What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2026-05-05 compared with 2025-11-04 · 165 added, 178 removed, 530 unchanged (39% of the section changed)

3 unchanged sentences

(in thousands, except share and per share data)

September 30,

2026 December 31,

Current assets:

2 unchanged sentences

Accounts receivable, net 34,192 26,081

Inventory 28,651 25,753

Prepaid expenses and other current assets 26,622 26,133

5 unchanged sentences

Other long-term assets 2,518 3,286

Total assets $ 442,316 $ 480,196

Liabilities, Convertible Preferred Stock and Stockholders’ equity

2 unchanged sentences

Accrued expenses and other current liabilities 80,045 83,855

Other current liability - LG Chem

Lease liability 676 650

9 unchanged sentences

150,000 shares authorized;

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.

115,000 and 132,500 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively.

Liquidation preference of $ 115,000 and $ 132,500 as of March 31, 2026, and December 31, 2025, respectively.

114,710 130,957

Stockholders’ equity:

1 unchanged sentence

9,850,000 shares authorized;

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

no shares issued and outstanding at March 31, 2026 and December 31, 2025

Common stock, $ 0.001 par value:

120,000,000 shares authorized;

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

68,445,084 and 67,205,321 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital 1,529,909 1,491,675

Accumulated other comprehensive (loss)

Accumulated other comprehensive income (loss) 444 ( 796 )

Accumulated deficit ( 1,407,516 ) ( 1,351,877 )

( 1,304,372 )

( 1,155,338 )

Total stockholders’ equity 122,906 139,069

4 unchanged sentences

(in thousands, except share and per share data)

Three months ended September 30,

Nine months ended September 30,

Three months ended March 31,

Product revenue, net $ 60,112 $ 37,718

9 unchanged sentences

Other income (expense), net ( 1,704 ) ( 644 )

Gain on settlement of forward contract

Interest expense ( 4,583 ) ( 5,409 )

2 unchanged sentences

Loss before income taxes ( 55,094 ) ( 49,418 )

Provision (benefit) for income taxes

Provision for income taxes 545 80

Net loss $ ( 55,639 ) $ ( 49,498 )

Accrued dividends on convertible preferred stock ( 1,104 ) ( 1,322 )

2 unchanged sentences

Weighted-average common shares outstanding, basic and diluted 67,974,193 63,059,165

Other comprehensive loss:

Net loss attributable to common stockholders

Net loss $ ( 55,639 ) $ ( 50,820 )

Other comprehensive income (loss):

Foreign currency translation adjustment 1,784 ( 2 )

6 unchanged sentences

Series A Convertible

Preferred Stock

Preferred Stock Common Stock Additional

Capital Accumulated

Comprehensive

Income (Loss) Accumulated

Deficit Total

Stockholders’

Income (Loss)

Shares Amount Shares Amount

Balance at December 31, 2025 132,500 $ 130,957 67,205,321 $ 67 $ 1,491,675 $ ( 796 ) $ ( 1,351,877 ) $ 139,069

( 1,155,338 )

Stock compensation expense — — — — 23,099 — — 23,099

1 unchanged sentence

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units — — 936,949 2 6,095 — — 6,097

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

Tax withholding on vesting of restricted stock — — ( 77,643 ) — ( 8,458 ) — — ( 8,458 )

Conversion of Series A preferred stock redeemable to common stock ( 17,500 ) ( 17,351 ) 364,582 — 17,351 — — 17,351

Accretion of preferred stock dividends — 1,104 — — ( 1,104 ) — — ( 1,104 )

1 unchanged sentence

Net unrealized loss on marketable securities — — — — — ( 544 ) — ( 544 )

Net loss — — — — — — ( 55,639 ) ( 55,639 )

Balance at March 31, 2026 115,000 $ 114,710 68,445,084 $ 69 $ 1,529,909 $ 444 $ ( 1,407,516 ) $ 122,906

( 1,204,836 )

Stock compensation expense

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

Net unrealized loss on marketable securities

Balance at June 30, 2025

( 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, 2024 150,000 142,820 62,390,654 61 1,177,045 ( 39 ) ( 1,155,338 ) 21,729

