Arcus Biosciences Reports Fourth-Quarter and Full-Year 2024 Financial Results and Provides a Pipeline Update
Arcus Biosciences (NYSE:RCUS) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its cancer therapy pipeline. The company's lead drug casdatifan showed promising results in Phase 1/1b ARC-20 study for clear cell renal cell carcinoma (ccRCC), with over 30% confirmed overall response rate in two cohorts and favorable safety profile.
Key financial metrics include:
- Cash position of $992 million as of December 31, 2024
- Q4 2024 revenues of $36 million
- R&D expenses increased to $111 million in Q4 2024
- Net loss of $94 million in Q4 2024
The company plans to initiate the Phase 3 PEAK-1 study evaluating casdatifan with cabozantinib in H1 2025, with initial combination data expected mid-2025. Arcus completed a $150 million financing and expects current funding to support pivotal trials through initial readouts.
Arcus Biosciences (NYSE:RCUS) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nel suo pipeline di terapie oncologiche. Il farmaco principale dell'azienda, casdatifan, ha mostrato risultati promettenti nello studio di Fase 1/1b ARC-20 per il carcinoma renale a cellule chiare (ccRCC), con oltre il 30% di tasso di risposta complessiva confermata in due coorti e un profilo di sicurezza favorevole.
I principali indicatori finanziari includono:
- Posizione di cassa di 992 milioni di dollari al 31 dicembre 2024
- Ricavi del Q4 2024 pari a 36 milioni di dollari
- Le spese per R&S sono aumentate a 111 milioni di dollari nel Q4 2024
- Perdita netta di 94 milioni di dollari nel Q4 2024
L'azienda prevede di avviare lo studio di Fase 3 PEAK-1 per valutare casdatifan in combinazione con cabozantinib nel primo semestre del 2025, con i dati iniziali della combinazione attesi per metà 2025. Arcus ha completato un finanziamento di 150 milioni di dollari e si aspetta che il finanziamento attuale supporti studi cruciali fino ai primi risultati.
Arcus Biosciences (NYSE:RCUS) ha informado sobre sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en su cartera de terapias contra el cáncer. El medicamento líder de la compañía, casdatifan, mostró resultados prometedores en el estudio de Fase 1/1b ARC-20 para el carcinoma de células renales de células claras (ccRCC), con más del 30% de tasa de respuesta general confirmada en dos cohortes y un perfil de seguridad favorable.
Los principales indicadores financieros incluyen:
- Posición de efectivo de 992 millones de dólares al 31 de diciembre de 2024
- Ingresos del Q4 2024 de 36 millones de dólares
- Los gastos de I+D aumentaron a 111 millones de dólares en el Q4 2024
- Pérdida neta de 94 millones de dólares en el Q4 2024
La compañía planea iniciar el estudio de Fase 3 PEAK-1 evaluando casdatifan junto con cabozantinib en la primera mitad de 2025, con datos iniciales de combinación esperados para mediados de 2025. Arcus completó un financiamiento de 150 millones de dólares y espera que el financiamiento actual apoye ensayos fundamentales hasta los primeros resultados.
아르쿠스 바이오사이언스(NYSE:RCUS)가 2024년 4분기 및 연간 재무 결과를 발표하며 암 치료 파이프라인에서의 중요한 진행 상황을 강조했습니다. 회사의 주요 약물인 카스다티판은 투명 세포 신장 세포 암(ccRCC)에 대한 1/1b 단계 ARC-20 연구에서 30% 이상의 확인된 전체 반응률을 보였으며, 안전성 프로필도 유리합니다.
주요 재무 지표는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 9억 9200만 달러
- 2024년 4분기 매출 3600만 달러
- 2024년 4분기 연구 개발 비용 1억 1100만 달러로 증가
- 2024년 4분기 순손실 9400만 달러
회사는 2025년 상반기에 카스다티판과 카보잔티닙을 평가하는 3상 PEAK-1 연구를 시작할 계획이며, 초기 조합 데이터는 2025년 중반에 예상됩니다. 아르쿠스는 1억 5000만 달러의 자금을 확보했으며, 현재 자금이 초기 결과까지 주요 시험을 지원할 것으로 기대하고 있습니다.
