What changed in this filing

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Item 1. Financial Statements

2025-10-30 compared with 2025-08-05 · 182 added, 202 removed, 666 unchanged (37% of the section changed)

3 unchanged sentences

(in thousands, except share and par value data)

June 30, 2025

September 30, 2025

December 31, 2024

24 unchanged sentences

Class A common stock, $ 0.001 par value;

authorized shares— 200,000,000 at June 30, 2025 and December 31, 2024;

issued and outstanding shares— 19,190,723 and 19,125,377 at June 30, 2025 and December 31, 2024, respectively.

authorized shares— 200,000,000 at September 30, 2025 and December 31, 2024;

issued and outstanding shares— 22,765,839 and 19,125,377 at September 30, 2025 and December 31, 2024, respectively.

Class B common stock, $ 0.001 par value;

authorized shares— 20,000,000 at June 30, 2025 and December 31, 2024;

issued and outstanding shares— 6,729,172 at June 30, 2025 and December 31, 2024.

authorized shares— 20,000,000 at September 30, 2025 and December 31, 2024;

issued and outstanding shares— 6,416,672 and 6,729,172 at September 30, 2025 and December 31, 2024, respectively.

Preferred stock, $ 0.001 par value;

authorized shares— 10,000,000 at June 30, 2025 and December 31, 2024;

no shares issued or outstanding at June 30, 2025 and December 31, 2024.

authorized shares— 10,000,000 at September 30, 2025 and December 31, 2024;

no shares issued or outstanding at September 30, 2025 and December 31, 2024.

Additional paid-in-capital

11 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended Six Months Ended

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

Research and development

$ 14,063 $ 7,901 $ 27,775 $ 15,679

General and administrative

3,839 3,043 8,237 5,195

Total operating expenses

17,902 10,944 36,012 20,874

Loss from operations

( 17,902 ) ( 10,944 ) ( 36,012 ) ( 20,874 )

Other income (expense):

Interest income

2,029 2,001 4,279 3,637

Change in fair value of warrant liability

— 11 — ( 107 )

Other expense, net

( 167 ) ( 77 ) ( 297 ) ( 82 )

Other income (expense), net

Total other income, net

1,862 1,935 3,982 3,448

$ ( 16,040 ) $ ( 9,009 ) $ ( 32,030 ) $ ( 17,426 )

Other comprehensive income (loss):

Unrealized gain (loss) on marketable securities

( 23 ) ( 69 ) 76 ( 235 )

Other comprehensive income:

Unrealized gain on marketable securities

Comprehensive loss

$ ( 16,063 ) $ ( 9,078 ) $ ( 31,954 ) $ ( 17,661 )

Net loss per share, basic and diluted (a)

$ ( 0.62 ) $ ( 0.39 ) $ ( 1.24 ) $ ( 1.35 )

Weighted-average shares of common stock outstanding, basic and diluted

_____________

Basic and diluted per share amounts are the same for Class A and Class B shares.

8 unchanged sentences

Balance at December 31, 2024

25,854,549 $ 26 $ 315,371 $ 71 $ ( 117,402 ) $ 198,066

Exercise of stock options

17,000 — 24 — — 24

Stock-based compensation

— — 2,569 — — 2,569

— — — — ( 15,990 ) ( 15,990 )

Unrealized gain on marketable securities

— — — 99 — 99

Balance at March 31, 2025

25,871,549 $ 26 $ 317,964 $ 170 $ ( 133,392 ) $ 184,768

Shares purchased through employee stock purchase plan

48,346 — 267 — — 267

Stock-based compensation

— — 2,418 — — 2,418

— — — — ( 16,040 ) ( 16,040 )

Unrealized loss on marketable securities

— — — ( 23 ) — ( 23 )

Balance at June 30, 2025

25,919,895 $ 26 $ 320,649 $ 147 $ ( 149,432 ) $ 171,390

Convertible Class A and Class B Additional Accumulated Other Total

Issuance of common stock in at-the-market offering, net of issuance costs

Exercise of stock options

Stock-based compensation

Unrealized gain on marketable securities

Balance at September 30, 2025

Convertible Class A and Class B Additional

Accumulated Other Total

Preferred Stock

29 unchanged sentences

— $ — 25,723,276 $ 26 $ 310,174 $ ( 127 ) $ ( 92,570 ) $ 217,503

Exercise of stock options

— — 12,800 — 13 — — 13

Stock-based compensation

— — — — 2,291 — — 2,291

— — — — — — ( 10,267 ) ( 10,267 )

Unrealized gain on marketable securities

— — — — — 688 — 688

Balance at September 30, 2024

— $ — 25,736,076 $ 26 $ 312,478 $ 561 $ ( 102,837 ) $ 210,228

The accompanying notes are an integral part of these unaudited condensed financial statements.

2 unchanged sentences

(in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities

$ ( 32,030 ) $ ( 17,426 )

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

3 unchanged sentences

Accretion of premiums/discounts on marketable securities, net

( 692 ) ( 2,092 )

Change in fair value of warrant liability

Loss on disposal of property and equipment

Gain on sale of equipment

Gain on marketable securities

4 unchanged sentences

Accrued expenses

( 2,964 ) ( 1,841 )

Operating lease liabilities

Net cash used in operating activities

( 30,073 ) ( 16,474 )

Investing activities

Purchase of property and equipment

( 91 ) ( 266 )

Proceeds from sale of equipment

Purchases of marketable securities

( 59,128 ) ( 99,649 )

Sales and maturities of marketable securities

88,018 69,747

Net cash provided by (used in) investing activities

28,799 ( 30,168 )

Financing activities

1 unchanged sentence

Proceeds from issuance of common stock upon initial public offering, net of underwriting discounts and commissions and other offering costs

Proceeds from issuance of common stock in at-the-market offering, net of commissions and other offering costs

Proceeds from exercise of stock options

1 unchanged sentence

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

( 1,159 ) 61,704

Net increase in cash and cash equivalents

Cash and cash equivalents at beginning of period

21,943 15,526

Cash and cash equivalents at end of period

$ 20,784 $ 77,230

Supplemental disclosure of noncash investing and financing activities

24 unchanged sentences

Since its inception, the Company has devoted substantially all its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital to support and expand such activities and providing general and administrative support for these operations.

