10-Q 1 kzr-20240630.htm 10-Q 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2024

OR

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

For the transition period from ______________ to ______________

Commission File Number: 001-38542

 

Kezar Life Sciences, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-3366145

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

4000 Shoreline Court, Suite 300

South San Francisco, CA, 94080

(650) 822-5600

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading symbol

Name of each exchange on which registered

Common Stock, $0.001 par value

KZR

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of August 9, 2024, the registrant had 72,962,220 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations

2

Condensed Consolidated Statements of Comprehensive Loss

3

 

Condensed Consolidated Statement of Stockholders’ Equity

4

Condensed Consolidated Statements of Cash Flows

5

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

19

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

27

Item 4.

Controls and Procedures

27

PART II.

OTHER INFORMATION

Item 1.

Legal Proceedings

28

Item 1A.

Risk Factors

28

Item 6.

Exhibits

67

 

 

 

 

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. In some cases, you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “potential,” “project,” “plan,” “expect,” “seek,” “target” or similar expressions, or the negative or plural of these words or expressions. These forward-looking statements include statements concerning the following:

 

our plans to develop and commercialize our product candidates;
the initiation, timing, progress and expected results of our current and future clinical trials and our research and development programs;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to maintain and establish collaborations or strategic relationships or obtain additional funding;
the timing and likelihood of obtaining regulatory approval of our current and future product candidates;
the potential milestone and royalty payments under certain of our license agreements;
our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates;
our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources;
the implementation of our business model and strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights and the duration of our patent rights covering our product candidates;
developments or disputes concerning our intellectual property or other proprietary rights;
the scalability and commercial viability of our manufacturing methods and processes;
our expectations regarding government and third-party payor coverage and reimbursement;
our ability to compete in the markets for our product candidates;
general economic, political, and market conditions and overall fluctuations in the financial markets in the United States and abroad, including as a result of bank failures, public health crisis or geopolitical tensions;
the impact of government laws and regulations;
developments relating to our competitors and our industry; and
other factors that may impact our financial results.

These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in greater detail under the heading “Risk Factors” and elsewhere in this report. You should not rely upon forward-looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements in this report, whether as a result of new information, future events or otherwise, after the date of this report.

Unless the context otherwise requires, the terms “Kezar,” “Kezar Life Sciences,” “the Company,” “we,” “us,” “our” and similar references in this Quarterly Report on Form 10-Q refer to Kezar Life Sciences, Inc. and our wholly owned Australian subsidiary, Kezar Life Sciences Australia Pty Ltd.

 

 

 

 

 

ii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

KEZAR LIFE SCIENCES, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,276

 

 

$

35,493

 

Marketable securities

 

 

135,906

 

 

 

165,879

 

Prepaid expenses and other current assets

 

 

3,435

 

 

 

5,578

 

Total current assets

 

 

167,617

 

 

 

206,950

 

Property and equipment, net

 

 

3,391

 

 

 

3,912

 

Operating lease right-of-use asset

 

 

2,391

 

 

 

4,778

 

Other assets

 

 

6,522

 

 

 

5,595

 

Total assets

 

$

179,921

 

 

$

221,235

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,263

 

 

$

8,251

 

Accrued and other current liabilities

 

 

9,363

 

 

 

6,481

 

Operating lease liabilities, current

 

 

3,260

 

 

 

3,012

 

Debt, current

 

 

2,609

 

 

 

 

Total current liabilities

 

 

17,495

 

 

 

17,744

 

Operating lease liabilities, noncurrent

 

 

4,152

 

 

 

5,852

 

Debt, noncurrent

 

 

7,589

 

 

 

10,069

 

Total liabilities

 

 

29,236

 

 

 

33,665

 

Stockholders' equity:

 

 

 

 

 

 

Common stock, $0.001 par value, 250,000,000 and 250,000,000 shares
   authorized as of June 30, 2024 (unaudited) and December 31, 2023, respectively;
   
72,887,538 and 72,779,077 shares issued and outstanding as of
   June 30, 2024 (unaudited) and December 31, 2023, respectively

