Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data
The financial statements required to be filed pursuant to this Item 8 are appended to this report. An index of those financial statements is found in Item 15 of Part IV of this Annual Report on Form 10-K.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
102
Item 9A. Controls and P rocedures
Management’s Evaluation of our Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (2) accumulated and communicated to our management, including our principal executive and principal financial and accounting officers, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives.
Our management, with the participation of our principal executive officer and principal financial and accounting officer, evaluated the effectiveness of our disclosure controls and procedures at the end of the period covered by this Annual Report on Form 10-K. Based upon such evaluation, our principal executive officer and principal financial and accounting officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of such date.
Changes in Internal Control Over Financial Reporting
There were no changes in the Company's internal control over financial reporting that occurred during the quarterly period ended December 31, 2020 that have materially affected, or are reasonably likely to materially effect, the Company's internal control over financial reporting.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Under the supervision of and with the participation of our principal executive officer and principal financial officer, our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2020 based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in “Internal Control—Integrated Framework” (2013). Based on this assessment, management concluded that our internal control over financial reporting was effective as of December 31, 2020.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm on our internal control over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies.”
Item 9B. Other Information
None.
103
Part III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this item will be contained in our definitive proxy statement to be filed with the SEC in connection with the Annual Meeting of Stockholders within 120 days after December 31, 2020, or the Proxy Statement, and is incorporated in this Annual Report on Form 10-K by reference.
Item 11. Executive Compensation.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by reference.
Item 14. Principal Accounting Fees and Services.
The information required by this item will be contained in the Proxy Statement and is incorporated in this Annual Report on Form 10-K by reference.
104
Part IV
Item 15. Exhibits, Financial Statement Schedules.
(a) The following documents are filed as part of this report:
(1) FINANCIAL STATEMENTS
The following documents are included on pages F-1 through F-27 attached hereto and are filed as part of this Annual Report on Form 10-K.
Report of Independent Registered Public Accounting Firm
F-2
Audited Financial Statements:
Balance Sheets
F-3
Statements of Operations and Comprehensive Income
F-4
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
F-5
Statements of Cash Flows
F-6
Notes to Financial Statements
F-7
(2) FINANCIAL STATEMENT SCHEDULES
All schedules to the financial statements are omitted as the required information is either inapplicable or presented in the financial statements.
(3) EXHIBITS
The exhibits listed in the accompanying Exhibit Index are filed as part of, or incorporated by reference into, this report.
105
Exhibit Index
(a) Exhibits.
Exhibit
Number
Exhibit Description
Incorporated by Reference
Filed
Herewith
Form
Date
Number
3.1
Amended and Restated Certificate of Incorporation.
8-K
5/28/2019
3.1
3.2
Amended and Restated Bylaws.
8-K
5/28/2019
3.2
4.1
Reference is made to Exhibits 3.1 through 3.2 .
4.2
Form of Common Stock Certificate.
S-1/A
5/13/2019
4.2
4.3
Description of Common Stock .
X
10.1†
License agreement by and between IDEAYA Biosciences, Inc. and Novartis International Pharmaceutical, Inc. dated as of September 19, 2018.
S-1
4/26/2019
10.1
10.2(a)†
Evaluation, Option and License Agreement by and among IDEAYA Biosciences, Inc., Cancer Research Technology Ltd. and University of Manchester dated as of April 28, 2017.
S-1
4/26/2019
10.2(a)
10.2(b)
Amendment #1 to Evaluation, Option and License Agreement by and among IDEAYA Biosciences, Inc., Cancer Research Technology Ltd. and University of Manchester dated as of April 24, 2019.
S-1
4/26/2019
10.2(b)
10.2(c)
Amendment #2 to Evaluation, Option and License Agreement by and among IDEAYA Biosciences, Inc., Cancer Research Technology Ltd. and University of Manchester dated as of March 3, 2020.
10-K
3/24/2020
10.2(c)
10.3(a)#
2019 Incentive Award Plan.
S-1/A
5/13/2019
10.5(a)
10.3(b)#
Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Incentive Award Plan.
S-1/A
5/13/2019
10.5(b)
10.3(c)#
Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2019 Incentive Award Plan.
S-1/A
5/13/2019
10.5(c)
10.3(d)#
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2019 Incentive Award Plan.
S-1/A
5/13/2019
10.5(d)
10.4#
Employee Stock Purchase Plan.
S-1/A
5/13/2019
10.6
10.5(a)#
2015 Equity Incentive Plan, as amended.
S-1
4/26/2019
10.4(a)
10.5(b)#
Form of Stock Option Agreement under the 2015 Equity Incentive Plan.
S-1
4/26/2019
10.4(b)
10.5(c)#
Form of Early Exercise Stock Option Agreement under the 2015 Equity Incentive Plan.
S-1
4/26/2019
10.4(c)
10.5(d)#
Form of Stock Purchase Right Grant Notice and Restricted Stock Purchase Agreement under 2015 Equity Incentive Plan .
S-1
4/26/2019
10.4(d)
106
10.6#
Employment Agreement by and between IDEAYA Biosciences, Inc. and Yujiro Hata.
S-1/A
5/13/2019
10.7(b)
10.7#
Employment Agreement by and between IDEAYA Biosciences, Inc. and Michael Dillon.
S-1/A
5/17/2019
10.8
10.8#
Employment Agreement by and between IDEAYA Biosciences, Inc. and Paul Stone.
S-1/A
5/17/2019
10.12
10.9#
Amended and Restated Employment Agreement by and between IDEAYA Biosciences, Inc. and Jason Throne.
X
10.10
Non-Employee Director Compensation Program.
S-1/A
5/17/2019
10.13
10.11
Form of indemnification agreement for directors and officers.
S-1/A
5/13/2019
10.14
10.12
Lease Agreement by and between IDEAYA Biosciences, Inc. and ARE-SAN FRANCISCO NO. 17, LLC dated August 26, 2016.
S-1
4/26/2019
10.15
10.13
Letter Agreement Amendment to Lease Agreement by and between IDEAYA Biosciences, Inc. and ARE-SAN FRANCISCO NO. 17, LLC dated January 27, 2017.
S-1
4/26/2019
10.16
10.14
First Amendment to Lease Agreement by and between IDEAYA Biosciences, Inc. and ARE-SAN FRANCISCO NO. 17, LLC dated May 31, 2018.
S-1
4/26/2019
10.17
10.15
Second Amendment to Lease Agreement by and between IDEAYA Biosciences, Inc. and ARE-SAN FRANCISCO NO. 17, LLC dated September 30, 2019.
10-Q
11/13/2019
10.11
10.16(a)†
Clinical Trial Collaboration and Supply Agreement between IDEAYA Biosciences, Inc. and Pfizer Inc. dated as of March 11, 2020.
10-Q
5/12/2020
10.4
10.16(b)†
Amendment No. 1 to Clinical Trial Collaboration and Supply Agreement between Pfizer Inc. and IDEAYA Biosciences, Inc. dated as of September 23, 2020.
10-Q
11/12/2020
10.1
10.17†
Collaboration, Option and License Agreement between GlaxoSmithKline Intellectual Property (No. 4) Limited and IDEAYA Biosciences, Inc. dated as of June 15, 2020.
10-Q
8/12/2020
10.3
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (included on signature page to this Annual Report on Form 10-K).
X
31.1
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1*
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
107
101.INS
XBRL Instance Document
X
101.SCH
XBRL Taxonomy Extension Schema Document
X
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
XBRL Taxonomy Extension Labels Linkbase Document
X
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document
X
†
Certain information in this exhibit has been excluded pursuant to Regulation S-K, Item 601(b)(10).
#
Indicates management contract or compensatory plan.
*
The certification attached as Exhibit 32.1 that accompanies this Annual Report on Form 10-K is not deemed filed with the SEC and is not to be incorporated by reference into any filing of IDEAYA Biosciences, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.
Item 16. Form 10-K Summary.
None.
108
INDEX TO THE FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F-2
Balance Sheets
F-3
Statements of Operations and Comprehensive Loss
F-4
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
F-5
Statements of Cash Flows
F-6
Notes to Financial Statements
F-7
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of IDEAYA Biosciences, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of IDEAYA Biosciences, Inc. (the “Company”) as of December 31, 2020 and 2019, and the related statements of operations and comprehensive loss, of redeemable convertible preferred stock and stockholders’ equity (deficit) and of cash flows for each of the three years in the period ended December 31, 2020, including the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2020 in conformity with accounting principles generally accepted in the United States of America.
Change in Accounting Principle
As discussed in Note 2 to the financial statements, the Company changed the manner in which it accounts for leases in 2019.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
San Jose, California
March 23, 2021
We have served as the Company's auditor since 2017.
F-2
IDEAYA Biosciences, Inc.
