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季報 季度報告 10-Q 2026-05-15

財季:截至 2026 年 3 月 31 日止三個月(2026 年第一季)

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📄 **申報類型:10-Q(季度業績)** **公司:aTyr Pharma, Inc. (ATYR)** **財季:截至 2026 年 3 月 31 日止三個月(2026 年第一季)** ### 業績重點 - 期內淨虧損為 **1,080 萬美元**(每股虧損 0.11 美元),較去年同期 1,490 萬美元虧損(每股虧損 0.17 美元)顯著收窄,主要因為研發開支減少。 - 研發開支由 1,180 萬美元降至 **730 萬美元**,主因是主力候選藥物 efzofitimod 的臨床試驗費用減少。 - 截至 2026 年 3 月 31 日,公司持有現金、現金等價物及可供出售投資合共 **6,830 萬美元**,累計虧損約 **6.17 億美元**。管理層認為現有資金足以支持未來至少 12 個月的營運需求。 ### 臨床開發進展 - **Efzofitimod(主要候選藥物)**:針對肺結節病相關間質性肺病的全球第三期 EFZO-FIT 研究,未達主要終點(口服皮質類固醇劑量減少)。但次要終點顯示臨床意義改善,包括 King’s Sarcoidosis Questionnaire (KSQ)-Lung 評分及類固醇完全停用比例。FDA 建議以強制肺活量(FVC)作為新第三期試驗的主要終點,並將給藥頻率由每四週一次增至每三週一次。公司計劃於 2026 年 6 月提交新藥臨床試驗申請。 - **EFZO-CONNECT 研究**:針對系統性硬化症相關間質性肺病的第二期概念驗證試驗,預計 2026 年上半年完成招募。 - 其他管線:ATYR0101(針對纖維化疾病)及 ATYR0750(靶向 FGFR4)仍在臨床前開發階段。 ### 重大合作終止 - 日本合作夥伴 **Kyorin Pharmaceutical** 於 2026 年 5 月 12 日無故終止合作協議,將於 90 天後生效。aTyr 將收回日本市場的開發及商業化權利,但亦失去未來總值 **1.55 億美元** 的里程碑及特許權使用費。 ### 法律訴訟 - 公司正面對兩宗合併的證券集體訴訟,指控管理層對 efzofitimod 的陳述失實。2026
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10-Q
 
 
 
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 

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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 March 31, 2026
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: 001-37378
 
ATYR PHARMA, INC.
(Exact name of registrant as specified in its charter)
 
 

 
 
 
 
 

 
 Delaware

 20-3435077

 

 
 (State or other jurisdiction 
of incorporation or organization)

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

 

 
  

  

 

 
 10240 Sorrento Valley Road, Suite 300, San Diego, CA

 92121

 

 
 (Address of principal executive offices)

 (Zip Code)

 

 (858) 731-8389
(Registrant’s telephone number, including area code) 
 
Securities registered pursuant to Section 12(b) of the Act:

 
 
 
 
 
 

 
 Title of each class

 Trading Symbol(s)

 Name of each exchange on which registered

 

 
 Common Stock, par value $0.001 per share

 ATYR

 The Nasdaq Capital Market

 

 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 May 11, 2026, there were 98,051,212 shares of the registrant’s common stock, par value $0.001 per share, outstanding.
 
 

  

 
  

 ATYR PHARMA, INC.
FORM 10-Q
TABLE OF CONTENTS
 

 
 
 
 
 
 

 
  

 Page

 

 
 PART I. FINANCIAL INFORMATION

 

 

 

 
 Item 1. Financial Statements

 

 3

 

 
 Condensed Consolidated Balance Sheets as of March 31, 2026 (unaudited) and December 31, 2025

 

 3

 

 
 Condensed Consolidated Statements of Operations for the three months ended March 31, 2026 and 2025 (unaudited)

 

 4

 

 
 Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2026 and 2025 (unaudited)

 

 5

 

 
 Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2026 and 2025 (unaudited)

  

 6

 

 
 Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025 (unaudited)

 

 7

 

 
 Notes to Condensed Consolidated Financial Statements (unaudited)

 

 8

 

 
 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 16

 

 
 Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

 23

 

 
 Item 4. Controls and Procedures

 

 23

 

 
 PART II. OTHER INFORMATION

 

  

 

 
 Item 1. Legal Proceedings

 

 24

 