The Company incurred a net loss of $ 16.0 million and $ 32.0 million for the three and six months ended June 30, 2025 , respectively.

The Company had an accumulated deficit of $ 149.4 million as of June 30, 2025 .

From its inception through June 30, 2025 , the Company has financed its operations primarily through issuance of convertible promissory notes, convertible preferred stock financings, a term loan, a global license and development agreement (the “J&J License Agreement”) the Company entered in February 2023 with Janssen Pharmaceutica NV, a Johnson & Johnson company, and net proceeds of approximately $ 107.9 million received in April 2024 from the IPO.

As of June 30, 2025 , the Company had cash, cash equivalents and marketable securities of $ 175.5 million.

The Company incurred a net loss of $ 12.8 million and $ 44.8 million for the three and nine months ended September 30, 2025 , respectively.

The Company had an accumulated deficit of $ 162.2 million as of September 30, 2025 .

From its inception through September 30, 2025 , the Company has financed its operations primarily from the sale of equity securities and convertible equity securities, borrowings under credit facilities, a global license and development agreement (the “J&J License Agreement”) the Company entered in February 2023 with Janssen Pharmaceutica NV, a Johnson & Johnson company, net proceeds of approximately $ 107.9 million received in April 2024 from the IPO.

In May 2025, the Company entered into a Sales Agreement with Leerink Partners LLC (the “Sales Agreement”) relating to the offer and sale of up to $ 75.0 million in shares of its Class A common stock, par value $ 0.001 per share (the “Shares”) in an “at-the-market” offering program (the “ATM Program”).

During the three months ended September 30, 2025, the Company sold 3,241,110 shares of its Class A common stock pursuant to the Sales Agreement.

The shares of Class A common stock were sold at a weighted average price of $ 6.04 per share, resulting in gross proceeds of $ 19.6 million.

The Company raised $ 19.0 million in net proceeds after deducting sales agent commissions and offering costs of $ 0.6 million.

As of September 30, 2025 , the Company had cash, cash equivalents and marketable securities of $ 182.4 million.

Management believes the Company's existing cash, cash equivalents and marketable securities will be sufficient to support its operations for at least 12 months from the issuance date of these unaudited condensed financial statements.

4 unchanged sentences

Unaudited Interim Condensed Financial Statements

The condensed balance sheet as of June 30, 2025 , condensed statements of operations and comprehensive loss and condensed statements of convertible preferred stock and stockholders’ equity (deficit) for the three and six months ended June 30, 2025 and 2024, and condensed statements of cash flows for the six months ended June 30, 2025 and 2024, and related notes to condensed financial statements are unaudited.

The condensed balance sheet as of September 30, 2025 , condensed statements of operations and comprehensive loss and condensed statements of convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2025 and 2024, and condensed statements of cash flows for the nine months ended September 30, 2025 and 2024, and related notes to condensed financial statements are unaudited.

These unaudited interim condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the periods presented.

The condensed results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period.

The condensed results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period.

The condensed balance sheet as of December 31, 2024 included herein was derived from the audited financial statements as of that date.

1 unchanged sentence

Summary of Significant Accounting Policies

During the six months ended June 30, 2025 , there were no significant changes to the Company's significant accounting policies as described in the Company's Annual Report on Form 10 -K for the year ended December 31, 2024, filed with the SEC on March 6, 2025.

During the nine months ended September 30, 2025 , there were no significant changes to the Company's significant accounting policies as described in the Company's Annual Report on Form 10 -K for the year ended December 31, 2024, filed with the SEC on March 6, 2025.

Basis of Presentation

43 unchanged sentences

The following table summarizes the amortized cost and fair value of the Company’s marketable securities by major investment category (in thousands):

June 30, 2025

September 30, 2025

Maturity in Years

2 unchanged sentences

3 years or less

$ 55,740 $ 91 $ ( 27 ) $ 55,804

Certificate of deposit

6,199 2 ( 1 ) 6,200

Corporate debt securities

2 years or less

67,326 57 ( 13 ) 67,370

Commercial paper

10,609 4 ( 1 ) 10,612

2,336 1 ( 1 ) 2,336

Asset-backed securities

3 years or less

12,343 35 — 12,378

Total $ 154,553 $ 190 $ ( 43 ) $ 154,700

December 31, 2024

3 unchanged sentences

3 years or less

$ 57,232 $ 57 $ ( 134 ) $ 57,155

Certificate of deposit

8,519 6 ( 1 ) 8,524

Corporate debt securities

2 years or less

80,751 110 ( 39 ) 80,822

Commercial paper

22,265 11 ( 1 ) 22,275

2,145 1 — 2,146

Asset-backed securities

2 years or less

11,834 61 — 11,895

Total $ 182,746 $ 246 $ ( 175 ) $ 182,817

The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, current and expected future economic conditions.

The Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis.

As of June 30, 2025 and December 31, 2024, the Company did not record an allowance for credit loss related to its investment portfolio.

As of June 30, 2025 , 62 out of 237 of our available-for-sale debt securities were in an aggregate gross unrealized loss position.

As of September 30, 2025 and December 31, 2024, the Company did not record an allowance for credit loss related to its investment portfolio.

As of September 30, 2025 , 18 out of 219 of our available-for-sale debt securities were in an aggregate gross unrealized loss position.

As of December 31, 2024, 86 out of 252 of our available-for-sale debt securities were in an aggregate gross unrealized loss position.