2 unchanged sentences

Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units — — 494,853 1 2,225 — — 2,226

Issuance of common stock as consideration for LGC license

Foreign currency translation adjustment

Unrealized loss on marketable securities

Balance at March 31, 2024

( 1,036,108 )

Issuance of Series A Preferred Stock, net of $ 2,250 of issuance costs

Stock-based compensation expense

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

Accretion of preferred stock dividends — 1,322 — — ( 1,322 ) — — ( 1,322 )

Foreign currency translation adjustment

Unrealized loss on marketable securities

Balance at June 30, 2024

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

— — 587,510 — 32,108 — — 32,108

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 — — — — — ( 2 ) — ( 2 )

Unrealized gain on marketable securities

Balance at September 30, 2024

( 1,112,010 )

Unrealized loss on marketable securities — — — — — ( 10 ) — ( 10 )

Net loss — — — — — — ( 49,498 ) ( 49,498 )

Balance at March 31, 2025 150,000 $ 144,142 63,494,892 $ 62 $ 1,223,772 $ ( 51 ) $ ( 1,204,836 ) $ 18,947

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

2 unchanged sentences

(in thousands)

Nine months ended September 30,

Three months ended March 31,

Operating activities

Net loss $ ( 55,639 ) $ ( 49,498 )

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

5 unchanged sentences

Change in fair value of embedded derivative liability 330 80

Gain on settlement of forward contract

Acquired IPR&D assets classified as investing activities

Foreign currency (gain) loss 1,352 —

Other non-cash items 178 —

Changes in operating assets and liabilities:

Accounts receivable ( 8,110 ) 687

Inventory ( 3,086 ) ( 575 )

Prepaid expenses and other current assets ( 487 ) ( 3,204 )

6 unchanged sentences

Maturities of short-term investments 99,251 58,333

Acquisition of IPR&D assets

Net cash (used in) provided by investing activities

Net cash provided by investing activities 57,052 24,812

Financing activities

Repayment of deferred royalty obligation ( 4,288 ) ( 4,615 )

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

Proceeds from the exercise of stock options 6,095 2,226

Tax withholding on vesting of restricted stock ( 8,458 ) —

Proceeds from issuance of common stock from ESPP 1,251 854

Proceeds from Series A Preferred Stock, net of issuance costs

Gain on settlement of forward contract

Proceeds from ATM equity offering — 34,034

Net cash provided by financing activities

Net cash (used in) provided by financing activities ( 5,400 ) 32,499

Effect of exchange rates on cash 448 ( 2 )

Net increase (decrease) in cash, cash equivalents and restricted cash

Net increase in cash, cash equivalents and restricted cash 7,915 16,958

Cash, cash equivalents and restricted cash at beginning of period 54,823 89,601

1 unchanged sentence

Supplemental disclosure of non-cash investing and financing activities:

Non-current liability issued in exchange for the acquisition of IPR&D

Issuance of common stock in exchange for IPR&D

Accretion of preferred stock dividends $ 1,104 $ 1,322

4 unchanged sentences

Rhythm Pharmaceuticals, Inc.

(the “Company” or “we”) is a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients living with rare neuroendocrine diseases.

We are focused on advancing our melanocortin-4 (MC4R) receptor agonists, including our lead asset, IMCIVREE ® (setmelanotide), as a precision medicine designed to treat hyperphagia and severe obesity caused by rare MC4R pathway diseases.

While obesity affects hundreds of millions of people worldwide, we are developing therapies for a subset of individuals who have hyperphagia, a pathological insatiable hunger and impaired satiety accompanied by persistent and abnormal food-seeking behaviors, decreased energy expenditure and severe obesity due to diseases such as acquired or congenital hypothalamic obesity (“HO”) Bardet-Biedl syndrome (BBS) or other diseases caused by impaired MC4R pathway signaling.

(the “Company” or “we”) is a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients and their families living with rare neuroendocrine diseases.

We are focused on advancing our melanocortin-4 receptor agonists, including our lead asset, IMCIVREE (setmelanotide), as a precision medicine designed to treat hyperphagia and severe obesity caused by MC4R pathway diseases.

