U2AF1

Continued progress on the development of emavusertib Strong balance sheet with $68.5 million in cash and investments; cash runway into 2025 Management to host conference call today at 8:30 a.m. ET LEXINGTON, Mass., Nov. 2, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies, today reported its business update and financial results for the quarter ended September 30, 2023. "Since the removal of the partial clinical hold, we have re-started patient enrollment in both the Phase 1/2 TakeAim Leukemia monotherapy and TakeAim Lymphoma combination studies and expect to initiate a triplet combination study in AML in the fourth quarter. We also expect to present updated data from the TakeAim Lymphoma combination study at ASH in December," said James Dentzer, President and CEO of Curis. Third Quarter 2023 and Recent Operational Highlights Emavusertib (IRAK4 Inhibitor) TakeAim Leukemia Curis is currently enrolling relapsed or refractory (R/R) AML/MDS patients with FLT3 or spliceosome mutation (U2AF1 or SF3B1) who have received < 3 prior lines of treatment. The Company expects additional data from this study in the first half of 2024. The Company expects to initiate a triplet combination study of emavusertib with azacitidine and venetoclax in the fourth quarter. This Phase 1 study is intended to evaluate emavusertib's safety, as well as its ability enhance the effectiveness of azacitidine and venetoclax. Initial data from this study is expected in the second half of 2024. TakeAim Lymphoma Curis is focusing its lymphoma clinical development efforts on Primary CNS lymphoma (PCNSL), a rare form of extranodal non-Hodgkin lymphoma for which there are limited treatment options. The Company is currently enrolling PCNSL patients in its TakeAim Lymphoma study in which patients are being treated with a combination of emavusertib and ibrutinib. The Company will present updated data from the study at the 65th ASH Annual Meeting December 9-12, 2023, which will include a PCNSL patient subset. Upcoming Milestones Curis expects updated clinical data from the TakeAim Lymphoma combination study with ibrutinib at the ASH Annual Meeting. The Company expects updated clinical data from the TakeAim Leukemia monotherapy study in the first half of 2024. The Company expects initial clinical data from the triplet combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the second half of 2024. Corporate In July 2023, Curis completed a registered direct offering with net proceeds of approximately $13.8 million. On September 28, 2023, the Company effected a 1-for-20 reverse stock split of its common stock. Third Quarter 2023 Financial Results For the third quarter of 2023, Curis reported a net loss of $12.2 million or $2.13 per share on both a basic and diluted basis as compared to $13.3 million or $2.83 per share on both a basic and diluted basis, for the same period in 2022. Curis reported a net loss of $35.7 million or $6.96 per share on both a basic and diluted basis, for the nine months ended September 30, 2023 as compared to a net loss of $45.3 million or $9.82 per share on both a basic and diluted basis for the same period in 2022. Revenues for the third quarters of 2023 and 2022 were both $2.8 million. Revenues for both periods consist of royalty revenues from Genentech and Roche's sales of Erivedge®. Revenues for the nine months ended September 30, 2023 and 2022 were both $7.3 million. Research and development expenses were $10.4 million for the third quarter of 2023, as compared to $10.8 million for the same period in 2022. The decrease was primarily attributable to lower employee-related costs due to a reduction in headcount, partially offset by increased clinical costs. Research and development expenses were $29.5 million for the nine months ended September 30, 2023, as compared to $34.6 million for the same period in 2022. General and administrative expenses were $4.8 million for the third quarter of 2023, as compared to $4.6 million for the same period in 2022. The increase was primarily attributable to higher professional, legal, and consulting services costs. General and administrative expenses were $13.8 million for the nine months ended September 30, 2023, as compared to $15.3 million for the same period in 2022. Other income, net was $0.2 million for the third quarter of 2023, as compared to other expense, net of $0.7 million for the same period in 2022. Other income (expense), net primarily consisted of interest income partially offset by non-cash expense related to the sale of future royalties. Other income, net was $0.4 million for the nine months ended September 30, 2023 compared to other expense, net $2.5 million for the same period in 2022. Curis's cash, cash equivalents and investments totaled $68.5 million, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments to enable its planned operations into 2025. Conference Call Information Curis management will host a conference call today, November 2, 2023, at 8:30 a.m. ET, to discuss the business update and these financial results. To access the live conference call, please dial 1-888-390-0546 from the United States or 1-416-764-8688 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the Investors section. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies in combination with the BTK inhibitor, ibrutinib, and as a monotherapy in the Phase 1/2 TakeAim Leukemia study in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib (CA-4948). Curis licensed its rights to Erivedge® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to Curis's plans, strategies and objectives, cash runway, statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the initiation, progression, expansion, use, safety, efficacy, dosage and potential benefits of emavusertib in clinical trials as a monotherapy and/or as a combination therapy, Curis's plans and timelines to provide preliminary, interim and/or additional data from its ongoing or planned clinical trials, its ability to further patient enrollment in its TakeAim Leukemia and TakeAim Lymphoma studies, and initiate its AML triplet study, any statements concerning Curis's expectations regarding its interactions with the FDA, statements with respect to mutations or potential biomarkers, and statements of assumptions underlying any of the foregoing. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, the FDA may take further regulatory action with regard to Curis's clinical trials. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreements with Aurigene and ImmuNext will continue for their full terms, or the CRADA with NCI, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to commercialize Erivedge in basal cell carcinoma. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K and Form 10-Q, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. SOURCE Curis, Inc.