As of June 30, 2025 and December 31, 2024, all of our available-for-sale debt securities in an unrealized loss position for which an allowance for credit losses has not been recorded had continuous unrealized loss positions of less than 12 months.

As of September 30, 2025 and December 31, 2024, all of our available-for-sale debt securities in an unrealized loss position for which an allowance for credit losses has not been recorded had continuous unrealized loss positions of less than 12 months.

The following tables summarize our available-for-sale debt securities in an unrealized loss position for which an allowance for credit losses has not been recorded, aggregated by major security type (in thousands):

June 30, 2025

Fair Value Unrealized Losses

September 30, 2025

Unrealized Losses

Government agency securities

Certificate of deposit 3,806 ( 1 )

Corporate debt securities

Commercial paper 4,590 ( 1 )

Yankee debt 1,516 ( 1 )

Total $ 53,859 $ ( 43 )

December 31, 2024

Fair Value Unrealized Losses

Unrealized Losses

Government agency securities

2 unchanged sentences

Commercial paper

Total $ 60,961 $ ( 175 )

Fair Value Measurements

9 unchanged sentences

Fair Value Measurements Using

Quoted Prices in Significant Other Significant

Quoted Prices in

Significant Other

Active Markets

1 unchanged sentence

Assets (Level 1)

As of June 30, 2025:

September 30, 2025:

Cash equivalents

$ 19,848 $ 19,848 $ — $ —

Government agency securities

55,804 55,804 — —

Certificates of deposits

6,200 — 6,200 —

Corporate debt securities

67,370 — 67,370 —

Commercial paper

10,612 — 10,612 —

2,336 — 2,336 —

Asset-backed securities

12,378 — 12,378 —

Total financial assets

$ 174,548 $ 75,652 $ 98,896 $ —

As of December 31, 2024:

December 31, 2024:

Cash equivalents

$ 21,042 $ 21,042 $ — $ —

Government agency securities

57,155 57,155 — —

Certificates of deposits

8,524 — 8,524 —

Corporate debt securities

80,822 — 80,822 —

Commercial paper

22,275 — 22,275 —

2,146 — 2,146 —

Asset-backed securities

11,895 — 11,895 —

Total financial assets

$ 203,859 $ 78,197 $ 125,662 $ —

The carrying amounts of the Company’s financial instruments, including cash, cash equivalents and marketable securities, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities.

Included in cash and cash equivalents at June 30, 2025 and December 31, 2024 are money market funds with a carrying value and fair value of $ 2.2 million and $ 3.9 million, respectively, based upon a Level 1 fair value assessment.

The carrying amounts of the Company’s financial instruments, including cash, cash equivalents, prepaid and other current assets, accounts payable, and accrued liabilities, approximate fair value due to their short maturities.

Included in cash and cash equivalents at September 30, 2025 and December 31, 2024 are money market funds with a carrying value and fair value of $ 8.8 million and $ 3.9 million, respectively, based upon a Level 1 fair value assessment.

Accrued Expenses

Accrued expenses consisted of the following (in thousands):

September 30,

Accrued compensation expenses

$ 1,770 $ 3,338

Accrued research and development expenses

2 unchanged sentences

Total accrued expenses

$ 3,747 $ 6,711

Stockholders ’ Equity (Deficit)

Sales Agreement

In May 2025, the Company entered into a Sales Agreement (the “Agreement”) with Leerink Partners LLC (“Leerink Partners”) relating to the offer and sale of up to $ 75.0 million in shares of its Class A common stock, par value $ 0.001 per share (the “Shares”).

The Company is not obligated to make any sales of Shares under the Agreement.

Any sales under the Agreement will be made pursuant to an “at-the-market offering” (the “ATM Program”) in accordance with Rule 415 (a)( 4 ) under the Securities Act of 1933, as amended.

The Company has not sold any shares of its Class A common stock under the Agreement during the three months ended June 30, 2025.

In May 2025, the Company entered into the Sales Agreement.

During the three months ended September 30, 2025, the Company sold 3,241,110 shares of its Class A common stock pursuant to the Sales Agreement.

The shares of Class A common stock were sold at a weighted average price of $ 6.04 per share, resulting in gross proceeds of $ 19.6 million.

The Company raised $ 19.0 million in net proceeds after deducting sales agent commissions and offering costs of $ 0.6 million.

The Company has two classes of common stock:

1 unchanged sentence

Class A common stock has one vote per share and Class B common stock has no votes per share.

As of June 30, 2025 , of the authorized 200,000,000 shares of Class A common stock, 19,190,723 shares of Class A common stock were issued and outstanding, and of the authorized 20,000,000 shares of Class B common stock, 6,729,172 shares of Class B common stock were issued and outstanding.

As of September 30, 2025 , of the authorized 200,000,000 shares of Class A common stock, 22,765,839 shares of Class A common stock were issued and outstanding, and of the authorized 20,000,000 shares of Class B common stock, 6,416,672 shares of Class B common stock were issued and outstanding.

As of September 30, 2024 , of the authorized 200,000,000 shares of Class A common stock, 19,006,904 shares of Class A common stock were issued and outstanding, and of the authorized 20,000,000 shares of Class B common stock, 6,729,172 shares of Class B common stock were issued and outstanding.

