IMRA IMARA Inc.

3.28
-0.14  -4%
Previous Close 3.42
Open 3.37
52 Week Low 3.06
52 Week High 29.1
Market Cap $86,184,368
Shares 26,275,722
Float 13,233,710
Enterprise Value $-12,260,031
Volume 46,851
Av. Daily Volume 120,204
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Upcoming Catalysts

Drug Stage Catalyst Date
Tovinontrine (IMR-687)
Sickle cell disease
Phase 2a
Phase 2a
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Tovinontrine (IMR-687) - (Ardent)
Sickle cell disease (SCD)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Tovinontrine (IMR-687) - (Forte)
b-thalassemia
Phase 2b
Phase 2b
Phase 2b interim data showed an uptrend observed in transfusion-dependent subjects treated with higher dose for reduced transfusion burden. The dose was generally well-tolerated in this patient population, noted November 16, 2021. Efficacy analysis expected 1Q 2022.

Latest News

  1. 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



    Primary Logo

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  2. 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



    Primary Logo

    View Full Article Hide Full Article
  3.    Interim analysis data for Phase 2b clinical trials of tovinontrine (IMR-687) in patients with beta-thalassemia and sickle cell disease expected in fourth quarter of 2021

    Introduction of pipeline program IMR-261, a novel oral clinic-ready Nrf2 activator shown to reactivate fetal hemoglobin and reduce VOCs in preclinical models of sickle cell disease

    Building team for planned HFpEF Phase 2 trial, led by hiring of Dr. Toni Bransford, a seasoned cardiologist and heart failure clinical developer

    Company to host conference call and live webcast today at 8:30 AM ET

    BOSTON, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to…

       Interim analysis data for Phase 2b clinical trials of tovinontrine (IMR-687) in patients with beta-thalassemia and sickle cell disease expected in fourth quarter of 2021

    Introduction of pipeline program IMR-261, a novel oral clinic-ready Nrf2 activator shown to reactivate fetal hemoglobin and reduce VOCs in preclinical models of sickle cell disease

    Building team for planned HFpEF Phase 2 trial, led by hiring of Dr. Toni Bransford, a seasoned cardiologist and heart failure clinical developer

    Company to host conference call and live webcast today at 8:30 AM ET

    BOSTON, Nov. 09, 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 reported financial results for the third quarter ending September 30, 2021 and reviewed recent business highlights.

    "Following the completion of enrollment in both our Ardent trial of tovinontrine (IMR-687) for sickle cell disease (SCD) and in the transfusion-dependent thalassemia (TDT) cohort of our Forte trial of tovinontrine for beta-thalassemia, we remain on track to report interim analysis data from these higher dose trials in the fourth quarter of 2021. Furthermore, we expect to report data from the primary analysis of the Ardent trial and to conduct a key efficacy analysis in TDT patients in the Forte trial in the first quarter of 2022," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "We also expect to present 12-month VOC data from our ongoing Phase 2a open label extension study of tovinontrine in patients with sickle cell disease at the American Society of Hematology (ASH) Annual Meeting to be held December 11-14, 2021."

    Dr. Ballal continued, "I also am pleased to introduce our newest pipeline asset, IMR-261, a clinic-ready oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. We are excited about the potential for this compound, which the medical literature suggests has promise in a broad array of red blood cell diseases, including disorders of hemoglobin. We are also looking forward to presenting key preclinical data on IMR-261 in an oral presentation at the ASH Annual Meeting.

    Finally, we are excited about the potential for tovinontrine's application in heart failure with preserved ejection fraction (HFpEF) and will be presenting preclinical data for this indication at the American Heart Association (AHA) Scientific Sessions to be held November 13-15, 2021. Importantly, we have been building the team that will lead our HFpEF clinical development program, including our recent appointment of seasoned cardiologist Toni Bransford, M.D., as our Vice President, Clinical Development. Toni brings significant experience to our team in the strategy, design and conduct of heart failure trials, and specifically HFpEF trials. We expect to commence a Phase 2 clinical trial of tovinontrine in HFpEF in 2022."

    Recent Corporate Highlights

    Completion of Patient Enrollment in Ardent Phase 2b Clinical Trial

    In August, Imara announced the completion of patient enrollment in the Ardent Phase 2b clinical trial of tovinontrine for SCD. The Ardent trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of tovinontrine administered once daily in adult patients with SCD. Approximately 115 patients have been randomized to the tovinontrine higher dose arm (once daily dose of 300 mg or 400 mg based on patient weight), tovinontrine lower dose arm (once daily dose of 200 mg or 300 mg based on patient weight), or placebo. The trial is being conducted at approximately 50 sites in 13 different countries. Imara expects to report interim data from the Ardent trial in the fourth quarter of 2021, primary efficacy analysis data in the first quarter of 2022 and final analysis data in the second half of 2022.

