What changed in this filing

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Item 1. Financial Statements

2025-11-04 compared with 2025-08-05 · 121 added, 94 removed, 587 unchanged (27% of the section changed)

3 unchanged sentences

(in thousands, except share and per share data)

September 30,

Current assets:

25 unchanged sentences

150,000 shares authorized;

150,000 and 150,000 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively.

Liquidation preference of $ 150,000 as of June 30, 2025.

150,000 and 150,000 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively.

Liquidation preference of $ 150,000 as of September 30, 2025.

Stockholders’ equity:

1 unchanged sentence

10,000,000 shares authorized;

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

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

Common stock, $ 0.001 par value:

120,000,000 shares authorized;

63,913,185 and 62,390,654 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

66,684,077 and 62,390,654 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

9 unchanged sentences

(in thousands, except share and per share data)

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Product revenue, net

12 unchanged sentences

Interest income

Total other (expense), net

Total other income (expense), net

Loss before income taxes

Provision for income taxes

Provision (benefit) for income taxes

Accrued dividends on convertible preferred stock

5 unchanged sentences

Foreign currency translation adjustment

Unrealized (loss), net on marketable securities

Unrealized gain (loss), net on marketable securities

Comprehensive loss

13 unchanged sentences

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

Issuance of common stock upon completion of ATM equity offering, net of $ 739 offering costs

Issuance of common stock upon completion of ATM equity offering, net of $ 0.7 million of offering costs

Accretion of preferred stock dividends

4 unchanged sentences

Stock compensation expense

Issuance of common stock in connection with ESPP

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

4 unchanged sentences

( 1,251,468 )

Stock compensation expense

Issuance of common stock in connection with ESPP

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

Issuance of common stock upon completion of public offering, net of $ 12.6 million of offering costs

Accretion of preferred stock dividends

Foreign currency translation adjustment

Net unrealized loss on marketable securities

Balance at September 30, 2025

( 1,304,372 )

Balance at December 31, 2023

9 unchanged sentences

Stock-based compensation expense

Issuance of common stock in connection with ESPP

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

Issuance of common stock as consideration for LGC license

Accretion of preferred stock dividends

3 unchanged sentences

( 1,068,369 )

Stock-based compensation expense

Issuance of common stock in connection with ESPP

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units

Accretion of preferred stock dividends

Foreign currency translation adjustment

Unrealized gain on marketable securities

Balance at September 30, 2024

( 1,112,010 )

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

2 unchanged sentences

(in thousands)

Six months ended June 30,

Nine months ended September 30,

Operating activities

23 unchanged sentences

Repayment of deferred royalty obligation

Proceeds from issuance of common stock upon completion of public offering, net of offering costs

Proceeds from the exercise of stock options

30 unchanged sentences

The Company has incurred operating losses and experienced negative cash flows from operations since inception.

As of June 30, 2025, the Company had an accumulated deficit of $ 1.3 billion.

As of September 30, 2025, the Company had an accumulated deficit of $ 1.3 billion.

The Company has funded these losses primarily from the proceeds from the sales of common and preferred stock, product revenue, asset sales, royalty financing, out-license arrangements, as well as capital contributions received from the former parent company, Rhythm Holdings LLC.

While the Company is generating product revenue, management expects operating losses to continue for the foreseeable future.

The Company has devoted substantially all of its resources to its drug development efforts, comprised of research and development, the acquisition of in process research and development assets, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property, commercialization activities and general and administrative functions relating to these operations.

The Company has devoted substantially all of its resources to its drug development efforts, comprising research and development, the acquisition of in process research and development assets, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property, commercialization activities and general and administrative functions relating to these operations.

The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations.

As of June 30, 2025, the Company had $ 291.0 million of cash and cash equivalents and short-term investments on hand.

As of September 30, 2025, the Company had $ 416.1 million of cash and cash equivalents and short-term investments on hand.

In the future, the Company will be dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, proceeds from out license arrangements, product sales and funded research and development programs to maintain the Company's operations and meet the Company's obligations.

There is no guarantee

that additional equity or other financing will be available to the Company on acceptable terms, or at all.

no guarantee that additional equity or other financing will be available to the Company on acceptable terms, or at all.

If the Company fails to obtain additional funding when needed, the Company would be forced to scale back, terminate its operations or seek to merge with or be acquired by another company.

5 unchanged sentences

As permitted under these rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted.