Balance Sheets
(in thousands, except share and per share amounts)
December 31,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
72,037
$
34,067
Short-term marketable securities
211,548
64,889
Accounts receivable
1,877
—
Prepaid expenses and other current assets
3,143
2,698
Total current assets
288,605
101,654
Restricted cash
106
106
Long-term marketable securities
—
1,526
Property and equipment, net
4,271
4,642
Right-of-use assets
5,205
5,057
Other non-current assets
82
16
Total assets
$
298,269
$
113,001
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$
953
$
709
Accrued liabilities
8,516
5,023
Contract liability
27,613
—
Operating lease liabilities, current
1,540
1,145
Other current liabilities
18
63
Total current liabilities
38,640
6,940
Long-term contract liability
56,160
—
Long-term operating lease liabilities
5,183
5,627
Other non-current liabilities
12
34
Total liabilities
99,995
12,601
Commitments and contingencies (Note 6)
Stockholders’ equity
Preferred stock, $0.0001 par value, 10,000,000 shares authorized as of December 31,
2020 and December 31, 2019; no shares issued and outstanding as of
December 31, 2020 and December 31, 2019
—
—
Common stock, $0.0001 par value, 300,000,000 shares authorized as of
December 31, 2020 and December 31, 2019; 29,537,216 and 20,339,461 shares
issued and outstanding as of December 31, 2020 and December 31, 2019
3
2
Additional paid-in capital
325,250
192,824
Accumulated other comprehensive income
7
65
Accumulated deficit
(126,986
)
(92,491
)
Total stockholders’ equity
198,274
100,400
Total liabilities and stockholders’ equity
$
298,269
$
113,001
The accompanying notes are an integral part of these financial statements.
F-3
IDEAYA Biosciences, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Year Ended December 31,
2020
2019
2018
Collaboration revenue
$
19,538
$
—
$
—
Total revenue
19,538
—
—
Operating expenses
Research and development
39,698
34,319
31,749
General and administrative
15,184
9,952
4,668
Total operating expenses
54,882
44,271
36,417
Loss from operations
(35,344
)
(44,271
)
(36,417
)
Interest income and other income (expense), net
849
2,296
2,071
Net loss
(34,495
)
(41,975
)
(34,346
)
Change in unrealized (losses) gains on marketable securities
(58
)
96
(30
)
Comprehensive loss
$
(34,553
)
$
(41,879
)
$
(34,376
)
Net loss per common share, basic and diluted
$
(1.40
)
$
(3.36
)
$
(35.92
)
Weighted-average number of common shares outstanding
used in computing net loss per share, basic and diluted
24,721,775
12,496,957
956,252
The accompanying notes are an integral part of these financial statements.
F-4
IDEAYA Biosciences, Inc.
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
Accumulated
Total
Redeemable Convertible
Additional
Other
Stockholders'
Preferred Stock
Common Stock
Paid-In
Comprehensive
Accumulated
Equity
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Deficit
(Deficit)
Balances as of January 1, 2018
4,379,916
$
26,084
1,263,416
$
—
$
432
$
(1
)
$
(16,170
)
$
(15,739
)
Issuance of Series A redeemable convertible preferred stock,
net of issuance costs of $5, adjusted for the redeemable
convertible preferred stock liability of $3,137
1,414,811
14,651
—
—
—
—
—
—
Issuance of Series B redeemable convertible preferred stock,
net of issuance costs of $176
7,081,452
93,844
—
—
—
—
—
—
Issuance of Series B redeemable convertible preferred stock
pursuant to license agreement
263,615
3,812
—
—
—
—
—
—
Issuance of common stock upon exercise of stock options
—
—
19,591
—
28
—
—
28
Early exercised common stock options
—
—
70,583
—
—
—
—
—
Repurchase of early exercised shares
(17,900
)
—
—
—
—
—
Vesting of early exercised common stock options and restricted stock
—
—
—
—
189
—
—
189
Stock-based compensation
—
—
—
—
950
—
—
950
Other comprehensive loss
—
—
—
—
—
(30
)
—
(30
)
Net loss
—
—
—
—
—
—
(34,346
)
(34,346
)
Balances as of December 31, 2018
13,139,794
$
138,391
1,335,690
$
—
$
1,599
$
(31
)
$
(50,516
)
$
(48,948
)
Conversion of redeemable convertible preferred stock into
common stock
(13,139,794
)
(138,391
)
13,139,794
1
138,390
—
—
138,391
Issuance of common stock upon initial public offering, net of
issuance costs
—
—
5,750,000
1
50,246
—
—
50,247
Issuance of common stock upon exercise of stock options
—
—
135,563
—
307
—
—
307
Early exercised common stock options
—
—
2,112
—
—
—
Repurchase of early exercised shares
—
—
(23,698
)
—
—
—
—
—
Vesting of early exercised common stock options and restricted stock
—
—
—
—
114
—
—
114
Stock-based compensation
—
—
—
—
2,168
—
—
2,168
Other comprehensive income
—
—
—
—
—
96
—
96
Net loss
—
—
—
—
—
—
(41,975
)
(41,975
)
Balances as of December 31, 2019
—
$
—
20,339,461
$
2
$
192,824
$
65
$
(92,491
)
$
100,400
Issuance of common stock upon follow-on public offering, net of
issuance costs
—
—
7,166,667
1
100,663
—
—
100,664
Issuance of common stock in private placement, net of
issuance costs
—
—
1,333,333
—
19,988
—
—
19,988
Issuance of common stock related to at-the-market offering program,
net of issuance costs
—
—
410,896
—
6,582
—
—
6,582
Issuance of common stock upon exercise of stock options
—
—
256,583
—
1,202
—
—
1,202
Employee stock purchase plan (ESPP) purchase
—
—
40,794
—
326
—
—
326
Repurchase of early exercised shares
—
—
(10,518
)
—
—
—
—
—
Vesting of early exercised common stock options
—
—
—
—
56
—
—
56
Stock-based compensation
—
—
—
—
3,609
—
—
3,609
Other comprehensive loss
—
—
—
—
—
(58
)
—
(58
)
Net loss
—
—
—
—
—
—
(34,495
)
(34,495
)
Balances as of December 31, 3020
—
$
—
29,537,216
$
3
$
325,250
$
7
$
(126,986
)
$
198,274
The accompanying notes are an integral part of these financial statements.
F-5
IDEAYA Biosciences, Inc.
Statements of Cash Flows
(in thousands)
Year Ended December 31,
2020
2019
2018
Cash flows from operating activities
Net loss
$
(34,495
)
$
(41,975
)
$
(34,346
)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities
Depreciation and amortization
1,381
1,245
886
Net amortization (accretion) of premiums (discounts) on marketable securities
578
(473
)
(808
)
Stock-based compensation
3,609
2,168
950
Issuance of Series B redeemable convertible preferred stock pursuant to
license agreement
—
—
3,812
Change in fair value of redeemable convertible preferred stock liability
—
—
(70
)
Landlord contributions for leasehold improvements
—
—
367
Loss (gain) on sale of property and equipment
2
14
(54
)
Gain on sale of marketable securities
(18
)
(8
)
(11
)
Changes in assets and liabilities
Accounts receivable
(1,877
)
—
—
Prepaid expenses and other assets
(510
)
(1,963
)
(243
)
Right-of-use assets
(148
)
1,093
—
Accounts payable
225
(195
)
322
Accrued and other liabilities
2,992
2,030
1,672
Contract liabilities
83,773
—
—
Deferred rent
—
—
(97
)
Lease liabilities
(49
)
(1,249
)
—
Net cash provided by (used in) operating activities
55,463
(39,313
)
(27,620
)
Cash flows from investing activities
Purchases of property and equipment, net
(493
)
(1,353
)
(1,708
)
Purchases of marketable securities
(242,314
)
(88,004
)
(133,301
)
Maturities of marketable securities
96,564
73,528
65,830
Sales of marketable securities
—
18,094
6,000
Net cash (used in) provided by investing activities
(146,243
)
2,265
(63,179
)
Cash flows from financing activities
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs
—
—
105,358
Proceeds from issuance of common stock in public offering, net of issuance costs
100,664
50,321
—
Proceeds from issuance of common stock in private placement, net of issuance costs
19,988
—
—
Proceeds from issuance of common stock related to at-the-market offering
program, net of issuance costs
6,582
—
—
Proceeds from exercise of common stock options, net of repurchases
1,190
289
91
Proceeds from ESPP purchases
326
—
—
Payments of deferred offering costs
—
—
(71
)
Net cash provided by financing activities
128,750
50,610
105,378
Net increase in cash, cash equivalents and restricted cash
37,970
13,562
14,579
Cash, cash equivalents and restricted cash
Cash, cash equivalents and restricted cash, at beginning of period
34,173
20,611
6,032
Cash, cash equivalents and restricted cash, at end of period
$
72,143
$
34,173
$
20,611
Reconciliation of cash, cash equivalents and restricted cash
Cash and cash equivalents
$
72,037
$
34,067
$
20,505
Restricted cash
$
106
$
106
$
106
Cash, cash equivalents and restricted cash
$
72,143
$
34,173
$
20,611
Supplemental disclosure of cash flow information:
Cash paid for income taxes
$
1
$
1
$
1
Cash paid for interest
$
82
$
91
$
99
Supplemental non-cash investing and financing activities:
Right-of-use asset obtained in exchange for new operating lease liability
$
1,191
$
—
$
—
Issuance of Series B redeemable convertible preferred stock pursuant to license agreement
$
—
$
—
$
3,812
Unpaid deferred offering costs
$
—
$
—
$
499
Vesting of early exercised options and restricted stock
$
56
$
114
$
189
Purchases of property and equipment in accounts payable and accrued liabilities
$
520
$
—
$
604
Extinguishment of redeemable convertible preferred stock liability
$
—
$
—
$
3,137
Conversion of redeemable convertible preferred stock into common stock
$
—
$
138,391
$
—
The accompanying notes are an integral part of these financial statements.
