On November 5, 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 third quarter ended September 30, 2020 and provided an update on recent developments (Press release, IGM Biosciences, NOV 5, 2020, View Source [SID1234570117]).

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"We are very pleased with the progress that we have made through the first three quarters of 2020 in advancing our pipeline programs both in the clinic and in research," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Our lead IgM antibodies, IGM-2323 and IGM-8444, are moving forward in clinical trials, and we look forward to presenting initial, first-in-human clinical data from our Phase 1 trial of IGM-2323 at the upcoming ASH (Free ASH Whitepaper) Annual Meeting in December and to presenting initial clinical data from our Phase 1 trial of IGM-8444 in 2021."

Pipeline Updates:

IGM-2323

Phase 1 data to be presented at American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. IGM will report initial data from its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory Non-Hodgkin’s Lymphoma (NHL), the first-in-human application of IGM’s engineered IgM antibody technology, at the ASH (Free ASH Whitepaper) Annual Meeting being held virtually December 5-8, 2020.
IGM-8444

Initiated Phase 1 trial of IGM-8444. IGM announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and NHL. IGM expects to report initial data from this Phase 1 trial in 2021.
IGM-7354

IGM-7354 preclinical data to be presented at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The poster, titled "Targeting IL-15 delivery to PD-L1 Expressing Tumors using an Anti-PD-L1 x IL-15 Cytokine Fusion IgM to Enhance T Cell and NK Cell Mediated Tumor Cytotoxicity", will be made available online via the meeting’s virtual poster hall beginning on Monday, November 9 at 8:00 a.m. ET.

Corporate Updates:

Multi-year antibody discovery collaboration with AbCellera announced. IGM and AbCellera announced that they have entered into a multi-year, multi-target strategic research collaboration and license agreement intended to expedite discovery of novel IgM antibodies. AbCellera will generate panels of antibodies for multiple therapeutic targets identified by IGM using its full-stack, AI-powered antibody discovery technology, and IGM will have the rights to develop and commercialize the novel antibodies resulting from this collaboration.

Third Quarter 2020 Financial Results:

Cash and Investments: Cash and investments as of September 30, 2020 were $180.2 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the third quarter of 2020, R&D expenses were $15.8 million, compared to $8.3 million for the same period in 2019.
General and Administrative (G&A) Expenses: For the third quarter of 2020, G&A expenses were $4.7 million, compared to $2.4 million for the same period in 2019.
Net Loss: For the third quarter of 2020, net loss was $20.3 million, or a loss of $0.66 per share, compared with a net loss of $10.2 million, or a loss of $2.41 per share, for the same period in 2019.
Shares Outstanding: Weighted-average shares outstanding for the third quarter of 2020 were 30.6 million, compared to 4.2 million for the same period in 2019.

2020 Financial Guidance:

IGM expects non-GAAP operating expenses for 2020 to be approximately $80 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $9 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 to be $89 – $94 million. IGM expects to end 2020 with a balance of over $140 million in cash and investments.