 
 Item 1A. Risk Factors

 

 24

 

 
 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

 63

 

 
 Item 3. Defaults Upon Senior Securities

 

 63

 

 
 Item 4. Mine Safety Disclosures

 

 63

 

 
 Item 5. Other Information

 

 63

 

 
 Item 6. Exhibits

 

 66

 

 
 SIGNATURES

 

 68

 

  

  

 
  

 PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
aTyr Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 March 31,

  

  

 December 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
  

  

 (unaudited)

  

  

  

  

 

 
 Assets

  

  

  

  

  

  

 

 
 Current assets:

  

  

  

  

  

  

 

 
 Cash and cash equivalents

  

 $

 10,008

  

  

 $

 10,743

  

 

 
 Available-for-sale investments

  

  

 56,505

  

  

  

 67,944

  

 

 
 Other receivables

  

  

 477

  

  

  

 873

  

 

 
 Prepaid expenses

  

  

 586

  

  

  

 677

  

 

 
 Total current assets

  

  

 67,576

  

  

  

 80,237

  

 

 
 Restricted cash

  

  

 1,805

  

  

  

 2,235

  

 

 
 Property and equipment, net

  

  

 4,237

  

  

  

 4,263

  

 

 
 Operating lease, right-of-use assets

  

  

 5,441

  

  

  

 5,524

  

 

 
 Financing lease, right-of-use assets

  

  

 447

  

  

  

 596

  

 

 
 Other assets

  

  

 148

  

  

  

 148

  

 

 
 Total assets

  

 $

 79,654

  

  

 $

 93,003

  

 

 
 Liabilities and Stockholders’ Equity

  

  

  

  

  

  

 

 
 Current liabilities:

  

  

  

  

  

  

 

 
 Accounts payable

  

 $

 2,755

  

  

 $

 3,891

  

 

 
 Accrued expenses

  

  

 7,458

  

  

  

 9,791

  

 

 
 Current portion of operating lease liability

  

  

 890

  

  

  

 836

  

 

 
 Current portion of financing lease liability

  

  

 596

  

  

  

 630

  

 

 
 Total current liabilities

  

  

 11,699

  

  

  

 15,148

  

 

 
 Long-term operating lease liability, net of current portion

  

  

 10,063

  

  

  

 10,308

  

 

 
 Long-term financing lease liability, net of current portion

  

  

 151

  

  

  

 259

  

 

 
 Commitments and contingencies (Note 4)

  

  

  

  

  

  

 

 
 Stockholders’ equity:

  

  

  

  

  

  

 

 
 Preferred stock, $0.001 par value per share; 5,000,000 undesignated authorized shares as of March 31, 2026 (unaudited) and December 31, 2025, respectively; no shares issued or outstanding as of March 31, 2026 (unaudited) and December 31, 2025

  

  

 —

  

  

  

 —

  

 

 
 Common stock, $0.001 par value per share; 170,000,000 authorized shares as of March 31, 2026 (unaudited) and December 31, 2025; issued and outstanding shares – 98,051,212 as of March 31, 2026 (unaudited) and 98,031,104 as of December 31, 2025

  

  

 98

  

  

  

 98

  

 

 
 Additional paid-in capital

  

  

 674,861

  

  

  

 673,554

  

 

 
 Accumulated other comprehensive loss

  

  

 (70

 )

  

  

 (8

 )

 

 
 Accumulated deficit

  

  

 (616,955

 )

  

  

 (606,164

 )

 

 
 Total aTyr Pharma, Inc. stockholders’ equity

  

  

 57,934

  

  

  

 67,480

  

 

 
 Noncontrolling interest in Pangu BioPharma Limited

  

  

 (193

 )

  

  

 (192

 )

 

 
 Total stockholders’ equity

  

  

 57,741

  

  

  

 67,288

  

 

 
 Total liabilities and stockholders’ equity

  

 $

 79,654

  

  

 $

 93,003

  

 

  
See accompanying notes.
 