The following table summarizes the changes in Class A common stock and Class B common stock for the nine months ended September 30, 2025 ( in shares):

Class A Class B

Balance at December 31, 2024 19,125,377 6,729,172

Exercise of stock options 17,000 —

Balance at March 31, 2025 19,142,377 6,729,172

Shares purchased through employee stock purchase plan 48,346 —

Balance at June 30, 2025 19,190,723 6,729,172

Issuance of common stock in at-the-market offering 3,241,110 —

Conversion of Class B common stock into Class A common stock 312,500 ( 312,500 )

Exercise of stock options 21,506 —

Balance at September 30, 2025 22,765,839 6,416,672

The following table summarizes the changes in Class A common stock and Class B common stock for the nine months ended September 30, 2024 ( in shares):

Class A Class B

Balance at December 31, 2023 2,349,554 —

Exercise of stock options 34,872 —

Balance at March 31, 2024 2,384,426 —

Issuance of common stock in connection with initial public offering 7,423,682 —

Conversion of convertible preferred stock to common stock upon initial public offering 9,177,064 6,729,172

Exercise of stock options 8,932 —

Balance at June 30, 2024 18,994,104 6,729,172

Exercise of stock options 12,800 —

Balance at September 30, 2024 19,006,904 6,729,172

Class A common stock reserved for future issuance consisted of the following:

September 30,

Common stock options granted and outstanding

8 unchanged sentences

7,747,997 5,997,577

There are no shares of Class B common stock reserved for future issuance as of June 30, 2025 and December 31, 2024.

There are no shares of Class B common stock reserved for future issuance as of September 30, 2025 and December 31, 2024.

Stock Options

4 unchanged sentences

The number of shares initially reserved for issuance under the 2024 Plan was 2,700,000 .

As of June 30, 2025 , there were 1,700,924 shares of the Company’s Class A common stock available for issuance under the 2024 Plan.

As of September 30, 2025 , there were 1,662,457 shares of the Company’s Class A common stock available for issuance under the 2024 Plan.

The aggregate number of shares reserved for issuance under the 2024 Plan will automatically increase on the first day of each fiscal year of the Company, commencing in 2025 and ending in (and including) 2034, by a number equal to the lesser of (a) 5 % of the aggregate shares of Class A common stock and Class B common stock issued and outstanding as of the last day of the prior fiscal year, or (b) a number of shares of Class A common stock determined by the Company's board of directors.

22 unchanged sentences

( 4,956 ) 9.67 — —

Balance at June 30, 2025

Balance at September 30, 2025

5,597,573 $ 9.41 7.55 $ 19,858

Options vested and expected to vest as of June 30, 2025

Options vested and expected to vest as of September 30, 2025

5,571,573 $ 9.44 7.54 $ 19,669

Options exercisable as of June 30, 2025

Options exercisable as of September 30, 2025

2,749,352 $ 7.71 6.02 $ 13,611

The aggregate intrinsic value of options exercised during the six months ended June 30, 2025 and 2024 was $ 0.2 million and $ 0.4 million, respectively, determined as of the date of exercise.

The aggregate intrinsic value of options exercised during the nine months ended September 30, 2025 and 2024 was $ 0.3 million and $ 0.6 million, respectively, determined as of the date of exercise.

Options exercisable include options which are not vested but are available to be early exercised.

As of June 30, 2025 , there were no options available to be early exercised.

As of September 30, 2025 , there were no options available to be early exercised.

As of December 31, 2024, of the 2,114,772 options exercisable, 35,794 options were available to be early exercised.

3 unchanged sentences

The fair value of stock options expected to vest was estimated using the following weighted-average assumptions:

Three Months Ended Six Months Ended

Three Months Ended September 30,

Nine Months Ended September 30,

Expected term (in years)

5 unchanged sentences

Dividend yield

The weighted-average grant-date fair value per share of stock options granted and expected to vest as of their grant date during the three months ended June 30, 2025 and 2024 wa s $ 3.33 and $ 13.53 per share, respectively.

The weighted-average grant-date fair value per share of stock options granted and expected to vest as of their grant date during the six months ended June 30, 2025 and 2024 wa s $ 6.37 and $ 13.55 per share, respectively.

The Company recorded $ 1.3 million and $ 1.1 million in stock-based compensation in general and administrative and research and development, respectively, for the three months ended June 30, 2025 .

The Company recorded $ 0.9 million and $ 0.6 million in stock-based compensation in general and administrative and research and development, respectively, for the three months ended June 30, 2024 .

The Company recorded $ 2.8 million and $ 2.2 million in stock-based compensation in general and administrative and research and development, respectively, for the six months ended June 30, 2025 .

The Company recorded $ 1.3 million and $ 1.0 million in stock-based compensation in general and administrative and research and development, respectively, for the six months ended June 30, 2024 .

As of June 30, 2025 , there was approximately $ 25.4 million of total unrecognized stock-based compensation related to stock-based compensation arrangements, which is expected to be recognized over a weighted-average period of approximately 2.9 years.

The weighted-average grant-date fair value per share of stock options granted and expected to vest as of their grant date during the three months ended September 30, 2025 and 2024 was $ 4.84 and $ 16.21 per share, respectively.

The weighted-average grant-date fair value per share of stock options granted and expected to vest as of their grant date during the nine months ended September 30, 2025 and 2024 was $ 6.33 and $ 13.63 per share, respectively.

Stock-based compensation

Stock-based compensation has been reported in the condensed statements of operations and comprehensive loss as follows (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

Research and development $ 1,176 $ 922 $ 3,353 $ 1,930

General and administrative 1,393 1,369 4,203 2,623

Total $ 2,569 $ 2,291 $ 7,556 $ 4,553

As of September 30, 2025 , there was approximately $ 23.1 million of total unrecognized stock-based compensation related to stock-based compensation arrangements, which is expected to be recognized over a weighted-average period of approximately 2.7 years.

Employee Stock Purchase Plan

4 unchanged sentences

The number of shares initially reserved for issuance under the 2024 ESPP was 280,000 .

As of June 30, 2025 , there were 472,203 shares of the Company’s common stock reserved and available for issuance under the 2024 ESPP.

As of September 30, 2025 , there were 472,203 shares of the Company’s common stock reserved and available for issuance under the 2024 ESPP.

The number of shares reserved for issuance under the 2024 ESPP will automatically increase on the first day of each fiscal year of the Company, commencing in 2025 and ending in (and including) 2044, by a number equal to the lesser of (i) 280,000 shares, (ii) 1 % of the aggregate shares of Class A common stock and Class B common stock issued and outstanding on the last day of the prior fiscal year, or (iii) a number of shares determined by the Company's board of directors.

