EX-99.1 2 aciu-20240513xex99d1.htm EX-99.1

Exhibit 99.1

Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

As of

March 31, 

December 31, 

    

Note

    

2024

    

2023

Assets

 

  

 

  

 

  

Non-current assets

 

  

 

  

 

  

Property, plant and equipment

 

5

 

3,236

 

3,376

Right-of-use assets

 

6

 

3,341

 

3,508

Intangible asset

 

8

 

50,416

 

50,416

Long-term financial assets

 

6

 

415

 

361

Total non-current assets

 

57,408

 

57,661

Current assets

 

 

Prepaid expenses

 

9

 

3,917

 

6,437

Accrued income

 

3

 

267

 

246

Other current receivables

 

 

868

 

622

Accounts receivable

11

14,800

Short-term financial assets

 

10

 

47,812

 

24,554

Cash and cash equivalents

 

10

 

57,009

 

78,494

Total current assets

 

109,873

 

125,153

Total assets

 

167,281

 

182,814

Shareholders' equity and liabilities

 

 

Shareholders’ equity

 

 

Share capital

 

 

2,093

 

2,089

Share premium

 

 

475,286

 

474,907

Treasury shares

 

12

 

(105)

 

(105)

Currency translation differences

(35)

(51)

Accumulated losses

 

(332,558)

 

(316,197)

Total shareholders’ equity

 

144,681

 

160,643

Non-current liabilities

 

 

Long-term lease liabilities

 

6

 

2,657

 

2,825

Net employee defined benefit liabilities

 

 

5,819

 

5,770

Total non-current liabilities

 

8,476

 

8,595

Current liabilities

 

 

Trade and other payables

 

 

2,837

 

1,679

Accrued expenses

 

7

 

10,541

 

11,087

Deferred income

 

3

 

74

 

138

Short-term lease liabilities

 

6

 

672

 

672

Total current liabilities

 

14,124

 

13,576

Total liabilities

 

22,600

 

22,171

Total shareholders’ equity and liabilities

 

167,281

 

182,814

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).


Condensed Consolidated Statements of Income/(Loss) (Unaudited)

(In CHF thousands, except for per-share data)

For the Three Months

Ended March 31, 

Note

2024

2023

Revenue

    

  

    

  

    

  

Contract revenue

 

3.1

 

 

Total revenue

 

 

 

 

Operating expenses

 

 

Research & development expenses

 

 

(15,165)

 

(13,873)

General & administrative expenses

 

 

(4,971)

 

(4,106)

Other operating income/(expense), net

 

3.2

 

68

 

408

Total operating expenses

 

(20,068)

 

(17,571)

Operating loss

 

(20,068)

 

(17,571)

Financial income

 

 

629

 

209

Financial expense

 

 

(36)

 

(97)

Exchange differences

 

 

1,613

 

(51)

Finance result, net

13

 

2,206

 

61

Loss before tax

 

(17,862)

 

(17,510)

Income tax expense

 

 

 

(3)

Loss for the period

 

(17,862)

 

(17,513)

Loss per share:

4

 

 

Basic and diluted loss per share for the period attributable to equity holders

 

 

(0.18)

 

(0.21)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)

(In CHF thousands)

For the Three Months

ended March 31, 

    

Note

    

2024

    

2023

Loss for the period

 

(17,862)

 

(17,513)

Items that will be reclassified to income or loss in subsequent periods (net of tax):

 

 

Currency translation differences

 

16

 

(8)

Items that will not to be reclassified to income or loss in subsequent periods (net of tax):

 

 

Remeasurement gains on defined-benefit plans (net of tax)

 

 

 

Other comprehensive income/(loss)

 

16

 

(8)

Total comprehensive loss, net of tax

 

(17,846)

 

(17,521)

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

2


Condensed Consolidated Statements of Changes in Equity (Unaudited)

(In CHF thousands)

    

    

    

    

    

    

Currency

    