 

 3

 
  

 aTyr Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
  

  

 (unaudited)

  

 

 
 Operating expenses:

  

  

  

  

  

  

 

 
 Research and development

  

 $

 7,317

  

  

 $

 11,814

  

 

 
 General and administrative

  

  

 4,119

  

  

  

 3,959

  

 

 
 Total operating expenses

  

  

 11,436

  

  

  

 15,773

  

 

 
 Loss from operations

  

  

 (11,436

 )

  

  

 (15,773

 )

 

 
 Total other income (expense), net

  

  

 644

  

  

  

 892

  

 

 
 Consolidated net loss

  

  

 (10,792

 )

  

  

 (14,881

 )

 

 
 Net loss attributable to noncontrolling interest in Pangu BioPharma Limited

  

  

 1

  

  

  

 1

  

 

 
 Net loss attributable to aTyr Pharma, Inc.

  

 $

 (10,791

 )

  

 $

 (14,880

 )

 

 
 Net loss per share, basic and diluted

  

 $

 (0.11

 )

  

 $

 (0.17

 )

 

 
 Shares used in computing net loss per share, basic and diluted

  

  

 98,043,839

  

  

  

 86,485,126

  

 

 See accompanying notes.
 
 

 4

 
  

 aTyr Pharma, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
  

  

 (unaudited)

  

 

 
 Consolidated net loss

  

 $

 (10,792

 )

  

 $

 (14,881

 )

 

 
 Other comprehensive loss:

  

  

  

  

  

  

 

 
 Change in unrealized loss on available-for-sale investments, net of tax

  

  

 (62

 )

  

  

 (26

 )

 

 
 Comprehensive loss

  

  

 (10,854

 )

  

  

 (14,907

 )

 

 
 Comprehensive loss attributable to noncontrolling interest in Pangu BioPharma Limited

  

  

 1

  

  

  

 1

  

 

 
 Comprehensive loss attributable to aTyr Pharma, Inc. common stockholders

  

 $

 (10,853

 )

  

 $

 (14,906

 )

 

  
See accompanying notes.
 
 
 
 

 5

 
  

 aTyr Pharma, Inc.
Condensed Consolidated Statements of Stockholders’ Equity 
(in thousands, except share data)
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
  

 Three Months Ended March 31, 2026 (unaudited)

  

 

 
  

 Common Stock

  

 Additional
Paid-In

  

 Other
Comprehensive

  

 Accumulated

  

 Noncontrolling

  

 Total
Stockholders’

  

 

 
  

 Shares

  

 Amount

  

 Capital

  

 Gain/(Loss)

  

 Deficit

  

 Interest

  

 Equity

  

 

 
 Balance as of December 31, 2025

  

 98,031,104

  

 $

 98

  

 $

 673,554

  

 $

 (8

 )

 $

 (606,164

 )

 $

 (192

 )

 $

 67,288

  

 

 
 Issuance of common stock upon release of restricted stock units

  

 20,108

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

 

 
 Stock-based compensation

  

 —

  

  

 —

  

  

 1,307

  

  

 —

  

  

 —

  

  

 —

  

  

 1,307

  

 

 
 Net unrealized loss on investments, net of tax

  

 —

  

  

 —

  

  

 —

  

  

 (62

 )

  

 —

  

  

 —

  

  

 (62

 )

 

 
 Net loss

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 (10,791

 )

  

 (1

 )

  

 (10,792

 )

 

 
 Balance as of March 31, 2026

  

 98,051,212

  

 $

 98

  

 $

 674,861

  

 $

 (70

 )

 $

 (616,955

 )

 $

 (193

 )

 $

 57,741

  

 

 
  

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
  

 Three Months Ended March 31, 2025 (unaudited)

  

 

 
  

 Common Stock

  

 Additional
Paid-In

  

 Other
Comprehensive

  

 Accumulated

  

 Noncontrolling

  

 Total
Stockholders’

  

 

 
  

 Shares

  

 Amount

  

 Capital

  

 Gain/(Loss)

  

 Deficit

  

 Interest

  

 Equity

  

 

 
 Balance as of December 31, 2024

  

 84,038,922

  

 $

 84

  

 $

 602,021

  

 $

 (40

 )

 $

 (532,046

 )

 $

 (187

 )

 $

 69,832

  

 

 
 Issuance of common stock upon release of restricted stock units

  

 21,108

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 —

  

 

 
 Issuance of common stock upon exercise of stock options

  

 900

  

  

 —

  

  

 2

  

  

 —

  

  

 —

  

  

 —

  

  

 2

  

 

 
 Issuance of common stock from at-the-market offerings, net of offering costs

  

 4,941,895

  

  

 5

  

  

 18,752

  

  

 —

  

  

 —

  

  

 —

  

  

 18,757

  

