10-Q 1 idya-20220930.htm 10-Q 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 AND EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

OR

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

For the transition period from to

Commission File Number: 001-38915

 

IDEAYA Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

47-4268251

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

7000 Shoreline Court, Suite 350

South San Francisco, California

 

94080

(Address of principal executive offices)

 

(Zip Code)

 

(650) 443-6209

(telephone number, including area code)

 

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 per share

 

IDYA

 

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 3, 2022, the registrant had 48,113,501 shares of common stock, $0.0001 par value per share, outstanding.

 

 


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that 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,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. 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 under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements are subject to numerous risks, including, without limitation, the following:

the scope, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials, including our IDE397 Phase 1/2 and IDE196 Phase 1/2 clinical trials;
our clinical and regulatory development plans;
the scope, progress, results and costs related to the research and development of our precision medicine target and biomarker discovery platform, including costs related to the development of our proprietary libraries and database of tumor genetic information and specific cancer-target dependency networks;
our expectations about the impact of the COVID-19 pandemic on our business, and operations, including clinical trials, manufacturing suppliers and collaborators, and on our results of operations and financial condition;
the availability of companion diagnostics for biomarkers associated with our product candidates and any future product candidates, or the cost of coordinating and/or collaborating with certain diagnostic companies for the manufacture and supply of companion diagnostics;
the timing of and costs involved in obtaining and maintaining regulatory approval for any of current or future product candidates and companion diagnostics, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
our expectations regarding the potential market size and size of the potential patient populations for IDE397, IDE196, our other product candidates and any future product candidates, if approved for commercial use;
the timing and amount of any milestone, royalty or other payments we may or may not receive pursuant to any current or future collaboration or license agreement, including under the Collaboration, Option and License Agreement with GSK;
our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including our Collaboration, Option and License Agreement with GSK, our Clinical Trial Collaboration and Supply Agreements with Pfizer Inc., Clinical Trial and Supply Agreement with Amgen Inc., our License Agreement with Novartis and our Option and License Agreement with Cancer Research United Kingdom, or Cancer Research UK, and University of Manchester;

1


 

the timing of commencement of future nonclinical studies and clinical trials and research and development programs;
our ability to acquire, discover, develop and advance product candidates into, and successfully complete, clinical trials;
our intentions and our ability to establish collaborations and/or partnerships;
the timing or likelihood of regulatory filings and approvals for our product candidates;
our commercialization, marketing and manufacturing capabilities and expectations;
our intentions with respect to the commercialization of our product candidates;
the pricing and reimbursement of our product candidates, if approved;
the implementation of our business model and strategic plans for our business, product candidates and technology platforms, including additional indications for which we may pursue;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection;
our potential involvement in lawsuits in connection with enforcing our intellectual property rights;
our potential involvement in third party interference, opposition, derivation or similar proceedings with respect to our patent rights and other challenges to our patent rights and patent infringement claims;
estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;
our future financial performance; and
developments and projections relating to our competitors and our industry, including competing therapies and procedures.

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

 

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, 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 occur or be achieved, and actual results could differ materially from those projected in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

2


 

IDEAYA Biosciences, Inc.

Form 10-Q for Quarterly Period Ended September 30, 2022

Table of Contents

 

PART I—FINANCIAL INFORMATION

4

Item 1. Financial Statements (Unaudited)

4

Condensed Balance Sheets

4

Condensed Statements of Operations and Comprehensive Loss

5

Condensed Statements of Stockholders’ Equity

6

Condensed Statements of Cash Flows

8

Notes to Condensed Financial Statements (Unaudited)

9

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

27

Item 3. Quantitative and Qualitative Disclosures About Market Risk

44

Item 4. Controls and Procedures

44

PART II—OTHER INFORMATION

45

Item 1. Legal Proceedings

45

Item 1A. Risk Factors

45

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

106

Item 3. Defaults Upon Senior Securities

106

Item 4. Mine Safety Disclosures

106

Item 5. Other information

106

Item 6. Exhibits

107

SIGNATURES

108

 

3


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (UNAUDITED).

