CARMAT Announces Its 2024 Annual Results
PARIS--(BUSINESS WIRE)--Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the world's most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the ' Company ' or ' CARMAT '), today announces its annual results for the year ending December 31, 2024 1.
2024 annual results
Revenues of €7.0 million, corresponded to the sale of 17 Aeson® artificial hearts for commercial implants (Germany, Italy, Spain, and Poland) and to the sale of 25 Aeson® artificial hearts in the EFICAS clinical trial in France.
As a result of a tight cost control, the operating loss for 2024 was contained at €49.2 million, showing a slight improvement over the prior year (-€52.5 million).
In 2024, CARMAT has dedicated most of its efforts and resources to:
- commercial development in Europe;
- pursuing the EFICAS clinical study in France;
- implementing actions required to resume the Early Feasibility Study (EFS) in the United States;
- strengthening and optimizing its supply chain;
- reinforcing its financial structure.
Taking into account net financial expense (-€3.2 million), non-recurring items (-€0.6 million), and research tax credit (+€1.7 million), the net loss for 2024 stood at €51.4 million, improving by €2.5 million compared to 2023.
For 2024 key developments, readers are kindly invited to refer to the dedicated press release issued on January 8, 2025, and to subsequent press releases available on the Company's website: www.carmatsa.com.
Cash position and financial structure
Cash and cash runway
As of December 31, 2024, CARMAT's cash position stood at €4.7 million (vs. €8.0 million at end 2023), reflecting the following cash flows:
The Company reduced its combined operating and investing cash burn by 23% in 2024 (-€13.7 million vs. 2023). This translated into monthly cash burn of €3.7 million in 2024, compared to €4.9 million per month in 2023.
In terms of financing in 2024, the Company:
- carried out three capital increases for a total gross amount of €42.8 million (€16.5 million in January, €16.0 million in May, and €10.3 million in September);
- received the final €0.3 million tranche of a €1.4 million grant (CAP23) awarded to CARMAT under the 'Plan de Relance pour l'industrie – Secteurs Stratégiques' call for projects;
- secured €2.5 million via the equity financing line signed on July 5, 2024 with Vester Finance;
- paid €0.7 million in interest due on its loans (EIB loan and government-backed loans), or 'PGEs').
In addition, the Company raised a further €9.7 million 2 in gross proceeds post-year-end, on January 31, 2025.
On March 26, 2025, CARMAT also signed a new equity financing line with IRIS Capital Investment ("IRIS") for a maximum of 9,000,000 shares (approximately 15% of its capital) over 24 months 3.
Based on these developments, the Company believes that its available secured financial resources should allow it to fund its operations until mid-June 2025, under its current business plan.
Net financial debt
On March 22, 2024, the Company reached an agreement with all its financial creditors (European Investment Bank 'EIB', BNP Paribas 'BNPP', and Bpifrance 'BPI') on new loan repayment terms 4.
As a result of this agreement, CARMAT's net financial debt stood at €53.1 million at December 31, 2024, broken down as follows:
* Due within 12 months
Expand
The Company's financial liabilities include:
- outstanding principal and accrued interest on the EIB loan for a total of €24.8 million 5;
- outstanding principal and accrued interest on the two PGEs (government-backed loans) for a total of €9.5 million; 6
- as well as accrued interest on repayable advances: €9.9 million from Bpifrance, and €0.1 million from the 'France 2030' plan.
Short-term financial liabilities mainly relate to repayments due under the PGEs in 2025.
*
**
The 2024 financial statements were approved by the Board of Directors on April 25, 2025, on a going concern basis. Audit procedures by the Company's statutory auditor have been completed and his report is in the process of being issued. The Company expects to publish its 2024 Universal Registration Document (including the annual financial report) as soon as the audit report is received, anticipated by no later than April 30, 2025.
As of the date of this press release, available cash and cash equivalents are not sufficient to fund CARMAT's operations over the next 12 months. Based on its current business plan, the Company estimates its cash runway to mid-June 2025, with 12-month funding needs of approximately €35 million.
CARMAT is actively exploring various financing options to secure the resources required to continue its activities beyond June 2025.
