GlobeNewswire Inc | Nov 5, 2020 07:02AM EST

November 05, 2020

MOUNTAIN VIEW, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- - Initial Data from Phase 1 Trial of IGM-2323 in Relapsed/refractory Non-Hodgkins Lymphomato be Presented at the 62nd American Society of Hematology Annual Meeting and Exposition in December -

-First-in-Human Clinical Trial of IGM-8444 for the Treatment of Solid Cancers and Non-Hodgkins Lymphoma Initiated -

IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the third quarter ended September 30, 2020 and provided an update on recent developments.

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 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) Annual Meeting. IGM will report initial data from its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory Non-Hodgkins Lymphoma (NHL), the first-in-human application of IGMs engineered IgM antibody technology, at the ASH 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-7354preclinical data to be presented at Society for Immunotherapy of Cancer (SITC) 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 meetings 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 ofSeptember 30, 2020 were$180.2 million, compared to $236.6million 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$0.66per 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.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to IGMs plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding, the Companys IgM technology platform, its IgM antibodies and IGM-2323 and IGM-8444, statements regarding the Companys Phase 1 clinical trials of IGM-2323 and IGM-8444, including the timing of reporting initial data from those clinical trials, the presentation of initial, first-in-human clinical data from the Companys Phase 1 trial of IGM-2323 at the ASH Annual Meeting in December, the Companys development strategy for IGM-2323 and IGM-8444, the potential of, and expectations regarding, the collaboration with AbCellera and the nature and scope of such collaboration, the Companys future financial and operating performance, including its financial guidance for the full year 2020 and year end 2020 cash and investments balance, and statements by IGMs Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGMs operations, the manufacturing of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and on its collaborations and related efforts; IGMs early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGMs ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the risk that all necessary regulatory approvals cannot be obtained; IGMs ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGMs ability to enroll patients in its ongoing and future clinical trials; the potential for clinical trials of IGM-2323, IGM-8444 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results; IGMs ability to successfully manufacture and supply its product candidates for clinical trials; IGMs ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGMs ability to obtain, maintain and protect its intellectual property rights; developments relating to IGMs competitors and its industry, including competing product candidates and therapies; risks related to collaborations with third parties, including the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of any such collaboration; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGMs filings with the Securities and Exchange Commission (SEC), including IGMs Annual Report on Form 10-K filed with the SEC on March 26, 2020, IGMs Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020 and in IGMs future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact:Argot PartnersDavid Pitts212-600-1902igmbio@argotpartners.com

FINAL 11-04-2020 IGM Biosciences, Inc. Selected Statement of Operations Data (unaudited) (in thousands, except share and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Operating expenses: Research and development ^ $ 15,829 $ 8,279 $ 45,431 $ 22,494 (1) General and administrative 4,732 2,394 13,110 6,067 ^(1) Total operating 20,561 10,673 58,541 28,561 expenses Loss from (20,561 ) (10,673 ) (58,541 ) (28,561 ) operations Other income, 291 501 1,808 243 net Net $ (20,270 ) $ (10,172 ) $ (56,733 ) $ (28,318 ) loss Net loss per share, $ (0.66 ) $ (2.41 ) $ (1.86 ) $ (16.13 ) basic and diluted Weighted-average common shares outstanding, basic 30,646,729 4,222,259 30,563,614 1,755,526 and diluted ^ Amounts include stock-based (1) compensation expense as follows: Research and $ 1,244 $ 116 $ 2,957 $ 330 development General and 1,350 218 2,915 284 administrative Total stock-based compensation $ 2,594 $ 334 $ 5,872 $ 614 expense IGM Biosciences, Inc. Selected Balance Sheet Data (unaudited) (in thousands) September 30, December 31, 2020 2019 Cash and $ 180,236 $ 236,607 investments Total 211,717 261,350 assets Accrued liabilities 7,472 3,305 Total 23,541 21,119 liabilities Accumulated (163,938 ) (107,205 ) deficit Total stockholders' 188,176 240,231 equity