IMRA IMARA Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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IMR-687 (Ardent)
Sickle cell disease (SCD)
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Phase 2b
Phase 2b
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IMR-687 (Forte)
b-thalassemia
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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IMR-687
Sickle cell disease
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Phase 2a
Phase 2a
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Phase 2a data released January 6, 2021. Biomarker results showed no meaningful changes in F-cells, fetal hemoglobin (HbF) levels, or Hb levels from baseline through week 24 in monotherapy arm. In combo arm an overall increase in F-cells and HbF levels from baseline to week 24 was shown, but Hb levels did not meaningfully change.
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Latest News
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On-track to report interim analyses for both Ardent sickle cell disease and Forte beta-thalassemia Phase 2b clinical trials in the second half of 2021
Completed enrollment in the transfusion-dependent beta-thalassemia arm of the Forte Phase 2b trial
Higher dose arms open in both the Ardent and Forte Phase 2b clinical trials
Applications now being accepted for 2021 Real Impact grant program
Company to host conference call and live webcast today at 8:30 AM ET
BOSTON, May 11, 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, today reported financial results for the first quarter ended March 31, 2021 and reviewed recent business highlights.
"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."
Recent Corporate Highlights and Updates
Higher Dose Arms Opened in Global Phase 2b Clinical Trials of IMR-687
Following recommendations from separate independent data monitoring committees for the Ardent and Forte Phase 2b clinical trials of IMR-687 for sickle cell disease and beta-thalassemia, respectively, Imara has opened the higher dose IMR-687 treatment arms. Enrollment is proceeding in each study at either the IMR-687 higher dose (once daily dose of 300 mg or 400 mg based on patient weight), IMR-687 lower dose (once daily dose of 200 mg or 300 mg based on patient weight), or placebo. Imara expects to report interim data from the Ardent and Forte Phase 2b clinical trials in the second half of 2021, data from the primary analysis from each of these trials in the first half of 2022 and data from the final analysis from each of these trials in the second half of 2022.
Opening of Applications Process for 2021 Real Impact Grants
Imara's Real Impact grant program moves into its second year after distributing $125,000 in funding in 2020 to community-based organizations dedicated to raising awareness for and support of the sickle cell and beta-thalassemia patient communities. Imara expects to increase total grant funding to $150,000 for 2021, which will be distributed according to three key areas of need: social determinants of health (including COVID-19 relief), virtual support programs and community-based organization capacity. The application window is open until May 14th and organizations are encouraged to apply at the following link: https://webportalapp.com/sp/login/real_impact_grants
Completed Preclinical Studies in Heart Failure Indication
Imara completed preclinical studies of IMR-687 in heart failure with preserved ejection fraction, or HFpEF, during the first quarter. The results of these studies continue to support the further development of IMR-687 in HFpEF and Imara is formulating a clinical development plan for IMR-687 in this indication.
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.
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.
Conference Call and Webcast Information
Imara will host a conference call and live webcast today at 8:30 a.m. ET to discuss its first 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 7598753. 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. 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.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 in patients with sickle cell disease and beta-thalassemia, (ii) the plan for reporting of comprehensive data on the completed Phase 2a clinical trial in sickle cell disease and additional data from the open label extension clinical trial in sickle cell disease, (iii) the plan for reporting of preclinical data in HFpEF (iv) the Company's beliefs regarding the strength of its clinical data, the therapeutic potential of IMR-687 and advancement of its 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 mid-2022. 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 enroll, dose and readout data from its open label extension clinical trial of IMR-687 in sickle cell disease and its Phase 2b clinical trials of IMR-687 in sickle cell disease and beta-thalassemia; the Company's ability to advance the development of IMR-687 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 IMR-687; and other factors discussed in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, 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
818-516-2746Investor Contact:
Michael Gray
617-835-4061
[email protected]IMARA INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(Unaudited)March 31,
2021December 31,
2020Cash, cash equivalents and investments $ 75,592 $ 88,222 Working capital(1) 74,858 84,158 Total assets 81,687 90,842 Total liabilities 6,093 6,407 Accumulated deficit (106,370 ) (96,113 ) Total stockholders' equity 75,594 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
March 31,2021 2020 Operating expenses: Research and development $ 7,115 $ 5,793 General and administrative 3,165 1,559 Total operating expenses 10,280 7,352 Loss from operations (10,280 ) (7,352 ) Total other income: Interest income 83 132 Other income (expense) (60 ) 5 Total other income, net 23 137 Net loss $ (10,257 ) $ (7,215 ) Accretion of Series B convertible preferred stock — (7,858 ) Net loss attributable to common stockholders—basic and diluted $ (10,257 ) $ (15,073 ) Weighted-average common shares outstanding—basic and diluted 17,577,454 3,493,359 Net loss per share attributable to common stockholders—basic and diluted $ (0.58 ) $ (4.31 ) 
- 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.