More specifically, the Company believes—based on its current discussions with potential investors—that it should be in a position to carry out a new capital increase by mid-June 2025, extending its cash runway by several months. CARMAT believes that its recent progress (2.5-fold increase in sales between Q1 2024 and Q1 2025, imminent completion of EFICAS patient enrolment, conditional FDA approval in April 2025 to initiate the second EFS cohort in the U.S., and recent peer-reviewed scientific publications) should facilitate this operation.
However, the Company cannot guarantee that the necessary financing will be secured. This creates a significant degree of uncertainty that could impact the Company's ability to continue as a going concern.
If CARMAT is unable to obtain the required funding, applying standard French accounting rules and assumptions for going concern may no longer be appropriate for valuing its assets and liabilities.
***
About CARMAT
CARMAT is a French MedTech that designs, manufactures and markets the Aeson ® artificial heart. The Company's ambition is to make Aeson ® the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world's first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson ® could save, every year, the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson ® is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson ® is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d'Arcy. The Company can rely on the talent and expertise of a multidisciplinary team of circa 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).
For more information, please go to www.carmatsa.com and follow us on LinkedIn.
Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to CARMAT shares in any country.
This press release may contain forward-looking statements by the Company regarding its objectives and prospects. These forward-looking statements are based on the current estimates and anticipations of the Company's management and are subject to risk factors and uncertainties, including those described in its universal registration document filed with the French Financial Markets Authority (Autorité des marchés financiers) (the 'AMF') under number D.24-0374, as updated by the amendment to the 2023 universal registration document filed with the AMF on September 17, 2024 under number D.24-0374-A01 (together, the '2023 Universal Registration Document'), which are available free of charge on the websites of CARMAT (www.carmatsa.com) and the AMF (www.amf-france.org).
Readers' attention is particularly drawn to the fact that the Company's current cash runway is limited to the end of May 2025 (excluding the flexible equity financing line entered into with IRIS, which was announced on March 27, 2025). The Company is also subject to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the pace and results of ongoing or planned clinical trials, technological evolution and competitive environment, regulatory changes, industrial risks, and all risks associated with the Company's growth management. The Company's forward-looking statements mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties, whether unknown or not considered material and specific by the Company as of today.
Aeson® is an active implantable medical device commercially available in the European Union and other countries recognising the CE mark. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients with end-stage biventricular heart failure (Intermacs classes 1-4) who cannot benefit from maximal medical therapy or a left ventricular assist device (LVAD) and who are likely to benefit from a heart transplant within 180 days of implantation. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician's manual, patient's manual and alarm booklet) must be read carefully to learn about the characteristics of Aeson® and the information required for patient selection and proper use (contraindications, precautions, side effects) of Aeson®. In the United States, Aeson® is currently only available as part of a feasibility clinical trial approved by the Food & Drug Administration (FDA).
________________________________
1
The 2024 annual financial statements were approved by the Board of Directors on April 25, 2025. Audit procedures by the Company's statutory auditor have been completed and his report is in the process of being issued. The Company expects to publish its 2024 Universal Registration Document (including the annual financial report) as soon as the audit report is received, anticipated by no later than April 30, 2025.
2
Refer to the dedicated press release issued by the Company on January 31, 2025.
3
Refer to the dedicated press release issued by the Company on March 27, 2025.
4
Refer to the dedicated press release issued by the Company on March 22, 2024.
5
Including Tranche 1 of the EIB loan, currently being equitized.
6
PGEs contracted with BNP Paribas for one, and with Bpifrance for the other.
