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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES 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 001-39386

ALX ONCOLOGY HOLDINGS INC.

(Exact name of Registrant as specified in its Charter)

 

Delaware

85-0642577

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

323 Allerton Avenue

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

650-466-7125

(Registrant’s telephone number, including area code)

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

ALXO

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YesNo

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). YesNo

As of August 5, 2024, the registrant had 52,671,790 shares of common stock outstanding, $0.001 par value per share.

 

 


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:

 

our financial performance;
the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements;
the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;
our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our ability to grow a sales team;
the implementation of our strategic plans for our business and product candidates;
our ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for various diseases;
our reliance on third parties to conduct preclinical research activities, and for the manufacture of our product candidates;
the beneficial characteristics, mechanisms of action, safety profile, efficacy and therapeutic effects of our product candidates;
the progress and focus of our current and future clinical trials, and the reporting of data from those trials;
our ability to advance product candidates into and successfully complete clinical trials;
the ability of our clinical trials, including collaborations and investigator sponsored trials, to demonstrate the safety and efficacy of our product candidates, and other positive results;
the success of competing therapies that are or may become available;
developments relating to our competitors and our industry, including competing product candidates and therapies;
our plans relating to the further development and manufacturing of our product candidates, including additional indications that we may pursue;
existing regulations and regulatory developments in the United States and other jurisdictions;
our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved;
our continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture of our product candidates;
our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;
the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform and product candidates;
our ability to retain the continued service of our key personnel, the impacts of any executive officer changes, and to identify, hire, and then retain additional qualified personnel;
the impact of the COVID-19 pandemic, rising interest rates, bank failures or instability in the financial services sector, or geopolitical risks on our business;

 


 

our plans for and prospects of our acquisitions and other business development activities, and our ability to successfully capitalize on these opportunities;
changes in our financial and internal controls; and
our anticipated use of our existing cash and cash equivalents, short-term and long-term investments, and the funds available from our term loan.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

 


 

Table of Contents

 

Page

PART I

FINANCIAL INFORMATION

Item 1

Financial Statements (Unaudited)

5

 

Condensed Consolidated Balance Sheets

5

 

Condensed Consolidated Statements of Operations

6

 

Condensed Consolidated Statements of Comprehensive Loss

7

 

Condensed Consolidated Statements of Stockholders’ Equity

8

 

Condensed Consolidated Statements of Cash Flows

9

 

Notes to Condensed Consolidated Financial Statements

10

Item 2

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

20

Item 3

Quantitative and Qualitative Disclosures about Market Risk

31

Item 4

Controls and Procedures

32

 

PART II

OTHER INFORMATION

 

Item 1

Legal Proceedings

33

Item 1A

Risk Factors

33

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

80

Item 3

Defaults Upon Senior Securities

80

Item 4

Mine Safety Disclosures

80

Item 5

Other Information

80

Item 6

Exhibits

81

 

 

SIGNATURES

82

 

 

 


 

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

ALX ONCOLOGY HOLDINGS INC.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

15,534

 

 

$

22,406

 

Short-term investments

 

 

141,189

 

 

 

160,330

 

Prepaid expenses and other current assets

 

 

11,989

 

 

 

5,923

 

Total current assets

 

 

168,712

 

 

 

188,659

 

Property and equipment, net

 

 

3,316

 

 

 

3,589

 

Long-term investments

 

 

29,475

 

 

 

35,411

 

Other assets

 

 

13,115

 

 

 

14,894

 

Total assets

 

$

214,618

 

 

$

242,553

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

8,146

 

 

$

8,591

 

Payable and accrued liabilities due to related party

 

 

226

 

 

 

543

 

Accrued expenses and other current liabilities

 

 

30,077

 

 

 

26,867

 

Total current liabilities

 

 

38,449

 

 

 

36,001

 

Term loan, non-current

 

 

9,769

 

 

 

9,639

 

Other non-current liabilities

 

 

7,083

 

 

 

7,201

 

Total liabilities

 

 

55,301

 

 

 

52,841

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, $0.001 par value; 1,000,000,000 shares authorized
     as of June 30, 2024 and December 31, 2023;
52,452,749 and
     
