 - IND for IGM-8444 for treatment of patients with solid cancers cleared by FDA -- Kathy Miller, Ph.D., appointed Vice President, Antibody Discovery -- Phase I clinical trial of IGM-2323 continues -MOUNTAIN VIEW, Calif., Aug. 06, 2020 GLOBE NEWSWIRE -- 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 second quarter ended June 30, 2020 and provided an update on recent developments.We continue to make steady progress advancing our pipeline of engineered IgM antibodies, said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. Today, we are pleased to announce that the FDA has cleared our Investigational New Drug IND application for IGM-8444, our anti-Death Receptor 5 IgM antibody, which we believe may prove to be helpful in treating a broad range of solid and hematologic malignancies. Later this year, we look forward to beginning our Phase 1 trial of IGM-8444 in solid cancers and to sharing our initial clinical data from our Phase 1 trial of IGM-2323 in relapsedrefractory NHL.IGM-8444 Investigational New Drug IND application for IGM-8444 cleared by the U.S. Food and Drug Administration FDA. IGM today announced that the FDA has cleared the Company to proceed to conduct clinical trials pursuant to its IND for IGM-8444, an IgM antibody targeting the Death Receptor 5 DR5 protein, which may prove to be useful for the treatment of patients with solid and hematologic malignancies. The proposed multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed andor refractory solid cancers. The key objectives of this Phase 1 clinical trial are to provide an initial assessment of pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy.Corporate Updates Kathy Miller, Ph.D., appointed as Vice President, Antibody Discovery. IGM today announced the appointment of Kathy Miller, Ph.D., as Vice President, Antibody Discovery. Prior to joining IGM, Dr. Miller served as Vice President, Biotherapeutics at Five Prime Therapeutics from 2015-2020. She has also served in various scientific and leadership roles at Novartis Institutes for Biomedical Research, and at Merck Research Laboratories at the former DNAXSchering Plough site. Dr. Miller received a B.S. and a Ph.D. in Molecular Genetics from The Ohio State University and conducted post-doctoral research at Genentech. Phase I Clinical Trial of IGM-2323. IGM is continuing the dose escalation portion of its Phase I clinical trial evaluating IGM-2323 in patients with relapsedrefractory NHL, the first-in-human application of IGMs engineered IgM antibody technology. IGM continues to expect to present initial data from this clinical trial in the fourth quarter of 2020.Second Quarter 2020 Financial Results Cash and Investments: Cash and investments as of June 30, 2020 were 203.1 million, compared to 236.6 million as of December 31, 2019. Research and Development RD Expenses: For the second quarter of 2020, RD expenses were 15.0 million, compared to 8.3 million for the same period in 2019. General and Administrative GA Expenses: For the second quarter of 2020, GA expenses were 4.4 million, compared to 2.2 million for the same period in 2019. Net Loss: For the second quarter of 2020, net loss was 18.8 million, or a loss of 0.62 per share, compared with a net loss of 10.7 million, or a loss of 19.08 per share, for the same period in 2019. Shares Outstanding: Weighted-average shares outstanding for the second quarter of 2020 were 30.6 million, compared to 0.6 million for the same period in 2019.2020 Financial GuidanceIGM reiterates its previously issued financial guidance which consisted of 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. 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 StatementsThis 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, statements regarding the Companys Phase 1 clinical trial of IGM-8444, including the commencement of that clinical trial, and the Companys Phase I trial of IGM-2323, including the timing of reporting initial data from that clinical trial, the Companys future financial and operating performance, including its 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 current clinical trials, enrollment in its current and future clinical trials and on the collaboration 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; 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; IGMs ability to successfully manufacture and supply its product candidates for clinical trials; IGMs ability to accurately forecast future financial results in the current environment; 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; 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 August 6, 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. IGM Biosciences, Inc. Selected Statement of Operations Data unaudited in thousands, except share and per share data Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Operating expenses: Research and development 1 15,019 8,303 29,602 14,215 General and administrative 1 4,388 2,228 8,378 3,673 Total operating expenses 19,407 10,531 37,980 17,888 Loss from operations 19,407 10,531 37,980 17,888 Other income expense, net 568 145 1,517 258 Net loss 18,839 10,676 36,463 18,146 Net loss per share, basic and diluted0.62 19.08 1.19 36.17 Weighted-average common shares outstanding, basic and diluted 30,551,736 559,671 30,521,600 501,716 1Amounts include stock-based compensation expense as follows: Research and development 1,047 109 1,713 214 General and administrative 908 32 1,565 66 Total stock-based compensation expense1,955 141 3,278 280 IGM Biosciences, Inc. Selected Balance Sheet Data unaudited in thousands June 30, December 31, 2020 2019 Cash and investments 203,124 236,607 Total assets 229,057 261,350 Accrued liabilities 4,333 3,305 Total liabilities 22,104 21,119 Accumulated deficit 143,668 107,205 Total stockholders equity 206,953 240,231 Contact: Argot Partners David Pitts 212-600-1902 