Expand
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO
Data Highlights Transformative Promise of CAR T in Solid Tumors Phase 1 Trial with ALLO-316 Demonstrated Potential to Provide Meaningful Clinical Benefit in Patients with CD70 TPS ≥ 50% Advanced or Metastatic RCC A Single Dose of ALLO-316 Achieved a 31% Confirmed Response Rate Four of Five Confirmed Responders Remain in Response Including One Ongoing Remission Over 12 Months Robust Expansion, Persistence, and Tumor Infiltration of ALLO-316 Seen with Standard Lymphodepletion, Showcasing Dagger® Technology as a Next-Generation Allogeneic Platform Phase 1 Safety Profile was Manageable; Proactive Diagnostic and Management Strategies Proved Effective in Mitigating IEC-HS While Preserving Efficacy SOUTH SAN FRANCISCO, Calif., June 01, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma (RCC) during an oral presentation at the 2025 ASCO Annual Meeting. The Phase 1 TRAVERSE trial enrolled patients with advanced or metastatic renal cell RCC. Leveraging the proprietary Dagger® technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The presentation focused on the Phase 1b expansion cohort from the Phase 1 TRAVERSE study in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million AlloCAR T™ cells. 'ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,' said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. 'Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.' 'Patients diagnosed with advanced or metastatic renal cell carcinoma often face a median survival in months after exhausting standard therapies,' said Samer A. Srour, MB ChB, MS, Associate Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and lead investigator of the TRAVERSE trial. 'These updated results from a larger cohort of patients with confirmed CD70 positive tumors provide compelling evidence that treatment with ALLO-316 can reduce tumor burden, control disease, and in some cases deliver durable responses. These findings underscore the clinical promise of an allogeneic CAR T to address the significant unmet needs in solid tumors and offer hope to patients who have exhausted other options.' In the Phase 1b expansion cohort, 22 patients whose tumors had progressed on multiple prior therapies were treated with lymphodepletion and 20 were treated with ALLO-316. All patients had tumors resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had ≥2+ prior TKI, and 41% had prior belzutifan. Sixteen of the ALLO-316 treated patients had a high CD70 Tumor Proportion Score (TPS >50%). The Phase 1b expansion cohort evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) following a standard FC lymphodepletion regimen (fludarabine (30 mg/m2/day) and cyclophosphamide (500 mg/m2/day) for 3 days). The median time from enrollment to the start of therapy was four days. A single dose of ALLO-316 stabilized or reversed disease progression in the majority of patients. In the 16 patients with CD70 TPS ≥50%, the trial demonstrated a Confirmed Overall Response Rate (ORR) of 31% with 44% achieving a minimum of 30% reduction in tumor burden. Of the five confirmed responders, four maintain ongoing responses, with one in sustained remission for over 12 months. The median duration of response (mDOR) has not yet been reached, indicating the potential for long-term disease control. CD70+ patients Phase 1b(N=20) ORR (confirmed CR or PR per RECIST v1.1), n/N (%) 5/20 (25) CD70 TPS ≥50%CD70 TPS <50% 5/16 (31)0/4 (0) RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product. The most frequent Grade ≥3 events were hematologic and there were no treatment-related Grade 5 events. The most common all-grade adverse events were cytokine release syndrome (CRS) (68%; with no grade ≥3), neutropenia (68%), decreased white blood cell count (68%), anemia (59%), and thrombocytopenia (55%). Immune effector cell-associated neurotoxicity syndrome (ICANS) was 18% (with no grade ≥3) and no graft-versus-host disease (GvHD) occurred. Improved recognition of IEC-HS symptoms led to diagnosis in 36% of patients with 2 patients (9%) experiencing a short-term Grade 3 (one) or Grade 4 (one patient) event. Newly implemented diagnostic and management algorithms significantly mitigated IEC-HS, with no associated Grade 5 events. TEAEs ≥20% incidence in Phase 1b, n (%) Phase 1b (N=22a) All Grades Grade ≥3 Neutropenia 15 (68) 15 (68) White blood cell count decreased 15 (68) 15 (68) Anemia 13 (59) 9 (41) Thrombocytopenia 12 (55) 6 (27) Nausea 8 (36) 0 ALT increased 7 (32) 2 (9) Peripheral edema 7 (32) 0 Pyrexia 7 (32) 0 Arthralgia 6 (27) 0 AST increased 6 (27) 2 (9) Fatigue 5 (23) 0 Headache 5 (23) 0 AEs of Special Interest Any Grade Grade ≥3 CRS 15 (68) 0 Infection 10 (45) 8 (36) IEC-HS 8 (36) 2 (9)b ICANS 4 (18) 0 Graft-versus-host disease 0 0 IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis. a Includes 2 patients who received LD but did not receive ALLO-316 b One patient experienced G4 IEC-HS based on GI bleeding with subsequent improvement and 1 patient experienced G3 IEC-HS based on hypotension managed without pressors with subsequent improvement. About ALLO-316 (TRAVERSE)ALLO-316 is an AlloCAR