While obesity affects hundreds of millions of people worldwide, we are developing therapies for a subset of individuals who have hyperphagia, a pathological hunger, and severe obesity due to an impaired MC4R pathway, which may be caused by traumatic injury or genetic variants.

The MC4R pathway is an endocrine pathway in the brain that is responsible for regulating hunger, caloric intake and energy expenditure, which consequently affect body weight.

IMCIVREE, an MC4R agonist for which we hold worldwide rights, is the first-ever therapy developed for patients with certain rare diseases that is approved or authorized in the United States, European Union, and Great Britain, Canada, and other countries and regions.

IMCIVREE, an MC4R agonist for which we hold worldwide rights, is the first-ever therapy developed for patients with certain rare diseases that is approved or authorized in the United States, European Union (EU), Great Britain, Canada and other countries and regions.

The Company is a Delaware corporation organized in February 2013 under the name Rhythm Metabolic, Inc., and as of October 2015, under the name Rhythm Pharmaceuticals, Inc.

6 unchanged sentences

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

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

As of March 31, 2026, the Company had an accumulated deficit of $ 1.4 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.

1 unchanged sentence

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

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

As of March 31, 2026, the Company had $ 340.6 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.

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

There is 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.

Management believes that the Company's existing cash resources will be sufficient to fund the Company’s operations through at least the next twelve months from the filing of this Quarterly Report on Form 10-Q with the SEC .

Management believes that the Company's existing cash resources will be sufficient to fund the Company’s operations through at least the next 24 months from the filing of this Quarterly Report on Form 10-Q with the SEC .

Summary of Significant Accounting Policies

3 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 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.

The accompanying condensed consolidated balance sheet as of March 31, 2026, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2026 and 2025, the condensed consolidated statements of convertible preferred stock and stockholders’ equity for the three months ended March 31, 2026 and 2025 and the condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 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, 2025 and include all adjustments, which are all normal recurring adjustments, necessary for the fair presentation of the interim financial statements.

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 results for the three months ended March 31, 2026 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 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.

As of March 31, 2026, 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, 2025.

Use of Estimates

15 unchanged sentences

The Company and the chief executive officer view the Company’s operations and manage its business as one operating segment.

In November 2023, the FASB issued ASU 2023-07 – Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which improves segment disclosure requirements, primarily through enhanced disclosure requirements for significant segment expenses.

The improved disclosure requirements apply to all public entities that are required to report segment information, including those with only one reportable segment.

The Company adopted the guidance in the fiscal year beginning January 1, 2024.

There was no impact on the Company’s reportable segments identified and additional required disclosures have been included in Note 15, Segment and Geographic Information .

Off-Balance Sheet Risk and Concentrations of Credit Risk

5 unchanged sentences

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

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.

For the three months ended March 31, 2026, and 2025, approximately 61 % and 65 % of all the Company’s revenue was generated from a single customer in the United States.

Additionally, a single international customer also generated approximately 12 % of the Company's revenue during the three months ended March 31, 2026.

As of March 31, 2026, and December 31, 2025, approximately 56 % and 56 %, 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.

4 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 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.

During the three months ended March 31, 2026 and 2025, the Company did not recognize any credit losses related to its available-for-sale debt securities.

Further, as of March 31, 2026 and December 31, 2025, the Company did not record an allowance for credit losses related to its available-for-sale debt securities.

Accounts Receivable, net

3 unchanged sentences

The Company's contracts with its customers have customary payment terms that generally require payment within 90 days.

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

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.

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

As of March 31, 2026 and December 31, 2025, the Company determined an allowance for credit losses was not required based upon our review of contractual payments and our customers’ circumstances.

Revenue Recognition

3 unchanged sentences

In the United States (the “U.S.”), which accounts for the largest portion of our total revenues, the Company sells its product to one specialty pharmacy.

The product is distributed through third-party logistics, or 3PL, distribution agent that does not take title to the product.

The product is distributed through a third-party logistics provider, or 3PL, distribution agent that does not take title to the product.

Once the product is delivered to the Company’s specialty pharmacy provider, our customer in the U.S., the customer (or “wholesaler”) takes title to the product.