F-6
IDEAYA Biosciences, Inc.
Notes to Financial Statements
1. Organization
Description of the Business
IDEAYA Biosciences, Inc. (the “Company”) is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. The Company is headquartered in South San Francisco, California and was incorporated in the State of Delaware in June 2015. To date, the Company has been primarily engaged in business planning, research, development, recruiting and raising capital.
Initial Public Offering
On May 22, 2019, the Company’s registration statement on Form S-1 (File No. 333-231081) relating to its initial public offering (“IPO”) of common stock became effective. The IPO closed on May 28, 2019 at which time the Company issued 5,750,000 shares of its common stock at a price of $10.00 per share, which included shares issued upon the underwriters’ exercise of their overallotment option to purchase 750,000 additional shares. In addition, upon closing the IPO, all outstanding shares of the redeemable convertible preferred stock converted into 13,139,794 shares of common stock. The Company received an aggregate of $50.2 million in cash, net of underwriting discounts and commissions of $4.0 million, and after deducting offering costs of $3.3 million.
Follow-On Offering
On June 22, 2020, the Company completed an underwritten public offering and sold and issued 6,666,667 shares of common stock at a price to the public of $15.00 per share for gross proceeds of $100.0 million. On July 22, 2020, the Company sold and issued an additional 500,000 shares of common stock upon the exercise of the overallotment option by the underwriters for gross proceeds of $7.5 million. The aggregate net proceeds to the Company were $100.7 million after deducting underwriting discounts and commissions and other offering costs.
Private Placement
The Company entered into a stock purchase agreement with Glaxo Group Limited, or GGL, on June 17, 2020, pursuant to which, on August 3, 2020, the Company sold 1,333,333 shares at a price of $15.00 per shares to GGL for net proceeds of $20.0 million in a private placement.
At-the-Market Offering
On June 1, 2020, the Company entered into an open market sale agreement with Jefferies LLC (“Jefferies”), pursuant to which the Company may offer and sell shares of its common stock with an aggregate offering price of up to $50.0 million under an “at the market” offering program (the “ATM Offering”). For the year ended December 31, 2020, the Company sold an aggregate of 410,896 shares for net proceeds of $6.6 million after deducting sales commission and other expenses.
From January 2021 through March 22, 2021, the Company additionally sold an aggregate of 2,709,385 shares for gross proceeds of $43.3 million in the ATM Offering.
Liquidity
The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $127.0 million as of December 31, 2020. The Company has historically financed its operations primarily through the sale of convertible notes, redeemable convertible preferred stock and common stock, and payments received from its collaboration arrangement. To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any revenue from commercial products since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses into clinical development activities for its lead product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry as discussed under Risks and Uncertainties in Note 2. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending would have a material adverse effect on the Company’s ability to achieve its intended business objectives.
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As of December 31, 2020 , the Company had cash, cash equivalents and m arketable securities of $ 283.6 million. Management believes that the Company’s current cash, cash equivalents and marketable securities will be sufficient to fund its planned operations for at least 12 months from the date of the issuance of these financial statements.
2. Summary of Significant Accounting Policies
Basis of Presentation
The financial statements and accompanying notes have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
Reverse Stock Split
In May 2019, the Company’s board of directors approved a 1-for-10.2564 reverse stock split of the Company’s common stock and redeemable convertible preferred stock, which was effected on May 21, 2019. The par value and authorized shares of the common stock and redeemable convertible preferred stock were not adjusted as a result of the reverse stock split. All issued and outstanding common stock, options to purchase common stock and per share amounts contained in these financial statements have been retroactively adjusted to give effect to the reverse stock split for all periods presented.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Such estimates include useful lives of property and equipment, determination of the discount rate for operating leases, accruals for research and development activities, revenue recognition, stock-based compensation, and income taxes. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates.
Segments
The Company operates and manages its business as one operating and reportable segment, which is the business of research and development for oncology-focused precision medicine. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. All of the Company's long-lived assets are located in the United States.
Risks and Uncertainties
The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer, contract research organizations and collaboration partners, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials and collaboration activities; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.
Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will receive the necessary approvals, or that any approved products will be commercially viable. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.
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Beginning in late 2019, the outbreak of a novel strain of virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes coronavirus disease 2019, or COVID-19, has evolved into a global pandemic. The extent of the impact of the coronavirus outbreak on the Company’s business will depend on certain developments, including the duration and spread of the outbreak and the extent and severity of the impact on the Company’s clinical trial activities, research activities and suppliers, all of which are uncertain and cannot be predicted. At this point, the extent to which the coronavirus outbreak may materially impact the Company’s financial condition, liquidity or results of operations is uncertain.
The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents, marketable securities and accounts receivable. Substantially all the Company’s cash is held by one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits.
The Company’s investment policy addresses credit ratings, diversification, and maturity dates. The Company invests its cash equivalents and marketable securities in money market funds, U.S. government securities, commercial paper, and corporate bonds. The Company limits its credit risk associated with cash equivalents and marketable securities by placing them with banks and institutions it believes are highly creditworthy and in highly rated investments and, by policy, limits the amount of credit exposure with any one commercial issuer. The Company has not experienced any credit losses on its deposits of cash, cash equivalents or marketable securities.
Accounts receivable represents amounts due from GlaxoSmithKline. The Company monitors economic conditions to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection.
Cash and Cash Equivalents
Cash equivalents that are readily convertible to cash are stated at cost, which approximates fair value. The Company considers all highly liquid investments purchased with an original or remaining maturity of three months or less at the date of purchase to be cash equivalents.
Restricted Cash
Restricted cash as of December 31, 2020 and December 31, 2019 consisted of cash balances held as security in connection with the Company’s facility lease agreement in South San Francisco, California. The balances are classified as long-term assets on the Company’s balance sheet.
Marketable Securities
Marketable securities are investments in marketable securities with maturities greater than three months at the time of purchase. The Company determines the appropriate classification of its investments in marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company has classified and accounted for its marketable securities as available-for-sale. After consideration of the Company’s risk versus reward objectives and liquidity requirements, the Company may sell these securities prior to their stated maturities. The Company classifies highly liquid securities with maturities beyond 12 months as long-term marketable securities in the balance sheet. These securities are carried at fair value as determined based upon quoted market prices or pricing models for similar securities. Unrealized gains and losses, if any, are excluded from earnings and are reported as a component of accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income on the statements of operations and comprehensive loss. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. The Company did not identify any of its marketable securities as other-than-temporarily impaired as of December 31, 2020 and December 31, 2019 .
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Fair Value of Financial Instruments
The carrying amounts of the Company’s certain financial instruments, including cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities and market interest rates if applicable. Refer to Note 3 for details on the fair value of marketable securities.
Property and Equipment, Net
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which is generally between three and five years. Leasehold improvements are stated at cost and amortized over the shorter of the useful lives of the assets or the lease term . Maintenance and repairs are charged to expense as incurred. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations and comprehensive loss in the period realized.
Impairment of Long-Lived Assets
The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Recoverability is measured by comparison of the carrying amount of the asset or asset group to the future net cash flows which the asset or asset group is expected to generate. If such asset or asset group is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset or asset group exceeds the fair value of the asset or asset group. There have been no such impairments of long-lived assets for the years ended December 31, 2020 and December 31, 2019.
Leases
Upon adoption of ASC 842, Leases on January 1, 2019, the Company determined if any arrangement is a lease, or contains a lease, at inception. Operating leases are included in right-of-use (“ROU”) assets, lease liabilities, and long-term lease liabilities on the Company’s balance sheet.
The Company determines if an arrangement is a lease, or contains a lease, at inception. Operating leases are included in right-of-use (“ROU”) assets, lease liabilities, and long-term lease liabilities on the Company’s balance sheet .
ROU assets and lease liabilities are recognized based on the present value of the future lease payments over the lease term at commencement date. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The ROU asset also includes any lease payments made to the lessor at or before the commencement date, minus lease incentives received, and initial direct costs incurred. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company combines lease and nonlease components.
Revenue Recognition
The Company follows Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.
The Company applies the five-step model to contracts when (1) parties have approved the contract and are committed to performing respective obligations, (2) the Company can identify each party’s rights regarding the goods or services to be transferred, (3) the Company can identify the payment terms for the goods or services to be transferred, (4) the contract has commercial substance, and (5) it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines the performance obligations by assessing whether each promised good or service is distinct. Goods or services that are not distinct are bundled with other goods or services in the contract until a bundle of goods or services that is distinct is created. The Company then recognizes as revenue the amount of the transaction price that
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is allocated to the respective performance obligations when (or as) the performance obligations are satisfied. The Company constrains its estimate of the transaction price up to the amount (the “variable consideration constraint”) that a significant reversal of recognized revenue is not probable.
Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other promised goods or services identified in an arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the license at the point in time when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other goods or services, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress toward satisfying the performance obligation for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition.