Arcus Biosciences (NYSE:RCUS) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en évidence des progrès significatifs dans son pipeline de thérapies contre le cancer. Le médicament phare de l'entreprise, le casdatifan, a montré des résultats prometteurs dans l'étude de Phase 1/1b ARC-20 pour le carcinome rénal à cellules claires (ccRCC), avec un taux de réponse global confirmé de plus de 30 % dans deux cohortes et un profil de sécurité favorable.
Les principaux indicateurs financiers comprennent :
- Position de trésorerie de 992 millions de dollars au 31 décembre 2024
- Chiffre d'affaires du Q4 2024 de 36 millions de dollars
- Les dépenses de R&D ont augmenté à 111 millions de dollars au Q4 2024
- Perte nette de 94 millions de dollars au Q4 2024
L'entreprise prévoit de lancer l'étude de Phase 3 PEAK-1 évaluant le casdatifan avec le cabozantinib au premier semestre 2025, avec des données initiales de combinaison attendues pour le milieu de 2025. Arcus a complété un financement de 150 millions de dollars et s'attend à ce que le financement actuel soutienne des essais cruciaux jusqu'aux premiers résultats.
Arcus Biosciences (NYSE:RCUS) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und erhebliche Fortschritte in seiner Krebsbehandlungspipeline hervorgehoben. Das Hauptmedikament des Unternehmens, Casdatifan, zeigte vielversprechende Ergebnisse in der Phase 1/1b ARC-20-Studie für klarzelliges Nierenzellkarzinom (ccRCC), mit über 30% bestätigter Gesamtansprechrate in zwei Kohorten und einem günstigen Sicherheitsprofil.
Wichtige finanzielle Kennzahlen sind:
- Liquiditätsposition von 992 Millionen Dollar zum 31. Dezember 2024
- Umsätze im Q4 2024 von 36 Millionen Dollar
- F&E-Ausgaben stiegen im Q4 2024 auf 111 Millionen Dollar
- Nettverlust von 94 Millionen Dollar im Q4 2024
Das Unternehmen plant, die Phase-3-Studie PEAK-1 zu starten, in der Casdatifan zusammen mit Cabozantinib in der ersten Hälfte von 2025 evaluiert wird, wobei erste Kombinationsdaten für Mitte 2025 erwartet werden. Arcus hat eine Finanzierung in Höhe von 150 Millionen Dollar abgeschlossen und erwartet, dass die aktuelle Finanzierung entscheidende Studien bis zu den ersten Ergebnissen unterstützt.
- Strong efficacy data for casdatifan with >30% response rate in ccRCC
- Robust cash position of $992M plus new $150M financing
- 81-87% disease control rate in ARC-20 study
- Revenue increased to $36M in Q4 2024 from $31M in Q4 2023
- Net loss increased to $94M in Q4 2024 from $81M in Q4 2023
- R&D expenses rose to $111M from $93M year-over-year
- Higher enrollment costs impacting expenses
Insights
Arcus Biosciences' Q4 and full-year 2024 results showcase a company strategically positioning itself around a potential breakthrough asset while maintaining a robust financial foundation. The standout development is casdatifan's impressive clinical profile in renal cell carcinoma, with data suggesting potential best-in-class efficacy among HIF-2α inhibitors.
The ARC-20 study results are particularly compelling when viewed in competitive context. The confirmed ORR exceeding 30% in two cohorts surpasses the approximately 25% ORR seen with Merck's approved HIF-2α inhibitor belzutifan. Even more significant is the low primary progression rate (14-19%) and the remarkable durability of response - with only 2 of 26 responders progressing at data cutoff. The 9.7-month median PFS for the 50mg cohort (with other cohorts not yet reaching median) compares favorably to the historical 14-16 month PFS typically seen with first-line TKI therapy, especially considering these were heavily pre-treated patients.
Financially, Arcus has executed a masterful capital strategy, ending 2024 with
Management's strategic pivot is evident in their commentary. CEO Terry Rosen's statement about "conserving capital and allocating greater resources to maximizing the potential of casdatifan" signals a deliberate portfolio prioritization. This is a prudent approach given:
- Arcus now has full developmental and commercial control of casdatifan
- The asset's differentiated safety profile relative to VEGFR TKIs positions it favorably in the treatment paradigm
- The AstraZeneca collaboration provides external validation and resource-efficient development opportunities
The company's pipeline beyond casdatifan maintains momentum with three Phase 3 programs (PEAK-1 for casdatifan, STAR-221 for domvanalimab, and PRISM-1 for quemliclustat). This balanced approach of focused investment on their lead asset while advancing other programs demonstrates disciplined capital allocation.