LEXINGTON, Mass., July 6, 2023 /PRNewswire/ -- Curis, Inc., (Nasdaq: CRIS), a biotechnology company focused on the development of emavusertib, an orally available small molecule triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS). "We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 prior lines of treatment). We also plan to initiate a front-line combination study of emavusertib with azacitidine and venetoclax. We believe emavusertib has the potential to be the cornerstone agent in the treatment of hematological malignancies." said James Dentzer, President and Chief Executive Officer of Curis. "In 2024, we expect to have updated data from the TakeAim Leukemia monotherapy study, clarification of a monotherapy registrational study design, and initial data from an azacitidine and venetoclax combination study." On April 4, 2022, the Company announced that the FDA placed a partial clinical hold on the TakeAim Leukemia study. On August 30, 2022, the Company announced that the FDA notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase of the TakeAim Leukemia study, so that the Company could enroll at least nine additional patients at the 200 mg BID dose level. On July 6, 2023, the Company announced the FDA had removed the partial clinical hold on the TakeAim Leukemia study and that the RP2D has been established at 300 mg BID. In the TakeAim Leukemia study, as of the March 17, 2023 data cutoff for patients dosed prior to February 9, 2023, 84 patients received emavusertib monotherapy, ranging from doses of 200 mg to 500 mg BID. Significant blast count reductions have been observed across all patient groups, regardless of dose level, mutation status, or number of prior lines of treatment. Emerging from these data are two genetically-defined subpopulations of relapsed/refractory (R/R) patients who have demonstrated compelling responses in monotherapy: AML patients with FLT3 mutation and AML patients with spliceosome mutation (U2AF1 or SF3B1 mutation) who have received ≤ 2 prior lines of treatment. In these subpopulations of evaluable patients (patients whose disease has been determined to be evaluable for objective response with baseline and post-treatment marrow assessments) treated with 300 mg BID, 2 of 3 patients with a FLT3 mutation achieved a CR (Complete Response), and 2 of 3 patients with spliceosome mutation achieved a CR or CRh (Complete Response with Partial Hematologic Recovery). The duration of response for these patients ranged from 5.6 to 7.0 months. "A significant unmet need remains for patients with AML and MDS with the majority of front-line patients relapsing with currently available treatment options," said Dr. Reinhard von Roemeling, Senior Vice President of Clinical Development of Curis. "Emavusertib has the potential to be uniquely positioned as an addition to frontline therapy in combination with standard of care and also as a monotherapy in targeted R/R patient populations." About emavusertib (CA-4948) Emavusertib is a triple target inhibitor (IRAK4, FLT3 and CLK). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax. About TakeAim Studies TakeAim Leukemia Study (NCT04278768) – study is open for enrollment. TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment. About Curis, Inc. Curis is a biotechnology company focused development of emavusertib, a triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, emavusertib (CA-4948). Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies, both as a monotherapy and in combination with BTK inhibitor ibrutinib, and the Phase 1/2 TakeAim Leukemia study in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to Curis's plans, strategies and objectives to resume and further patient enrollment in its TakeAim Leukemia study, initiate a front-line combination study of emavusertib with azacitidine and venetoclax, and provide updated data from such studies and clarification of a monotherapy registrational study design for its TakeAim Leukemia study, statements concerning product research, development, clinical trials and studies and commercialization plans, timelines, anticipated results or the therapeutic potential of drug candidates including any statements regarding the initiation, progression, expansion, use, safety, efficacy, dosage and potential benefits of emavusertib in clinical trials as a monotherapy and/or as a combination therapy, the progression, use and potential benefits of CI-8993, Curis's plans and timelines to provide preliminary, interim and/or additional data from its ongoing or planned clinical trials, its ability to further patient enrollment in its TakeAim Leukemia and TakeAim Lymphoma studies, any statements concerning Curis's expectations regarding its interactions with the FDA, statements with respect to mutations or potential biomarkers, and statements of assumptions underlying any of the foregoing. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, the FDA may take further regulatory action with regard to Curis's clinical trials. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreements with Aurigene and ImmuNext will continue for their full terms, or the CRADA with NCI, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to commercialize Erivedge in basal cell carcinoma. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K and Form 10-Q, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. SOURCE Curis, Inc.

