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 November 3, 2022, IGM Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. 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 3, 2022. |
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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 3, 2022 |
By: |
/s/ Misbah Tahir |
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Misbah Tahir |
Exhibit 99.1
IGM Biosciences Announces Third Quarter 2022 Financial Results and Provides Corporate Update
– Data from T cell Engager Portfolio for Hematologic Malignancies, Including First Preclinical Data for IGM-2644 and IGM-2537, Selected for Poster Presentations at 2022 ASH Annual Meeting –
– Data Update from Phase 1 Trial of Imvotamab Demonstrates Durable Benefit for R/R NHL Patients, with 7/8 Complete Response Patients Tumor Free After 1 Year –
MOUNTAIN VIEW, Calif., November 03, 2022 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, today announced its financial results for the third quarter ended September 30, 2022 and provided an update on recent developments.
“We have made substantial progress in advancing our IgM platform in the third quarter, particularly in expanding the body of evidence underlying our T cell engager portfolio for hematologic malignancies and in generating additional clinical data for IGM-8444. We continue to believe that each of our T cell engager product candidates has the potential to change the treatment paradigm in its respective indication. Notably, we are excited to share the first insight into the preclinical profiles of IGM-2644, our CD38 x CD3 bispecific IgM antibody, and IGM-2537, our CD123 x CD3 bispecific IgM antibody, during poster presentations at the upcoming ASH meeting in December,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Additionally, today we are providing an update from the Phase 1 dose escalation trial of imvotamab in relapsed and/or refractory NHL describing its durable benefit for relapsed and/or refractory NHL patients. We look forward to sharing an initial Phase 2 efficacy and safety update for imvotamab and an initial efficacy and safety update on the FOLFIRI combination for IGM-8444 in Q1 2023.”
Pipeline Updates
Imvotamab (CD20 x CD3)
IGM-2644 (CD38 x CD3)
IGM-2537 (CD123 x CD3)
IGM-8444 (DR5)
IGM-7354 (IL-15 x PD-L1)
Corporate Updates
Third Quarter 2022 Financial Results
2022 Financial Guidance
IGM is updating its financial guidance and expects to end 2022 with a balance of more than $410 million in cash and investments and full year GAAP operating expenses of $240 million to $245 million including estimated non-cash stock-based compensation expense of approximately $45 million. IGM estimates full year collaboration revenue of approximately $1 million related to the Sanofi agreement.
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, infectious diseases and autoimmune and inflammatory diseases. The Company’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. The Company 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, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including imvotamab, IGM-8444, IGM-7354, IGM-2644 and IGM-2537; expectations regarding IGM's collaborations with Sanofi and ADC Therapeutics, including the potential benefits and results of each collaboration and the objectives of each collaboration; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of imvotamab, IGM-8444, IGM-7354 and IGM-2644, including the timing of initiation of clinical trials, patient enrollment, data reporting and scientific presentations; the expected timing of filing an IND for IGM-2537; IGM’s expectations regarding its financial position and guidance, including collaboration revenue, operating expenses, stock-based compensation expense, and ending 2022 cash and investments; 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: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacture of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties, including the agreement with Sanofi; 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 preclinical studies and 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, if needed; 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; general economic and market conditions; 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 3, 2022 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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2022 |
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2021 |
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2022 |
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2021 |
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Collaboration revenue |
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$ |
331 |
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$ |
— |
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$ |
697 |
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$ |
— |
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Operating expenses: |
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Research and development (1) |
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48,179 |
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34,196 |
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134,272 |
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87,857 |
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General and administrative (1) |
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12,664 |
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10,003 |
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38,117 |
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26,786 |
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Total operating expenses |
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60,843 |
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44,199 |
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172,389 |
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114,643 |
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Loss from operations |
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(60,512 |
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(44,199 |
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(171,692 |
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(114,643 |
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Other income (expense) |
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Interest income |
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2,475 |
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35 |
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3,289 |
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121 |
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Other expense |
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— |
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— |
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(123 |
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— |
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Total other income (expense) |
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2,475 |
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35 |
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3,166 |
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121 |
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Net Loss |
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$ |
(58,037 |
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$ |
(44,164 |
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$ |
(168,526 |
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$ |
(114,522 |
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Net loss per share, basic and diluted |
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$ |
(1.32 |
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$ |
(1.32 |
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$ |
(4.15 |
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$ |
(3.43 |
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Weighted-average common shares outstanding, basic and diluted |
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44,034,652 |
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33,438,477 |
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40,634,893 |
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33,380,143 |
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(1) Amounts include stock-based compensation expense as follows:
Research and development |
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$ |
6,096 |
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$ |
3,095 |
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$ |
19,038 |
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$ |
7,605 |
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General and administrative |
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4,720 |
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3,117 |
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14,563 |
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9,720 |
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Total stock-based compensation expense |
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$ |
10,816 |
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$ |
6,212 |
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$ |
33,601 |
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$ |
17,325 |
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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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2022 |
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2021 |
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Cash and investments |
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$ |
469,139 |
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$ |
229,542 |
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Total assets |
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540,936 |
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298,127 |
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Accounts payable |
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2,731 |
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5,584 |
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Accrued liabilities |
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32,647 |
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18,876 |
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Deferred revenue |
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149,303 |
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— |
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Total liabilities |
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212,761 |
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53,219 |
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Accumulated deficit |
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(522,250 |
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(353,724 |
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Total stockholders' equity |
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328,175 |
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244,908 |
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