The accompanying condensed consolidated balance sheet as of June 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024, the condensed consolidated statements of convertible preferred stock and stockholders’ equity for the three and six months ended June 30, 2025 and 2024 and the condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 and the related footnote disclosures are unaudited.

The accompanying condensed consolidated balance sheet as of September 30, 2025, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, the condensed consolidated statements of convertible preferred stock and stockholders’ equity for the three and nine months ended September 30, 2025 and 2024 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024 and the related footnote disclosures are unaudited.

In management's opinion, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2024 and include all adjustments, which are all normal recurring adjustments, necessary for the fair presentation of the interim financial statements.

The results for the six months ended June 30, 2025 are not necessarily indicative of the results expected for the full fiscal year, any other interim periods, or any future year or period.

The results for the nine months ended September 30, 2025 are not necessarily indicative of the results expected for the full fiscal year, any other interim periods, or any future year or period.

The accompanying unaudited condensed consolidated financial statements reflect the application of certain significant accounting policies as described below and elsewhere in these notes to the unaudited condensed consolidated financial statements.

As of June 30, 2025, there have been no material changes in the Company's significant accounting policies from those that were disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

As of September 30, 2025, there have been no material changes in the Company's significant accounting policies from those that were disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Use of Estimates

26 unchanged sentences

The Company does not require collateral to secure amounts due from its customers.

For the three months ended June 30, 2025 and 2024, approximately 66 % and 74 % of all of the Company’s revenue was generated from a single customer in the United States.

As of June 30, 2025 and December 31, 2024, approximately 48 % and 67 %, respectively, of the Company’s accounts receivable was outstanding from a single customer in the United States.

For the three months ended September 30, 2025, and 2024, approximately 74 % and 68 % of all the Company’s revenue was generated from a single customer in the United States.

For the nine months ended September 30, 2025, and 2024, approximately 69 % and 73 % of all the Company’s revenue was generated from a single customer in the United States.

As of September 30, 2025, and December 31, 2024, approximately 55 % and 67 %, respectively, of the Company’s accounts receivable was outstanding from a single customer in the United States.

The Company relies on third-party manufacturers and suppliers for the manufacture and supply of its product.

11 unchanged sentences

Short-term investments consist of investments with maturities greater than 90 days, as of the date of purchase.

The Company has classified its investments with maturities beyond one year as short term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations.

The Company has classified its investments with maturities beyond one year as short term, based on their highly liquid

nature and because such marketable securities represent the investment of cash that is available for current operations.

The Company considers its investment portfolio available-for-sale.

Accordingly, these investments are recorded at fair value,

which is based on quoted market prices.

Accordingly, these investments are recorded at fair value, which is based on quoted market prices.

Unrealized gains and losses are reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity.

2 unchanged sentences

When assessing the risk of credit loss, management considers factors such as the severity and the reason for the decline in value (i.e., any changes to the rating of the security by a rating agency or other adverse conditions specifically related to the security) and management's intended holding period and time horizon for selling.

During the three and six months ended June 30, 2025 and 2024, the Company did not recognize any credit losses related to its available-for-sale debt securities.

Further, as of June 30, 2025 and December 31, 2024, the Company did not record an allowance for credit losses related to its available-for-sale debt securities.

During the three and nine months ended September 30, 2025 and 2024, the Company did not recognize any credit losses related to its available-for-sale debt securities.

Further, as of September 30, 2025 and December 31, 2024, the Company did not record an allowance for credit losses related to its available-for-sale debt securities.

Accounts Receivable, net

4 unchanged sentences

The Company analyzes amounts that are past due for collectability, and periodically evaluates the creditworthiness of its customers.

As of June 30, 2025 and December 31, 2024, the Company determined an allowance for doubtful accounts was not required based upon our review of contractual payments and our customers’ circumstances.

As of September 30, 2025 and December 31, 2024, the Company determined an allowance for credit losses was not required based upon our review of contractual payments and our customers’ circumstances.

Revenue Recognition

71 unchanged sentences

To the extent the Company’s estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of our deferred royalty obligation.

The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires the Company to make estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized.

The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs require the Company to make estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized.

Prior to receiving approval from the FDA in November 2020 to sell IMCIVREE in the United States, the Company expensed all costs incurred related to the manufacture of IMCIVREE as research and development expense because of the inherent risks associated with the development of a drug candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates.