Customer options for additional goods or services: If a contract contains customer options that allow the customer to acquire additional goods or services, including a license to the Company’s intellectual property, the goods and services underlying the customer options are evaluated to determine whether they are deemed to represent a material right. In determining whether the customer option has a material right, the Company assesses whether there is an option to acquire additional goods or services at a discount. If the customer option is determined not to represent a material right, the option is not considered to be a performance obligation. If the customer option is determined to represent a material right, the material right is recognized as a separate performance obligation. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until the option is exercised.
Milestone payments: At the inception of each arrangement or amendment that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 prescribes two methods to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. If it is probable that a significant revenue reversal would not occur when the uncertainty associated with the milestone is resolved, the associated milestone value is included in the transaction price. Milestone payments that are highly susceptible to factors outside the Company’s influence, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. If there is more than one performance obligation, the transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Upfront payments and fees are recorded as contract liabilities upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Contractual cost sharing payments received from a customer or collaboration partner are accounted for as variable consideration. The Company includes an expected value in the transaction price. Contractual cost sharing payments made to a
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customer or collaboration partner are accounted for as a reduction to the transaction price if such payments are not related to distinct goods or services received from the customer or collaboration partner.
Contracts may be amended to account for changes in contract specifications and requirements. Contract modifications exist when the amendment either creates new, or changes existing, enforceable rights and obligations. When contract modifications create new performance obligations and the increase in consideration approximates the standalone selling price for goods and services related to such new performance obligations as adjusted for specific facts and circumstances of the contract, the modification is accounted for as a separate contract. If a contract modification is not accounted for as a separate contract, the Company accounts for the promised goods or services not yet transferred at the date of the contract modification (the remaining promised goods or services) prospectively, as if it were a termination of the existing contract and the creation of a new contract, if the remaining goods or services are distinct from the goods or services transferred on or before the date of the contract modification. The Company accounts for a contract modification as if it were a part of the existing contract if the remaining goods or services are not distinct and, therefore, form part of a single performance obligation that is partially satisfied at the date of the contract modification. In such case the effect that the contract modification has on the transaction price, and on the entity’s measure of progress toward complete satisfaction of the performance obligation, is recognized as an adjustment to revenue (either as an increase in or a reduction of revenue) at the date of the contract modification (the adjustment to revenue is made on a cumulative catch-up basis).
Upfront payment contract liabilities resulting from the Company’s license and collaboration agreements do not represent a financing component as the payment is not financing the transfer of goods and services, and the technology underlying the licenses granted reflects research and development expenses already incurred by the Company. As such, the Company does not adjust its revenues for the effects of a significant financing component.
Research and Development Expenses
Research and development expenses consist of compensation costs, employee benefit costs, costs for contract manufacturing organizations (“CMOs”), costs for contract research organizations (“CROs”), costs for sponsored research, consulting costs, costs for laboratory supplies, costs for product licenses, facility-related expenses and depreciation. All research and development costs are charged to research and development expenses within the statements of operations and comprehensive loss as incurred. Payments associated with licensing agreements to acquire exclusive licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are also expensed as incurred. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered.
Accrued Research and Development
The Company has entered into various agreements with CMOs and CROs. The Company’s research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Stock-Based Compensation
The Company accounts for stock-based compensation arrangements with employees in accordance with ASC 718, Stock Compensation. The Company accounts for stock-based compensation arrangements using a fair value method which requires the recognition of compensation expense related to all stock-based awards. The fair value method requires the Company to estimate the fair value of stock option awards on the date of grant using an option pricing model. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted, which is expensed on a straight-line basis over the vesting period. Generally, the stock options the Company has granted to its employees have a 10 year term and vest over a 4-year period with 1-year cliff vesting.
For the year ended December 31, 2018, the Company accounted for stock options issued to non-employees based on the estimated fair value of the awards using the Black-Scholes option pricing model in accordance with ASC 505-50, Equity-Based Payment to Non-employees . Stock-based compensation expense related to stock options granted to non-employees was recognized as the stock options vested. The Company believes that the fair value of the stock options is more reliably measurable than the fair value of the services received. Stock options granted to non-employees were recorded at their fair
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value on the measurement date and we re subject to periodic adjustments as such options vest ed and at the end of each reporting period , and the resulting change in value, if any, wa s recognized in the Company’s statements of operations and comprehensive loss during the period the related services we re rendered.
Upon adoption of ASU 2018-07, Compensation–Stock Compensation (Topic 718): Improvements to Non-employee Share–Based Payment Accounting , as described below under Recently Adopted Accounting Pronouncements, starting January 1, 2019, the Company accounts for stock options issued to non-employees in accordance with ASC 718, Stock Compensation. The fair value method requires the Company to estimate the fair value of stock-based awards on the date of grant using an option pricing model. The Company uses the Black-Scholes option pricing model to determine the fair value of options granted, which is expensed on a straight-line basis over the vesting period.
Income Taxes
The Company accounts for income taxes using the asset and liability method whereby deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are currently in effect unless such rate is expected to be different when the deferred item reverses. Valuation allowances are established where necessary to reduce deferred tax assets to the amounts expected to be realized. Deferred tax assets and liabilities are classified as noncurrent on the balance sheet.
The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that has a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits in interest expense and other expense, respectively.
Comprehensive Loss
Comprehensive loss represents all changes in stockholders’ equity (deficit) except those resulting from and distributions to stockholders.
Net Loss per Share Attributable to Common Stockholders
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, stock options and restricted stock that is subject to repurchase at the original purchase price are considered to be potentially dilutive securities. Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities. The Company considers the shares issued upon the early exercise of stock options subject to repurchase to be participating securities, because holders of such shares have non-forfeitable dividend rights in the event a dividend is paid on common stock. The holders of early exercised shares subject to repurchase do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) under its accounting standard codifications (“ASC”) or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below.
Recently Adopted Accounting Pronouncements
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , which modifies the disclosure requirements on fair value measurements. ASU 2018-13 removes the requirement to disclose: the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy; the policy for timing of transfers between levels; and the valuation processes for Level 3 fair value measurements. For public business entities, this ASU is effective for fiscal years beginning after
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December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this ASU on January 1, 2020 . The adoption did not result in a material impact on the Company’s financial statements and related disclosures.
In August 2018, the FASB issued ASU 2018-15, Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 requires that certain implementation costs incurred in a cloud computing arrangement be deferred and recognized over the term of the arrangement. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this ASU on January 1, 2020, using the prospective transition method. The adoption did not result in a material impact on the Company’s financial statements and related disclosures.
In November 2018, the FASB issued ASU 2018-18, Collaborative arrangements (Topic 808)—Clarifying the interaction between Topic 808 and Topic 606 . ASU 2018-18 (i) clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account, (ii) adds unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606, and (iii) requires that in a transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. For public business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company adopted this ASU on January 1, 2020. The adoption did not result in a material impact on the Company’s financial statements and related disclosures .
New Accounting Pronouncements Not Yet Adopted
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in earlier recognition of credit losses. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The FASB subsequently issued supplemental guidance to ASC 326 within ASU 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief , ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) and ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses . ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. ASU 2019-10 extended the effectiveness of Topic 326 for smaller reporting companies until fiscal years beginning after December 31, 2020. Early adoption is permitted. The Company is currently evaluating the impact the adoption of these ASUs will have on its financial statements and related disclosures.
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and improves consistent application of and simplifies GAAP for other areas of Topic 740 by clarifying existing guidance. For public business entities, this ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this ASU will have on its financial statements and related disclosures .
3. Fair Value Measurement and Marketable Securities
The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date .
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Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities .
Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model .
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
As of December 31, 2020, financial assets measured and recognized at fair value are as follows (in thousands):
December 31, 2020
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Assets
U.S. government securities
Level 1
$
80,020
$
10
$
—
$
80,030
Corporate bonds
Level 2
72,573
11
(14
)
72,570
Commercial paper
Level 2
63,948
—
—
63,948
Marketable securities
216,541
21
(14
)
216,548
Money market funds ( 1)
Level 1
67,065
—
—
67,065
Total fair value of assets
$
283,606
$
21
$
(14
)
$
283,613
(1)
Included in cash and cash equivalents on the balance sheet
As of December 31, 2019, financial assets measured and recognized at fair value are as follows (in thousands):
December 31, 2019
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Assets
U.S. government securities
Level 1
$
24,973
$
32
$
—
$
25,005
Corporate bonds
Level 2
39,185
37
(4
)
39,218
Commercial paper
Level 2
2,192
—
—
2,192
Marketable securities
66,350
69
(4
)
66,415
Money market funds ( 1)
Level 1
34,008
—
—
34,008
Total fair value of assets
$
100,358
$
69
$
(4
)
$
100,423
(1)
Included in cash and cash equivalents on the balance sheet
As of December 31, 2020, all marketable securities had a remaining maturity of one year or less. As of December 31, 2019, all marketable securities had a remaining maturity of one year or less, except for corporate bonds with a fair value of $ 1.5 million that had maturities of one to two years. There were no financial liabilities measured and recognized at fair value as of December 31, 2020 and December 31, 2019.