T™ investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of 'off-the-shelf' CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit and follow @AllogeneTx on X and LinkedIn. Cautionary Note on Forward-Looking Statements for Allogene This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as 'develop,' 'potential,' 'expect,' 'can,' 'enable,' 'showing,' 'generate,' 'may,' 'could,' 'designed to,' 'promise,' 'hope,' 'ongoing,' 'indicating,' 'mitigate,' 'evaluate,' 'pioneer,' 'goal' or 'will,' including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of ALLO-316 to treat patients with advanced or metastatic RCC or to provide meaningful clinical benefit in patients with advanced RCC; the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors and to generate deep and durable remissions; the potential that ALLO-316 can reduce tumor burden, control disease, and deliver durable responses; the design and potential benefits of our Dagger technology; whether the Dagger® technology will become the next-generation allogeneic platform; ALLO-316 and the Dagger technology's ability to enable robust CAR T cell expansion and persistence and tumor infiltration; the potential of ALLO-316 to address the unmet need in solid tumors or offer hope to patients who have exhausted other options; the transformative potential of our AlloCAR T™ in solid tumors; the potential advantages of the RMAT and Fast Track designation; and our ability to deliver cell therapy on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene's expectations and actual results, including, risks and uncertainties related to: the limited nature of our Phase 1 data from our clinical trials and the extent to which such data may or may not be validated in any future clinical trials; the extent to which the Food and Drug Administration disagrees with our clinical or regulatory plans or the import of our clinical results, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; RMAT and Fast Track designations may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval and the designations can be revoked if the criteria for eligibility cease to be met; and challenges with manufacturing or optimizing manufacturing of our product candidates. These and other risks are discussed in greater detail in Allogene's filings with the Securities and Exchange Commission (SEC), including without limitation under the 'Risk Factors' heading in its Quarterly Report on Form 10-Q for the year ended March 31, 2025. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. AlloCAR T™ and Dagger® are trademarks of Allogene Therapeutics, Inc. Allogene's investigational AlloCAR T™ oncology products utilize Cellectis technologies. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T™ program. Allogene Media/Investor Contact:Christine CassianoEVP, Chief Corporate Affairs & Brand Strategy while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
2 hours ago
- Business Wire
Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response
HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today presented the first data for casdatifan plus cabozantinib in an oral presentation by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. 'I was very encouraged to see that nearly half of patients had a confirmed response to the casdatifan plus cabozantinib combination despite short follow-up,' said Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber, the Jerome and Nancy Kohlberg Chair and professor of medicine at Harvard Medical School, and lead investigator of ARC-20. 'Casdatifan plus cabozantinib was well tolerated, and the safety profile was consistent with that of either agent alone, supporting their potential as a combination therapy. I look forward to enrolling patients into the PEAK-1 trial as soon as it is open.' 'The initial data for casdatifan plus cabozantinib in the ARC-20 study have already exceeded the historic benchmarks for either agent alone, as well as that of another HIF-2a inhibitor plus cabozantinib in the same second-line setting,' said Terry Rosen, Ph.D., chief executive officer of Arcus. 'These data serve as the proof of concept for PEAK-1, which will be initiated in the coming weeks and is designed to generate evidence to change the standard of care for people who have progressed on prior immunotherapy treatment.' ARC-20 is a Phase 1/1b dose-escalation and expansion study that includes a cohort evaluating once-daily 100mg of casdatifan plus 60mg of cabozantinib in patients with ccRCC who had progressed on prior immunotherapy. At the time of the data cutoff (DCO, March 14, 2025), 42 participants were evaluable for safety, and 24 reached at least 12 weeks of follow-up and were evaluable for efficacy. Among the safety-evaluable population (N=42), most participants (79%) had an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor of intermediate or poor. Nearly half (46%) of the efficacy-evaluable population (N=24) achieved a confirmed response per RECIST 1.1, and only one patient had primary progressive disease. The vast majority of the efficacy-evaluable population remains on treatment. In the safety-evaluable population, no