UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2023, IGM Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
Description |
99.1 |
Press Release of IGM Biosciences, Inc., dated November 13, 2023 |
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104 |
Cover Page Interactive Data file (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IGM BIOSCIENCES, INC. |
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Date: |
November 13, 2023 |
By: |
/s/ Misbah Tahir |
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Misbah Tahir |
Exhibit 99.1
IGM Biosciences Announces Third Quarter 2023 Financial Results
– Third IND cleared for imvotamab in autoimmune diseases –
– International sites opened for aplitabart randomized clinical trial –
MOUNTAIN VIEW, Calif., Nov. 13, 2023 – 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 quarter ended September 30, 2023.
“During the third quarter, we continued to execute across our clinical development pipeline," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We have significantly expanded the number of active sites for our aplitabart randomized study, including multiple international sites, begun our Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis and received FDA clearance of our IND application to begin a third Phase 1b autoimmune clinical trial of imvotamab. Our progress in the clinical development of these pipeline product candidates reinforces our commitment to the broad development of our Death Receptor 5 agonist platform and our T cell engager platform for autoimmune diseases."
Pipeline Progress
Aplitabart (DR5 agonist)
Imvotamab (CD20 x CD3)
IGM-7354 (IL-15 x PD-L1)
IGM-2644 (CD38 x CD3)
Third Quarter 2023 Financial Results
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2023 with more than $325 million in cash and investments, and the Company expects its existing cash and investments and anticipated collaboration payments to fund operations into the second half of 2025.
About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, IGM-7354 and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, IGM-7354 and IGM-2644, including patient enrollment; IGM’s expectations regarding its financial position and guidance, including collaboration revenue, operating expenses, stock-based compensation expense, ending 2023 cash and investments and projected cash runway; and statements
by IGM’s 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: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM's ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM's ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Quarterly Report on Form 10-Q filed with the SEC on November 13, 2023 and in IGM’s 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 Partners
David Pitts
212-600-1902
igmbio@argotpartners.com
IGM Biosciences, Inc.
Selected Statement of Operations Data
(unaudited)
(in thousands, except share and per share data)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Collaboration revenue |
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$ |
509 |
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$ |
331 |
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$ |
1,479 |
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$ |
697 |
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Operating expenses: |
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Research and development (1) |
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54,762 |
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48,179 |
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161,329 |
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134,272 |
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General and administrative (1) |
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12,507 |
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12,664 |
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38,492 |
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38,117 |
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Total operating expenses |
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67,269 |
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60,843 |
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199,821 |
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172,389 |
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Loss from operations |
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(66,760 |
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(60,512 |
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(198,342 |
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(171,692 |
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Other income (expense): |
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Interest income |
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5,011 |
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2,475 |
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13,077 |
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3,289 |
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Other expense |
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— |
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— |
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(20 |
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(123 |
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Total other income (expense) |
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5,011 |
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2,475 |
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13,057 |
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3,166 |
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Loss before income tax expense |
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(61,749 |
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(58,037 |
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(185,285 |
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(168,526 |
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Income tax expense |
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(240 |
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— |
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(436 |
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— |
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Net loss |
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$ |
(61,989 |
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$ |
(58,037 |
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$ |
(185,721 |
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$ |
(168,526 |
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Net loss per share, basic and diluted |
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$ |
(1.04 |
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$ |
(1.32 |
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$ |
(3.73 |
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$ |
(4.15 |
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Weighted-average common shares outstanding, basic and diluted |
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59,580,402 |
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44,034,652 |
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49,778,716 |
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40,634,893 |
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(1) Amounts include stock-based compensation expense as follows:
Research and development |
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$ |
7,391 |
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$ |
6,096 |
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$ |
22,078 |
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$ |
19,038 |
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General and administrative |
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4,563 |
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4,720 |
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15,232 |
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14,563 |
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Total stock-based compensation expense |
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$ |
11,954 |
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$ |
10,816 |
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$ |
37,310 |
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$ |
33,601 |
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IGM Biosciences, Inc.
Selected Balance Sheet Data
(unaudited)
(in thousands)
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash and investments |
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$ |
386,991 |
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$ |
427,162 |
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Total assets |
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474,350 |
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513,499 |
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Accounts payable |
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3,913 |
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2,512 |
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Accrued liabilities |
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27,933 |
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33,621 |
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Deferred revenue |
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147,452 |
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148,931 |
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Total liabilities |
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220,488 |
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226,236 |
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Accumulated deficit |
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(760,547 |
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(574,826 |
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Total stockholders' equity |
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253,862 |
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287,263 |
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