49,951,989 shares issued and outstanding as of June 30, 2024
     and December 31, 2023, respectively

 

 

52

 

 

 

50

 

Additional paid-in capital

 

 

720,590

 

 

 

675,678

 

Accumulated other comprehensive income (loss)

 

 

(73

)

 

 

256

 

Accumulated deficit

 

 

(561,252

)

 

 

(486,272

)

Total stockholders’ equity

 

 

159,317

 

 

 

189,712

 

Total liabilities and stockholders’ equity

 

$

214,618

 

 

$

242,553

 

See accompanying notes to these condensed consolidated financial statements (unaudited).

5


 

ALX ONCOLOGY HOLDINGS 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

 

$

34,653

 

 

$

29,482

 

 

$

66,370

 

 

$

54,245

 

General and administrative

 

 

6,872

 

 

 

7,295

 

 

 

12,917

 

 

 

14,735

 

Total operating expenses

 

 

41,525

 

 

 

36,777

 

 

 

79,287

 

 

 

68,980

 

Loss from operations

 

 

(41,525

)

 

 

(36,777

)

 

 

(79,287

)

 

 

(68,980

)

Interest income

 

 

2,563

 

 

 

2,666

 

 

 

5,185

 

 

 

4,977

 

Interest expense

 

 

(429

)

 

 

(372

)

 

 

(856

)

 

 

(759

)

Other (expense) income, net

 

 

(8

)

 

 

324

 

 

 

(22

)

 

 

419

 

Net loss

 

$

(39,399

)

 

$

(34,159

)

 

$

(74,980

)

 

$

(64,343

)

Net loss per share, basic and diluted

 

$

(0.76

)

 

$

(0.84

)

 

$

(1.47

)

 

$

(1.57

)

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

 

 

51,831,157

 

 

 

40,875,457

 

 

 

50,969,089

 

 

 

40,869,021

 

See accompanying notes to these condensed consolidated financial statements (unaudited).

6


 

ALX ONCOLOGY HOLDINGS 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

 

$

(39,399

)

 

$

(34,159

)

 

$

(74,980

)

 

$

(64,343

)

Other comprehensive gain (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized (loss) gain on available-for-sale investments

 

 

(101

)

 

 

(224

)

 

 

(329

)

 

 

533

 

Total comprehensive loss

 

$

(39,500

)

 

$

(34,383

)

 

$

(75,309

)

 

$

(63,810

)

See accompanying notes to these condensed consolidated financial statements (unaudited).

7


 

ALX ONCOLOGY HOLDINGS 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

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2023

 

 

49,951,989

 

 

$

50

 

 

$

675,678

 

 

$

256

 

 

$

(486,272

)

 

$

189,712

 

Issuance of common stock under
   equity incentive plans

 

 

113,385

 

 

 

 

 

 

237

 

 

 

 

 

 

 

 

 

237

 

Issuance of common stock through
   ATM offering, net of commissions
   and offering costs of $
0.1 million

 

 

211,819

 

 

 

 

 

 

3,024

 

 

 

 

 

 

 

 

 

3,024

 

Stock-based compensation

 

 

 

 

 

 

 

 

7,031

 

 

 

 

 

 

 

 

 

7,031

 

Unrealized loss on available-for-sale
   investments

 

 

 

 

 

 

 

 

 

 

 

(228

)

 

 

 

 

 

(228

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,581

)

 

 

(35,581

)

Balance as of March 31, 2024

 

 

50,277,193

 

 

 

50

 

 

 

685,970

 

 

 

28

 

 

 

(521,853

)

 

 

164,195

 

Issuance of common stock under
   equity incentive plans

 

 

321,753

 

 

 

 

 

 

861

 

 

 

 

 

 

 

 

 

861

 

Issuance of common stock under
   employee stock purchase plan

 

 

59,712

 

 

 

 

 

 

306

 

 

 

 

 

 

 

 

 

306

 

Issuance of common stock through
   ATM offering, net of commissions
   and offering costs of $
0.8 million

 

 

1,794,091

 

 

 

2

 

 

 

26,201

 

 

 

 

 

 

 

 

 

26,203

 

Stock-based compensation

 

