Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports required by the Exchange Act is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive and financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Annual Report. Based on the foregoing, our principal executive and financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.
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 Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our principal executive and financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the framework in Internal Control — Integrated Framework (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report, which is included herein.
88
Change in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with management’s evaluation of such internal control that occurred during our most recent quarter ended December 31, 2023 that have materially affected, or are reasonably likely to material affect, our internal control over financial reporting.
89
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Kura Oncology, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Kura Oncology, Inc.’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Kura Oncology, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the balance sheets of the Company as of December 31, 2023 and 2022, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 27, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
San Diego, California
February 27, 2024
90
Item 9 B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
91
PART III
Item 10. Directors, Executive Off icers and Corporate Governance.
The information required by this item and not set forth below will be set forth in the sections headed “Election of Directors” and “Executive Officers” in our definitive proxy statement for our 2024 Annual Meeting of Stockholders, or Proxy Statement, to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023, and is incorporated herein by reference.
We have adopted a written code of ethics for directors, officers, including our principal executive and financial officer and our principal accounting officer, and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at www.kuraoncology.com under the Corporate Governance section of our Investors & Media page. Our website and the information contained on, or that can be accessed through, the website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. We will promptly disclose on our website (i) the nature of any amendment to the Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Business Conduct and Ethics that is granted to one of these specified individuals that is required to be disclosed pursuant to SEC rules and regulations, the name of such person who is granted the waiver and the date of the waiver.
Item 11. Executiv e Compensation.
The information required by this item will be set forth in the sections headed “Executive Compensation” and “Non-Employee Director Compensation” in our Proxy Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters.
The information required by this item will be set forth in the section headed “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement and is incorporated herein by reference.
The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item will be set forth in the sections headed “Certain Relationships and Related Party Transactions” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accoun tant Fees and Services.
The information required by this item will be set forth in the section headed “Ratification of Selection of Independent Registered Public Accounting Firm” in our Proxy Statement and is incorporated herein by reference.
92
PART IV
Item 15. Exhibit and Financ ial Statement Schedules.
1. Financial Statements . We have filed the following documents as part of this Annual Report:
Page
Report of Independent Registered Public Accounting Firm
F- 1
Balance Sheets
F- 3
Statements of Operations and Comprehensive Loss
F- 4
Statements of Stockholders’ Equity
F- 5
Statements of Cash Flows
F- 6
Notes to Financial Statements
F- 7
2. Financial Statement Schedules.
There are no financial statement schedules provided because the information called for is either not required or is shown either in the financial statements or the notes thereto.
3. Exhibits
Exhibit
Number
Description
Filed
Herewith
Incorporated by Reference herein
from Form or
Schedule
Filing Date
SEC File/Reg.
Number
3.1
Amended and Restated Certificate of Incorporation of the Registrant, as amended.
8-K
(Exhibit 3.1)
6/14/2017
001-37620
3.2
Amended and Restated Bylaws of the Registrant.
8-K
(Exhibit 3.2)
6/14/2017
001-37620
4.1
Form of Common Stock certificate.
8-K
(Exhibit 4.1)
3/12/2015
000-53058
4.2
Warrant to Purchase Stock by Registrant on April 27, 2016 to Oxford Finance LLC.
10-Q
(Exhibit 4.3)
8/10/2016
001-37620
4.3
Form of Warrant Agreement issued by the Registrant on November 2, 2022 to certain Lenders.
10-K
(Exhibit 4.3)
2/23/2023
001-37620
4.4
Amended and Restated Warrant Agreement, dated as of November 29, 2022, by and between the Registrant and Hercules Capital, Inc.
10-K
(Exhibit 4.4)
2/23/2023
001-37620
4.5
Warrant Agreement, dated as of November 29, 2022, by and between the Registrant and Hercules Capital IV, L.P.
10-K
(Exhibit 4.5)
2/23/2023
001-37620
4.6
Form of Pre-Funded Warrant.
8-K
(Exhibit 4.1)
6/14/2023
001-37620
4.7
Description of Registrant’s Common Stock.
10-K
(Exhibit 4.3)
2/25/2020
001-37620
4.8
Form of Pre-Funded Warrant.
8-K
(Exhibit 4.1)
1/26/2024
001-37620
4.9***
Registration Rights Agreement, dated January 26, 2024, by and among the Registrant and the persons party thereto.
8-K
(Exhibit 10.2)
1/26/2024
001-37620
93
Exhibit
Number
Description
Filed
Herewith
Incorporated by Reference herein
from Form or
Schedule
Filing Date
SEC File/Reg.
Number
10.1+
Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan and Forms of Stock Option Agreement, Notice of Exercise and Stock Option Grant Notice thereunder.
8-K
(Exhibit 99.1)
6/2/2023
001-37620
10.2+
Form of Restricted Stock Purchase Agreement and Restricted Stock Purchase Award Notice under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan.
8-K
(Exhibit 10.2)
3/12/2015
000-53058
10.3+
Kura Oncology, Inc. 2015 Employee Stock Purchase Plan.
8-K
(Exhibit 10.3)
3/12/2015
000-53058
10.4+
Form of Indemnification Agreement by and between the Registrant and each of its directors and officers.
8-K
(Exhibit 10.4)
3/12/2015
000-53058
10.5*
License Agreement, dated December 18, 2014, by and between the Registrant and Janssen Pharmaceutica NV.
10-K
(Exhibit 10.5)
2/24/2021
001-37620
10.6*
Patent License Agreement, effective as of December 22, 2014, by and between the Registrant and the Regents of the University of Michigan, as amended on March 3, 2015, July 22, 2015, September 29, 2016, February 1, 2017.
10-K
(Exhibit 10.8)
2/24/2021
001-37620
10.7*
Fifth Amendment to Patent License Agreement, effective as of May 24, 2017, by and between the Registrant and the Regents of the University of Michigan.
10-K
(Exhibit 10.9)
2/24/2021
001-37620
10.8+
Amended and Restated Executive Employment Agreement, effective as of January 29, 2016, by and between the Registrant and Troy E. Wilson, Ph.D., J.D.
10-K
(Exhibit 10.15)
3/17/2016
001-37620
10.9
Amendment No. 1 to License Agreement, dated June 6, 2016, by and between the Registrant and Janssen Pharmaceutica NV.
10-Q
(Exhibit 10.3)
8/10/2016
001-37620
10.10**
Sixth Amendment to Patent License Agreement, effective as of August 24, 2017, by and between the Registrant and the Regents of the University of Michigan.
10-K
(Exhibit 10.23)
3/12/2018
001-37620
10.11+
Executive Employment Agreement, effective as of August 9, 2019, by and between the Registrant and Kathleen Ford.
10-Q
(Exhibit 10.3)
11/5/2019
001-37620
10.12
Office Lease Agreement, dated January 8, 2020, by and between the Registrant and BRE CA Office Owners LLC.
10-Q
(Exhibit 10.28)
2/25/2020
001-37620
10.13
Office Lease Agreement, dated March 24, 2020, by and between the Registrant and East Office Operating Limited Partnership.
10-Q
(Exhibit 10.5)
5/4/2020
001-37620
10.14
First Amendment to Office Lease Agreement, dated May 2, 2020 by and between the Registrant and BRE CA Office Owner LLC.
10-Q
(Exhibit 10.8)
5/4/2020
001-37620
94
Exhibit
Number
Description
Filed
Herewith
Incorporated by Reference herein
from Form or
Schedule
Filing Date
SEC File/Reg.
Number
10.15+
Amended and Restated Non-Employee Director Compensation Policy.
10-Q
(Exhibit 10.1)
8/9/2023
001-37620
10.16+
Form of International Stock Option Grant Notice, International Stock Option Agreement and International Notice of Exercise under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan.
10-Q
(Exhibit 10.2)
8/9/2023
001-37620
10.17
Second Amendment to Office Lease Agreement, dated October 27, 2020 by and between the Registrant and BRE CA Office Owner LLC.