18 unchanged sentences

If such assets are considered to be impaired, the Company measures the impairment to be recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset, less the cost to sell.

No events or changes in circumstances existed to require an impairment assessment during the three and six months ended June 30, 2025 and 2024, respectively.

No events or changes in circumstances existed to require an impairment assessment during the three and nine months ended September 30, 2025 and 2024, respectively.

Acquired IPR&D and Milestone Expenses

In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to in-process research and development projects are expensed as acquired IPR&D and recorded as a component of research and development expense in the condensed consolidated statements of operations and comprehensive net loss unless the project has an alternative future use.

In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to in-process research and development (“IPR&D”) projects are expensed as acquired IPR&D and recorded as a component of research and development expense in the condensed consolidated statements of operations and comprehensive net loss unless the project has an alternative future use.

These costs include upfront and development milestone payments related to licensing arrangements, or other asset acquisitions that provide rights to develop, manufacture and/or sell pharmaceutical products.

Where contingent development milestone payments are due to third parties, prior to regulatory approval, the payment obligations are expensed when the achievement of the underlying milestone becomes probable.

Regulatory and commercial milestone

payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the remaining useful life of the related product.

Regulatory and

commercial milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the remaining useful life of the related product.

Foreign Currency Translation

4 unchanged sentences

Changes resulting from foreign currency translation are included in accumulated other comprehensive income (loss) on the Company’s consolidated statement of stockholders’ equity.

Net foreign currency exchange transaction gains (losses), which are included in other (expense) income, net on our consolidated statements of operations, were immaterial for the six months ended June 30, 2025 and 2024, respectively.

Net foreign currency exchange transaction gains (losses), which are included in other (expense) income, net on our consolidated statements of operations, were immaterial for the nine months ended September 30, 2025 and 2024, respectively.

Fair Value Measurements

6 unchanged sentences

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

The Company’s cash equivalents and marketable securities and derivative asset as of June 30, 2025 and December 31, 2024 were carried at fair value, determined according to the fair value hierarchy.

The Company’s cash equivalents and marketable securities and derivative asset as of September 30, 2025 and December 31, 2024 were carried at fair value, determined according to the fair value hierarchy.

See Note 6, Fair Value of Financial Assets and Liabilities, for further discussion.

The carrying amounts reflected in the condensed consolidated balance sheets for accounts payable and accrued expenses and other current liabilities approximate their fair values due to their short-term maturities as of June 30, 2025 and December 31, 2024, respectively.

Net Loss Per Share

5 unchanged sentences

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Stock options

1 unchanged sentence

Performance stock units

Common stock reserved for the conversion of Series A convertible preferred stock

Common stock issuable upon the conversion of Series A convertible preferred stock

Potential common shares

12 unchanged sentences

We are currently evaluating the impact of the new standard on our consolidated financial statements which is expected to result in enhanced disclosures, however, we do not otherwise expect the adoption of the new guidance to have a material impact on our financial condition or results of operations.

In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03, Income Statement—Reporting Comprehensive Income (Topic 220):

Disaggregation of Income Statement Expenses .

The ASU requires additional information about specific expenses in certain notes to the consolidated financial statements.

The new guidance will be effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027.

Early adoption is permitted.

Upon adoption, the impact of ASU 2024-03 will be limited to certain notes to the consolidated financial statements;

the company is currently evaluating the impact of this guidance.

Asset Acquisitions

5 unchanged sentences

As of January 4, 2024, the fair value of common stock issued was $ 18.7 million.

The total purchase consideration also includes an additional $ 40.0 million license fee payable in 18 months , whose present value at closing was $ 33.7 million, and $ 0.8 million of transaction costs which are recorded as selling, general and administrative expenses.

The carrying value of the license fee payable is $ 40.0 million as of June 30, 2025, and is reflected in current liabilities on our condensed consolidated balance sheet.

On July 1, 2025, the Company made the final consideration payment of $ 40.0 million to LGC for the Company’s asset purchase of their proprietary compound bivamelagon from January 2024.

The total purchase consideration also included an additional $ 40.0 million license fee payable in 18 months , which had a present value at closing of $ 33.7 million, and $ 0.8 million of transaction costs which are recorded as selling, general and administrative expenses.

On July 1, 2025, the Company made this additional payment of $ 40.0 million to LGC.

In addition, under the terms of the license agreement, we agreed to pay LGC up to $ 205 million in cash upon achieving various regulatory and sales milestones based on net sales of bivamelagon.