Looking ahead, multiple catalysts in 2025-2026 could drive significant value creation, including the casdatifan + cabozantinib data (mid-2025), EDGE-Gastric survival data (fall 2025), and three Phase 3 readouts in the 2026 timeframe. The company's strategic positioning in the competitive RCC landscape, coupled with its robust financial foundation, creates a compelling investment thesis centered on casdatifan's potential to reshape treatment paradigms in RCC.
The new clinical data for casdatifan represents a potentially significant advancement in the treatment landscape for clear cell renal cell carcinoma (ccRCC). HIF-2α inhibition directly targets the fundamental pathophysiology of ccRCC, addressing the consequences of VHL gene inactivation that occurs in approximately
What stands out in the ARC-20 study results is not just the confirmed ORR exceeding 30% in two cohorts, but the context in which these responses occurred - in heavily pretreated patients who had progressed on both immunotherapy and VEGFR-TKI therapy. This represents a population with effective treatment options and typically poor outcomes. The observed response rates compare favorably to the approximately
Even more compelling from a clinical perspective is the durability of response, with only 2 of 26 confirmed responders having discontinued due to progression at data cutoff. This suggests the potential for deep and sustained tumor control, which is particularly valuable in the advanced RCC setting where maintaining quality of life during extended treatment periods is crucial. The 9.7-month median PFS in the 50mg cohort is impressive for a third-line therapy, especially considering that median PFS for standard therapies in this setting typically ranges from 4-7 months.
The safety profile appears to be a key differentiator. While specific toxicity data wasn't detailed in the release, management's emphasis on a "preferable safety profile relative to standard-of-care VEGFR tyrosine kinase inhibitors" is noteworthy. VEGFR-TKIs are associated with significant toxicities including hypertension, hand-foot syndrome, diarrhea, and fatigue that often lead to dose reductions or discontinuations. If casdatifan truly offers comparable or superior efficacy with reduced toxicity, this would represent a meaningful clinical advantage.
Arcus's development strategy is particularly sophisticated, pursuing multiple parallel paths that could position casdatifan across the RCC treatment continuum:
- The PEAK-1 Phase 3 trial evaluating casdatifan + cabozantinib vs. cabozantinib addresses the post-IO setting where new options are needed
- The first-line monotherapy cohort in favorable-risk patients explores a setting where physicians might prefer a less toxic approach than current IO-TKI combinations
- The combination with zimberelimab (anti-PD-1) explores potential synergy between HIF-2α inhibition and immunotherapy
- The AstraZeneca collaboration studying combination with volrustomig (PD-1/CTLA-4 bispecific) targets the lucrative first-line setting
From a mechanistic perspective, the combinations are scientifically rational. HIF-2α inhibition may complement both immunotherapy and anti-angiogenic approaches. HIF-2α regulates genes involved in angiogenesis, cell proliferation, and immune evasion, so inhibiting this pathway could potentially enhance responses to both IO and TKI therapies through non-overlapping mechanisms.
If the promising efficacy and safety signals are confirmed in larger studies, casdatifan could potentially reshape treatment algorithms in RCC. The favorable toxicity profile could make it an attractive option earlier in treatment sequences, particularly for patients who prioritize quality of life or have comorbidities that make them poor candidates for more toxic regimens. The multiple development paths being pursued simultaneously create multiple opportunities for success and could establish casdatifan as a backbone therapy across various stages of RCC treatment.