 

 
 Stock-based compensation

  

 —

  

  

 —

  

  

 1,178

  

  

 —

  

  

 —

  

  

 —

  

  

 1,178

  

 

 
 Net unrealized loss on investments, net of tax

  

 —

  

  

 —

  

  

 —

  

  

 (26

 )

  

 —

  

  

 —

  

  

 (26

 )

 

 
 Net loss

  

 —

  

  

 —

  

  

 —

  

  

 —

  

  

 (14,880

 )

  

 (1

 )

  

 (14,881

 )

 

 
 Balance as of March 31, 2025

  

 89,002,825

  

 $

 89

  

 $

 621,953

  

 $

 (66

 )

 $

 (546,926

 )

 $

 (188

 )

 $

 74,862

  

 

  
See accompanying notes.

 6

 
  

  
aTyr Pharma, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
  

  

 (unaudited)

  

 

 
 Cash flows from operating activities:

  

  

  

 

 
 Consolidated net loss

  

 $

 (10,792

 )

  

 $

 (14,881

 )

 

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

  

  

  

  

  

  

 

 
 Depreciation and amortization

  

  

 162

  

  

  

 167

  

 

 
 Stock-based compensation

  

  

 1,307

  

  

  

 1,178

  

 

 
 Accretion of discount of available-for-sale investment securities

  

  

 (255

 )

  

  

 (523

 )

 

 
 Amortization of right-of-use assets

  

  

 232

  

  

  

 216

  

 

 
 Changes in operating assets and liabilities:

  

  

  

  

  

  

 

 
 Other receivables

  

  

 396

  

  

  

 748

  

 

 
 Prepaid expenses and other assets

  

  

 91

  

  

  

 2,159

  

 

 
 Accounts payable and accrued expenses

  

  

 (3,467

 )

  

  

 (4,322

 )

 

 
 Operating lease liability

  

  

 (191

 )

  

  

 (162

 )

 

 
 Net cash used in operating activities

  

  

 (12,517

 )

  

  

 (15,420

 )

 

 
 Cash flows from investing activities:

  

  

  

  

  

  

 

 
 Purchases of property and equipment

  

  

 (138

 )

  

  

 —

  

 

 
 Purchases of available-for-sale investment securities

  

  

 (5,868

 )

  

  

 (23,105

 )

 

 
 Maturities of available-for-sale investment securities

  

  

 17,500

  

  

  

 18,685

  

 

 
 Net cash provided by (used in) investing activities

  

  

 11,494

  

  

  

 (4,420

 )

 

 
 Cash flows from financing activities:

  

  

  

  

  

  

 

 
 Proceeds from issuance of common stock through option exercises

  

  

 —

  

  

  

 2

  

 

 
 Proceeds from issuance of common stock from at-the-market offerings, net of offering costs

  

  

 —

  

  

  

 18,757

  

 

 
 Principal paid on finance lease liabilities

  

  

 (142

 )

  

  

 (131

 )

 

 
 Net cash (used in) provided by financing activities

  

  

 (142

 )

  

  

 18,628

  

 

 
 Net change in cash, cash equivalents and restricted cash

  

  

 (1,165

 )

  

  

 (1,212

 )

 

 
 Cash, cash equivalents and restricted cash at beginning of period

  

  

 12,978

  

  

  

 14,006

  

 

 
 Cash, cash equivalents and restricted cash at the end of period

  

 $

 11,813

  

  

 $

 12,794

  

 

 
 

  

  

  

  

  

  

 

 
 Cash and cash equivalents at the end of period

  

 $

 10,008

  

  

 $

 10,362

  

 

 
 Restricted cash at the end of period

  

  

 1,805

  

  

  

 2,432

  

 

 
 Cash, cash equivalents and restricted cash at the end of period

  

 $

 11,813

  

  

 $

 12,794

  

 

 
 

 

  

  

  

  

  

 

 
 Supplemental disclosure of cash flow information:

  

  

  

  

  

  

 

 
 Interest paid

  

 $

 17

  

  

 $

 28

  

 

 
 Purchases of property and equipment in accounts payable

  

 $

 15

  

  

 $

 17

  

 

  
See accompanying notes.
 

 7

 
  

 aTyr Pharma, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
 
1. Organization, Business, Basis of Presentation and Summary of Significant Accounting Policies
Organization and Business
We were incorporated in the state of Delaware on September 8, 2005. We are a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. Our discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by our proprietary library of domains derived from all 20 tRNA synthetases.