Share

Share

Treasury

Accumulated

translation

    

Note

    

capital

    

premium

    

shares

    

losses

    

differences

    

Total

Balance as of January 1, 2023

1,797

431,323

(124)

(264,015)

10

168,991

Net loss for the period

(17,513)

(17,513)

Other comprehensive loss

 

 

 

 

 

 

(8)

 

(8)

Total comprehensive loss

 

 

 

 

 

(17,513)

 

(8)

 

(17,521)

 

 

Share-based payments

 

 

 

 

1,472

 

 

1,472

Issuance of shares, net of transaction costs:

 

 

  

 

  

 

  

 

  

 

  

 

  

restricted share awards

 

 

0

 

49

 

 

(49)

 

 

0

exercise of options

 

 

 

(7)

 

 

 

 

(7)

Balance as of March 31, 2023

 

 

1,797

 

431,365

 

(124)

 

(280,105)

 

2

 

152,935

    

    

    

    

    

    

Currency

    

Share

Share

Treasury

Accumulated

translation

    

Note

    

capital

    

premium

    

shares

    

losses

    

differences

    

Total

Balance as of January 1, 2024

 

2,089

 

474,907

 

(105)

 

(316,197)

 

(51)

 

160,643

Net loss for the period

 

 

 

 

(17,862)

 

 

(17,862)

Other comprehensive loss

 

 

 

 

 

 

16

 

16

Total comprehensive loss

 

 

 

 

(17,862)

 

16

 

(17,846)

 

 

Share-based payments

 

 

 

 

1,882

 

 

1,882

Issuance of shares, net of transaction costs:

 

 

 

  

 

 

 

restricted share awards

 

4

 

376

 

0

 

(381)

 

 

(1)

exercise of options

 

0

 

3

 

 

 

 

3

Balance as of March 31, 2024

 

2,093

 

475,286

 

(105)

 

(332,558)

 

(35)

 

144,681

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

3


Condensed Consolidated Statements of Cash Flows (Unaudited)

(In CHF thousands)

For the Three Months

Ended March 31, 

Note

2024

2023

Operating activities

    

  

    

  

    

  

    

Loss for the period

 

(17,862)

 

(17,513)

Adjustments to reconcile net loss for the period to net cash flows:

 

 

Depreciation of property, plant and equipment

 

5

 

389

 

436

 

Depreciation of right-of-use assets

 

6

 

167

 

134

 

Finance (income), net

 

13

 

(2,068)

 

(59)

 

Share-based compensation expense

 

 

1,882

 

1,472

 

Change in net employee defined benefit liability

 

 

49

 

132

 

Interest expense

 

13

 

35

 

97

 

Changes in working capital:

 

  

 

  

(Increase)/decrease in prepaid expenses

 

9

 

2,520

 

(737)

 

(Increase)/decrease in accrued income

 

3

 

(21)

 

190

 

(Increase)/decrease in accounts receivable

11

14,800

(Increase)/decrease in other current receivables

 

 

(255)

 

(206)

 

(Decrease)/increase in accrued expenses

 

7

 

(24)

 

(751)

 

(Decrease)/increase in deferred income

 

3

 

(64)

 

(172)

 

(Decrease)/increase in trade and other payables

 

 

1,156

 

208

 

Cash provided by/(used in) operating activities

 

704

 

(16,769)

Interest received

 

 

357

 

67

 

Interest paid

 

 

(32)

 

(97)

 

Finance expenses paid

 

 

(5)

 

(2)

 

Net cash flows provided by/(used in) operating activities

 

1,024

 

(16,801)

 

  

 

  

Investing activities

 

  

 

  

Short-term financial assets, net

 

10

 

(23,258)

 

43,000

 

Purchases of property, plant and equipment

 

5

 

(249)

 

(200)

 

Rental deposits

6

(54)

Net cash flows provided by/(used in) investing activities

 

(23,561)

 

42,800

 

  

 

  