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BOSTON, May 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, today announced that the company will host a conference call and live webcast on Tuesday, May 11, 2021 at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 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 7598753. 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. 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.Media Contact:
Gina Nugent
Ten Bridge Communications
617-460-3579
[email protected]Investor Contact:
Michael Gray
617-835-4061
[email protected] -
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BOSTON, March 29, 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, today announced that applications for the second-annual ‘Real Impact' community support initiative are open.
The grant program, which was introduced in 2020 to fund nonprofit, community-based organizations (CBOs) serving patients and families, had far-reaching effects in its first year. In addition to supporting patients and families affected by rare blood disorders, in 2020 the grant program provided an aggregate of $125,000 to twenty-five CBOs with support and services for the communities they serve.
Imara will increase grant funding totaling up to $150,000 in 2021 across three key areas: social determinants of health (including COVID-19 relief), virtual support programs and community-based organization (CBO) capacity.
"2020 marked an incredibly difficult time for those living with SCD and beta-thalassemia and we've been inspired by the innovative ways grant recipients have used their funds to improve the lives of patients," said Jennifer Fields, MPH, Imara's Director, Advocacy and Engagement. "We look forward to supporting the 2021 program and encourage all organizations who meet the grant criteria to apply."
The grants will be awarded to recipients in the U.S. in the following project categories:
- Social Determinants of Health (including COVID-19 relief): Funds will support organizations that are working to address social drivers that impact health, disease management, education and other basic needs.
- Virtual Support Programs: Funds will support virtual community programs that encourage access to telehealth services, mental health care programs, and/or focus on other educational development areas for patients with SCD or beta-thalassemia.
- Community Based Organizational (CBO) Capacity: Funds will support nonprofit organizations' internal operations (e.g., personnel, program development and execution and other activities) to better fulfill their patient-focused missions.
"As we continue to progress our Phase 2b programs in sickle cell disease and beta-thalassemia, it is essential to be supporting patients and their families in new ways," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "Imara continues to put patients first and the Real Impact grant program is a key embodiment of Imara's core mission. We look forward to supporting the 2021 recipients in their ongoing commitment to the patient community."
Applications will be accepted online from March 29 through 11:59 p.m. ET on May 14, 2021. Nonprofit organizations may apply for grants in a selected category. A team of reviewers will evaluate the applications and determine the final grant recipients based on the clear identification of an unmet need, plan of execution, level of impact within the target community and measures of success. Recipients across the three grant programs will be announced and awarded in June 2021.
All applications must be submitted through the online process by May 14, 2021 and include the required supporting materials. For additional information on the grants, eligibility criteria and instructions on how to apply, CBOs can refer to the application website: Imara's Real Impact Awards or at the following link: https://webportalapp.com/sp/login/real_impact_grants.
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. 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 size, scope and timing of the Real Impact grant program. 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 those discussed in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, 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:
Gina Nugent
Ten Bridge Communications
617-460-3579
[email protected]Investor Contact:
Michael Gray
617-835-4061
[email protected] - Social Determinants of Health (including COVID-19 relief): Funds will support organizations that are working to address social drivers that impact health, disease management, education and other basic needs.