F-15
4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
Useful Life
As of December 31,
(In Years)
2020
2019
Laboratory equipment
5
$
4,793
$
4,034
Computer equipment
3
117
117
Software
3
118
118
Leasehold improvements
Shorter of useful
life or lease term
2,716
2,581
Furniture and fixtures
5
421
308
Total property and equipment
8,165
7,158
Less: Accumulated depreciation and amortization
(3,894
)
(2,516
)
Property and equipment, net
$
4,271
$
4,642
Depreciation and amortization expense was $1.4 million, $1.2 million and $0.9 million for the years ended December 31, 2020 , December 31, 2019 and December 31, 2018, respectively.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
As of December 31,
2020
2019
Accrued research and development expenses
$
5,259
$
2,787
Accrued salaries and benefits
2,685
1,733
Legal and professional fees
543
457
Other
29
46
Accrued liabilities
$
8,516
$
5,023
5. Operating Leases
The Company leases its laboratory and office facilities in South San Francisco, California under a non-cancelable operating lease with expiration date in July 2024 (“Original Lease”).
On September 30, 2019, the Company and the landlord of the laboratory and office facilities in South San Francisco entered into a second amendment (“Second Amendment”) to lease additional office spaces at the same location. The Company accounts for the Second Amendment as a separate contract and recognized a related right-of-use (“ROU”) asset and lease liability of $1.2 million on the lease commencement date in August 2020.
The maturities of operating lease liabilities as of December 31, 2020 are as follows (in thousands):
As of December 31, 2020
Operating Leases
2021
1,930
2022
1,982
2023
2,036
2024
1,647
Total lease payments
7,595
Less: Interest
(872
)
Present value of lease liabilities
$
6,723
Amounts recognized on the balance sheet
Current lease liabilities
$
1,540
Long-term lease liabilities
5,183
Total lease liabilities
$
6,723
F-16
Operating lease cost was $1.5 million and $1.5 million for the years ended December 31, 2020 and December 31, 2019, respectively.
As of December 31, 2020 , the ROU assets of $5.2 million are included in non-current assets on the balance sheet, and lease liabilities of $6.7 million are included in current liabilities and non-current liabilities on the balance sheet.
As of December 31, 2020, the remaining term for the operating lease in South San Francisco, California is 3.6 years, and the discount rate used to measure the lease liability for such operating lease upon recognition is 7.0% for the Original Lease and 6.0% for the Second Amendment. The Company has one right to extend the lease term of the operating lease in South San Francisco for two years by giving the landlord written notice. The remaining term does not include the additional two years, as the Company assessed at commencement date that it was not reasonably certain to extend the lease term.
During the years ended December 31, 2020 and December 31, 2019 , cash paid for amounts included in operating lease liabilities of $1.7 million and $1.7 million, respectively, is included in cash flows from operating activities on the statement of cash flows.
6. Commitments and Contingencies
Contingencies
From time to time, the Company may be involved in litigation related to claims that arise in the ordinary course of its business activities. The Company accrues for these matters when it is probable that future expenditures will be made and these expenditures can be reasonably estimated. As of December 31, 2020 , the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s financial position, results of operations or cash flows .
Indemnification
The Company enters into standard indemnification arrangements in the ordinary course of business with vendors, clinical trial sites and other parties. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the fair value of these agreements is not material.
7. Income Taxes
No provision for income taxes was recorded for the years ended December 31, 2020 , December 31, 2019 and December 31, 2018. The Company has incurred net operating losses only in the United States since its inception. The Company has not reflected any benefit of such net operating loss carryforwards in the financial statements.
The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows:
Year Ended December 31,
2020
2019
2018
Federal statutory income tax rate
21.0
%
21.0
%
21.0
%
State income taxes
(1.9
%)
7.0
%
6.9
%
Change in valuation allowance
(21.5
%)
(31.4
%)
(29.4
%)
Research tax credits
2.7
%
3.6
%
2.7
%
Other permanent differences
(0.3
%)
(0.4
%)
(1.3
%)
Change in fair value of redeemable convertible preferred stock liability
0.0
%
0.2
%
0.1
%
Provision for income taxes
0.0
%
0.0
%
0.0
%
F-17
The tax effects of temporary differences and carryforwards of the deferred tax assets are presented below (in thousands):
As of December 31,
2020
2019
Deferred tax assets:
Net operating loss carryforwards
$
13,418
$
23,947
Research and development credit carryforwards
3,813
2,995
Lease liability
1,420
1,895
Intangible assets
1,274
1,809
Stock-based compensation
705
407
Accruals and reserves
505
436
Deferred revenue
17,332
—
Gross deferred tax assets
38,467
31,489
Less: Valuation allowance
(36,879
)
(29,462
)
Deferred tax assets, net of valuation allowance
1,588
2,027
Deferred tax liabilities:
Right-of-use assets
(1,100
)
(1,415
)
Property and equipment
(488
)
(612
)
Net deferred tax assets
$
—
$
—
The Company has established a full valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.
ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance.
As of December 31, 2020, the Company had net operating loss carryforwards of $35.8 million available to reduce future taxable income, if any, for federal income tax purposes. As of December 31, 2020, the Company had net operating loss carryforwards of $83.8 million available to reduce future taxable income, if any, for California state income tax purposes. If not utilized, the federal carryforwards of $11.7 million and the state carryforwards of $83.8 million will begin to expire in 2037 and 2036, respectively. The federal net operating loss carryforwards of $24.1 million arising after December 31, 2017 do not expire.
The Company also had federal and state research and development credit carryforwards of $2.6 million and $2.5 million, respectively, as of December 31, 2020. The federal credits will expire starting in 2037 if not utilized and the state research credit can be carried forward indefinitely.
The Tax Reform Act of 1986 limits the use of net operating loss carryforwards in certain situations where changes occur in the stock ownership of a company. The annual limitation may result in the expiration of net operating losses and credits before utilization. The Company performed a Section 382 analysis through December 31, 2020. The Company has experienced ownership changes in the past and in the current year. As a result of the ownership changes, some of the tax attribute carryforwards may be permanently limited as they will expire unused. The Company is continuing to analyze the impact of the limitation. Subsequent ownership changes may affect the limitation in future years.
Related to unrecognized tax benefits noted below, the Company accrued no penalties or interest during the years ended December 31, 2020, December 31, 2019 and December 31, 2018. The Company does not expect its unrecognized tax benefit balance to change materially over the next 12 months.
The Company had $0.9 million and $0.7 million of unrecognized tax benefits as of December 31, 2020 and December 31, 2019, respectively.
F-18
The following table summarizes the activity related to the Company’s unrecognized tax benefits (in thousands).
Balance as of January 1, 2019
$
399
Increase related to prior year tax positions
59
Increase related to current year tax positions
288
Balance as of December 31, 2019
$
746
Increase related to prior year tax positions
2
Increase related to current year tax positions
153
Balance as of December 31, 2020
$
901
The Company files income tax returns in the U.S. federal jurisdiction and in California. For jurisdictions in which tax filings have been filed, all tax years remain open for examination by the federal and California state authorities for three and four years, respectively, from the date of utilization of any net operating losses or credits.
8. Common Stock
As of December 31, 2020 and December 31, 2019 , the Company’s certificate of incorporation authorized the Company to issue 300,000,000 shares of common stock at a par value of $0.0001 per share. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the Company’s board of directors. As of December 31, 2020, no dividends have been declared to date.
The Company had reserved common stock for future issuance as follows:
As of December 31,
2020
2019
Exercise of outstanding options under the 2015 and 2019 Plans
2,591,456
1,962,332
Issuance of common stock options under the 2019 Plan
975,135
1,036,746
Issuance of common stock options under the Employee Stock Purchase Plan
357,600
195,000
Total
3,924,191
3,194,078
9. Stock-Based Compensation
2019 Incentive Award Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Incentive Award Plan (the “2019 Plan”), under which the Company may grant cash and equity-based incentive awards to the Company’s employees, consultants and directors. Following the effectiveness of the 2019 Plan, the Company will not make any further grants under the 2015 Equity Incentive Plan (the “2015 Plan”). However, the 2015 Plan continues to govern the terms and conditions of the outstanding awards granted under it. Shares of common stock subject to awards granted under the 2015 Plan that are forfeited or lapse unexercised and which following the effective date of the 2019 Plan are not issued under the 2015 Plan will be available for issuance under the 2019 Plan.
Options granted under the 2019 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to Company employees (including officers and directors who are also employees). NSOs may be granted to Company employees and consultants.
The exercise price of an ISO and NSO shall not be less than 100% of the estimated fair value of the shares on the date of grant. The exercise price of an ISO granted to an employee who, at the time of grant, owns stock representing more than 10% of the voting power of all classes of stock of the Company (a “10% stockholder”) shall be no less than 110% of the estimated fair value of the shares on the date of grant. Options granted under the 2019 Plan have a term of 10 years (or five years if granted to a 10% stockholder) and generally vest over a 4-year period with 1-year cliff vesting.
2015 Equity Incentive Plan
In 2015, the Company established its 2015 Plan which provides for the granting of stock options to employees and consultants of the Company. Options granted under the 2015 Plan may be either ISOs or NSOs.