- New data from the Phase 1/1b ARC-20 study showed that casdatifan improved upon the rate of primary progression, overall response rate (ORR) and progression-free survival (PFS) relative to published data from studies with HIF-2a inhibitors to date
- Initiation of the Phase 3 study for PEAK-1 evaluating casdatifan in combination with cabozantinib versus cabozantinib in immuno-oncology (IO)-experienced patients with clear cell renal cell carcinoma (ccRCC) is expected in the first half of 2025; initial data from the cohort of ARC-20 evaluating casdatifan plus cabozantinib are expected to be presented in mid-2025
-
Arcus completed a
financing and continues to be well positioned to advance its pipeline with$150 million in cash, cash equivalents and marketable securities as of December 31, 2024 (excluding proceeds from the offering)$992 million
“Last week, we presented data from nearly 90 ccRCC patients demonstrating casdatifan’s potential best-in-class profile,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “Given the strong efficacy and preferable safety profile relative to standard-of-care VEGFR tyrosine kinase inhibitors, we believe casdatifan can play an important role in the treatment of every patient diagnosed with ccRCC. Arcus now has full developmental and commercial control of casdatifan, and we are pursuing a robust development plan in multiple ccRCC settings, which include our first Phase 3 trial, PEAK-1, expected to initiate next quarter, as well as our clinical collaboration with AstraZeneca. We are extremely well capitalized to execute on these plans, and we continue to evaluate and pursue opportunities to conserve capital and allocate greater resources to maximizing the potential of casdatifan.”
Pipeline Highlights:
Casdatifan (HIF-2a inhibitor)
Casdatifan Updates:
-
New clinical data from three monotherapy expansion cohorts in ARC-20 were presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium in February. At the time of data cut-off (DCO, January 3, 2025), the efficacy-evaluable population included a total of 87 patients with ccRCC who had received at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor (TKI) therapy. These data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC:
-
Despite limited follow-up, two of the cohorts exceeded
30% confirmed ORR (inclusive of one partial response that confirmed after the DCO) -
Rates of primary progressive disease (progression at or before their first disease assessment) ranged from
14% to19% -
Most patients (81
-87% ) experienced disease control with either a partial response or stable disease - Only two confirmed responders out of the 26 across all cohorts had discontinued due to progression, indicating the potential for a long duration of response
- A 9.7-month median PFS was reached for the 50mg twice-daily casdatifan monotherapy cohort; median PFS was not yet reached for other cohorts
- No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses
-
Despite limited follow-up, two of the cohorts exceeded
Planned Data Readouts:
- Mid-2025: Safety and initial efficacy data for the ARC-20 cohort evaluating casdatifan plus cabozantinib in IO-experienced patients.
- Fall 2025: More mature data from the cohorts evaluating casdatifan monotherapy in patients who had progressed on both an anti-PD-1 and a TKI therapy.
- 2026: More mature data from the casdatifan + cabozantinib cohort and initial data from the new ARC-20 cohorts evaluating casdatifan in the first-line (1L) and IO-experienced settings.
Upcoming Study and Cohort Initiations:
-
Three new expansion cohorts within ARC-20 will be initiated in the first quarter of 2025:
- Casdatifan plus zimberelimab in all-comer 1L ccRCC
- Casdatifan monotherapy in favorable-risk 1L ccRCC
- Casdatifan monotherapy in the IO-experienced setting for patients with ccRCC who have not received a VEGFR-TKI therapy
- The Phase 3 PEAK-1 study evaluating casdatifan in combination with cabozantinib versus cabozantinib in IO-experienced ccRCC is expected to initiate in the second quarter of 2025.
- A Phase 1b study, part of AstraZeneca’s eVOLVE portfolio of trials, evaluating casdatifan in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in IO-naive patients, is expected to initiate in 2025. AstraZeneca is operationalizing this study.
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)
- Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in the fall of 2025.
- The first Phase 3 data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221 evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer 1L metastatic upper GI adenocarcinomas and is expected in 2026.
CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist)
Quemliclustat:
-
In the fourth quarter of 2024, Arcus initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in pancreatic cancer. In February 2025, Arcus’s partner, Taiho, dosed their first patient in
Japan for PRISM-1.
Etrumadenant:
- Arcus plans to meet with the FDA in the first half of 2025 to clarify next steps for ARC-9, evaluating etrumadenant plus zimberelimab, FOLFOX, chemotherapy and bevacizumab (EZFB) versus regorafenib in third-line metastatic colorectal cancer (mCRC).
Early Clinical Programs
- Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in non-small cell lung cancer (NSCLC) in the second half of 2025.
