Imara Inc. (IMRA) Tops Q1 EPS by 25c

Imara Inc. (NASDAQ: IMRA) reported Q1 EPS of ($0.58), $0.25 better than the analyst estimate of ($0.83).

First Quarter 2021 Financial Results

• Cash Position: Cash, cash equivalents and investments were $75.6 million as of March 31, 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 $7.1 million for the first quarter of 2021, as compared to $5.8 million for the first quarter of 2020. The increase of $1.3 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 $3.2 million for the first quarter of 2021, as compared to $1.6 million for the first quarter of 2020. The increase of $1.6 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 $10.3 million, or $0.58 per share, for the first quarter of 2021, as compared to a net loss of $15.1 million, or $4.31 per share, for the first quarter of 2020.

“We have made substantial enrollment progress in our higher dose Phase 2b clinical trials for patients with sickle cell disease and beta-thalassemia, which are designed to test higher doses of IMR-687,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We are now conducting these studies at approximately 75 clinical trial sites across 20 countries and have fully enrolled the transfusion-dependent beta-thalassemia arm of the Forte trial. We remain on track to complete the respective protocol-driven interim analyses for the Ardent and Forte trials and to report interim data in the second half of 2021 for both programs. Furthermore, following the recommendation of independent data monitoring committees, we opened the higher dose treatment arms in both Phase 2b clinical trials and are currently testing IMR-687 at daily dose levels of up to 400 mg.”

Dr. Ballal continued, “In addition to our progress in the Phase 2b clinical trials, we reported topline data from our Phase 2a clinical trial of IMR-687 in sickle cell disease, in which IMR-687 was well tolerated, and promising reductions in rates of vaso-occlusive crises (VOCs) were observed with variable changes in certain biomarkers, including HbF and F-cells. We also reported preliminary data from our Phase 2a open label extension trial, which showed that IMR-687 was well tolerated and in which increases in fetal hemoglobin and F-cells were observed. We plan to present comprehensive VOC data from the completed, 93-patient, placebo-controlled Phase 2a clinical trial, as well as additional data from the ongoing open label extension trial, at the European Hematology Association (EHA) 2021 Virtual Congress in June 2021.”

“We have also been working to explore the therapeutic potential of IMR-687 in additional indications. We are pleased to have successfully completed pre-clinical studies of IMR-687 in heart failure with preserved ejection fraction, or HFpEF, and we plan to present these encouraging data at an upcoming cardiovascular medical meeting later in 2021,” said Dr. Ballal.

“Finally, we are proud to continue with our Real Impact community support program, which provides needed resources to community-based organizations around the country that serve patients and families with sickle cell disease and beta-thalassemia,” Dr. Ballal stated. “We have now opened the application process for the Real Impact grant program and expect to award up to $150,000 in funding in 2021 to deserving community-based organizations. We are committed to the sickle cell and beta-thalassemia patient community and supporting these groups are core to the Imara mission.”

Financial Guidance

The Company currently expects that its full-year 2021 research and development expenses will range between $50 million and $55 million and that its full-year 2021 general and administrative expenses will range between $12 million and $14 million. The Company expects that its cash, cash equivalents and investments as of March 31, 2021, will be sufficient to enable it to fund its planned operations into mid-2022.

For earnings history and earnings-related data on Imara Inc. (IMRA) click here.

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