F-19
2019 Employee Stock Purchase Plan
In May 2019, the Company’s board of directors adopted and the Company’s stockholders approved the 2019 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides eligible employees with the opportunity to acquire an ownership interest in the Company through periodic payroll deductions up to 15% of eligible compensation. The offering period is determined by the Company in its discretion but may not exceed 27 months. The per-share purchase price on the applicable exercise date for an offering period is equal to the lesser of 85% of the fair market value of the common stock at either the first business day or last business day of the offering period, provided that no more than 4,000 shares of common stock may be purchased by any one employee during each offering period. The ESPP is intended to constitute an “employee stock purchase plan” under Section 423(b) of the Internal Revenue Code of 1986, as amended. A total of 195,000 shares of common stock were initially reserved for issuance under the ESPP, subject to an annual increase on January 1 of each year, beginning on January 1, 2020. For the years ended December 31, 2020 and December 31, 2019, the Company recorded $0.2 million and less than $0.1 million of compensation expense related to participation in the ESPP.
Stock-Based Compensation Expense
Total stock-based compensation expense recorded related to awards granted to employees and non-employees was as follows (in thousands):
Year Ended December 31,
2020
2019
2018
Research and development
$
1,234
$
956
$
410
General and administrative
2,375
1,212
540
Total stock-based compensation expense
$
3,609
$
2,168
$
950
Stock Options
Activity under the Company’s 2015 and 2019 Plans is set forth below:
Outstanding Options
Shares
available
for Grant
Shares
Weighted-
Average
Exercise
Price
Weighted-
Average
Remaining
Contractual
Term (Years)
Balance, January 1, 2020
1,036,746
1,962,332
$
6.03
8.63
Additional shares authorized
813,578
—
Options granted
(1,252,826
)
1,252,826
$
8.48
Options exercised
—
(256,583
)
$
4.68
Options repurchased
10,518
—
$
1.08
Options canceled
367,119
(367,119
)
$
6.58
Balance, December 31, 2020
975,135
2,591,456
$
7.27
8.36
Exercisable as of December 31, 2020
844,226
$
5.79
7.55
Vested and expected to vest as of
December 31, 2020
2,591,456
$
7.27
8.36
The weighted-average grant-date fair value of options granted during the years ended December 31, 2020 and December 31, 2019 was $6.16 and $6.73 per share, respectively. The aggregate intrinsic value of options exercised for the years ended December 31, 2020 and December 31, 2019 was $1.7 million and $0.8 million, respectively. Intrinsic values are calculated as the difference between the exercise price of the underlying options and the fair value of the common stock on the date of exercise.
As of December 31, 2020, the total unrecognized stock-based compensation expense for stock options was $8.5 million, which is expected to be recognized over a weighted-average period of 2.51 years.
F-20
Early Exercise of Stock Options
The terms of the 2015 Plan permit the exercise of options granted under the 2015 Plan prior to vesting, subject to required approvals. The shares so acquired prior to vesting are subject to a lapsing repurchase right in favor of the Company at the original purchase price of such shares, exercisable upon a termination of the holder’s service with the Company prior to full vesting. The proceeds are initially recorded in other liabilities from the early exercise of stock options and are reclassified to additional paid-in capital as the Company’s repurchase right lapses. During the years ended December 31, 2020 and December 31, 2019, the Company repurchased 10,518 and 23,698 shares of common stock, respectively. As of December 31, 2020 and December 31, 2019, shares that were subject to repurchase were 14,460 and 84,964, respectively. The aggregate exercise price of early exercised shares as of December 31, 2020 and December 31, 2019 was less than $0.1 million and $0.1 million, respectively, which were recorded in other current liabilities and other non-current liabilities.
Black-Scholes Assumptions
The fair values of options were calculated using the assumptions set forth below:
Year Ended December 31,
2020
2019
2018
Expected term
5.5 - 6.1 years
5.4 - 6.1 years
5.8 - 6.1 years
Expected volatility
84.9 % - 98.3%
77.2% - 85.5%
80.3% - 82.3%
Risk-free interest rate
0.3% - 1.5%
1.4% - 2.5 %
2.6% - 3.1%
Dividend yield
0%
0%
0%
Expected term . The expected term represents the weighted-average period the stock options are expected to remain outstanding and is based on the options’ vesting terms, contractual terms and industry peers, as the Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior.
Expected Volatility . The Company uses an average historical stock price volatility of a peer group of publicly traded companies to be representative of its expected future stock price volatility, as the Company does not have sufficient trading history for its common stock. For purposes of identifying these peer companies, the Company considers the industry, stage of development, size and financial leverage of potential comparable companies. For each grant, the Company measures historical volatility over a period equivalent to the expected term. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.
Risk-Free Interest Rate . The risk-free rate assumption is based on U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options.
Expected Dividend Rate . The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be zero.
The Company accounts for forfeitures as they occur.
Fair Value of Common Stock
The fair value of the Company’s common stock is determined based on its closing market price on the date of grant.
Restricted Stock
Restricted stock activity was as follows:
Number of Shares Underlying Outstanding Restricted
Stock Awards
Weighted
Average
Grant Date
Fair Value
Unvested, December 31, 2019
14,625
$
0.82
Vested
—
Unvested, December 31, 2020
14,625
$
0.82
F-21
As of December 31, 2020 and December 31, 2019, 14,625 shares of restricted stock were outstanding with an aggregate purchase price of less than $0.1 million, which is recorded in other non-current liabilities on the balance sheets. The restricted stock vests upon the achievement of pre-defined research milestones. The holder of restricted stock has voting and dividend rights with respect to such shares held without regard to vesting. Shares of restricted stock are subject to a right of repurchase at the original purchase price held by the Company. As the restricted stock was purchased by an employee at a price equal to its fair value at the time of issuance, there was no stock-based compensation expense related to these awards. The total fair value of restricted stock vested during the years ended December 31, 2020 and December 31, 2019 was zero and $0.1 million in each period.
10. Significant Agreements
GlaxoSmithKline Collaboration, Option and License Agreement
In June 2020, the Company entered into a Collaboration, Option and License Agreement, or the GSK Collaboration Agreement, with an affiliate of GlaxoSmithKline, GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4), Limited, or GSK, pursuant to which the Company and GSK have entered into a collaboration for its synthetic lethality programs targeting methionine adenosyltransferase 2a, or MAT2A, DNA Polymerase Theta, or Pol Theta or POLQ, and Werner Helicase, or WRN. On July 27, 2020 (“Effective Date”), the Company and GSK received Hart-Scott-Rodino Antitrust Improvements Act clearance, or HSR Clearance, and the GSK Collaboration Agreement became effective.
Pursuant to the GSK Collaboration Agreement, GSK agreed to pay the Company $100.0 million (the “Upfront Payment”) within ten business days of the Effective Date of the GSK Collaboration Agreement. On July 31, 2020, the Company received the Upfront Payment.
MAT2A Program
For the MAT2A program, the Company will lead research and development through early clinical development. GSK has an exclusive option to obtain an exclusive license to continue development of and commercialize MAT2A products arising out of the MAT2A program, or the Option, exercisable within a specified time period after the Company delivers to GSK a data package resulting from its conduct of a MAT2A Phase 1 monotherapy clinical trial. At such time of exercise, GSK has agreed to pay the Company an option exercise payment of $50.0 million.
GSK may initiate, or request that the Company initiates, a Phase 1 combination clinical trial for a MAT2A product and GSK’s Type I PRMT inhibitor (GSK3368715) product, or the MAT2A Combination Trial, prior to GSK’s exercise of the Option. The Company will be responsible for the costs of research and early clinical development activities that the Company conducts for the MAT2A program prior to GSK’s exercise of the Option, excluding the costs of conducting the MAT2A Combination Trial. GSK will be solely responsible for costs of the conduct of the MAT2A Combination Trial, except for supply of the MAT2A product therefor, to be provided by the Company at its own cost.
Subject to GSK’s exercise of the Option, GSK will lead later stage global clinical development for the MAT2A program, with IDEAYA responsible for 20% and GSK responsible for 80% of further development costs. The cost-sharing percentages will be adjusted based on the actual ratio of U.S. to global profits for MAT2A products, as measured three and six years after global commercial launch thereof.
Subject to GSK’s exercise of the Option, the Company will be eligible to receive future development and regulatory milestones of up to $465.0 million, and commercial milestones of up to $475.0 million, with respect to each MAT2A product. Additionally, the Company is entitled to receive 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of MAT2A products by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions. The Company will have a right to opt-out of the 50% U.S. net profit share and corresponding development cost share for the MAT2A program, in which case the Company would be eligible to receive tiered royalties on U.S. net sales of MAT2A products by GSK, its affiliates and their sublicensees at the same royalty rates as for global non-U.S. net sales thereafter, with economic adjustments based on the stage of the MAT2A program at the time of opt-out.
F-22
Pol Theta Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize POLQ products arising out of the POLQ program. GSK and the Company will collaborate on ongoing preclinical research for the POLQ program, and GSK will lead clinical development for the POLQ program. GSK will be responsible for all research and development costs for the POLQ program, including those incurred by the Company.
The Company will be eligible to receive future development and regulatory milestones of up to $485.0 million, with respect to each POLQ product, including as applicable, for multiple POLQ products that target certain alternative protein domains or are based on alternative modalities. Additionally, the Company is eligible to receive up to $475.0 million of commercial milestones with respect to each POLQ product. The Company is also entitled to receive tiered royalties on global net sales of POLQ products by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions.