 

 

 

 

 

 

 

7,252

 

 

 

 

 

 

 

 

 

7,252

 

Unrealized loss on available-for-sale
   investments

 

 

 

 

 

 

 

 

 

 

 

(101

)

 

 

 

 

 

(101

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(39,399

)

 

 

(39,399

)

Balance as of June 30, 2024

 

 

52,452,749

 

 

$

52

 

 

$

720,590

 

 

$

(73

)

 

$

(561,252

)

 

$

159,317

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2022

 

 

40,861,386

 

 

$

41

 

 

$

589,735

 

 

$

(845

)

 

$

(325,467

)

 

$

263,464

 

Issuance of common stock under
   equity incentive plans

 

 

1,663

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,351

 

 

 

 

 

 

 

 

 

6,351

 

Unrealized gain on available-for-sale
   investments

 

 

 

 

 

 

 

 

 

 

 

757

 

 

 

 

 

 

757

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,184

)

 

 

(30,184

)

Balance as of March 31, 2023

 

 

40,863,049

 

 

 

41

 

 

 

596,086

 

 

 

(88

)

 

 

(355,651

)

 

 

240,388

 

Issuance of common stock under
   equity incentive plans

 

 

76,210

 

 

 

 

 

 

112

 

 

 

 

 

 

 

 

 

112

 

Issuance of common stock under
   employee stock purchase plan

 

 

52,920

 

 

 

 

 

 

338

 

 

 

 

 

 

 

 

 

338

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,237

 

 

 

 

 

 

 

 

 

6,237

 

Unrealized loss on available-for-sale
   investments

 

 

 

 

 

 

 

 

 

 

 

(224

)

 

 

 

 

 

(224

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,159

)

 

 

(34,159

)

Balance as of June 30, 2023

 

 

40,992,179

 

 

$

41

 

 

$

602,773

 

 

$

(312

)

 

$

(389,810

)

 

$

212,692

 

See accompanying notes to these condensed consolidated financial statements (unaudited).

8


 

ALX ONCOLOGY HOLDINGS INC.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2024

 

 

2023

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(74,980

)

 

$

(64,343

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

434

 

 

 

420

 

Non-cash lease costs

 

 

851

 

 

 

611

 

Stock-based compensation

 

 

14,283

 

 

 

12,588

 

Net accretion of discounts on investments

 

 

(2,870

)

 

 

(2,764

)

Accretion of term loan discount and issuance costs

 

 

130

 

 

 

123

 

Loss on disposal of fixed asset

 

 

10

 

 

 

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(6,066

)

 

 

(1,963

)

Other assets

 

 

1,915

 

 

 

3,425

 

Accounts payable

 

 

(443

)

 

 

(3,944

)

Payable and accrued liabilities due to related party

 

 

(317

)

 

 

(1,390

)

Accrued expenses and other current liabilities

 

 

3,660

 

 

 

(1,802

)

Other non-current liabilities

 

 

(1,097

)

 

 

(488

)

Net cash used in operating activities

 

 

(64,490

)

 

 

(59,527

)

Investing activities

 

 

 

 

 

 

Purchase of investments

 

 

(94,249

)

 

 

(118,730

)

Maturities of investments

 

 

121,867

 

 

 

169,667

 

Purchase of property and equipment

 

 

(238

)

 

 

(2,429

)

Net cash provided by investing activities

 

 

27,380

 

 

 

48,508

 

Financing activities

 

 

 

 

 

 

Proceeds from ATM offering, net of commissions and offering costs of $0.9 million

 

 

29,227

 

 

 

 

Proceeds from exercise of stock options under equity incentive plan

 

 

1,098

 

 

 

112

 

Proceeds from issuance of common stock under employee stock purchase plan

 

 

306

 

 

 

338

 

Principal payments on finance leases

 

 

(393

)

 

 

(214

)

Net cash provided by financing activities

 

 

30,238

 

 

 

236

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(6,872

)

 

 

(10,783

)

Cash, cash equivalents and restricted cash at beginning of year

 

 

22,472

 

 

 

48,888

 

Cash, cash equivalents and restricted cash at end of period

 

$

15,600

 

 