unexpected safety risks were identified at the time of DCO, and casdatifan plus cabozantinib had an acceptable safety profile with no meaningful overlapping toxicity for the two drugs. Only two patients discontinued any drug, and no patients discontinued treatment with both drugs. The incidence of treatment-emergent adverse events (TEAEs) with casdatifan, particularly anemia and hypoxia, was similar to TEAEs observed with casdatifan monotherapy, and there were no casdatifan-related Grade 4 or 5 adverse events. The incidence of TEAEs associated with each drug was consistent with what is expected for each drug alone. A summary of the efficacy and safety results is below. Arcus is pursuing a broad development program in both the immuno-oncology (IO)-naive and post-IO settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. These studies include: Arcus's planned Phase 3 study, PEAK-1, which will evaluate casdatifan plus cabozantinib versus cabozantinib monotherapy as a first- or second-line treatment in patients with metastatic ccRCC who have previously received anti-PD-1/PD-L1 therapy. The primary endpoint will be PFS with a key secondary endpoint of overall survival. eVOLVE-RCC02, a Phase 1b/3 study sponsored by AstraZeneca, which will evaluate casdatifan plus volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, as first-line treatment for participants with ccRCC. ARC-20, which includes three cohorts evaluating casdatifan in earlier-line settings, including casdatifan plus zimberelimab in first-line ccRCC, casdatifan monotherapy in favorable risk ccRCC, and casdatifan monotherapy in immunotherapy-experienced, TKI-naive settings. Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 446724 on Monday, June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Participants may also register for the call online using the following link: To access the live webcast and accompanying slide presentation, please visit the 'Investors & Media' section of the Arcus Biosciences website at A replay will be available following the live event. About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis and key oncogenic pathways, which leads to cancer cell death. Clear cell renal cell carcinoma is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma. Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. About RCC According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including domvanalimab, an Fc-silent anti-TIGIT antibody being studied in combination with zimberelimab, an anti-PD-1 antibody, for upper gastrointestinal and non-small cell lung cancer, casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences' clinical and preclinical programs, please visit Forward Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr. Choueiri's and Dr. Rosen's quotes and statements regarding: the potency, efficacy or safety of casdatifan, including its potential for a best-in-class profile and potential as a combination therapy; and Arcus's development plans for the casdatifan program, including expected timing and design for new studies and cohorts and plans for generating data to support initiation of future studies. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks associated with: interim data not being replicated in future studies evaluating the same investigational molecules or regimen; the unexpected emergence of adverse events or other undesirable side effects with casdatifan; risks associated with manufacturing or supplying product for such clinical trials; uncertainties in timelines associated with the conduct of clinical studies and with respect to the regulatory application process; difficulties associated with the management of the collaboration activities with our strategic partners or expanded clinical programs; changes in the competitive landscape for Arcus's programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the 'Risk Factors' section of Arcus's most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
Business Upturn
3 hours ago
- Business Upturn
Announcing Balaji Karumanchi as Founder & CEO of Excelhire – The AI-Agentic Hiring Intelligence Platform
About Balaji Karumanchi Balaji Karumanchi is a seasoned entrepreneur and visionary technologist with over two decades of experience in enterprise solutions, AI innovation, and HR tech. With Excelhire, he's redefining how organizations approach talent acquisition — with intelligence, automation, and a relentless focus on hiring outcomes. About Excelhire Excelhire is a next-gen hiring platform powered by a system of AI Agents that automate and optimize the recruitment process from end to end. Designed for modern hiring teams, Excelhire delivers faster, fairer, and more efficient hiring through continuous, intelligent automation. Click here for Media Contact Details Submit your press release Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Business Wire is an American company that disseminates full-text press releases from thousands of companies and organizations worldwide to news media, financial markets, disclosure systems, investors, information web sites, databases, bloggers, social networks and other audiences.