Principles of Consolidation
Our unaudited condensed consolidated financial statements include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma Limited (Pangu BioPharma). All intercompany transactions and balances are eliminated in consolidation.

Unaudited Interim Financial Information
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP) and follow the requirements of the U.S. Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. In our opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of our financial position and our results of operations and cash flows for periods presented. These statements do not include all disclosures required by U.S. GAAP and should be read in conjunction with our financial statements and accompanying notes for the fiscal year ended December 31, 2025, contained in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 5, 2026. The results of the interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period.

Liquidity and Financial Condition
We have incurred net losses and negative cash flows from operations since our inception in 2005, including a consolidated net loss of $10.8 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $617.0 million. We currently have an “at-the-market” offering program (the Jefferies ATM Offering Program) through an Open Market Sale AgreementSM with Jefferies LLC (Jefferies). We did not utilize the Jefferies ATM Offering Program during the three months ended March 31, 2026. 
We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years at a minimum. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to raise substantial additional capital to fund our operations. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical and clinical development efforts and the timing and nature of the regulatory approval process for our product candidates. We anticipate that we will seek to fund our operations through equity offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements, and when we are closer to commercialization of our product candidates potentially through debt financings. However, we may be unable to raise additional capital or enter into such arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such arrangements when needed would have a negative impact on our financial condition and ability to develop our product candidates.
We believe that our existing cash, cash equivalents, restricted cash and available-for-sale investments of $68.3 million as of March 31, 2026 will be sufficient to meet our material cash requirements from known contractual and other obligations for a period of at least one year from the filing date of this Quarterly Report on Form 10-Q.

Restricted Cash
As of March 31, 2026, restricted cash was approximately $1.8 million, which was held as a security deposit in conjunction with our corporate headquarters facility lease and financing leases as discussed further in Note 4 - Commitments and Contingencies. 

 8

 
  

 Allowance of Credit Losses
For available-for-sale investments 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 investments 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 income (loss) on the unaudited condensed consolidated 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 investments for purposes of identifying and measuring an impairment. Accrued interest receivable on available-for-sale investments is recorded within other receivables on our unaudited condensed consolidated 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.

Use of Estimates
Our unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure for these items in our unaudited condensed consolidated financial statements and accompanying notes. The most significant estimates in our unaudited condensed consolidated financial statements relate to clinical trial and research and development expenses. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ materially from these estimates and assumptions.

Accrued Expenses
Accrued expenses include salaries, wages, benefits costs, consulting fees, legal and research and development costs. We have entered into contractual arrangements related to our clinical studies with clinical research organizations (CROs) and contracted development and manufacturing organizations (CDMOs) and recognize expense based on work completed and efforts expended pursuant to our contractual arrangements. We make estimates of our accrued CRO costs as of each balance sheet date based on facts and circumstances known at the time and include total trial management costs, sites activated, patients enrolled and number of patient visits. We estimate the time period over which services will be performed and the level of effort to be expended in each period. There may be instances in which payments made to our service providers including CROs and CDMOs, will temporarily exceed the level of services provided and result in a prepayment of the expense. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense balance accordingly. Historically, our estimated accrued liabilities have materially approximated actual expenses incurred.

Leases
We determine if an arrangement is a lease at inception. Short-term leases with an initial term of 12 months or less are not recorded on our balance sheet. For long-term leases with an initial term of greater than 12 months, we recognize a right-of-use asset (ROU) and a lease liability based on the present value of future lease payments using an estimated rate of interest that we would pay to borrow equivalent funds on a collateralized basis at the lease commencement date. We determine the lease term at the commencement date by considering whether renewal options and termination options are reasonably assured of exercise. Rent expense for operating leases is recognized on a straight-line basis over the lease term and is included in operating expenses in our unaudited condensed consolidated statements of operations. For financing leases, interest expense and amortization of the ROU is included in operating expenses in our unaudited condensed consolidated statements of operations and variable lease payments are expensed as incurred.
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 ROU asset.
Our ROU assets consist of a non-cancelable operating lease for our corporate headquarters and financing leases for various research and development and information technology equipment.

 9

 
  

 We do not separate lease and non-lease components for our long-term leases.