Financing activities

 

  

 

  

Proceeds from issuance of common shares – equity plan, net of transaction costs

 

 

2

 

(6)

 

Transaction costs and stamp duty associated with the public offerings of common shares previously recorded in Accrued expenses

(521)

Transaction costs associated with the sale of treasury shares in public offering previously recorded in Accrued expenses

(2)

Principal payments of lease obligations

 

6

 

(167)

 

(135)

 

Net cash flows (used in) financing activities

 

(688)

 

(141)

 

  

 

  

Net increase/(decrease) in cash and cash equivalents

 

(23,225)

 

25,858

Cash and cash equivalents at January 1

 

78,494

 

31,586

Exchange gain/(loss) on cash and cash equivalents

 

1,740

 

(10)

Cash and cash equivalents at March 31

 

57,009

 

57,434

Net increase/(decrease) in cash and cash equivalents

 

(23,225)

 

25,858

Supplemental non-cash activity

 

  

 

  

Transaction costs associated with the sale of treasury shares in public offering recorded in Accrued expenses

 

 

25

 

 

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

4


Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(In CHF thousands, except share and per share amounts)

1.Corporate information

AC Immune SA was founded in 2003. The Company controls a fully-owned subsidiary, AC Immune USA, Inc. (“AC Immune USA” or “Subsidiary” and, together with AC Immune SA, “AC Immune,” “ACIU,” “Company,” “we,” “our,” “ours,” “us”), which was organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group.

AC Immune SA is a clinical-stage biopharmaceutical company leveraging our two proprietary technology platforms to discover, design and develop novel proprietary medicines and diagnostics for prevention and treatment of neurodegenerative diseases (NDD) associated with protein misfolding. Misfolded proteins are generally recognized as the leading cause of NDD, such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), with common mechanisms and drug targets, such as amyloid beta (Abeta), Tau, alpha-synuclein (a-syn) and TDP-43. Our corporate strategy is founded upon a three-pillar approach that targets (i) AD, (ii) focused non-AD NDD including Parkinson’s disease, ALS and NeuroOrphan indications and (iii) diagnostics. We use our two unique proprietary platform technologies, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to discover, design and develop novel medicines and diagnostics to target misfolded proteins.

The Interim Condensed Consolidated Financial Statements of AC Immune SA as of and for the three months ended March 31, 2024 were authorized for issuance by the Company’s Audit and Finance Committee on May 12, 2024.

2.Basis of preparation and changes to the Company’s accounting policies

Statement of compliance

These Interim Condensed Consolidated Financial Statements as of March 31, 2024 and for the three months ended March 31, 2024 and 2023, have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB), and such financial information should be read in conjunction with the audited consolidated financial statements in AC Immune’s Annual Report on Form 20-F for the year ended December 31, 2023.

Basis of measurement

These Interim Condensed Consolidated Financial Statements have been prepared under the historical cost convention.

Functional and reporting currency

These Interim Condensed Consolidated Financial Statements and accompanying notes are presented in Swiss Francs (CHF), which is AC Immune SA’s functional currency and the Group’s reporting currency. The Company’s subsidiary has a functional currency of the U.S. Dollar (USD). The following exchange rates have been used for the translation of the financial statements of AC Immune USA:

    

For the

Three Months Ended March 31, 

Year Ended December 31,

2024

    

2023

2023

CHF/USD

 

  

 

  

 

  

Closing rate, USD 1

 

0.914

 

0.923

 

0.851

Weighted-average exchange rate, USD 1

 

0.883

 

0.935

 

0.908

5


Critical judgments and accounting estimates

The preparation of the Company’s Interim Condensed Consolidated Financial Statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions that affect the amounts reported in the Interim Condensed Consolidated Financial Statements and accompanying notes, and the related application of accounting policies as it relates to the reported amounts of assets, liabilities, income and expenses.

The areas where AC Immune has had to make judgments, estimates and assumptions relate to (i) revenue recognition on Licensing and Collaboration Agreements (LCAs), (ii) clinical development accruals, (iii) net employee defined benefit liability, (iv) share-based compensation, (v) right-of-use assets and lease liabilities and (vi) our IPR&D asset (intangible asset). Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

Fair value of financial assets and liabilities

The Company’s financial assets and liabilities are composed of receivables, short-term financial assets, cash and cash equivalents, trade payables and lease liabilities. The fair value of these financial instruments approximates their respective carrying values due to the short-term maturity of these instruments, and are held at their amortized cost in accordance with IFRS 9, unless otherwise explicitly noted.

Accounting policies, new standards, interpretations and amendments adopted by the Company

The accounting policies adopted in the preparation of the Interim Condensed Consolidated Financial Statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2023.

There are no new IFRS standards, amendments or interpretations that are mandatory as of January 1, 2024 that are relevant to the Company. Additionally, in April 2024, the IASB issued IFRS 18 Presentation and Disclosure in Financial Statements (IFRS 18). The new standard on presentation and disclosure in the financial statements will change the structure of the statement of profit or loss, require disclosures for certain profit or loss performance measure that are reported outside of the financial statements, and will enhance principles on aggregation and disaggregation within the notes to the financial statements. This new standard will be effective for annual reporting periods beginning on January 1, 2027 and will require retroactive adoption. The Company is currently evaluating the new standard to determine if it will have a material impact on the Company’s financial statements.

Going concern

The Company believes that it will be able to meet all of its obligations as they fall due for at least 12 months from the filing date of this Form 6-K, after considering the Company’s cash position of CHF 57.0 million and short-term financial assets of CHF 47.8 million as of March 31, 2024. Hence, these unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going-concern basis.

To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from its LCAs and grants. The Company is a clinical stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company’s business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed and our ability to raise additional capital as needed. These risks may require us to take certain measures such as delaying, reducing or eliminating certain programs. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the pharmaceutical and biopharmaceutical industries, (iii) successfully move its product candidates through clinical development, (iv) attract and retain key personnel and (v) acquire capital to support its operations.

6


3.Contract revenue and other operating income

For the three months ended March 31, 2024 and 2023, AC Immune generated no contract revenues.

3.1Licensing and collaboration agreements

For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2023, please refer to Note 14.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.

On January 22, 2024, the Company announced that it will regain all global rights to the anti-amyloid beta antibody crenezumab and the anti-Tau antibody semorinemab following termination of the collaboration agreements with Genentech, a member of the Roche Group, and Roche, which termination was effective in April 2024.

3.2Grant income

Grants from the Michael J. Fox Foundation

For a discussion of our Grants from the Michael J. Fox Foundation (MJFF) for the fiscal year ended December 31, 2023, please refer to Note 14.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.

For the three months ended March 31, 2024 and 2023, the Company has recognized less than CHF 0.1 million and CHF 0.4 million in grant income, respectively. As of March 31, 2024, the balance in deferred income is nil.

4.Loss per share

    

For the Three Months

Ended March 31, 

In CHF thousands except for share and per share data

    

2024

    

2023

Loss per share (EPS)

 

  

 

  

Numerator

 

  

 

  

Net loss attributable to equity holders of the Company

 

(17,862)

 

(17,513)

Denominator

 

  

 

  

Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders

 

99,385,471

 

83,625,826

Basic and diluted loss per share for the period attributable to equity holders

 

(0.18)

 

(0.21)

The weighted-average number of potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:

    

For the Three Months

Ended March 31, 

    

2024

    

2023

Share options issued and outstanding (in-the-money)

 

1,979,372

 

97,875

Restricted share awards subject to future vesting

 

1,737,742

 

1,236,774

7


5.Property, plant and equipment

The following table shows the movement in the net book values of property, plant and equipment for the three months ended March 31, 2024:

    

As of March 31, 2024

    

IT

    

Lab

    

Leasehold

    

Assets under

    

In CHF thousands

Furniture

equipment

equipment

improvements

construction

Total

Acquisition cost:

 

  

 

  

 

  

 

  

 

  

 

  

Balance at December 31, 2023

 

309

 

2,168

 

10,233

 

1,662

 

 

14,372

Additions

 

 

42

 

167

 

40

 

 

249

Balance at March 31, 2024

 

309

 

2,210

 

10,400

 

1,702

 

 

14,621

Accumulated depreciation:

 

 

 

 

 

 

Balance at December 31, 2023

 

(212)

 

(1,851)

 

(8,101)

 

(832)

 

 

(10,996)

Depreciation expense

 

(12)

 

(55)

 

(255)

 

(67)

 

 

(389)

Balance at March 31, 2024

 

(224)

 

(1,906)

 

(8,356)

 

(899)

 

 

(11,385)

Carrying amount:

 

 

  

 

  

 

  

 

  

 

  

December 31, 2023

 

97

 

317

 

2,132

 

830

 

 

3,376

March 31, 2024

 

85

 

304

 

2,044

 

803

 

 

3,236

AC Immune continues to enhance its laboratory equipment to support its R&D functions. This effort has continued since the year ended December 31, 2023, with CHF 0.2 million invested in lab equipment, representing an increase of 1.6% from the beginning of the year in this category.

6.Right-of-use assets, long-term financial assets and lease liabilities

AC Immune recognized no additions for its right-of-use of leased assets for the three months ended March 31, 2024.

Regarding lease liabilities, the amortization depends on the rate implicit in the contract or the incremental borrowing rate for the respective lease component. The weighted averages of the incremental borrowing rates are 3.5% for buildings, 5.3% for office equipment and 2.6% for IT equipment, respectively.

The following table shows the movements in the net book values of right-of-use of leased assets for the three months ended March 31, 2024:

    

    

Office

    

IT

    

In CHF thousands

Buildings

equipment

equipment

Total

Balance as of December 31, 2023

 

3,446

 

50

 

12

 

3,508

Depreciation

 

(157)

 

(6)

 

(4)

 

(167)

Balance as of March 31, 2024

 

3,289

 

44

 

8

 

3,341

There are no variable lease payments that are not included in the measurement of lease obligations. All extension options have been included in the measurement of lease obligations.

8


For the three months ended March 31, 2024, and 2023, the impact on the Company’s condensed consolidated statements of income/(loss) and the condensed consolidated statements of cash flows is as follows:

For the Three Months

Ended March 31, 

In CHF thousands

    

2024

    

2023

Statements of income/(loss)

 

  

 

  

Depreciation of right-of-use assets

 

167

 

134

Interest expense on lease liabilities

 

30

 

24

Expense for short-term leases and leases of low value

 

193

 

298

Total

 

390

 

456

Statements of cash flows

 

 

  

Total cash outflow for leases

 

391

 

458

The following table presents the contractual undiscounted cash flows for lease obligations as of March 31, 2024:

As of

In CHF thousands

    

March 31, 2024

Less than one year

 

778

1-3 years

 

1,522

3-5 years

 

1,317

Total

 

3,617

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of both March 31, 2024 and December 31, 2023, respectively. These deposits are presented in Long-term financial assets on the Company’s condensed consolidated balance sheets.

7.Accrued expenses

    

As of

In CHF thousands

March 31, 2024

December 31, 2023

Accrued expenses

 

10,541

 

11,087

Total accrued expenses

 

10,541

 

11,087

Accrued expenses consists of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF 10.5 million and CHF 11.1 million as of March 31, 2024 and December 31, 2023, respectively.

8.Intangible assets

AC Immune’s acquired IPR&D asset is a clinically-validated active vaccine candidate for the treatment of Parkinson’s disease. The asset is not yet ready for use until the asset obtains market approval and is therefore not currently being amortized. The carrying amount and net book value are detailed below:

    

As of March 31, 2024

As of December 31, 2023

    

Gross

    

    

    

Gross

    

    

carrying

Accumulated

Net book

carrying

Accumulated

Net book

In CHF thousands

amount

amortization

value

amount

amortization

value

Acquired IPR&D asset

50,416

 

 

50,416

 

50,416

 

 

50,416

Total intangible assets

50,416

 

 

50,416

 

50,416

 

 

50,416

In accordance with IAS 36 Impairment of Assets, the IPR&D asset is reviewed at least annually for impairment by assessing the fair value less costs to sell (recoverable amount) and comparing this to the carrying value of the asset. The valuation is considered to be Level 3 in the fair value hierarchy in accordance with IFRS 13 Fair Value Measurement due to unobservable inputs used in the valuation. The Company has determined the IPR&D asset not to be impaired as of

9


December 31, 2023. As of March 31, 2024, the Company did not identify any triggering events that could result in an impairment of the IPR&D asset.

9.Prepaid expenses

Prepaid expenses include prepaid R&D costs, administrative costs, and employee social obligations totaling CHF 3.9 million and CHF 6.4 million as of March 31, 2024 and December 31, 2023, respectively.

10.Cash and cash equivalents and short-term financial assets

The following table summarizes AC Immune’s cash and cash equivalents and short-term financial assets as of March 31, 2024 and December 31, 2023:

    

As of

In CHF thousands

March 31, 2024

    

December 31, 2023

Cash and cash equivalents

 

57,009

 

78,494

Total cash and cash equivalents

 

57,009

 

78,494

    

As of

In CHF thousands

March 31, 2024

    

December 31, 2023

Short-term financial assets due in one year or less

 

47,812

 

24,554

Total short-term financial assets

 

47,812

 

24,554

For the three months ended March 31, 2024, the net investments associated with the short-term financial assets amounted to CHF 23.3 million, compared to net proceeds associated with the maturity of investments of CHF 43.0 million in the prior comparable period.

11.Accounts receivable

As of March 31, 2024, the balance of accounts receivable is nil following the receipt of the CHF 14.8 million milestone payment from Janssen, which was due as of December 31, 2023 under our collaboration and license agreement for achieving the targeted launch of the Phase 2b clinical study.

12.Treasury shares

For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2023, please refer to Note 12 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.

As of March 31, 2024 and December 31, 2023, the Company had 5,236,012 and 5,243,958 treasury shares remaining, respectively.

13.Finance result, net

For the three months ended March 31, 2024 and 2023, AC Immune recorded CHF 2.2 million and CHF 0.1 million in net financial gains, respectively. The increase is primarily related to favorable foreign currency exchange differences related to movement in the CHF versus foreign currencies, predominantly the US Dollar, and the transition from negative to positive interest rates for our interest-bearing deposit accounts.

14.Subsequent events

Management has evaluated subsequent events after the balance sheet date, through the issuance of these Interim Condensed Consolidated Financial Statements, for appropriate accounting and disclosures.

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On May 11, 2024, the Company entered into a Worldwide Exclusive Option and License Agreement for its Anti-Amyloid Beta Active Immunotherapy, ACI-24.060 for Alzheimer’s Disease with Takeda Pharmaceuticals USA, Inc. (Takeda). Under the terms of the agreement, the Company will receive an upfront payment of USD 100 (CHF 91) million from Takeda and be eligible to receive payments of up to approximately USD 2.1 (CHF 1.9) billion including an Option exercise fee in the low-to-mid hundred million USD and potential development, commercial and sales-based milestone payments. The Company is also eligible to receive tiered mid-to-high teens percentages royalties on worldwide net sales. The Company will be responsible for completing the Phase 1b/2 ABATE trial. Takeda will have an undisclosed defined period of time to exercise its option after receiving predefined clinical data on the first three AD patient cohorts from the ABATE study. Following option exercise, Takeda will conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.

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