On August 9, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the second quarter ended June 30, 2021 and provided an update on recent developments (Press release, IGM Biosciences, AUG 9, 2021, View Source [SID1234586121]).

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"We continue to make steady progress in the development of our innovative product pipeline, including the successful completion of the initial dose escalation portion of our IGM-2323 Phase 1 clinical trial," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We look forward to announcing a recommended Phase 2 dose for IGM-2323, presenting initial dose escalation data from the Phase 1 trial of IGM-8444, initiating a Phase 1 trial for IGM-6268 and filing an IND for IGM-7354 this year. "

Pipeline Updates

IGM-2323

Phase 1 dose escalation completed; dose expansion continues. IGM continues to advance the clinical development of IGM-2323, the Company’s IgM-based CD20 x CD3 bispecific antibody, for the treatment of non-Hodgkin’s lymphoma (NHL). The Company cleared its highest planned dose escalation cohort, a top dose of 1000 mg, without a dose limiting toxicity, and is currently treating additional patients in four Phase 1 dose cohorts with top doses of 100 mg, 300 mg, 600 mg and 1000 mg, respectively. IGM expects to select a recommended Phase 2 dose in 2021.
IGM-8444

Additional dose cohorts cleared in Phase 1. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM Death Receptor 5 (DR5) agonist, for the treatment of a potentially broad range of solid tumors and hematologic malignancies. IGM has cleared its third dose cohort (3 mg/kg) of the single-agent portion of its Phase 1 clinical study and is currently treating patients in its highest dose escalation cohort (10 mg/kg) with every two-week single agent dosing. IGM has also cleared the first dose cohort of the FOLFIRI combination portion of the Phase 1 study and is currently treating patients in the second of four planned FOLFIRI combination dose escalation cohorts. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in 2021.
Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 in 2021.
IGM-6268

New pipeline candidate for the treatment and prevention of COVID-19 expected to advance into the clinic this year. In June 2021, IGM announced IGM-6268, which represents the expansion of the Company’s IgM platform into infectious diseases. IGM-6268 is an IgM version of an anti-SARS-CoV-2 IgG monoclonal antibody and is being developed as an intranasally administered agent for the treatment and prevention of COVID-19. IGM expects to initiate a Phase 1 clinical trial of IGM-6268 in 2021.
Nature manuscript published. In June 2021, Nature published an article entitled "Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants". The article describes results from preclinical studies demonstrating significantly greater neutralization of SARS-CoV-2 with an IgM antibody compared to IgG antibodies, the potent neutralization of all evaluated mutant Variants of Concern and Variants of Interest, and the ability to provide effective preventative and therapeutic protection when delivered intranasally in mice. The article was co-authored by researchers at IGM, The University of Texas Medical Branch at Galveston and The University of Texas Health Science Center at Houston.
IGM-7354

Investigational New Drug (IND) application expected to be filed this year. IGM plans to file an IND application with the U.S. Food and Drug Administration (FDA) for IGM-7354, the Company’s IL‑15 x PD‑L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies.
Corporate Updates

Chris Takimoto appointed Chief Medical Officer. Dr. Takimoto brings 30 years of experience in cancer research and development. Most recently, Dr. Takimoto was Senior Vice President, Oncology at Gilead Sciences, Inc. Prior to Gilead, he served as Chief Medical Officer of Forty Seven, Inc., a biotechnology company formed out of Stanford University and acquired by Gilead Sciences in 2020.
Second Quarter 2021 Financial Results

Cash and Investments: Cash and investments as of June 30, 2021 were $301.8 million, compared to $366.3 million as of December 31, 2020.
Research and Development (R&D) Expenses: For the second quarter of 2021, R&D expenses were $30.1 million, compared to $15.0 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the second quarter of 2021, G&A expenses were $8.6 million, compared to $4.4 million for the same period in 2020.
Net Loss: For the second quarter of 2021, net loss was $38.7 million, or a loss of $1.16 per share, compared to a net loss of $18.8 million, or a loss of $0.62 per share, for the same period in 2020.
2021 Financial Guidance

IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments.