Full Press Release Details
Imara Reports Full Year 2020 Financial Results and Business Highlights
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, Mar. 5, 2021 - 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
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.
Full Year 2020 Financial Results
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.
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.
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CONSOLIDATED BALANCE SHEET DATA
| December 31, 2020 | December 31, 2019 | |||||||
| Cash, 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 | ) |
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| 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 |