Welcome to our dedicated page for Rafael Holdings news (Ticker: RFL), a resource for investors and traders seeking the latest updates and insights on Rafael Holdings stock.
Rafael Holdings, Inc. reports developments as a biotechnology company focused on pharmaceutical development and interests in clinical-stage and early-stage pharmaceutical and medical device companies. Its lead program is Trappsol® Cyclo™, a hydroxypropyl-beta-cyclodextrin product candidate evaluated for Niemann-Pick Disease Type C1, with additional cyclodextrin-related work in neurodegenerative disease.
Recurring company news covers clinical development of Cyclo Therapeutics programs, scientific presentations, patent and licensing activity, quarterly and annual financial results, and governance changes. Updates also address the company’s consolidated expenses following the Cyclo Therapeutics acquisition and its portfolio interests in healthcare and medical-device development.
Rafael Pharmaceuticals announced positive results from the interim futility analysis of its Phase 3 trial (ARMADA 2000) for CPI-613® (devimistat) in treating relapsed or refractory acute myeloid leukemia (AML). Conducted by an independent Data Monitoring Committee on June 25, 2021, the trial was deemed non-futile, allowing it to continue. The interim analysis involved 142 patients and indicated a predefined response rate threshold was met. Devimistat targets cancer cell energy metabolism, potentially enhancing treatment efficacy while reducing side effects for various cancers.
Rafael Pharmaceuticals announced that data regarding its lead compound, devimistat, will be presented at the 2021 ESMO World Gastrointestinal Congress from June 30 to July 3. This presentation will focus on ongoing trials for devimistat in treating pancreatic and biliary tract cancer. Both cancers have low survival rates, with biliary cancer at 9% and pancreatic cancer at 10.8% over five years. Devimistat targets cancer cell metabolism and may improve treatment outcomes, with pivotal Phase 3 trials already approved by the FDA.
Rafael Pharmaceuticals announced that the FDA has granted orphan drug designation for CPI-613 (devimistat) to treat biliary cancer. This rare form of cancer affects approximately 12,000 people annually in the U.S. Devimistat has also received orphan drug status for pancreatic cancer, AML, and others, totaling seven designations. The company emphasizes the urgent need for effective treatments for rare cancers, as current options have limited response rates. Devimistat targets mitochondrial processes to enhance cancer therapy effectiveness with reduced side effects.
Rafael Holdings, Inc. (NYSE: RFL) and Rafael Pharmaceuticals presented at the Raymond James 2021 Human Health Innovation Conference on June 22, 2021. Key figures included CEO Ameet Mallik and President Sanjeev Luther. The companies are focused on developing novel cancer therapies, particularly through Rafael Pharmaceuticals, which is advancing multiple clinical studies for its lead drug, CPI-613 (devimistat). This includes ongoing Phase 3 trials for metastatic pancreatic cancer and acute myeloid leukemia. The companies aim to create a publicly traded late-stage clinical oncology entity, enhancing their market position.
Rafael Holdings, Inc. (NYSE: RFL) has announced a merger with Rafael Pharmaceuticals, a late-stage oncology firm specializing in cancer metabolism therapeutics. The merger, unanimously approved by both boards, aims to create a publicly traded company focused on innovative cancer treatments. Key figures include Howard Jonas as Chairman and Ameet Mallik as CEO. The merger includes the acquisition of Altira Capital for $30 million and requires a capital raise of at least $50 million. The lead drug, CPI-613 (devimistat), is in Phase 3 trials for metastatic pancreatic cancer, with results expected in Q4 2021.
Rafael Holdings, Inc. (NYSE: RFL) reported Q3 FY 2021 revenue of $1.0 million, down from $1.2 million year-over-year, primarily due to asset sales and reduced parking revenues amid the COVID pandemic. The loss per share was $0.15, compared to $0.14 in the prior year. The company appointed Ameet Mallik as CEO and William Conkling as Chief Commercial Officer. A shelf registration statement for up to $250 million of Class B common stock was filed. Rafael Pharmaceuticals anticipates pivotal trial data for pancreatic cancer in Q4 2021.
Rafael Holdings, Inc. (NYSE: RFL) announced the appointment of three new members to its Board of Directors: Ameet Mallik, CEO; Shannon Thyme Klinger, Chief Legal Officer of Moderna; and Mark McCamish, CEO of IconOVir Bio. Chairman Howard Jonas expressed optimism, stating the new board members bring significant expertise to advance the company's oncology pipeline. Ameet Mallik highlighted the importance of their industry experience in maximizing the potential of their therapeutics.
Rafael Holdings, Inc. (NYSE: RFL) announced a grant of 908,497 restricted shares of Class B common stock to CEO Ameet Mallik on May 27, 2021, as part of his employment agreement. The shares will vest over the next few years, with initial shares vesting on May 6, 2022, followed by monthly vesting until April 2025. This stock grant was made under the company's 2018 Equity Incentive Plan and approved by the Compensation Committee, serving as an inducement for Mr. Mallik's hiring which took effect on May 1, 2021.
Rafael Pharmaceuticals will present two posters at the 2021 ASCO Annual Meeting from June 4-8, discussing trials on devimistat for pancreatic and biliary tract cancers. Presentation Abstract #TPS4158 explores the efficacy of gemcitabine and cisplatin, while Abstract #TPS4176 focuses on devimistat paired with (m)FOLFIRINOX. Sanjeev Luther, the company’s President, emphasizes significant advancements despite challenges. Devimistat, a first-in-class compound, targets cancer cell metabolism, showing promise for future cancer treatments.
Rafael Holdings, Inc. (NYSE: RFL) announced an inducement grant on April 15, 2021, to Chief Commercial Officer William Conkling for options to purchase 118,409 shares of Class B common stock. The exercise price is set at $40.85, reflecting the closing price on the previous trading day. The options will vest over a period, starting with 29,602 on April 15, 2022, followed by monthly vesting. This grant is part of Rafael's 2018 Equity Incentive Plan, designed to attract key talent while adhering to NYSE Rule 303A.08.