BOSTON, Nov. 05, 2020 (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, today reported financial results for the third quarter ended September 30, 2020 and reviewed recent business highlights.
“We continue to advance IMR-687 across multiple indications and as part of global, multi-center clinical trials, despite COVID-19,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We have initiated patient dosing in our Phase 2b clinical trials of IMR-687 in both sickle cell disease and beta-thalassemia and have activated sites around the world. In addition, we also continued to make progress on the regulatory front as we were granted Orphan Drug designation by the European Commission for the treatment of patients with sickle cell disease.”
Dr. Ballal continued, “We have also made important progress on our Phase 2a open label extension clinical trial in adult patients with sickle cell disease. In August 2020, we reported initial data from the first two patients in this clinical trial who had received at least six-months of treatment. The data indicated potential benefits of IMR-687 with respect to reported vaso-occlusive crises trends, healthcare facility use and associated biomarkers. We plan to report additional data from these two patients at the annual American Society of Hematology 2020 virtual meeting in December 2020. Importantly, enrollment in the open label extension clinical trial has increased to 23 patients and we expect to report additional data during the first quarter of 2021 on approximately 10 to 15 patients from the OLE clinical trial.”
Recent Corporate Highlights and Updates
- Patient Dosing Underway in Phase 2b Clinical Trials: Imara dosed the first patients in both its Ardent Phase 2b sickle cell disease (SCD) clinical trial and its Forte Phase 2b beta-thalassemia clinical trial. Imara plans to report formal interim analyses from the Ardent and Forte Phase 2b clinical trials when 33 and 30 patients, respectively, have completed 24 weeks of treatment. Due to COVID-19 related recruitment delays, the company expects to report interim data from the Ardent and Forte Phase 2b clinical trials in the second half of 2021 rather than the first half of 2021 as originally planned.
- Completed Dosing in Phase 2a Clinical Trial: Imara completed dosing patients in the Phase 2a clinical trial in patients with SCD during the third quarter of 2020 and plans to report top-line data from this trial late in the fourth quarter of 2020. Imara also expects to report additional data from two patients in its ongoing Phase 2a open label extension (OLE) clinical trial in adult patients with SCD at the annual American Society of Hematology (ASH) 2020 virtual meeting in December 2020 as well as data from approximately 10 to 15 patients in the OLE clinical trial in the first quarter of 2021.
- IMR-687 Granted Regulatory Designation: The European Commission granted IMR-687 Orphan Disease designation for the treatment of SCD. IMR-687 has previously been granted Orphan Drug, Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCD.
- Expanded Pipeline: Exploratory research indicating potential cardioprotective effects of IMR-687 in SCD and heart failure were presented at the 15th Annual Sickle Cell and Thalassemia Conference held virtually October 26-31, 2020. These results, which include analysis of a sub-set of SCD patients from the Phase 2a clinical trial, demonstrate that IMR-687 in combination with HU reduced N-terminal (NT)-pro hormone B-type natriuretic peptide (NT-proBNP), a biomarker used to measure cardiovascular risk. NT-proBNP is being measured as an exploratory endpoint in both the Ardent and Forte Phase-2b clinical trials. In addition, preclinical data in heart failure with preserved ejection fraction (HFpEF), also referred to as diastolic heart failure, were also presented, showing potential benefits of IMR-687 across several relevant cardiac biomarkers.
Third Quarter 2020 Financial Results
- Cash Position: Cash, cash equivalents and investments were $96.1 million as of September 30, 2020, as compared to cash, cash equivalents and investments of $28.9 million as of December 31, 2019.
- Research and Development Expenses: Research and development expenses were $9.5 million for the third quarter of 2020, as compared to $5.1 million for the third quarter of 2019. The increase of $4.4 million was primarily related to the development and manufacturing of clinical materials, clinical research and oversight of the Company’s clinical trials and investigative fees related to the development of IMR-687, as well as increased personnel-related and other research and development operational costs.
- General and Administrative Expenses: General and administrative expenses were $3.0 million for the third quarter of 2020, as compared to $1.7 million for the third quarter of 2019. The increase of $1.2 million was primarily due to increased personnel-related and other general and administrative operational costs as a result of operating as a public company.
- Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $12.4 million, or $0.72 per share, for the third quarter of 2020, as compared to a net loss of $6.6 million, or $9.43 per share, for the third quarter of 2019.
Financial Guidance
The Company currently expects that its full-year 2020 research and development expenses will range between $32 million and $37 million rather than the $35 million to $40 million originally estimated and that its full-year 2020 general and administrative expenses will range between $9 million and $10 million. The Company expects that its cash, cash equivalents and investments as of September 30, 2020, will be sufficient to enable it to fund its planned operations into mid-2022.
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. Imara is currently advancing IMR-687, a highly selective, potent small molecule inhibitor of PDE9 that is an oral, once-a-day, potentially disease-modifying treatment for sickle cell disease and beta-thalassemia. IMR-687 is being designed to have a multimodal mechanism of action that acts on red blood cells, white blood cells, adhesion mediators and other cell types. For more information, please visit www.imaratx.com.