WRN Program
Pursuant to the GSK Collaboration Agreement, GSK holds a global, exclusive license to develop and commercialize WRN products arising out of the WRN program. The Company and GSK will collaborate on ongoing preclinical research for the WRN program, and GSK will lead clinical development for the WRN program, with IDEAYA responsible for 20% and GSK responsible for 80% of such global research and development costs. The cost-sharing percentages will be adjusted based on the actual ratio of U.S. to global profits for WRN products, as measured three and six years after global commercial launch thereof.
The Company will be eligible to receive future development milestones of up to $485.0 million, with respect to each WRN product, including as applicable, for multiple WRN products that are based on alternative modalities. Additionally, the Company will be eligible to receive up to $475.0 million of commercial milestones with respect to each WRN product. The Company will be entitled to receive 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of WRN products by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions. The Company will have a right to opt-out of the 50% U.S. net profit share and corresponding research and development cost share for the WRN program, and would be eligible to receive tiered royalties on U.S. net sales of WRN products by GSK, its affiliates and their sublicensees at the same royalty rates as for global non-U.S. net sales thereafter, with economic adjustments based on the stage of the WRN program at the time of opt-out.
General
Under the terms of the GSK Collaboration Agreement, subject to certain exceptions, the Company and GSK will not, directly or through third parties, develop or commercialize other products whose primary and intended mechanism of action is the modulation of WRN, POLQ, or MAT2A (unless GSK does not exercise the Option, in which case such restriction shall cease to apply with respect to MAT2A) for an agreed upon period of time. The Company and GSK will form a joint steering committee, joint development committees, and joint commercialization committees responsible for coordinating all activities under the GSK Collaboration Agreement. Ownership of intellectual property developed under the GSK Collaboration Agreement is allocated between or shared by the parties depending on development and subject matter.
GSK’s royalty obligations continue with respect to each country and each product until the later of (i) the date on which such product is no longer covered by certain intellectual property rights in such country and (ii) the 10th anniversary of the first commercial sale of such product in such country.
Each party has the right to sublicense its rights under the GSK Collaboration Agreement subject to certain conditions.
The GSK Collaboration Agreement will continue in effect on a product-by-product and country-by-country basis until the expiration of the obligation to make payments under the GSK Collaboration Agreement with respect to such product in each country, unless earlier terminated by either party pursuant to its terms. Either the Company or GSK may terminate the GSK Collaboration Agreement for the other party’s insolvency or certain uncured breaches. The Company may terminate the GSK Collaboration Agreement if GSK or any of its sublicensees or affiliates challenge certain patents of the Company. GSK may terminate the GSK Collaboration Agreement in its entirety or on a target-by-target basis upon 90-day notice to the Company.
F-23
Pfizer Clinical Trial Collaboration and Supply Agreement
In March 2020, the Company entered into a clinical trial collaboration and supply agreement with Pfizer Inc., or the Supply Agreement, which was subsequently amended in September 2020. Pursuant to the Supply Agreement, Pfizer supplies the Company with their MEK inhibitor, binimetinib, and cMET inhibitor, crizotinib, to evaluate the combination in patients with tumors harboring activating GNAQ or GNA11 hotspot mutations. Under the Supply Agreement, the Company will sponsor a Phase 1/2 clinical trial for its product candidate, IDE196, and Pfizer will supply the Company with binimetinib and crizotinib for use in the clinical trial at no cost to the Company. The Supply Agreement provides that the Company and Pfizer will jointly own clinical data generated from the clinical trial.
Novartis License Agreement
In September 2018, the Company entered into a license agreement with Novartis International Pharmaceuticals Ltd. (“Novartis”) to develop and commercialize Novartis’ LXS196 (also known as IDE196), a Phase 1 protein kinase C (“PKC”) inhibitor for the treatment of cancers having GNAQ and GNA11 mutations. In consideration of license and rights granted under the license agreement, the Company made a one-time cash payment of $2.5 million to Novartis and issued 263,615 shares of Series B redeemable convertible preferred stock with a fair value of $3.8 million to an affiliate of Novartis, which were recorded within research and development expenses on the Company’s statements of operations and comprehensive loss, as the products have not reached technological feasibility and do not have alternative future use. Under the license agreement, the Company is liable to make contingent development and sales milestone payments of up to $29.0 million and mid to high single digit royalty payments of the net sales of licensed products.
11. Revenue Recognition
The Company recognizes revenue in accordance with ASC 606 for the GSK Collaboration Agreement (see No. 10, Significant Agreements).
Disaggregation of Revenue
The following table presents revenue disaggregated by research program (in thousands):
Year Ended December 31, 2020
MAT2A
$
6,048
Pol Theta
7,917
WRN
5,573
Total collaboration revenue
$
19,538
Contract balances
As of December 31, 2020 , the Company had $1.9 million of accounts receivable and $83.8 million of contract liabilities related to the GSK Collaboration Agreement.
The following table presents the significant changes in the balance of contract liabilities during the year ended December 31, 2020 (in thousands):
Contract liabilities
Receipt of the Upfront Payment
$
100,000
Reclassification to revenue, as the result of performance obligations satisfied
(19,538
)
Cash received for cost reimbursement
1,434
Increase in accounts receivable
1,877
Total
$
83,773
The timing of revenue recognition, billings, and cash collections results in accounts receivable, contract assets, and contract liabilities on the balance sheets. Based on the estimated reimbursable program costs for a quarter, the Company recognizes accounts receivable, which are derecognized upon reimbursement. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded. Contract liabilities are recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met.
F-24
Performance obligations
The Company has identified the following six performance obligations associated with the GSK Collaboration Agreement:
(1)
Preclinical and Phase 1 Monotherapy clinical research and development services under the MAT2A program (“MAT2A R&D Services”)
(2)
Preclinical research services and the related license to IDEAYA-owned technology under the Pol Theta program (“Pol Theta R&D Services”)
(3)
Preclinical research services and the related license to IDEAYA-owned technology under the WRN program (“WRN R&D Services”)
(4)
Material right associated with the option to license IDEAYA-owned technology under the MAT2A program (defined as the “Option” in Note 10)
(5)
Material right associated with the option to license to IDEAYA-owned technology under the MAT2A program to the extent necessary for preclinical activities in preparation for the MAT2A Combination Trial (“Preclinical MAT2A License”)
(6)
Material right associated with the supply of MAT2A product for the MAT2A Combination Trial (“MAT2A Supply”)
The Company will recognize revenue related to amounts allocated to the MAT2A R&D services as the underlying services are performed over the period through the delivery of the data package, which will be generated from its conduct of the MAT2A Phase 1 monotherapy clinical trial. The Company uses its internal research and development capability and may also engage third-party clinical research organizations, or CROs, in transferring the MAT2A R&D services, for which the Company acts as a principal.
With respect to the Pol Theta and WRN programs, the Company identified two promises: (1) granting of the license to develop and commercialize Pol Theta and WRN products, respectively, and (2) the preclinical research services. The Company has determined that these two promises are not distinct within the context of the contract. As of the effective date of the GSK Collaboration Agreement, both programs were at an early stage, and the Company was yet to identify any development candidate for either program, which will require the completion of certain preclinical studies. After the Company and GSK identify a development candidate, a series of IND-enabling studies will be conducted before an Investigational New Drug application is submitted to the FDA. Due to the early stage of development, the Company’s preclinical research services are expected to transform the underlying technology and significantly modify or customize the license. Therefore, the two promises are not distinct from each other and are accounted for as a single performance obligation for each of the Pol Theta and WRN programs, respectively. The Company will recognize revenue related to amounts allocated to the Pol Theta R&D Services and WRN R&D Services as the underlying services are performed over the period through the completion of the Pol Theta and WRN preclinical research programs, respectively. Within 90 days from the end of each calendar quarter, GSK will reimburse the Pol Theta program costs incurred by the Company. Within 75 days from the end of each calendar quarter, the Company and GSK will determine the amounts of WRN program costs incurred by both parties and the net amount owed by GSK to the Company or by the Company to GSK, which will be paid within 75 days from such determination by a reimbursing party. The Company uses its internal research capability and may also engage third-party clinical research organizations, or CROs, in transferring the Pol Theta R&D services and WRN R&D services, for which the Company acts as a principal.
Upon exercise of the Option, GSK will obtain the license to develop and commercialize MAT2A products. The Company has concluded that this Option results in a material right as the option exercise fee contains a discount that GSK would not have otherwise received. The Company has determined the nature of the license to develop and commercialize MAT2A products to be functional. After exercise of the Option, the Company will recognize revenue, when it makes the underlying MAT2A technology available to GSK, which will immediately be able to use and benefit from its right to use the intellectual property.
The Company has identified two additional customer options under the MAT2A program, both of which have been determined a material right. GSK may elect to conduct certain preclinical activities in preparation for the MAT2A Combination Trial and may elect to exercise the option to license to MAT2A technology. GSK may be able to use and exploit the license to the extent necessary for GSK’s performance of such preclinical activities. The Company will not receive any consideration for providing such license and has concluded that this license option results in a material right as it involves a discount that GSK would not have otherwise received. The Company has determined the nature of such license to MAT2A technology to be functional. As of December 31, 2020 , GSK has exercised the Preclinical MAT2A License, and the Company has made the underlying MAT2A technology available to GSK, which is immediately able to use and benefit from its right to use the intellectual property. Accordingly, the Company recognized revenue from the Preclinical MAT2A License in the year ended December 31, 2020 .