Financial Results for Fourth Quarter and Full Year 2024:
-
Cash, Cash Equivalents and Marketable Securities were
as of December 31, 2024, compared to$992 million as of December 31, 2023. The increase during the period is primarily due to the receipt of$866 million in cash from Gilead for their January 2024 equity investment, the receipt of the$320 million option continuation payment from Gilead in July 2024 and proceeds from our$100 million term loan, partially offset by the use of cash in research and development activities. Arcus expects its cash and investments, together with the proceeds from the equity financing in February 2025, will provide funding through our initial pivotal read-outs for domvanalimab, quemliclustat and casdatifan including STAR-221, PRISM-1 and PEAK-1.$50 million -
Revenues were
for the fourth quarter 2024, compared to$36 million for the same period in 2023. In the fourth quarter 2024, Arcus recognized$31 million in License and development service revenues related to the advancement of programs under the Gilead collaboration, as well as$28 million in Other collaboration revenue related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement.$8 million -
Research and Development (R&D) Expenses were
for the fourth quarter 2024, compared to$111 million for the same period in 2023. The net increase of$93 million was primarily driven by higher costs associated with our early-stage R&D and preclinical program activities, driven by higher enrollment in our studies for casdatifan, higher expense incurred on Gilead-led studies for domvanalimab, as well as increases in compensation cost related to our growing headcount. Non-cash stock-based compensation expense was$18 million for each of the fourth quarter 2024 and 2023. For the fourth quarter 2024 and 2023, Arcus recognized gross reimbursements of$9 million and$41 million , respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. Gross reimbursements were$42 million for the full year 2024, compared to$165 million for 2023. Our partnership reimbursements were flat compared to the prior year despite the increases in gross costs, due to increases in Gilead-led activities and programs fully funded by us. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements.$162 million -
General and Administrative (G&A) Expenses were
for the fourth quarter 2024, compared to$28 million for the same period in 2023. Non-cash stock-based compensation expense was$29 million for the fourth quarter 2024, compared to$8 million for the same period in 2023.$9 million -
Net Loss was
for the fourth quarter 2024, compared to$94 million for the same period in 2023.$81 million
Arcus Ongoing and Announced Clinical Studies:
Trial Name |
Arms |
Setting |
Status |
NCT No. |
Kidney Cancer |
||||
PEAK-1 |
cas + cabo vs. cabo |
Post-IO ccRCC |
Planned Phase 3 |
TBD |
AstraZeneca Collaboration (part of eVOLVE portfolio) |
cas + volru |
2L+ IO-Naive ccRCC |
Planned Phase 1b |
TBD |
ARC-20 |
cas, cas + cabo |
2L+ Cancer Patients/ccRCC |
Ongoing Phase 1/1b |
|
Upper Gastrointestinal Cancers |
||||
STAR-221 |
dom + zim + chemo vs. nivo + chemo |
1L Gastric, GEJ and EAC |
Ongoing Registrational Phase 3 |
|
EDGE-Gastric (ARC-21) |
dom +/- zim +/- chemo |
1L/2L Upper GI Malignancies |
Ongoing Randomized Phase 2 |
|
Lung Cancer |
||||
STAR-121
|
dom + zim + chemo vs. pembro + chemo |
1L NSCLC (PD-L1 all-comers) |
Ongoing Registrational Phase 3 |
|
PACIFIC-8
|
dom + durva vs. durva |
Unresectable Stage 3 NSCLC |
Ongoing Registrational Phase 3 |
|
EDGE-Lung |
dom +/- zim +/- quemli +/- chemo |
1L/2L NSCLC (lung cancer platform study) |
Ongoing Randomized Phase 2 |
|
VELOCITY-Lung
|
dom +/- zim +/- sacituzumab govitecan-hziy or other combos |
1L/2L NSCLC (lung cancer platform study) |
Ongoing Randomized Phase 2 |
|
Pancreatic Cancer |
||||
PRISM-1 |
quemli + gem/nab-pac vs. gem/nab-pac |
1L PDAC |
Ongoing Randomized Phase 3 |
|
ARC-8 |
quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac |
1L PDAC |
Ongoing Randomized Phase 1/1b |
|
Colorectal Cancer |
||||
ARC-9 |
etruma + zim + mFOLFOX vs. SOC |
2L/3L/3L+ CRC |
Ongoing Randomized Phase 2 |
|
Other |
||||
ARC-25 |
AB598 |
Gastric Cancer |
Ongoing Phase 1 |
|
ARC-27 |
AB801 |
NSCLC |
Ongoing Phase 1 |
cabo: cabozantinib; cas: casdatifan; ccRCC: clear cell renal cell carcinoma; CRC: colorectal cancer; dom: domvanalimab; durva: durvalumab; EAC: esophageal adenocarcinoma; etruma: etrumadenant; GEJ: gastroesophageal junction; gem/nab-pac: gemcitabine/nab-paclitaxel; GI: gastrointestinal; nivo: nivolumab; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines 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 expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, A2a/A2b receptors, CD39 and AXL. For more information about Arcus Biosciences’s clinical and preclinical programs, please visit www.arcusbio.com.
