1. BOSTON, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced that Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara, will present at the H.C. Wainwright BioConnect 2022 Virtual Conference being held January 10–13, 2022.

    A webcast of the pre-recorded presentation will be made available at 7:00 AM ET on Monday, January 10th and will be available under "Events and Presentations" in the Investors section of the company's website at www.imaratx.com.

    About Imara
    Imara Inc. is a clinical-stage…

    BOSTON, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced that Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara, will present at the H.C. Wainwright BioConnect 2022 Virtual Conference being held January 10–13, 2022.

    A webcast of the pre-recorded presentation will be made available at 7:00 AM ET on Monday, January 10th and will be available under "Events and Presentations" in the Investors section of the company's website at www.imaratx.com.

    About Imara

    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. For more information, please visit www.imaratx.com.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

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  2. Oral presentation provides first look at new program, IMR-261, a novel, oral, clinic-ready nuclear factor erythroid 2-related factor 2 (Nrf2) activator

    SCD Townes mouse model demonstrates IMR-261 activation of Nrf2 increases HbF and F-cells, reduces VOCs and reduces markers of adhesion and hemolysis

    Beta-thalassemia mouse model shows IMR-261 increases hemoglobin and improves ineffective erythropoiesis

    BOSTON, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced the presentation of data from its nuclear…

    Oral presentation provides first look at new program, IMR-261, a novel, oral, clinic-ready nuclear factor erythroid 2-related factor 2 (Nrf2) activator

    SCD Townes mouse model demonstrates IMR-261 activation of Nrf2 increases HbF and F-cells, reduces VOCs and reduces markers of adhesion and hemolysis

    Beta-thalassemia mouse model shows IMR-261 increases hemoglobin and improves ineffective erythropoiesis

    BOSTON, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced the presentation of data from its nuclear factor erythroid 2-related factor 2 (Nrf2) activator program, IMR-261, at the American Society of Hematology (ASH) Annual Meeting, held December 11-14, 2021.

    "I am excited by these preclinical data demonstrating the beneficial effect of IMR-261 in mouse models of sickle cell disease and beta-thalassemia," said Dr. Betty Pace, Professor of Pediatrics at Augusta University and Director of the Comprehensive Sickle Cell Program Telehealth Center. "Induction of fetal hemoglobin is an effective strategy to ameliorate the pathophysiology of sickle cell disease, and the direct mechanistic role of Nrf2 in fetal hemoglobin reactivation has been established by my lab and other researchers. Nrf2-mediated protection against oxidative stress further highlights the therapeutic potential of IMR-261 for the treatment of hemoglobin disorders and potentially more broadly."

    Preclinical studies evaluated the impact of IMR-261 using in-vitro cell cultures and in-vivo mouse models of sickle cell disease (SCD) and beta-thalassemia. In CD34+ cells from sickle cell and healthy donors, high dose IMR-261 reactivated HbF by approximately 7-fold versus placebo, whereas lower dose IMR-261 reactivated HbF by approximately 4-fold versus placebo. Furthermore, an approximately 3-fold increase in F-cells was seen in both high dose and low dose groups when compared to placebo. In the Townes mouse model of SCD, high dose IMR-261 reactivated HbF by approximately 2.2-fold when compared to placebo (8.3 ng/ml versus 3.7 ng/ml). In addition, high dose IMR-687 significantly decreased select markers of hemolysis and increased hemoglobin (Hb) by approximately 1.1 g/dL when compared to placebo (8.7 g/dL versus 7.6 g/dL).

    In a separate experiment in Townes SCD mice that assessed VOC reduction after administration of TNF-alpha, IMR-261 significantly reduced the presence of red blood cells on occluded vessels when compared to placebo. IMR-261 was also tested in a mouse model of beta-thalassemia (Hbbth1/th1) and showed significant increases in Hb and reductions in ineffective erythropoiesis at the high dose.

    "We are pleased to report robust data with IMR-261 in validated preclinical models of SCD and beta-thalassemia," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "IMR-261 also has the potential to work across several areas beyond hemoglobin disorders and we are exploring diseases of iron overload to further expand our portfolio reach. It is exciting to have this clinical-ready asset and we look forward to providing further updates on study plans in 2022."

