What changed in this filing

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Item 1. Financial Statements

2025-11-06 compared with 2025-08-11 · 73 added, 75 removed, 439 unchanged (25% of the section changed)

3 unchanged sentences

(In thousands, except share amounts)

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Current assets:

26 unchanged sentences

Convertible preferred stock, $ 0.01 par value;

40,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

0 shares issued and outstanding as of June 30, 2025 and December 31, 2024

40,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

0 shares issued and outstanding as of September 30, 2025 and December 31, 2024

Common stock, $ 0.01 par value;

400,000,000 shares authorized as of June 30, 2025 and December 31, 2024;

145,685,442 shares and 144,220,986 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

400,000,000 shares authorized as of September 30, 2025 and December 31, 2024;

146,625,722 shares and 144,220,986 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital 2,846,278 2,764,880

7 unchanged sentences

(In thousands, except share and per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

12 unchanged sentences

Net loss $ ( 126,902 ) $ ( 107,192 ) $ ( 383,991 ) $ ( 308,020 )

Other comprehensive loss:

Net unrealized loss on marketable securities, net of tax

( 1,098 ) ( 1,363 ) ( 1,081 ) ( 3,302 )

Other comprehensive income (loss):

Net unrealized gain (loss) on marketable securities, net of tax 162 8,188 ( 919 ) 4,886

Comprehensive loss $ ( 126,740 ) $ ( 99,004 ) $ ( 384,910 ) $ ( 303,134 )

8 unchanged sentences

Issuances under equity incentive plans 1,042,249 11 5,224 — — 5,235

455,335 5 4,647 — — 4,652

Vesting of restricted stock units 1,362,487 14 ( 14 ) — — —

2 unchanged sentences

Other comprehensive loss — — — ( 919 ) — ( 919 )

— — — ( 1,081 ) — ( 1,081 )

Balance at September 30, 2025 146,625,722 $ 1,793 $ 2,846,278 $ 1,101 $ ( 1,922,975 ) $ 926,197

Balance at June 30, 2025 145,685,442 $ 1,783 $ 2,820,404 $ 939 $ ( 1,796,073 ) $ 1,027,053

Balance at March 31, 2025 145,251,258 $ 1,778 $ 2,790,825 $ 2,037 $ ( 1,671,954 ) $ 1,122,686

Issuances under equity incentive plans 586,914 6 577 — — 583

2 unchanged sentences

Net loss — — — — ( 126,902 ) ( 126,902 )

Other comprehensive loss

Other comprehensive income

— — — 162 — 162

Balance at June 30, 2025 145,685,442 $ 1,783 $ 2,820,404 $ 939 $ ( 1,796,073 ) $ 1,027,053

Balance at September 30, 2025 146,625,722 $ 1,793 $ 2,846,278 $ 1,101 $ ( 1,922,975 ) $ 926,197

Balance at December 31, 2023 138,385,498 $ 1,711 $ 2,144,811 $ 643 $ ( 1,116,211 ) $ 1,030,954

5 unchanged sentences

Net loss — — — — ( 308,020 ) ( 308,020 )

Other comprehensive loss — — — ( 3,302 ) — ( 3,302 )

Other comprehensive income — — — 4,886 — 4,886

Balance at September 30, 2024 143,840,029 $ 1,764 $ 2,735,433 $ 5,529 $ ( 1,424,231 ) $ 1,318,495

Balance at June 30, 2024 143,123,582 $ 1,757 $ 2,704,992 $ ( 2,659 ) $ ( 1,317,039 ) $ 1,387,051

Balance at March 31, 2024 142,512,856 $ 1,751 $ 2,673,033 $ ( 1,296 ) $ ( 1,218,013 ) $ 1,455,475

Issuances under equity incentive plans

4 unchanged sentences

Net loss — — — — ( 107,192 ) ( 107,192 )

Other comprehensive loss — — — ( 1,363 ) — ( 1,363 )

Balance at June 30, 2024 143,123,582 $ 1,757 $ 2,704,992 $ ( 2,659 ) $ ( 1,317,039 ) $ 1,387,051

Other comprehensive income — — — 8,188 — 8,188

Balance at September 30, 2024 143,840,029 $ 1,764 $ 2,735,433 $ 5,529 $ ( 1,424,231 ) $ 1,318,495

See accompanying notes to unaudited condensed consolidated financial statements.