 

 

73

 

 

 

73

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized; zero shares issued
   and outstanding as of June 30, 2024 (unaudited) and December 31, 2023

 

 

 

 

 

 

Additional paid-in capital

 

 

544,965

 

 

 

538,390

 

Accumulated other comprehensive loss

 

 

(385

)

 

 

(130

)

Accumulated deficit

 

 

(393,968

)

 

 

(350,763

)

Total stockholders' equity

 

 

150,685

 

 

 

187,570

 

Total liabilities and stockholders' equity

 

$

179,921

 

 

$

221,235

 

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

1


 

KEZAR LIFE SCIENCES, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

16,298

 

 

$

20,999

 

 

$

33,470

 

 

$

39,317

 

General and administrative

 

 

5,603

 

 

 

5,785

 

 

 

12,142

 

 

 

11,991

 

Restructuring and impairment charges

 

 

1,482

 

 

 

 

 

 

1,482

 

 

 

 

Total operating expenses

 

 

23,383

 

 

 

26,784

 

 

 

47,094

 

 

 

51,308

 

Loss from operations

 

 

(23,383

)

 

 

(26,784

)

 

 

(47,094

)

 

 

(51,308

)

Interest income

 

 

2,237

 

 

 

2,861

 

 

 

4,690

 

 

 

5,556

 

Interest expense

 

 

(401

)

 

 

(385

)

 

 

(801

)

 

 

(755

)

Net loss

 

$

(21,547

)

 

$

(24,308

)

 

$

(43,205

)

 

$

(46,507

)

Net loss per common share, basic and diluted

 

$

(0.30

)

 

$

(0.34

)

 

$

(0.59

)

 

$

(0.64

)

Weighted-average shares used to compute net loss per common
   share, basic and diluted

 

 

72,845,869

 

 

 

72,461,850

 

 

 

72,822,890

 

 

 

72,395,410

 

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

2


 

KEZAR LIFE SCIENCES, INC.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

(In thousands)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss

 

$

(21,547

)

 

$

(24,308

)

 

$

(43,205

)

 

$

(46,507

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

14

 

 

 

(5

)

 

 

(15

)

 

 

(17

)

Unrealized (loss) gain on marketable securities

 

 

(44

)

 

 

(302

)

 

 

(240

)

 

 

110

 

Total other comprehensive (loss) income, net of tax

 

 

(30

)

 

 

(307

)

 

 

(255

)

 

 

93

 

Comprehensive loss

 

$

(21,577

)

 

$

(24,615

)

 

$

(43,460

)

 

$

(46,414

)

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

3


 

KEZAR LIFE SCIENCES, INC.

Condensed Consolidated Statements of Stockholders' Equity

(Unaudited)

(In thousands, except share amounts)

 

 

 

COMMON STOCK

 

 

ADDITIONAL
PAID-IN

 

 

ACCUMULATED
OTHER
COMPREHENSIVE

 

 

ACCUMULATED

 

 

TOTAL
STOCKHOLDERS'

 

 

 

SHARES

 

 

AMOUNTS

 

 

CAPITAL

 

 

LOSS

 

 

DEFICIT

 

 

EQUITY

 

Balance at December 31, 2023

 

 

72,779,077

 

 

$

73

 

 

$

538,390

 

 

$

(130

)

 

$

(350,763

)

 

$

187,570

 

Issuance of common stock under employee stock incentive plans

 

 

22,282

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,434

 

 

 

 

 

 

 

 

 

3,434

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(225

)

 

 

 

 

 

(225

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,658

)

 

 

(21,658

)

Balance as of March 31, 2024

 

 

72,801,359

 

 

$

73

 

 

$

541,824

 

 

$

(355

)

 

$

(372,421

)

 

$

169,121

 

Issuance of common stock under employee stock incentive plans

 

 

86,179

 

 

 

 

 

 

56

 

 

 

 

 

 

 

 

 

56

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,085

 

 

 

 

 

 

 

 

 

3,085

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(30

)

 

 

 

 

 

(30

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,547

)

