RFL Rafael Holdings Inc

Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced that it will present two posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021. These presentations will discuss the ongoing trials studying devimistat in pancreatic cancer and biliary tract cancer.

“We are incredibly proud to have data to share in two hard-to-treat cancers; as challenging as the past year has been to ensure that we continue to move the needle, we have been able to make significant progress,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “The data continues to show us hope for the future, with our continued commitment to patients at the forefront.”

Presentation Details:Title:  Abstract #TPS4158: A multicenter, randomized phase 1b/2 study of gemcitabine and cisplatin with or without CPI-613 as first-line therapy for patients with advanced unresectable biliary tract cancer (BilT-04)Date: June 4, 2021Time: 8:00 a.m. ETLocation: ASCO Meeting Library

Title:  Abstract #TPS4176: A phase II open-label study of CPI-613 in combination with modified (m)FOLFIRINOX in patients with locally advanced pancreatic cancer.Date: June 4, 2021Time: 8:00 a.m. ETLocation: ASCO Meeting Library

“It’s an honor to be able to present our ongoing research in pancreatic cancer at one of the most renowned meetings in clinical oncology. As pancreatic cancer remains a challenge for patients and clinicians, each presentation is an opportunity to share the potential for devimistat as a future treatment option,” said David L. Bajor M.D., Assistant Professor, Seidman Cancer Center, University Hospitals Cleveland, Case Comprehensive Cancer Center. 

“Advanced biliary cancer remains a challenge for patients and clinicians and it is crucial to continue to investigate promising novel agents, such as devimistat in this rare cancer,” said Vaibhav Sahai, MBBS, M.S., Principal Investigator, University of Michigan. 

About CPI-613® (devimistat) CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000) and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.

About Rafael Pharmaceuticals, Inc.Rafael Pharmaceuticals is a leader in the growing field of cancer metabolism. The company is developing a new, first-in-class category of metabolic oncology therapeutics that attack hard-to-treat cancers by targeting the metabolic processes the disease needs to survive, grow and proliferate. Rafael Pharmaceuticals’ lead compound, CPI-613® (devimistat), is a highly selective, well-tolerated and effective anti-cancer agent that is being evaluated in ongoing and completed Phase 1, 2 and 3 clinical trials. Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Burkitt’s, peripheral T-cell lymphomas and soft tissue sarcoma. The Company's investors include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more information, please visit www.rafaelpharma.com.

Safe Harbor StatementThis press release contains forward-looking statements. These statements relate to future events or the company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.

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Rafael Media Contact:Diana Cleinmarkrafael@antennagroup.com (408) 713-1216