    IMR-261, formerly known as CXA-10, was previously evaluated by Complexa, Inc. in Phase 2 clinical trials for focal segmental glomerulosclerosis (FSGS) and pulmonary arterial hypertension (PAH). Independent medical literature suggests potential promise in a broad array of RBC diseases, including hemoglobin disorders and iron overload diseases.

    Presentation at the American Society of Hematology (ASH) Annual Meeting:

    Title: IMR-261, a Novel Oral Nrf2 Activator, Induces Fetal Hemoglobin in Human Erythroblasts, Reduces VOCs, and Ameliorates Ineffective Erythropoiesis in Experimental Mouse Models of Sickle Cell Disease and Beta-Thalassemia

    Abstract: 853

    Presenter: Thiago Trovati Maciel, Ph.D., INSERM, France

    The presentation will be available on the Investors section of the Imara website.

    About IMR-261

    IMR-261 (formerly CXA-10) is an activator of nuclear factor erythroid 2–related factor 2, or Nrf2. Nrf2 coordinates the expression of antioxidant genes in response to oxidative stress, regulates inflammation, inhibits the NF-kB pathway, and reactivates fetal hemoglobin, or HbF. In preclinical sickle cell disease models, IMR-261 significantly increased HbF and F-cells, improved hemolytic markers, and decreased vaso-occlusive crises. In a preclinical beta-thalassemia model, IMR-261 increased hemoglobin and enabled RBC maturation. Imara has initiated work on drug product manufacturing for IMR-261, as it explores potential clinical development paths.

    About Imara

    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. For more information, please visit www.imaratx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company's potential clinical development plans for IMR-261 and beliefs regarding the therapeutic potential of IMR-261. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research and development activities; and other factors discussed in the "Risk Factors" section of the Company's most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

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  3. BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced the presentation of 12-month data from its Phase 2a open-label extension (OLE) trial for tovinontrine (IMR-687) as a potential treatment for sickle cell disease (SCD) at the American Society of Hematology (ASH) Annual Meeting, held December 11-14, 2021.

    "These 12-month OLE data highlight the potential for tovinontrine to have longer term impact on VOC reductions. They also build upon previously-reported positive VOC results from the Phase 2a and…

    BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced the presentation of 12-month data from its Phase 2a open-label extension (OLE) trial for tovinontrine (IMR-687) as a potential treatment for sickle cell disease (SCD) at the American Society of Hematology (ASH) Annual Meeting, held December 11-14, 2021.

    "These 12-month OLE data highlight the potential for tovinontrine to have longer term impact on VOC reductions. They also build upon previously-reported positive VOC results from the Phase 2a and OLE clinical trials," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "Reducing VOC rate is an established endpoint for regulatory approval and is becoming the primary endpoint of our ongoing Ardent Phase 2b clinical trial of tovinontrine in patients with sickle cell disease. We expect to report initial VOC data from the Ardent clinical trial in the first quarter of 2022 and continue to work with the FDA on a path towards registration."

    SCD OLE Data Highlights:

    Imara is conducting a four-year OLE clinical trial, a safety and tolerability study comprised of patients who completed Imara's Phase 2a clinical trial of tovinontrine in SCD. Subjects in the OLE clinical trial have received a once-daily dose of tovinontrine of 200 mg, and are in the process of being dose escalated to a once-daily dose of up to 400 mg. Of the 26 subjects enrolled, 21 were evaluable at month 12 as of the data cut-off.

    Tovinontrine was generally well-tolerated as a monotherapy as well as in combination with hydroxyurea. There were no clinically-significant changes in lab safety data, ECGs or vital signs, and no patients have discontinued the study due to adverse events. The median annualized VOC rate was reduced by 38% in subjects previously in the placebo group in the Phase 2a clinical trial (N=7), with median annualized VOC rates of 5.0 (Phase 2a) and 3.1 (OLE) per year; median duration of treatment was 6.4 months and 11.6 months, respectively.

