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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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 March 7, 2024, IGM Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 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 |
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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: |
March 7, 2024 |
By: |
/s/ Misbah Tahir |
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Misbah Tahir |
Exhibit 99.1
IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
MOUNTAIN VIEW, Calif., Mar. 7, 2024 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.
“We made significant progress during 2023 in the clinical development of our two lead product candidates in therapeutic areas that we believe have the greatest potential to produce significant near-term value,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Enrollment in our randomized clinical trial of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer continues to be encouraging, and we expect to expeditiously complete our target enrollment of 110 patients. If the control arm of this randomized study demonstrates the expected median progression free survival of approximately six months, we will be able to begin evaluating the benefit of aplitabart in enhancing progression free survival by the end of this year."
Mr. Schwarzer continued, “We also initiated two Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and in severe rheumatoid arthritis. We are encouraged by the initial level of investigator and patient interest that we have seen in these clinical trials, and we are optimistic that we will be able to generate meaningful initial clinical data by the end of 2024.”
Pipeline Updates
Aplitabart (DR5 agonist)
Imvotamab (CD20 x CD3)
IGM-2644 (CD38 x CD3)
Fourth Quarter and Full Year 2023 Financial Results
2024 Financial Guidance
The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million, including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026.
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 and autoimmune and inflammatory 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, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including the timing of clinical trial initiation and patient enrollment; IGM’s expectations regarding its financial position and guidance, including non-cash stock-based compensation expense, collaboration revenue, ending 2024 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; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties; 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 Annual Report on Form 10-K filed with the SEC on March 7, 2024 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
(in thousands, except share and per share data)
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Three Months Ended |
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Twelve Months Ended |
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December 31, |
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December 31, |
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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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$ |
651 |
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$ |
372 |
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$ |
2,130 |
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$ |
1,069 |
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Operating expenses: |
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Research and development (1) |
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54,190 |
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45,018 |
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215,519 |
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179,289 |
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General and administrative (1) |
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11,580 |
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11,618 |
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50,072 |
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49,736 |
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Total operating expenses |
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65,770 |
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56,636 |
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265,591 |
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229,025 |
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Loss from operations |
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(65,119 |
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(56,264 |
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(263,461 |
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(227,956 |
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Other income (expense) |
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Interest income |
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4,666 |
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3,746 |
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17,743 |
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7,035 |
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Other expense |
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— |
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(58 |
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(20 |
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(181 |
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Total other income (expense) |
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4,666 |
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3,688 |
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17,723 |
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6,854 |
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Loss before income tax expense |
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(60,453 |
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(52,576 |
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(245,738 |
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(221,102 |
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Income tax expense |
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(242 |
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— |
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(678 |
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— |
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Net loss |
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$ |
(60,695 |
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$ |
(52,576 |
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$ |
(246,416 |
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$ |
(221,102 |
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Net loss per share, basic and diluted |
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$ |
(1.01 |
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$ |
(1.19 |
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$ |
(4.71 |
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$ |
(5.32 |
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Weighted-average common shares outstanding, basic and diluted |
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59,829,077 |
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44,241,491 |
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52,311,958 |
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41,543,954 |
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(1) Amounts include stock-based compensation expense as follows:
Research and development |
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$ |
5,421 |
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$ |
6,582 |
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$ |
27,499 |
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$ |
25,620 |
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General and administrative |
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3,816 |
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4,527 |
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19,048 |
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19,090 |
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Total stock-based compensation expense |
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$ |
9,237 |
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$ |
11,109 |
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$ |
46,547 |
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$ |
44,710 |
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IGM Biosciences, Inc.
Selected Balance Sheet Data
(in thousands)
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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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$ |
337,677 |
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$ |
427,162 |
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Total assets |
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423,411 |
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513,499 |
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Accounts payable |
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1,326 |
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2,512 |
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Accrued liabilities |
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31,544 |
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33,621 |
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Deferred revenue |
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146,801 |
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148,931 |
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Total liabilities |
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220,177 |
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226,236 |
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Accumulated deficit |
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(821,242 |
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(574,826 |
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Total stockholders' equity |
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203,234 |
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287,263 |
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