2 unchanged sentences

(In thousands)

Six Months Ended

Nine Months Ended

September 30,

Operating activities

47 unchanged sentences

These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.

During the six months ended June 30, 2025 there were no material changes to the Company's significant accounting and financial reporting policies from those reflected in the 2024 Annual Report on Form 10-K.

During the nine months ended September 30, 2025 there were no material changes to the Company's significant accounting and financial reporting policies from those reflected in the 2024 Annual Report on Form 10-K.

For further information with regard to the Company’s Significant Accounting Policies, please refer to Note 1, "Significant Accounting Policies," to the Company’s Consolidated Financial Statements included in the 2024 Annual Report on Form 10-K.

17 unchanged sentences

The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Condensed Consolidated Balance Sheets.

As of June 30, 2025 and December 31, 2024, the Company had no off-balance sheet concentrations of credit risk.

As of September 30, 2025 and December 31, 2024, the Company had no off-balance sheet concentrations of credit risk.

The Company is subject to a number of risks similar to other clinical-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties.

8 unchanged sentences

Impairments, if any, are based on the excess of the carrying amount over the recoverable amount of the asset.

There were no impairments during the three and six months ended June 30, 2025 and 2024.

There were no impairments during the three and nine months ended September 30, 2025 and 2024.

Cash, Cash Equivalents and Restricted Cash

1 unchanged sentence

Cash equivalents are reported at fair value.

Cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Statements of Cash Flows is composed of cash and cash equivalents reported in the Condensed Consolidated Balance Sheets and restricted cash of $ 3.1 million and $ 1.6 million as of June 30, 2025 and December 31, 2024, respectively, which is included within other non-current assets in the Condensed Consolidated Balance Sheets.

Cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Statements of Cash Flows is composed of cash and cash equivalents reported in the Condensed Consolidated Balance Sheets and restricted cash of $ 3.1 million and $ 1.6 million as of September 30, 2025 and December 31, 2024, respectively, which is included within other non-current assets in the Condensed Consolidated Balance Sheets.

Marketable Securities

27 unchanged sentences

Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.

The weighted-average common shares outstanding as of June 30, 2025 and June 30, 2024 include pre-funded warrants to purchase shares of common stock that were issued in connection with the February 2024 private placement, as discussed further in Note 7 - " Common Stock ".

The weighted-average common shares outstanding as of September 30, 2025 and September 30, 2024 include pre-funded warrants to purchase shares of common stock that were issued in connection with the February 2024 private placement, as discussed further in Note 7 - " Common Stock ".

Recently Issued Accounting Pronouncements

13 unchanged sentences

Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands):

June 30, 2025

September 30, 2025

Level 1 Level 2 Level 3 Total

5 unchanged sentences

Long-term marketable securities:

government treasuries 66,852 — — 66,852

Corporate debt securities — 24,703 — 24,703

14 unchanged sentences

The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly.

The Company has not transferred any assets or liabilities between the fair value measurement levels for the six months ended June 30, 2025 or for the year ended December 31, 2024.

The Company has not transferred any assets or liabilities between the fair value measurement levels for the nine months ended September 30, 2025 or for the year ended December 31, 2024.

Marketable Securities

All marketable securities were considered available-for-sale at June 30, 2025 and December 31, 2024.

All marketable securities were considered available-for-sale at September 30, 2025 and December 31, 2024.

On a recurring basis, the Company records its marketable securities at fair value using Level 1 or Level 2 inputs as discussed in Note 2, "Fair Value Measurements".

The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):

June 30, 2025

September 30, 2025

Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value

7 unchanged sentences

Long-term marketable securities:

government treasuries

66,664 188 — 66,852

Corporate debt securities

22 unchanged sentences

$ 1,014,372 $ 2,595 $ ( 223 ) $ 1,016,744

As of June 30, 2025 and December 31, 2024, some of the Company's marketable securities were in an unrealized loss position.