    The low median annualized VOC rate for tovinontrine-treated patients in the Phase 2a clinical trial was maintained in subjects in the OLE clinical trial (N=14), with median annualized VOC rates of 0 (Phase 2a) and 2.0 (OLE) per year; median duration of treatment was 6.4 months and 11.8 months, respectively.

    22% (4/18) of evaluable subjects had an absolute increase in fetal hemoglobin (HbF) greater than 3%. 47% (9/19) of subjects had an absolute increase in F-cells greater than 6%; F-cell increases were observed in 18 out of 19 evaluable subjects.

    "We're happy to be closing out 2021 by sharing positive 12-month VOC data for tovinontrine as a potential candidate to treat sickle cell disease," said Dr. Ballal. "The Imara team is looking forward to making further progress in 2022 towards our goal of delivering accessible, effective treatment options for patients suffering from disorders of hemoglobin."

    Beta-thalassemia Preclinical Data Highlights:

    In addition to the 12-month OLE data, Imara also reported preclinical data studying the effects of tovinontrine in beta-thalassemia mouse models. The preclinical results showed tovinontrine improved markers of beta-thalassemia, including an increase in total hemoglobin and red blood cell count. Based in part on these results, Imara is currently conducting the Forte Phase 2b clinical trial of tovinontrine in beta-thalassemia and expects to report data from transfusion-dependent subjects with beta-thalassemia in the first quarter of 2022.

    Presentations at the American Society of Hematology (ASH) Annual Meeting:

    Title: Treatment with IMR-687, a Highly Selective PDE9 Inhibitor, Increases HbF and Reduces VOCs in Adults with Sickle Cell Disease in a Long-Term, Phase 2a, Open-Label Extension Study

    Abstract: 2046

    Presenter: Biree Andemariam, M.D., Associate Professor at UConn School of Medicine, Director of the New England Sickle Cell Institute at UConn Health

    Title: PDE9 Inhibition By IMR-687 Improves Markers of Beta-Thalassemia in the Hbbth1/th1 Experimental Mouse Model

    Abstract: 945

    Presenter: Jennifer O'Cain, Ph.D., Imara Inc.

    The presentations will be available on the Investors section of the Imara website.

    About Tovinontrine (IMR-687)

    Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). Tovinontrine has a multimodal mechanism of action that acts primarily on red blood cells, or RBCs, and has the potential to act on white blood cells, or WBCs, adhesion mediators and other cell types. PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production on RBCs. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia. Blocking PDE9 acts to increase cGMP levels, which is associated with lower WBC activation and reduced adhesion across various cell types, both of which also contribute to SCD, including the occurrence of vaso-occlusive crises (VOCs). Increasing cGMP levels is also associated with several additional benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia.

    About Imara

    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. For more information, please visit www.imaratx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the timing for reporting of additional data from the Company's Ardent and Forte Phase 2b clinical trials of tovinontrine (IMR-687) in patients with sickle cell disease and beta-thalassemia and (ii) the Company's engagement with the FDA regarding tovinontrine and (iii) the Company's beliefs regarding the strength of its clinical data, the therapeutic potential of tovinontrine and advancement of its development programs. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Ardent and Forte Phase 2b clinical trials of tovinontrine in sickle cell disease and beta-thalassemia; the Company's ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the "Risk Factors" section of the Company's most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

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  4. Primary endpoint to be changed to annualized rate of VOCs following written U.S. Food and Drug Administration recommendation

    No change to conduct or size of trial planned; Ardent trial remains on track for interim analysis of VOC rates in first quarter of 2022

    BOSTON, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S…

    Primary endpoint to be changed to annualized rate of VOCs following written U.S. Food and Drug Administration recommendation

    No change to conduct or size of trial planned; Ardent trial remains on track for interim analysis of VOC rates in first quarter of 2022

    BOSTON, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA).

    Imara requested feedback from the FDA on the draft statistical analysis plan (SAP) for the Ardent trial in which fetal hemoglobin (HbF) response was the primary endpoint and annualized rate of vaso-occlusive crises (VOCs) was the key secondary endpoint. In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs. HbF response will continue to be evaluated as a key secondary endpoint. The endpoint revisions do not affect the conduct of the trial or operational aspects of the study. As part of its recommendation, the FDA suggested further interactions regarding the revised SAP and engagement on the potential of the current program for regulatory decision-making.