10-Q
(Exhibit 10.2)
11/5/2020
001-37620
10.18+
Amendment to Amended and Restated Executive Employment Agreement, effective as of February 19, 2021, by and between the Registrant and Troy E. Wilson, Ph.D., J.D.
10-K
(Exhibit 10.36)
2/24/2021
001-37620
10.19+
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan.
10-K
(Exhibit 10.22)
2/23/2023
001-37620
10.20+
Executive Employment Agreement, effective as of July 22, 2020, by and between the Registrant and Stephen Dale, M.D.
10-Q
(Exhibit 10.7)
5/6/2021
001-37620
10.21+
Amendment to Executive Employment Agreement, effective as of February 22, 2021, by and between the Registrant and Stephen Dale, M.D.
10-Q
(Exhibit 10.8)
5/6/2021
001-37620
10.22
Lease Agreement, dated May 11, 2021, by and between the Registrant and BP3-SD5 5510 Morehouse Drive LLC.
10-Q
(Exhibit 10.1)
8/5/2021
001-37620
10.23+
Form of International Restricted Stock Unit Award Grant Notice and International Restricted Stock Unit Award Agreement under the Kura Oncology, Inc. Amended and Restated 2014 Equity Incentive Plan.
10-K
(Exhibit 10.30)
2/24/2022
001-37620
10.24+
Executive Employment Agreement, effective as of October 18, 2021, by and between the Registrant and Teresa Bair.
10-K
(Exhibit 10.31)
2/24/2022
001-37620
10.25
Loan and Security Agreement dated as of November 2, 2022 by and between the Registrant and Hercules Capital, Inc.
8-K
(Exhibit 10.2)
11/3/2022
001-37620
10.26+
Executive Employment Agreement, effective as of August 14, 2023, by and between the Registrant and Brian Powl.
10-Q
(Exhibit 10.1)
11/2/2023
001-37620
10.27
First Amendment to Lease, dated as of August 30, 2023, by and between the Registrant and East Office Operating Limited Partnership.
10-Q
(Exhibit 10.2)
11/2/2023
001-37620
10.28
First Amendment to Loan and Security Agreement, dated as of October 2, 2023, by and between the Registrant and Hercules Capital, Inc.
10-Q
(Exhibit 10.3)
11/2/2023
001-37620
95
Exhibit
Number
Description
Filed
Herewith
Incorporated by Reference herein
from Form or
Schedule
Filing Date
SEC File/Reg.
Number
10.29
Sales Agreement, dated November 2, 2023, by and among the Registrant, Leerink Partners LLC and Cantor Fitzgerald & Co.
10-Q
(Exhibit 10.4)
11/2/2023
001-37620
10.30+
Kura Oncology, Inc. 2023 Inducement Option Plan and Forms of Stock Option Grant Notice, Option Agreement and Notice of Exercise thereunder.
8-K
(Exhibit 99.1)
12/22/2023
001-37620
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (see signature page).
X
31.1
Certification of Principal Executive and Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1
Certification of Principal Executive and Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1350.
X
97.1
Kura Oncology, Inc. Incentive Compensation Recoupment Policy.
X
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101.INS).
X
+ Indicates management contract or compensatory plan.
* Certain portions of this exhibit (indicated by “[***]”) have been omitted as the Registrant has determined (i) the omitted information is not material and (ii) the omitted information would likely cause harm to the Registrant if publicly disclosed.
** Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
*** Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.
Item 16. For m 10-K Summary.
None.
96
SIGNAT URES
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 Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized .
Kura Oncology, Inc.
Date: February 27, 2024
By:
/s/ Troy E. Wilson, Ph.D., J.D.
Troy E. Wilson, Ph.D., J.D.
President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Troy E. Wilson, Ph.D., J.D. and Thomas Doyle, and each of them, as his or her true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the SEC, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ Troy E. Wilson, Ph.D., J.D.
President, Chief Executive Officer and
Chairman of the Board of Directors
February 27, 2024
Troy E. Wilson, Ph.D., J.D.
(Principal Executive and Financial Officer)
/s/ Thomas Doyle
Senior Vice President, Finance & Accounting
February 27, 2024
Thomas Doyle
(Principal Accounting Officer)
/s/ Helen Collins, M.D.
Director
February 27, 2024
Helen Collins, M.D.
/s/ Faheem Hasnain
Director
February 27, 2024
Faheem Hasnain
/s/ Thomas Malley
Director
February 27, 2024
Thomas Malley
/s/ Diane Parks
Director
February 27, 2024
Diane Parks
/s/ Carol Schafer
Director
February 27, 2024
Carol Schafer
/s/ Mary Szela
Director
February 27, 2024
Mary Szela
97
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Kura Oncology, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Kura Oncology, Inc. (the Company) as of December 31, 2023 and 2022, the related statements of operations and comprehensive loss, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and 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 at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 27, 2024 expressed an unqualified opinion thereon.
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 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 in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. 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.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F- 1
Clinical Trial Research and Development Expenses and Accruals
Description of
the Matter
During 2023, the Company incurred $115.2 million for research and development expenses and as of December 31, 2023, the Company accrued $7.7 million for clinical trial research and development expenses. As described in Note 2 of the financial statements, the Company records accruals for estimated costs of research and development activities that include contract services for clinical trials. Clinical trial activities are accrued and expensed based on estimates of the period in which services and efforts are expended by contract research organizations (“CROs”) and other third parties. Estimates are determined by reviewing cost information provided by CROs and other third-party vendors, contractual arrangements with CROs and the scope of work to be performed.
Auditing management’s accounting for accrued third-party clinical trial research and development expenses is especially challenging as evaluating the progress or stage of completion of the activities under the Company’s research and development agreements is dependent upon a high volume of data from third-party service providers and internal clinical personnel.
How We
Addressed the
Matter in Our
Audit
We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accounting for accrued third-party clinical trial research and development expenses. This included management’s assessment of the assumptions and data underlying the accrued third-party clinical trial research and development expenses estimate.
To test the completeness of the Company’s accrued third-party clinical trial research and development expenses, among other procedures, we obtained supporting evidence of the research and development activities performed for significant clinical trials. We inspected supporting evidence of clinical trial and project status review between internal personnel and third-party service providers to corroborate the status of significant research and development activities. We performed inquiries with clinical project managers to corroborate the status of significant research and development activities. To test the appropriate measurement of accrued research and development costs, we compared the costs for a sample of transactions against the related invoices and contracts, confirmed amounts incurred to-date with third-party service providers, and performed lookback analyses. We also examined a sample of subsequent payments to evaluate the completeness of the accrued third-party clinical trial research and development expenses.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2015.
San Diego, California
February 27, 2024
F- 2
KURA ONCOLOGY, INC.
BALANCE SHEETS
(In thousands, except par value data)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
37,318
$
51,802
Short-term investments
386,639
386,183
Prepaid expenses and other current assets
8,524
8,441
Total current assets
432,481
446,426
Property and equipment, net
1,859
2,540
Operating lease right-of-use assets
6,993
3,842
Other long-term assets
7,602
3,498
Total assets
$
448,935
$
456,306
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable and accrued expenses
$
33,757
$
21,739
Current operating lease liabilities
1,506
2,318
Total current liabilities
35,263
24,057
Long-term debt, net
9,332
9,158
Long-term operating lease liabilities
6,362
2,548
Other long-term liabilities
705
265
Total liabilities
51,662
36,028
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 10,000 shares authorized;
no shares issued and outstanding
—
—
Common stock, $ 0.0001 par value; 200,000 shares authorized;
74,350 and 68,314 shares issued and outstanding as of
December 31, 2023 and 2022, respectively
7
7
Additional paid-in capital
1,119,976
997,111
Accumulated other comprehensive loss
( 1,271
)
( 8,032
)
Accumulated deficit
( 721,439
)
( 568,808
)
Total stockholders’ equity
397,273
420,278
Total liabilities and stockholders’ equity
$
448,935
$
456,306
See accompanying notes to financial statements.