The Company has no t recognized an allowance for credit losses as of June 30, 2025 or December 31, 2024.

As of September 30, 2025 and December 31, 2024, some of the Company's marketable securities were in an unrealized loss position.

The Company has no t recognized an allowance for credit losses as of September 30, 2025 or December 31, 2024.

The Company determined that it had the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery.

2 unchanged sentences

All marketable securities with unrealized losses as of each balance sheet date have been in a loss position for less than twelve months or the loss is not material.

As of June 30, 2025, all of the Company’s marketable securities have an effective maturity of less than two years .

As of September 30, 2025, all of the Company’s marketable securities have an effective maturity of less than two years .

Research and Development Funding Collaboration Agreement

6 unchanged sentences

Accordingly, payments received will be recorded as a liability, and recognized by the Company as a reduction to research and development expenses over the estimated Phase 2a study period as the underlying research and development costs are incurred.

Under this arrangement, the Company recognized a $ 3.8 million and $ 8.8 million offset to research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2025, respectively, and the Company recognized a $ 2.3 million offset to research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss for both the three and six months ended June 30, 2024.The Company recorded current and non-current deferred research and development funding liabilities of $ 19.9 million and $ 10.4 million, respectively on the Condensed Consolidated Balance Sheet as of June 30, 2025.

Under this arrangement, the Company recognized an offset to research and development expenses of $ 3.7 million and $ 12.5 million in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2025, respectively, and $ 2.5 million and $ 4.8 million for the three and nine months ended September 30, 2024, respectively.

The Company recorded current and non-current deferred research and development funding liabilities of $ 22.6 million and $ 4.0 million, respectively on the Condensed Consolidated Balance Sheet as of September 30, 2025.

The Company recorded a current deferred research and development funding liability of $ 14.1 million on the Consolidated Balance Sheet as of December 31, 2024.

6 unchanged sentences

as such, the Company expects to receive no future milestone or royalty payments from Biogen related to the ATV:Abeta program.

There were no changes to the terms of the LRRK2 Agreement during the three and six months ended June 30, 2025 or 2024.

The Company has no remaining performance obligations under the Biogen Collaboration Agreement, and therefore no contract liability remained on the Condensed Consolidated Balance Sheets as of June 30, 2025 or December 31, 2024 .

As of June 30, 2025, the Company had no t recorded milestone revenue or product sales under the Biogen Collaboration Agreement.

There were no changes to the terms of the LRRK2 Agreement during the three and nine months ended September 30, 2025 or 2024.

As of September 30, 2025, the Company had no t recorded milestone revenue or product sales under the Biogen Collaboration Agreement.

In October 2018, the Company entered into a Collaboration and License Agreement ("Sanofi Collaboration Agreement") with Genzyme Corporation, a wholly-owned subsidiary of Sanofi S.A.

The details of the Sanofi Collaboration Agreement and the payments the Company has received, and is entitled to receive, are further described in Note 5, "Collaboration Agreements", to the consolidated financial statements in the Company's 2024 Annual Report on Form 10-K.

The Company has no remaining performance obligations under the Sanofi Collaboration Agreement, and therefore no contract liability remains on the Condensed Consolidated Balance Sheets as of June 30, 2025 or December 31, 2024 .

On February 24, 2025, Denali and Sanofi executed a side letter terminating Sanofi's license to the central nervous system ("CNS") Products program including SAR443820/DNL788.

1 unchanged sentence

Under the Sanofi Collaboration Agreement, the Company is eligible to receive milestone payments totaling up to approximately $ 495.0 million upon achievement of certain clinical, regulatory and sales milestone events for Peripheral Products, and variable royalties on worldwide net sales.

As of June 30, 2025, the Company had earned milestone payments of $ 100.0 million and had no t recorded any product sales under the Sanofi Collaboration Agreement.

As of September 30, 2025, the Company had earned milestone payments of $ 100.0 million and had no t recorded any product sales under the Sanofi Collaboration Agreement.

In January 2018, the Company entered into a Collaboration and Option Agreement ("Takeda Collaboration Agreement") with Takeda Pharmaceutical Company Limited ("Takeda").

5 unchanged sentences

The ATV:TREM2 program termination became effective 60 days following the notice date, and subsequently, there are no future milestones, cost, or profit sharing related to this agreement.

As of June 30, 2025, the Company had earned an aggregate of $ 10.0 million in option fee payments and $ 10.0 million in milestone payments from Takeda under the PTV:PGRN and ATV:TREM2 Collaboration Agreements, and had no t recorded any product sales under either agreement.

As of September 30, 2025, the Company had earned an aggregate of $ 10.0 million in option fee payments and $ 10.0 million in milestone payments from Takeda under the PTV:PGRN and ATV:TREM2 Collaboration Agreements, and had no t recorded any product sales under either agreement.

Cost Sharing Payments and Reimbursements

Cost sharing payments to collaboration partners recorded as expenses in research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss, and cost sharing reimbursements from collaboration partners recorded as an offset to expense in research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss are as follows (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

10 unchanged sentences

_________________________________

(1) Cost sharing reimbursements of $ 1.4 million and $ 1.5 million were recorded as a receivable within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024, respectively.

(2) Cost sharing payments due to Biogen of $ 4.2 million and $ 2.5 million were recorded within accounts payable on the Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024, respectively.

(1) Cost sharing reimbursements of $ 1.9 million and $ 1.5 million were recorded as a receivable within prepaid expenses and other current assets on the Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024, respectively.

(2) Cost sharing payments due to Biogen of $ 4.1 million and $ 2.5 million were recorded within accounts payable on the Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024, respectively.

Commitments and Contingencies

3 unchanged sentences

Both leases are further described in Note 7, "Commitments and Contingencies," to the consolidated financial statements in the Company's 2024 Annual Report on Form 10-K.

Within the total ROU assets for the SLC Lease, the Company recorded assets of $ 44.4 million and $ 41.6 million as of June 30, 2025 and December 31, 2024, respectively , which were purchased by the Company but are considered to be owned by the landlord.

The current finance lease liability is included in other accrued costs and current liabilities in the Condensed Consolidated Balance Sheet as of June 30, 2025 .

There were no changes to the terms of the leases recognized under ASC 842 during the three and six months ended June 30, 2025 or 2024.

Operating lease costs, excluding variable lease costs, were $ 1.9 million and $ 3.8 million for the three and six months ended June 30, 2025, respectively, and $ 1.9 million and $ 3.9 million for the three and six months ended June 30, 2024, respectively.

Variable lease costs related to the operating lease were $ 1.2 million and $ 2.5 million for the three and six months ended June 30, 2025, respectively, and $ 1.2 million and $ 2.3 million for the three and six months ended June 30, 2024, respectively.

Finance lease costs representing amortization of ROU assets and interest on lease liability were $ 0.9 million and $ 0.2 million, respectively, for the three months ended June 30, 2025, and $ 1.8 million and $ 0.4 million, respectively, for the six months ended June 30, 2025.

There was no finance lease costs for the three and six months ended June 30, 2024.

Upon completion of construction in the second quarter of 2025, the Company recorded total assets of approximately $ 47.4 million within the Finance lease ROU asset, which were purchased by the Company but are considered to be owned by the landlord.

The current finance lease liability is included in other accrued costs and current liabilities in the Condensed Consolidated Balance Sheet as of September 30, 2025 .

There were no changes to the terms of the leases recognized under ASC 842 during the three and nine months ended September 30, 2025 or 2024.

Operating lease costs, excluding variable lease costs, were $ 1.9 million and $ 5.7 million for the three and nine months ended September 30, 2025, respectively, and $ 1.9 million and $ 5.8 million for the three and nine months ended September 30, 2024, respectively.

Variable lease costs related to the operating lease were $ 1.5 million and $ 4.1 million for the three and nine months ended September 30, 2025, respectively, and $ 1.6 million and $ 3.9 million for the three and nine months ended September 30, 2024, respectively.

