On March 30, 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 fourth quarter and full year ended December 31, 2020 and provided an update on recent developments (Press release, IGM Biosciences, MAR 30, 2021, View Source [SID1234577354]).

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"IGM reached a number of important milestones in 2020, including the presentation of encouraging initial results from our Phase 1 trial of IGM-2323 at the 2020 ASH (Free ASH Whitepaper) Annual Meeting and the initiation of our Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and non-Hodgkin’s lymphoma," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "While 2020 was filled with significant accomplishments, we expect that 2021 will be even more productive. We expect to complete dose escalation in the Phase 1 study of IGM-2323 and establish a recommended Phase 2 dose, as well as complete initial dose escalation studies with IGM-8444 and initiate combination clinical studies of IGM-8444 with a standard chemotherapy regimen and with birinapant, our newly licensed Inhibitor of Apoptosis Proteins antagonist. We also expect to file an IND for our IL-15 x PD-L1 antibody, IGM-7354, in 2021."

Pipeline Updates

IGM-2323

Recommended Phase 2 dose expected in 2021. IGM has now cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs and is currently open to enrollment to what is planned to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling to the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the Phase 1 dose escalation study and establish a recommended Phase 2 dose in 2021.
IGM-8444

Additional dose cohorts cleared. IGM has now cleared the first two dose cohorts of the single-agent portion of its Phase 1 clinical study and is currently open to enrollment to the third (3 mg/kg) of four single-agent biweekly dose escalation cohorts. IGM is also currently open to enrollment to its first chemotherapy combination dose cohort and its first single-agent weekly dose cohort. IGM expects to report initial data in solid tumors from the dose escalation portion of this Phase 1 trial in the second half of 2021.
Entered into exclusive licensing agreement with Medivir for birinapant. In January 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. IGM plans to begin clinical testing of birinapant in combination with IGM-8444 this year.
IGM-7354

File Investigational New Drug (IND) application. IGM expects to file an IND application with the U.S. Food and Drug Administration (FDA) in 2021 for IGM-7354 in order to begin clinical testing. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is attached to the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.
Corporate Updates

Completed manufacturing facility. Construction of IGM’s new cGMP manufacturing facility in Mountain View, California has been completed. IGM expects that cGMP manufacturing at this facility will begin in 2021.
Completed upsized underwritten public offering of common stock.In December 2020, IGM closed a public offering of its common stock and prefunded warrants, with gross proceeds of $230.0 million, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Investments: Cash and investments as of December 31, 2020 were $366.3 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2020, R&D expenses were $19.6 million and $65.0 million, respectively, compared to $12.8 million and $35.3 million for the fourth quarter and year ended 2019, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2020, G&A expenses were $5.1 million and $18.3 million, respectively, compared to $3.2 million and $9.2 million for the fourth quarter and year ended 2019, respectively.
Net Loss: For the fourth quarter of 2020, net loss was $24.6 million, or a loss of $0.79 per share, compared to a net loss of $14.8 million, or a loss of $0.49 per share, for the fourth quarter of 2019. For the year ended 2020, net loss was $81.4 million, or a loss of $2.65 per share, compared to a net loss of $43.1 million, or a loss of $4.80 per share, for the year ended 2019.
2021 Financial Guidance
IGM expects 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.

Conference Call and Webcast
IGM will host a conference call and webcast to discuss this announcement today, March 30, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2447309. A live audio webcast of the event may also be accessed through the "Investors" section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event.