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Independent Data Monitoring Committees endorse opening higher dose IMR-687 treatment arms in ongoing Ardent and Forte Phase 2b clinical trials after review of safety and tolerability data at lower doses
Safety Review Committee in Phase 2a open label extension trial supports daily dose increase to align with higher dose arms of Phase 2b clinical trials
BOSTON, March 17, 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, today announced that separate independent data monitoring committees (DMCs) for the Ardent and Forte Phase 2b clinical trials of IMR-687 for sickle cell disease and beta-thalassemia, respectively, have recommended opening of the higher dose IMR-687 treatment arm in each of these studies following review of available safety and tolerability data. These additional arms were pre-specified in the two protocols and enrollment is proceeding in each study at the IMR-687 higher dose (once daily dose of 300 mg or 400 mg based on patient weight), IMR-687 lower dose (once daily dose of 200 mg or 300 mg based on patient weight), or placebo.
"We are pleased that the DMCs' review of safety data has resulted in opening of the higher dose arms in the Forte Phase 2b clinical trial in patients with beta-thalassemia in January and more recently in the Ardent Phase 2b clinical trial in patients with sickle cell disease in March," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "We designed each of these trials to allow for the additional higher dose arm of IMR-687 and expect to report preliminary data from the higher dose arms as part of our planned data readouts in the second half of 2021. Dosing in our recently completed Phase 2a clinical trial in sickle cell disease started as low as 50 mg per day and escalated sequentially to 100 mg or 200 mg per day over 16-24 weeks. Dosing in the Phase 2b clinical trials is substantially higher, both at the starting dose and through the treatment period, which is 36 weeks for the Forte trial and 52 weeks for the Ardent trial."
Similar to the Phase 2b clinical trials, a separate safety review committee reviewed the available safety and tolerability data from patients in Imara's ongoing Phase 2a open label extension (OLE) clinical trial of IMR-687 in patients with sickle cell disease and recommended increasing the daily dose from 200mg to either 300 mg or 400 mg, based on patient weight. This dose level is identical to the higher dose arms of the Phase 2b clinical trials and it is anticipated that patients will begin dose escalation to the higher dose under an amended protocol by mid-2021.
Additional information about the Ardent, Forte and OLE clinical trials can be found at www.clinicaltrials.gov.
About IMR-687
IMR-687 is a highly selective and potent small molecule inhibitor of PDE9. PDE9 uniquely degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology. Lower levels of cGMP are often found in people with sickle cell disease and beta-thalassemia and are associated with impaired blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide-mediated vasodilation.
Blocking PDE9 acts to increase cGMP levels, which are associated with reactivation of fetal hemoglobin, or HbF, a natural hemoglobin produced during fetal development. Increased levels of HbF in red blood cells have been demonstrated to improve symptomology and lower disease burden in patients with sickle cell disease and patients with beta-thalassemia. IMR-687 is designed to have a multimodal mechanism of action that acts on red blood cells, white blood cells, adhesion mediators, and other cell types.
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. 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 (i) content of, and timing with respect to, the reporting of data from the Ardent and Forte Phase 2b clinical trials in patients with sickle cell disease and beta-thalassemia and (ii) the timing with respect to dose escalation of IMR-687 as part of the OLE clinical trial (iii) the Company's beliefs regarding the tolerability and therapeutic potential of IMR-687 and advancement of its clinical program. 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 conduct and readout data from its ongoing clinical trials of IMR-687; the Company's ability to advance the development of IMR-687 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 IMR-687, replicate scientific and non-clinical data in both subsequent case report readouts and in clinical trials and other factors discussed in the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K, 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:
Gina Nugent
Ten Bridge Communications
617-460-3579
[email protected]Investor Contact:
Michael Gray
617-835-4061
[email protected] -
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Significant progress advancing IMR-687 as an oral, once-a-day potentially disease modifying treatment for sickle cell disease and beta-thalassemia
Reports new Phase 2a open label extension clinical trial data
Company to host conference call and live webcast today at 8:30 a.m. ET
BOSTON, March 05, 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, today reported financial results for the year ended December 31, 2020 and reviewed recent business highlights.
"2020 was a pivotal year for Imara during which we advanced IMR-687 into global Phase 2b clinical trials for sickle cell disease and beta-thalassemia, reported clinical data supporting IMR-687 as a novel treatment for sickle cell disease and were granted important regulatory designations for IMR-687. We also launched our Real Impact Grant initiative to support local community-based organizations serving patients and families affected by rare blood disorders. In addition, we initiated preclinical studies of IMR-687 in heart failure with preserved ejection fraction and are currently developing a Phase 2 protocol for potential clinical development in this indication," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "We also successfully completed an initial public offering, raising gross proceeds of $86.5 million, and strengthened our leadership team with key hires."
Dr. Ballal continued, "We have been building on this progress in 2021, including reporting topline results from our Phase 2a clinical trial in January and today's disclosure of preliminary data from our ongoing Phase 2a open label extension trial. Later this year, we expect to report further data from the Phase 2a trials as well as interim data from the Ardent and Forte Phase 2b clinical trials of IMR-687 in sickle cell disease and beta-thalassemia, respectively."
Recent Corporate Highlights and Updates- Reporting Additional Data from Phase 2a Open Label Extension (OLE) Clinical Trial: Imara conducted a review of 24 patients enrolled in its OLE clinical trial as of December 31, 2020, including data from approximately 12 patients who have completed at least four months of treatment on the OLE clinical trial. Preliminary data from these patients demonstrated a mean absolute increase in fetal hemoglobin (HbF) and F-cells after four months of treatment. In addition, updates to two case narratives initially presented in the third quarter of 2020 showed sustained improvements over baseline in HbF and F-cells, as well as favorable trends in reported vaso-occlusive crises.
Additional details can be found in the Company's Annual Report on Form 10-K, which is expected to be filed with the U.S. Securities and Exchange Commission this morning.
- Reported Phase 2a Clinical Data for IMR-687 in SCD: Imara reported topline results from its Phase 2a clinical trial of IMR-687 in adult patients with SCD in January 2021. The data from this completed clinical trial demonstrated that IMR-687 was well-tolerated as a monotherapy and in combination with hydroxyurea. As part of the safety analysis, promising reductions in the rate of vaso-occlusive crises/sickle cell-related pain crises, were observed in certain monotherapy IMR-687 treated patients versus placebo.
- Phase 2b Clinical Trials Progressing: Imara plans to report interim data from both the Ardent Phase 2b SCD clinical trial of IMR-687 and the Forte Phase 2b beta-thalassemia clinical trial of IMR-687 in the second half of 2021, when 33 and 30 patients, respectively, have completed 24 weeks of treatment.
- Initiation of Pediatric Clinical Program on Track for the First Half of 2021: Imara anticipates initiating a pediatric clinical program of IMR-687 in SCD in the first half of 2021. Imara expects to conduct a Phase 1/2 clinical trial in adolescents (12-17 years old) comprised of a single ascending dose phase, followed by a 36-week multiple dose expansion phase. In December 2020, the Company held a Type C meeting with the FDA during which the agency expressed alignment with the overall clinical trial design and indicated the study could be submitted with the adult study data in the same new drug application (NDA).
- Expanded Leadership Team: Imara expanded its leadership team with the appointments of Kenneth Attie, M.D., as Senior Vice President and Chief Medical Officer and Lynette Hopkinson as Senior Vice President of Regulatory. Prior to joining Imara, Dr. Attie served as Vice President of Medical Research at Acceleron Pharma, and Ms. Hopkinson served as Vice President, Global Head of Cystic Fibrosis Regulatory Strategy and Commercial Regulatory Affairs at Vertex Pharmaceuticals.