Domvanalimab, etrumadenant, quemliclustat and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan, AB598 and AB801 are also investigational molecules, and Arcus has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.
About the Gilead Collaboration
In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing four investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 and May 2023 to include research directed to two targets for oncology and two targets for inflammatory diseases.
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. Rosen’s quote and statements regarding: Arcus’s expectation that its cash and investments are sufficient to provide funding through its initial pivotal readouts for domvanalimab, quemliclustat and casdatifan; the timing of future study milestones, including the expected timing for data readout for STAR-221 and plans to disclose or present study analyses or data, including any analyses or data from ARC-20 or EDGE-Gastric; whether data and results from studies validate our pipeline or support further development of a program; the potency, efficacy or safety of Arcus’s investigational products, including their potential for a best-in-class profile; and the initiation, design of and associated timing for future studies and cohorts, including statements about PEAK-1 and the new cohorts in ARC-20. 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 preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; unfavorable global economic, political and trade conditions; Arcus’s dependence on the collaboration with third parties such as Gilead and Taiho for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities 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
The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) |
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|
Three Months Ended
|
|
Years Ended
|
||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenues: |
|
|
|
|
|
|
|
License and development service revenue |
|
|
|
|
|
|
|
Other collaboration revenue |
8 |
|
9 |
|
36 |
|
37 |
Total revenues |
36 |
|
31 |
|
258 |
|
117 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
111 |
|
93 |
|
448 |
|
340 |
General and administrative |
28 |
|
29 |
|
120 |
|
117 |
Impairment of long-lived assets |
— |
|
— |
|
20 |
|
— |
Total operating expenses |
139 |
|
122 |
|
588 |
|
457 |
|
|
|
|
|
|
|
|
Loss from operations |
(103) |
|
(91) |
|
(330) |
|
(340) |
|
|
|
|
|
|
|
|
Non-operating income (expense): |
|
|
|
|
|
|
|
Interest and other income, net |
12 |
|
11 |
|
52 |
|
41 |
Interest expense |
(2) |
|
— |
|
(4) |
|
(2) |
Total non-operating income, net |
10 |
|
11 |
|
48 |
|
39 |
|
|
|
|
|
|
|
|
Loss before income taxes |
(93) |
|
(80) |
|
(282) |
|
(301) |
|
|
|
|
|
|
|
|
Income tax expense |
(1) |
|
(1) |
|
(1) |
|
(6) |
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
91.7 |
|
72.6 |
|
90.1 |
|
74.0 |
Selected Consolidated Balance Sheet Data (unaudited) (In millions) |
|||
|
December 31,
|
|
December 31,
|
Cash, cash equivalents and marketable securities |
|
|
|
Total assets |
1,150 |
|
1,095 |
Total liabilities |
665 |
|
633 |
Total stockholders’ equity |
485 |
|
462 |
Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2025. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250225681705/en/
Investor Inquiries:
Pia Eaves
VP of Investor Relations & Strategy
(617) 459-2006
peaves@arcusbio.com
Media Inquiries:
Holli Kolkey
VP of Corporate Affairs
(650) 922-1269
hkolkey@arcusbio.com
Maryam Bassiri
AD, Corporate Communications
(510) 406-8520
mbassiri@arcusbio.com
Source: Arcus Biosciences
FAQ
What were the key clinical results for casdatifan in the ARC-20 study for RCUS?
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When will RCUS initiate the Phase 3 PEAK-1 trial for casdatifan?
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