Revenue Recognition
We evaluate our agreements under Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers and ASC Topic 808, Collaborative Arrangements. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreement, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. We use key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
We recognize revenue in one of two ways, over time or at a point in time. We recognize revenue over time when we are executing on our performance obligation over time and our partner receives benefit over time. For example, we recognize revenue over time when we provide research and development services. We recognize revenue at a point in time when we transfer control of a distinct performance obligation to our partner. For example, if a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. 

Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants for common stock, options and restricted stock units outstanding under our stock option plans and estimated shares to be purchased under our employee stock purchase plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position.
Potentially dilutive securities not considered for the calculation of diluted net loss per share are as follows (in common stock equivalents):

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Common stock options and restricted stock units

  

  

 13,835,392

  

  

  

 9,420,566

  

 

 
 Employee stock purchase plan

  

  

 40,707

  

  

  

 34,143

  

 

 
 Total

  

  

 13,876,099

  

  

  

 9,454,709

  

 

 

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 (CODM) in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in one operating segment, which includes all activities related to the discovery and development of our product candidates. Our CODM is our Chief Executive Officer, who reviews and evaluates consolidated research and development expenses, general and administrative expenses, net loss, net cash used in operating activities and our consolidated cash and cash equivalents for purposes of making operating decisions, allocating resources and planning and forecasting future periods. 

 10

 
  

 The table below summarizes the significant expense categories regularly reviewed by our CODM for the three months ended March 31, 2026 and 2025.
 

 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

 Three Months Ended March 31,

  

 

 
  

  

 2026

  

  

 2025

  

 

 
 Research and development expenses:

  

  

  

  

  

  

 

 
 Efzofitimod expenses

  

 $

 3,535

  

  

 $

 8,804

  

 

 
 Preclinical development and other shared research and development expenses

  

  

 3,355

  

  

  

 2,560

  

 

 
 Non-cash expenses (depreciation and stock-based compensation)

  

  

 427

  

  

  

 450

  

 

 
 Total research and development expenses

  

  

 7,317

  

  

  

 11,814

  

 

 
  

  

  

  

  

  

  

 

 
 General and administrative expenses:

  

  

  

  

  

  

 

 
 Other general and administrative expenses

  

  

 3,076

  

  

  

 3,064

  

 

 
 Non-cash expenses (depreciation and stock-based compensation)

  

  

 1,043

  

  

  

 895

  

 

 
 Total general and administrative expenses

  

  

 4,119

  

  

  

 3,959

  

 

 
  

  

  

  

  

  

  

 

 
 Other segment items (1)

  

  

 644

  

  

  

 892

  

 

 
  

  

  

  

  

  

  

 

 
 Consolidated net loss

  

 $

 (10,792

 )

  

 $

 (14,881

 )

 

 
  

  

  

  

  

  

  

 

 
 (1) Other segment items includes interest income and interest expense.

  

 

 

 
Recent Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items on the face of the income statement. The standard is effective for annual reporting periods beginning after December 15, 2026 and interim periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact of the standard on our consolidated financial statements and related disclosure.

2. Fair Value Measurements 
The carrying amounts of cash equivalents, prepaid and other assets, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. Investment securities are recorded at fair value.
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets.
Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly.
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
Financial assets measured at fair value on a recurring basis consist of investment securities. Investment securities are recorded at fair value, defined as the exit price in the principal market in which we would transact, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Level 2 securities are valued using quoted market prices for similar instruments, non-binding market prices that are corroborated by observable market data, or discounted cash flow techniques and include our investments in commercial paper, corporate debt securities and U.S. government agencies securities. We have no financial liabilities measured at fair value on a recurring basis. None of our non-financial assets and liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented.

 11

 
  

 Assets measured at fair value on a recurring basis are as follows (in thousands):
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

  

  

  

 Fair Value Measurements Using

  

 

 
  

  

 Total

  

  

 Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)

  

  

 Significant
Other
Observable
Inputs
(Level 2)

  

  

 Significant
Unobservable
Inputs
(Level 3)

  

 

 
 As of March 31, 2026

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Assets:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Current:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Cash equivalents

  

 $

 7,345

  

  

 $

 7,345

  

  

 $

 —

  

  

 $

 —

  

 

 
 Available-for-sale investments:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Commercial paper

  

  

 23,753

  

  

  

 —

  

  

  

 23,753

  

  

  

 —

  

 

 
 Corporate debt securities

  

  