    Completion of TDT Patient Enrollment in Forte Phase 2b Clinical Trial

    In August, Imara announced the completion of patient enrollment in the transfusion dependent thalassemia (TDT) cohort and increased enrollment in the non-transfusion dependent thalassemia (NTDT) cohort of the Forte Phase 2b clinical trial of tovinontrine for beta-thalassemia. The Forte trial is a randomized, double-blind, placebo-controlled Phase 2b clinical trial designed to evaluate the safety and tolerability of tovinontrine administered once daily in adult patients with beta-thalassemia. Imara expects to report interim data from the TDT cohort in the fourth quarter of 2021 and to conduct a key efficacy analysis of the full TDT cohort in the first quarter of 2022. Data from the final analysis is expected in the second half of 2022. In addition, Imara expects to report interim data from the NTDT cohort of the Forte trial in the first half of 2022.

    Closed $50 Million Public Offering

    On July 16, 2021, Imara closed an underwritten public offering of shares of its common stock at a public offering price of $6.00 per share, for gross proceeds of approximately $50 million before underwriting discounts and commissions and offering expenses.

    Announcement of Acquisition of IMR-261

    IMR-261, formerly known as CXA-10, was acquired by Imara and was previously evaluated by Complexa, Inc. in Phase 2 clinical trials in focal segmental glomerulosclerosis (FSGS) and pulmonary arterial hypertension (PAH). IMR-261 is an activator of nuclear factor erythroid 2–related factor 2, or Nrf2. In-vitro and in-vivo studies show that 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. In addition, independent medical literature suggests potential promise in a broad array of red blood cell diseases, including disorders of hemoglobin. Imara has initiated work on drug product manufacturing for IMR-261, as it explores potential clinical development paths.

    Participation in Investor Conferences

    Imara presented or participated in multiple investor conferences during the third quarter, including the Citi 16th Annual BioPharma Virtual Conference, H.C. Wainwright 23rd Annual Global Investment Conference, Morgan Stanley 19th Annual Global Healthcare Conference, SCB Leerink CybeRx Series and 2021 Cantor Virtual Global Healthcare Conference.

    Third Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $102.8 million as of September 30, 2021, as compared to cash, cash equivalents and investments of $88.2 million as of December 31, 2020.

    • Research and Development Expenses: Research and development expenses were $10.4 million for the third quarter of 2021, as compared to $9.5 million for the third quarter of 2020. The increase of $0.9 million was primarily related to the development and manufacturing of clinical materials, clinical research and oversight of the Company's clinical trials and investigator fees related to the development of tovinontrine (IMR-687), as well as increased personnel-related and other research and development operating costs.

    • General and Administrative Expenses: General and administrative expenses were $3.3 million for the third quarter of 2021, as compared to $3.0 million for the third quarter of 2020. The increase of $0.3 million was primarily due to increased personnel-related and other general and administrative operating costs.

    • Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $13.6 million, or $0.55 per share, for the third quarter of 2021, as compared to a net loss of $12.4 million, or $0.72 per share, for the third quarter of 2020.

    Financial Guidance

    The Company currently expects that its full-year 2021 research and development expenses will range between $40 million and $45 million and that its full-year 2021 general and administrative expenses will range between $12 million and $13 million. The Company expects that its cash, cash equivalents and investments as of September 30, 2021 will be sufficient to enable it to fund its planned operations into the first quarter of 2023.

    Conference Call and Webcast Information

    Imara will host a conference call and live webcast today at 8:30 a.m. ET to discuss its third quarter 2021 financial results and other business updates. The live webcast will be available under "Events and Presentations" in the Investors section of the Company's website at imaratx.com. The conference call can be accessed by dialing 1 (833) 519-1307 (U.S. domestic) or +1 (914) 800-3873 (international) and referring to conference ID 1235955. A replay of the webcast will be archived on the Imara website following the presentation.