    "We welcome the FDA's recommendations and are in the process of changing the primary endpoint of the Ardent trial to be annualized rate of VOCs and moving HbF response to be a key secondary endpoint," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "A reduction in VOC rate is an established approval endpoint, and we are engaging the FDA further on this and related topics, including possible streamlined paths to registration."

    Dr. Ballal continued, "In light of this endpoint revision, the previously planned fourth quarter interim analysis will no longer occur. That interim analysis had been designed to have a focus on safety and pharmacodynamic biomarkers, including HbF, but did not include a review of VOCs. The first review of data from the Ardent trial, including annualized VOC rate, will be conducted when all subjects have completed assessment at Week 24 or terminated early, and is planned for the first quarter of 2022, subject to our upcoming discussions with the FDA. Final data analysis from the Ardent trial remains on track for the second half of 2022. In June 2021, we reported promising data from our Phase 2a and open label extension clinical trials in SCD that demonstrated reduced annualized rates of VOCs in patients treated with tovinontrine versus placebo. We expect to present updated 12-month VOC data from our ongoing Phase 2a open label extension clinical trial at the American Society of Hematology Annual Meeting in December 2021."

    About the Ardent Phase 2b Clinical Trial

    The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled. The planned primary efficacy objective will be to evaluate the annualized rate of vaso-occlusive crises (VOCs) in patients dosed with tovinontrine (IMR-687) as compared to placebo. A key secondary endpoint will be to evaluate the proportion of all patients with fetal hemoglobin (HbF) response, defined as an absolute increase from baseline of at least 3% in HbF, as compared to placebo. Additional endpoints include the evaluation of the effect of tovinontrine versus placebo on other VOC-related outcome measures, HbF-associated biomarkers, markers of red blood cell hemolysis, white blood cell adhesion markers and quality of life measures over the course of a one-year treatment period. For more information about the Ardent trial visit ClinicalTrials.gov here.

    The FDA has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations and the European Commission has granted Orphan Drug designation for tovinontrine for the treatment of SCD.

    About Tovinontrine (IMR-687)

    Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which is associated with several benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia.

    About Sickle Cell Disease

    Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder. The disease causes structural abnormalities in hemoglobin that cause red blood cells to become inflexible and elongated, ultimately blocking blood flow to organs, which can lead to vaso-occlusive crises (VOCs). SCD is characterized by debilitating pain, progressive multi-organ damage and early death. The global prevalence of SCD is estimated to be approximately 4.4 million patients, including an estimated 100,000 patients in the United States and 134,000 patients in the European Union.

    About Imara

    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. For more information, please visit www.imaratx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the Company's plans to change the primary and secondary endpoints for the Ardent Phase 2b clinical trial of tovinontrine (IMR-687), (ii) the timing for reporting of additional data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in patients with sickle cell disease and (iii) the Company's planned discussions with the FDA regarding the regulatory pathway for tovinontrine. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in sickle cell disease; the Company's ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the "Risk Factors" section of the Company's most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

    617-835-4061



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  5. Positive trend observed in transfusion-dependent subjects treated with higher dose tovinontrine for reduced transfusion burden

    Tovinontrine was generally well-tolerated in this patient population

    BOSTON, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced data from a pre-specified interim analysis from its ongoing Forte Phase 2b clinical trial of tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with beta-thalassemia.

    "Today's announcement of the first clinical data exploring tovinontrine's…

    Positive trend observed in transfusion-dependent subjects treated with higher dose tovinontrine for reduced transfusion burden

    Tovinontrine was generally well-tolerated in this patient population

    BOSTON, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat subjects suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced data from a pre-specified interim analysis from its ongoing Forte Phase 2b clinical trial of tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with beta-thalassemia.

