Rigel Pharmaceuticals and MD Anderson Announce Strategic Alliance to Advance REZLIDHIA in AML and Other Cancers

SOUTH SAN FRANCISCO - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) and The University of Texas MD Anderson Cancer Center (MD Anderson) today announced a multi-year strategic development collaboration to expand the evaluation of REZLIDHIA (olutasidenib) in acute myeloid leukemia (AML) and other hematologic cancers.

The alliance brings together MD Anderson's clinical research expertise with Rigel's differentiated targeted molecule. Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative neoplasms (MPN), in combination with other agents. The collaboration will also support the evaluation of olutasidenib as monotherapy in lower-risk MDS and as maintenance therapy in post-hematopoietic stem cell transplant patients.

'We are excited to enter into this strategic alliance with the exceptional team at MD Anderson to evaluate REZLIDHIA as a potential therapy for a broad range of IDH1-mutant cancers,' said Raul Rodriguez, Rigel's president and CEO. 'We believe REZLIDHIA has the potential to become a standard of care for patients in urgent need of new hematology-oncology therapies. We look forward to a close collaboration with MD Anderson to advance this as a new therapeutic option for more patients.'

REZLIDHIA is a potent, selective, oral, small-molecule inhibitor of mutated IDH1 (mIDH1)1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. REZLIDHIA is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with R/R AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

'Based on its differentiated profile and compelling clinical data to date, REZLIDHIA has the potential, beyond its currently approved indication, to benefit patients with various cancers where mutant IDH1 is thought to play a role,' said Courtney DiNardo, M.D., professor of Leukemia. 'We look forward to collaborating with Rigel to conduct in-depth studies that will determine the broader potential of REZLIDHIA in these patient populations.'

Rigel and MD Anderson will jointly lead all clinical development efforts, which will be overseen by a joint steering committee. Rigel will provide $15 million in time-based milestone payments and study material over the five-year collaboration. Rigel will retain all rights to its programs under the collaboration.

About AML

Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About Rigel

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California.

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world, and, in 1971, it became one of the nation's first National Cancer Institute (NCI)-designated comprehensive cancer centers. MD Anderson is No. 1 for cancer in U.S. News & World Report's 'Best Hospitals' rankings and has been named one of the nation's top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Forward Looking Statements

This press release contains forward-looking statements relating to, among other things, the potential and market opportunity of REZLIDHIA (olutasidenib), both as a monotherapy and in combination with other agents, as a therapeutic for R/R AML and other conditions, the potential of REZLIDHIA as a therapy for a broad range of mIDH1 cancers, the potential of REZLIDHIA to become a standard of care for patients in need of new hematology-oncology therapies and the benefits of Rigel's collaboration with MD Anderson Cancer Center. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as 'potential', 'may', 'will' and similar expressions in reference to future periods. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks and uncertainties and are subject to changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the risks and uncertainties of clinical trials and drug development; risks and uncertainties of commercialization and marketing of olutasidenib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that olutasidenib may have unintended side effects, adverse reactions or incidents of misuse; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

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