$

38,105

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

Purchase of property and equipment in accounts payable and accrued expenses

 

$

1,340

 

 

$

75

 

Right-of-use asset acquired under finance leases

 

$

1,035

 

 

$

 

 

 

 

 

 

 

 

Reconciliation of cash and cash equivalents and restricted cash:

 

 

 

 

 

 

Cash and cash equivalents

 

$

15,534

 

 

$

38,039

 

Restricted cash (included in other assets)

 

 

66

 

 

 

66

 

Total cash and cash equivalents and restricted cash

 

$

15,600

 

 

$

38,105

 

See accompanying notes to these condensed consolidated financial statements (unaudited).

9


 

ALX ONCOLOGY HOLDINGS INC.

Notes to Condensed Consolidated Financial Statements

(unaudited)

(1) ORGANIZATION

Organization

ALX Oncology Holdings Inc., or the Company, was formed as a Delaware corporation on April 1, 2020, or Inception. The Company was formed for the purpose of completing the Company’s initial public offering of its common stock and related transactions in order to carry on the business of ALX Oncology Limited. The Company is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system.

ALX Oncology Holdings Inc. is incorporated in Delaware. ALX Oncology Limited, incorporated in Ireland, is a wholly-owned subsidiary of ALX Oncology Holdings Inc. ALX Oncology Inc., incorporated in Delaware, is a wholly-owned subsidiary of ALX Oncology Limited. Alexo International Holdings Limited, incorporated in Malta, is a wholly-owned subsidiary of ALX Oncology Inc. All the companies, except for ALX Oncology Holdings Inc., are collectively known as the Subsidiaries.

As of June 30, 2024, the Company has devoted substantially all of its efforts to the formation and financing of the Company, as well as product development, and has not realized product revenues from its planned principal operations. The Company does not have manufacturing facilities and all manufacturing related activities are contracted out to third-party service providers.

Management expects to incur additional losses in the future to conduct product candidate research and development and to conduct pre-commercialization activities and recognizes that the Company will likely raise additional capital to fully implement its business plan. The Company intends to raise such capital through the sale of additional equity, debt financings and/or strategic alliances with third parties. However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms acceptable to the Company. If the Company is unsuccessful in its efforts to raise additional financing, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate some of its development programs or its future commercialization efforts, out-license intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above, any of which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all. The Company believes that the existing capital resources will be sufficient to fund the projected operating requirements for at least the next twelve months.

(2) SIGNIFICANT ACCOUNTING POLICIES

Basis of Preparation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 7, 2024.

The condensed consolidated balance sheet as of June 30, 2024 included herein was derived from the audited financial statements as of that date, but does not include all disclosures including notes required by U.S. GAAP.

The accompanying condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year ending December 31, 2024.

Principles of Consolidation

All intercompany balances and transactions have been eliminated in consolidation.

10


 

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. On an ongoing basis, management evaluates its estimates, including, but not limited to, those related to the estimated useful lives of long-lived assets, clinical trial accruals, fair value of assets and liabilities, fair value of investments and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Significant Accounting Policies

There have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. The new guidance also modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. ASU 2020-06 is effective for annual periods beginning after December 15, 2023, including interim periods within those annual periods. Early adoption is permitted. ASU 2020-06 allows companies to adopt the guidance through either a modified retrospective method of transition or a fully retrospective method of transition. The Company’s adoption of ASU 2020-06 on January 1, 2024 did not have an impact on its condensed consolidated financial statements and related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (ASU 2023-07). The amendments in ASU 2023-07 are intended to improve reportable segment disclosure, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for annual periods beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The amendments in this ASU should be applied retrospectively to all prior periods presented in the financial statements. Early adoption is permitted. The Company is evaluating the impact of this guidance on its consolidated financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 requires enhanced annual disclosures regarding the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for annual periods beginning after December 15, 2024 and may be adopted on a prospective or retrospective basis. Early adoption is permitted. The Company is evaluating the impact of this guidance on its consolidated financial statements and related disclosures.

11


 

(3) FAIR VALUE OF FINANCIAL INSTRUMENTS

The fair value of the Company’s financial assets and liabilities are determined in accordance with the fair value hierarchy established in ASC 820, Fair Value Measurements and Disclosures.

