- Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia (ET) Presented at
- Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis Presented at EHA 2022 -
- First Participant Dosed in Investigator-Sponsored Phase 1/2 Study of Bomedemstat in Combination with Atezolizumab in Small Cell
- Obtained Advice from
“We were delighted to present updated positive data on our Phase 2 trial of bomedemstat in essential thrombocythemia (ET) at EHA in June. In our updated dataset, bomedemstat demonstrated hematologic and symptomatic improvement in ET patients and, importantly, demonstrated the durability of these hematologic responses. These data will support our ongoing discussions with the FDA, as we target an End of Phase 2 meeting with the FDA later this year, and move towards initiating the pivotal trial,” said
Second Quarter 2022 and Subsequent Highlights
- Presented Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at EHA 2022. In
June 2022 , Imago presented updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with ET. As of the data cutoff date of29 April 2022 : bomedemstat demonstrated normalization of platelets in the absence of new thromboembolic events (the primary efficacy endpoint of this study) in 94% of patients; as well as durability of hematologic response with 81% of patients achieving normalized platelet counts for at least 12 weeks (ELN criteria defining a durable response in ET); 58% of patients treated with bomedemstat experienced symptomatic improvement (defined as a decrease in Total Symptom Score) at 24 weeks; and both JAK2 and CALR mutation burdens were decreased during treatment with bomedemstat. As of the data cutoff date, the most common adverse events (AEs) were dysgeusia, fatigue, constipation, and arthralgia. Twelve patients reported a total of 19 serious adverse events (SAEs) with six deemed related to bomedemstat by the investigator. There have been no dose limiting toxicities (DLTs) or deaths related to drug. The EHA data cut represented the last presentation before the End-of-Phase 2 meeting with FDA expected later this year. - Presented Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis at EHA 2022. In
June 2022 , the Company presented updated positive data from its ongoing global Phase 2 clinical study evaluating bomedemstat in patients with MF. As of the data cutoff date of29 April 2022 , in addition to improvements in the standard metrics of spleen volume reduction and symptom scores, long term treatment with bomedemstat showed: 52% of evaluable patients had reductions in mutant allele frequencies, including ASXL1; 85% of evaluable patients demonstrated improved or stable fibrosis scores; and 90% of patients who were transfusion independent at baseline had stable or improved hemoglobin. The most common non-hematologic AE was dysgeusia. Of 14 drug related SAEs, 5 were Grade 2, 8 Grade 3 and 1 Grade 4 (thrombocytopenia). There have been no DLTs or deaths related to drug. Eligible MF patients completing this Phase 2 study have rolled into an extension study to evaluate the longer-term safety and impact of bomedemstat on the natural history of MF. Imago plans to commence an investigator-sponsored evaluation of bomedemstat in combination with ruxolitinib in patients with MF who have a sub-optimal response to JAK inhibition or are treatment naïve in the Fall 2022. - Announced First Participant Dosed in Investigator-Sponsored Study of Bomedemstat in Combination with Atezolizumab in Small Cell
Lung Cancer , the first clinical study of Bomedemstat in patients with Solid Tumors. InMay 2022 , Imago announced that the first participant had been treated in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tecentriq®) during the maintenance phase of treatment in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC). The Phase 1/2 open-label study will enroll approximately 30 participants diagnosed with ES-SCLC to establish the safety and tolerability of a combination treatment with bomedemstat and atezolizumab. The study is being conducted inSeattle and led byRafael Santana-Davila , M.D., associate professor at the University ofWashington School of Medicine andJoseph Hiatt , M.D., Ph.D., ofFred Hutchinson Cancer Center (“Fred Hutch”), and in collaboration with theNational Cancer Institute (NCI) fundedFred Hutch Lung Specialized Project of Research Excellence. - Completed Enrollment in Phase 2 Study of Bomedemstat in Essential Thrombocythemia. In
May 2022 , Imago announced the completion of enrollment for the Phase 2 clinical study of bomedemstat for the treatment of ET with 73 patients enrolled, exceeding the initial target enrollment of 60 patients. This study is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat, an oral lysine-specific demethylase 1 (LSD1) inhibitor, in patients with ET who have failed at least one standard therapy. - Obtained Advice from
FDA Clinical Outcomes Assessment (COA) Group with Regard to Patient Reported Outcome (PRO) Endpoints for the Company’s Planned Phase 3 Trial of Bomedemstat in ET Patients. InJune 2022 , Imago discussed with FDA the proposed instruments to assess patient-reported symptoms and outcomes for key secondary endpoints.
