What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-08-05 compared with 2025-05-14 · 193 added, 107 removed, 675 unchanged (31% of the section changed)

3 unchanged sentences

(in thousands, except share and par value data)

March 31, 2025

June 30, 2025

December 31, 2024

24 unchanged sentences

Class A common stock, $ 0.001 par value;

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

issued and outstanding shares— 19,142,377 and 19,125,377 at March 31, 2025 and December 31, 2024, respectively.

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.

Class B common stock, $ 0.001 par value;

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

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

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.

Preferred stock, $ 0.001 par value;

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

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

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.

Additional paid-in-capital

11 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended March 31,

Three Months Ended Six Months Ended

Operating expenses:

2 unchanged sentences

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

2 unchanged sentences

Interest income

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

Change in fair value of warrant liability

— 11 — ( 107 )

Other expense, net

2 unchanged sentences

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 )

Comprehensive loss

25 unchanged sentences

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

Convertible Class A Additional Accumulated Other Comprehensive Total

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

Preferred Stock

Comprehensive

Stockholders'

Income (Loss)

Equity (Deficit)

Balance at December 31, 2023

9 unchanged sentences

15,906,236 $ 192,620 2,384,426 $ 2 $ 7,988 $ ( 58 ) $ ( 83,561 ) $ ( 75,629 )

Issuance of common stock in connection with initial public offering, net of issuance costs of $ 10,912

— — 7,423,682 7 107,860 — — 107,867

Conversion of convertible preferred stock to common stock upon initial public offering

( 15,906,236 ) ( 192,620 ) 15,906,236 17 192,603 — — 192,620

Reclassification of warrant from liability to equity

— — — — 216 — — 216

Exercise of stock options

— — 8,932 — 13 — — 13

Stock-based compensation

— — — — 1,494 — — 1,494

— — — — — — ( 9,009 ) ( 9,009 )

Unrealized loss on marketable securities

— — — — — ( 69 ) — ( 69 )

Balance at June 30, 2024

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

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

2 unchanged sentences

(in thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Operating activities

7 unchanged sentences

Change in fair value of warrant liability

Gain on marketable securities ( 2 ) —

Loss on disposal of property and equipment

Gain on marketable securities

Changes in operating assets and liabilities

Prepaid expenses and other current assets

Other long-term assets

Accounts payable

11 unchanged sentences

88,018 69,747

Net cash provided by investing activities

Net cash provided by (used in) investing activities

28,799 ( 30,168 )

Financing activities

Payments of deferred offering costs

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

Proceeds from exercise of stock options

Net cash provided by (used in) financing activities

Net increase in cash and cash equivalents

Proceeds from employee stock purchase plan

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

( 1,159 ) 61,704

Cash and cash equivalents at beginning of period

2 unchanged sentences

$ 20,784 $ 77,230

Supplemental disclosure of noncash investing and financing activities

Conversion of convertible preferred stock to common stock upon initial public offering $ — $ 192,620

Reclassification of warrant from liability to equity $ — $ 216

Reclassification of deferred offering costs paid in prior year to equity $ — $ 343

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

4 unchanged sentences

Contineum Therapeutics, Inc.

(the “Company”), is a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of NI&I indications with significant unmet need.

(the “Company”), is a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (“NI&I”) indications with significant unmet need.

The Company was incorporated in the state of Delaware in 2009, and in November 2023 changed its name from Pipeline Therapeutics, Inc.

13 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 for the three months ended March 31, 2025 .

The Company had an accumulated deficit of $ 133.4 million as of March 31, 2025 .

From its inception through March 31, 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 March 31, 2025 , the Company had cash, cash equivalents and marketable securities of $ 190.7 million.

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.

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 March 31, 2025 , condensed statements of operations and comprehensive loss, condensed statements of convertible preferred stock and stockholders’ equity (deficit), and condensed statements of cash flows for the three months ended March 31, 2025 and 2024, and related notes to condensed financial statements are unaudited.

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.

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 months ended March 31, 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 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 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 three months ended March 31, 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 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.