The number of shares reserved under the 2024 ESPP will automatically be adjusted in the event of a stock split, stock dividend or a reverse stock split (including an adjustment to the per-purchase period share limit).

During the six months ended June 30, 2025 , there were 48,346 shares purchased under the 2024 ESPP and the recorded expense was $ 0.1 million.

During the six months ended June 30, 2024 , there were no shares purchased under the 2024 ESPP and the recorded expense was not material.

During the three months ended September 30, 2025 , there were no shares purchased under the 2024 ESPP and the recorded expense was not material.

During the nine months ended September 30, 2025 , there were 48,346 shares purchased under the 2024 ESPP and the recorded expense was $ 0.1 million.

During the three and nine months ended September 30, 2024 , there were no shares purchased under the 2024 ESPP and the recorded expense was not material.

License Agreement

13 unchanged sentences

The remaining consideration consists of future contingent milestone-based payments and sales-based royalties.

As of June 30, 2025 , all variable consideration under the J&J License Agreement was fully constrained.

As of September 30, 2025 , all variable consideration under the J&J License Agreement was fully constrained.

In August 2023, the Company elected to conduct a Phase 2 trial using PIPE- 307 for patients with multiple sclerosis, which was considered a contract modification under the accounting guidance that added promised goods or services that are distinct at a price that is below the standalone selling price.

3 unchanged sentences

Accordingly, the variable consideration allocated to the Phase 2 trial will be recognized as the study is completed using a cost-based measure of progress and when the amounts are no longer probable of a significant reversal.

As of June 30, 2025 , no amounts had been recognized related to the Phase 2 trial as no additional variable consideration has been received subsequent to the contract modification.

As of September 30, 2025 , no amounts had been recognized related to the Phase 2 trial as all remaining variable consideration was fully constrained subsequent to the contract modification.

Commitments and Contingencies

Operating Lease

The Company leases office and lab space in San Diego, California under a non-cancelable operating lease (“Science Center Drive Lease”).

The lease commenced in March 2018 and has a 5 -year initial term.

The lease includes a renewal option, which includes an option to renew for five additional years.

During 2021, the Company amended the lease to include additional space in the building with the right to use the new space beginning in October 2021, for an additional 3 years.

In October 2023, the Company executed a noncancelable operating lease for new premises to be used for office, research and development and laboratory purposes (“General Atomics Court Lease”), with the same landlord as the Science Center Drive Lease.

9 unchanged sentences

Below is a summary of the Company’s operating lease right-of-use assets and lease liabilities (in thousands, except for years and %):

June 30, December 31,

September 30,

Operating lease right-of-use assets

$ 4,774 $ 5,467

Operating lease liability obligations, current

$ 1,477 $ 1,452

Operating lease liability obligations, less current portion

Total lease liability obligations

$ 5,493 $ 6,259

Weighted-average remaining lease term

Weighted-average discount rate

During the three months ended June 30, 2025 and 2024, the Company recognized $ 0.4 million and $ 0.3 million, respectively, in operating lease expenses, which are included in operating expenses in the Company's statements of operations and comprehensive loss.

During the six months ended June 30, 2025 and 2024, the Company recognized $ 0.8 million and $ 0.6 million, respectively, in operating lease expenses, which are included in operating expenses in the Company's statements of operations and comprehensive loss.

During the three months ended September 30, 2025 and 2024, the Company recognized $ 0.4 million and $ 0.3 million, respectively, in operating lease expenses, which are included in operating expenses in the Company's statements of operations and comprehensive loss.

During the nine months ended September 30, 2025 and 2024, the Company recognized $ 1.2 million and $ 0.9 million, respectively, in operating lease expenses, which are included in operating expenses in the Company's statements of operations and comprehensive loss.

Supplemental cash flow information related to operating leases are as follows (in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

Cash paid for amounts included in the measurement of lease liabilities

Future minimum lease payments for the Company’s operating lease liabilities as of June 30, 2025 are as follows (in thousands):

Future minimum lease payments for the Company’s operating lease liabilities as of September 30, 2025 are as follows (in thousands):

Total minimum lease payments

4 unchanged sentences

From time to time, the Company may become involved in various legal proceedings and claims that arise in the ordinary course of our business activities.

As of June 30, 2025 , the Company was not currently a party to any material legal proceedings.

As of September 30, 2025 , the Company was not currently a party to any material legal proceedings.

Other Commitments

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The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts):

Three Months Ended

Six Months Ended

Three Months Ended September 30,

Nine Months Ended September 30,

Net loss applicable to common stockholders

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Basic and diluted

For the three and six months ended June 30, 2025 and 2024, net loss is attributable equally to each share of Class A common stock and Class B common stock and is determined based on the weighted-average number of the respective class of common stock outstanding.

For the three and nine months ended September 30, 2025 and 2024, net loss is attributable equally to each share of Class A common stock and Class B common stock and is determined based on the weighted-average number of the respective class of common stock outstanding.

Weighted-average common shares include shares of the Company's Class A common stock and Class B common stock.

The basic and diluted net loss per share amounts are the same for Class A common stock and Class B common stock.

The Company’s potentially dilutive securities, which include common stock options and a common stock warrant have been excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2025 and 2024 , as the effect would reduce the net loss per share.

The Company’s potentially dilutive securities, which include common stock options and a common stock warrant have been excluded from the computation of diluted net loss per share for the three and nine months ended September 30, 2025 and 2024 , as the effect would reduce the net loss per share.

Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

The following potentially dilutive securities have been excluded from the diluted per share calculation for the periods presented as they would be anti-dilutive:

September 30,

Common stock options

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Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Significant and other segment expenses

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Unallocated internal research and development costs include employee-related expenses that cannot be directly attributable to a specific research project, stock-based compensation for employees engaged in research and development functions, facilities, depreciation and other related expenses.

