- Data updates for Bomedemstat Phase 2 trials in Essential Thrombocythemia (ET) and Myelofibrosis (MF) to be presented at the
- Start-up activities for Bomedemstat pivotal Phase 3 ET and Phase 2 PV trials continuing to advance -
“Imago continues to make progress in the clinical development of Bomedemstat for the treatment of MPNs including essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF). Enrollment in the ongoing Phase 2 ET study is complete and all patients remaining on study will have been treated for 24 weeks by year end. Imago has announced positive data for Bomedemstat in the treatment of ET and MF and will present additional data in an oral presentation for ET and a poster for MF at the ASH Annual Meeting on
Third Quarter 2022 and Subsequent Highlights
- Announced Oral and Poster Presentations at the Upcoming 64th
American Society of Hematology Annual Meeting. OnNovember 3 , Imago announced that an abstract entitled “A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Essential Thrombocythemia (ET)” had been accepted for an oral presentation onDecember 12, 2022 at the ASH Annual Meeting. A second abstract entitled “A Phase 2 Study of the LSD1 Inhibitor Bomedemstat (IMG-7289) for the Treatment of Advanced Myelofibrosis (MF): Updated Results and Genomic Analyses” will be presented as a poster. - Study Start-up Activities. During the quarter, Imago advanced important study start-up activities for both the Bomedemstat pivotal Phase 3 ET and Phase 2 PV trials, including submission of both protocols to the
U.S. Food and Drug Administration (FDA) for review. The Company anticipates initiation of both studies in early 2023.
Third Quarter 2022 Financial Results
- Cash, Cash Equivalents, and Short-Term Investments: As of
September 30, 2022 , Imago had cash, cash equivalents, and short-term investments of$178.4 million compared to$217.4 million as ofDecember 31, 2021 . Based on current operating plans and financing arrangements, management believes its cash runway extends into 2025. - Research & Development (R&D) Expenses: R&D expenses for the quarter ended
September 30, 2022 were$13.5 million (including stock-based compensation expense of$0.5 million ), compared to$8.7 million for the same period in 2021. The overall increase in R&D expenses was primarily related to the start-up activities related to preparations for the planned Phase 3 clinical trial for ET and Phase 2 clinical trial for PV, continued development of commercial material and material to support the ongoing and new clinical trials, and salaries and non-cash stock-based compensation expense related to R&D employees, as we ramped up our operations. - General and Administrative (G&A) Expenses: G&A expenses for the quarter ended
September 30, 2022 were$4.1 million (including stock-based compensation expense of$1.2 million ), compared to$3.0 million for the same period in 2021. The increase of$1.1 million was primarily due to an increase of$0.7 million in stock-based compensation expense, as a result of increased headcount, and$0.3 million in professional fees attributable to accounting, legal, audit costs, and other public company expenses. - Net Loss: Net loss for the quarter ended
September 30, 2022 was$16.8 million , compared to$11.7 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 “anticipate,” “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 | $ | 7,293 | $ | 11,226 | ||||
Short-term investments | 171,121 | 206,184 | ||||||
Prepaid expenses and other current assets | 3,626 | 3,894 | ||||||
Total current assets | 182,040 | 221,304 | ||||||
Property and equipment, net | 2 | 2 | ||||||
Other long-term assets | 4,415 | 3,480 | ||||||
Total assets | $ | 186,457 | $ | 224,786 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,898 | $ | 3,459 | ||||
Accrued research and development expenses | 6,823 | 4,213 | ||||||
Accrued and other current liabilities | 3,117 | 2,420 | ||||||
Total current liabilities | 13,838 | 10,092 | ||||||
Commitments and contingencies (Note 6) | ||||||||
Stockholders’ equity: | ||||||||
Common stock, | 3 | 3 | ||||||
Additional paid-in capital | 332,996 | 327,387 | ||||||
Accumulated other comprehensive loss | (816 | ) | (43 | ) | ||||
Accumulated deficit | (159,564 | ) | (112,653 | ) | ||||
Total stockholders’ equity | 172,619 | 214,694 | ||||||
Total liabilities and stockholders’ equity | $ | 186,457 | $ | 224,786 |
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 13,453 | $ | 8,680 | $ | 35,632 | $ | 20,551 | ||||||||
General and administrative | 4,095 | 3,040 | 12,445 | 7,159 | ||||||||||||
Total operating expenses | 17,548 | 11,720 | 48,077 | 27,710 | ||||||||||||
Loss from operations | (17,548 | ) | (11,720 | ) | (48,077 | ) | (27,710 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 194 | 72 | 406 | 241 | ||||||||||||
Other income (expense), net | 578 | (22 | ) | 760 | (116 | ) | ||||||||||
Total other income, net | 772 | 50 | 1,166 | 125 | ||||||||||||
Net loss | $ | (16,776 | ) | $ | (11,670 | ) | $ | (46,911 | ) | $ | (27,585 | ) | ||||
Net loss per share, basic and diluted | $ | (0.50 | ) | $ | (0.44 | ) | $ | (1.39 | ) | $ | (2.85 | ) | ||||
Weighted-average shares used in computing net loss per share, basic and diluted | 33,765,515 | 26,671,511 | 33,716,219 | 9,688,747 |
Source:
2022 GlobeNewswire, Inc., source