On August 12, 2022 Imago BioSciences, Inc. ("Imago" or the "Company") (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 second quarter ended June 30, 2022 and provided business updates (Press release, Imago BioSciences, AUG 12, 2022, View Source [SID1234618253]).
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"We were delighted to present updated positive data on our Phase 2 trial of bomedemstat in essential thrombocythemia (ET) at EHA (Free EHA Whitepaper) 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 Hugh Young Rienhoff, Jr., M.D, Chief Executive Officer of Imago. "At EHA (Free EHA Whitepaper), we also presented positive data from our advanced myelofibrosis (MF) Phase 2 trial where bomedemstat demonstrated improvements in total symptom scores, fibrosis grades, spleen volumes and anemia, as well as reductions in mutant allele frequencies. Looking ahead, we plan to evaluate bomedemstat in combination with ruxolitinib in MF patients in a trial starting in the Fall 2022. Lastly, in addition to our long-held plans to study bomedemstat in other myeloproliferative neoplasms, such as polycythemia vera, we were pleased to see initiation of the first solid tumor clinical study of bomedemstat, an investigator-sponsored study of bomedemstat in combination with atezolizumab for small cell lung cancer."
Second Quarter 2022 and Subsequent Highlights
Presented Positive Data from the Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at EHA (Free EHA Whitepaper) 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 of 29 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 (Free EHA Whitepaper) 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 (Free EHA Whitepaper) 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 of 29 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. In May 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 in Seattle and led by Rafael Santana-Davila, M.D., associate professor at the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred 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. In June 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) (Free ASH Whitepaper) Annual Meeting in December 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 of December 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.