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 30, 2023, IGM Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 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 March 30, 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: |
March 30, 2023 |
By: |
/s/ Misbah Tahir |
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Misbah Tahir |
Exhibit 99.1
IGM Biosciences Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
– Encouraging initial data from IGM-8444 combination with FOLFIRI; first patient dosed in randomized trial –
– Imvotamab to move forward into clinical studies in multiple autoimmune diseases –
– Initiation of Phase 1 clinical trial for targeted immunostimulatory IL-15 cytokine IGM-7354 in patients with solid tumors –
– Company to hold conference call and webcast today at 4:30 p.m. EDT –
MOUNTAIN VIEW, Calif., March 30, 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 fourth quarter and full year ended December 31, 2022 and provided an update on recent developments.
“During 2022 we continued to extend the application of our IgM antibody platform by preparing imvotamab for clinical trials in autoimmune diseases and signing an exclusive worldwide collaboration agreement with Sanofi to develop novel IgM agonist antibodies for oncology and autoimmune diseases,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Also, and perhaps most significantly, the initial clinical results from IGM-8444, our anti-death receptor 5 IgM antibody, highlight the exciting potential of IgM antibodies as agonist antibody medicines. We are announcing today that we have dosed the first patient in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients. We are also pleased with the expanded safety and efficacy data for imvotamab at 100 mg that we have developed through our non-Hodgkin's lymphoma clinical trials, and we believe that imvotamab’s encouraging safety profile may be an important differentiating factor in the exciting new field of T cell engagers in autoimmune disease.”
Mr. Schwarzer continued, “We expect that 2023 will also be an important year for the expansion and validation of IGM’s platform. Already this year, we have treated the first patients in our initial clinical study of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, which could be used for the treatment of patients with solid and hematologic malignancies, potentially in combination with cellular therapies, such as CAR-T and CAR-NK cells. We are also initiating clinical studies of IGM-2644, our CD38 x CD3 T cell engaging IgM antibody, which we hope will prove to be a safe and more potent form of anti-CD38 therapy for multiple myeloma, including for patients who have previously been treated with daratumumab. We also plan to file Investigational New Drug applications and initiate clinical studies for imvotamab in multiple autoimmune diseases this year, beginning with systemic lupus erythematosus and rheumatoid arthritis.”
Pipeline Updates
IGM-8444 (DR5)
Imvotamab (CD20 x CD3)
IGM-7354 (IL-15 x PD-L1)
IGM-2644 (CD38 x CD3)
Fourth Quarter and Full Year 2022 Financial Results
2023 Financial Guidance
The Company expects full year 2023 GAAP operating expenses of $290 million to $300 million, including estimated non-cash stock-based compensation expense of approximately $50 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with a balance of approximately $200 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2024.
Conference Call and Webcast
IGM will host a live conference call and webcast at 4:30 p.m. EDT today, March 30, 2023, to discuss the Company's financial results and provide a corporate update. The webcast can be accessed by clicking the link: https://edge.media-server.com/mmc/p/ud83kix8 and will also be available on the "Events and Presentations" page in the "Investors" section of the Company's website.
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. 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 and IGM-2644; expectations regarding IGM’s collaboration with Sanofi, including the potential benefits and results of such collaboration and the objectives of such collaboration and any future collaborations; 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 filing INDs, initiation of clinical trials and 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 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; 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 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; 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 30, 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
(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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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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$ |
372 |
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$ |
— |
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$ |
1,069 |
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$ |
— |
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Operating expenses: |
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Research and development (1) |
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45,018 |
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39,169 |
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179,289 |
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127,026 |
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General and administrative (1) |
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11,618 |
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11,511 |
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49,736 |
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38,297 |
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Total operating expenses |
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56,636 |
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50,680 |
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229,025 |
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165,323 |
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Loss from operations |
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(56,264 |
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(50,680 |
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(227,956 |
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(165,323 |
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Other income (expense) |
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Interest income |
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3,746 |
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38 |
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7,035 |
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159 |
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Other expense |
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(58 |
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— |
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(181 |
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— |
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Total other income (expense) |
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3,688 |
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38 |
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6,854 |
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159 |
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Net Loss |
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$ |
(52,576 |
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$ |
(50,642 |
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$ |
(221,102 |
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$ |
(165,164 |
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Net loss per share, basic and diluted |
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$ |
(1.19 |
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$ |
(1.50 |
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$ |
(5.32 |
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$ |
(4.93 |
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Weighted-average common shares outstanding, basic and diluted |
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44,241,491 |
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33,775,358 |
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41,543,954 |
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33,479,782 |
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(1) Amounts include stock-based compensation expense as follows:
Research and development |
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$ |
6,582 |
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$ |
4,659 |
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$ |
25,620 |
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$ |
12,264 |
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General and administrative |
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4,527 |
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3,889 |
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19,090 |
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13,609 |
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Total stock-based compensation expense |
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$ |
11,109 |
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$ |
8,548 |
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$ |
44,710 |
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$ |
25,873 |
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IGM Biosciences, Inc.
Selected Balance Sheet Data
(in thousands)
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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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$ |
427,162 |
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$ |
229,542 |
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Total assets |
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513,499 |
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298,127 |
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Accounts payable |
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2,512 |
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5,584 |
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Accrued liabilities |
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33,621 |
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18,876 |
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Deferred revenue |
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148,931 |
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— |
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Total liabilities |
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226,236 |
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53,219 |
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Accumulated deficit |
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(574,826 |
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(353,724 |
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Total stockholders' equity |
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287,263 |
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244,908 |
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