F- 3
KURA ONCOLOGY, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share data)
Years Ended December 31,
2023
2022
2021
Operating Expenses:
Research and development
$
115,235
$
92,812
$
84,721
General and administrative
50,569
47,053
46,537
Total operating expenses
165,804
139,865
131,258
Other Income (Expense):
Interest and other income, net
14,722
4,254
1,206
Interest expense
( 1,549
)
( 229
)
( 414
)
Total other income, net
13,173
4,025
792
Net Loss
$
( 152,631
)
$
( 135,840
)
$
( 130,466
)
Net loss per share, basic and diluted
$
( 2.08
)
$
( 2.03
)
$
( 1.97
)
Weighted average number of shares used in computing
net loss per share, basic and diluted
73,229
66,990
66,352
Comprehensive Loss:
Net loss
$
( 152,631
)
$
( 135,840
)
$
( 130,466
)
Other comprehensive income (loss):
Unrealized gain (loss) on marketable securities
and foreign currency
6,761
( 6,243
)
( 1,835
)
Comprehensive loss
$
( 145,870
)
$
( 142,083
)
$
( 132,301
)
See accompanying notes to financial statements.
F- 4
KURA ONCOLOGY, INC.
STATEMENTS OF STOCKHOLD ERS’ EQUITY
(In thousands)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Comprehensive
Accumulated
Stockholders’
Shares
Par Value
Capital
Income (Loss)
Deficit
Equity
Balance as of December 31, 2020
66,194
$
7
$
913,354
$
46
$
( 302,502
)
$
610,905
Share-based compensation expense
—
—
23,579
—
—
23,579
Issuance of common stock under equity plans
378
—
4,426
—
—
4,426
Other comprehensive loss
—
—
—
( 1,835
)
—
( 1,835
)
Net loss
—
—
—
—
( 130,466
)
( 130,466
)
Balance as of December 31, 2021
66,572
7
941,359
( 1,789
)
( 432,968
)
506,609
Issuance of common stock, net of offering costs
1,370
—
24,721
—
—
24,721
Share-based compensation expense
—
—
26,318
—
—
26,318
Issuance of common stock under equity plans
372
—
4,419
—
—
4,419
Issuance of warrants in connection with debt facility
—
—
294
—
—
294
Other comprehensive loss
—
—
—
( 6,243
)
—
( 6,243
)
Net loss
—
—
—
—
( 135,840
)
( 135,840
)
Balance as of December 31, 2022
68,314
7
997,111
( 8,032
)
( 568,808
)
420,278
Issuance of common stock, net of offering costs
5,661
—
60,919
—
—
60,919
Issuance of pre-funded warrants to purchase common stock, net of offering costs
—
—
32,658
—
—
32,658
Share-based compensation expense
—
—
28,082
—
—
28,082
Issuance of common stock under equity plans
375
—
1,206
—
—
1,206
Other comprehensive income
—
—
—
6,761
—
6,761
Net loss
—
—
—
—
( 152,631
)
( 152,631
)
Balance as of December 31, 2023
74,350
$
7
$
1,119,976
$
( 1,271
)
$
( 721,439
)
$
397,273
See accompanying notes to financial statements.
F- 5
KURA ONCOLOGY, INC.
STATEMENTS OF CASH FLOWS
(In thousands)
Years Ended December 31,
2023
2022
2021
Operating Activities
Net loss
$
( 152,631
)
$
( 135,840
)
$
( 130,466
)
Adjustments to reconcile net loss to net cash used in operating
activities:
Share-based compensation expense
28,082
26,318
23,579
Amortization of premium and accretion of discounts on
marketable securities, net
( 9,420
)
1,610
4,391
Depreciation expense
849
759
558
Non-cash interest expense
477
73
399
Loss from extinguishment of debt
—
—
212
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 1,960
)
( 2,935
)
( 357
)
Operating lease right-of-use and other long-term assets
( 685
)
571
( 329
)
Accounts payable and accrued expenses
10,327
( 802
)
( 2,518
)
Other long-term liabilities
137
184
( 20
)
Net cash used in operating activities
( 124,824
)
( 110,062
)
( 104,551
)
Investing Activities
Maturities of marketable securities
425,549
303,908
319,969
Purchases of marketable securities
( 409,824
)
( 270,655
)
( 445,657
)
Purchases of property and equipment
( 168
)
( 626
)
( 1,147
)
Net cash provided by (used in) investing activities
15,557
32,627
( 126,835
)
Financing Activities
Proceeds from issuances of common stock and pre-funded warrants, net of offering costs
93,577
24,721
—
Proceeds from issuance of stock under equity plans
1,206
4,419
4,426
Proceeds from long-term debt
—
10,000
—
Payment of fees related to issuance of long-term debt
—
( 575
)
—
Repayment of long-term debt
—
—
( 7,250
)
Payment of fees related to extinguishment of debt
—
—
( 611
)
Net cash provided by (used in) financing activities
94,783
38,565
( 3,435
)
Net decrease in cash, cash equivalents
( 14,484
)
( 38,870
)
( 234,821
)
Cash and cash equivalents at beginning of period
51,802
90,672
325,493
Cash and cash equivalents at end of period
$
37,318
$
51,802
$
90,672
Supplemental disclosure of cash flow information:
Interest paid
$
1,064
$
73
$
784
Supplemental non-cash disclosures:
Warrants issued in connection with debt facility
$
—
$
294
$
—
See accompanying notes to financial statements.
F- 6
KURA ONCOLOGY, INC.
Notes to Financial Statements
1. Description of Business
Kura Oncology, Inc. is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline consists of small molecule product candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes, and we intend to pair them with molecular or cellular diagnostics to identify those patients most likely to respond to treatment. We are conducting clinical trials of three product candidates: ziftomenib, tipifarnib and KO-2806. We also have additional programs that are at a discovery stage. We own global commercial rights to all of our programs and product candidates. We plan to advance our product candidates through a combination of internal development and strategic partnerships while maintaining significant development and commercial rights.
References in these Notes to Financial Statements to “Kura Oncology, Inc.,” “we,” “our” or “us,” refer to Kura Oncology, Inc.
2. Summary of Significant Accounting Policies
Reclassifications
The prior period restricted cash balance of approximately $ 0.2 million has been reclassified to other long-term assets in the accompanying financial statements. See Note 8, Commitments and Contingencies, for further details.
Use of Estimates
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States. The preparation of our financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. We operate in a single industry segment which is the discovery and development of precision medicines for the treatment of cancer. Troy E. Wilson, our president and chief executive officer, who serves as the chief operating decision-maker, reviews the operating results on an aggregate basis and manages the operations as a single operating segment in the United States.
Cash and Cash Equivalents
Cash and cash equivalents consist of checking, money market and highly liquid investments that are readily convertible to cash and that have an original maturity of three months or less from date of purchase. The carrying amounts approximate fair value due to the short maturities of these instruments.
F- 7
Short-Term Investments
Short-term investments are marketable securities with maturities greater than three months from date of purchase that are specifically identified to fund current operations. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. The cost of short-term investments is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in interest income. Dividend and interest income is recognized as interest income on the statements of operations and comprehensive loss when earned. Short-term investments are classified as available-for-sale securities and carried at fair value with unrealized gains and non-credit related losses recorded in other comprehensive loss and included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities are determined on a specific identification basis and included in interest and other income, net on the statements of operations and comprehensive loss.
Allowance for Credit Losses
For available-for-sale securities in an unrealized loss position, we first assess whether we intend to sell, or if it is more likely than not that we will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For available-for-sale securities that do not meet the aforementioned criteria, we evaluate whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the severity of the impairment, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest income through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is included in other comprehensive loss on the statements of operations and comprehensive loss.
