta 2026.
Corvus Pharmaceuticals는 2024년 3분기 임상 프로그램에 대한 업데이트를 제공했습니다. 이 회사는 소퀄리티닙에 대해 두 가지 임상 시험을 진행 중입니다: 말초 T 세포 림프종(PTCL)에 대한 3상 시험과 아토피성 피부염에 대한 1상 시험이며, 중간 데이터는 2024년 12월에 공개될 예정입니다. 재무 하이라이트로는 2024년 9월 30일 기준 현금 보유액이 4,170만 달러이며, 10월에 발행된 워런트 행사로 추가로 590만 달러가 있습니다. 3분기 순손실은 4,020만 달러로, 이 중 3,280만 달러는 비현금 워런트 부채 손실입니다. 연구개발비는 연간 기준 400만 달러에서 520만 달러로 증가했습니다. 이 회사는 현재의 현금이 2026년까지 운영 자금을 지원할 것으로 예상하고 있습니다.
Corvus Pharmaceuticals a fourni des mises à jour pour le troisième trimestre 2024 concernant ses programmes cliniques. L'entreprise avance dans deux essais cliniques pour le soquelitinib : un essai de phase 3 dans le lymphome T périphérique (PTCL) et un essai de phase 1 dans la dermatite atopique, avec des données intermédiaires attendues pour décembre 2024. Les points forts financiers incluent une position de trésorerie de 41,7 millions de dollars au 30 septembre 2024, avec des fonds supplémentaires de 5,9 millions de dollars provenant de l'exercice de warrants en octobre. La perte nette du troisième trimestre était de 40,2 millions de dollars, y compris une perte de 32,8 millions de dollars liée à des passifs de warrants non monétaires. Les dépenses en R&D ont augmenté à 5,2 millions de dollars contre 4,0 millions de dollars l'année précédente. L'entreprise s'attend à ce que la trésorerie actuelle finance ses opérations jusqu'en 2026.
Corvus Pharmaceuticals hat Aktualisierungen zum dritten Quartal 2024 zu seinen klinischen Programmen bereitgestellt. Das Unternehmen arbeitet an zwei klinischen Studien für Soquelitinib: einer Phase-3-Studie bei peripherem T-Zell-Lymphom (PTCL) und einer Phase-1-Studie bei atopischer Dermatitis, wobei Zwischenberichte im Dezember 2024 erwartet werden. Zu den finanziellen Eckdaten gehört eine liquide Mittelposition von 41,7 Millionen USD zum 30. September 2024, einschließlich weiterer 5,9 Millionen USD aus der Ausübung von Warrants im Oktober. Der Nettverlust im dritten Quartal betrug 40,2 Millionen USD, einschließlich eines Verlusts von 32,8 Millionen USD aus nicht zahlungswirksamen Warrants. Die F&E-Ausgaben stiegen im Jahresvergleich von 4,0 Millionen USD auf 5,2 Millionen USD. Das Unternehmen geht davon aus, dass das aktuelle Bargeld die Operationen bis 2026 finanzieren wird.
- Strong cash position of $41.7M with additional $5.9M from warrant exercises
- Cash runway extended into 2026
- FDA granted Orphan Drug Designation and Fast Track designation for soquelitinib in T cell lymphoma
- Net loss increased to $40.2M in Q3 2024 from $6.0M in Q3 2023
- R&D expenses increased 30% year-over-year to $5.2M
- $32.8M non-cash loss from warrant liability due to stock price increase
Insights
The Q3 2024 results reveal significant financial developments for Corvus Pharmaceuticals. The company maintains a healthy cash position of
Notable is the substantial net loss of
The clinical development pipeline shows promising momentum. Soquelitinib's dual-track development in PTCL and atopic dermatitis represents a strategic approach to both rare disease and broader market opportunities. The completion of the first cohort in atopic dermatitis with no safety signals is encouraging, while the ongoing Phase 3 PTCL trial could address an significant unmet need, supported by FDA Orphan Drug and Fast Track designations.
The interim efficacy threshold being met in the ciforadenant RCC trial suggests potential clinical benefit, though the delayed data presentation warrants careful interpretation. The novel ITK inhibition mechanism targeting multiple T cell pathways could differentiate soquelitinib in the competitive immunology space.
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Enrolling Patients in Second Dosing Cohort
Interim Data from Atopic Dermatitis Trial Expected to be Announced December 2024
Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open
Conference call today at 4:30 p.m. ET / 1:30 p.m. PT
BURLINGAME, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the third quarter ended September 30, 2024.
“There is strong interest from clinicians and patients in both of our clinical programs for soquelitinib – the registration Phase 3 clinical trial in PTCL and the Phase 1 clinical trial in atopic dermatitis – and we are pleased with ongoing enrollment in these trials,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “ITK inhibition offers a novel mechanism of action that inhibits multiple parallel signaling pathways that modulate T cell function and immunity, giving it broad potential across a range of indications in oncology and immune disease. Its clinical potential has already been demonstrated in PTCL and we look forward to presenting interim data from our Phase 1 clinical trial in atopic dermatitis in December. We are excited for the potential of ITK inhibition to provide a new oral treatment option for atopic dermatitis, with the potential for improved efficacy, and with a more convenient and tolerable profile than biologics.”
