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Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 September 30, 2021

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: 001-40502

 

Lyell Immunopharma, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

83-1300510

(State or other jurisdiction of

incorporation or organization)

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

201 Haskins Way

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 695-0677

 

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, $0.0001 par value

 

LYEL

 

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 November 5, 2021, the registrant had 240,471,497 shares of common stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

4

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)

5

 

Condensed Consolidated Statements of Cash Flows

7

 

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

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

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

Item 4.

Controls and Procedures

38

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

39

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

80

Item 3.

Defaults Upon Senior Securities

80

Item 4.

Mine Safety Disclosures

81

Item 5.

Other Information

81

Item 6.

Exhibits

81

Signatures

82

 

 

 

 

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Table of Contents

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 Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned nonclinical studies and clinical trials, results of nonclinical studies, clinical trials, research and development costs, planned regulatory submissions, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, 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 “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” 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 sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements;

• the accuracy of our estimates regarding expenses, revenue opportunities, capital requirements and needs for additional financing;

• the scope, progress, results and costs of developing LYL797, LYL845 or any other product candidates we may develop, and conducting preclinical studies and clinical trials, including for LYL797 and LYL845;

• the timing and costs involved in obtaining and maintaining regulatory approval of LYL797, LYL845 or any other product candidates we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations for our product candidates for various diseases;

• our expectations regarding GSK’s plans for the NY-ESO-1 programs;

• our plans relating to commercializing LYL797, LYL845 or any other product candidates we may develop, if approved, including the geographic areas of focus and our ability to grow a sales force;

• the size of the market opportunity for LYL797, LYL845 or any other product candidates we may develop in each of the diseases we target;

• our reliance on third parties to conduct nonclinical research activities for LYL797, LYL845 or any other product candidates we may develop;

• the characteristics, safety, efficacy and therapeutic effects of LYL797, LYL845 or any other product candidates we may develop;

• our estimates of the number of patients in the United States who suffer from the diseases we target and the number of subjects that will enroll in our clinical trials;

• the progress and focus of our current and future clinical trials, and the reporting of data from those trials, including the timing thereof;

• the ability of our clinical trials to demonstrate the safety and efficacy of LYL797, LYL845 or any other product candidates we may develop, and other positive results;

1


Table of Contents

• the success of competing therapies that are, or may become, available;

• developments relating to our competitors and our industry, including competing product candidates and therapies;

• our plans relating to the further development and manufacturing of LYL797, LYL845 or any other product candidates we may develop, including additional indications that we may pursue;

• existing regulations and regulatory developments in the United States and other jurisdictions;

• our potential and ability to successfully manufacture and supply LYL797, LYL845 or any other product candidates we may develop for clinical trials and for commercial use, if approved;

• the rate and degree of market acceptance of LYL797, LYL845 or any other product candidates we may develop, as well as the pricing and reimbursement of LYL797, LYL845 or any other product candidates we may develop, if approved;

• our continued reliance on third parties to conduct additional clinical trials of LYL797, LYL845 or any other product candidates we may develop, and for the manufacture of our product candidates;

• the scope of protection we are able to establish and maintain for intellectual property rights, including LYL797, LYL845 or any other product candidates we may develop;

• our ability to retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel;

• our expectations regarding the impact of the COVID-19 pandemic on our business and operations, including clinical trials, manufacturing suppliers, collaborators, use of contract research organizations (CROs) and employees;

• our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the JOBS Act); and

• our anticipated use of our existing cash, cash equivalents and marketable securities.