IDEAYA Biosciences, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

101,954

 

 

$

92,046

 

Short-term marketable securities

 

 

284,290

 

 

 

154,724

 

Accounts receivable

 

 

3,449

 

 

 

1,103

 

Prepaid expenses and other current assets

 

 

3,744

 

 

 

3,123

 

Total current assets

 

 

393,437

 

 

 

250,996

 

Restricted cash

 

 

106

 

 

 

106

 

Long-term marketable securities

 

 

7,691

 

 

 

121,293

 

Property and equipment, net

 

 

6,679

 

 

 

4,763

 

Right-of-use assets

 

 

2,848

 

 

 

3,898

 

Other non-current assets

 

 

146

 

 

 

291

 

Total assets

 

$

410,907

 

 

$

381,347

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

3,645

 

 

$

2,100

 

Accrued liabilities

 

 

16,988

 

 

 

12,320

 

Contract liability

 

 

10,267

 

 

 

29,040

 

Operating lease liabilities - current

 

 

1,827

 

 

 

1,699

 

Total current liabilities

 

 

32,727

 

 

 

45,159

 

Long-term contract liability

 

 

7,314

 

 

 

31,192

 

Long-term operating lease liabilities

 

 

2,097

 

 

 

3,482

 

Total liabilities

 

 

42,138

 

 

 

79,833

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of
   September 30, 2022 and December 31, 2021;
no shares issued and
   outstanding as of September 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value, 300,000,000 shares authorized as of
   September 30, 2022 and December 31, 2021;
48,090,358 and 38,533,045 
   shares issued and outstanding as of September 30, 2022 and
   December 31, 2021

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

583,968

 

 

 

478,970

 

Accumulated other comprehensive loss

 

 

(4,002

)

 

 

(712

)

Accumulated deficit

 

 

(211,202

)

 

 

(176,748

)

Total stockholders’ equity

 

 

368,769

 

 

 

301,514

 

Total liabilities and stockholders’ equity

 

$

410,907

 

 

$

381,347

 

 

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

4


 

IDEAYA Biosciences, Inc.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Collaboration revenue

 

$

29,699

 

 

$

8,976

 

 

$

46,909

 

 

$

24,979

 

Total revenue

 

 

29,699

 

 

 

8,976

 

 

 

46,909

 

 

 

24,979

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

22,372

 

 

 

15,503

 

 

 

64,823

 

 

 

42,048

 

General and administrative

 

 

6,667

 

 

 

5,186

 

 

 

18,145

 

 

 

14,830

 

Total operating expenses

 

 

29,039

 

 

 

20,689

 

 

 

82,968

 

 

 

56,878

 

Income (loss) from operations

 

 

660

 

 

 

(11,713

)

 

 

(36,059

)

 

 

(31,899

)

Other income

 

 

 

 

 

 

 

 

 

 

 

 

Interest income and other income, net

 

 

955

 

 

 

131

 

 

 

1,605

 

 

 

349

 

Net income (loss)

 

$

1,615

 

 

$

(11,582

)

 

$

(34,454

)

 

$

(31,550

)

Unrealized losses on marketable securities

 

 

(373

)

 

 

(46

)

 

 

(3,290

)

 

 

(57

)

Comprehensive income (loss)

 

$

1,242

 

 

$

(11,628

)

 

$

(37,744

)

 

$

(31,607

)

Net income (loss) per common share, basic

 

$

0.04

 

 

$

(0.31

)

 

$

(0.88

)

 

$

(0.92

)

Weighted average number of common shares
     outstanding used in computing net income
    (loss) per share, basic

 

 

40,301,568

 

 

 

37,769,910

 

 

 

39,191,098

 

 

 

34,157,578

 

Net income (loss) per common share, diluted

 

$

0.04

 

 

$

(0.31

)

 

$

(0.88

)

 

$

(0.92

)

Weighted average number of common shares
     outstanding used in computing net income
    (loss) per share, diluted

 

 

41,109,571

 

 

 

37,769,910

 

 

 

39,191,098

 

 

 

34,157,578

 

 

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

5


 

IDEAYA Biosciences, Inc.