F-25
If GSK elects to conduct the MAT2A Combination Trial, the Company will supply MAT2A product to be used for the MAT2A Combination Trial at its own cost. The Company has concluded that this supply option results in a material right as it involves a discount that GSK would not have otherwise received. The Company will recognize revenue, as it transfers the control of the MAT2A product to GSK. The Company has not supplied MAT2A product as of December 31, 2020 .
Transaction price allocated to the remaining performance obligations
At inception of the GSK Collaboration Agreement, the Company determined that the transaction price was $108.5 million, including the Upfront Payment, and the estimated reimbursable program costs. The following table presents the transaction price allocated to the remaining performance obligations as of December 31, 2020 (in thousands):
Performance Obligations
Allocation of Transaction Price
MAT2A R&D Services
$
16,144
Pol Theta R&D Services
25,776
WRN R&D Services
27,785
The Option
17,235
MAT2A Supply
2,351
Total transaction price allocated to the remaining performance obligations
$
89,291
The Company applies the sales-based royalty exception to the commercial milestones and tiered royalties for all programs because GSK would ascribe significantly more value to the license than to the other goods or services to which the commercial milestones and tiered royalties relate. The Company will be entitled to receive the commercial milestones either when the first commercial sale occurs, or when the predefined net sales in a calendar year are achieved, upon which the variability will be resolved. Also, the Company will be entitled to receive the tiered royalties during a calendar year when global net sales of each product occur, upon which the variability will be resolved.
Significant judgements
In applying ASC 606 to the GSK Collaboration Agreement, the Company made the following judgments that significantly affect the timing and amount of revenue recognition:
(i)
Determination of the transaction price, including whether any variable consideration is included at inception of the contract
The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer. The transaction price must be determined at inception of a contract and may include amounts of variable consideration. However, there is a constraint on inclusion of variable consideration in the transaction price, if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future.
The decision as to whether or not it is probable that a significant reversal of revenue will occur in the future, depends on the likelihood and magnitude of the reversal and is highly susceptible to factors outside the Company’s influence (for example, the Company cannot determine the outcome of clinical trials; the Company cannot determine if or when the counterparty will initiate or complete clinical trials; and the Company cannot determine if or when an regulatory agency provides any approval). In addition, the uncertainty is not expected to be resolved for a long period and finally, the Company has limited experience in the field. Therefore, at inception of the GSK Collaboration Agreement, development and regulatory milestones were fully constrained and were not included in the transaction price based on the factors noted above.
The Company constrains estimates of other variable consideration, such as reimbursable program costs, to amounts that are not expected to result in a significant revenue reversal in the future. The Company re-evaluates the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
F-26
(ii)
Determination of the estimate of the standalone selling price of performance obligations
In order to recognize revenue under ASC 606, for contracts for which more than one distinct performance obligation has been identified, the Company must allocate the transaction price to the performance obligations based upon their standalone selling prices. The best evidence of standalone selling price is an observable price of a good or service when sold separately by an entity in similar circumstances to similar customers. If such evidence is not available, standalone selling price should be estimated so that the amount that is allocated to each performance obligation equals the amount that the entity expects to receive for transferring goods or services. The Company has identified more than one performance obligation in the GSK Collaboration Agreement. Since evidence based on observable prices is not available for the performance obligations, the Company considered market conditions and entity-specific factors, including those contemplated in negotiating the agreements, as well as certain internally developed estimates.
The Company determined the estimate of standalone selling price of the MAT2A R&D Services by using the expected costs of satisfying the performance obligation, adjusted for probabilities of technical success where appropriate. The Company determined the estimate of standalone selling price of the Pol Theta R&D Services and WRN R&D Services by using a combination of risk-adjusted net present value analysis and the expected costs of satisfying the performance obligation, adjusted for probabilities of technical success where appropriate. The Company determined the estimate of standalone selling price of the Option by using risk-adjusted net present value analysis. Finally, the Company determined the estimate of standalone selling price of the Preclinical MAT2A License and MAT2A Supply by using the expected costs of satisfying the performance obligation.
(iii)
Determination of the method of allocation of the transaction price to the distinct performance obligations
At inception of the GSK Collaboration Agreement, the Company allocated the transaction price among the six performance obligations based on their relative selling prices, determined as described above.
(iv)
Determination of the timing of satisfaction of performance obligations
The Company recognizes revenue from the MAT2A R&D Services, Pol Theta R&D Services and WRN R&D Services over time, as GSK simultaneously receives and consumes the benefits provided by the Company’s performance as the Company performs. The Company measures its progress toward complete satisfaction of the MAT2A R&D Services, Pol Theta R&D Services and WRN R&D Services based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligations. As the Company performs, it shares the results of research and development studies with GSK through the joint development committee. Accordingly, the cost incurred method faithfully depicts the Company’s performance of the MAT2A R&D Services, Pol Theta R&D Services and WRN R&D Services.
The license to IDEAYA-owned technology under the MAT2A program underlying the Option and Preclinical MAT2A License is functional in nature. Upon the exercise of the material right associated with the option to license to IDEAYA-owned technology under the MAT2A program, the Company will recognize revenue upon the later of transfer of the underlying technology to GSK and the beginning of the period during which GSK is able to use and benefit from its right to use the underlying technology.
After the exercise of the material right associated with the supply of MAT2A product for the MAT2A Combination Trial, the Company recognize revenue as it transfers the control of MAT2A product to GSK.
F-27
1 2 . Net Loss Per Share Attributable to Common Stockholders
The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share data):
Year Ended December 31,
2020
2019
2018
Numerator:
Net loss attributable to common stockholders
$
(34,495
)
$
(41,975
)
$
(34,346
)
Denominator:
Weighted-average shares outstanding
24,783,287
12,669,367
1,338,776
Less: weighted-average shares of restricted stock that are
subject to repurchase
(61,512
)
(172,410
)
(382,524
)
Weighted-average shares used in computing net loss per share
attributable to common stock, basic and diluted
24,721,775
12,496,957
956,252
Net loss per share attributable to common stockholders, basic and
diluted
$
(1.40
)
$
(3.36
)
$
(35.92
)
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:
As of December 31,
2020
2019
2018
Redeemable convertible preferred stock
—
—
13,139,794
Options to purchase common stock
2,591,456
1,962,332
1,598,864
Restricted stock
14,625
14,625
19,492
Restricted stock acquired upon early exercise of stock options
14,460
84,964
237,853
Total
2,620,541
2,061,921
14,996,003
As of December 31, 2020, the Company has contributions from plan participant of $0.3 million under the ESPP, which if converted, would be equivalent to 30,454 shares based on 85% of the stock price at the beginning of the offering period.
13. 401(k) Retirement Savings Plan
In 2016, the Company adopted a 401(k) plan for all employees who have met certain eligibility requirements. Under the agreement, employees may elect to contribute up to 90% of their eligible compensation to a 401(k) plan, subject to certain limitations. The Company is responsible for administrative costs of the 401(k) plan. The Company may, at its discretion, make matching or profit - sharing contributions to the 401(k) plan . For the year s ended December 31, 2020 , December 31, 2019 and December 31, 2018 , the Company made matching contributions of $0.2 million, $0.2 million and less than $0.1 million, respectively.
14. Related Party Transactions
The Company incurred $1.3 million of research and development expenses during the year ended December 31, 2018 in relation to agreements for pharmaceutical research, development and manufacturing activities with entities affiliated with a former director of the Company, Edward Hu. Mr. Hu resigned from the Company’s board of directors in January 2019.
15. Subsequent Event
From January 2021 through March 22, 2021, the Company sold an aggregate of 2,709,385 shares for gross proceeds of $43.3 million in the ATM Offering.
F-28
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized, in South San Francisco, California on March 23, 2021.
IDEAYA Biosciences, Inc.
By:
/s/ Yujiro Hata
Yujiro Hata
President and Chief Executive Officer
Power of Attorney
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Yujiro Hata and Paul Stone, and each of them acting individually, as his or her true and lawful attorneys-in-fact and agents, each with full power of substitution, for him in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K (including post-effective amendments), and to file the same, with all exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, with full power of each to act alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed by the following persons in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Yujiro Hata
President, Chief Executive Officer and Director
(Principal Executive Officer)
March 23, 2021
Yujiro Hata
/s/ Paul Stone, J.D.
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
March 23, 2021
Paul Stone, J.D.
/s/ Timothy Shannon, M.D.
Chairman of the Board of Directors
March 23, 2021
Timothy Shannon, M.D.
/s/ Garret Hampton, Ph.D.
Director
March 23, 2021
Garret Hampton, Ph.D.
/s/ Susan L. Kelley, M.D.
Director
March 23, 2021
Susan L. Kelley, M.D.
/s/ Scott Morrison
Director
March 23, 2021
Scott Morrison
/s/ Terry Rosen, Ph.D.
Director
March 23, 2021
Terry Rosen, Ph.D.
/s/ Jeffrey Stein, Ph.D.
Director
March 23, 2021
Jeffrey Stein, Ph.D.
/s/ Wendy Yarno
Director
March 23, 2021
Wendy Yarno