22 unchanged sentences

We estimate these rebates based upon a range of possible outcomes that are probability-weighted for the estimated payer mix.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability that is included in accrued expenses and other current liabilities on our condensed consolidated balance sheets.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a liability that is

included in accrued expenses and other current liabilities on our condensed consolidated balance sheets.

On a quarterly basis, we update our estimates and record any adjustments in the period that we identify the adjustments.

16 unchanged sentences

Such agreements may include the transfer of intellectual property rights in the form of licenses, transfer of technological know-how, delivery of drug substances, research and development services, and participation on certain committees with the counterparty.

Payments made by the

customers may include non-refundable upfront fees, payments upon the exercise of customer options, payments based upon the achievement of defined milestones, and royalties on sales of products and product candidates if they are approved and commercialized.

Payments made by the customers may include non-refundable upfront fees, payments upon the exercise of customer options, payments based upon the achievement of defined milestones, and royalties on sales of products and product candidates if they are approved and commercialized.

If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize the transaction price allocated to the license as revenue upon transfer of control of the license.

41 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 nine months ended September 30, 2025 and 2024, respectively.

No events or changes in circumstances existed to require an impairment assessment during the three months ended March 31, 2026 and 2025, respectively.

Acquired IPR&D and Milestone Expenses

2 unchanged sentences

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 nine months ended September 30, 2025 and 2024, respectively.

Net foreign currency exchange transaction gains (losses), which are included in other income (expense), net on our consolidated statements of operations, were $ 1.4 million and $ 0.0 million for the three months ended March 31, 2026 and 2025, 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 September 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 March 31, 2026 and December 31, 2025 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 September 30, 2025 and December 31, 2024, respectively.

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 March 31, 2026 and December 31, 2025, respectively.

Net Loss Per Share

5 unchanged sentences

Three Months Ended

Nine Months Ended

September 30,

Stock options 6,511,250 7,157,931

10 unchanged sentences

Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

Recently adopted accounting pronouncements

In December 2024, the FASB issued ASU 2023-09, "Income Taxes (Topic 740):

Improvements to Income Tax Disclosures , or ASU 2023-09.

Improvements to Income Tax Disclosures".

The new guidance requires that an entity, on an annual basis, disclose additional income tax information, primarily related to the rate reconciliation and income taxes paid.

1 unchanged sentence

The amendments in this update are effective for us beginning in fiscal year ending December 31, 2025.

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.

The Company has adopted this update on a prospective basis.

The adoption of this guidance resulted in expanded disclosures in its consolidated financial statements.

Recently issued accounting pronouncements, not yet adopted

In December 2025, the FASB issued ASU 2025-12 “Codification Improvements” to address suggestions received from stakeholders on the Accounting Standards Codification and to make other incremental improvements to U.S.

The update represents changes to the Codification that clarify, correct errors, or make minor improvements.

The amendments make the Codification easier to understand and apply.

The guidance is effective for fiscal years beginning after December 15, 2026, including interim periods within those fiscal years.

The Company is in the process of evaluating this guidance to determine the impact it may have on its consolidated financial statements.

In December 2025, the FASB issued ASU 2025-11, “Interim Reporting (Topic 270) Narrow-Scope Improvements.” The amendments in this update provide clarity on interim disclosure requirements and the applicability of Topic 270.

The amendments in this update also include a disclosure principle that requires entities to disclose events since

the end of the last annual reporting period that have a material impact on the entity.

The amendments in this ASU are required to be adopted for interim periods within annual reporting 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.

The Company is in the process of evaluating this guidance to determine the impact it may have on its consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03 “Income Statement:

Reporting Comprehensive Income—Expense Disaggregation Disclosures,” which requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses.

ASU 2024-03 is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027.

Early adoption is permitted.

The amendments may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements.

The Company is in the process of evaluating this guidance to determine the impact it may have on its consolidated financial statement disclosures.

Asset Acquisitions

7 unchanged sentences

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.

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

In addition, and subject to the completion of Phase 2 development of bivamelagon, the Company has agreed to pay LGC royalties of between low- to mid single digit percent of net revenues from its MC4R portfolio, including bivamelagon, commencing in 2029 and dependent upon achievement of various regulatory and indication approvals, and subject to customary deductions and anti-stacking.

7 unchanged sentences

Inventory consists of the following (in thousands):

September 30,

2026 December 31,

Raw Materials $ 5,653 $ 6,745

WIP 1,781 1,631

Finished Goods 21,217 17,377

2 unchanged sentences

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

September 30,

2026 December 31,

Research and development costs $ 17,800 $ 17,084

1 unchanged sentence

Payroll related 14,398 22,433

Royalties 3,005 2,870

Sales allowances 33,071 31,564

Other 5,145 4,078

Accrued expenses and other current liabilities $ 80,045 $ 83,855

Fair Value of Financial Assets and Liabilities

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.

As of March 31, 2026 and December 31, 2025, the carrying amount of cash and cash equivalents and short-term investments was $ 340.6 million and $ 388.9 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

September 30, 2025 using:

March 31, 2026 using:

Level 1 Level 2 Level 3 Total

Cash equivalents:

5 unchanged sentences

Derivative asset — — 850 850

Total $ 108,110 $ 217,774 $ 850 $ 326,734

Fair Value Measurements as of

December 31, 2025 using:

Level 1 Level 2 Level 3 Total

Cash equivalents:

Commercial Paper

Money market funds $ 33,949 $ — $ — $ 33,949

3 unchanged sentences

Derivative asset — — 1,180 1,180

The estimated fair value of the derivative asset relates to our Royalty Interest Financing Agreement (RIFA) with HealthCare Royalty Partners was determined using Level 3 inputs.

Total $ 105,826 $ 262,771 $ 1,180 $ 369,777

The estimated fair value of the derivative asset related to our Royalty Interest Financing Agreement (RIFA) with HealthCare Royalty Partners was determined using Level 3 inputs.

The fair value measurement of the derivative asset is sensitive to changes in the unobservable inputs used to value the financial instrument.

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

Nine months ended

September 30,

Three months ended

Beginning aggregate estimated fair value of Level 3 liability (asset) $ ( 1,180 ) $ ( 270 )

Change in fair value of embedded derivative 330 80

Fair value of forward contract - Series A Convertible Preferred Stock

Settlement of forward contract

Ending aggregate estimated fair value of Level 3 liability (asset) $ ( 850 ) $ ( 190 )

1 unchanged sentence

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

September 30, 2025

March 31, 2026

Corporate debt securities and commercial paper (due within 1 year) $ 217,812 $ 66 $ ( 104 ) $ 217,774

Treasury Securities 60,620 102 ( 8 ) 60,714

$ 278,432 $ 168 $ ( 112 ) $ 278,488

December 31, 2025

1 unchanged sentence

Treasury Securities 71,634 243 — 71,877

$ 334,046 $ 613 $ ( 11 ) $ 334,648

Intangible Assets

As of September 30, 2025

As of December 31, 2024

Estimated life (years)

As of March 31, 2026 As of December 31, 2025

Estimated life (years) Cost Accumulated

Amortization Net Cost Accumulated

Amortization Net

Capitalized Milestones 11 $ 9,000 $ ( 3,894 ) $ 5,106 $ 9,000 $ ( 3,681 ) $ 5,319

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.

As of March 31, 2026, the Company’s finite-lived net intangible assets, which totaled $ 5.1 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 September 30, 2025, amortization expense for the next five years and beyond is summarized as follows (in thousands):

As of March 31, 2026, amortization expense for the next five years and beyond is summarized as follows (in thousands):

2026 (remainder) $ 641

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.

Thereafter 1,046

Total $ 5,106

Amortization expense totaled $ 0.2 million for each of the three months ended March 31, 2026 and 2025, 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 $ 0.1 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 Company recorded an income tax provision of approximately $ 0.5 million and $ 0.1 million for the three months ended March 31, 2026, and 2025, 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.

The Company expects to maintain a full valuation allowance against its net deferred tax assets for the year ending December 31, 2026.

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.

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

Series A Convertible Preferred Stock

On April 1, 2024, the Company entered into an Investment Agreement (the “Investment Agreement”) with certain affiliates of Perceptive Advisors LLC (“Perceptive”) and certain other investors (each, an “Investor” and collectively, the “Investors”), relating to the issuance and sale of 150,000 shares of a new series of the Company’s Series A Convertible Preferred Stock, par value $ 0.001 per share, titled the “Series A Convertible Preferred Stock” (the “Convertible Preferred Stock”), for an aggregate purchase price of $ 147.8 million, net of $ 2.3 million of issuance costs, or $ 1,000 per share (the “Issuance”).

Preferred Stock, par value $ 0.001 per share, titled the “Series A Convertible Preferred Stock” (the “Convertible Preferred Stock”), for an aggregate purchase price of $ 147.8 million, net of $ 2.3 million of issuance costs, or $ 1,000 per share (the “Issuance”).

The Issuance closed on April 15, 2024.

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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 September 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 March 31, 2026 .

On December 4, 2025, and in accordance with the terms described below, a holder of the Company's Series A Convertible Preferred Stock exercised their right to convert 17,500 shares of Series A Convertible Preferred Stock to common shares.

Each of the 17,500 shares of Series A Convertible Preferred Stock converted to 20.8333 shares of common stock, resulting in a total of 364,582 shares of common stock.

The Company reclassified the carrying value of the converted shares of $ 17.2 million from Series A convertible Preferred Stock to common stock and additional paid in capital, for this non-cash financing event.

On January 26, 2026, and in accordance with the terms described below, the same holder exercised its right to convert another 17,500 shares of Series A Convertible Preferred Stock to common shares.

Each of the 17,500 preferred shares converted to 20.8333 shares of common stock, resulting in a total of 364,582 shares of common stock.

The Company reclassified the carrying value of the converted shares of $ 17.4 million from Series A convertible Preferred Stock to common stock and additional paid in capital, for this non-cash financing event.

The Convertible Preferred Stock has the following rights and privileges:

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Specifically, as long as the Convertible Preferred Stock are outstanding, each of the following events require at least a two thirds affirmative vote of the Convertible Preferred Stock holders:

(a) any amendment or modification of the Certificate of Incorporation to authorize or create, or to increase the authorized number of shares of, any class or series of Dividend Parity Stock, Liquidation Parity Stock, Dividend Senior Stock or Liquidation Senior Stock, (b) any amendment, modification, repeal or waiver of any provision of the Certificate of Incorporation or the Amended and Restated Certificate of Designations that adversely affects the rights, preferences, privileges or powers of the Convertible Preferred Stock, (c) increase or decrease the number of authorized shares of Convertible Preferred Stock or issue additional shares of Convertible Preferred Stock, (d) the Company’s consolidation or combination with, or merger with or into, another Person, or any binding or statutory share exchange or involving the Convertible Preferred Stock, in each case unless:

modification, repeal or waiver of any provision of the Certificate of Incorporation or the Amended and Restated Certificate of Designations that adversely affects the rights, preferences, privileges or powers of the Convertible Preferred Stock, (c) increase or decrease the number of authorized shares of Convertible Preferred Stock or issue additional shares of Convertible Preferred Stock, (d) the Company’s consolidation or combination with, or merger with or into, another Person, or any binding or statutory share exchange or involving the Convertible Preferred Stock, in each case unless:

(i) the Convertible Preferred Stock either (x) remains outstanding after such consolidation, combination, merger, share exchange or reclassification;

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The amount payable on the redemption date is equal to 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).

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 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.

If a change of control occurs, each holder shall have the right to require the Company to repurchase all, or any whole number of shares that is less than all, of the holder’s Convertible Preferred Stock at an amount equal to 1.75 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 March 31, 2026 , 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 be not 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.

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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 $ 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.

The Company accrued dividends of $ 1.1 million and $ 1.3 million for the three months ended March 31, 2026 and March 31, 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 March 31, 2026 and December 31, 2025 is $ 114.7 million and $ 131.0 million, respectively.

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

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The amendments contained in the Amended and Restated Certificate of Designations (x) limited the voting rights of the Convertible Preferred Stock to 24.9438 shares of the Company’s common stock per $ 1,000 liquidation preference of Convertible Preferred Stock and (y) eliminated a 1 % step up in the interest rate that otherwise would have applied in the unlikely event that the Company was required to obtain and failed to obtain stockholder approval for certain conversion shares underlying the Convertible Preferred Stock.

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 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.

O n February 26, 2026, the Company filed with the Securities Exchange Commission (the “SEC”) a registration statement on Form S-3ASR containing a prospectus covering the resale from time to time by the Investors of up to an aggregate of 2,395,831 shares of common stock, to satisfy registration rights that the Company granted to such stockholders in connection with the Issuance.

The Company has 10,000,000 shares of Preferred Stock authorized, of which 150,000 shares are designated for the Series A Convertible Preferred Stock.

As of March 31, 2026 , an aggregate of 19,823,095 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 9,784,464 shares of common stock, as well as 6,386,116 of shares available under the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) and 1,225,153 shares of common stock available for future grants under the Company’s Employee Stock Purchase Plan.

Additionally, this reserve includes 2,395,831 shares of common stock for issuance to satisfy the shares of common stock issuable upon conversion of the remaining 115,000 shares of Convertible Preferred Stock.

On January 26, 2026 one of the Company's Series A Convertible Preferred Stock holders exercised their conversion right and converted 17,500 Convertible Preferred A Stock into 364,582 shares of common stock.

Refer to Note 9, Series A Convertible Preferred Stoc k, for further information

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

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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.

1 to Sales Agreement (the “Amendment”) to increase the aggregate offering price of the shares of common stock that may be issued and sold pursuant to the Sales Agreement to $ 200.0 million (excluding the aggregate offering price of shares of common stock issued and sold pursuant to the Sales Agreement prior to February 29, 2024).

In connection with the Amendment, on February 29, 2024, the Company filed with the SEC a prospectus supplement, dated February 29, 2024, which, combined with the Base Prospectus (together, the “New Prospectus”), amended the Prior Prospectus in its entirety.

The issuances and sales under the Sales Agreement, as amended by the Amendment, will be made pursuant to the Registration Statement and the New Prospectus.

On February 26, 2026, the Company and TD Securities (USA) LLC (“TD Cowen”) entered into a Sales Agreement (the “Sales Agreement”) pursuant to which the Company may issue and sell shares of its common stock, having an aggregate offering price of up to $ 200.0 million, from time to time through an “at the market” equity offering program under which TD Cowen acts as sales agent.

The Sales Agreement supersedes the prior Sales Agreement between TD Cowen and the Company, dated November 2, 2021, as amended on February 29, 2024.

In connection with the Sales Agreement, on February 26, 2026, the Company filed with the SEC a registration statement on Form S-3ASR containing a base prospectus and a prospectus supplement, each dated February 26, 2026, pursuant to which issuances and sales under the Sales Agreement will be made.

Between December 10, 2024 and December 31, 2024, the Company sold 744,595 shares of common stock in the ATM Program for net proceeds of $ 41.2 million.

Between January 1, 2025 and January 21, 2025, the Company sold an additional 587,510 shares of common stock in the ATM Program for net proceeds of approximately $ 32.1 million.

On January 4, 2024, the Company issued 432,143 shares of common stock as partial consideration for its acquisition of the worldwide rights to LGC’s proprietary compound bivamelagon.

On February 9, 2022, the Company’s board of directors adopted the Inducement Plan, without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market LLC listing rules or Rule 5635(c)(4).

In accordance with Rule 5635(c)(4), awards under the Inducement Plan may only be made to a newly hired employee who has not previously been a member of the Company’s board of directors, or an employee who is being rehired following a bona fide period of non-employment by the Company or a subsidiary, as a material inducement to the employee’s entering into employment with the Company or its subsidiary.

In accordance with Rule 5635(c)(4), awards under the Inducement Plan may only be made to a newly hired employee who has not previously

been a member of the Company’s board of directors, or an employee who is being rehired following a bona fide period of non-employment by the Company or a subsidiary, as a material inducement to the employee’s entering into employment with the Company or its subsidiary.