    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 HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2 (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 data from the Company's ongoing Phase 2b clinical trials of tovinontrine (IMR-687) in patients with sickle cell disease and beta-thalassemia and preclinical data for tovinontrine in HFpEF, (ii) the Company's timing and clinical development plans for tovinontrine in HFpEF, (iii) the Company's clinical development plans for the potential development of IMR-261 (iv) the Company's beliefs regarding the strength of its clinical data, the therapeutic potential of tovinontrine and IMR-261 and advancement of its preclinical and clinical program, and (v) financial guidance regarding the Company's projected operating expenses and sufficiency of the Company's capital resources to fund its operations into the first quarter of 2023. 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 its open label extension clinical trial of tovinontrine in sickle cell disease and its 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

    617-835-4061

     

    IMARA INC.

    CONDENSED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)

    (Unaudited)

      September 30,

    2021
      December 31,

    2020
     
    Cash, cash equivalents and investments $102,839  $88,222 
    Working capital(1)  98,809   84,158 
    Total assets  107,027   90,842 
    Total liabilities  7,654   6,407 
    Accumulated deficit  (133,178)  (96,113)
    Total stockholders' equity  99,373   84,435 

    (1)   Working capital is defined as current assets less current liabilities.



    IMARA INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share data)

    (Unaudited)

      Three Months Ended

    September 30,

     Nine Months Ended

    September 30,
      2021    2020    2021   2020  
    Operating expenses:                    
    Research and development $10,397    $9,533    $27,586   $23,195  
    General and administrative  3,262     2,961     9,522    6,953  
    Total operating expenses  13,659     12,494     37,108    30,148  
    Loss from operations  (13,659)    (12,494)    (37,108)   (30,148) 
    Total other income, (net):                    
    Interest income  30     126     161    368  
    Other expense  (18)    (55)    (118)   (62) 
    Total other income, (net)  12     71     43    306  
    Net loss $(13,647)   $(12,423)   $(37,065)  $(29,842) 
    Accretion of Series B convertible preferred stock                (7,858) 
    Net loss attributable to common stockholders—basic and diluted $(13,647)   $(12,423)   $(37,065)  $(37,700) 
    Weighted-average common shares outstanding—basic and diluted  24,898,346     17,349,813     20,099,976    12,696,368  
    Net loss per share attributable to common stockholders—basic and diluted $(0.55)   $(0.72)   $(1.84)  $(2.97) 
    Comprehensive loss:                    
    Net loss $(13,647)   $(12,423)   $(37,065)  $(29,842) 
    Other comprehensive income:                    
    Unrealized loss on investments  (2)    (24)    (6)   (8) 
    Comprehensive loss $(13,649)   $(12,447)   $(37,071)  $(29,850) 





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  4. Preclinical data from three different mouse models of HFpEF to be presented at American Heart Association (AHA) Scientific Sessions

    HFpEF development to be led by cardiologist Toni Bransford, M.D., FACC, FASE Imara's new Vice President of Clinical Development

    BOSTON, Nov. 08, 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, announced data today in three preclinical mouse models of heart failure with preserved ejection fraction (HFpEF) treated with tovinontrine (IMR-687). Selective inhibition of phosphodiesterase-9 (PDE9) with…

    Preclinical data from three different mouse models of HFpEF to be presented at American Heart Association (AHA) Scientific Sessions

    HFpEF development to be led by cardiologist Toni Bransford, M.D., FACC, FASE Imara's new Vice President of Clinical Development

    BOSTON, Nov. 08, 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, announced data today in three preclinical mouse models of heart failure with preserved ejection fraction (HFpEF) treated with tovinontrine (IMR-687). Selective inhibition of phosphodiesterase-9 (PDE9) with tovinontrine was shown to be effective for prevention and treatment of cardiac hypertrophy and renal dysfunction, indicating that tovinontrine may be a promising treatment option for patients suffering from HFpEF. Imara also announced the appointment of Toni Bransford, M.D., as Vice President of Clinical Development, with responsibilities that include leading the design and execution of a Phase 2 proof-of-concept study in HFpEF. Dr. Bransford holds extensive experience leading clinical development of cardiovascular therapies and specifically HFpEF studies.

    "The data from our pre-clinical models in concert with published literature regarding the role of PDE9 in heart failure suggest that tovinontrine has potential as a treatment for HFpEF," said Deepak Gupta, M.D., M.S.C.I, Assistant Professor of Medicine at Vanderbilt University Medical Center's Division of Cardiovascular Medicine. "In three distinct mouse models of HFpEF, compared with control mice, tovinontrine was shown to not only reduce the median size of cardiomyocytes, but also lower plasma B-type and atrial natriuretic peptide levels. Moreover, markers of renal dysfunction, including blood urea nitrogen and urine albumin-to-creatinine ratio, were lower in mice treated with tovinontrine compared with vehicle treated mice in all models. Notably, tovinontrine did not significantly change heart rate or blood pressure. Overall, the results and safety profile in preclinical models of HFpEF are encouraging for the advancement of this program into the clinic."