Other segment items primarily include change in fair value of warrant liability and other expense, net.

Subsequent Events

In July 2025, the Company closed an at-the-market (“ATM”) offering of 2,122,000 shares of its Class A common stock.

The shares of Class A common stock were sold at a weighted average price of $ 4.03 per share, resulting in gross proceeds of $ 8.6 million.

The Company raised $ 8.4 million in net proceeds after deducting sales agent commissions of $ 0.2 million.

Other segment items primarily include change in fair value of warrant liability and other income (expense), net.

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

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We are developing PIPE-307 in collaboration with J&J.

Our wholly-owned lead asset, PIPE-791, is a novel, brain penetrant, small molecule inhibitor of the lysophosphatidic acid 1 receptor (“LPA1R”) in development for idiopathic pulmonary fibrosis (“IPF”), progressive multiple sclerosis (“PrMS”), and chronic pain.

LPA1R antagonism is a clinically validated mechanism in IPF, and we believe that our preclinical studies and Phase 1 healthy volunteer data support the development of PIPE-791 for IPF, as well as PrMS and chronic pain.

Specifically, based on its high bioavailability, low plasma protein binding, and long receptor occupancy time in our preclinical studies compared to the preclinical data of other LPA1R antagonists, we believe PIPE-791 has the potential to be a differentiated LPA1R therapy.

We have completed a Phase 1 clinical trial of PIPE-791 in healthy volunteers in support of clinical development in IPF, PrMS and chronic pain.

In December 2024, we commenced a Phase 1b open-label trial to measure the relationship of pharmacokinetics to lung and brain receptor occupancy by positron emission tomography (“PET”) imaging.

We expect the topline data from this trial will be available in the third quarter of 2025.

This Phase 1b PET trial, along with our preclinical studies data, will inform dose selection in our future Phase 2 trials of PIPE-791.

We plan to initiate a Phase 2 global proof-of-concept clinical trial in IPF in the fourth quarter of 2025.

We have completed a Phase 1 clinical trial of PIPE-791 in healthy volunteers in support of clinical development in IPF and chronic pain as well as a Phase 1b open-label trial to measure the relationship of pharmacokinetics (“PK”) to lung and brain receptor occupancy by positron emission tomography (“PET”) imaging to inform dose selection in our future Phase 2 trials of PIPE-791.

We plan to initiate a global Phase 2 clinical trial in IPF in the fourth quarter of 2025.

In March 2025, we announced the initiation of patient dosing in an exploratory PIPE-791 Phase 1b, randomized, double-blind, placebo-controlled, crossover, chronic pain trial for the treatment of chronic pain associated with two separate indications, chronic osteoarthritis and chronic low back pain.

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In addition, we are leveraging our drug discovery capabilities to expand our clinical portfolio.

In January 2024, we nominated and commenced preclinical studies for CTX-343, a peripherally-restricted (unable to access the central nervous system) LPA1R antagonist.

In parallel, we are actively conducting preclinical and discovery-phase experiments targeting other NI&I indications where our internally-discovered molecules may have therapeutic potential.

We are actively conducting preclinical and discovery-phase experiments targeting other NI&I indications where our internally-discovered molecules may have therapeutic potential.

We have a portfolio of novel and proprietary small molecule programs that we believe can modulate innate pathways to restore function in NI&I indications.

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We are conducting, at our own expense, a Phase 2 clinical trial of PIPE-307 in patients with RRMS.

We completed enrollment of our Phase 2 clinical trial in December 2024, and expect the topline data from this trial will be available in the third quarter of 2025.

J&J has the right to discontinue our clinical trial if it has good faith concerns that this trial presents safety risks or could have a material adverse effect on its development or commercialization of PIPE-307.

In addition, J&J has the right, in its sole discretion, to further develop or to elect not to develop PIPE-307 for this indication.

We completed enrollment of our Phase 2 clinical trial in December 2024, and expect the topline data from this trial will be available in the fourth quarter of 2025.

J&J has the right, in its sole discretion, to further develop or to elect not to develop PIPE-307 for this indication.

In December 2024, J&J began recruiting an estimated 124 adult participants for a Phase 2 trial of PIPE-307/JNJ-89495120 for the potential treatment of MDD.

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We do not have any products approved for sale and we have not yet generated any revenue from product sales.

We did not recognize any revenue for the three and six months ended June 30, 2025 or 2024.

We did not recognize any revenue for the three and nine months ended September 30, 2025 or 2024.

Operating Expenses

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Certain employee activities that cannot be allocated to any one specific project or management related activities are considered indirect costs.

The following tables summarize our research and development expenses for the three and six months ended June 30, 2025 and 2024.

The following tables summarize our research and development expenses for the three and nine months ended September 30, 2025 and 2024.

The direct external development program expenses reflect external costs attributable to our clinical development and preclinical programs and personnel costs that can be directly attributed to a development program.

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Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

(in thousands)

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Results of Operations

Comparison of the Three Months Ended June 30, 2025 and 2024

Comparison of the Three Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations (in thousands) for the periods indicated:

Three Months Ended

September 30,

Operating expenses:

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Change in fair value of warrant liability

Other expense, net

Other income (expense), net

Total other income, net

Research and development expenses .

Research and development expenses were $14.1 million and $7.9 million for the three months ended June 30, 2025 and 2024, respectively.