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 these forward-looking statements. Except as required by applicable law, we undertake no obligation to update or supplement any forward-looking statements publicly, or to update or supplement the reasons that actual results could differ materially from those projected in these forward-looking statements, even if new information becomes available in the future.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

2


Table of Contents

PART 1. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Lyell Immunopharma, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except per share amounts)

(unaudited)

 

 

September 30,
2021

 

 

December 31,
2020

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

393,504

 

 

$

140,406

 

Short-term marketable securities

 

 

225,417

 

 

 

472,213

 

Prepaid expenses and other current assets

 

 

12,226

 

 

 

4,928

 

Total current assets

 

 

631,147

 

 

 

617,547

 

Restricted cash

 

 

466

 

 

 

466

 

Long-term marketable securities

 

 

317,511

 

 

 

79,995

 

Other investments

 

 

83,448

 

 

 

83,448

 

Property and equipment, net

 

 

115,857

 

 

 

77,045

 

Right-of-use assets, net

 

 

47,236

 

 

 

47,010

 

Other non-current assets

 

 

2,669

 

 

 

2,769

 

Total assets

 

$

1,198,334

 

 

$

908,280

 

 

 

 

 

 

 

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,526

 

 

$

9,396

 

Accrued liabilities and other current liabilities

 

 

25,058

 

 

 

28,021

 

Success payment liabilities

 

 

25,116

 

 

 

5,773

 

Deferred revenue

 

 

5,581

 

 

 

6,095

 

Total current liabilities

 

 

59,281

 

 

 

49,285

 

Operating lease liabilities, non-current

 

 

65,684

 

 

 

50,957

 

Deferred revenue, non-current

 

 

81,883

 

 

 

89,066

 

Other non-current liabilities

 

 

5,012

 

 

 

532

 

Total liabilities

 

 

211,860

 

 

 

189,840

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value; zero and 195,021 shares
   authorized at September 30, 2021 and December 31, 2020, respectively;
zero
   and
194,474 shares issued and outstanding at September 30, 2021 and at
   December 31, 2020, respectively

 

 

-

 

 

 

1,010,968

 

Stockholders' equity (deficit):

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000 and zero shares authorized
   at September 30, 2021 and December 31, 2020, respectively;
zero shares
   issued and outstanding at September 30, 2021 and December 31, 2020

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 500,000 and 264,905 shares authorized
   at September 30, 2021 and December 31, 2020, respectively;
239,789
   and
15,570 shares issued and outstanding at September 30, 2021 and
   at December 31, 2020, respectively

 

 

24

 

 

 

2

 

Additional paid-in capital

 

 

1,487,171

 

 

 

41,357

 

Accumulated other comprehensive (loss) income

 

 

(65

)

 

 

256

 

Accumulated deficit

 

 

(500,656

)

 

 

(334,143

)

Total stockholders' equity (deficit)

 

 

986,474

 

 

 

(292,528

)

Total liabilities, convertible preferred stock and stockholders' equity (deficit)

 

$

1,198,334

 

 

$

908,280

 

 

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

3


Table of Contents

Lyell Immunopharma, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share amounts)

(unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

 

$

2,755

 

 

$

1,070

 

 

$

7,828

 

 

$

5,444

 

Operating expenses (income):

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

31,433

 

 

 

24,501

 

 

 

119,408

 

 

 

147,153

 

General and administrative

 

 

21,241

 

 

 

13,570

 

 

 

57,184

 

 

 

32,012

 

Other operating income, net

 

 

(758

)

 

 

(158

)

 

 

(1,526

)

 

 

(1,308

)

Total operating expenses

 

 

51,916

 

 

 

37,913

 

 

 

175,066

 

 

 

177,857

 

Loss from operations

 

 

(49,161

)

 

 

(36,843

)

 

 

(167,238

)

 

 

(172,413

)

Interest income

 

 

270

 

 

 

1,096

 

 

 

842

 

 

 

5,318

 

Other income (expense), net

 

 

16

 

 

 

28

 

 

 

(117

)

 

 

1,480

 

Net loss

 

 

(48,875

)

 

 

(35,719

)

 

 

(166,513

)

 

 

(165,615

)

Other comprehensive (loss) gain:

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized (loss) gain on marketable
   securities

 

 

(138

)

 

 

(598

)

 

 

(321

)

 

 

139

 

Net comprehensive loss

 

$

(49,013

)

 

$

(36,317

)

 

$

(166,834

)

 

$

(165,476

)

Net loss attributed to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(48,875

)

 

$

(35,719

)

 

$

(166,513

)

 

$

(165,615

)

Deemed dividends upon repurchase of
   convertible preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,582

)

Net loss attributed to common stockholders

 

$

(48,875

)

 

$

(35,719

)

 

$

(166,513

)

 

$

(169,197

)

Net loss per common share, basic and diluted

 

$

(0.20

)

 

$

(2.57

)

 

$

(1.66

)

 

$

(13.40

)

Weighted-average shares used to compute net
   loss per common share, basic and diluted

 

 

239,384

 

 

 

13,893

 

 

 

100,603

 

 

 

12,625

 

 

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

4


Table of Contents

Lyell Immunopharma, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of June 30, 2021

 

 

-

 

 

$

-

 

 

 

 

238,549

 

 

$

24

 

 

$

1,473,639

 

 

$

73

 

 

$

(451,781

)

 

$

1,021,955

 

Initial public offering costs

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

(39

)

 

 

-

 

 

 

-

 

 

 

(39

)

Issuance of common stock
   upon exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

265

 

 

 

-

 

 

 

529

 

 

 

-

 

 

 

-

 

 

 

529

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

975

 

 

 

-

 

 

 

13,042

 

 

 

-

 

 

 

-

 

 

 

13,042

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

 

 

 

(138

)

 

 

-

 

 

 

(138

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(48,875

)

 

 

(48,875

)

Balance as of September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

239,789

 

 

$

24

 

 

$

1,487,171

 

 

$

(65

)

 

$

(500,656

)

 

$

986,474

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

(Deficit) Equity

 

Balance as of December 31, 2020

 

 

194,474

 

 

$

1,010,968

 

 

 

 

15,570

 

 

$

2

 

 

$

41,357

 

 

$

256

 

 

$

(334,143

)

 

$

(292,528

)

Proceeds from initial public offering,
   net of $33,198 in issuance costs

 

 

-

 

 

 

-

 

 

 

 

25,000

 

 

 

2

 

 

 

391,800

 

 

 

-

 

 

 

-

 

 

 

391,802

 

Conversion of convertible preferred
   stock to common stock

 

 

(194,474

)

 

 

(1,010,968

)

 

 

 

194,474

 

 

 

20

 

 

 

1,010,948

 

 

 

-

 

 

 

-

 

 

 

1,010,968

 

Issuance of common stock upon
   exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

776

 

 

 

-

 

 

 

2,043

 

 

 

-

 

 

 

-

 

 

 

2,043

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

3,969

 

 

 

-

 

 

 

41,023

 

 

 

-

 

 

 

-

 

 

 

41,023

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(321

)

 

 

-

 

 

 

(321

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(166,513

)

 

 

(166,513

)

Balance as of September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

239,789

 

 

$

24

 

 

$

1,487,171

 

 

$

(65

)

 

$

(500,656

)

 

$

986,474

 

 

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

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Table of Contents

Lyell Immunopharma, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Deficit

 

Balance as of June 30, 2020

 

 

194,474

 

 

$

1,010,968

 

 

 

 

13,097

 

 

$

1

 

 

$

18,266

 

 

$

1,191

 

 

$

(259,567

)

 

$

(240,109

)

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

 

1,207

 

 

 

-

 

 

 

9,783

 

 

 

-

 

 

 

-

 

 

 

9,783

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(598

)

 

 

-

 

 

 

(598

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(35,719

)

 

 

(35,719

)

Balance as of September 30, 2020

 

 

194,474

 

 

$

1,010,968

 

 

 

 

14,304

 

 

$

1

 

 

$

28,049

 

 

$

593

 

 

$

(295,286

)

 

$

(266,643

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Deficit

 

Balance as of December 31, 2019

 

 

152,116

 

 

$

519,163

 

 

 

 

11,181

 

 

$

1

 

 

$

18,108

 

 

$

454

 

 

$

(129,671

)

 

$

(111,108

)

Issuance of Series C convertible
   preferred stock, net of $
533 
   in issuance costs

 

 

42,905

 

 

 

492,467

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock to
   strategic partners

 

 

-

 

 

 

-

 

 

 

 

275

 

 

 

-

 

 

 

1,004

 

 

 

-