We elected the practical expedient to exclude the applicable accrued interest from both the fair value and amortized costs basis of our available-for-sale securities for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale securities is recorded in prepaid expenses and other current assets on our balance sheets. Our accounting policy is to not measure an allowance for credit loss for accrued interest receivable and to write-off any uncollectible accrued interest receivable as a reversal of interest income in a timely manner, which we consider to be in the period in which we determine the accrued interest will not be collected by us.
Concentration of Credit Risk
Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments. We maintain deposits in federally insured financial institutions in excess of federally insured limits. We have established guidelines to limit our exposure to credit risk by placing investments with high credit quality financial institutions, diversifying our investment portfolio and placing investments with maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity.
Employee Retention Credit
Under the Coronavirus Aid, Relief, and Economic Security Act of 2020, or CARES Act, we were eligible to claim the employee retention credit, which is a refundable tax credit against certain employment taxes. For the year ended December 31, 2023, we recognized $ 2.8 million of employee retention credits related to wages paid to our employees from July 2020 through September 2021 within operating expenses as a reduction to personnel costs in the statements of operations and comprehensive loss. We filed for the credit with the Internal Revenue Service in the first quarter of 2023. As of December 31, 2023, an employee retention credit receivable of $ 2.8 million was included within prepaid expenses and other current assets on the balance sheets.
F- 8
Fair Value Measurements
Fair value is defined as the 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, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
• Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities;
• Level 2 - Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable;
• Level 3 - Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.
Property and Equipment
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Computer software and equipment are depreciated over their estimated useful lives of three to five years . Laboratory equipment is depreciated over its estimated useful life of five years . Furniture and fixtures are depreciated over their estimated useful lives of five years . Leasehold improvements are depreciated over the lesser of the term of the related lease or the useful life of the asset.
Impairment of Long-Lived Assets
We review our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. For the years ended December 31, 2023, 2022 and 2021 , there were no impairments of the value of long-lived assets.
Leases
We determine if an arrangement is a lease or contains lease components at inception. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. For operating leases with an initial term greater than 12 months, we recognize operating lease right-of-use, or ROU, assets and operating lease liabilities based on the present value of lease payments over the lease term at commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms may include options to extend or terminate when we are reasonably certain that the options will be exercised. We do not separate lease components from non-lease components. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term.
If a lease is modified, the modified contract is evaluated to determine whether it is or contains a lease. If a lease continues to exist, the lease modification is determined to be a separate contract when the modification grants the lessee an additional ROU that is not included in the original lease and the lease payments increase commensurate with the standalone price for the additional ROU. A lease modification that results in a separate contract will be accounted for in the same manner as a new lease. For a modification that is not a separate contract, we reassess the lease classification using the modified terms and conditions and the facts and circumstances as of the effective date of the modification and recognize the amount of the remeasurement of the lease liability for the modified lease as an adjustment to the corresponding operating lease ROU asset.
F- 9
Research and Development Expenses
Research and development expenses consist of costs associated with our research and development activities including salaries, benefits, share-based compensation and other personnel costs, clinical trial costs, manufacturing costs for non-commercial products, fees paid to external service providers and consultants, facilities costs and supplies, equipment and materials used in clinical and preclinical studies and research and development. All such costs are charged to research and development expense as incurred when these expenditures have no alternative future uses. We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed or such time when we do not expect the goods to be delivered or services to be performed. Payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses in other research and development projects or otherwise, and therefore have no separate economic value, are expensed as research and development costs at the time such costs are incurred. As of December 31, 2023 , we had no in-licensed technologies that have alternative future uses in research and development projects or otherwise.
Clinical Trial Costs and Accruals
A significant portion of our clinical trial costs relate to contracts with contract research organizations, or CROs. The financial terms of our CRO contracts may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our financial statements by matching those expenses with the period in which services and efforts are expended. As part of the process of preparing our financial statements, we rely on cost information provided by our CROs concerning monthly expenses as well as reimbursement for pass through costs. We are also required to estimate certain of our expenses resulting from our obligations under our CRO contracts. Accordingly, our clinical trial expense accrual is dependent upon the timely and accurate reporting of CROs and other third-party vendors. If the contracted amounts are modified, for instance, as a result of changes in the clinical trial protocol or scope of work to be performed, we modify our accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Historically, we have had no material changes in clinical trial expense that had a material impact on our results of operations or financial position.
Patent Costs
We expense all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in general and administrative expenses on the statements of operations and comprehensive loss.
Share-Based Compensation
Our share-based awards are measured at fair value on the date of grant based upon the estimated fair value of common stock. The fair value of awards expected to vest are recognized and amortized on a straight-line basis over the requisite service period of the award less actual forfeitures. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option pricing model, or Black-Scholes model, that requires the use of assumptions including volatility, expected term, risk-free rate and the fair value of the underlying common stock. We estimate the fair value of restricted stock units and performance-based restricted stock units granted based on the closing market price of our common stock on the date of grant. Actual forfeitures are applied as they occur, and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited.
Income Taxes
Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet “a more likely than not” threshold, we recognize the benefit of uncertain tax positions in the financial statements.
F- 10
Comprehensive Loss
Comprehensive loss is defined as the change in equity during the period from transactions and other events and non-owner sources. For the periods presented, accumulated other comprehensive loss consisted of unrealized gains and losses on marketable securities and foreign currency.
Net Loss per Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, which includes the shares related to outstanding pre-funded warrants (see Note 9), but excludes other potential common stock equivalents. Pre-funded warrants are considered outstanding for the purposes of computing basic and diluted net loss per share because shares may be issued for little or no additional consideration, and are fully vested and exercisable. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common shares and common stock equivalents outstanding for the period. As we have reported net loss for the years ended December 31, 2023, 2022 and 2021, dilutive net loss per common share is the same as basic net loss per common share for those periods. Common stock equivalents outstanding are comprised of stock options, restricted stock units, performance-based restricted stock units, warrants and employee stock purchase plan rights and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. Common stock equivalents outstanding as of December 31, 2023, 2022 and 2021 totaling approximately 12,642,000 , 9,266,000 and 7,156,000 , respectively, were excluded from the computation of dilutive weighted-average shares outstanding because their effect would be anti-dilutive.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that we adopt as of the specified effective date. We have evaluated recently issued accounting pronouncements and, based on our preliminary assessment, we do not believe any will have a material impact on our financial statements or related footnote disclosures.
3. Investments
We invest in available-for-sale securities consisting of U.S. Treasury securities, corporate debt securities, non-U.S. government and supranational debt securities, money market funds, U.S. Agency bonds and commercial paper. Available-for-sale securities are classified as either cash and cash equivalents or short-term investments on the balance sheets.
The following tables summarize, by major security type, our short-term investments that are measured at fair value on a recurring basis, in thousands:
December 31, 2023
Maturities
(years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated Fair Value
Cash equivalents:
Money market funds
1 or less
$
13,590
$
—
$
—
$
13,590
Short-term investments:
U.S. Treasury securities
2 or less
300,388
395
( 569
)
300,214
Corporate debt securities
2 or less
64,591
4
( 825
)
63,770
Non-U.S. government debt securities
1 or less
15,000
—
( 273
)
14,727
U.S. Agency bonds
1 or less
7,931
—
( 3
)
7,928
Total short-term investments
387,910
399
( 1,670
)
386,639
Total
$
401,500
$
399
$
( 1,670
)
$
400,229
F- 11
December 31, 2022
Maturities
(years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated Fair Value
Cash equivalents:
Money market funds
1 or less
$
37,878
$
—
$
—
$
37,878
U.S. Agency bonds
1 or less
9,956
—
—
9,956
Total cash equivalents
47,834
—
—
47,834
Short-term investments:
U.S. Treasury securities
2 or less
183,051
16
( 3,018
)
180,049
Corporate debt securities
2 or less
115,763
—
( 3,931
)
111,832
Commercial paper
1 or less
52,941
—
—
52,941
Non-U.S. government and supranational debt securities
2 or less
26,268
—
( 950
)
25,318
U.S. Agency bonds
1 or less
16,192
11
( 160
)
16,043
Total short-term investments
394,215
27
( 8,059
)
386,183
Total
$
442,049
$
27
$
( 8,059
)
$
434,017
Short-term investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund our operations, as necessary. As of December 31, 2023 and 2022, short-term investm ents of $ 336.6 million and $ 274.3 million, respectively, had maturities less than one year, and short-term investments of $ 50.0 million and $ 111.9 million, respectively, had maturities between one to two years. Realized gains and losses were de minimis for the years ended December 31, 2023, 2022 and 2021.