 27,729

  

  

  

 —

  

  

  

 27,729

  

  

  

 —

  

 

 
 Municipal bonds

  

  

 5,023

  

  

  

 —

  

  

  

 5,023

  

  

  

 —

  

 

 
 Total available-for-sale investments

  

  

 56,505

  

  

  

 —

  

  

  

 56,505

  

  

  

 —

  

 

 
 Total assets measured at fair value

  

 $

 63,850

  

  

 $

 7,345

  

  

 $

 56,505

  

  

 $

 —

  

 

  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

  

  

  

 Fair Value Measurements Using

  

 

 
  

  

 Total

  

  

 Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)

  

  

 Significant
Other
Observable
Inputs
(Level 2)

  

  

 Significant
Unobservable
Inputs
(Level 3)

  

 

 
 As of December 31, 2025

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Assets:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Current:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Cash equivalents

  

 $

 7,916

  

  

 $

 7,916

  

  

 $

 —

  

  

 $

 —

  

 

 
 Available-for-sale investments:

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Commercial paper

  

  

 33,626

  

  

  

 —

  

  

  

 33,626

  

  

  

 —

  

 

 
 Corporate debt securities

  

  

 29,281

  

  

  

 —

  

  

  

 29,281

  

  

  

 —

  

 

 
 Municipal bonds

  

  

 5,037

  

  

  

 —

  

  

  

 5,037

  

  

  

 —

  

 

 
 Total available-for-sale investments

  

  

 67,944

  

  

  

 —

  

  

  

 67,944

  

  

  

 —

  

 

 
 Total assets measured at fair value

  

 $

 75,860

  

  

 $

 7,916

  

  

 $

 67,944

  

  

 $

 —

  

 

 
As of March 31, 2026 and December 31, 2025, available-for-sale investments are detailed as follows (in thousands): 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

  

  

 March 31, 2026

  

 

 
  

  

 Contractual Maturity

  

 Gross
Amortized
Cost

  

  

 Gross
Unrealized
Gains

  

  

 Gross
Unrealized
Losses

  

  

 Market Value

  

 

 
 Available-for-sale investments:

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Commercial paper

  

 Within 1 year

  

 $

 23,756

  

  

 $

 3

  

  

 $

 (6

 )

  

 $

 23,753

  

 

 
 Corporate debt securities

  

 Within 1 year

  

  

 27,747

  

  

  

 —

  

  

  

 (18

 )

  

  

 27,729

  

 

 
 Municipal bonds

  

 Within 1 year

  

  

 5,022

  

  

  

 1

  

  

  

 —

  

  

  

 5,023

  

 

 
  

  

  

  

 $

 56,525

  

  

 $

 4

  

  

 $

 (24

 )

  

 $

 56,505

  

 

  
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
  

  

  

  

 December 31, 2025

  

 

 
  

  

 Contractual Maturity

  

 Gross
Amortized
Cost

  

  

 Gross
Unrealized
Gains

  

  

 Gross
Unrealized
Losses

  

  

 Market Value

  

 

 
 Available-for-sale investments:

  

  

  

  

  

  

  

  

  

  

  

  

  

  

 

 
 Commercial paper

  

 Within 1 year

  

 $

 33,602

  

  

 $

 24

  

  

 $

 —

  

  

 $

 33,626

  

 

 
 Corporate debt securities

  

 Within 1 year

  

  

 29,269

  

  

  

 17

  

  

  

 (5

 )

  

  

 29,281

  

 

 
 Municipal bonds

  

 Within 1 year

  

  

 5,031

  

  

  

 6

  

  

  

 —

  

  

  

 5,037

  

 

 
  

  

  

  

 $

 67,902

  

  

 $

 47

  

  

 $

 (5

 )

  

 $

 67,944

  

 

  

 12

 
  

 We evaluate our available-for-sale debt securities for credit losses when the amortized cost basis exceeds fair value. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in interest income through an allowance account. Unrealized gains and losses that are not credit-related are included in accumulated other comprehensive loss. When evaluating an investment for impairment, we review factors such as the severity of the impairment, changes in underlying credit ratings, our intent to sell or the likelihood that we would be required to sell the investment before its anticipated recovery in market value and the probability that the scheduled cash payments will continue to be made. We recorded no allowance for credit losses in the unaudited condensed consolidated statements of operations and comprehensive loss during the three months ended March 31, 20