IDEAYA Biosciences, Inc. [IDYA] Filings

10-Q 1 idya-20220930.htm 10-Q 10-Q

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


☐	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;

•

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.

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

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.

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.

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.

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.

IDEAYA Biosciences, Inc.

Condensed Statements of Cash Flows

(in thousands)

(Unaudited)


		Nine Months Ended September 30,
		2022

IDEAYA Biosciences, Inc. [IDYA] Filings
10-Q	[2022-11-08]
10-Q	[2022-08-15]
10-Q	[2022-05-10]
10-K	[2022-03-18]
10-Q	[2021-11-15]
10-Q	[2021-08-10]
10-Q	[2021-05-10]
10-K	[2021-03-23]
10-Q	[2020-11-12]
10-Q	[2020-08-12]
10-Q	[2020-05-12]
10-K	[2020-03-24]
10-Q	[2019-11-13]
10-Q	[2019-08-12]
S-1	[2019-04-26]