As of December 31, 2023 and 2022 , 16 available-for-sale securities with a fair market value o f $ 155.2 million and 34 available-for-sale securities with a fair market value of $ 290.0 million, respectively, were in gross unrealized loss positions, $ 105.0 million and $ 172.4 million of which were in a continuous unrealized loss position for greater than 12 months, respectively. We do not intend to sell these available-for-sale securities, and it is not more likely than not that we will be required to sell these securities prior to recovery of their amortized cost basis. Based on our review of these available-for-sale securities, the unrealized losses as of December 31, 2023 were primarily due to changes in interest rates and not due to increased credit risks associated with specific securities . We have no allowance for credit losses as of December 31, 2023 and 2022. Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive loss.
Accrued interest receivable on available-for-sale securities were $ 1.1 million and $ 0.9 million as of December 31, 2023 and 2022, respectively. We have not written off any accrued interest receivables for the years ended December 31, 2023, 2022 and 2021 .
4. Fair Value Measurements
As of December 31, 2023 and 2022, we had cash equivalents and short-term investments measured at fair value on a recurring basis.
Available-for-sale securities consist of U.S. Treasury securities, which are measured at fair value using Level 1 inputs, and corporate debt securities, non-U.S. government and supranational debt securities, U.S. Agency bonds and commercial paper which are measured at fair value using Level 2 inputs. We determine the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. We validate the fair values of Level 2 financial instruments by comparing these fair values to a third-party pricing source.
F- 12
The following tables summarize, by major security type, our cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy, in thousands:
December 31, 2023
Total
Level 1
Level 2
Cash equivalents:
Money market funds
$
13,590
$
13,590
$
—
Short-term investments:
U.S. Treasury securities
300,214
300,214
—
Corporate debt securities
63,770
—
63,770
Non-U.S. government debt securities
14,727
—
14,727
U.S. Agency bonds
7,928
—
7,928
Total short-term investments
386,639
300,214
86,425
Total
$
400,229
$
313,804
$
86,425
December 31, 2022
Total
Level 1
Level 2
Cash equivalents:
Money market funds
$
37,878
$
37,878
$
—
U.S. Agency bonds
9,956
—
9,956
Total cash equivalents
47,834
37,878
9,956
Short-term investments:
U.S. Treasury securities
180,049
180,049
—
Corporate debt securities
111,832
—
111,832
Commercial paper
52,941
—
52,941
Non-U.S. government and supranational debt securities
25,318
—
25,318
U.S. Agency bonds
16,043
—
16,043
Total short-term investments
386,183
180,049
206,134
Total
$
434,017
$
217,927
$
216,090
We believe that our term loan facility bears interest at a rate that approximates prevailing market rates for instruments with similar characteristics and, accordingly, the carrying value of the term loan facility approximates fair value. The fair value of our term loan facility is determined using Level 2 inputs in the fair value hierarchy. See Note 6, Long-Term Debt, for further discussion of our term loan facility.
5. Balance Sheet Detail
Property and equipment consisted of the following, in thousands:
December 31,
2023
2022
Laboratory and computer equipment
$
1,657
$
1,568
Leasehold improvements
1,543
1,543
Furniture and fixtures
1,111
1,032
Property and equipment, gross
4,311
4,143
Less: accumulated depreciation
( 2,452
)
( 1,603
)
Property and equipment, net
$
1,859
$
2,540
Depreciation expense was $ 0.8 million , $ 0.8 million and $ 0.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
F- 13
Accounts payable and accrued expenses consisted of the following, in thousands:
December 31,
2023
2022
Accounts payable
$
2,300
$
1,533
Accrued clinical trial research and development expenses
7,737
2,440
Accrued other research and development expenses
9,265
5,030
Accrued compensation and benefits
13,153
10,300
Other accrued expenses
1,302
2,436
Total accounts payable and accrued expenses
$
33,757
$
21,739
6. Lo ng-Term Debt
On November 2, 2022, we entered into a loan and security agreement, or Loan Agreement, with several banks and other financial institutions or entities party thereto, or collectively Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as adminis trative agent and collateral agent for itself and the Lenders, or in such capacity, Agent. Under the terms of the Loan Agreement, we borrowed $ 10.0 million of an initial $ 25.0 million tranche of term loans, or the Tranche 1 Loan. On September 15, 2023 , the draw period for the remaining $ 15.0 million of the Tranche 1 Loan expired without us drawing down the additional loan. We have achieved the Tranche 2 Milestone (as defined in the Loan Agreement) and may borrow up to $ 35.0 million at any time until March 15, 2024 . Thereafter, we may borrow (i) an additional tranche of Term Loans in the amount of up to $ 40.0 million which will become available to us upon our satisfaction of certain terms and conditions set forth in the Loan Agreement, and (ii) a final tranche of term loans in the amount of up to $ 25.0 million, subject to the Lenders’ investment committee approval in its sole discretion. All of the Term Loans have a maturity date of November 2, 2027 , or the Maturity Date. Repayment of the Term Loans is interest only through (a) May 1, 2025 , with the satisfaction of the Interest Only Milestone 1 Conditions (as defined in the Loan Agreement), (b) if we satisfy the Interest Only Milestone 2 Conditions (as defined in the Loan Agreement), November 1, 2025 , and (c) if we satisfy the Approval Milestone (as defined in the Loan Agreement), November 1, 2026 . After the interest-only payment period, borrowings under the Loan Agreement are repayable in equal monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of December 31, 2023, the interest rate on the Term Loans w as 10.90 %.
At our option, we may prepay all or any portion of the outstanding Term Loans at any time. Prepayments made on or prior to the third anniversary of the date of the Loan Agreement will be subject to a prepayment fee equal to 1.50 % of the principal amount being prepaid. In addition, we paid a facility charge of approximately $ 0.1 million upon closing and an additional approximately $ 0.2 million of facility charges in November 2023 due to the availability of the Tranche 2 Loan. Additional facility charges will be incurred upon the availability of the Tranche 3 Loan or Tranche 4 Loan, in each case in the amount of 0.50 % of the amount of such tranche of loans. The Loan Agreement also provides for an end of term fee in an amount equal to the greater of approximately (i) $ 1.5 million (which is 6.05 % of the maximum amount of the first tranche of loans) or (ii) 6.05 % of the aggregate principal amount of loan advances actually made under the Loan Agreement, which fee is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.
The Loan Agreement also contains a minimum cash covenant, commencing on June 1, 2024, requiring us to hold cash in the United States and subject to a first-priority perfected security interest in favor of the Lenders in an amount greater than or equal to (x) 55.0% of the outstanding loan obligations if we have not received FDA approval for ziftomenib, or (y) 35.0% of the outstanding loan obligations if we have received FDA approval for ziftomenib, provided that neither (x) nor (y) will apply at any time our market capitalization is equal to or greater than $ 1,250.0 million. Additionally, the Loan Agreement contains minimum cash requirements in the event of (i) any Corporate Collaborations (as defined in the Loan Agreement) or (ii) any cash payment in respect of permitted convertible debt subject to the satisfaction of the Redemption Conditions (as defined in the Loan Agreement).
