On November 9, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Imago BioSciences, NOV 9, 2022, View Source [SID1234623550]).
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"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 (Free ASH Whitepaper) Annual Meeting on December 12, 2022," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago. "In addition, start-up activities continue to progress nicely for our planned Bomedemstat pivotal Phase 3 ET and Phase 2 PV trials, and we expect the investigator-sponsored study of Bomedemstat in combination with ruxolitinib for the treatment of MF to begin enrolling patients in the coming weeks."
Third Quarter 2022 and Subsequent Highlights
Announced Oral and Poster Presentations at the Upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. On November 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 on December 12, 2022 at the ASH (Free ASH Whitepaper) 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 of December 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.