Full Year 2020 Financial Results
- Cash Position: Cash, cash equivalents and investments were $88.2 million as of December 31, 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 $32.2 million for the year ended December 31, 2020, as compared to $19.0 million for the year ended December 31, 2019. The increase of $13.1 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 operating costs.
- General and Administrative Expenses: General and administrative expenses were $9.5 million for the year ended December 31, 2020, as compared to $5.1 million for the year ended December 31, 2019. The increase of $4.4 million was primarily due to increased personnel-related and other general and administrative operating costs as a result of operating as a public company.
- Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $49.2 million, or $3.53 per share, for the year ended December 31, 2020, as compared to a net loss of $23.5 million, or $33.40 per share, for the year ended December 31, 2019.
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 December 31, 2020, will be sufficient to enable it to fund its planned operations into mid-2022.
Conference Call and Webcast Information
Imara will host a conference call and live webcast today at 8:30 a.m. ET to discuss its full year 2020 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 1368162. 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. 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.
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 and the quality of data from the Company's ongoing OLE clinical trial and Phase 2b clinical trials in patients with sickle cell disease and beta-thalassemia and the reporting of additional data on the completed Phase 2a clinical trial in SCD, (ii) the design and timing of the Company's plans regarding a pediatric program for IMR-687 in patients with sickle cell disease, (iii) the Company's development plans for IMR-687 in heart failure with preserved ejection fraction; (iv) the Company's beliefs regarding the strength of its clinical data, the therapeutic potential of IMR-687 and advancement of its 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 mid-2022. 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 enroll, dose and readout data from its open label extension clinical trial of IMR-687 in sickle cell disease and its Phase 2b clinical trials of IMR-687 in sickle cell disease and beta-thalassemia; the Company's ability to advance the development of IMR-687 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 IMR-687; 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:
Gina Nugent
Ten Bridge Communications
617-460-3579
[email protected]Investor Contact:
Michael Gray
617-835-4061
[email protected]IMARA INC.
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(Unaudited)December 31,
2020December 31,
2019Cash, cash equivalents and investments $ 88,222 $ 28,907 Working capital(1) 84,158 26,426 Total assets 90,842 33,298 Total liabilities 6,407 4,382 Convertible preferred stock — 77,764 Accumulated deficit (96,113 ) (54,753 ) Total stockholders' equity (deficit) 84,435 (48,848 ) (1) Working capital is defined as current assets less current liabilities.
IMARA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(Unaudited)Years ended December 31, 2020 2019 Operating expenses: Research and development $ 32,154 $ 19,009 General and administrative 9,544 5,107 Total operating expenses $ 41,698 $ 24,116 Loss from operations (41,698 ) (24,116 ) Total other income: Interest income 483 578 Other income (expense) (145 ) 75 Total other income, net $ 338 $ 653 Net loss $ (41,360 ) $ (23,463 ) Accretion of Series B convertible preferred stock (7,858 ) — Net loss attributable to common stockholders—basic and diluted $ (49,218 ) $ (23,463 ) Net loss per share applicable to common stockholders—basic
and diluted$ (3.53 ) $ (33.40 ) Weighted-average common shares outstanding—basic and diluted $ 13,924,730 $ 702,455 - Reporting Additional Data from Phase 2a Open Label Extension (OLE) Clinical Trial: Imara conducted a review of 24 patients enrolled in its OLE clinical trial as of December 31, 2020, including data from approximately 12 patients who have completed at least four months of treatment on the OLE clinical trial. Preliminary data from these patients demonstrated a mean absolute increase in fetal hemoglobin (HbF) and F-cells after four months of treatment. In addition, updates to two case narratives initially presented in the third quarter of 2020 showed sustained improvements over baseline in HbF and F-cells, as well as favorable trends in reported vaso-occlusive crises.