Anticipated Upcoming Milestones
- End-of-Phase 2 meeting with FDA for bomedemstat in ET expected this year
- Anticipate initiating investigator-sponsored Phase 2 combination study of bomedemstat with ruxolitinib in MF in the Fall 2022
- Expect data updates for the bomedemstat Phase 2 trials in ET and MF at the
American Society of Hematology (ASH) Annual Meeting inDecember 2022
Second Quarter 2022 Financial Results
- Cash, Cash Equivalents and Short-term Investments: As of
June 30, 2022 , Imago had cash, cash equivalents and short-term investments of$190.0 million , compared to$217.4 million as ofDecember 31, 2021 . Based on current operating plans, management believes cash runway extends into 2025. - Research & Development (R&D) Expenses: R&D expenses for the quarter ended
June 30, 2022 were$9.7 million (including stock-based compensation expense of$0.7 million ), compared to$7.1 million for the same period in 2021. The overall increase in R&D expenses was primarily related to the commencement of a Phase 2 extension study started in the second half of 2021 for the long-term follow-up of patients from MF and ET clinical trials, and salaries and non-cash stock-based compensation expense for R&D employees as we ramped up our operations. - General and Administrative (G&A) Expenses: G&A expenses for the quarter ended
June 30, 2022 were$4.3 million (including stock-based compensation expense of$1.0 million ), compared to$1.7 million for the same period in 2021. The increase was primarily due to increases in professional fees attributable to accounting, legal, audit, and insurance expenses associated with public company operations and compensation and personnel-related costs, including stock-based compensation expense, as a result of increased headcount. - Net Loss: Net loss for the quarter ended
June 30, 2022 was$13.7 million , compared to$8.8 million for the same period in 2021.
About
Forward Looking Statements
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “may,” “will,” “should,” “expect,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
These statements may relate to, but are not limited to, the results, conduct, progress and timing of Imago clinical trials, timing of data presentations, the regulatory approval path for bomedemstat, plans for future operations, and expected cash runway, as well as assumptions relating to the foregoing. Forward looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Important factors that could affect future results and cause those results to differ materially from those expressed in the forward-looking statements include: our limited operating history and lack of products for commercial sale; our significant losses since inception and for the foreseeable future; our need for substantial additional financing; our unpredictable operating results, due to, for example, general economic conditions in
Except as required by law, Imago does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Contacts:
Media Contact:
will.zasadny@canalecomm.com
Investor Contact:
Laurence@gilmartinir.com
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
2022 | 2021 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 22,772 | $ | 11,226 | |||
Short-term investments | 167,238 | 206,184 | |||||
Prepaid expenses and other current assets | 2,562 | 3,894 | |||||
Total current assets | 192,572 | 221,304 | |||||
Property and equipment, net | 3 | 2 | |||||
Other long-term assets | 3,536 | 3,480 | |||||
Total assets | $ | 196,111 | $ | 224,786 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,584 | $ | 3,459 | |||
Accrued and other current liabilities | 6,189 | 6,633 | |||||
Total current liabilities | 8,773 | 10,092 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock, | 3 | 3 | |||||
Additional paid-in capital | 330,951 | 327,387 | |||||
Accumulated other comprehensive loss | (828 | ) | (43 | ) | |||
Accumulated deficit | (142,788 | ) | (112,653 | ) | |||
Total stockholders’ equity | 187,338 | 214,694 | |||||
Total liabilities and stockholders’ equity | $ | 196,111 | $ | 224,786 | |||
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
THREE MONTHS ENDED | SIX MONTHS ENDED | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 9,677 | $ | 7,099 | $ | 22,179 | $ | 11,871 | |||||||
General and administrative | 4,339 | 1,743 | 8,350 | 4,119 | |||||||||||
Total operating expenses | 14,016 | 8,842 | 30,529 | 15,990 | |||||||||||
Loss from operations | (14,016 | ) | (8,842 | ) | (30,529 | ) | (15,990 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest income | 148 | 82 | 212 | 169 | |||||||||||
Other income (expense), net | 127 | (46 | ) | 182 | (94 | ) | |||||||||
Total other income, net | 275 | 36 | 394 | 75 | |||||||||||
Net loss | $ | (13,741 | ) | $ | (8,806 | ) | $ | (30,135 | ) | $ | (15,915 | ) | |||
Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (8.13 | ) | $ | (0.89 | ) | $ | (15.06 | ) | |||
Weighted-average shares used in computing net loss per share, basic and diluted | 33,735,785 | 1,082,932 | 33,691,163 | 1,056,624 |
Source:
2022 GlobeNewswire, Inc., source