The following table presents the Company’s investments, which consist of cash equivalents and investments classified as available-for-sale investments, that are measured at fair value on a recurring basis by level within the fair value hierarchy as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30, 2024

 

 

 

Fair Value
Hierarchy
Level

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

Level 1

 

$

13,986

 

 

$

 

 

$

 

 

$

13,986

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

Level 1

 

 

68,064

 

 

 

2

 

 

 

(47

)

 

 

68,019

 

U.S. government agency securities

 

Level 2

 

 

6,037

 

 

 

4

 

 

 

(5

)

 

 

6,036

 

Corporate debt securities

 

Level 2

 

 

53,279

 

 

 

27

 

 

 

(37

)

 

 

53,269

 

Commercial paper

 

Level 2

 

 

13,872

 

 

 

 

 

 

(7

)

 

 

13,865

 

Asset-backed securities

 

Level 2

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

Level 1

 

 

14,278

 

 

 

14

 

 

 

(6

)

 

 

14,286

 

U.S. government agency securities

 

Level 2

 

 

3,500

 

 

 

 

 

 

(5

)

 

 

3,495

 

Corporate debt securities

 

Level 2

 

 

11,707

 

 

 

 

 

 

(13

)

 

 

11,694

 

Total

 

 

 

$

184,723

 

 

$

47

 

 

$

(120

)

 

$

184,650

 

 

 

 

December 31, 2023

 

 

 

Fair Value
Hierarchy
Level

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

Level 1

 

$

15,591

 

 

$

 

 

$

 

 

$

15,591

 

Corporate debt securities

 

Level 2

 

 

4,489

 

 

 

1

 

 

 

 

 

 

4,490

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

Level 1

 

 

74,790

 

 

 

80

 

 

 

(20

)

 

 

74,850

 

U.S. government agency securities

 

Level 2

 

 

28,215

 

 

 

 

 

 

(38

)

 

 

28,177

 

Corporate debt securities

 

Level 2

 

 

21,881

 

 

 

24

 

 

 

(3

)

 

 

21,902

 

Commercial paper

 

Level 2

 

 

34,967

 

 

 

22

 

 

 

(9

)

 

 

34,980

 

Asset-backed securities

 

Level 2

 

 

423

 

 

 

 

 

 

(2

)

 

 

421

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury securities

 

Level 1

 

 

14,737

 

 

 

75

 

 

 

 

 

 

14,812

 

U.S. government agency securities

 

Level 2

 

 

3,009

 

 

 

31

 

 

 

 

 

 

3,040

 

Asset-backed securities

 

Level 2

 

 

17,464

 

 

 

95

 

 

 

 

 

 

17,559

 

Total

 

 

 

$

215,566

 

 

$

328

 

 

$

(72

)

 

$

215,822

 

The fair value of cash equivalents and available-for-sale investments by classification included in the condensed consolidated balance sheets was as follows as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Cash equivalents

 

$

13,986

 

 

$

20,081

 

Short-term investments

 

 

141,189

 

 

 

160,330

 

Long-term investments

 

 

29,475

 

 

 

35,411

 

Total

 

$

184,650

 

 

$

215,822

 

Cash and cash equivalents in the above table excludes bank account cash of $1.5 million and $2.3 million as of June 30, 2024 and December 31, 2023, respectively.

12


 

The fair value of cash equivalents and available-for-sale investments by contractual maturity was as follows as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Maturing in one year or less

 

$

155,175

 

 

$

180,411

 

Maturing after one year through five years

 

 

29,475

 

 

 

35,411

 

Total

 

$

184,650

 

 

$

215,822

 

The primary objective of the Company’s investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. The Company’s investment policy limits investments to certain types of instruments issued by institutions with investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.

There were no transfers of financial instruments between the fair value measurement levels during the three months and six months ended June 30, 2024 and 2023 and there were no financial instruments classified as Level 3 as of June 30, 2024 and 2023.

