10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39045

 

IGM Biosciences, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

77-0349194

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

325 E. Middlefield Road

Mountain View, CA

94043

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 965-7873

 

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

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.

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of July 26, 2023, the registrant had 32,865,317 shares of common stock, $0.01 par value per share, and 25,500,383 shares of non-voting common stock, $0.01 par value per share, outstanding.

 


Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations

2

 

Condensed Consolidated Statements of Comprehensive Loss

3

Condensed Consolidated Statements of Stockholders’ Equity

4

Condensed Consolidated Statements of Cash Flows

6

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

Controls and Procedures

28

 

PART II.

 

OTHER INFORMATION

29

Item 1.

Legal Proceedings

29

Item 1A.

Risk Factors

29

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

77

Item 3.

Defaults Upon Senior Securities

77

Item 4.

Mine Safety Disclosures

77

Item 5.

Other Information

77

Item 6.

Exhibits

78

Signatures

79

 

 

 

 


 

Special Note Regarding Forward Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this report are forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would,” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about: the therapeutic applications for our IgM antibodies; the advantages of the properties of our IgM bispecific antibodies; the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our discovery programs; our ability to utilize our IgM antibody platform to generate and advance additional product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; whether, and for how long, we will rely on third parties to manufacture our product candidates for preclinical and clinical testing and to package, label, store and distribute our investigational product candidates; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; potential business disruptions affecting drug discovery, our preclinical studies or the initiation, patient enrollment, development and operation of our clinical trials; the sufficiency of our backup to our master cell banks; expectations regarding our collaboration agreement with Genzyme Corporation, a wholly owned subsidiary of Sanofi (Sanofi), including all financial aspects of the collaboration, the potential benefits and results of the collaboration, as well as plans and objectives with respect to the collaboration; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our expectations regarding the impact of macroeconomic conditions, such as inflation, supply chain disruptions and economic volatility, on our business; our expectations regarding the impact of health epidemics, such as the COVID-19 pandemic, and other catastrophic events on our business; our anticipated use of our existing resources; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash, cash equivalents, and marketable securities to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified professionals; the implementation of our business model, strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our IgM platform, product candidates and discovery programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; and the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates, and other positive results.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations, and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties, and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, or otherwise.

 

 


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

IGM Biosciences, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

 

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

150,702

 

 

$

121,231

 

Restricted cash

 

 

642

 

 

 

689

 

Marketable securities

 

 

236,167

 

 

 

305,931

 

Prepaid expenses and other current assets

 

 

14,249

 

 

 

10,570

 

 Total current assets

 

 

401,760

 

 

 

438,421

 

Property, plant and equipment, net

 

 

38,366

 

 

 

33,484

 

Operating lease right-of-use assets

 

 

38,413

 

 

 

39,591

 

Other non-current assets

 

 

2,119

 

 

 

2,003

 

 Total assets

 

$

480,658

 

 

$

513,499

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,936

 

 

$

2,512

 

Accrued liabilities

 

 

27,737

 

 

 

33,621

 

Lease liabilities

 

 

6,881

 

 

 

5,816

 

Deferred revenue

 

 

4,745

 

 

 

2,736

 

Total current liabilities

 

 

44,299

 

 

 

44,685

 

Lease liabilities, non-current

 

 

34,536

 

 

 

35,356

 

Deferred revenue, non-current

 

 

143,216

 

 

 

146,195

 

Total liabilities

 

 

222,051

 

 

 

226,236

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.01 par value; 200,000,000 shares authorized as of June 30, 2023 and
   December 31, 2022;
no shares issued and outstanding as of June 30, 2023 and
   December 31, 2022

 

 

 

 

 

 

Common stock, $0.01 par value; 1,000,000,000 shares authorized as of June 30, 2023 and
   December 31, 2022;
32,864,056 and 29,394,436 shares issued and outstanding as of
   June 30, 2023 and December 31, 2022, respectively

 

 

329

 

 

 

294

 

Non-voting common stock, $0.01 par value; 200,000,000 shares authorized
   as of June 30, 2023 and December 31, 2022;
19,875,383 and 13,687,883 shares issued
   and outstanding as of June 30, 2023 and December 31, 2022, respectively

 

 

199

 

 

 

137

 

Additional paid-in-capital

 

 

957,089

 

 

 

862,359

 

Accumulated other comprehensive loss

 

 

(452

)

 

 

(701

)

Accumulated deficit

 

 

(698,558

)

 

 

(574,826

)

Total stockholders’ equity

 

 

258,607

 

 

 

287,263

 

Total liabilities and stockholders’ equity

 

$

480,658

 

 

$

513,499

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

1


IGM Biosciences, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Collaboration revenue

 

$

448

 

 

$

366

 

 

$

970

 

 

$

366

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

55,673

 

 

 

47,218

 

 

 

106,567

 

 

 

86,093

 

General and administrative

 

 

12,983

 

 

 

12,372

 

 

 

25,985

 

 

 

25,453

 

Total operating expenses

 

 

68,656

 

 

 

59,590

 

 

 

132,552

 

 

 

