Arcus Bioscience - RCUS STOCK NEWS

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) announced that its Compensation Committee has granted equity awards to one new employee. The grants include options to purchase 5,550 shares of common stock at an exercise price of $11.07 per share, which matched the closing price on February 21, 2025. Additionally, the employee received restricted stock units to acquire 2,800 shares of common stock. These equity awards were issued under the company's 2020 Inducement Plan, which was established in January 2020 under the NYSE Listed Company Manual Rule 303A.08's 'inducement exception'.

Arcus Biosciences (NYSE:RCUS) has retained full rights to casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma (ccRCC), following the expiration of Gilead Sciences' option window. The company has also priced a $150 million common stock offering with participation from new and existing investors, including Gilead.

New data from the ARC-20 study showed improvements in progression rates, overall response rate (ORR), and progression-free survival (PFS) for casdatifan monotherapy. The company estimates a $5 billion market opportunity for this treatment. Key upcoming milestones include the initiation of the Phase 3 PEAK-1 trial in Q2 2025 and a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with their anti-PD-1/CTLA-4 bispecific antibody.

Arcus Biosciences (NYSE:RCUS) has announced the pricing of an underwritten public offering of 13,636,364 shares of common stock at $11.00 per share, aiming to raise approximately $150 million in gross proceeds. The offering is expected to close around February 19, 2025.

The company plans to use the net proceeds to fund ongoing research and development activities, including the clinical development of casdatifan, manufacturing-related costs, and other general corporate purposes. Goldman Sachs, Leerink Partners, and Evercore ISI are serving as joint book-running managers for the offering.

Arcus Biosciences (NYSE:RCUS) presented new data for casdatifan, their HIF-2a inhibitor for metastatic kidney cancer, showing promising results across three monotherapy cohorts. The 50mg twice-daily cohort achieved a 9.7-month median progression-free survival, while other cohorts had not yet reached their median.

Key findings include a 33% confirmed response rate in the 100mg cohort using tablet formulation, which is the expected go-forward dose for pivotal studies. Across all cohorts, 81-87% of patients experienced disease control with either partial response or stable disease. The study involved heavily pretreated patients, with 52-59% having received at least three prior lines of therapy.

Casdatifan demonstrated an acceptable safety profile, with low discontinuation rates. The company plans to advance the drug through multiple development programs, including the Phase 3 PEAK-1 study in combination with cabozantinib.

Arcus Biosciences (NYSE:RCUS) has announced new employment inducement grants for its recently appointed Chief Medical Officer, Dr. Richard Markus, and two new employees. Dr. Markus received an option to purchase 305,328 shares of common stock at $12.45 per share and restricted stock units for 75,193 shares. Additionally, two new employees were granted options to purchase 9,150 shares at $12.45 per share and restricted stock units for 4,600 shares. These equity awards were granted under the Company's 2020 Inducement Plan, approved under NYSE Listed Company Manual Rule 303A.08's inducement exception.

Arcus Biosciences (NYSE:RCUS) announced upcoming presentation of new data from their ARC-20 study at the 2025 ASCO GU Symposium. The presentation will showcase safety and efficacy data for casdatifan, their HIF-2a inhibitor, in treating clear cell renal cell carcinoma (ccRCC).

The presentation will include initial data from the 100mg once-daily tablet cohort, which is their selected dose for Phase 3 studies, along with updated data from the 50mg twice-daily and 50mg once-daily expansion cohorts. Dr. Toni Choueiri from Dana-Farber Cancer Institute will present the findings on February 15, 2025.

Arcus is advancing casdatifan's development program, including the planned initiation of their Phase 3 study (PEAK-1) in the first half of 2025, a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig, and new cohorts to evaluate the treatment in first-line settings.

Arcus Biosciences (NYSE:RCUS) has announced new employment inducement grants approved by its Compensation Committee. The grants include stock options for 31,800 shares at an exercise price of $13.33 per share and restricted stock units for 16,000 shares of common stock. These equity awards were granted to four new employees under the company's 2020 Inducement Plan, which was established under NYSE Listed Company Manual Rule 303A.08's inducement exception. The exercise price reflects the closing price of RCUS stock on January 23, 2024.

Arcus Biosciences (NYSE:RCUS) has appointed Richard Markus, M.D., Ph.D. as Chief Medical Officer, effective January 31, 2025, replacing Dimitry Nuyten, M.D., Ph.D. Dr. Markus will oversee the company's clinical development organization and portfolio, which includes seven clinical-stage programs with multiple Phase 3 studies.

The company plans to initiate PEAK-1, its fifth registrational Phase 3 study, in the first half of 2025, evaluating casdatifan plus cabozantinib in clear-cell renal cell carcinoma patients. Dr. Markus brings extensive experience from his 13-year tenure at Amgen, where he served as vice president of global development and oversaw multiple product approvals. Most recently, he founded Dantari, a clinical-stage oncology-focused antibody-drug conjugate company.