Results from Phase 3 COMMANDS study, selected for ASCO’s official press program, show nearly twice as many patients treated with Reblozyl achieved superior transfusion independence with concurrent hemoglobin increase vs. epoetin alfa, including in clinically relevant subgroups Reblozyl demonstrated a durable response, with nearly 2.5 years median transfusion independence, 1 year longer than epoetin alfa Additional results, to be presented during the plenary session at the European Hematology Association Congress, show Reblozyl demonstrated clinical benefit across patients with spectrum of MDS mutations PRINCETON, NJ, USA I May 25, 2023 I Bristol Myers Squibb (NYSE: BMY) today announced first results from the Phase 3 COMMANDS study, an open-label, randomized trial evaluating Reblozyl ® (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia in adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require red blood cell (RBC) transfusions and are ESA-naïve. Results from the study will be featured as part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 3 p.m. EDT (Abstract #7003), and in an oral presentation of select abstracts during a plenary session at the European Hematology Association (EHA) Congress on June 10, 2:45 p.m. CEST (Abstract #S102). “Chronic anemia, low hemoglobin levels and transfusion dependency are the primary clinical challenges for patients with lower-risk MDS, increasing the risk of death by more than half compared to those who do not require transfusions,” said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. “Results from the COMMANDS study showed treatment with Reblozyl compared to epoetin alfa led to superior and statistically significant improvements in red blood cell transfusion independence and hemoglobin increase, improvements in response durability, and equal or better outcomes across all subgroups, with acceptable safety and tolerability for patients with ESA-naïve, lower-risk MDS.” The primary endpoint evaluated in the COMMANDS study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase of ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks. COMMANDS Study Results at ASCO At the time of the interim analysis, 147 evaluable patients received Reblozyl and 154 evaluable patients received epoetin alfa, with median treatment durations of 41.6 and 27 weeks, respectively. Results showed 58.5% (n=86) of patients receiving Reblozyl vs. 31.2% (n=48) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean hemoglobin (Hb) increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001). HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl patients vs. 51.3% (n=79) of epoetin alfa patients (p<0.0001). Patients treated with Reblozyl achieved more durable responses vs. epoetin alfa, with a median duration of response of RBC-TI ≥12 weeks (Week 1 to end of treatment) of 126.6 vs. 77 weeks. Within the first 24 weeks of treatment, RBC-TI of at least 24 weeks was achieved by 47.6% (n=70) of Reblozyl patients vs. 29.2% (n=45) of epoetin alfa patients (P=0.0006). Benefit with Reblozyl was also observed in clinically relevant subgroups, and results showed a consistent safety profile and no new safety signals. COMMANDS Study Results at EHA Data to be presented at EHA included both efficacy and safety consistent with results at ASCO, and showed Reblozyl demonstrated favorable outcomes compared to epoetin alfa across common MDS mutations (SF3B1, SF3B1a, ASXL1, TET2, DNMT3A, EZH2, IDH2, U2AF1) and had a higher probability of achieving clinical benefit, regardless of overall mutational burden. A supplemental Biologics License Application for Reblozyl is currently under Priority Review with the U.S. Food and Drug Administration (FDA) for treatment of anemia in ESA-naïve adult patients with very low- to intermediate-risk MDS who may require RBC transfusions with an assigned Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2023. The European Medicines Agency has also validated the Type II Variation for Reblozyl in this patient population. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. “Clinical experience has demonstrated that just one in three patients with low-risk myelodysplastic syndromes experience responses to erythroid stimulating agents over 6-18 months, leaving a significant need for more effective options to address chronic anemia,” said Matteo Giovanni Della Porta, study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy. “In the COMMANDS study, the median duration of red blood cell transfusion independence was nearly one year longer with Reblozyl than with epoetin alfa and showed safety consistent with its known profile, demonstrating its potential as a first-line treatment in patients with transfusion-dependent, very low- to intermediate-risk MDS.” “Results being presented at ASCO and EHA reinforce the notion that Reblozyl should be used as the initial treatment of anemia in patients with lower- to intermediate-risk myelodysplastic syndromes,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “As a potentially more effective and durable upfront treatment option, Reblozyl could shift the paradigm for standard of care among these patients.” About MDS Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production of healthy red blood cells (RBC), white blood cells and platelets, which can lead to anemia and frequent or severe infections. 1,2 People with MDS who develop anemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation. 3 Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections. 4 Patients who become RBC transfusion-dependent have a significantly shorter overall survival than those who are not dependent on transfusions, partially due to iron overload or to more severe bone marrow disease than in non-transfusion dependent patients. 5 About Reblozyl ® (luspatercept-aamt) Reblozyl , a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models. 6 Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of: Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. In the U.S., Reblozyl is not indicated for use in patients with non-transfusion-dependent beta thalassemia. Please see full Prescribing Information and Summary of Product Characteristics for REBLOZYL. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram . References: SOURCE: Bristol Myers Squibb