On May 12, 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 first quarter ended March 31, 2022 and provided a corporate update (Press release, Imago BioSciences, MAY 12, 2022, View Source [SID1234614472]).
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"I am delighted by the clinical progress Imago has made, which was underscored by the completion of enrollment in the Phase 2 trial of bomedemstat for treatment of ET as well as positive interim data from our two Phase 2 trials in ET and MF presented at ASH (Free ASH Whitepaper) 2021 with additional data from these trials to be presented at the upcoming EHA (Free EHA Whitepaper) congress in June. In addition, the Fred Hutchinson Cancer Research Center has initiated dosing in a Phase 1/2 combination study of bomedemstat and atezolizumab for the treatment of small cell lung cancer and we remain on track to initiate our second combination study in the first half of 2022, which is a Phase 2 trial of bomedemstat and ruxolitinib for the treatment of MF," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "As we continue to assemble a seasoned leadership team, I am pleased to have had Mike join as Chief Operating and Business Officer, as Laura Eichorn transitioned from the Chief Operating Officer role into the Chief Financial Officer on a permanent basis. Looking ahead, Imago expects to initiate a registrational study of bomedemstat for the treatment of ET, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), around the end of 2022."
First Quarter 2022 Highlights
Announced results of preliminary discussions with the U.S. Food and Drug Administration (FDA), about key trial design parameters for a registration-directed Phase 3 program of bomedemstat for the treatment of ET. Based on these discussions, we believe a two-arm trial comparing bomedemstat to best available therapy may provide the basis for regulatory approval for the second-line treatment of ET. Subject to final review of the Phase 3 protocol, we have alignment on the study population of patients with ET, viz., those patients who are intolerant of or resistant to hydroxyurea, the agents in the control arm and the composite primary endpoint of durable normalization of platelet and white counts and hemostasis in the absence of progression. Based on completion of enrollment for the Phase 2 clinical trial in ET, and subsequent End of Phase 2 meeting, we expect to submit a final protocol for a registrational Phase 3 pivotal program in 2022, with the first patient dosed thereafter. With positive results from the pivotal clinical program, we would expect to submit applications for regulatory approval with the FDA and the EMA for ET.
Announced completion of enrollment in the Phase 2 trial of bomedemstat for the treatment of ET with 73 patients enrolled on May 3, 2022. To be enrolled in the Phase 2 ET trial, patients had to be intolerant of, or inadequately managed by treatment with one standard-of-care drug, generally hydroxyurea, and also had one or more high-risk prognostic factors, such as being over 60 years of age or having a history of clotting or bleeding events. Primary endpoints of this clinical trial are safety and tolerability, as well as the reduction of platelet count to ≤400 x 109/L, in the absence of any clotting or bleeding events. We are also evaluating several exploratory endpoints, including reduction in mutant allele frequency and prevention of transformation to MF or acute myeloid leukemia. In this Phase 2 trial, as well as our Phase 2 MF trial, we have used platelet count as a biomarker of bomedemstat activity on megakaryocyte function, allowing for individualized dosing. Patients from this trial are eligible to transition into an ongoing Phase 2 Extension Study initiated in 2021 enabling the collection of long-term safety and pharmacodynamic data.
Expanded Executive Leadership. In March 2022, Imago announced the appointments of Michael Arenberg as Chief Operating and Business Officer and Laura G. Eichorn as our Chief Financial Officer. Mr. Arenberg succeeds Ms. Eichorn as COO and is charged with leading strategic operations, investor relations, commercial development and business development of Imago. Ms. Eichorn has transitioned from interim Chief Financial Officer to serving in that role on a permanent basis.
Recent Highlights
Announced that the Fred Hutchinson Cancer Research Center has dosed the initial participant in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC). The study is being led by Rafael Santana-Davila, M.D., associate professor in 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. This single-center, open-label study is designed to assess the safety, dose-limiting toxicity, and progression-free survival of bomedemstat in approximately 34 patients with ES-SCLC. More information on this trial can be found on www.clinicaltrials.gov under the identifier NCT05191797.
Announced Data Presentations at the Upcoming 27th EHA (Free EHA Whitepaper) Congress. In May 2022, Imago announced that two abstracts have been accepted for poster presentation at EHA (Free EHA Whitepaper), to be presented on June 10, 2022: "A Phase 2 Study of The LSD1 Inhibitor IMG-7289 (Bomedemstat) For The Treatment Of Essential Thrombocythemia (ET)"; and "A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced Myelofibrosis."
Anticipated Upcoming Milestones
Data updates for bomedemstat in MF and ET at EHA (Free EHA Whitepaper) on June 10, 2022
Anticipate initiating Phase 2 combination study of bomedemstat with ruxolitinib in MF in 1H 2022
Expect an End-of-Phase 2 meeting with FDA for bomedemstat in ET in 2H 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
First Quarter 2022 Financial Results
Cash and Cash Equivalents: As of March 31, 2022, Imago had cash and cash equivalents and short-term investments of $205.8 million, compared to $82.7 million as of March 31, 2021 and $217.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2022 were $12.5 million (including stock-based compensation expense of $0.7 million) as compared to $4.8 million for the same period in 2021. The overall increase in R&D expenses was primarily related to increased manufacturing costs of drug supplies for our ongoing and planned clinical trials, continued clinical development activities in separate Phase 2 clinical trials for ET and MF, commencement of a Phase 2 extension study started in the second half of 2021 for the long-term follow-up of patients from the ongoing ET and MF clinical trials, and an increase in personnel-related costs, particularly with respect to an increase in the number of research and development employees, including stock-based compensation expense, as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2022 were $4.0 million (including stock-based compensation expense of $0.7 million) as compared to $2.4 million for the same period in 2021 primarily due to increasing expense associated with operating a publicly traded company and personnel-related costs.
Net Loss: Net loss for the quarter ended March 31, 2022 was $16.4 million compared to $7.1 million for the same period in 2021.