Rafael Holdings Stock Price, News & Analysis

Rafael Holdings, Inc. (NYSE: RFL) announced leadership changes, with Bill Conkling taking over as CEO from Ameet Mallik on February 1, 2022. Conkling has over 20 years of experience in oncology, previously holding key leadership roles at Immunomedics and Novartis Oncology. Dr. Rick Ewing is appointed as Head of Drug Discovery, bringing over 30 years of experience from Bristol Myers Squibb. Mallik will remain on the Board of Directors and chair the Transition Committee. The company continues to focus on developing cancer and immune metabolism therapeutics through its Barer Institute and investments in clinical-stage companies.

Rafael Pharmaceuticals announced positive developments in its Phase 2 clinical trial for CPI-613® (devimistat) combined with gemcitabine and cisplatin in treating biliary tract cancer. The trial, now open at multiple prestigious cancer centers, continues to show a strong enrollment rate and maintains safety standards. This cancer type is rare, with less than 20,000 cases annually in the U.S. and a low survival rate. CPI-613® is designed to target cancer cell metabolism, enhancing chemotherapy efficacy while potentially reducing side effects.

Rafael Pharmaceuticals has announced the successful completion of the first cohort in the APOLLO 613 Phase 1/2 clinical trial for CPI-613® (devimistat), aimed at treating relapsed clear cell sarcoma, with no dose-limiting toxicity observed. Patient enrollment for the second cohort has commenced, reflecting a significant unmet need for effective rare cancer treatments. The trial expands to additional sites including Seattle Children’s and Atrium Health Wake Forest Baptist. Devimistat targets mitochondrial cancer metabolism and is designated as an orphan drug by the FDA.

Rafael Holdings, Inc. (NYSE: RFL) reported significant financial losses in its Q1 FY2022 results, with a net loss of approximately $129.4 million or $6.49 per share, largely due to impairments related to Rafael Pharmaceuticals. Revenues slightly decreased to $1.0 million from $1.1 million year-over-year. R&D expenses surged to $2.2 million, up from $0.5 million in the prior year, while SG&A expenses rose sharply to $12.9 million driven by stock-based compensation. The leadership transition is set for February 1, 2022, aiming to refine strategic focus.

Rafael Pharmaceuticals announced a significant publication detailing its Phase 2 clinical trial results of CPI-613 (devimistat) for refractory Burkitt lymphoma. A key highlight was a patient achieving near complete metabolic remission after four cycles, leading to complete remission after seven cycles, showcasing potential where few treatment options exist. The trial is ongoing, with recruitment at prestigious institutions like MD Anderson and Memorial Sloan Kettering. Rafael's pipeline includes further site openings planned for Q1 2022, aiming to enhance treatment options for rare cancers.

Rafael Holdings (NYSE: RFL) announces leadership changes, effective February 1, 2022. Ameet Mallik transitions from CEO to Chairman, remaining an engaged board member. Patrick Fabbio adds the role of President to his current CFO position, while Dr. Mimi Huizinga expands her responsibilities to Head of Research and Development. The company is refocusing after disappointing results from Phase 3 trials for its lead product, CPI-613. William Conkling, Ashok David Marin, Brandi Robinson, and Melissa Lozner will depart by January 2022, as part of the transition.

Rafael Pharmaceuticals has opened new trial sites for the APOLLO 613 Phase 1/2 clinical trial of CPI-613® (devimistat) in combination with hydroxychloroquine for patients with clear cell sarcoma. The first patient has been enrolled at City of Hope, with additional sites now available at Cleveland Clinic Children’s and University of Michigan’s Rogel Cancer Center. With clear cell sarcoma being aggressive and difficult to treat, the company aims to provide more treatment options. Devimistat targets cancer cell metabolism and has FDA orphan drug designation for several cancers.

Rafael Pharmaceuticals announced the European Medicines Agency (EMA) has granted orphan drug designation to CPI-613® (devimistat) for treating Burkitt's lymphoma, a rare cancer affecting mainly children. This designation is the third for devimistat by the EMA, complementing seven orphan drug designations by the FDA in the U.S. Burkitt's lymphoma represents about 1% of adult lymphoma cases, with few treatment options available. The company aims to address the urgent need for effective therapies for patients with relapsed or refractory cases.

Rafael Pharmaceuticals announced disappointing results from its AVENGER 500 Phase 3 trial, which assessed CPI-613^® (devimistat) combined with modified FOLFIRINOX for metastatic pancreatic cancer. The study did not meet its primary endpoint of improving overall survival, reporting 11.1 months for devimistat plus mFFX versus 11.7 months for standard FOLFIRINOX (HR=0.95, p=0.66).

In addition, the ARMADA 2000 trial in relapsed acute myeloid leukemia was halted due to lack of efficacy, as recommended by an independent committee.