111,546

 

Loss from operations

 

 

(68,208

)

 

 

(59,224

)

 

 

(131,582

)

 

 

(111,180

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

3,894

 

 

 

760

 

 

 

8,066

 

 

 

814

 

Other expense

 

 

 

 

 

(131

)

 

 

(20

)

 

 

(123

)

Total other income (expense)

 

 

3,894

 

 

 

629

 

 

 

8,046

 

 

 

691

 

Loss before income tax expense

 

 

(64,314

)

 

 

(58,595

)

 

 

(123,536

)

 

 

(110,489

)

Income tax expense

 

 

(109

)

 

 

 

 

 

(196

)

 

 

 

Net loss

 

$

(64,423

)

 

$

(58,595

)

 

$

(123,732

)

 

$

(110,489

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.43

)

 

$

(1.33

)

 

$

(2.76

)

 

$

(2.84

)

Weighted-average common shares outstanding, basic and diluted

 

 

45,122,900

 

 

 

43,919,092

 

 

 

44,796,644

 

 

 

38,906,839

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

2


IGM Biosciences, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

(in thousands)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net loss

 

$

(64,423

)

 

$

(58,595

)

 

$

(123,732

)

 

$

(110,489

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized (loss) gain on marketable securities

 

 

(105

)

 

 

(269

)

 

 

249

 

 

 

(396

)

Comprehensive loss

 

$

(64,528

)

 

$

(58,864

)

 

$

(123,483

)

 

$

(110,885

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


IGM Biosciences, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

 

Non-Voting

 

 

Additional

 

 

Accumulated
Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Common Stock

 

 

Paid-In-

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance—December 31, 2022

 

 

29,394,436

 

 

$

294

 

 

 

13,687,883

 

 

$

137

 

 

$

862,359

 

 

$

(701

)

 

$

(574,826

)

 

$

287,263

 

Exercise of stock options

 

 

40,774

 

 

 

 

 

 

 

 

 

 

 

 

75

 

 

 

 

 

 

 

 

 

75

 

Vest of restricted stock units

 

 

64,863

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

354

 

 

 

 

 

 

354

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,047

 

 

 

 

 

 

 

 

 

11,047

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(59,309

)

 

 

(59,309

)

Balance—March 31, 2023

 

 

29,500,073

 

 

$

295

 

 

 

13,687,883

 

 

$

137

 

 

$

873,480

 

 

$

(347

)

 

$

(634,135

)

 

$

239,430

 

Issuance of common stock in connection
   with public offering and private
   placement, net of offering costs

 

 

3,187,500

 

 

$

32

 

 

 

6,187,500

 

 

$

62

 

 

$

68,297

 

 

$

 

 

$

 

 

 

68,391

 

Exercise of stock options

 

 

10,788

 

 

 

 

 

 

 

 

 

 

 

 

14

 

 

 

 

 

 

 

 

 

14

 

Vest of restricted stock units

 

 

81,136

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

Purchases under employee stock
   purchase plan

 

 

84,559

 

 

 

1

 

 

 

 

 

 

 

 

 

990

 

 

 

 

 

 

 

 

 

991

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(105

)

 

 

 

 

 

(105

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,309

 

 

 

 

 

 

 

 

 

14,309

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(64,423

)

 

 

(64,423

)

Balance—June 30, 2023

 

 

32,864,056

 

 

$

329

 

 

 

19,875,383

 

 

$

199

 

 

$

957,089

 

 

$

(452

)

 

$

(698,558

)

 

$

258,607

 

 

 

4


IGM Biosciences, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

Non-Voting

 

 

Additional

 

 

Accumulated
Other

 

 

 

 

 

Total

 

 

Common Stock

 

 

Common Stock

 

 

Paid-In-

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance—December 31, 2021

 

 

26,066,818

 

 

$

261

 

 

 

6,431,205

 

 

$

64

 

 

$

598,373

 

 

$

(66

)

 

$

(353,724

)

 

$

244,908

 

Exercise of stock options

 

 

23,432

 

 

 

 

 

 

 

 

 

 

 

 

133

 

 

 

 

 

 

 

 

 

133

 

Vest of restricted stock units

 

 

1,713

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(127

)

 

 

 

 

 

(127

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,499

 

 

 

 

 

 

 

 

 

11,499

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(51,894

)

 

 

(51,894

)

Balance—March 31, 2022

 

 

26,091,963

 

 

$

261

 

 

 

6,431,205

 

 

$

64

 

 

$

610,005

 

 

$

(193

)

 

$

(405,618

)

 

$

204,519

 

Issuance of common stock in connection
   with public offering, net of offering
   costs

 

 

1,304,347

 

 

$

28

 

 

 

8,695,653

 

 

$

73

 

 

$

217,886

 

 

$

 

 

$

 

 

 

217,987

 

Conversion of non-voting common
   stock into voting common stock

 

 

1,438,975

 

 

 

 

 

 

(1,438,975

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

6,140

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Vest of restricted stock units

 

 

85,510

 

 

 

1

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

Purchases under employee stock
   purchase plan

 

 

38,544