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):

March 31, 2025

June 30, 2025

Maturity in Years

35 unchanged sentences

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

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

As of March 31, 2025 , 60 out of 243 of our available-for-sale debt securities were in an aggregate gross unrealized loss position.

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

As of March 31, 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 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.

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):

March 31, 2025

June 30, 2025

Fair Value Unrealized Losses

Government agency securities $ 18,818 $ ( 27 )

Certificate of deposit 3,806 ( 1 )

Corporate debt securities 25,129 ( 13 )

Commercial paper 4,590 ( 1 )

Yankee debt 1,516 ( 1 )

Total $ 53,859 $ ( 43 )

21 unchanged sentences

Assets (Level 1)

As of March 31, 2025:

As of June 30, 2025:

Cash equivalents

30 unchanged sentences

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 March 31, 2025 and December 31, 2024 are money market funds with a carrying value and fair value of $ 5.0 million and $ 3.9 million, respectively, based upon a Level 1 fair value assessment.

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.

Accrued Expenses

8 unchanged sentences

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.

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 March 31, 2025 , of the authorized 200,000,000 shares of Class A common stock, 19,142,377 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 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.

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

9 unchanged sentences

7,769,503 5,997,577

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

There are no shares of Class B common stock reserved for future issuance as of June 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 March 31, 2025 , there were 1,887,766 shares of the Company’s Class A common stock available for issuance under the 2024 Plan.

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.

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.

4 unchanged sentences

The 2024 Plan will terminate automatically ten years after the date when the Company's board of directors adopted the 2024 Plan.

Stock option activity under the 2024 Plan and 2012 Plan is as follows:

In April 2025, the Company granted inducement awards outside of the 2024 Plan to the Company's Chief Medical Officer and Head of Development in the form of an option to purchase 286,000 shares of the Company's Class A common stock with an exercise price per share equal to $ 4.50 .

The option awards were granted as an inducement material to his commencement of employment with the Company in accordance with Nasdaq Listing Rule 5635 (c)( 4 ).

These inducement awards are included in stock-based compensation and the following tables.

Stock option activity is as follows:

Options Outstanding

11 unchanged sentences

Options expired

Balance at March 31, 2025

( 4,956 ) 9.67 — —

Options Vested and Expected to Vest as of March 31, 2025

Balance at June 30, 2025

5,580,612 $ 9.43 7.78 $ 2,908

Options Exercisable as of March 31, 2025

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

5,554,612 $ 9.46 7.77 $ 2,908

The aggregate intrinsic value of options exercised during the three months ended March 31, 2025 and 2024 was $ 0.2 million and $ 0.3 million, respectively, determined as of the date of exercise.

Options exercisable as of June 30, 2025

2,622,801 $ 7.30 6.13 $ 2,908

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.

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

As of March 31, 2025 , of the 2,212,484 options exercisable, 112 options are available to be early exercised.

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

As of June 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.

The Company estimated the fair value of stock options using the Black-Scholes valuation model.

1 unchanged sentence

Previously recognized compensation expense for an award is reversed in the period that the award is forfeited.

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

Three Months Ended March 31,

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

Three Months Ended Six Months Ended

Expected term (in years)

5.69 6.05 5.96 6.03

Expected volatility

95 % 110 % 94 % 110 %

Risk free interest rate

1 unchanged sentence

Dividend yield

The weighted-average grant-date fair value per share of stock options granted during the three months ended March 31, 2025 and 2024 wa s $ 7.64 and $ 13.66 per share, respectively.

The Company recorded $ 1.5 million and $ 1.1 million in stock-based compensation in general and administrative and research and development, respectively, for the three months ended March 31, 2025 .

The Company recorded $ 0.4 million and $ 0.4 million in stock-based compensation in general and administrative and research and development, respectively, for the three months ended March 31, 2024.

As of March 31, 2025 , there was approximately $ 26.3 million of total unrecognized stock-based compensation related to nonvested stock-based compensation arrangements, which is expected to be recognized over a weighted-average period of approximately 3.1 years.

As of March 31, 2024, there was approximately $ 9.2 million of total unrecognized stock-based compensation related to nonvested stock-based compensation arrangements, which was expected to be recognized over a weighted-average period of approximately 1.3 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 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.

Employee Stock Purchase Plan

4 unchanged sentences

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

As of March 31, 2025 , there were 520,549 shares of the Company’s common stock reserved and available for issuance under the 2024 ESPP.

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.

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 three months ended March 31, 2025 , there were no shares purchased under the 2024 ESPP and the recorded expense was not material.

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.

License Agreement

13 unchanged sentences

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

As of March 31, 2025 , all variable consideration under the J&J License Agreement was fully constrained.

As of June 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 March 31, 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 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.

Commitments and Contingencies

15 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 %):

March 31, December 31,

June 30, December 31,

Operating lease right-of-use assets $ 5,007 $ 5,467

4 unchanged sentences

Weighted-average discount rate 9.0 % 9.0 %

During the three months ended March 31, 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 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.

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

March 31, March 31 ,

Six Months Ended June 30,

Cash paid for amounts included in the measurement of lease liabilities $ 756 $ —

Future minimum lease payments for the Company’s operating lease liabilities as of March 31, 2025 are as follows (in thousands):

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

Total minimum lease payments 6,890

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 March 31, 2025, the Company was not currently a party to any material legal proceedings.

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

Other Commitments

4 unchanged sentences

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 March 31,

Three Months Ended

Six Months Ended

Net loss applicable to common stockholders

$ ( 15,990 ) $ ( 8,417 )

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

25,868,935 2,369,067

Net loss per share:

Basic and diluted

$ ( 0.62 ) $ ( 3.55 )

For the three months ended March 31, 2025 , 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 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.

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 convertible preferred stock, common stock options, a preferred stock warrant, and a common stock warrant have been excluded from the computation of diluted net loss per share for the three months ended March 31, 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 six months ended June 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:

As of March 31,

Convertible preferred stock (as converted to common stock)

Common stock options

5,107,770 2,881,863

Preferred stock warrant (as converted to common stock)

Common stock warrant

9 unchanged sentences

The following table provides the operating financial results of our single reportable segment (in thousands):

Three Months Ended March 31,

Three Months Ended

Six Months Ended

Significant and other segment expenses

Research and development

PIPE-791 $ 5,554 $ 2,861

PIPE-307 2,615 2,075

CTX-343 1,378 312

Discovery programs

3 unchanged sentences

Other segment items (2)

Net loss $ ( 15,990 ) $ ( 8,417 )

______________________

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.

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

15 unchanged sentences

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 residence 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.

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 top-line data from this trial will be available in the second quarter of 2025.

This Phase 1b PET trial will inform dose selection for our planned Phase 2 trials of PIPE-791 in IPF and PrMS.

On March 4, 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, osteoarthritis and low back pain.

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.

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.

We expect to enroll approximately 40 patients at up to five sites in the U.S., and a treatment duration of 28 days.

We anticipate top-line data from this trial in early 2026.

We anticipate topline data from this trial in the first half of 2026.

Our second drug candidate, PIPE-307, is a novel, small molecule selective inhibitor of the muscarinic type 1 receptor (“M1R”), in development for depression and relapse-remitting multiple sclerosis (“RRMS”).

2 unchanged sentences

In January 2025, we announced that we have fully enrolled our Phase 2 VISTA trial.

We expect the top-line data from this trial will be available in the second half of 2025.

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

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 major depressive disorder (“MDD”).

This trial is a randomized, double-blind, multicenter, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with MDD.

This trial is a randomized, double-blind, multi-center, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of PIPE-307/JNJ-89495120 as monotherapy in adult participants with MDD.

We believe PIPE-307 is the most advanced selective M1R antagonist in clinical development.

17 unchanged sentences

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 top-line data from this trial will be available in the second half of 2025.

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.

1 unchanged sentence

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.

The J&J License Agreement expires on a licensed product-by-product and country-by-country basis upon the last to occur of:

11 unchanged sentences

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 months ended March 31, 2025 or 2024.