F- 14
In addition, the Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. The Loan Agreement also contains events of default that are customary for financings of this type relating to, among other things, payment defaults, breach of covenants, material adverse effects, breach of representations and warranties, cross-default to material indebtedness, bankruptcy-related defaults, judgment defaults, breach of the financial covenants described above, and the occurrence of certain change of control events. Following an event of default and any applicable cure period, a default interest rate equal to the then-applicable interest rate plus 5.0 % may be applied to the outstanding principal balance, and the Lenders will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Loan Agreement, in addition to other remedies available to them as our secured c reditors. We were in compliance with all covenants of the Loan Agreement as of December 31, 2023.
In addition, in connection with the entry into the Loan Agreement, we issued warrants to certain of the Lenders, or collectively, the Warrants, to purchase up to 26,078 shares of our common stock at an exercise price of $ 14.38 per share, or the Warrant Shares. The Warrants may be exercised through the earlier of (i) the seventh anniversary of November 2, 2022 and (ii) the consummation of certain acquisition transactions involving us, as set forth in the Warrants. The number of Warrant Shares for which the Warrants are exercisable and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants. If we make additional draws on the Tranche 2 Loan, Tranche 3 Loan or Tranche 4 Loan, upon the funding of such additional tranches, the Warrants shall become exercisable for an additional aggregate number of shares of our common stock equal to 1.50 % of each drawn amount divided by the exercise price of $ 14.38 per share.
The initial tranche 1 borrowing of $ 10.0 million and the warrants issued upon closing to purchase 26,078 shares of our common stock are accounted for as freestanding debt and equity financial instruments, respectively, as they are legally detachable and separately exercisable. The additional borrowings available under the Tranche 1 Loan, Tranche 2 Loan, Tranche 3 Loan and Tranche 4 Loan plus the additional warrants to purchase shares of our common stock, which would be issued concurrently, are accounted for as a single freestanding financial instrument that are not assets or obligations of ours; this financial instrument meets the loan commitment derivative scope exception and will be accounted for when and if we borrow additional tranches in the future.
In connection with the Loan Agreement, we recognized the initial 26,078 issued warrants at their relative fair value of approximately $ 0.3 million, and we incurred debt issuance costs of $ 0.6 million, which were recorded as debt discounts. The fair value of the warrants, debt issuance costs and end of term fee are being amortized and accreted into interest expense using the effective interest rate method over the term of the loan.
The following table summarizes maturities of principal obligation payments under the term loan facility as of December 31, 2023, in thousands:
Years Ending December 31,
2025
$
2,307
2026
3,798
2027
3,895
Total principal outstanding
10,000
Less: unamortized discounts
( 668
)
Long-term debt, net
$
9,332
In November 2018, we entered into a loan and security agreement with Silicon Valley Bank, or the SVB Loan Agreement, providing for up to $ 20.0 million in a series of term loans. Upon entering into the SVB Loan Agreement, we borrowed $ 7.5 million, or the SVB Term Loan. The SVB Term Loan had a scheduled maturity date of May 1, 2023 . In May 2021, we paid $ 6.6 million to repay all amounts owed under the SVB Term Loan, which included a final payment of $ 0.6 million, representing 7.75 % of the SVB Term Loan which was being accrued through interest expense using the effective interest method, and a prepayment fee of $ 30,000 . In accordance with ASC 470-50, Debt Modifications and Extinguishments, we accounted for the transaction as an extinguishment of debt. Accordingly, we recorded a loss of approximately $ 0.2 million, which is included in interest expense on the statements of operations and comprehensive loss for the year ended December 31, 2021.
F- 15
7. License Agreements
The University of Michigan License Agreement
In December 2014 , we entered into a license agreement with the Regents of the University of Michigan, or the University of Michigan, which was amended in March 2015, July 2015, September 2016, February 2017, May 2017 and August 2017, under which we received certain license rights for a non-refundable upfront license, annual maintenance fees and payments upon achievement of certain development and sales-based milestones. The licensed asset consists of several compounds, including our development candidate ziftomenib. All future development, regulatory and commercial work on the asset will be completed fully and at our sole expense. The University of Michigan retains the right to use the asset for non-commercial research, internal and/or educational purposes, with the right to grant the same limited rights to other non-profit research institutions.
The agreement will terminate upon the last-to-expire patent rights, or may be terminated by us at any time with 90 days written notice of termination or terminated by the University of Michigan upon a bankruptcy by us, payment failure by us that is not cured within 30 days or a material breach of the agreement by us that is not cured within 60 days .
Janssen License Agreement
In December 2014 , we entered into a license agreement with Janssen which was amended in June 2016, under which we received certain intellectual property rights related to tipifarnib in all indications other than virology for a non-refundable $ 1.0 million upfront license fee and payments upon achievement of certain development and sales-based milestones. Tipifarnib is a clinical-stage compound and all ongoing development, regulatory and commercial work will be completed fully and at our sole expense.
The agreement will terminate upon the last-to-expire patent rights or last-to-expire royalty term, or may be terminated by us with 180 days written notice of termination. Either party may terminate the agreement in the event of material breach of the agreement that is not cured within 45 days. Janssen may also terminate the agreement due to our lack of diligence that is not cured within a three-month period.
Future Milestone Payments under License Agreements
Collectively, all of our license agreements provide for specified development, regulatory and sales-based milestone payments up to a total of $ 80.2 million payable upon occurrence of each stated event, of which $ 0.5 million relates to the initiation of certain development activities, $ 28.9 million relates to the achievement of specified regulatory approvals for the first indication and up to $ 50.8 million relates to the achievement of specified levels of product sales. Additional payments will be due for each subsequent indication if specified regulatory approvals are achieved. As of December 31, 2023, we have paid milestone payments tot aling $ 0.3 million u nder the above-mentioned license agreements. Furthermore, if all the programs are successfully commercialized, we will be required to pay tiered royalties on annual net product sales ranging from the low single digits to the low teens, depending on the volume of sales and the respective agreement.
8. Commitments and Contingencies
Operating Leases
We currently have three operating leases for administrative and research and development office and lab space in San Diego, California and Boston, Massachusetts that expire between July 2024 and July 2031 . Under the terms of the operating leases, we are required to pay our proportionate share of property taxes, insurance and normal maintenance costs. Two of our leases include renewal options for an additional five years , which were not included in the determination of the ROU asset or lease liability as the renewal was not reasonably certain at the inception of the lease. Our San Diego corporate headquarters lease and our San Diego lease for lab and office space provided for $ 1.0 million and $ 0.1 million, respectively, in reimbursements for allowable tenant improvements, which effectively reduced the total lease payments owed.
F- 16
On August 30, 2023, we entered into an amendment to the lease agreement for office space in Boston, Massachusetts, or the Amendment, pursuant to which the term of the lease was extended by seven years , or the Extended Term, such that the lease will now expire in July 2031. The minimum rent payable during the Extended Term is approximately $ 0.1 million per month for the first year, which amount will increase by 2 % per year over the Extended Term. The Amendment provides (i) a rent credit in the amount of approximately $ 0.5 million to be applied as a credit against the rent payments due for the months of August 2023 through July 2024, inclusive, and (ii) a tenant improvement allowance in an amount not to exceed approximately $ 0.8 million, in each case subject to certain conditions. We elected to apply the tenant improvement allowance as a credit against the rent payments due for the months of August 2024 through March 2025, inclusive. Prior to the Amendment, we were required to maintain a standby letter of credit of approximately $ 0.2 million during the term of the lease. Under the terms of the Amendment, we are required to maintain a cash deposit of approximately $ 0.2 million during the term of the lease which was included within other long-term assets in the balance sheet.
Maturities of our lease liabilities as of December 31, 2023 are as follows, in thousands:
Year Ending December 31,
2024
$
1,545
2025
1,964
2026
1,344
2027
1,371
2028
1,398
Thereafter
3,740
Total lease payments
11,362
Less: imputed interest
( 3,494
)
Total operating lease liabilities
$
7,868
As of December 31, 2023 and 2022 , the weighted-average discount rate was 10.4 % and 5.5 %, respectively, and the weighted-average remaining lease term was 6.2 years and 2.3 years, respectively.