2 unchanged sentences

Such increased rate would only apply on net sales of bivamelagon for the limited remainder of the royalty term in the relevant region.

The assets acquired were In-Process Research and Development (“IPR&D”) assets.

The assets acquired were -IPR&D assets.

However, since the IPR&D assets were determined to have no alternative future use, the Company recognized the $ 92.4 million of purchase consideration as research and development expense in the three months ended March 31, 2024.

3 unchanged sentences

Inventory consists of the following (in thousands):

September 30,

Raw Materials

3 unchanged sentences

Accrued expenses and other current liabilities consisted of the following (in thousands):

September 30,

Research and development costs

4 unchanged sentences

Fair Value of Financial Assets and Liabilities

As of June 30, 2025 and December 31, 2024, the carrying amount of cash and cash equivalents and short-term investments was $ 291.0 million and $ 320.6 million respectively, which approximates fair value.

As of September 30, 2025 and December 31, 2024, the carrying amount of cash and cash equivalents and short-term investments was $ 416.1 million and $ 320.6 million respectively, which approximates fair value.

Cash and cash equivalents and short-term investments includes investments in U.S.

5 unchanged sentences

Fair Value Measurements as of

June 30, 2025 using:

September 30, 2025 using:

Cash equivalents:

27 unchanged sentences

The following tables set forth a summary of the changes in the estimated fair value of our embedded derivative liability (asset) (in thousands):

Six months ended

Nine months ended

September 30,

Beginning aggregate estimated fair value of Level 3 liability (asset)

5 unchanged sentences

The following tables summarize the Company's marketable securities (in thousands):

June 30, 2025

September 30, 2025

Corporate debt securities and commercial paper (due within 1 year)

4 unchanged sentences

Intangible Assets

As of June 30, 2025

As of September 30, 2025

As of December 31, 2024

1 unchanged sentence

Capitalized Milestones

As of June 30, 2025, the Company’s finite-lived net intangible assets, which totaled $ 5.7 million, resulted from the capitalization of certain milestone payments made to Ipsen Pharma, S.A.S., or Ipsen, in accordance with the terms of the Company’s license agreement with Ipsen, in connection with the Company’s first commercial sale of IMCIVREE in the U.S.

As of September 30, 2025, the Company’s finite-lived net intangible assets, which totaled $ 5.5 million, resulted from the capitalization of certain milestone payments made to Ipsen Pharma, S.A.S., or Ipsen, in accordance with the terms of the Company’s license agreement with Ipsen, in connection with the Company’s first commercial sale of IMCIVREE in the U.S.

in March 2021 and in France in March 2022.

As of June 30, 2025, amortization expense for the next five years and beyond is summarized as follows (in thousands):

As of September 30, 2025, amortization expense for the next five years and beyond is summarized as follows (in thousands):

2025 (remainder)

Amortization expense totaled $ 0.2 million for each of the three months ended June 30, 2025 and 2024, respectively.

Amortization expense totaled $ 0.4 million for each of the six months ended June 30, 2025 and 2024, respectively.

Amortization expense totaled $ 0.2 million for each of the three months ended September 30, 2025 and 2024, respectively.

Amortization expense totaled $ 0.6 million for each of the nine months ended September 30, 2025 and 2024, respectively.

Amortization expense is included in cost of sales in the condensed consolidated statements of operations and comprehensive loss.

The Company recorded an income tax provision of approximately $ 0.3 million and $ 0.5 million for the three months ending June 30, 2025, and 2024, respectively.

The Company recorded an income tax provision of approximately $ 0.4 million and $ 0.8 million for the six months ending June 30, 2025, and 2024, respectively.

The Company recorded an income tax provision of approximately $ 0.1 million and ($ 0.3 ) million for the three months ended September 30, 2025, and 2024, respectively.

The Company recorded an income tax provision of approximately $ 0.5 million and $ 0.4 million for the nine months ended September 30, 2025, and 2024, respectively.

The income tax provision is a result of taxable income from the Company’s foreign jurisdictions.

The Company expects to maintain a full valuation allowance against its net deferred tax assets for the year ended December 31, 2025.

On July 4, 2025, the One Big Beautiful Bill (“OBBB”) Act, which includes a broad range of tax reform provisions, was signed into law in the United States.

The Company is currently evaluating the impact of OBBB on its consolidated financial statements.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”), which includes a broad range of tax reform provisions, was signed into law in the United States.

The Company has evaluated the income tax effects of the OBBBA in accordance with ASC 740, Income Taxes, and has determined that the enactment of the OBBBA does not have a material impact on its current or deferred income tax expense, financial position, or results of operations for the period ended.

The Company will continue to evaluate the provisions that go into effect in the future.

Series A Convertible Preferred Stock

12 unchanged sentences

The Company classifies its Convertible Preferred Stock outside of stockholders’ equity as the redemption of such shares is outside the Company’s control.

The Company did not adjust the carrying values of the Convertible Preferred Stock to redemption value as the shares are not probable of becoming redeemable as of June 30, 2025.

The Company did not adjust the carrying values of the Convertible Preferred Stock to redemption value as the shares are not probable of becoming redeemable as of September 30, 2025.

The Convertible Preferred Stock has the following rights and privileges:

14 unchanged sentences

multiplied by the sum of the Liquidation Preference (i.e., Initial Liquidation Preference of $ 1,000 per share plus PIK Dividends) plus any unpaid Regular Dividends (to the extent such accumulated and unpaid Regular Dividends are not included in such Liquidation Preference).

As of June 30, 2025, the Company did not adjust the carrying value of the Convertible Preferred Stock to its redemption value, since a change of control was determined to not be probable.

As of September 30, 2025, the Company did not adjust the carrying value of the Convertible Preferred Stock to its redemption value, since a change of control was determined to not be probable.

After the second anniversary, dividends on the Convertible Preferred Stock accrue quarterly, at a 6 % annual rate, and if not paid out in cash before the quarter end, will become PIK Dividends and added to the liquidation preference, or original issue price plus PIK Dividends.

1 unchanged sentence

Accordingly, the Company accretes the dividends, using the effective interest method, from Issuance to the first contractual call date, April 15, 2029.

The Company accrued dividends of $ 2.7 million for the six months ended June 30, 2025, as a reduction to Additional Paid-In Capital and an increase to the carrying value of Convertible Preferred Stock.

The carrying value of Convertible Preferred Stock as of June 30, 2025 is $ 145.5 million.

The Company accrued dividends of $ 4.0 million for the nine months ended September 30, 2025, as a reduction to Additional Paid-In Capital and an increase to the carrying value of Convertible Preferred Stock.

The carrying value of Convertible Preferred Stock as of September 30, 2025 is $ 146.9 million.

Holders of Convertible Preferred Stock have the option to convert any number of whole shares at any time.

6 unchanged sentences

On July 10, 2024, the Company filed with the Securities Exchange Commission (the “SEC”) a prospectus supplement to the prospectus included in the Company’s registration statement on Form S-3ASR filed with the SEC on March 2, 2023, covering the resale from time to time by the Investors of up to an aggregate of 3,124,995 shares of common stock, to satisfy registration rights that the Company granted to such stockholders in connection with the Issuance.

As of June 30, 2025, an aggregate of 16,174,070 shares of common stock were reserved for issuance under the Company’s stock plans, which include stock options, restricted stock units, and performance stock units that have been granted covering 9,883,607 shares of common stock, as well as 5,002,335 of shares available under the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) and 1,256,597 shares of common stock available for future grants under the Company’s Employee Stock Purchase Plan.

Additionally, as of June 30, 2025, 3,125,000 shares of common stock were reserved for issuance to satisfy the estimated 3,124,995 shares of common stock issuable upon conversion of the 150,000 shares of Convertible Preferred Stock.

As of September 30, 2025, an aggregate of 18,895,825 shares of common stock were reserved for issuance under the Company’s stock plans, which include stock options, restricted stock units, and performance stock units that have been granted covering 9,679,630 shares of common stock, as well as 4,818,706 of shares available under the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) and 1,240,958 shares of common stock available for future grants under the Company’s Employee Stock Purchase Plan.

Additionally, this reserve includes 3,125,000 shares of common stock for issuance to satisfy the estimated 3,124,995 shares of common stock issuable upon conversion of the 150,000 shares of Convertible Preferred Stock.

On July 9, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Morgan Stanley & Co.

LLC and BofA Securities, Inc., as the representatives of the several underwriters named in the Underwriting Agreement (collectively, the “Underwriters”), in connection with a follow-on offering, issuance and sale by the Company of 2,058,824 shares of the Company’s common stock.

The offering price of the shares of common stock to the public was $ 85.00 per share.

In addition, under the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to 308,823 additional shares of Common Stock, at the public offering price per share, less underwriting discounts and commissions.

On July 10, 2025, the Underwriters exercised the option in full.

The closing of the sale of the shares pursuant to the offering, including the shares sold pursuant to the exercise in full of the option, took place on July 11, 2025, resulting in net proceeds of approximately $ 188.7 million, net of $ 12.6 million of underwriting discounts and commissions, and other offering expenses incurred by the Company, for a total share issuance of 2,367,647 .

On February 29, 2024, the Company and Cowen and Company, LLC (“Cowen”) entered into Amendment No.

14 unchanged sentences

Stock options granted under the Inducement Plan expire no more than 10 years from the date of grant.

As of June 30, 2025, 548,390 stock option awards and 412,065 restricted stock unit awards have been granted under the Inducement Plan, net of forfeitures.

As of June 30, 2025, 39,545 shares of common stock are available for future grant under the Inducement Plan.

As of September 30, 2025, 543,741 stock option awards and 406,709 restricted stock unit awards have been granted under the Inducement Plan, net of forfeitures.

As of September 30, 2025, 49,550 shares of common stock are available for future grant under the Inducement Plan.

Related-Party Transactions

Expenses paid directly to related parties for the three and six months ended June 30, 2025 and 2024, were immaterial.

Outstanding payments due to related parties as of June 30, 2025 and December 31, 2024 were also immaterial.

Expenses paid directly to related parties for the three and nine months ended September 30, 2025 and 2024, were immaterial.

Outstanding payments due to related parties as of September 30, 2025 and December 31, 2024 were also immaterial.

Significant Agreements

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As the repayment of the funded amount is contingent upon worldwide net product sales and upfront payments, milestones, and royalties, the repayment term may be shortened or extended depending on actual worldwide net product sales and upfront payments, milestones, and royalties.

We made repayments of $ 8.9 million in the six months ended June 30, 2025.

As of June 30, 2025 we have made cumulative payments of $ 29.4 million.

We made repayments of $ 14.5 million in the nine months ended September 30, 2025.

As of September 30, 2025 we have made cumulative payments of $ 34.9 million.

The Investors’ rights to receive the Revenue Interests will terminate on the date on which the Investors have received payments equal to a certain percentage of the funded portion of the Investment Amount including the aggregate of all payments made to the Investors as of such date, each percentage tier referred to as the Hard Cap, unless the RIFA is earlier terminated.

2 unchanged sentences

The repayment period commenced on July 8, 2022 for the Initial Investment Amount, and expires on the earlier of (i) the date at which the Investors received cash payments totaling an aggregate of a Hard Cap ranging from 185 % to 250 % of the Initial Investment Amount or (ii) the legal maturity date of July 8, 2034.

If the Investors have not received payments equal to 250 % of the Investment Amount by the twelve-year anniversary of the initial closing date, we will be

required to pay an amount equal to the Investment Amount plus a specific annual rate of return less payments previously received by Investors.

If the Investors have not received payments equal to 250 % of the Investment Amount by the twelve-year anniversary of the initial closing date, we will be required to pay an amount equal to the Investment Amount plus a specific annual rate of return less payments previously received by Investors.

In the event of a change of control, we are obligated to pay Investors an amount equal to the Hard Cap in effect at the time, ranging from 185 % to 250 % plus any Under Performance Payment of the Investment Amount less payments previously received by Investors.

6 unchanged sentences

We determined the fair value of the derivative using an option pricing Monte Carlo simulation model taking into account the probability of change of control occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 2, Summary of Significant Accounting Policies , to our condensed consolidated financial statements.

The aggregate fair value of the embedded derivative asset (liability) was $ 0.7 million and $ 0.3 million as of June 30, 2025 and December 31, 2024, respectively.

The aggregate fair value of the embedded derivative asset (liability) was $ 1.1 million and $ 0.3 million as of September 30, 2025 and December 31, 2024, respectively.

We will remeasure the embedded derivative to fair value each reporting period until the time the features lapse and/or termination of the deferred royalty obligation.

For the three months ended June 30, 2025 and 2024, we recognized other income of $ 0.5 million and $ 0.3 million, respectively, due to the remeasurement of the embedded derivative liability.