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

Operating Expenses

18 unchanged sentences

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 months ended March 31, 2025 and 2024.

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

1 unchanged sentence

Three Months Ended

Six Months Ended

(in thousands)

Direct external development program expense

38 unchanged sentences

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

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

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

11 unchanged sentences

Research and development expenses .

Research and development expenses were $13.7 million and $7.8 million for the three months ended March 31, 2025 and 2024, respectively.

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

The increase of $6.1 million from period to period was due to the following:

$3.8 million increase in contract research organization costs primarily related to our ongoing VISTA Phase 2 clinical trial for PIPE-307 for the potential treatment of RRMS, Phase 1b trial for PIPE-791 for the treatment of chronic pain, and Phase 1b PET trial for PIPE-791,

$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;

$1.5 million increase in personnel-related expense related to an overall increase in personnel from period to period;

1 unchanged sentence

$0.2 million increase in facilities costs.

$0.2 million increase in biology and chemistry supplies, and

$0.1 million increase in expenses for toxicology studies primarily for PIPE-791.

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

General and administrative expenses .

General and administrative expenses were $4.4 million and $2.2 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $2.2 million was due to a $1.1 million increase in non-cash stock-based compensation, a $0.7 million increase in personnel-related expenses related to an overall increase in personnel from period to period, a $0.2 million increase in director and officer insurance associated with our recently completed IPO, and a $0.1 million increase in facilities costs.

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

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

Six Months Ended

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Interest income

Interest income was $2.3 million and $1.6 million for the three months ended March 31, 2025 and 2024, respectively.

The increase of $0.6 million was due to an increase in funds invested in marketable securities.

Change in fair value of warrant liability

Other expense, net

Total other income, net

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.

The increase of $12.1 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;

$2.3 million increase in personnel-related expense related to an overall increase in personnel from period to period;

$1.2 million increase in non-cash stock-based compensation;

$0.5 million increase in facilities costs.

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.

Liquidity and Capital Resources

2 unchanged sentences

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.

We also expect to incur additional costs associated with our operating as a public company, including significant legal, accounting, investor relations, director and officer insurance, and other expenses that we did not incur as a private company.

Through March 31, 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 March 31, 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.

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.

1 unchanged sentence

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

As of March 31, 2025, we had an accumulated deficit of $133.4 million.

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $190.7 million.

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.

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.

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.

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.

3 unchanged sentences

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

Three Months Ended

Six Months Ended

Net cash used in operating activities

Net cash provided by investing activities

Net cash provided by (used in) financing activities

Net increase in cash and cash equivalents

Net cash provided by (used in) investing activities

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Operating Activities

Net cash used in operating activities was $14.4 million for the three months ended March 31, 2025, which related to our net loss of $16.0 million and a $1.1 million change in operating assets and liabilities, partially offset by $2.7 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 $8.0 million for the three months ended March 31, 2024, which was due to our net loss of $8.4 million, partially offset by $0.1 million of non-cash charges such as stock-based compensation, depreciation and amortization, amortization of premiums/discounts on marketable securities and amortization of right-of-use assets and a $0.3 million change in operating assets and liabilities.

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.

Investing Activities

Net cash provided by investing activities was $14.9 million for the three months ended March 31, 2025, which related to $48.7 million of sales and maturities of marketable securities, partially offset by $33.7 million of purchases of marketable securities.

Net cash provided by investing activities was $8.7 million for the three months ended March 31, 2024, which consisted of $39.5 million of sales and maturities of marketable securities, partially offset by $30.7 million of purchases of marketable securities and $0.1 million of purchases of property and equipment.

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.

Financing Activities

Net cash provided by financing activities was approximately $24,000 for the three months ended March 31, 2025, which related to proceeds from the exercise of stock options.

Net cash used in financing activities was approximately $18,000 for the three months ended March 31, 2024, which was primarily due to payment of deferred offering costs offset by proceeds from the exercise of stock options.

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.

Funding Requirements

24 unchanged sentences

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 $7.3 million as of March 31, 2025.

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

22 unchanged sentences

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