Finance lease costs representing amortization of ROU assets and interest on lease liability were $ 0.9 million and $ 0.2 million, respectively, for the three months ended September 30, 2025, and $ 2.7 million and $ 0.5 million, respectively, for the nine months ended September 30, 2025.

Finance lease costs representing amortization of ROU assets and interest on lease liability were $ 0.4 million and $ 0.1 million, respectively, for both the three and nine months ended September 30, 2024.

The following tables contain a summary of other information pertaining to the Company’s leases for the periods presented (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

Operating cash flows from operating lease $ 2,980 $ 2,885 $ 8,813 $ 8,532

As of June 30,

As of September 30,

Weighted-average remaining lease term (in years):

2 unchanged sentences

Finance lease

13.5 years 14.5 years

Weighted-average discount rate applied (%):

1 unchanged sentence

Finance lease 13.7 % 13.7 %

The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating and finance lease liabilities recorded in the Condensed Consolidated Balance Sheet as of June 30, 2025 (in thousands):

Year Ended December 31:

1 unchanged sentence

Finance Lease

2025 (six months) $ 5,960 $ 1,736

2025 (three months) $ 2,980 $ 195

2026 12,182 794

14 unchanged sentences

Unless earlier terminated, the DMSA will expire when all development and manufacturing services are completed, which is not expected to be before January 2028.

As of June 30, 2025 and December 31, 2024, the Company had total non-cancellable purchase commitments under the DMSA of $ 9.1 million and $ 36.7 million, respectively.

During the three months ended June 30, 2025 and 2024, the Company incurred costs of $ 1.3 million and $ 6.2 million, respectively, and made payments of $ 4.9 million and $ 16.8 million, respectively, for the development and manufacturing services rendered under the DMSA.

During the six months ended June 30, 2025 and 2024, the Company incurred costs of $ 3.9 million and $ 22.6 million, respectively, and made payments of $ 10.9 million and $ 30.3 million, respectively, for the development and manufacturing services rendered under the DMSA.

As of September 30, 2025 and December 31, 2024, the Company had total non-cancellable purchase commitments under the DMSA of $ 7.5 million and $ 36.7 million, respectively.

During the three months ended September 30, 2025 and 2024, the Company incurred costs of $ 0.7 million and $ 6.0 million, respectively, and made payments of $ 1.0 million and $ 1.9 million, respectively, for the development and manufacturing services rendered under the DMSA.

During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $ 4.6 million and $ 28.6 million, respectively, and made payments of $ 11.9 million and $ 32.2 million, respectively, for the development and manufacturing services rendered under the DMSA.

In the normal course of business, the Company enters into other firm purchase commitments primarily related to research and development activities.

The Company had contractual obligations under certain clinical and manufacturing agreements other than the DMSA of $ 57.8 million and $ 24.1 million, as of June 30, 2025 and December 31, 2024, respectively, with certain amounts subject to cost sharing with Takeda.

The Company had contractual obligations under certain clinical and manufacturing agreements other than the DMSA of $ 31.9 million and $ 24.1 million, as of September 30, 2025 and December 31, 2024, respectively, with certain amounts subject to cost sharing with Takeda.

Contingencies

4 unchanged sentences

The Pre-Funded Warrants were classified as a component of permanent equity in the Company’s consolidated balance sheet as they are freestanding financial instruments that are immediately exercisable, do not embody an obligation for the Company to repurchase its shares and permit the holders to receive a fixed number of shares of common stock upon exercise.

All of the Pre-Funded Warrants issued in the private placement were outstanding as of June 30, 2025.

All of the Pre-Funded Warrants issued in the private placement were outstanding as of September 30, 2025.

