On March 24, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the full year ended December 31, 2021 (Press release, Imago BioSciences, MAR 24, 2022, View Source [SID1234610887]).
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"I am very gratified by the clinical progress Imago has made in 2021, underlined by the positive and promising interim Phase 2 data in both essential thrombocythemia (ET) and myelofibrosis (MF) presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Additionally, Imago made great strides as a company with a successful initial public offering on Nasdaq and expansion of our Board," said Dr. Hugh Young Rienhoff, Jr., M.D, Chief Executive Officer of Imago BioSciences. "Looking ahead, we plan to further our clinical programs in 2022 and additionally anticipate initiating two investigator-sponsored clinical studies in the first half of the year: a Phase 1 study of bomedemstat in combination with atezolizumab for the treatment of small cell lung cancer, and a Phase 2 study of bomedemstat in combination with ruxolitinib for the treatment of MF. We are currently making preparations for a registrational study of bomedemstat for the treatment of ET, subject to the completion of the ongoing trial and a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the second half of this year. Building on our strong progress in 2021 and balance sheet, we are eager to advance bomedemstat into a registrational study to address the serious needs of ET patients who are intolerant to hydroxyurea (HU) or have an inadequate response while also evaluating bomedemstat for other clinical indications."
Fourth Quarter 2021 and Subsequent Highlights
Presented Positive Data from Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at ASH (Free ASH Whitepaper) 2021: In December 2021, Imago presented a positive data update at the 2021 ASH (Free ASH Whitepaper) Annual Meeting and Exposition from the ongoing Phase 2 clinical trial of bomedemstat in patients with essential thrombocythemia (ET). As a monotherapy in a 2nd line ET population, bomedemstat demonstrated significant and durable hematologic control and symptom improvement while maintaining normal hemoglobin levels. The updated data demonstrated bomedemstat reduced a platelet count in the normal range within eight weeks, a primary clinical objective. As of the data cut-off date in November, bomedemstat continued to be generally well-tolerated and demonstrated an encouraging safety profile in ET patients.
Presented Positive Data from Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis at ASH (Free ASH Whitepaper) 2021: In December 2021, Imago presented a positive data update at the 2021 ASH (Free ASH Whitepaper) Annual Meeting and Exposition from the ongoing Phase 2 clinical trial of bomedemstat in patients with advanced myelofibrosis (MF). As of the data cut-off date in November, bomedemstat continued to be generally well-tolerated and demonstrated encouraging safety and distinct clinical benefit to patients, with 75% of the evaluable patients having a reduction in spleen volume from baseline.
Added Laurie Keating to Board of Directors: In November 2021, Imago appointed Laurie Keating, to its Board of Directors. Keating most recently served as Executive Vice President and Chief Legal Officer at Alnylam Pharmaceuticals where she led global public policy and government relations, legal, and intellectual property groups. She currently sits on the Board of Directors of Immuneering Corporation and chairs the Board of Directors of PepGen Inc. She has previously served as a director of privately held life sciences companies and MassBIO, a non-profit organization.
Added Michael Arenberg as Chief Operating and Business Officer: In March 2022, Mr. Arenberg joined the company after spending nearly 22 years at DURECT Corporation where he most recently served for the past three plus years as the company’s Chief Financial Officer. Before being appointed CFO, Mr. Arenberg held roles with increasing responsibilities including as Senior Vice President of Corporate and Business Development. Mr. Arenberg is a distinguished biopharmaceutical executive who will be charged with leading strategic operations, investor relations, commercial development and business development of Imago.
Appointed Laura G. Eichorn as Chief Financial Officer: Ms. Eichorn is a co-founding executive of Imago BioSciences who most recently served as our Chief Operating Officer and Interim Chief Financial Officer. She has more than 25 years of operational experience spanning finance, operations, human resources, and communications.
Fiscal Year 2021 Financial Results
Cash and Cash Equivalents: As of December 31, 2021, Imago had cash, cash equivalents, restricted cash and short-term investments of $217.4 million.
Research & Development (R&D) Expenses: R&D expenses were $11.7 million for the fourth quarter ended December 31, 2021 and $32.3 million for the full year ended December 31, 2021, as compared to $4.3 million for the quarter ended December 31, 2020, and $14.9 million for the full year ended December 31, 2020. The overall increase in R&D expense was related to continued development and manufacturing of drug supplies for our ongoing and planned clinical trials, continued clinical development activities due, in part, to increased consulting expenses added to support ongoing Phase 2 clinical trials in MF and ET, commencement of clinical pharmacology studies, commencement of a Phase 2 extension study for the continued treatment of patients currently enrolled in the ongoing ET and MF clinical trials, and an increase in personnel-related costs primarily due to growth 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 were $3.1 million for the fourth quarter ended December 31, 2021 and $10.3 million for the full year ended December 31, 2021, as compared to $1.3 million for the quarter ended December 31, 2020 and $3.2 million for the full year ended December 31, 2020. The overall increase in G&A expense was primarily due to compensation and personnel-related costs, including stock-based compensation expense, and expenses associated with operating as a public company.
Net Loss: Net loss was $14.7 million for the fourth quarter ended December 31, 2021 and $42.3 million for the full year ended December 31, 2021, as compared to $5.6 million for the quarter ended December 31, 2020 and $17.8 million for the full year ended December 31, 2020.