Research and development expenses were $11.0 million and $9.7 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $1.3 million from period to period was due to the following:

$4.3 million increase in contract research organization costs due to a $2.6 million increase in startup costs related to the Phase 2 trial for PIPE-791 for the treatment of IPF, a $1.0 million increase in costs related to the Phase 1b trial for PIPE-791 for the treatment of chronic pain, and a $0.7 million increase in costs related to the Phase 1b PET trial for PIPE-791;

$1.1 million increase in personnel-related expense related to an overall increase in personnel from period to period;

$0.5 million increase in non-cash stock-based compensation;

$1.1 million increase in contract research organization costs due to a $1.3 million increase in startup costs related to the Phase 2 trial for PIPE-791 for the treatment of IPF, a $1.0 million increase in costs related to the Phase 1b trial for PIPE-791 for the treatment of chronic pain, and a $0.4 million increase in costs related to the Phase 1b PET trial for PIPE-791, partially offset by a $1.6 million decrease in costs related to the VISTA Phase 2 clinical trial for PIPE-307 for the treatment of RRMS;

$0.3 million increase in facilities costs;

Partially offsetting these increases was a $0.3 million decrease in manufacturing expenses for PIPE-791 and CTX-343.

$0.3 million increase in non-cash stock-based compensation;

$0.1 million increase in biology and chemistry supplies.

Partially offsetting these increases was a $1.3 million decrease in expenses for toxicology studies primarily for PIPE-791 and a $0.3 million decrease in manufacturing expenses for PIPE-791 and CTX-343.

General and administrative expenses .

General and administrative expenses were $3.8 million and $3.0 million for the three months ended June 30, 2025 and 2024, respectively.

The increase of $0.8 million was due to a $0.5 million increase in non-cash stock-based compensation, a $0.5 million increase in personnel-related expenses related to an overall increase in personnel from period to period, and a $0.1 million increase in facilities costs.

Partially offsetting these increases was a $0.3 million decrease in market research costs.

Comparison of the Six Months Ended June 30, 2025 and 2024

General and administrative expenses were $3.9 million and $3.2 million for the three months ended September 30, 2025 and 2024, respectively.

The increase of $0.7 million was due to a $0.5 million increase in personnel-related expenses related to an overall increase in personnel from period to period, a $0.1 million increase in facilities costs, and a $0.1 million increase in other administrative costs.

Interest income .

Interest income was $2.0 million and $2.7 million for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $0.7 million was due to a decrease in funds invested in marketable securities and a decrease in the yields earned on our marketable securities during the three months ended September 30, 2024 compared to the three months ended September 30, 2025.

Comparison of the Nine Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations (in thousands) for the periods indicated:

Six Months Ended

Nine Months Ended

September 30,

Operating expenses:

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Research and development expenses .

Research and development expenses were $27.8 million and $15.7 million for the six months ended June 30, 2025 and 2024, respectively.

Research and development expenses were $38.8 million and $25.4 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $13.4 million from period to period was due to the following:

$8.1 million increase in contract research organization costs due to a $3.7 million increase in startup costs related to the Phase 2 trial for PIPE-791 for the treatment of IPF, a $2.1 million increase in costs related to the Phase 1b trial for PIPE-791 for the treatment of chronic pain, a $1.5 million increase in costs related to the Phase 1b PET trial for PIPE-791, and a $0.8 million increase in costs related to the VISTA Phase 2 clinical trial for PIPE-307 for the potential treatment of RRMS;

$9.1 million increase in contract research organization costs due to a $4.9 million increase in startup costs related to the Phase 2 trial for PIPE-791 for the treatment of IPF, a $3.1 million increase in costs related to the Phase 1b trial for PIPE-791 for the treatment of chronic pain, and a $1.9 million increase in costs related to the Phase 1b PET trial for PIPE-791, partially offset by a $0.8 million decrease in costs related to the VISTA Phase 2 clinical trial for PIPE-307 for the treatment of RRMS;

$3.6 million increase in personnel-related expense related to an overall increase in personnel from period to period;

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$0.8 million increase in facilities costs;

$0.6 million increase in consulting expenses.

Partially offsetting these increases was a $1.5 million decrease in expenses for toxicology studies primarily for PIPE-791 and a $0.6 million decrease in manufacturing expenses for PIPE-791 and CTX-343.

General and administrative expenses .

General and administrative expenses were $8.2 million and $5.2 million for the six months ended June 30, 2025 and 2024, respectively.

The increase of $3.0 million was primarily due to a $1.6 million increase in non-cash stock-based compensation, a $1.2 million increase in personnel-related expenses, and a $0.2 million increase in facilities costs.

Interest income .

Interest income was $4.3 million and $3.6 million for the six months ended June 30, 2025 and 2024, respectively.

The increase of $0.6 million was due to an increase in funds invested in marketable securities and an increase in the yields earned on our marketable securities from the six months ended June 30, 2024 to the six months ended June 30, 2025.

General and administrative expenses were $12.1 million and $8.4 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $3.7 million was primarily due to a $1.7 million increase in personnel-related expenses related to an overall increase in personnel from period to period, a $1.6 million increase in non-cash stock-based compensation, a $0.3 million increase in facilities costs and a $0.1 million increase in director and officer insurance.

Liquidity and Capital Resources

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We expect to incur substantial expenditures as we advance our drug candidates through clinical development, undergo the regulatory approval process, engage in other research and development activities to expand our pipeline of drug candidates, expand our operations and headcount, maintain and expand our intellectual property portfolio and, if we obtain approval for one or more of our drug candidates, launch commercial activities.

Through June 30, 2025, we have funded our operations primarily through the issuance of convertible promissory notes, private placements of our convertible preferred stock, the J&J License Agreement, and net proceeds from the IPO.

Through June 30, 2025, we have raised gross proceeds of approximately $312.8 million from the issuance of our convertible preferred stock, promissory notes, and Class A common stock in our IPO.

In addition, we received an upfront payment from the J&J License Agreement of $50.0 million and borrowed $5.0 million at the inception of the loan and security agreement with First Citizens Bank.

Through September 30, 2025, we have funded our operations primarily from the sale of equity securities and convertible equity securities, borrowings under credit facilities, the J&J License Agreement, and net proceeds from the IPO and ATM Program.

Through September 30, 2025, we have raised gross proceeds of approximately $332.4 million through equity issuances and an upfront payment from the J&J License Agreement of $50.0 million.