 

 

(21,547

)

Balance as of June 30, 2024

 

 

72,887,538

 

 

$

73

 

 

$

544,965

 

 

$

(385

)

 

$

(393,968

)

 

$

150,685

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COMMON STOCK

 

 

ADDITIONAL
PAID-IN

 

 

ACCUMULATED
OTHER
COMPREHENSIVE

 

 

ACCUMULATED

 

 

TOTAL
STOCKHOLDERS'

 

 

 

SHARES

 

 

AMOUNTS

 

 

CAPITAL

 

 

(LOSS) INCOME

 

 

DEFICIT

 

 

EQUITY

 

Balance at December 31, 2022

 

 

68,493,429

 

 

$

68

 

 

$

519,620

 

 

$

(923

)

 

$

(248,893

)

 

$

269,872

 

Cashless exercise of pre-funded warrants

 

 

2,236,233

 

 

 

2

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

Issuance of common stock under employee stock incentive plans

 

 

86,338

 

 

 

1

 

 

 

153

 

 

 

 

 

 

 

 

 

154

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,263

 

 

 

 

 

 

 

 

 

4,263

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

400

 

 

 

 

 

 

400

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,199

)

 

 

(22,199

)

Balance as of March 31, 2023

 

 

70,816,000

 

 

$

71

 

 

$

524,034

 

 

$

(523

)

 

$

(271,092

)

 

$

252,490

 

Cashless exercise of pre-funded warrants

 

 

1,556,643

 

 

 

2

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

Issuance of common stock under employee stock incentive plans

 

 

160,171

 

 

 

 

 

 

382

 

 

 

 

 

 

 

 

 

382

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

4,020

 

 

 

 

 

 

 

 

 

4,020

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(307

)

 

 

 

 

 

(307

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(24,308

)

 

 

(24,308

)

Balance as of June 30, 2023

 

 

72,532,814

 

 

$

73

 

 

$

528,434

 

 

$

(830

)

 

$

(295,400

)

 

$

232,277

 

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

4


 

KEZAR LIFE SCIENCES, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(43,205

)

 

$

(46,507

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

521

 

 

 

508

 

Stock-based compensation

 

 

6,519

 

 

 

8,283

 

Amortization of premiums and discounts on marketable securities

 

 

(2,902

)

 

 

(3,532

)

Amortization of debt discount and issuance costs and other
   non-cash interest

 

 

129

 

 

 

118

 

Impairment loss of right-of-use asset

 

 

1,549

 

 

 

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

2,143

 

 

 

2,246

 

Other assets

 

 

(927

)

 

 

(5,888

)

Accounts payable, accrued and other current liabilities

 

 

(3,106

)

 

 

2,453

 

Operating lease assets and liabilities

 

 

(614

)

 

 

(141

)

Net cash used in operating activities

 

 

(39,893

)

 

 

(42,460

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

 

 

 

(1,673

)

Purchases of marketable securities

 

 

(52,126

)

 

 

(95,233

)

Maturities of marketable securities

 

 

84,750

 

 

 

126,500

 

Net cash provided by investing activities

 

 

32,624

 

 

 

29,594

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock under employee stock incentive plans

 

 

56

 

 

 

536

 

Net cash provided by financing activities

 

 

56

 

 

 

536

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(4

)

 

 

(17

)

Net decrease in cash and cash equivalents

 

 

(7,217

)

 

 

(12,347

)

Cash and cash equivalents at the beginning of period

 

 

35,493

 

 

 

40,456

 

Cash and cash equivalents at the end of period

 

$

28,276

 

 

$

28,109

 

Supplemental disclosures of noncash investing and financing information:

 

 

 

 

 

 

Purchases of property and equipment in accounts payable

 

$

 

 

$

117

 

Par value of common stock upon cashless exercise of prefunded warrants

 

$

 

 

$

4

 

Supplemental disclosures

 

 

 

 

 

 

Cash paid for interest

 

$

672

 

 

$

637

 

 

 

 

 

 

 

 

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

5


 

Kezar Life Sciences, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. Organization and Description of the Business

Description of Business

Kezar Life Sciences, Inc. (the “Company,” “we,” “us,” or “our”) was incorporated in the state of Delaware in February 2015 and commenced operations in June 2015. The Company is a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases and cancer. The Company’s principal operations are in South San Francisco, California, and it operates in one segment.

Liquidity

Since commencing operations in mid-2015, substantially all of the Company’s efforts have been focused on research, development, and the advancement of the Company’s product candidates, zetomipzomib (KZR-616) and KZR-261. The Company’s ultimate success depends on the outcome of these ongoing research and development activities. The Company has not yet generated product sales and as a result has experienced operating losses since inception and had an accumulated deficit of $394.0 million as of June 30, 2024. The Company expects to incur additional losses in the future to conduct research and development and will need to raise additional capital to fully implement management’s business plan. The Company intends to raise such capital through the issuance of additional equity, including through at-the-market (“ATM”) offerings, and potentially through borrowings, strategic alliances with partner companies and other licensing transactions, such as our collaboration with Everest Medicines II (HK) Limited (“Everest”). However, if such financing is not available at adequate levels, the Company may need to reevaluate its operating plans. Management believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund the Company’s cash requirements for at least 12 months following the issuance of these financial statements.

In December 2021, the Company entered into a Sales Agreement (the “ATM Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company can offer and sell, from time to time at its sole discretion through Cowen, as its sales agent, shares of its common stock having an aggregate offering price of up to $200.0 million. Any shares of its common stock sold will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-261774). The Company will pay Cowen a commission up to 3.0% of the gross sales proceeds of any shares of its common stock sold through Cowen under the ATM Agreement and also has provided Cowen with indemnification and contribution rights. As of June 30, 2024, we have sold an aggregate of 11,986,003 shares of our common stock for gross proceeds of approximately $131.7 million at a weighted average purchase price of $10.98 per share pursuant to the ATM Agreement. As of June 30, 2024, approximately $68.3 million remains available under the ATM Agreement. No shares were sold under the ATM Agreement during the three months ended June 30, 2024.

2. Summary of Significant Accounting Policies

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023 and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 14, 2024 (the “Annual Report”), and there have been no material changes during the six months ended June 30, 2024.

Basis of Presentation and Consolidation

The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and include the Company’s accounts and those of its wholly owned Australian subsidiary, Kezar Life Sciences Australia Pty Ltd., which is a proprietary company limited by shares. All intercompany balances and transactions have been eliminated upon consolidation.

The condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Annual Report.

Unaudited Condensed Consolidated Financial Statements

The accompanying financial information as of June 30, 2024 is unaudited. The interim condensed consolidated financial statements included in this report reflect all adjustments (consisting only of normal recurring adjustments) that our management considers

 

6


 

necessary for the fair statement of the results of operations for the interim periods covered and of our financial condition at the date of the interim balance sheet. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The results for interim periods are not necessarily indicative of the results for the entire year or any other interim period. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in our Annual Report.

Use of Estimates

The preparation of financial statements in conformity with GAAP 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 revenue and expenses during the reporting period. Significant items subject to such judgments, estimates and assumptions include the valuation of marketable securities, impairment of long-lived assets, determining the fair-value of stock-based compensation, and evaluating the progress to completion of external research and development costs. Management bases its estimates on historical experience and on various other market-specific relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates.

Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its judgments, estimates and assumptions or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s condensed consolidated financial statements.

Recently Issued Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2023-09 Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires entities to disclose specific categories in the income tax rate reconciliation annually and provide additional information for reconciling items that meet a qualitative threshold. ASU 2023-09 also requires that entities disclose annually additional information about income taxes paid and disaggregated information for certain items. ASU 2023-09 is effective for the Company beginning on January 1, 2025. The Company is currently evaluating the impact of the adoption of ASU 2023-09 on its financial position, results of operations and cash flows.

In November 2023, the FASB issued Accounting Standards Update No. 2023-07 Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires entities with a single reportable segment to provide all the disclosures required by the amendments in ASU 2023-07 and all existing segment disclosures in Segment Reporting (Topic 280). ASU 2023-07 is effective for the Company beginning with the Form 10-K for the year ending December 31, 2024. The Company is currently evaluating the effect of adopting the update on its related disclosures.

There have been no other recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance that are expected to have a material impact on the Company’s condensed consolidated financial statements upon adoption.

3. Fair Value Measurements

Financial assets and liabilities are recorded at fair value. The carrying amount of certain financial instruments, including cash equivalents, other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. Assets and liabilities recorded at fair value on a recurring basis in the condensed consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1: Quoted prices in active markets for identical assets or liabilities.

 

7


 

Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the financial statements. The Company determines the fair value of Level 1 assets using quoted prices in active markets for identical assets. The Company reviews trading activity and pricing for Level 2 investments as of each measurement date. Level 2 inputs, which are obtained from various third-party data providers, represent quoted prices for similar assets in active markets and were derived from observable market data, or, if not directly observable, were derived from or corroborated by other observable market data.

In certain cases, where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3 within the valuation hierarchy. The Company did not have any financial assets or liabilities measured using Level 3 inputs as of June 30, 2024 or December 31, 2023.

The following table summarizes the Company’s financial assets measured at fair value on a recurring basis and classified under the appropriate level of the fair value hierarchy as described above (in thousands):

 

 

 

June 30, 2024

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

28,158

 

 

$

28,158

 

 

$

 

 

$

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

533

 

 

 

 

 

 

533

 

 

 

 

U.S. Treasury securities

 

 

51,889

 

 

 

51,889

 

 

 

 

 

 

 

Commercial paper

 

 

65,494

 

 

 

 

 

 

65,494

 

 

 

 

Corporate debt securities

 

 

10,990

 

 

 

 

 

 

10,990

 

 

 

 

U.S. government agency bonds

 

 

7,000

 

 

 

 

 

 

7,000

 

 

 

 

Total

 

$

164,064

 

 

$

80,047

 

 

$

84,017

 

 

$

 

 

 

 

December 31, 2023

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Financial Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

35,349

 

 

$

35,349

 

 

$

 

 

$

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

544

 

 

 

 

 

 

544

 

 

 

 

U.S. Treasury securities

 

 

54,175

 

 

 

54,175

 

 

 

 

 

 

 

Commercial paper

 

 

65,070

 

 

 

 

 

 

65,070

 

 

 

 

U.S. government agency bonds

 

 

46,090

 

 

 

 

 

 

46,090

 

 

 

 

Total

 

$

201,228

 

 

$

89,524

 

 

$

111,704

 

 

$

 

 

 

Nonrecurring Fair Value Measurements

The right-of-use (“ROU”) asset associated with Suite 400 of the Company's headquarters in South San Francisco, California, is a separate asset group measured at fair value on a nonrecurring basis as of December 31, 2023 due to an impairment recognized on the ROU asset at that date (see Note 6). The fair value of this asset group calculated as the present value of the estimated future cash flows of sublease income attributable to the ROU asset associated with Suite 400, was classified in Level 3 of the fair value hierarchy. When calculating the present value of the estimated future cash flows, sublease income was estimated to increase at a rate of 3.5% per year, and the cash flows were discounted using a rate of 13.3%. In June 2024, the Company recognized an additional $1.5 million

 

8


 

impairment charge in relation to Suite 400 to write off the net book value of the ROU asset as of June 30, 2024 as the estimated future cash flow from sublease income is zero due to current market conditions.

4. Available-for-Sale Securities

The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in the Company’s condensed consolidated balance sheets (in thousands):

 

 

 

June 30, 2024

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

28,158

 

 

$

 

 

$

 

 

$

28,158

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

533

 

 

 

 

 

 

 

 

 

533

 

U.S. Treasury securities

 

 

51,926

 

 

 

 

 

 

(37

)

 

 

51,889

 

Commercial paper

 

 

65,572

 

 

 

3

 

 

 

(81

)

 

 

65,494

 

Corporate debt securities

 

 

10,994

 

 

 

1

 

 

 

(5

)

 

 

10,990

 

U.S. government agency bonds

 

 

7,005

 

 

 

 

 

 

(5

)

 

 

7,000

 

Total

 

$

164,188

 

 

$

4

 

 

$

(128

)

 

$

164,064

 

Cash

 

 

 

 

 

 

 

 

 

 

 

118

 

Total cash, cash equivalent and marketable securities

 

 

 

 

 

 

 

 

 

 

$

164,182

 

 

 

 

December 31, 2023

 

 

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury money market funds

 

$

35,349

 

 

$

 

 

$

 

 

$

35,349

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Certificate of deposit

 

 

544

 

 

 

 

 

 

 

 

 

544

 

U.S. Treasury securities

 

 

54,066

 

 

 

151

 

 

 

(42

)

 

 

54,175

 

Commercial paper

 

 

65,038

 

 

 

41

 

 

 

(9

)

 

 

65,070

 

U.S. government agency bonds

 

 

46,115

 

 

 

27

 

 

 

(52

)

 

 

46,090

 

Total

 

$

201,112

 

 

$

219

 

 

$

(103

)

 

$

201,228

 

Cash

 

 

 

 

 

 

 

 

 

 

 

144

 

Total cash, cash equivalent and marketable securities

 

 

 

 

 

 

 

 

 

 

$

201,372

 

The Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of June 30, 2024 and December 31, 2023.

The following tables display additional information regarding gross unrealized losses and fair value by major security type for available-for-sale securities in an unrealized loss position as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30, 2024

 

 

 

Less than 12 consecutive months

 

 

 

Fair Value

 

 

Unrealized Losses

 

U.S. Treasury securities

 

$

48,463

 

 

$

(37

)

Commercial paper

 

 

47,574

 

 

 

(81

)

Corporate debt securities

 

 

7,814

 

 

 

(5

)

U.S. government agency bonds

 

 

7,000

 

 

 

(5

)

Total

 

$

110,851

 

 

$

(128

)

 

 

 

December 31, 2023

 

 

 

Less than 12 consecutive months

 

 

 

Fair Value

 

 

Unrealized Losses

 

U.S. Treasury securities

 

$

16,261

 

 

$

(42

)

Commercial paper

 

 

20,789

 

 

 

(9

)

U.S. government agency bonds

 

 

39,052

 

 

 

(52

)

Total

 

$

76,102

 

 

$

(103

)

 

 

9


 

The Company believes that the individual unrealized losses represent temporary declines primarily resulting from interest rate changes and intends to hold these marketable securities to their maturities.

The Company currently does not intend to sell these securities prior to maturity, and it is not more likely than not that the Company will be required to sell these securities before recovery of their amortized cost basis, which may be at maturity. The Company evaluated securities with unrealized losses to determine whether such losses, if any, were due to credit-related factors and determined that there were no credit-related losses to be recognized as of June 30, 2024. There were no sales of available-for-sale securities in any of the periods presented.

As of June 30, 2024, the amortized cost and estimated fair value of the Company’s available-for-sale securities by contractual maturity are shown below (in thousands):

 

 

Amortized

 

 

Estimated

 

Available-for-sale securities maturing in:

 

Cost

 

 

Fair Value

 

One year or less

 

$

164,188

 

 

$

164,064

 

Total available-for-sale securities

 

$

164,188

 

 

$

164,064

 

 

5. Balance Sheet Components

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

 

 

June 30,
2024

 

 

December 31,
2023

 

Receivable from Everest, current (Note 10)

 

$

1,312

 

 

$

1,596

 

Advance for clinical-related costs, current

 

 

773

 

 

 

1,818

 

Licenses, dues and subscriptions

 

 

662

 

 

 

506

 

Insurance

 

 

104

 

 

 

712

 

Interest receivable

 

 

374

 

 

 

695

 

Others

 

 

210

 

 

 

251

 

Total prepaid expenses and other current assets

 

$

3,435

 

 

$

5,578

 

Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

 

 

June 30,
2024

 

 

December 31,
2023

 

Leasehold improvements