On March 26, 2020 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, 2019 and provided an update on recent developments (Press release, IGM Biosciences, MAR 26, 2020, View Source [SID1234555865]).

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"2019 was a transformational year for IGM. The many highlights of the year included our successful initial public offering and the initiation of our first-in-human trial for our lead product candidate, IGM-2323, a CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL)," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We expect continued progress in 2020, with the filing of an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) for our second product candidate, IGM-8444 and the presentation of initial data from our clinical trial of IGM-2323. With thanks to the IGM team, we believe we are well positioned to remain the global leader in the research and development of engineered therapeutic IgM antibodies."

Recent Highlights and Pipeline Updates

IGM-2323 – Phase 1 trial initiated: In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL. This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. IGM expects to report initial data from this Phase 1 trial in the second half of 2020.

IGM-8444 – IND filing planned: IGM expects to file an IND application with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.

IGM-7354 – Next candidate announced: IGM nominated IGM-7354 as its third clinical candidate. 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 displayed on 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. IGM expects to file an IND with the FDA for IGM-7354 in 2021.

Fourth Quarter and Full Year 2019 Financial Results

Cash and Investments: Cash and investments as of December 31, 2019 were $236.6 million.

Research and Development (R&D) Expenses: For the fourth quarter and year ended 2019, R&D expenses were $12.8 million and $35.3 million, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2019, G&A expenses were $3.2 million and $9.2 million, respectively.
Net Loss: For the fourth quarter of 2019, net loss was $14.8 million, or a loss of $0.49 per share. For the year ended 2019, net loss was $43.1 million, or a loss of $4.80 per share.
Shares Outstanding: Weighted-average shares outstanding for the fourth quarter of 2019 were 30.5 million and for the full year of 2019 were 9.0 million shares.
2020 Financial Guidance

IGM estimates non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

Conference Call and Webcast

IGM will host a conference call and webcast to discuss this announcement today, March 26, 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 2991398. 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 through 11:59p.m. ET on April 25, 2020.