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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 August 31, 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: 001-39398

 

NURIX THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

27-0838048

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1700 Owens Street, Suite 205

San Francisco, CA

 

94158

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (415) 660-5320

 

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 $0.001 per share

 

NRIX

 

Nasdaq Global 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 October 8, 2021, the Registrant had 44,612,647 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact, including statements concerning our business strategy and plans, future operating results and financial position, as well as our objectives and expectations for our future operations, are forward-looking statements.

In some cases, you can identify forward-looking statements by such terminology as “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements about:

 

the timing of our planned investigational new drug application (IND) submissions for our lead drug candidates and other drug candidates;

 

the timing and conduct of our clinical trial programs for our lead drug candidates NX-2127, NX-1607, NX-5948, DeTIL-0255 and other drug candidates, including statements regarding the timing of initiation of the clinical trials;

 

the timing of, and our ability to obtain, marketing approvals for our lead drug candidates NX-2127, NX-1607, NX-5948, DeTIL-0255 and other drug candidates;

 

our plans to pursue research and development of other drug candidates;

 

the potential advantages of our DELigase platform and our drug candidates;

 

the extent to which our scientific approach and DELigase platform may potentially address a broad range of diseases;

 

the potential benefits of our arrangements with Sanofi S.A. and Gilead Sciences, Inc.;

 

the timing of and our ability to obtain and maintain regulatory approvals for our drug candidates;

 

the potential receipt of revenue from future sales of our drug candidates;

 

the rate and degree of market acceptance and clinical utility of our drug candidates;

 

our estimates regarding the potential market opportunity for our drug candidates;

 

our sales, marketing and distribution capabilities and strategy;

 

our ability to establish and maintain arrangements for the manufacturing of our drug candidates;

 

the impact of the ongoing coronavirus (COVID-19) pandemic, including the resurgence of cases relating to the spread of the Delta variant, on our business, clinical trials, financial condition, liquidity and results of operations;

 

the potential achievement of milestones and receipt of royalty payments under our collaborations;

 

our ability to enter into additional collaborations with third parties;

 

our intellectual property position;

 

our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

 

the impact of government laws and regulations; and

 

our competitive position.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, and financial needs. 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. We disclaim any intention or obligation to publicly update or revise any forward-looking statements for any reason or to conform such statements to actual results or revised expectations, except as required by law.


 


 

 

TABLE OF CONTENTS

 

 

 

Page

PART I.

FINANCIAL INFORMATION

1

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 Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

4

 

Condensed Consolidated Statements of Cash Flows

6

 

Notes to Condensed Consolidated Financial Statements

7

Item 2.

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

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

32

Item 4.

Controls and Procedures

32

PART II.

OTHER INFORMATION

33

Item 1.

Legal Proceedings

33

Item 1A.

Risk Factors

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

82

Item 3.

Defaults Upon Senior Securities

82

Item 4.

Mine Safety Disclosures

82

Item 5.

Other Information

82

Item 6.

Exhibits

83

SIGNATURES

84

 

 

 


 

 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

NURIX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(unaudited)

 

 

August 31,

 

 

November 30,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

147,440

 

 

$

119,356

 

Short-term investments

 

 

196,458

 

 

 

161,792

 

Contract assets

 

 

5,000

 

 

 

7,500

 

Income tax receivable

 

 

204

 

 

 

3,846

 

Prepaid expenses and other current assets

 

 

9,343

 

 

 

5,940

 

Total current assets

 

 

358,445

 

 

 

298,434

 

Long-term investments

 

 

121,480

 

 

 

90,890

 

Property and equipment, net

 

 

9,569

 

 

 

6,672

 

Restricted cash

 

 

286

 

 

 

170

 

Other assets

 

 

3,294

 

 

 

177

 

Total assets

 

$

493,074

 

 

$

396,343

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,861

 

 

$

3,412

 

Accrued and other current liabilities

 

 

11,569

 

 

 

8,328

 

Deferred revenue, current

 

 

35,250

 

 

 

32,799

 

Total current liabilities

 

 

50,680

 

 

 

44,539

 

Deferred revenue, net of current portion

 

 

66,381

 

 

 

60,685

 

Other long-term liabilities

 

 

796

 

 

 

850

 

Total liabilities

 

 

117,857

 

 

 

106,074

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value— 10,000,000 shares

   authorized as of August 31, 2021 and

   November 30, 2020; 0 shares issued and outstanding

   as of August 31, 2021 and November 30, 2020

 

 

 

 

 

 

Common stock, $0.001 par value— 500,000,000 shares

   authorized as of August 31, 2021 and

   November 30, 2020; 44,556,604 and 38,864,872 shares

   issued and outstanding as of August 31, 2021 and

   November 30, 2020, respectively

 

 

45

 

 

 

39

 

Additional paid-in-capital

 

 

558,421

 

 

 

393,841

 

Accumulated other comprehensive income (loss)

 

 

(59

)

 

 

87

 

Accumulated deficit

 

 

(183,190

)

 

 

(103,698

)

Total stockholders’ equity

 

 

375,217

 

 

 

290,269

 

Total liabilities and stockholders’ equity

 

$

493,074

 

 

$

396,343

 

 

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

1


 

NURIX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended August 31,

 

 

Nine Months Ended August 31,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Collaboration revenue

 

$

10,252

 

 

$

4,085

 

 

$

22,354

 

 

$

11,131

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

30,906

 

 

 

18,939

 

 

 

79,903

 

 

 

46,049

 

General and administrative

 

 

8,343

 

 

 

4,338

 

 

 

22,384

 

 

 

10,057

 

Total operating expenses

 

 

39,249

 

 

 

23,277

 

 

 

102,287

 

 

 

56,106

 

Loss from operations

 

 

(28,997

)

 

 

(19,192

)

 

 

(79,933

)

 

 

(44,975

)

Interest and other income, net

 

 

39

 

 

 

675

 

 

 

528

 

 

 

1,071

 

Loss before income taxes

 

 

(28,958

)

 

 

(18,517

)

 

 

(79,405

)

 

 

(43,904

)

Provision (benefit) for income taxes

 

 

(123

)

 

 

 

 

 

87

 

 

 

(20,576

)

Net loss

 

$

(28,835

)

 

$

(18,517

)

 

$

(79,492

)

 

$

(23,328

)

Net loss per share attributable to common

   stockholders, basic and diluted

 

$

(0.65

)

 

$

(1.09

)

 

$

(1.88

)

 

$

(2.90

)

Weighted-average number of shares outstanding,

   basic and diluted

 

 

44,374,389

 

 

 

16,937,934

 

 

 

42,344,420

 

 

 

8,052,905

 

 

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

 

2


 

 

NURIX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(unaudited)

 

 

 

Three Months Ended August 31,

 

 

Nine Months Ended August 31,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(28,835

)

 

$

(18,517

)

 

$

(79,492

)

 

$

(23,328

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on

   available-for-sale investments

 

 

(89

)

 

 

(1

)

 

 

(146

)

 

 

140

 

Total comprehensive loss

 

$

(28,924

)

 

$

(18,518

)

 

$

(79,638

)

 

$

(23,188

)

 

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

 

 

3


 

 

NURIX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except share amounts)

(unaudited)

 

 

Redeemable convertible

preferred stock

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

stockholders’

equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

(deficit)

 

Balance as of November 30, 2019

 

 

12,813,887

 

 

$

48,195

 

 

 

 

3,595,334

 

 

$

4

 

 

$

2,740

 

 

$

(2

)

 

$

(60,456

)

 

$

(57,714

)

Exercise of stock options

 

 

 

 

 

 

 

 

 

72,570

 

 

 

 

 

 

37

 

 

 

 

 

 

 

 

 

37

 

Repurchase of unvested early

   exercised stock options

 

 

 

 

 

 

 

 

 

(867

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early-exercised

   stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

31

 

 

 

 

 

 

 

 

 

31

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

176

 

 

 

 

 

 

 

 

 

176

 

Unrealized gain (loss) on

   available-for-sale

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

59

 

 

 

 

 

 

59

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,391

)

 

 

(12,391

)

Balance as of February 29, 2020

 

 

12,813,887

 

 

 

48,195

 

 

 

 

3,667,037

 

 

 

4

 

 

 

2,984

 

 

 

57

 

 

 

(72,847

)

 

 

(69,802

)

Issuance of Series D redeemable

   convertible preferred stock at

   $12.75 per share, net of

   issuance costs of $336

 

 

9,431,364

 

 

 

119,914

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

125,708

 

 

 

 

 

 

118

 

 

 

 

 

 

 

 

 

118

 

Vesting of early-exercised

   stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

22

 

 

 

 

 

 

 

 

 

22

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

474

 

 

 

 

 

 

 

 

 

474

 

Unrealized gain (loss) on

   available-for-sale

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

82

 

 

 

 

 

 

82

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,580

 

 

 

7,580

 

Balance as of May 31, 2020

 

 

22,245,251

 

 

 

168,109

 

 

 

 

3,792,745

 

 

 

4

 

 

 

3,598

 

 

 

139

 

 

 

(65,267

)

 

 

(61,526

)

Conversion of redeemable

   convertible preferred stock

   into common stock

 

 

(22,245,251

)

 

 

(168,109

)

 

 

 

22,245,251

 

 

 

22

 

 

 

168,087

 

 

 

 

 

 

 

 

 

168,109

 

Issuance of common stock upon

   initial public offering, net of

   offering costs of $20,308

 

 

 

 

 

 

 

 

 

12,550,000

 

 

 

13

 

 

 

218,130

 

 

 

 

 

 

 

 

 

218,143

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

258,182

 

 

 

 

 

 

262

 

 

 

 

 

 

 

 

 

262

 

Repurchase of unvested early

   exercised stock options

 

 

 

 

 

 

 

 

 

(982

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early-exercised

   stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

35

 

 

 

 

 

 

 

 

 

35

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,115

 

 

 

 

 

 

 

 

 

1,115

 

Unrealized gain (loss) on

   available-for-sale

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,517

)

 

 

(18,517

)

Balance as of August 31, 2020

 

 

 

 

$

 

 

 

 

38,845,196

 

 

$

39

 

 

$

391,227

 

 

$

138

 

 

$

(83,784

)

 

$

307,620

 

 

4


 

 

 

 

Redeemable convertible

preferred stock

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

stockholders’

equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

(deficit)

 

Balance as of November 30, 2020

 

 

 

 

$

 

 

 

 

38,864,872

 

 

$

39

 

 

$

393,841

 

 

$

87

 

 

$

(103,698

)

 

$

290,269

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

190,825

 

 

 

 

 

 

394

 

 

 

 

 

 

 

 

 

394

 

Repurchase of unvested early

   exercised stock options

 

 

 

 

 

 

 

 

 

(971

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early-exercised

   stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

 

 

 

40

 

Issuance under employee

   stock purchase plan

 

 

 

 

 

 

 

 

 

64,589

 

 

 

 

 

 

1,043

 

 

 

 

 

 

 

 

 

1,043

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,700

 

 

 

 

 

 

 

 

 

2,700

 

Unrealized gain (loss) on

   available-for-sale

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38

)

 

 

 

 

 

(38

)

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(24,275

)

 

 

(24,275

)

Balance as of February 28, 2021

 

 

 

 

 

 

 

 

 

39,119,315

 

 

 

39

 

 

 

398,018

 

 

 

49

 

 

 

(127,973

)

 

 

270,133

 

Issuance of common stock in

  connection with equity

  offering, net of offering

  costs of $643

 

 

 

 

 

 

 

 

 

5,175,000

 

 

 

5

 

 

 

150,152

 

 

 

 

 

 

 

 

 

150,157

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

109,232