    "Today's announcement of the first clinical data exploring tovinontrine's potential in transfusion-dependent patients with beta-thalassemia marks an important milestone for Imara and patients with beta-thalassemia seeking oral therapies," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "We are encouraged by the positive trend for transfusion burden reduction at the higher dose of tovinontrine. Furthermore, we are pleased that the interim data continue to demonstrate a favorable safety and tolerability profile at doses of tovinontrine up to 400 mg once daily. We look forward to a key efficacy analysis, which we expect will occur in the first quarter of 2022, with more subjects treated through 24 weeks. In addition, we are continuing to advance enrollment in the non-transfusion-dependent (NTDT) cohort of the trial and expect to report initial NTDT data in the first half of 2022."

    Highlights of the Forte Phase 2b Interim Analysis

    Subjects in the Forte trial were randomized to either a lower dose group (200 mg or 300 mg), higher dose group (300 mg or 400 mg), or placebo, utilizing a pre-defined weight gate. Of the 43 TDT subjects in this interim dataset, 35 completed at least 12 weeks of treatment and were in the analysis population for transfusion burden. Safety data through week 24 from higher and lower dose groups were pooled for this interim analysis to prevent unblinding of the study. The median baseline transfusion burden in each of the higher dose tovinontrine and placebo groups was 7.5 red blood cell (RBC) units/12 weeks. Furthermore, 54% of the subjects in the analysis population (19/35) had the more severe β00 genotype.

    Interim data from the Forte study demonstrated tovinontrine was well-tolerated, with the most frequent adverse events (≥10% of subjects in pooled tovinontrine dose groups) being nausea, headache and dizziness. Four (9.3%) subjects discontinued due to adverse events considered at least possibly related to study drug.

    The proportion of subjects who had a ≥33% reduction in transfusion burden (of at least 2 units) in any 12-week interval as compared to the 12-week interval prior to randomization was greater in the higher dose tovinontrine group (7/8) versus placebo, despite an unexpectedly high response rate in the placebo group (8/12). Lower dose tovinontrine did not show a higher response rate when compared to the placebo group. No substantial differences between groups were observed in transfusion burden response rate using a fixed interval (weeks 13-24). Red blood cell markers are not evaluable in these regularly transfused subjects. Additional data will be presented as part of a key efficacy analysis expected in the first quarter of 2022.

    About the Forte Phase 2b Clinical Trial

    The Forte study is a 9-month, global, randomized, double-blind, placebo-controlled, multicenter Phase 2b clinical trial evaluating the safety and tolerability of tovinontrine (IMR-687) in approximately 120 adult subjects with beta-thalassemia. Patient randomization is stratified by transfusion-dependent thalassemia (TDT) or non-transfusion-dependent thalassemia (NTDT). The primary objective of the study is safety and tolerability. For TDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo in reducing transfusion burden. For NTDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo on fetal hemoglobin as well as total hemoglobin. For more information about the Forte trial visit https://www.clinicaltrials.gov/ct2/show/NCT04411082.

    The U.S. Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations for tovinontrine for the treatment of beta-thalassemia.

    About Tovinontrine (IMR-687)

    Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which is associated with a number of benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia.

    About Beta-Thalassemia

    Beta-thalassemia, a hemoglobinopathy, is a rare inherited red blood cell disorder. The disease can lead to severe anemia, splenomegaly, skeletal abnormalities and iron overload leading to organ failure and early death. The prevalence of beta-thalassemia globally is estimated to be approximately 288,000, with an incidence of 60,000 births per year, and it is especially prevalent in northern Africa, South Asia, Southeast Asia, the Mediterranean region and the Middle East. The total combined prevalence of beta thalassemia in the European Union and United States is estimated to be approximately 19,000 patients.

    About Imara

    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. For more information, please visit www.imaratx.com.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the timing for reporting of additional data from the Company's Forte Phase 2b clinical trials of tovinontrine (IMR-687) in patients with beta-thalassemia and (ii) the Company's beliefs regarding the strength of its clinical data, the therapeutic potential of tovinontrine and advancement of its development programs. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company's business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Forte Phase 2b clinical trial of tovinontrine in beta-thalassemia; the Company's ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the "Risk Factors" section of the Company's most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

    617-835-4061



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