    "We are excited about extending our footprint into HFpEF with what we believe is a best-in-class PDE9 inhibitor and expect to initiate a Phase 2 clinical trial of tovinontrine in HFpEF in 2022," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "While studies of tovinontrine as a treatment for sickle cell disease and beta-thalassemia remain foundational to the company, we are excited by the pre-clinical data announced today, and the recent addition of Dr. Bransford, a deeply experienced clinical developer in the heart failure field."

    A virtual presentation of the preclinical data for tovinontrine in mouse models with HFpEF will take place at the American Heart Association (AHA) Scientific Sessions on Saturday, November 13, 2021 at 8:00 AM ET. A copy of the presentation will be available on the Investors section of the Imara website.

    To lead clinical development of tovinontrine as a treatment for HFpEF, Imara has appointed Toni Bransford, M.D., as Vice President of Clinical Development. A cardiologist, Dr. Bransford comes to Imara with 15 years of clinical development experience within global pharmaceuticals, biotech and clinical research organizations. Most recently, Dr. Bransford was a Senior Medical Director at Kaleido Biosciences, where she led clinical research programs for multiple projects and oversaw the translation of discovery programs.

    "I'm thrilled to be joining Imara at such an important moment for the company," said Dr. Bransford. "The potential behind tovinontrine as an accessible treatment for sickle cell disease and beta-thalassemia is very exciting, and I'm honored to have the opportunity to head development on a third possible indication for Imara's lead candidate. Having dedicated my career to treating heart disease, it is wonderful to see such a renaissance in the field of heart failure and particularly HFpEF. Tovinontrine heralds an expansion of possible medications for a disease with few treatment options today."

    Prior to her roles at Imara and Kaleido, Dr. Bransford accumulated extensive experience in the cardiovascular therapeutic area, previously as Senior Medical Director within the global clinical development program at Novartis, where she was clinical lead for the HFpEF program conducting the PARAMOUNT and PARAGON trials and was also responsible for leading regulatory authority interactions. Dr. Bransford also served at Schering Plough in the cardiovascular therapeutic area in coronary heart disease, as a Medical Director on the thrombin receptor antagonist program and as clinical lead for the TRACER trial. She has also held increasing levels of responsibility working with clinical research organizations, at one point serving as Executive Director of the cardiovascular therapeutic area for the Scientific Solutions Program of Worldwide Clinical Trials. Dr. Bransford earned her B.S. in biology from the University of Texas at Austin and her M.D. from the University of Texas Health San Antonio.

    About Heart Failure with Preserved Ejection Fraction

    Heart failure with preserved Ejection Fraction (HFpEF), also known as diastolic heart failure, is typically due to abnormalities of cardiac filling, which leads to symptoms such as shortness of breath, exercise intolerance, and fluid retention. HFpEF is one of the most common forms of heart failure but has relatively few treatment options to improve symptoms and outcomes.

    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 including heart failure with preserved ejection fraction (HFpEF). 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 SCD and beta-thalassemia and preclinical development for 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 (i) plans to present preclinical data on tovinontrine (IMR-687) and the quality of such data and (ii) clinical developments plans and timeline for tovinontrine in HFpEF and (iii) beliefs regarding the therapeutic potential of 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, 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. BOSTON, Nov. 04, 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 that the company will host a conference call and live webcast on Tuesday, November 9, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and review recent business highlights.

    A live webcast will be available under "Events and Presentations" in the Investors section of the company's website. The conference call can be accessed by dialing 1 (833) 519-1307 (U.S. domestic) or +1 (914) 800-3873 (international…

    BOSTON, Nov. 04, 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 that the company will host a conference call and live webcast on Tuesday, November 9, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and review recent business highlights.

    A live webcast will be available under "Events and Presentations" in the Investors section of the company's website. The conference call can be accessed by dialing 1 (833) 519-1307 (U.S. domestic) or +1 (914) 800-3873 (international) and referring to conference ID 1235955. A replay of the webcast will be archived on the Imara website following the presentation.

    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 HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2 (Nrf2). For more information, please visit www.imaratx.com.

    Media Contact:

    Marin Bergman

    Ten Bridge Communications

    818-516-2746

    Investor Contact:

    Michael Gray

    617-835-4061



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