Business Update and Strategy
Prioritized Program: Soquelitinib (Corvus’ selective ITK inhibitor)
Soquelitinib for Immune Diseases
- Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. Patients are followed for an additional 30 days after completing the 28 day course of therapy. The endpoints include safety and improvement in the Eczema Area and Severity Index. Patients and physicians are blinded to the treatment assignment. Enrollment in the first cohort (100 mg, twice per day) has been completed and the data review committee has met and found no safety signals. The second cohort (200 mg, once-daily) is now enrolling patients.
- Corvus plans to announce interim data from the Phase 1 clinical trial in December 2024.
- In November, Corvus plans to present new preclinical data highlighting the potential of soquelitinib to prevent lung damage, inflammation and pulmonary hypertension caused by systemic sclerosis at ACR Convergence 2024, the annual meeting of the American College of Rheumatology.
- Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications.
Soquelitinib for T Cell Lymphoma
- Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival.
- There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy.
Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)
- Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than
50% tumor volume reduction. The clinical trial is expected to enroll up to 60 patients and as of September 30, 2024, a total of 46 patients were enrolled in the trial. The protocol defined, interim pre-specified statistical threshold for efficacy is a50% increase above the32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC conducted by investigators at the Kidney Cancer Research Consortium. The analysis of the clinical trial continues to meet the threshold for efficacy and therefore enrollment continues. Along with our partners at the Kidney Cancer Research Consortium, we have decided to continue our follow-up of patients on the trial before presenting the data. Therefore, we will not be presenting this data at the GU Malignancy conference taking place in late November and will instead target a presentation sometime in 2025. - The Phase 1b/2 clinical trial in patients with metastatic RCC is supported by data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting highlighting the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer.
Financial Results
As of September 30, 2024, Corvus had cash, cash equivalents and marketable securities of
Research and development expenses for the three months ended September 30, 2024 totaled
The net loss for the three months ended September 30, 2024 was
Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, November 12, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2024 financial results. The conference call can be accessed by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.
About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company initiated a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib also is now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases.
About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about
PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.
About Atopic Dermatitis
Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to
About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies.
About Mupadolimab
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.
About Angel Pharmaceuticals
Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the potential of ciforadenant to overcome immunotherapy resistance in metastatic castration resistant prostate cancer; the potential of ITK inhibition to provide a new oral treatment option for atopic dermatitis; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s registrational Phase 3 clinical trial for PTCL with soquelitinib and its Phase 1 clinical trial for atopic dermatitis with soquelitinib; the timing of and the Company’s ability to launch clinical trials, including the soquelitinib Phase 1 clinical trial for solid tumors; the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 1 clinical trial for atopic dermatitis with soquelitinib and the registrational Phase 3 clinical trial for PTCL with soquelitinib; the availability and timing of clinical and preclinical data announcements and clinical readouts, including interim data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib and preclinical data highlighting the potential of soquelitinib to prevent lung damage, inflammation and pulmonary hypertension caused by systemic sclerosis; the estimated amount of net cash used in operating activities for 2024 and its ability to fund operations into 2026. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2024, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2024 and cash on hand providing funding into 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter ended September 30, 2024 are not necessarily indicative of its operating results for any future periods.
| CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) | ||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | $ | 5,222 | $ | 3,965 | $ | 13,411 | $ | 12,527 | ||||||||||
| General and administrative | 2,033 | 1,595 | 6,032 | 5,229 | ||||||||||||||
| Total operating expenses | 7,255 | 5,560 | 19,443 | 17,756 | ||||||||||||||
| Loss from operations | (7,255 | ) | (5,560 | ) | (19,443 | ) | (17,756 | ) | ||||||||||
| Interest income and other expense, net | 566 | 425 | 1,316 | 1,204 | ||||||||||||||
| Change in fair value of warrant liability | (32,846 | ) | — | (31,030 | ) | — | ||||||||||||
| Sublease income - related party | — | — | — | 56 | ||||||||||||||
| Loss from equity method investment | (682 | ) | (865 | ) | (1,023 | ) | (3,880 | ) | ||||||||||
| Net loss | $ | (40,217 | ) | $ | (6,000 | ) | $ | (50,180 | ) | $ | (20,376 | ) | ||||||
| Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (0.12 | ) | $ | (0.86 | ) | $ | (0.43 | ) | ||||||
| Shares used to compute net loss per share, basic and diluted | 66,701,086 | 48,971,246 | 58,513,303 | 47,683,792 | ||||||||||||||
| CORVUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| (unaudited) | ||||||
| Assets | ||||||
| Cash, cash equivalents and marketable securities | $ | 41,651 | $ | 27,149 | ||
| Operating lease right-of-use asset | 284 | 1,149 | ||||
| Other assets | 1,693 | 1,132 | ||||
| Investment in Angel Pharmaceuticals | 15,187 | 16,123 | ||||
| Total assets | $ | 58,815 | $ | 45,553 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable and accrued liabilities and other liabilities | $ | 6,088 | $ | 5,495 | ||
| Operating lease liability | 354 | 1,374 | ||||
| Warrant liability | 39,964 | — | ||||
| Stockholders' equity | 12,409 | 38,684 | ||||
| Total liabilities and stockholders' equity | $ | 58,815 | $ | 45,553 | ||
INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com
MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com
FAQ
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