Rafael Holdings Stock Price, News & Analysis

On September 14, 2021, Rafael Holdings, Inc. (NYSE: RFL) announced the appointment of Patrick Fabbio as Chief Financial Officer. With over 25 years of extensive experience in financial and operational roles within the life sciences sector, Fabbio aims to enhance the company’s financial strategy as it approaches pivotal clinical trial data for CPI-613®, targeting metastatic pancreatic cancer. CEO Ameet Mallik expressed confidence in Fabbio’s ability to drive growth in oncology therapeutics. Rafael Holdings continues to invest in its pipeline and aims for commercialization of its cancer metabolism therapies.

On August 26, 2021, Rafael Pharmaceuticals announced that CEO Sanjeev Luther will present at the World Orphan Drug Congress. His presentation, titled 'Leveraging Relationships in Ultra-rare Cancers,' will focus on the development of CPI-613® (devimistat) for ultra-rare cancers. Devimistat targets cancer cell metabolism, enhancing the effectiveness of chemotherapy while reducing side effects. The FDA has approved pivotal Phase 3 trials for devimistat in pancreatic cancer and acute myeloid leukemia and granted it orphan drug status for several cancers. More details will be available on Rafael’s website post-congress.

Rafael Pharmaceuticals has successfully completed a Phase 1b clinical trial of CPI-613® (devimistat) combined with gemcitabine and cisplatin for biliary tract cancer. This multicenter study, in collaboration with Michigan Medicine, showed promising results and identified the recommended Phase 2 dose. Phase 2 trials are currently enrolling patients to evaluate the efficacy of devimistat at maximum tolerated doses. Devimistat targets energy metabolism in cancer cells, aiming to improve treatment outcomes for patients with significant unmet medical needs.

Rafael Holdings (NYSE: RFL) has successfully closed a private investment in public equity (PIPE) financing, raising approximately $104.2 million. This financing involved the purchase of 2,833,425 shares of Class B common stock at $35.00 per share, with additional shares purchased at $44.42 by an investor linked to Howard Jonas. The transaction was orchestrated by SVB Leerink and Raymond James. The funds are expected to support Rafael Holdings' oncology initiatives, particularly through its partnerships in cancer therapy development.

Rafael Holdings, Inc. (NYSE: RFL) announced a private placement expected to generate gross proceeds of $104.2 million. The company will sell 2,833,426 shares of Class B common stock at $35.00 per share, plus 112,561 shares to an accredited investor at $44.42 per share, the closing price on August 19, 2021. The offering, not registered under the Securities Act, is subject to conditions and is set to close on August 24, 2021. A registration statement will be filed for resales of the securities.

Rafael Holdings, Inc. (NYSE: RFL) announced the addition of three senior executives: Gus Kodersha as Chief Technical Operations Officer, Melissa Lozner as Chief Compliance & Ethics Officer, and Brandi Robinson as Chief Corporate Affairs Officer. This strategic move aims to strengthen the company's leadership as it advances critical Phase 3 clinical trials, particularly for CPI-613® targeting metastatic pancreatic cancer. CEO Ameet Mallik emphasized the new leaders' extensive experience, which is expected to enhance the company’s potential in developing cancer metabolism therapeutics.

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.