Total cash paid for amounts included in the measurement of operating lease liabilities, net of tenant improvement reimbursements, was $ 2.1 million, $ 2.3 million and $ 2.1 million for the years ended December 31, 2023, 2022 and 2021 , respectively. Operating lease ROU assets obtained in exchange for operating lease liabilities were $ 4.7 million, zero and $ 1.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Total operating lease expense and rent expense were approximately $ 2.0 million for all the years ended December 31, 2023, 2022 and 2021.
Litigation
From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our results of operations or financial position.
F- 17
9. Stockholders’ Equity
In June 2023, we completed a public offering in which we sold an aggregate of 5,660,871 shares of our common stock at a price of $ 11.50 per share and pre-funded warrants to purchase 3,034,782 shares of our common stock at a price of $ 11.4999 per pre-funded warrant. The exercise price of each pre-funded warrant is $ 0.0001 per share and the pre-funded warrants are exercisable from the date of issuance until fully exercised. Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $ 93.6 million.
In February 2022, we entered into a Sales Agreement with SVB Securities LLC, Credit Suisse Securities (USA) LLC and Cantor Fitzgerald & Co., or the 2022 Sales Agreement, under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 150.0 million. We did not sell any shares of our common stock under the 2022 Sales Agreement.
On November 2, 2023, we terminated the 2022 Sales Agreement and we entered into a new Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $ 150.0 million. We have not sold any shares of our common stock under the ATM Facility.
In November 2022, we entered into a securities purchase agreement with Bristol-Myers Squibb Company, or BMS, pursuant to which BMS purchased an aggregate of 1,370,171 shares of our common stock at a purchase price of approximately $ 18.25 per share, for gross proceeds of approximately $ 25.0 million.
In November 2022, in connection with the Loan Agreement, we issued warrants to certain of the Lenders to purchase up to 26,078 shares of our common stock at an exercise price of $ 14.38 per share, which are outstanding as of December 31, 2023.
In connection with the loan and security agreement with Oxford Finance LLC and Silicon Valley Bank in 2016, we issued a warrant to Oxford Finance LLC to purchase up to 33,988 shares of our common stock at an exercise price of $ 3.31 per share, which remains outstanding as of December 31, 2023.
10. Share-Based Compensation
Equity Incentive Plan
In March 2015, our board of directors adopted our Amended and Restated 2014 Equity Incentive Plan, which was most recently amended in May 2023, or 2014 Plan, to, among other things, increase the shares available for future grant by 4,050,000 shares and remove the automatic annual 4 % increase to shares available for future grant. The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation to our employees, consultants and members of our board of directors. We issue shares of common stock upon the exercise of options and vesting of restricted stock unit awards and performance-based restricted stock unit awards with the source of those shares of common stock being newly issued shares. As of December 31, 2023, 24,327,686 shares of common stock had been reserved for issuance and 3,713,092 shares of common stock were available for grant under the 2014 Plan.
Inducement Option Plan
On December 18, 2023, our board of directors adopted the 2023 Inducement Option Plan, or Inducement Plan, to reserve 600,000 shares of our common stock to be used exclusively for grants of nonstatutory stock options to individuals that were not previously our employees or directors (or following a bona fide period of non-employment), as an inducement material to the individual’s entry into employment with us, pursuant to Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the Inducement Plan are substantially similar to our 2014 Plan. As of December 31, 2023, there were 600,000 shares available to be issued from the Inducement Plan.
F- 18
Employee Stock Purchase Plan
In March 2015, our board of directors adopted the 2015 Employee Stock Purchase Plan, or ESPP. The ESPP permits eligible employees to purchase our common stock at a discount through payroll deductions during defined six-month offering periods. Eligibl e employees may elect to withhold up to 15 % of their base earnings to purchase shares of our common stock at a price equal to 85 % of the fair market value on the first day of the offering period or the purchase date, whichever is lower. The number of shares of our common stock reserved for issuance under the ESPP will automatically increase on January 1 of each calendar year through January 1, 2025 by the lesser of 1 % of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year and 2,000,000 shares of common stock, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. In December 2023, the compensation committee of our board of directors elected not to automatically increase the number of shares of our common stock reserved for issuance under the ESPP in 202 4. As of December 31, 2023, we have issued 250,573 s hares of common stock, and 653,852 s hares of common stock are reserved for future issuance under the ESPP. Share-based compensation expense related to the ESPP for the years ended December 31, 2023, 2022 and 2021 was $ 0.3 million in each year.
Stock Options, Restricted Stock Unit Awards and Performance-Based Restricted Stock Unit Awards
Stock Options
The exercise price of all stock options granted was equal to the fair market value of such stock on the date of grant. Stock options generally vest over a four-year period. The maximum contractual term for all stock options is ten years . The following is a summary of stock option activity for the year ended December 31, 2023, in thousands (except per share and years data):
Number of
Options
Weighted Average
Exercise Price
per Share
Weighted Average
Remaining
Contractual
Term (years)
Aggregate
Intrinsic
Value
Outstanding as of December 31, 2022
8,425
$
18.12
Granted
2,857
$
11.74
Exercised
( 83
)
$
6.40
Canceled
( 902
)
$
18.01
Outstanding as of December 31, 2023
10,297
$
16.46
7.3
$
12,883
Vested and expected to vest as of December 31, 2023
10,297
$
16.46
7.3
$
12,883
Exercisable as of December 31, 2023
5,962
$
17.76
6.3
$
6,000
The aggregate intrinsic value in the above table is calculated as the difference between the closing price of our common stock as of December 31, 2023 of $ 14.38 per share and the exercise price of stock options that had strike prices below the closing price.
The following summarizes certain information regarding stock options, in thousands (except per share data):
Years Ended December 31,
2023
2022
2021
Cash received from options exercised
$
534
$
3,756
$
3,809
Intrinsic value of options exercised
$
280
$
701
$
3,475
Weighted-average grant date fair value per share
$
6.99
$
8.90
$
17.84
As of December 31, 2023 , unrecognized estimated compensation expense related to stock options was $ 37.1 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately 2.4 years.
F- 19
Restricted Stock Unit Awards
Restricted stock unit awards, or RSUs, are share awards that, upon vesting, will deliver to the holder shares of our common stock. We began issuing RSUs in 2021. The RSUs generally vest annually over four years .
The following is a summary of RSU activity for the year ended December 31, 2023, in thousands (except per share and years data):
Number of
RSUs
Weighted Average
Grant Date
Fair Value
per Share
Weighted Average
Remaining
Vesting Period (years)
Aggregate
Intrinsic
Value
Outstanding as of December 31, 2022
768
$
16.20
Granted
528
$
11.97
Released
( 218
)
$
16.59
Canceled
( 122
)
$
14.25
Outstanding as of December 31, 2023
956
$
14.03
1.2
$
13,748
Expected to vest as of December 31, 2023
956
$
14.03
1.2
$
13,748
As of December 31, 2023, unrecognized estimated compensation expense related to RSUs was $ 9.1 million, which is expected to be recognized over the weighted-average remaining requisite service period of approximately 2.2 years.
Performance-Based Restricted Stock Unit Awards
On May 31, 2023, upon approval by our stockholders of our amended 2014 Plan, we granted an aggregate of 1,313,100 performance-based restricted stock units, or PSUs, to certain executives. The PSUs vest in six equal tranches upon the achievement of certain milestones and service conditions.
As of December 31, 2023, we determined that the vesting of the PSUs was not probable and therefore have not included them in share-based compensation expense or unrecognized estimated compensation expense.