In addition, we borrowed $5.0 million at the inception of the loan and security agreement with First Citizens Bank.

Upon the closing of the IPO, our outstanding convertible preferred stock automatically converted into Class A common stock or Class B common stock, as applicable.

In April 2024, we raised approximately $107.9 million in net proceeds from the IPO.

As of June 30, 2025, we had an accumulated deficit of $149.4 million.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $175.5 million.

As of September 30, 2025, we had an accumulated deficit of $162.2 million.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $182.4 million.

Based on our current operating plan, we believe that our existing cash and cash equivalents and short-term investments, will be sufficient to meet our anticipated operating expenses and capital expenditure requirements through at least the next 12 months, following the date of this Quarterly Report on Form 10-Q.

In May 2025, we entered into a Sales Agreement (the “Agreement”) with Leerink Partners LLC (“Leerink Partners”) relating to the offer and sale of up to $75.0 million in shares of our Class A common stock, par value $0.001 per share (the “Shares”).

We are not obligated to make any sales of Shares under the Agreement.

Any sales under the Agreement will be made pursuant to an “at-the-market offering” (the “ATM Program”) in accordance with Rule 415(a)(4) under the Securities Act of 1933, as amended.

We did not sell any shares of our Class A common stock under the Agreement during the three months ended June 30, 2025.

In July 2025, the Company closed an ATM offering of 2,122,000 shares of its Class A common stock.

In May 2025, the Company entered into the Sales Agreement.

During the three months ended September 30, 2025, the Company sold 3,241,110 shares of its Class A common stock pursuant to the Sales Agreement.

The shares of Class A common stock were sold at a weighted average price of $6.04 per share, resulting in gross proceeds of $19.6 million.

The Company raised $8.4 million in net proceeds after deducting sales agent commissions of $0.2 million.

The Company raised $19.0 million in net proceeds after deducting sales agent commissions and offering costs of $0.6 million.

As we continue to pursue our business plan, we expect to finance our operations through both public and private sales of equity, debt financings or other commercial arrangements, which could include milestone payments from collaborations, strategic partnerships or marketing, distribution, licensing or other strategic arrangements with third parties.

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The following table sets forth a summary of our cash flows for the periods indicated (in thousands):

Six Months Ended

Nine Months Ended

September 30,

Net cash used in operating activities

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Operating Activities

Net cash used in operating activities was $30.1 million for the six months ended June 30, 2025, which related to our net loss of $32.0 million and a $3.0 million change in operating assets and liabilities, partially offset by $4.9 million of non-cash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and non-cash operating lease expense.

Net cash used in operating activities was $16.5 million for the six months ended June 30, 2024, which primarily related to our net loss of $17.4 million, partially offset by $0.8 million of non-cash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and non-cash operating lease expense, and $0.1 million change in operating assets and liabilities.

Net cash used in operating activities was $42.3 million for the nine months ended September 30, 2025, which related to our net loss of $44.8 million and a $5.3 million change in operating assets and liabilities, partially offset by $7.8 million of non-cash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and non-cash operating lease expense.

Net cash used in operating activities was $22.6 million for the nine months ended September 30, 2024, which primarily related to our net loss of $27.7 million, partially offset by $2.6 million of non-cash charges for stock-based compensation, depreciation and amortization, accretion of premiums/discounts on investments, and non-cash operating lease expense, and $2.4 million change in operating assets and liabilities.

Investing Activities

Net cash provided by investing activities was $28.8 million for the six months ended June 30, 2025, which related to $88.0 million of sales and maturities of marketable securities, partially offset by $59.1 million of purchases of marketable securities and $0.1 million or purchases of property and equipment.

Net cash used in investing activities was $30.2 million for the six months ended June 30, 2024, which primarily related to $99.6 million of purchases of marketable securities and $0.3 million of purchases of property and equipment, partially offset by $69.7 million of sales and maturities of marketable securities.

Net cash provided by investing activities was $43.7 million for the nine months ended September 30, 2025, which related to $121.7 million of sales and maturities of marketable securities, partially offset by $77.8 million of purchases of marketable securities and $0.2 million for purchases of property and equipment.

Net cash used in investing activities was $60.4 million for the nine months ended September 30, 2024, which primarily related to $172.1 million of purchases of marketable securities and $0.3 million of purchases of property and equipment, partially offset by $112.0 million of sales and maturities of marketable securities.

Financing Activities

Net cash provided by financing activities was approximately $0.1 million for the six months ended June 30, 2025, which was primarily related to $0.3 million of proceeds from employee stock purchase plan, partially offset by $0.2 million in payments of deferred offering costs.

Net cash provided by financing activities was $108.3 million for the six months ended June 30, 2024, which primarily related to $108.2 million of net proceeds from the issuance of common stock in the Company's IPO and $0.1 million of proceeds from the exercise of stock options.

Net cash provided by financing activities was approximately $19.2 million for the nine months ended September 30, 2025, which was primarily related to $19.0 million of proceeds from the issuance of common stock in the ATM Program, $0.3 million of proceeds from employee stock purchase plan, and $0.2 million of proceeds from the exercise of stock options, partially offset by $0.3 million in payments of deferred offering costs.

Net cash provided by financing activities was $108.4 million for the nine months ended September 30, 2024, which primarily related to $107.9 million of net proceeds from the issuance of common stock in the Company's IPO and $0.1 million of proceeds from the exercise of stock options.

Funding Requirements

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Our contractual obligations and commitments relate to our operating leases that relate primarily to our leases of office and laboratory space in San Diego, California.

Our total contractual commitments for our lease agreements amount to approximately $6.9 million as of June 30, 2025.

Our total contractual commitments for our lease agreements amount to approximately $7.3 million as of September 30, 2025.

We enter into contracts in the normal course of business for contract research services, contract manufacturing services, professional services and other services and products for operating purposes.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements