Rafael Holdings Stock Price, News & Analysis

Cornerstone Pharmaceuticals announced new preclinical data on CPI-613^® (devimistat) targeting carcinoma catabolism, published in PLOS ONE. This study highlights devimistat's ability to suppress the mitochondrial TCA cycle, crucial for tumor metabolism. Significant results include one complete remission in ongoing Phase 1 trials for relapsed, refractory Burkitt lymphoma. CEO Sanjeev Luther emphasized the potential for devimistat to improve outcomes for patients with rare cancers. The drug has received orphan drug designation from the FDA and EMA for several indications.

Rafael Holdings, Inc. (NYSE: RFL) reported its financial results for the three and nine months ended April 30, 2022. The company had cash reserves of $59.4 million and incurred a net loss of $5.5 million for Q3, up from $2.6 million the previous year. Revenue for the quarter was $0.9 million, slightly down from $1 million. Over the first nine months, net loss totaled $119.9 million, significantly higher than $12.2 million in the prior year, primarily due to an impairment loss. R&D expenses increased to $6.9 million as the company focuses on its early-stage drug development pipeline.

Cranbury, NJ, June 1, 2022 - Cornerstone Pharmaceuticals, formerly Rafael Pharmaceuticals, announced three abstracts will be presented at the ASCO Annual Meeting from June 3-7, 2022, in Chicago. These abstracts focus on CPI-613® (devimistat) in treating rare cancers, specifically clear cell sarcoma and biliary tract cancer, with special emphasis on pancreatic cancer. Key presentations will be made by notable researchers, discussing promising trial results. The company aims to advance treatment options for patients suffering from rare cancers.

Cranbury, NJ (May 24, 2022) – Cornerstone Pharmaceuticals announced that the European Medicines Agency (EMA) has granted orphan drug designation to CPI-613® (devimistat) for treating advanced unresectable biliary tract cancer. This rare cancer affects over 2,000 people annually in the UK, with increasing incidence rates. The designation marks the fourth for devimistat by the EMA, which is also recognized by the FDA for seven indications in the U.S. Strong Phase 2 trial enrollment suggests promise for devimistat in addressing significant unmet clinical needs in biliary tract cancer.

Cranbury, NJ, May 19, 2022 – Rafael Pharmaceuticals has officially changed its name to Cornerstone Pharmaceuticals, aligning with its mission to develop therapies for rare cancers. The company emphasized its commitment to addressing significant unmet needs in cancer treatment through its lead compound, CPI-613® (devimistat), which has received orphan drug designation from the FDA for multiple cancers.

Ongoing clinical trials for Burkitt's lymphoma, biliary tract cancer, and clear cell sarcoma are meeting key milestones, with new trials expected to launch in Q2 and Q3 2022.

Rafael Holdings, Inc. (NYSE: RFL) reported its financial results for the second quarter of fiscal 2022, ending January 31, 2022. The company experienced a net loss of $2.3 million, or $0.12 per share, significantly reduced from a $8.2 million loss in the same quarter of the previous year. Revenues slightly increased to $1.1 million. R&D expenses surged to $3.3 million, reflecting advancements in their pipeline. The company holds $65.0 million in cash and cash equivalents, with a total net loss of $114.3 million for the first half fiscal 2022.

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.