Form 8-K - Current report

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): August 14, 2024

   

IGM Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)


Delaware	001-39045	77-0349194
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

325 E. Middlefield Road
Mountain View, California		94043
(Address of Principal Executive Offices)		(Zip Code)

    Registrant’s Telephone Number, Including Area Code: (650) 965-7873

   

    Not Applicable

   

(Former Name or Former Address, if Changed Since Last Report)

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.01 per share	IGMS	The Nasdaq Global Select Market

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 August 14, 2024, IGM Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024. 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 No.	Description
99.1	Press Release of IGM Biosciences, Inc., dated August 14, 2024

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 hereunto duly authorized.


			IGM BIOSCIENCES, INC.

Date:	August 14, 2024	By:	/s/ Misbah Tahir
			Misbah Tahir Chief Financial Officer

Exhibit 99.1

IGM Biosciences Announces Second Quarter 2024 Financial Results and Provides Corporate Update

– Enrollment complete in aplitabart randomized colorectal cancer clinical trial; top-line PFS results expected by the end of 1Q25 –

– Second dose cohort cleared in imvotamab rheumatoid arthritis clinical trial –

– First dose cohort cleared in imvotamab systemic lupus erythematosus clinical trial –

MOUNTAIN VIEW, Calif., August 14, 2024 – IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended June 30, 2024 and provided an update on recent developments.

“We continue to make significant progress in the clinical development of our two lead product candidates," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We are pleased to have completed enrollment of 127 patients in our randomized study of 3mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer. We are also pleased to have successfully cleared the first two cohorts of our clinical trial of imvotamab in severe rheumatoid arthritis as well as the first cohort of our clinical trial of imvotamab in severe systemic lupus erythematosus."

Pipeline Updates

Aplitabart (death receptor 5 agonist)

•

Clinical development of aplitabart advances.

•

Enrollment completed in randomized colorectal cancer clinical trial. The Company announced that it has completed enrollment in its randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. A total of 127 patients, exceeding the trial design target of 110 patients, were enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will depend on the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025.

Imvotamab (CD20 x CD3 T cell engager)

•

Clinical development of imvotamab in autoimmune diseases advances.

•

First and second dose cohorts in rheumatoid arthritis successfully completed. The Company announced that it has cleared both the first and second dose cohorts of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis and is currently enrolling the third cohort. This study is designed to evaluate three cohorts of progressively higher dose regimens of imvotamab, with each cohort designed to recruit eight patients, six of whom receive imvotamab and two of whom receive placebo.

•

First dose cohort in systemic lupus erythematosus successfully completed. The Company announced that it has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE), with each dose cohort designed to recruit six patients, all of whom are to be treated with

imvotamab. The Company is currently enrolling patients in a second dose cohort and plans to enroll a third dose cohort, with each cohort at progressively higher dose regimens of imvotamab.

•

Enrollment initiated in myositis. The Company has initiated recruitment of patients in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis).

IGM-2644 (CD38 x CD3 T cell engager)

•

Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company has made significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. The Company currently expects to begin enrolling patients in a single arm, open-label clinical study testing IGM-2644 in generalized myasthenia gravis (gMG) by the end of 2024.

Second Quarter 2024 Financial Results

•

Cash and Investments: Cash and investments as of June 30, 2024 were $256.4 million, compared to $337.7 million as of December 31, 2023.

•

Collaboration Revenue: For the second quarter of 2024, collaboration revenues were $1.3 million compared to $0.4 million for the second quarter of 2023.

•

Research and Development (R&D) Expenses: For the second quarter of 2024, R&D expenses were $42.0 million, compared to $55.7 million for the second quarter of 2023.

•

General and Administrative (G&A) Expenses: For the second quarter of 2024, G&A expenses were $10.6 million, compared to $13.0 million for the second quarter of 2023.

•

Net Loss: For the second quarter of 2024, net loss was $47.9 million, or a loss of $0.79 per share, compared to a net loss of $64.4 million, or a loss of $1.43 per share, for the second quarter of 2023.

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 $2 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 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 with respect to patient enrollment, dosing, and the timing of the release of data; IGM’s expectations regarding its financial position and results, including its stock-based compensation expense and collaboration revenue, 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; 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; uncertainties related to IGM's ability to realize the contemplated benefits of its pipeline prioritization efforts and related reduction in force; 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 August 14, 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

(unaudited)

(in thousands, except share and per share data)


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2024			2023			2024			2023
Collaboration revenue	$	1,254		$	448		$	1,751		$	970

Operating expenses:
Research and development (1)		41,962			55,673			85,777			106,567
General and administrative (1)		10,649			12,983			21,187			25,985
Total operating expenses		52,611			68,656			106,964			132,552
Loss from operations		(51,357	)		(68,208	)		(105,213	)		(131,582	)

Other income (expense):
Interest income		3,455			3,894			7,495			8,066
Other expense		—			—			—			(20	)
Total other income (expense)		3,455			3,894			7,495			8,046
Loss before income tax expense		(47,902	)		(64,314	)		(97,718	)		(123,536	)
Income tax expense		—			(109	)		—			(196	)
Net loss	$	(47,902	)	$	(64,423	)	$	(97,718	)	$	(123,732	)

Net loss per share, basic and diluted	$	(0.79	)	$	(1.43	)	$	(1.62	)	$	(2.76	)
Weighted-average common shares outstanding, basic and diluted		60,434,161			45,122,900			60,274,285			44,796,644

(1) Amounts include stock-based compensation expense as follows:


Research and development	$	4,807	$	8,248	$	9,169	$	14,687
General and administrative		3,621		6,061		7,181		10,669
Total stock-based compensation expense	$	8,428	$	14,309	$	16,350	$	25,356

IGM Biosciences, Inc.

Selected Balance Sheet Data

(unaudited)

(in thousands)


	June 30,			December 31,
	2024			2023
Cash and investments	$	256,381		$	337,677
Total assets		336,501			423,411
Accounts payable		3,259			1,326
Accrued liabilities		26,461			31,544
Deferred revenue		145,050			146,801
Total liabilities		214,143			220,177
Accumulated deficit		(918,960	)		(821,242	)
Total stockholders' equity		122,358			203,234

Document And Entity Information	Aug. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 14, 2024
Entity Registrant Name	IGM Biosciences, Inc.
Entity Central Index Key	0001496323
Entity Emerging Growth Company	true
Entity File Number	001-39045
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	77-0349194
Entity Address, Address Line One	325 E. Middlefield Road
Entity Address, City or Town	Mountain View
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94043
City Area Code	(650)
Local Phone Number	965-7873
Entity Information, Former Legal or Registered Name	Not Applicable
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	IGMS
Security Exchange Name	NASDAQ