For the six months ended June 30, 2025 and 2024, we recognized other income of $ 0.4 million and $ 0.8 million, respectively, due to the remeasurement of the embedded derivative liability or asset.

The carrying value of the deferred royalty obligation as of June 30, 2025 was $ 109.8 million based on $ 100.0 million of proceeds, net of the fair value of the bifurcated embedded derivative liability upon execution of the RIFA, and debt issuance costs incurred.

The carrying value is classified as $ 3.8 million within current liabilities and $ 106.0 million within long-term liabilities on the consolidated balance sheet as of June 30, 2025.

The carrying value of the deferred royalty obligation approximated fair value as of June 30, 2025 and December 31, 2024.

The effective interest rate as of June 30, 2025 was 17.01 %.

For the three months ended September 30, 2025 and 2024, we recognized other income (expense) of $ 0.4 million and ($ 0.5 ) million, respectively, due to the remeasurement of the embedded derivative asset.

For the nine months ended September 30, 2025 and 2024, we recognized other income (expense) of $ 0.8 million and ($ 1.3 ) million, respectively, due to the remeasurement of the embedded derivative liability or asset.

The carrying value of the deferred royalty obligation as of September 30, 2025 was $ 109.0 million based on $ 100.0 million of proceeds, net of the fair value of the bifurcated embedded derivative liability upon execution of the RIFA, and debt issuance costs incurred.

The carrying value is classified as $ 5.6 million within current liabilities and $ 103.4 million within long-term liabilities on the consolidated balance sheet as of September 30, 2025.

The carrying value of the deferred royalty obligation approximated fair value as of September 30, 2025 and December 31, 2024.

The effective interest rate as of September 30, 2025 was 17.39 %.

In connection with the deferred royalty obligation, we incurred debt issuance costs totaling $ 3.3 million.

5 unchanged sentences

The Company is not presently subject to any pending or threatened litigation that it believes, if determined adversely to the Company, individually, or taken together, would reasonably be expected to have a material adverse effect on its business or financial results.

The Company is party to various agreements, principally relating to licensed technology, that require future payments relating to milestones whose achievement may become probable in subsequent periods, or royalties on future

sales of specified products.

Additionally, the Company is party to various contracts with CROs and CMOs that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement.

Based on the Company’s current development plans as of June 30, 2025, the Company does not deem it probable that we will make material milestone payments to third parties during the next 12 months from the filing of this Form 10-Q, in connection with our license agreements.

Based on the Company’s current development plans as of September 30, 2025, the Company does not deem it probable that we will make material milestone payments to third parties during the next 12 months from the filing of this Form 10-Q, in connection with our license agreements.

These milestones are generally recognized in the period in which the achievement of the underlying milestones becomes probable.

5 unchanged sentences

A single management team that reports to the Chief Executive Officer comprehensively manages the entire business.

The Company meets the aggregation criteria of ASC 280 and therefore has one reportable segment for the six months ended June 30, 2025.

The Company meets the aggregation criteria of ASC 280 and therefore has one reportable segment for the nine months ended September 30, 2025.

The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands):

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

Net product revenue - U.S.

11 unchanged sentences

Interest income (expense), net

Other segment expenses is composed of acquired in-process research and development costs associated with the acquisition of LGC’s proprietary compound bivamelagon in the three months ended March 31, 2024.

Income taxes (benefit)

Other segment expenses are composed of acquired IPR&D costs associated with the acquisition of LGC’s proprietary compound bivamelagon in the three months ended March 31, 2024.

Geographic Data

1 unchanged sentence

Total product revenue, net, by geographic area was as follows (in thousands):

Three months ended June 30,

Six months ended June 30,

Three months ended September 30,

Nine months ended September 30,

International

Total product revenue, net

As of June 30, 2025 and December 31, 2024, long-lived assets at locations outside the United States were not material.

As of September 30, 2025 and December 31, 2024, long-lived assets at locations outside the United States were not material.

Subsequent Events

The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure.

On July 9, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Morgan Stanley & Co.

The offering price of the shares of common stock to the public was $ 85.00 per share.

On July 10, 2025, the Underwriters exercised the option in full.

The closing of the sale of the shares pursuant to the offering, including the shares sold pursuant to the exercise in full of the option, took place on July 11, 2025, resulting in net proceeds of approximately $ 189.2 million, net of underwriting discounts and commissions, but excluding certain other offering expenses payable by the Company, for a total share issuance of 2,367,647 .

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