As of June 30, 2024 and December 31, 2023, accrued interest receivable related to the Company’s investments of $1.2 million and $1.0 million, respectively, was included in prepaid expenses and other current assets on the condensed consolidated balance sheet. In addition, as of June 30, 2024, receivable related to the Company’s matured investments of $5.0 million was included in prepaid expenses and other current assets on the condensed consolidated balance sheet.

As of June 30, 2024, the unrealized losses for available-for-sale investments were non-credit related and the Company does not intend to sell the investments that were in an unrealized loss position, nor does it foresee or project that it will be required to sell those investments before recovery of their amortized costs basis, which may be maturity. As of June 30, 2024 and 2023, no allowance for credit losses for the Company’s investments was recorded. As of June 30, 2024 and December 31, 2023, securities with a fair value of $3.0 million and $5.9 million, respectively, were in a continuous net unrealized loss position for more than 12 months. As of June 30, 2024 and 2023, the Company has not recognized any impairment losses on available-for-sale investments.

(4) BALANCE SHEET COMPONENTS

Prepaid Expenses and Other Current Assets

The following table presents the components of prepaid expenses and other current assets as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Interest and other receivables

 

$

6,240

 

 

$

996

 

Prepaid clinical expenses

 

 

4,314

 

 

 

3,049

 

Prepaid expenses

 

 

1,051

 

 

 

830

 

Prepaid insurance

 

 

69

 

 

 

609

 

Other current assets

 

 

315

 

 

 

439

 

Total prepaid expenses and other current assets

 

$

11,989

 

 

$

5,923

 

Property and Equipment, Net

The following table presents the components of property and equipment, net as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Leasehold improvements

 

$

2,513

 

 

$

2,513

 

Laboratory equipment

 

 

1,819

 

 

 

1,733

 

Computer hardware and software

 

 

485

 

 

 

414

 

Furniture and fixtures

 

 

166

 

 

 

166

 

Property and equipment, gross

 

 

4,983

 

 

 

4,826

 

Less: accumulated depreciation

 

 

(1,667

)

 

 

(1,237

)

Property and equipment, net

 

$

3,316

 

 

$

3,589

 

Depreciation was $0.2 million for the three months ended June 30, 2024 and 2023. Depreciation was $0.4 million for the six months ended June 30, 2024 and 2023.

13


 

Other Assets

The following table presents the components of other assets as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Long-term prepaid clinical expenses

 

$

5,113

 

 

$

7,442

 

Operating lease right-of-use assets

 

 

4,442

 

 

 

4,847

 

Finance lease right-of-use assets

 

 

2,946

 

 

 

2,405

 

Long-term prepaid contract manufacturing costs

 

 

414

 

 

 

 

Other

 

 

200

 

 

 

200

 

Total other assets

 

$

13,115

 

 

$

14,894

 

Accrued Expenses and Other Current Liabilities

The following table presents the components of accrued expenses and other current liabilities as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Accrued contract manufacturing

 

$

13,190

 

 

$

9,543

 

Accrued clinical and nonclinical study costs

 

 

10,412

 

 

 

8,873

 

Accrued compensation and related expenses

 

 

3,870

 

 

 

6,067

 

Accrued property and equipment

 

 

186

 

 

 

179

 

Other

 

 

2,419

 

 

 

2,205

 

Total accrued expenses and other current liabilities

 

$

30,077

 

 

$

26,867

 

 

(5) LEASES

The Company has non-cancelable operating leases for its offices located in the U.S. As of June 30, 2024, these leases expire on various dates between 2026 and 2030. Certain lease agreements include one or more options to renew, with renewal terms that can extend the lease up to two years after expiration. The Company has the right to exercise or forego the lease renewal options. The lease agreements do not contain any material residual value guarantees or material restrictive covenants.

The following table presents the maturities and balance sheet information of the Company’s operating lease liabilities as of June 30, 2024 (in thousands, except lease term and discount rate):

 

 

June 30, 2024

 

 

 

Operating Leases

 

 

Finance Leases

 

2024

 

$

638

 

 

$

528

 

2025

 

 

1,305

 

 

 

1,056

 

2026

 

 

1,187

 

 

 

1,056

 

2027

 

 

912

 

 

 

616

 

2028

 

 

939

 

 

 

 

Thereafter

 

 

1,130