Stock-Based Awards

1 unchanged sentence

Stock Option Activity

The following table summarizes stock option activity for the six months ended June 30, 2025:

The following table summarizes stock option activity for the nine months ended September 30, 2025:

Number of Options

5 unchanged sentences

( 472,987 ) 26.27

Balance at June 30, 2025 22,599,944 $ 24.97

Vested and expected to vest at June 30, 2025 21,790,073 $ 25.87

Exercisable at June 30, 2025 13,450,734 $ 28.16

( 844,371 ) 0.68

Balance at September 30, 2025 21,442,215 $ 26.37

Vested and expected to vest at September 30, 2025 21,442,215 $ 26.37

Exercisable at September 30, 2025 13,292,134 $ 29.41

The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions:

Six Months Ended June 30,

Nine Months Ended September 30,

Expected term (in years)

6 unchanged sentences

Restricted Stock Activity

The following table summarizes restricted stock unit ("RSU") activity for the six months ended June 30, 2025:

The following table summarizes restricted stock unit ("RSU") activity for the nine months ended September 30, 2025:

Number of RSU shares Weighted-Average Fair Value at Date of Grant per Share

3 unchanged sentences

Forfeited ( 160,762 ) 21.84

Unvested and expected to vest at June 30, 2025 5,127,874 $ 23.24

Unvested and expected to vest at September 30, 2025 5,177,362 $ 21.97

Stock-Based Compensation Expense

The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

7 unchanged sentences

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

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

7 unchanged sentences

Net loss per share $ ( 0.74 ) $ ( 0.63 ) $ ( 2.24 ) $ ( 1.89 )

Potentially dilutive securities, including options issued and outstanding, Employee Stock Purchase Plan (“ESPP”) shares issuable, and restricted shares subject to future vesting that were not included in the diluted per share calculations for the periods presented because they would be anti-dilutive totaled approximately 28.5 million and 23.3 million shares as of June 30, 2025 and 2024, respectively.

Potentially dilutive securities, including options issued and outstanding, Employee Stock Purchase Plan (“ESPP”) shares issuable, and restricted shares subject to future vesting that were not included in the diluted per share calculations for the periods presented because they would be anti-dilutive totaled approximately 27.4 million and 22.7 million shares as of September 30, 2025 and 2024, respectively.

Divestiture of Preclinical Small Molecule Programs

6 unchanged sentences

This divestiture did not meet the criteria for reporting discontinued operations as the sale does not represent a strategic shift in the Company’s business.

The Company recognized a gain on divestiture of approximately $ 14.5 million in the Condensed Consolidated Statements of Operations and Comprehensive Loss during the six months ended June 30, 2024, representing the difference between the fair value of the consideration received and the carrying amount of the Divested Assets.

The Company recognized a gain on divestiture of approximately $ 14.5 million in the Condensed Consolidated Statements of Operations and Comprehensive Loss during the nine months ended September 30, 2024, representing the difference between the fair value of the consideration received and the carrying amount of the Divested Assets.

The Company recorded the investment in the shares of Series A Preferred Stock at $ 15.0 million which represents the fair value of the shares on the date of issuance.

There have been no subsequent observable price changes in orderly transactions for the identical or similar equity securities of Tenvie, and as such, the measurement of this investment remains unchanged, with the $ 15.0 million included within other non-current assets in the Condensed Consolidated Balance Sheets as of both June 30, 2025 and December 31, 2024.

Segment Information

1 unchanged sentence

There have been no material changes to the Company's segment structure, the basis of segmentation, or the measurement basis for segment profit or loss or segment assets, compared to those disclosed in Note 14, "Segment Information", to the consolidated financial statements in the Company's 2024 Annual Report on Form 10-K.

The following table presents selected financial information with respect to the Company’s single operating segment for the three and six months ended June 30, 2025 and 2024 (in thousands):

The following table presents selected financial information with respect to the Company’s single operating segment for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Therapeutics Segment

Three Months Ended June 30, Six Months Ended June 30,

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

2025 2024 2025 2024

15 unchanged sentences

Segment loss before income taxes $ ( 126,902 ) $ ( 107,192 ) $ ( 383,991 ) $ ( 308,020 )

There is no difference between the segment loss before income taxes and total consolidated loss before income taxes for the three and six months ended June 30, 2025 and 2024.

There is no difference between the segment loss before income taxes and total consolidated loss before income taxes for the three and nine months ended September 30, 2025 and 2024.

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