Condensed Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances as of June 30, 2022

 

 

38,704,010

 

 

$

4

 

 

$

485,763

 

 

$

(3,629

)

 

$

(212,817

)

 

$

269,321

 

Issuance of common stock upon follow-on public offering,
     net of issuance costs

 

 

8,761,905

 

 

 

1

 

 

 

86,073

 

 

 

 

 

 

 

 

 

86,074

 

Issuance of common stock related to at-the-market offering program,
     net of issuance costs

 

 

599,671

 

 

 

0

 

 

 

8,980

 

 

 

 

 

 

 

 

 

8,980

 

Issuance of common stock upon exercise of stock options

 

 

24,772

 

 

 

 

 

 

148

 

 

 

 

 

 

 

 

 

148

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,004

 

 

 

 

 

 

 

 

 

3,004

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(373

)

 

 

 

 

 

(373

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,615

 

 

 

1,615

 

Balances as of September 30, 2022

 

 

48,090,358

 

 

$

5

 

 

$

583,968

 

 

$

(4,002

)

 

$

(211,202

)

 

$

368,769

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of June 30, 2021

 

 

33,033,793

 

 

$

3

 

 

$

387,215

 

 

$

(4

)

 

$

(146,954

)

 

$

240,260

 

Issuance of common stock upon follow-on public offering,
     net of issuance costs

 

 

5,333,333

 

 

 

1

 

 

 

85,989

 

 

 

 

 

 

 

 

 

85,990

 

Issuance of common stock upon exercise of stock options

 

 

95,960

 

 

 

 

 

 

806

 

 

 

 

 

 

 

 

 

806

 

Vesting of early exercised common stock options

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,198

 

 

 

 

 

 

 

 

 

2,198

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(46

)

 

 

 

 

 

(46

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,582

)

 

 

(11,582

)

Balances as of September 30, 2021

 

 

38,463,086

 

 

$

4

 

 

$

476,211

 

 

$

(50

)

 

$

(158,536

)

 

$

317,629

 

 

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

 

 

 

6


 

 

 

 

IDEAYA Biosciences, Inc.

Condensed Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances as of December 31, 2021

 

 

38,533,045

 

 

$

4

 

 

$

478,970

 

 

$

(712

)

 

$

(176,748

)

 

$

301,514

 

Issuance of common stock upon follow-on public offering, net of issuance costs

 

 

8,761,905

 

 

 

1

 

 

 

86,073

 

 

 

 

 

 

 

 

 

86,074

 

Issuance of common stock related to at-the-market offering program, net of issuance costs

 

 

601,844

 

 

 

 

 

 

8,905

 

 

 

 

 

 

 

 

 

8,905

 

Issuance of common stock upon exercise of stock options

 

 

147,685

 

 

 

 

 

 

931

 

 

 

 

 

 

 

 

 

931

 

Employee stock purchase plan (ESPP) purchase

 

 

45,879

 

 

 

 

 

 

435

 

 

 

 

 

 

 

 

 

435

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,654

 

 

 

 

 

 

 

 

 

8,654

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(3,290

)

 

 

 

 

 

(3,290

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,454

)

 

 

(34,454

)

Balances as of September 30, 2022

 

 

48,090,358

 

 

$

5

 

 

$

583,968

 

 

$

(4,002

)

 

$

(211,202

)

 

$

368,769

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of December 31, 2020

 

 

29,537,216

 

 

$

3

 

 

$

325,250

 

 

$

7

 

 

$

(126,986

)

 

$

198,274

 

Issuance of common stock upon follow-on public offering, net of issuance costs

 

 

5,333,333

 

 

 

1

 

 

 

85,989

 

 

 

 

 

 

 

 

 

85,990

 

Issuance of common stock related to at-the-market offering program

 

 

3,407,872

 

 

 

 

 

 

57,286

 

 

 

 

 

 

 

 

 

57,286

 

Issuance of common stock upon exercise of stock options

 

 

155,920

 

 

 

 

 

 

1,163

 

 

 

 

 

 

 

 

 

1,163

 

Employee stock purchase plan (ESPP) purchase

 

 

28,745

 

 

 

 

 

 

327

 

 

 

 

 

 

 

 

 

327

 

Vesting of early exercised common stock options and restricted stock

 

 

 

 

 

 

 

 

23

 

 

 

 

 

 

 

 

 

23

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,173

 

 

 

 

 

 

 

 

 

6,173

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(57

)

 

 

 

 

 

(57

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(31,550

)

 

 

(31,550

)

Balances as of September 30, 2021

 

 

38,463,086

 

 

$

4

 

 

$

476,211

 

 

$

(50

)

 

$

(158,536

)

 

$

317,629

 

 

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

 

7


 

IDEAYA Biosciences, Inc.

Condensed Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2022