Share-Based Compensation Expense
Total share-based compensation expense included on the statements of operations and comprehensive loss was comprised of the following, in thousands:
Years Ended December 31,
2023
2022
2021
Research and development
$
12,660
$
10,373
$
7,454
General and administrative
15,422
15,945
16,125
Total share-based compensation expense
$
28,082
$
26,318
$
23,579
We estimated the fair value of stock options and ESPP stock purchase rights using the Black-Scholes model based on the date of grant with the following assumptions:
Options
ESPP
Years Ended December 31,
Years Ended December 31,
2023
2022
2021
2023
2022
2021
Expected term (in years)
5.48 — 6.05
5.45 — 6.57
5.50 — 6.08
0.50
0.50
0.50
Expected volatility
59.9 % — 66.9 %
67.1 % — 71.9 %
72.0 % — 74.6 %
51.0 % — 52.7 %
61.0 % — 75.8 %
44.8 % — 61.8 %
Risk-free interest rate
3.5 % — 4.7 %
1.6 % — 4.2 %
0.6 % — 1.3 %
5.4
%
1.6 %— 4.6 %
0.0 %— 0.1 %
Expected dividend yield
—
—
—
—
—
—
F- 20
Expected term. The expected term of stock options represents the period that the stock options are expected to remain outstanding. Beginning in 2022, we determined our expected term assumption using our own historical exercise experience. In prior years, due to our limited historical exercise behavior, we determined the expected term assumption using the simplified method. The expected term of the ESPP stock purchase rights is six months, which represents the length of each purchase period.
Expected volatility. Beginning in 2022, expected volatility for stock options was calculated based on our historical volatility. In prior years, due to our limited trading history, expected volatility was based, in part, on our historical volatility and the historical volatility of comparable publicly-traded companies. Expected volatility for the ESPP stock purchase rights is based on our historical volatility.
Risk-free interest rate. The risk-free interest rates are based on the U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.
Expected dividend yield. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future.
11. Related Party Transactions
Our president and chief executive officer is also the sole managing member and a significant stockholder of Araxes Pharma LLC, or Araxes. We have a management services agreement with Araxes pursuant to which Araxes pays us monthly fees for management services calculated based on costs incurred by us in the provision of services to Araxes, plus a reasonable mark-up. For the years ended December 31, 2023, 2022 and 2021, we recorded management fee income of approximate ly $ 0.1 million each year, which is included in interest and other income, net on the statements of operations and comprehensive loss. In addition, the agreement allows for Araxes to reimburse us an amount equal to the number of full-time equivalents performing research and development services for Araxes, plus actual expenses as reasonably incurred. For the years ended December 31, 2023 , 2022 and 2021, we did no t record any reimbursements for research and development expenses provided to Araxes.
12. Employee Benefit Plan
We have a defined contribution 401(k) plan for all employees. Under the terms of the plan, employees may make voluntary contributions as a percentage or defined amount of compensation. We provided a safe harbor contribution of 4.0 % of the employee’s compensation, not to exceed eligible limits. For the years ended December 31, 2023, 2022 and 2021, we incurred approximately $ 1.5 million, $ 1.2 million and $ 1.0 million, respectively, in expenses related to the safe harbor contribution.
13. Income Taxes
For the years ended December 31, 2023, 2022 and 2021 , we did no t record a provision for income taxes due to a full valuation against our deferred taxes.
Our effective income tax rate differs from the statutory federal rate of 21 % for the years ended December 31, 2023, 2022 and 2021, due to the following, in thousands:
Years Ended December 31,
2023
2022
2021
Income taxes at statutory federal rate
$
( 32,053
)
$
( 28,526
)
$
( 27,398
)
State income tax, net of federal benefit
( 11,027
)
( 9,721
)
( 9,758
)
Research and development tax credits
( 10,551
)
( 6,970
)
( 5,850
)
Share-based compensation
4,125
3,998
2,819
Other
( 332
)
( 69
)
( 496
)
Valuation allowance
49,838
41,288
40,683
Income tax expense
$
—
$
—
$
—
F- 21
Significant components of our deferred tax assets and liabilities are shown below, in thousands:
December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$
144,451
$
125,986
Research and development tax credit carryforwards
31,816
20,876
Section 174 capitalization
33,947
16,684
Share-based compensation
8,946
6,599
Accruals
3,396
2,713
Operating lease liabilities
2,311
1,430
Other
1,139
1,018
Other comprehensive income
373
2,360
Total deferred tax assets
226,379
177,666
Deferred tax liabilities
( 2,198
)
( 1,338
)
Less: valuation allowance
( 224,181
)
( 176,328
)
Net deferred tax assets
$
—
$
—
As of December 31, 2023 , we had federal net operating loss, or NOL, carryforwards of $ 457.3 million, of which $ 381.8 million can be carried forward indefinitely. The remaining federal net operating loss carryforwards of $ 75.5 million will begin to expire in 2034 , unless previously utilized. As of December 31, 2023, we had state loss carryforwards of $ 703.4 million, which will begin to expire in 2030 , unless previously utilized. We also have federal and state research and development credit carryforwards of $ 35.1 million and $ 7.7 million, respectively, as of December 31, 2023 . The federal research and development credits will begin to expire in 2034 , unless previously utilized. Of the state research and development credits, $ 3.7 million will carryforward indefinitely and approximately $ 4.0 million will begin to expire in 2031 , unless previously utilized.
We file tax returns as prescribed by the tax laws of the jurisdictions in which we operate. Our tax years since inception are subject to examination by the federal and state jurisdictions due to the carryforward of unutilized net operating losses and research and development credits. We have not been, nor are we currently, under examination by the federal or any state tax authority.
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use existing deferred tax assets. Based on the weight of the evidence, including our limited existence and losses since inception, management has determined that it is more likely than not that the deferred tax assets will not be realized and therefore has recorded a full valuation allowance against the deferred taxes. The valuation allowance increased by $ 47.9 million from December 31, 2023.
Pursuant to Sections 382 and 383 of the Internal Revenue Code, or IRC, annual use of our NOL or research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. We previously completed a study to assess whether an ownership change, as defined by IRC Section 382, had occurred from our formation through March 31, 2016. Based upon this study, we determined that an ownership change occurred but concluded the annual utilization limitation would be sufficient to utilize our pre-ownership change NOLs and research and development credits prior to expiration. We completed additional studies and concluded no further ownership changes occurred through December 31, 2021. We plan to complete a 382 study for 2023, however, we do not expect any material limitations to the utilization of NOL’s or research and development credits. Future ownership changes may limit our ability to utilize remaining tax attributes. Any carryforwards that will expire prior to utilization as a result of such additional limitations will be removed from deferred tax assets, with a corresponding reduction of the valuation allowance.
In accordance with authoritative guidance, the impact of an uncertain income tax position is recognized at the largest amount that is “more likely than not” to be sustained upon audit by the relevant taxing authority. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained.
F- 22
The following table summarizes the activity related to our unrecognized tax benefits, in thousands:
December 31,
2023
2022
2021
Gross unrecognized tax benefits at the beginning of the year
$
6,485
$
4,402
$
2,978
Increases related to prior year tax positions
82
67
—
Increases from tax positions taken in the current year
3,547
2,016
1,424
Gross unrecognized tax benefits at the end of the year
$
10,114
$
6,485
$
4,402
Our practice is to recognize interest and penalties related to income tax matters in income tax expense. There was no accrued interest or penalties included on the balance sheets as of December 31, 2023 and 2022, and we have not recognized interest and penalties on the statements of operations and comprehensive loss for the years ended December 31, 2023, 2022 or 2021.
We do not expect that there will be a significant change in the unrecognized tax benefits over the next 12 months. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate.
14. Subsequent Events
On January 26, 2024 , we completed a private placement in which we sold to certain institutional accredited investors an aggregate of 1,376,813 shares of our common stock at a purchase price of $ 17.25 per share and pre-funded warrants to purchase up to an aggregate of 7,318,886 shares of common stock at a purchase price of $ 17.2499 per pre-funded warrant (representing the $ 17.25 per share purchase price less the exercise price of $ 0.0001 per warrant share), or the Private Placement. We received aggregate gross proceeds from the Private Placement of approximately $ 150.0 million, before deducting estimated offering expenses.
F- 23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.