An aggregate of 1,000,000 shares of the Company’s common stock have been reserved for issuance under the Inducement Plan.

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

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.

As of March 31, 2026, 530,695 stock option awards and 392,531 restricted stock unit awards have been granted under the Inducement Plan, net of forfeitures.

As of March 31, 2026, 77,116 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 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.

Expenses paid directly to related parties for the three months ended March 31, 2026 and 2025, were immaterial.

Outstanding payments due to related parties as of March 31, 2026 and December 31, 2025 were also immaterial.

Significant Agreements

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Prior to executing the termination agreement, the Company had recorded $ 1.3 million of deferred revenue related to this arrangement for unsatisfied performance obligations.

As a result of the Termination Agreement, the Company recognized the $ 6.3 million paid to RareStone as a reduction in previously-recognized license revenue as it represented consideration paid to a customer, and recognized all existing deferred revenue resulting in a net reduction in license revenue of $ 5.0 million.

Pursuant to the Termination Agreement, the RareStone Agreements were terminated and all rights and obligations under such agreements ceased.

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Under the terms of the RIFA, we received $ 37.5 million on June 29, 2022 upon FDA approval of IMCIVREE in BBS, referred to as the Initial Investment Amount, and we received an additional $ 37.5 million on September 29, 2022 of the Investment Amount upon EMA approval for BBS.

On September 12, 2023, we received the remaining $ 24.4 million of the Investment Amount, net of debt issuance costs, following the achievement of a specified amount of cumulative net sales of IMCIVREE between July 1, 2022 and September 30, 2023.

On September 12, 2023, we received the remaining $ 24.4 million of the

Investment Amount, net of debt issuance costs, following the achievement of a specified amount of cumulative net sales of IMCIVREE between July 1, 2022 and March 31, 2024.

As consideration for the Investment Amount and pursuant to the RIFA, we agreed to pay the Investors a tiered royalty on our annual net revenues, or Revenue Interest, including worldwide net product sales and upfront payments and milestones.

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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 $ 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.

We made repayments of $ 4.3 million in the three months ended March 31, 2026.

As of March 31, 2026 we have made cumulative payments of $ 44.6 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.

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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 $ 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 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 %.

The aggregate fair value of the embedded derivative asset (liability) was $ 0.9 million and $ 1.2 million as of March 31, 2026 and December 31, 2025, respectively.

We 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 March 31, 2026 and 2025, we recognized other expense of $( 0.3 ) million and $( 0.1 ) million, respectively, due to the remeasurement of the embedded derivative asset.

The carrying value of the deferred royalty obligation as of March 31, 2026 was $ 108.5 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 $ 10.1 million within current liabilities and $ 98.3 million within long-term liabilities on the consolidated balance sheet as of March 31, 2026.

The carrying value of the deferred

royalty obligation approximated fair value as of March 31, 2026 and December 31, 2025.

The effective interest rate as of March 31, 2026 was 17.16 %.

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

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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 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.

Based on the Company’s current development plans as of March 31, 2026, 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.

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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 nine months ended September 30, 2025.

The Company meets the aggregation criteria of ASC 280 and therefore has one reportable segment for the three months ended March 31, 2026 and March 31, 2025.

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

Three months ended September 30,

Nine months ended September 30,

Three months ended March 31,

Net product revenue - U.S.

$ 36,896 $ 24,369

Net product revenue - International 23,216 13,349

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Corporate, general & administrative 7,888 7,983

Other segment expenses

Other income (expense), net ( 1,704 ) ( 644 )

Interest income (expense), net ( 1,029 ) ( 1,770 )

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.

Income taxes 545 80

Net loss $ ( 55,639 ) $ ( 49,498 )

Geographic Data

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

Three months ended September 30,

Nine months ended September 30,

Three months ended March 31,

US $ 36,896 $ 24,369

International 23,216 13,349

Total product revenue, net $ 60,112 $ 37,718

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

As of March 31, 2026 and December 31, 2025, long-lived assets at locations outside the United States were not material.

Subsequent Events

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

What changed 10-Q

Item 1. Financial Statements